Educación del paciente en el tratamiento de la cardiopatía coronaria
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias de los estudios en curso
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Study design: Single centre RCT When randomised: After hospital discharge | |
| Participants | Inclusion criteria: Patients were eligible if they were aged > 18 years, had documented CHD, and were able to provide informed consent. | |
| Interventions | Description of intervention: The text message‐based prevention programme involved delivery of regular semi‐personalised text messages providing advice, motivation, and information that aimed to improve diet, increase physical activity, and encourage smoking cessation (if relevant). Content for each participant was selected using a prespecified algorithm dependent on key baseline characteristics. Each message was sent on 4 of 5 randomly selected weekdays and arrived at random times of the day during working hours. The general module of messages included information generally provided by secondary prevention programs, e.g. on chest pain action plans, guidelines and risk factor targets, and medications and adherence. Components: Education Delivered by: Text messages (A bank of messages was developed with input from investigators, clinicians, academics, and patients) Setting (home/centre): Home Teaching modalities: Individual Involvement of family: No Time of start after event: After discharge Dose: Length of session: NR Frequency/number of sessions: 4 messages per week Total duration: 24 weeks. Follow‐up further re‐inforcement: NR Theoretical basis for intervention: NR Co‐interventions: Both groups received 3 study management text messages providing allocation assignment, study contact details, and a reminder before the follow‐up appointment Comparator: Control participants received usual care, which generally included community follow‐up with most referred to inpatient cardiac rehabilitation, as determined by their usual physicians. Co‐interventions: Both groups received 3 study management text messages providing allocation assignment, study contact details, and a reminder before the follow‐up appointment | |
| Outcomes | Total mortality Withdrawals | |
| Source of funding | National Heart Foundation of Australia Grant‐in‐Aid and a BUPA Foundation Grant | |
| Conflicts of interest | All authors completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. No conflicts were reported | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation occurred via a computerised randomisation program accessed through a secure web interface |
| Allocation concealment (selection bias) | Low risk | Randomisation occurred via a computerised randomisation program accessed through a secure web interface |
| Blinding of outcome assessment (detection bias) | Low risk | “…minimizing unblinding at follow‐up by sending a message to participants asking them not to disclose their group allocation” |
| Incomplete outcome data (attrition bias) | Low risk | Intervention: 33/352 (9.4%) lost to follow‐up Control: 25/358 (7.0%) lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported |
| Were groups balanced at baseline? | Low risk | “Baseline characteristics were similar between the groups (Table 1)” |
| Intention to treat analysis | Low risk | “...and all intervention evaluations were performed on the principle of intention to treat.” |
| Did both groups receive comparable care? | Low risk | Co‐interventions were the same in both groups |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (4 sites) When randomised: NR | |
| Participants | Inclusion criteria: Aged > 60 years; diagnosed cardiac disease (arrhythmia, angina, MI, valvular disease); treated daily by at least one heart medication; seen by a physician at least once every six months. N randomised: total: 636; intervention: NR; comparator: NR Post MI: 45% Angina: 57% Post CABG: 32% Post PCI: 25% These groups were not mutually exclusive. Age: mean (range): total: 69.6 years (60 to 93 years); intervention: NR; comparator: NR | |
| Interventions | Description of intervention: The "Take PRIDE" programme introduces participants to a process for identifying and resolving problems they encounter in managing their heart disease. Participants are asked to follow the following steps: Problem selecting, Researching one's daily routine, Identifying a behavioural goal, Developing a plan to reach one's goal, and Establishing a reward for making progress. Basing decisions on the medical regimens recommended by their physicians, participants select a heart disease management problem to resolve using the PRIDE steps. The common target across subjects is the PRIDE problem‐solving process. The intervention aims to enable participants to apply this process to whichever management problem they confront. Components: Education Delivered by: Health educator Setting (home/centre): Centre Teaching modalities: Videotape, guidebook, interactive group teaching Involvement of family: NR Time of start after event: Six months to 20 years after initial diagnosis Dose: Length of session: 2 hours Frequency/number of sessions: 4 Total duration: 4 weeks Follow‐up further re‐inforcement: NR Theoretical basis for intervention: Based on social cognitive theory, particularly the principles of self‐regulation (Bandura 1986; Clark and Zimmerman 1990), problem identification, researching one's routine, Identifying a management goal, developing a plan to reach it, expressing one's reactions and establishing rewards for making progress Co‐interventions: NR Comparator: Usual care consisted of: "Seeing their physicians at the intervals specified by the particular physician and receiving any information or communications that would be provided as part of routine care in that setting". Co‐interventions: NR | |
| Outcomes | HRQoL ‐ Sickness Impact Profile Withdrawal from intervention and control group | |
| Source of funding | NR | |
| Conflicts of interest | NR | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Use of random number table" |
| Allocation concealment (selection bias) | Low risk | "As the numbers were generated, each was placed in a sealed envelope. They were stored in a locked drawer in my office. As participants completed their baseline interview I was given their names and opened the next envelope in the numerical sequence." Dodge JA (email communication) |
| Blinding of outcome assessment (detection bias) | Low risk | "Data collectors and data analysts were blinded. The health educators who delivered the intervention obviously knew who had been randomised to the intervention, but had no involvement with the collection of quantitative evaluation data at baseline or follow‐up." Dodge JA (email communication) |
| Incomplete outcome data (attrition bias) | Unclear risk | 455/636 had complete data at 18/12. "No appreciable difference in dropout rates between the intervention and control groups were found." Similarity of demographic details of those loss to follow up not discussed |
| Selective reporting (reporting bias) | Low risk | All outcomes listed in the methods are reported in the results |
| Were groups balanced at baseline? | Low risk | "There were no baseline differences between the experimental and control groups". |
| Intention to treat analysis | High risk | "Data analyses reported...participants who attended at least one of the four sessions." |
| Did both groups receive comparable care? | Low risk | Other than the stated intervention both groups appeared to have been treated similarly |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (6 sites) When randomised: At consent. Median of 13 years since initial cardiac diagnosis (range 6 months to 20 years) | |
| Participants | Inclusion criteria: > 60 years; female; cardiac disease treated daily with at least one medication; cardiac disease can be arrhythmia, angina, MI or valvular disease N randomised: total: 570; intervention: 309; comparator: 261 Post MI: 39% Angina: 45% Post CABG: 26% Post PCI: 29% These groups are not mutually exclusive. Age: mean (range): total: 71.9 years (range 60 to 93 years); intervention: NR; comparator: NR | |
| Interventions | Description of intervention: The goal was to enhance overall management of the heart condition by helping older women to be more self‐regulating. Adapted from "Take PRIDE" (Clark, Janz, Becker, et al, 1992; Clark et al,1997), participants selected an area of management that was problematic (e.g. exercise, medicine taking, diet). The program recommended a comprehensive approach to managing the heart condition, i.e. using medicines, following dietary recommendations, and exercising. Participants were provided information and assistance to be more self‐evaluating and active; e.g. each used a pedometer to log physical activity. During the intervening days, women used a workbook at home as a guide to carrying out the PRIDE steps Components: Education Delivered by: Trained health educators and peer leaders (selected graduates from the program that received extra training) Setting (home/centre): Centre (and home on intervening days) Teaching modalities: Class room group sessions (groups of 6 to 8 women). Workbook for use at home on the intervening days. Handouts summarising classroom sessions, daily self‐monitoring logs. Weekly telephone call during program period Involvement of family: NR Time of start after event: NR Dose: Length of session: 2 to 2.5 hours Frequency/number of sessions: weekly (4) Total duration: 4 weeks Follow‐up further re‐inforcement: A letter 3 months after program and a telephone call 6 months after Theoretical basis for intervention: Yes ‐ PRIDE: Problem identification, Researching one's routine, Identifying a management goal, Developing a plan to reach it, Expressing one's reactions and Establishing rewards for making progress. Co‐interventions: NR Comparator: “Usual care”: Control group members saw their physicians at the intervals specified by the particular physician and received any information or communications that would be provided as part of routine care in that setting | |
| Outcomes | Total mortality HRQoL ‐ Sickness Impact Profile Adverse events (Withdrawal from intervention group) Hospitalisations (numbers of admissions, inpatient days, hospital inpatient charges) (Wheeler 2003) Cost‐effectiveness (Wheeler 2003) | |
| Source of funding | National Heart, Lung, and Blood Institute | |
| Conflicts of interest | NR | |
| Notes | The following paper produced from the results of the same trial were used to inform the data collected: Wheeler 2003 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...women were assigned, by use of random number tables" (Clark 2000) |
| Allocation concealment (selection bias) | Unclear risk | NR |
| Blinding of outcome assessment (detection bias) | Low risk | "Interviewers were blind to women's participation in the program" (Clark 2000) |
| Incomplete outcome data (attrition bias) | Low risk | Table detailing withdrawals |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods reported in results |
| Were groups balanced at baseline? | High risk | Demographically similar but statistically significant differences in baseline disease symptoms and weight. |
| Intention to treat analysis | Low risk | Data was analysed in two different phases, one "an analysis of all women randomised" the other "all program women who attended one or more program sessions" (Clark 2000) |
| Did both groups receive comparable care? | Low risk | "In an effort to assure similar care to both the program and the control groups, no feedback about individual participants was provided to medical or nursing staff. The clinical staff had no knowledge of which patients had agreed to participate in research" (Clark 2000) |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT ‐ 3 groups When randomised: After collecting baseline data | |
| Participants | Inclusion criteria: Aged > 60 years; diagnosed cardiac condition (arrhythmia, angina, MI, congestive heart failure, valvular disease); treated by daily heart medication; seen by a physician in the last year; living within 1 hour drive of the study site N randomised: total: 575; intervention: Self Directed: 201; Group Format:190; comparator: 184 Post MI: 42% Angina: 38% Post CABG: NR Post PCI: NR These groups are not mutually exclusive. Age: mean (range): total: 72.8 years (60 to 90 years); Group: 73.1 years (61 to 87 years); Self‐directed: 72.7 years (61 to 88 years);comparator: 72.5 years (60 to 90 years) | |
| Interventions | Description of intervention: Comparison of a "Take PRIDE" ‐ based intervention, delivered in (i) self‐directed and (ii) group formats.The content of and the materials used with the two formats were the same. Both formats consisted of six units. Both groups received weekly telephone calls from a heath educator during the study period. The self directed group also had an instructional video tape that gave examples of group discussions. The content (instructor's manual,videotape, workbook and logs) was tailored to the unique roles, responsibilities and settings in which older women manage their heart disease. In the self‐directed format, women engage in the same self regulatory process at home in their own timeframe, while the group format women meet for 2–2 1/2 hours on a weekly basis. In the self‐directed version, motivation and support that are part of the social environment in the group format are provided via an instructional videotape that presents examples of group discussions. Weekly telephone calls from a health educator or a peer leader are also provided. Components: Education Delivered by: Trained health educators and peer leaders Setting (home/centre): Single orientation session at centre then home Teaching modalities: Groups of 6 to 8 women Involvement of family: NR Time of start after event: NR Dose: Length of session: 2 to 2.5 hours Frequency/number of sessions: 6 weekly sessions Total duration: 6 weeks Follow‐up further re‐inforcement: Participants in both formats received a monthly newsletter for three months following completion of their program. At six months, the group format women wee invited to attend a reunion and the self‐directed participants received an in‐depth motivational telephone call from the health educator Theoretical basis for intervention: Yes, described in separate paper Co‐interventions: NR Comparator: Usual care: "see their physician on the routine schedule and receive any information that would normally be provided as part of regular care in the practice." Co‐interventions: NR | |
| Outcomes | Total mortality HRQoL ‐ Sickness Impact Profile (SIP) Withdrawal from treatment | |
| Source of funding | Heart Division of the National Heart, Lung, and Blood Institute | |
| Conflicts of interest | NR | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...complied using...book of random numbers." |
| Allocation concealment (selection bias) | Low risk | "Sealed opaque and sequentially numbered envelopes." |
| Blinding of outcome assessment (detection bias) | Low risk | "Those assessing outcomes were blinded to the group allocation unless the participant happened to reference program participation during the follow‐up telephone interviews or at the physical assessment visit." Correspondence with author, J Dodge |
| Incomplete outcome data (attrition bias) | Low risk | Clear description of withdrawals from trial given |
| Selective reporting (reporting bias) | Low risk | Sickness Impact Profile numerical scores were not individually reported as no significant difference was found. These were subsequently made available through correspondence with author, J Dodge |
| Were groups balanced at baseline? | Low risk | "no significant differences among study conditions..." (Table 1) |
| Intention to treat analysis | Low risk | "Analyses were carried out using the women as they were randomised to each of the three study conditions" |
| Did both groups receive comparable care? | Low risk | "In an effort to ensure similar care to all participants, no feedback about individual study participants was provided to health care personnel at the study sites." |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (6 sites) When randomised: During their hospitalisation | |
| Participants | Inclusion criteria: At least 18 years of age, were hospitalised in a cardiac intensive care unit for an ACS (unstable angina, ST‐segment elevation MI, or non–ST‐segment elevation MI), and had at least 1 of the following education modifiable risk factors: current smoking (for ≥ 12 months), sedentary lifestyle (< 3 hours of physical activity per week), or overweight or obesity (body mass index ≥ 25 for overweight or ≥ 30 for obesity, calculated as weight in kilograms divided by height in meters squared). Patients also had to be willing and able to attend regular visits at an outpatient program. Exclusion criteria: NR Diagnosis (% of pts): ST elevation MI: intervention: 48.8%; comparator: 47.0% Non‐ST‐elevation MI: intervention: 35.2%; comparator: 32.9% Unstable angina: intervention:16.0%; comparator:20.1% Age (mean ± SD): total: NR; intervention: 58.0 years (± 10.9 years); comparator: 55.7 years (± 10.9 years) | |
| Interventions | Description of intervention: Patients attended the House of Education at least 6 times: within the first month after discharge and then at months 2, 3, 6, 9, and 12. Patients could attend additional consultations at any time up to 12 months after the index event. The content of the consultations was individualised according to a patient’s risk factors. Current smokers attended a consultation with the nurse specialised in the management of smoking cessation. The consultation with the dietician comprised an evaluation of the patient’s diet, followed by an explanation of the general principles for an adequately balanced diet. Components: Education Delivered by: Nurse who was specialised in smoking cessation counselling, and a dietician who had received training in physical activity counselling Setting (home/centre): Centre Teaching modalities: Individual Involvement of family: A consultation with the patient’s partner could be organised to improve the patient’s diet Time of start after event: Within a month after discharge Dose: Length of session: NR Frequency/number of sessions: At least 6 times Total duration: 12 months Follow‐up further re‐inforcement: Information related to the hospitalisation period, the patient’s risk factors, and objectives for risk factor management was recorded via the Internet system. An e‐mail was automatically sent to the staff at the House of Education and to the primary care physicians (general practice and cardiologists). The staff and the primary care physicians could log into the system using a secure access to see all patient information Theoretical basis for intervention: NR Co‐interventions: Information was recorded on the prescription of co‐interventions (e.g. nicotine supplements, hospitalisation in a rehabilitation centre, and others). The administration was left to the discretion of the care provider Comparator: Patients in the control group attended appointments with their primary care physician and primary care cardiologist within 1 month of discharge Co‐interventions: Information was recorded on the prescription of co‐interventions (e.g. nicotine supplements, hospitalisation in a rehabilitation centre, and others). The administration was left to the discretion of the care provider | |
| Outcomes | Total mortality Withdrawals HRQoL | |
| Source of funding | The study was funded by grant 960 110 211 from the Unions Régionales des Caisses d’Assurance Maladie | |
| Conflicts of interest | Dr Cohen has received a research grant for research nurses (RESICARD) and consultant and lecture fees from AstraZeneca, Bayer Pharma, Bohringer‐Ingelheim, Daiichi Sankyo, GlaxoSmithKline, and sanofi‐aventis. Dr Solol has received grants and honorarium from Servier, Roche, Pfizer, Bayer Pharma, Novartis, Alere, Thermofischer, sanofi‐aventis, Ipsen, and Vifor. Dr Montalescot has received research grants to the institution or consultant and lecture fees from Bayer Pharma, Bristol‐Myers Squibb, Boehriinger‐Ingelheim, Duke Institute, Europa, GlaxoSmithKline, Iroko, Lead‐Up, Novartis, Springer, TIMI group, WebMD, Wolters, AstraZeneca, Biotronik, Eli Lilly, The Medicines Company, Medtronic, Menarini, Roche, sanofi‐aventis, Pfizer, Accumetrics, Abbott Vascular, Daiichi Sankyo, Fédération Française de Cardiologie, Fondation de France, INSERM, Institut de France, Nanosphere, Stentys, and Société Française de Cardiologie. Dr Steg has received research grants from New York University School of Medicine, Servier, and sanofi‐aventis. He has served as a speaker or consultant to Ablynx, Amarin, Amgen, Astellas, AstraZeneca, Bayer Pharma, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Daiichi Sankyo, Eisai, GlaxoSmithKline, Eli Lilly, Medtronic, Merck‐Sharpe Dohme, Novartis, Otsuka, Pfizer, Roche, sanofi‐aventis, Servier, The Medicines Company, and Vivus. He has equity ownership in Aterovax. No other disclosures were reported | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “Patients were randomised according to a computer‐generated list with blocks of varying size stratified on centers" |
| Allocation concealment (selection bias) | Low risk | “The list was prepared and maintained by an independent statistician at the clinical trial unit. Allocation was concealed in sequentially numbered, sealed opaque envelopes.” |
| Blinding of outcome assessment (detection bias) | Low risk | “ independent research staff rather than the treating physician performed outcome assessments.” |
| Incomplete outcome data (attrition bias) | Low risk | Intervention: 48/251 (19.1 %) lost to follow‐up Control: 36/251 (14.3 %) lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes described in methods are reported |
| Were groups balanced at baseline? | Low risk | Baseline characteristics for patients in the 2 treatment groups were well balanced (Table 1) |
| Intention to treat analysis | Low risk | “The primary end point was analysed according to the intent‐to‐treat principle.” |
| Did both groups receive comparable care? | Low risk | Co‐interventions received by the two groups were similar (e.g. nicotine supplements, hospitalisation in a rehabilitation centre, and others) |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (18 sites) When randomised: NR | |
| Participants | Inclusion criteria: ≥ 6 month history of angina diagnosed by classical history N randomised: total: 688; intervention: 342; comparator: 346 Previous MI: 45% Age (mean ± SD): total: NR; intervention: 62.7 years (7.1) ; comparator: 63.6 years (6.8) | |
| Interventions | Description of intervention: "Patients in the intervention group were given practical relevant advice regarding cardiovascular risk factors. They were reviewed at four monthly intervals and given appropriate health education (Cupples 1994).” "Visited by a health visitor, whose brief was to discuss ways of living more easily with their disease and ways in which risks of further events might be reduced (O'Neill 1996)." "The education involved giving information which was tailored to the individuals' coronary risk factors and the use of medication (Cupples 1996)” Components: Education Delivered by: Health visitor Setting (home/centre): NR Teaching modalities: Individual one‐to‐one visits Involvement of family: NR Time of start after event: NA Dose: Length of session: NR Frequency/number of sessions: 6 visits (every 4 months for 2 years) Total duration: 2 years Follow‐up further re‐inforcement: Not following 2 year intervention Theoretical basis for intervention: NR Co‐interventions: NR Comparator: Patients in the usual care group received the same screening interview as the intervention group but once randomised to control had no further intervention. Co‐interventions: NR | |
| Outcomes | Total mortality Cardiovascular related mortality Hospitalisations recorded as part of cost analysis (not independently reported) (O'Neill 1996) HRQoL (Nottingham Health Profile Questionnaire) (Cupples 1996) Adverse events (withdrawal from intervention group) Cost Analysis (O'Neill 1996) | |
| Source of funding | The Medical Research Council | |
| Conflicts of interest | NR | |
| Notes | The following papers produced from the results of the same trial were used to inform the data collected: Cupples 1996; Cupples 1999; O'Neill 1996 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "generated by a computer program using permuted blocks (Cupples 1996)." |
| Allocation concealment (selection bias) | Low risk | "The health visitor opened an opaque, sealed, and numbered envelope containing the allocation" (Cupples 1994) |
| Blinding of outcome assessment (detection bias) | Low risk | "After 2 years both groups were reviewed by a research worker who had not previously been involved with the subjects" (Cupples 1994) At five year follow‐up: "nurse (performing interview) was blind to trial group allocation" (Cupples 1999) |
| Incomplete outcome data (attrition bias) | Low risk | Detailed report of withdrawals and losses to follow up reported. Cupples 1994 Yes; Cupples 1996 No; O'Neill 1996 No; Cupples 1999 No |
| Selective reporting (reporting bias) | Low risk | All relevant outcomes listed in methods were reported in methods |
| Were groups balanced at baseline? | Low risk | "No significant differences were found between the two groups at baseline" (Cupples 1994) |
| Intention to treat analysis | Low risk | "We also analysed the data in an intention to treat basis, with baseline or adjusted values being substituted for missing data, but this did not alter the conclusions (Cupples 1999)." |
| Did both groups receive comparable care? | Low risk | Both groups received same usual care and only difference between groups was the educational intervention |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (18 sites) When randomised: Following collection of baseline data | |
| Participants | Inclusion criteria: Diagnosis of ischemic heart disease, confirmed by their physician or hospital medical record, and if they lived independently (i.e. not in an institutional setting) Exclusion criteria: Patients were excluded if they had any of the following: complicating serious co‐morbidity such as a psychiatric illness or untreated malignancy, neurological disorder with impaired cognition, or inability to read or understand English N Randomised: total: 3522; intervention: 1777; comparator: 1745 ACS (100%) Age (mean ± SD): total: 67 ± 11 years; intervention: NR; comparator: NR | |
| Interventions | Description of intervention: Patients received education in three areas: information about ACS, anticipated emotional issues and social factors that could affect delay. Patients were given standardised information about typical and atypical symptoms of ACS and possible variability in symptom presentation. Patients were told that they might experience chest pressure or discomfort that was intermittent rather than constant, and that diaphoresis, shortness of breath, and pain radiation to parts of the body other than the left arm (e.g. neck or back) were also possible symptoms of ACS. They were advised to call emergency medical services immediately. Patients were asked to anticipate the emotional responses to ACS symptoms that might lead to delay, as well as to discuss their previous experiences accessing the medical system. The rewards of seeking treatment immediately were emphasised and emotional issues were addressed through role playing scenarios that were standardised across intervention group patients. The potential reaction of the family member was discussed (e.g. denial, fear, ambivalence, etc.) and the importance of and rewards for quick action were underscored Components: Education and counselling Delivered by: A nurse with expertise in cardiology Setting (home/centre): Home or centre Teaching modalities: Individual Involvement of family: Patients were asked to bring their spouse, another family member or friend to the intervention session whenever possible. These individuals were “deputised” to act as the decision maker if the patient hesitated to call emergency medical services Time of start after event: NR Dose: Length of session: 40 minutes Frequency/number of sessions: 1 Total duration: 55 minutes (40 min plus 15 min follow‐up call) Follow‐up further re‐inforcement: One month following the initial intervention session, the nurse who had provided the intervention called each patient and reviewed the main points from the initial session. The average length of the phone call was 15 minutes Theoretical basis for intervention: Based on Leventhal’s self regulatory model of illness behaviour Co‐interventions: At the time of the development of the educational intervention, patients who had no contraindications were encouraged to take one non‐enteric coated aspirin prior to arrival at the hospital as well as nitroglycerin (if prescribed), and this instruction was included Comparator: Usual care Co‐interventions: NR | |
| Outcomes | Total mortality Hospitalisations Withdrawals | |
| Source of funding | National Institutes of Health, National Institute of Nursing Research | |
| Conflicts of interest | No real or perceived conflicts of interest exist for any of the authors of this manuscript. | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Method of randomisation not described |
| Allocation concealment (selection bias) | High risk | Method of allocation concealment not described |
| Blinding of outcome assessment (detection bias) | Low risk | “Physicians caring for patients and nurses collecting follow‐up data were blinded to study assignment.” |
| Incomplete outcome data (attrition bias) | Low risk | Intervention: 197/1777 (11.1%) lost to follow‐up Control: 238/1745 (13.6%) lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods are described in the results |
| Were groups balanced at baseline? | High risk | “A check on randomisation revealed no significant differences between groups on a variety of demographic and clinical variables except for body mass index (P = 0.048), gender (with more females in the experimental group than control, P = 0.02), and insurance for ambulance use (with more patients with insurance in the control group compared to the experimental group, P = 0.04) (Table 1).” |
| Intention to treat analysis | High risk | ITT analysis is not described and data from patients lost to follow‐up are not included in analyses |
| Did both groups receive comparable care? | High risk | Intervention included counselling |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT When randomised: "When eligible beneficiaries are identified." | |
| Participants | Inclusion criteria: Enrolled in Medicare and receiving Medicard benefits; have congestive cardiac failure, diabetes or CAD N Randomised: total: 46,606; intervention: 33,267; comparator: 13,339 CAD (Not further defined): 69% In combination with heart failure: 10% In combination with diabetes: 19% With all three diagnoses: 12% Age (mean): total: 68.4 years; intervention: 68.4 years; comparator: 68.4 years | |
| Interventions | Description of intervention: "Nurse case managers provided education to patients on the recognition of signs and symptoms of their disease; how to monitor vital signs; the cause of diseases; how to better adhere to diet, exercise, and medication regimes; and strategies to cope with chronic illness. When providing education to patients, nurses use pre‐designed scripts. Geared towards educating patients on how to attain clinical goals." Components: Education Delivered by: Individually assigned nurse care manager Setting (home/centre): Home (telephone) Teaching modalities: "The intervention is primarily telephonic, but also had an in‐person component." Involvement of family: NR Time of start after event: NA Dose: Patients received 1.1 contacts per active month, on average Length of session: NR Frequency/number of sessions: NR Total duration: 18 months Follow‐up further re‐inforcement: Intervention continued until end of follow up period Theoretical basis for intervention: NR Co‐interventions: Patient assessment, care planning, routine nurse monitoring, patient self‐monitoring, care co‐ordination, and service arrangement Comparator: Not described Co‐interventions: NR | |
| Outcomes | Hospitalisations ‐ Emergency and inpatient use HRQoL (survey of selected 613 enrollees only and claims based quality of care measures) Cost analysis | |
| Source of funding | NR | |
| Conflicts of interest | "The authors are with Mathematica Policy Research, Inc. The statements expressed in this article are those of the authors and do not necessarily reflect the views or policies of Mathematica Policy Research, Inc., or the Centers for Medicare & Medicaid Services (CMS)." | |
| Notes | Analysed first and second 6 month periods, first year and 18 months. Population based study that only a relatively small proportion of those assigned to the intervention group actually actively continued to participate in. Therefore treatment effect may be difficult to statistically demonstrate | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | NR |
| Allocation concealment (selection bias) | Unclear risk | NR |
| Blinding of outcome assessment (detection bias) | Unclear risk | NR |
| Incomplete outcome data (attrition bias) | Low risk | Divided patients in to mediated ‐ those that fully engaged with the intervention and instructional ‐ those that were less that fully engaged but did not opt out. Breakdown of mediated patients demonstrated in a table. |
| Selective reporting (reporting bias) | Low risk | Primary outcomes stated in methods were reported in the results. |
| Were groups balanced at baseline? | Low risk | Detailed table (Table 4) of pre‐enrolment characteristics showed no statistically significant differences seen. Authors reported that there was a difference in that the treatment group utilised health services 5% more in 2 year run up period to the trial (not statistically significant) |
| Intention to treat analysis | Low risk | "intention to treat study design." |
| Did both groups receive comparable care? | High risk | Education only part of the intervention: "intervention components include patient assessment, care planning, routine nurse monitoring, patient self‐monitoring, education, care co‐ordination, and service arrangement." Physicians were alerted to "important changes in patients' health." |
| Study characteristics | ||
| Methods | Study design: Single centre RCT When randomised: After collecting baseline data | |
| Participants | Inclusion criteria: Aged 18 years or older, undergoing first PCI and had access to a telephone Diagnosis (% of pts): Age (mean ± SD): total: NR; intervention: 63.3 years (± 12.4); comparator: 60.6 years (± 8.7) | |
| Interventions | Description of intervention: The educational programme consisted of three booklets and three telephone follow‐up calls.The first booklet was discussed with participants before undergoing PCI procedure. The objective was to help the patient to understand his cardiac condition, the PCI procedure and how to cope with CAD in general. The other two booklets focused on self‐care related to the PCI itself and to day‐to‐day management of the disease, which were discussed with participants after PCI, on the day of procedure or on the following day. Three telephone calls were made (in the first, eighth and sixteenth week after hospital discharge), focusing on lifestyle changes. The telephone script contained questions on self‐care including: care of arm and leg used for the PCI procedure, changes in risk factors for CAD and correct use of medication. Each participant was asked whether s/he was successfully executing changes in physical activity, eating and smoking habits and verifying blood pressure. Then the investigator attempted to motivate the participant to make behavioural changes and discussed barriers to changing habits. Components: Education Delivered by: Two researchers Setting (home/centre): Centre Teaching modalities: Individual Involvement of family: NR Time of start after event: Programme commenced prior to PCI procedure Dose: Length of session: NR Frequency/number of sessions: 2 face‐to‐face sessions and 3 telephone calls Total duration: 16 weeks Follow‐up further re‐inforcement: Each participant was instructed to make a telephone call to the investigator for further questions or support for secondary prevention for CAD Theoretical basis for intervention: Based on the construct of self‐efficacy according to Albert Bandura’s Social Cognitive Theory (Bandura 2004) Co‐interventions: NR Comparator: Control group participants received the usual instructions given by healthcare providers at the hospital Co‐interventions: NR | |
| Outcomes | HRQoL Withdrawals | |
| Source of funding | Grants 2010/19761‐3 and 2010/10006‐8, São Paulo Research Foundation (FAPESP) | |
| Conflicts of interest | The authors state that there are no financial and personal relationships with people or organisations that could inappropriately influence this work | |
| Notes | *90 Patients were originally randomised but 24 were excluded after randomisation for the following reasons: further medical assessment indicated need for surgical revascularisation or clinical treatment (N = 20), or participant was enrolled in another educational programme (N = 4) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “A research staff member...generated the random allocation in Graphpad software” |
| Allocation concealment (selection bias) | Low risk | A research staff member…generated the random allocation in Graphpad software…concealing it from the investigators in sequentially numbered, sealed, opaque envelopes.” |
| Blinding of outcome assessment (detection bias) | Low risk | “Therefore, investigators who were un‐blinded to participant allocation helped with the data collection.” |
| Incomplete outcome data (attrition bias) | Low risk | Intervention: 4/34 (11.8%) lost to follow‐up Control: 2/32 (6.3%) lost to follow‐up (90 participants were originally randomised (45 in each group), but 24 participants were excluded immediately after randomisation as they were indicated for surgery or enrolled in another study) |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods are reported |
| Were groups balanced at baseline? | Low risk | “The intervention and control groups did not differ significantly in socio‐demographic and clinical characteristics at baseline (P > 0.12 for all variables).” |
| Intention to treat analysis | High risk | No ITT analysis is described and data from patients lost to follow‐up are not included in the analyses |
| Did both groups receive comparable care? | Low risk | Neither group received any co‐interventions other than medication |
| Study characteristics | ||
| Methods | Study design: Single centre RCT When randomised: After hospitalisation of at least 2 days | |
| Participants | Inclusion criteria: All patients with confirmed AMI and admitted to the hospital. N randomised: total: 288; intervention: 156; comparator: 132 Age (mean ± SD): intervention: 59.5 years (12.9); comparator: 60.9 years (10.8) | |
| Interventions | Description of intervention: "Structured intervention encompassing telephone follow up and an open telephone line" "to provide patients with information, education and support on the basis of individual needs. To provide patients with information about what are common questions after AMI and encourage elaboration on the issues if desired. One issue was addressed in each call." Components: Education and counselling Delivered by: Nurses with interests and experience in counselling and providing information to patients with ischaemic heart disease Setting (home/centre): Home (telephone) Teaching modalities: Telephone follow up Involvement of family: (telephone) "Lines were open to patients and relatives/relations" Time of start after event: On discharge following the event Dose: Length of session: As long as required (mean telephone call 6.88 min (SD 3.89)) Frequency/number of sessions: 8 (weekly first 4 weeks, then weeks 6, 8, 12 and 24). Total duration: 6 months (could stop earlier if requested) but encouraged to have at least the first 5 months intervention Follow‐up further re‐inforcement: None Theoretical basis for intervention: Intervention was developed on the basis of the Lazarus and Folkmans theory on stress, appraisal and copy, principles about patient education, findings from previous research and according to guideline recommendations. Co‐interventions: Counselling Comparator: Managed in accordance with current clinical practice. Included one visit to a physician at the outpatient clinic 6 to 8 weeks after discharge, and subsequent visits to the patient's general practitioner Co‐interventions: NR | |
| Outcomes | HRQoL (SF‐36) Re‐admission to hospital Mortality | |
| Source of funding | Haukeland University Hospital, the Norwegian Nurse Association, the Meltzer Foundation for grants, and the Norwegian Lung and Heart Foundation | |
| Conflicts of interest | "None" | |
| Notes | The following paper produced from the results of the same trial were used to inform the data collected: Hanssen 2009 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A simple randomisation procedure using a computer‐generated list of random numbers" |
| Allocation concealment (selection bias) | Low risk | "...group allocation in sealed opaque envelopes prepared by the researcher." |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not clear if researchers were blinded to group allocations |
| Incomplete outcome data (attrition bias) | Low risk | CONSORT diagram of trial flow reported with details of withdrawals and loss to follow up |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods reported in results. |
| Were groups balanced at baseline? | Low risk | "No statistically differences were found" in baseline characteristics |
| Intention to treat analysis | Low risk | Although intention to treat analysis not explicitly stated, the groups were analysed according to original random allocation |
| Did both groups receive comparable care? | High risk | Intervention included both education and counselling ‐ psychological based intervention. "Providing emotional support and alternative coping strategies" which was not received by control group |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (11 sites) When randomised: Shortly after hospitalisation | |
| Participants | Inclusion criteria: Patients aged 18 to 80 years were eligible if they had been diagnosed with an ACS (STEMI, non‐STEMI or unstable angina pectoris), within 8 weeks prior to entry into the study Exclusion criteria: Visits to the nurse coordinated prevention programmes not feasible; not available for follow‐up; surgery, percutaneous coronary intervention or other interventions expected within 8 weeks after inclusion; limited life expectancy (≤2 years); previously enrolled in the nurse coordinated prevention programme; New York Heart Association class III or class IV heart failure STEMI: intervention: 50%; comparator:48% NSTEMI: intervention: 33%; comparator:33% Unstable angina pectoris: intervention: 17%; comparator: 19% Age (mean ± SD): total: NR; intervention: 57.5 ± 9.9; comparator: 57.8 ± 10.4 | |
| Interventions | Description of intervention: The programme included four outpatient clinic visits to a cardiovascular nurse during the first 6 months: at weeks 2, 7, 12 and 17 after baseline. The nurse‐coordinated prevention programme followed a protocol based on national and international guidelines, focusing on (1) healthy lifestyles, (2) biometric risk factors and (3) medication adherence. During each visit, smoking status, dietary status, level of physical exercise, weight, waist circumference, blood pressure, total cholesterol, high‐density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides, glucose and HbA1c were reviewed. Nurses provided general lifestyle advice, including dietary advice. Nurses provided specific educational material and individual counselling to achieve smoking cessation, adequate physical exercise and healthy weight/fat distribution. There were no visits to the nurse‐coordinated prevention programme between 6 and 12 months Components: Education Delivered by: Registered nurses with a 4‐year bachelor’s degree and experience in the care of cardiac patients. All nurses were given a 3‐day course in motivational interviewing Setting (home/centre): Centre Teaching modalities: NR Involvement of family: NR Time of start after event: 2 weeks Dose: Length of session: NR Frequency/number of sessions: 4 sessions Total duration: 6 months Follow‐up further re‐inforcement: NR Theoretical basis for intervention: NR Co‐interventions: Adherence to prescribed medication was encouraged at each visit, including antithrombotic therapy and a statin. If discontinued, reasons for discontinuation were documented, and if possible the therapy was restarted Comparator: Usual care included outpatient clinic visits to treating cardiologists and other relevant specialists. This included referral to cardiovascular rehabilitation according to the national guidelines on cardiovascular rehabilitation. In short, cardiovascular rehabilitation typically consisted of a 12 week programme of evaluation of physical, psychological and social functioning, of providing education, physical exercise, and interventions to improve physical and social functioning and to improve cardiovascular risk factors and/or risk behaviour. Cardiologists were encouraged, in all patients, to adhere to current national and international guidelines for secondary prevention of cardiovascular disease Co‐interventions: As above | |
| Outcomes | Total mortality Hospitalisations Withdrawals | |
| Source of funding | The study was sponsored by an unrestricted grant from AstraZeneca, The Netherlands. The sponsor had no role in the design, data collection, data analysis, data interpretation and writing of this report | |
| Conflicts of interest | None | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “The online randomisation protocol consisted of a pre‐generated block‐stratified randomisation protocol” |
| Allocation concealment (selection bias) | Low risk | “Study personnel entered patient’s initials, date of birth and gender, and participating individuals were assigned a study identification number along with their allocation to either the intervention group or control group.” |
| Blinding of outcome assessment (detection bias) | Low risk | “The randomly assigned treatment of patients was not disclosed to treating cardiologists or general practitioners.” |
| Incomplete outcome data (attrition bias) | Low risk | Intervention: 23/375 (6.1%) lost to follow‐up Control: 35/379 (9.2%) lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods are reported |
| Were groups balanced at baseline? | Low risk | All characteristics and prognostic factors were similar in both groups at baseline |
| Intention to treat analysis | High risk | ITT analysis is not described, and data from patients lost to follow up are not included in the analyses |
| Did both groups receive comparable care? | Low risk | “Patients were randomised to either the nurse‐coordinated prevention programme in addition to usual care (intervention group) or usual care alone (control group).” |
| Study characteristics | ||
| Methods | Study design: Single centre RCT When randomised: NR | |
| Participants | Inclusion criteria: All elective CABG patients aged 18 to 80 years N randomised: total: 203; intervention: 101; comparator: 102 Previous AMI: intervention: 40%; comparator: 31% Age mean (range): total: 62 years; intervention: 62 years (39 to 77 years); comparator: 62 years (42 to 78 years) | |
| Interventions | Description of intervention: Structured information and psychological support for the topics of angina symptoms, medications, sexuality, anxiety, and depression. Material developed for the study Components: "A psycho‐educative intervention" Delivered by: Masters prepared critical care nurse with 12 years' experience Setting (home/centre): Home Teaching modalities: Home visits Involvement of family: NR Time of start after event: 2 weeks post CABG Dose: Length of session: 1 hour Frequency/number of sessions: 2 Total duration: 4 weeks Follow‐up further re‐inforcement: No Theoretical basis for intervention: NR Co‐interventions: Psychological support Comparator: Patients in the intervention group and the control group received standard discharge care that involved a non‐standardised short talk with the nurse/doctor Co‐interventions: NR | |
| Outcomes | HRQoL ‐ SF36 and Seattle Angina Questoinnaire (SAQ) | |
| Source of funding | NR | |
| Conflicts of interest | NR | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Statistician made the randomisation codes by using a computer program." |
| Allocation concealment (selection bias) | Low risk | "...a secretary created sealed opaque envelopes containing individual codes with sequential numbers." |
| Blinding of outcome assessment (detection bias) | Unclear risk | Blinding not described |
| Incomplete outcome data (attrition bias) | Low risk | Clear table demonstrating patients excluded and the attrition. All accounted for at the end of the trial. Minimal incomplete data from responses in each group in both questionnaires e.g. "number of respondents for each subscale and each measurement point ranged between 74 and 92 for each group" |
| Selective reporting (reporting bias) | Low risk | All stated outcomes SAQ and SF‐36 at 6 months reported |
| Were groups balanced at baseline? | Low risk | Baseline characteristics "did not differ significantly between groups". |
| Intention to treat analysis | Low risk | ITT not explicitly stated. Reported patient flow chart suggests that groups analysed according to original random allocation. |
| Did both groups receive comparable care? | High risk | "Patients in the intervention group and the control group received standard discharge care that involved a non‐standardised short talk with the nurse/doctor." However, the intervention contained psychological support which was not delivered to the control group |
| Study characteristics | ||
| Methods | Study design: Single centre RCT When randomised: NR | |
| Participants | Inclusion criteria: At least one coronary stenosis suitable for PCI and at least one additional clinically insignificant coronary artherosclerotic lesion that could be evaluated by quantitative computerised angiography; employed; able to perform bike test N randomised: total: 87; intervention: 46; comparator: 41 Previous MI: intervention: 43%; comparator: 32% Congestive heart failure: intervention: 9%; comparator: 5% Age (mean ± SD): total: 53 ± 7 years; intervention: 53 ± 7 years; comparator: 53 ± 7 years | |
| Interventions | Description of intervention: Intervention had a duration of 12 months, and started with a 4‐week residential stay at the intervention unit. This first phase consisted of intense health education and behaviour‐change activities, including lectures and discussions, but focusing mainly on practical skills training and habit rehearsal directed toward stress management and diet, exercise, and smoking habits. Much of the education, discussions, and introductory skills training in the different lifestyle areas were performed. The curriculum included regular group‐based practical skills training sessions in all areas; e.g. physical exercise,food preparation, biofeedback, and training in applied relaxation. The participants were also assigned daily “homework,” to be performed individually (or sometimes in groups) between the group sessions. Components: Education and behaviour change Delivered by: Trained nurse ("personal coach") Setting (home/centre): Residential stay in a centre Teaching modalities: A combination of group (5 to 8) and individually oriented intervention formats was used. Involvement of family: NR Time of start after event: NR Dose: Length of session: 4 weeks, then NR Frequency/number of sessions: NR Total duration: 12 months Follow‐up further re‐inforcement: yes for 1 year ("regular follow‐up contacts between the patient and his/her personal coach for verbal feedback, problem‐solving, and replanning discussions when needed (Lisspers 1999)"). Theoretical basis for intervention: No Co‐interventions: Stress management, exercise, smoking habits and dietary advice Comparator: One outpatient visit, then referral to family physician. Co‐interventions: NR | |
| Outcomes | Total mortality Total cardiovascular events, non fatal MI Total revascularisations (both CABG and PCI) Hospitalisations HRQoL: Angina Pectoris Quality of Life Questionnaire (AP‐QLQ) | |
| Source of funding | MF Insurance Co, the SPP Insurance Co, and The Swedish Heart and Lung Foundation | |
| Conflicts of interest | NR | |
| Notes | In direct communication with the author he described the program as a "behaviour change program" primarily and he viewed patient education as "secondary and supportive to behaviour change procedures." The following papers produced from the results of the same trial were used to inform the data collected: Hofman‐Bang 1999; Lisspers 2005 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | NR |
| Allocation concealment (selection bias) | Unclear risk | NR |
| Blinding of outcome assessment (detection bias) | High risk | Not reported in the paper but from direct communication with the author it was confirmed that those analysing the results were not blinded to the group allocation. |
| Incomplete outcome data (attrition bias) | Low risk | "Two patients in the intervention and four in the control group were excluded soon after randomisation at their own request leaving 87 subjects as the final patient population" (Hofman‐Bang 1999) |
| Selective reporting (reporting bias) | Low risk | All stated rehabilitation and secondary prevention endpoints in methods documented in results |
| Were groups balanced at baseline? | Low risk | Patient characteristics table and statistical comparison included. Apart from beta‐blocker usage, groups not different |
| Intention to treat analysis | Low risk | Intention to treat (ITT) not stated in the test but calculations stated in the results appear to be analysed according to original allocation worked out on an ITT basis |
| Did both groups receive comparable care? | High risk | As well as education: intervention group received stress management, exercise, smoking habits and dietary advice |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (13 sites) When randomised: Immediately after recruitment and anonymous completion of the baseline questionnaire | |
| Participants | Inclusion criteria: Patients with CHD and aged 18 to 89 years. Patients with confirmed coronary heart disease in whom an ergometric assessment had been carried out in the 12 weeks preceding the starting date of the study, and who had achieved a level of at least 2 minutes at 75 watts Diagnosis (% of pts): Age (mean ± SD): total: NR; intervention: 65.7 years; comparator: 65.8 years | |
| Interventions | Description of intervention: The lesson materials consisted of:
The patient brochure was intended for patients’ own independent study and for the purpose of repeating the previous module. Patients were able to enter comments and responses to questions, as in a workbook. Additionally, patients were given an exercise diary to enable them to document their daily physical activity. Components: Education Delivered by: Physicians and medical assistants Setting (home/centre): Centre Teaching modalities: individual Involvement of family: NR Time of start after event: NR Dose: Length of session: NR Frequency/number of sessions: NR Total duration: NR Follow‐up further re‐inforcement: NR Theoretical basis for intervention: NR Co‐interventions: NR Comparator: Patients in the control group continued to receive usual care from their primary care physicians/cardiologists Co‐interventions: NR | |
| Outcomes | HRQoL (MacNew) | |
| Source of funding | NR | |
| Conflicts of interest | "The authors declare that no conflict of interest exists" | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random sequence generation was not described |
| Allocation concealment (selection bias) | Low risk | “The study centre was located at the Bürgerhospital, Frankfurt am Main, and functioned as a central coordinating centre (headed by Ms Kufleitner). She randomised patients dynamically and communicated to the study practices whether a patient had been allocated to the intervention group or the control group” |
| Blinding of outcome assessment (detection bias) | High risk | “The study was designed as a randomised controlled and open intervention study” |
| Incomplete outcome data (attrition bias) | Low risk | Intervention group: 21/202 (3.0%) lost to follow‐up Control group: 19/205 (3.2%) lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods section were reported for all time points |
| Were groups balanced at baseline? | Low risk | Table 1 shows there to be no differences between the groups at baseline |
| Intention to treat analysis | High risk | “The primary end points were evaluated on the basis of an intention‐to‐treat analysis according to the LOCF (last observation carried forward) principle (Table 2).” This explanation is contradictory and implies that an intention‐to‐treat analysis was not actually conducted |
| Did both groups receive comparable care? | Low risk | No co‐interventions are described for either group |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (5 sites) When randomised: Within 2 to 4 days of hospital admission | |
| Participants | Inclusion criteria: 1) provisional ACS diagnosis; 2) clinically stable at time of enrolment; 3) access to a telephone; and 4) ability to read, understand, and communicate in English. In all cases, the diagnosis of ACS was based on the European Society of Cardiology Guidelines (2). The criteria included electrocardiograms, biochemical markers, and a physical examination. N randomised: total: 1944*; intervention: 972; comparator: 972 STEMI: total: 28.2 ; intervention:28.8; comparator: 27.6 NSTEMI: total: 36.3 ; intervention:38.5; comparator: 34.1 Unstable angina: total: 35.5 ; intervention:32.7; comparator: 38.4 Age (mean ± SD): total: 63.19 ± 11.68 years; intervention: 62.55 ± 11.71 years; comparator: 63.83 ± 11.62 years Percentage male: total: 72.1%; intervention: 72.9%;comparator: 71.2% | |
| Interventions | Description of intervention: The intervention was aimed at reducing total pre‐hospital delay time. The education was focused on pre‐hospital delay and included decision delay, physician delay, and transport delay. The research nurses used preprinted flip charts and prescriptive scripts as educational aids. The educational intervention was individualised to the patient’s specific needs and illness experiences, and sought to address the range of potential cognitive and emotional effects that the person with ACS symptoms may have experienced. Positive messages were reinforced and the ways that people tend to respond to symptoms were discussed together with the benefits of prompt reactions to symptoms Components: Education Delivered by: Research nurse Setting (home/centre): Centre Teaching modalities: Indiviudal Involvement of family: It was agreed that a nominated person would act as a confidant In the presence of symptoms and as a decision‐maker, if the patient themselves hesitated to contact the ambulance in the face of unresolved symptoms. If the nominated person was available, s/he was invited to be present during the delivery of the intervention Time of start after event: 2 to 4 days Dose: Length of session: 40 min Frequency/number of sessions: 1 Total duration: 6 months Follow‐up further re‐inforcement: At the end of the intervention, patients completed an action plan, which they were given to take home as a reminder of what to do if symptoms arose. Patients were telephoned 1 month after the intervention was delivered to reinforce the motivation to adhere to the components of the educational intervention. Six months later, those in the intervention group received a letter by post, which again reinforced the educational intervention and included a written reminder about the main intervention messages Theoretical basis for intervention: Leventhal’s Self‐Regulatory Model of Health and Illness Co‐interventions: Usual care – which included patient education Comparator: Usual care was not completely standardised between the research sites, but broadly comprised pre‐discharge patient education with respect to ACS symptoms, medications, modifiable risk factors, and advice about lifestyle adjustments. None of the sites delivered extensive information that focused solely on pre‐hospital delay or the factors that influence it Co‐interventions: NR | |
| Outcomes | Total mortality Withdrawals | |
| Source of funding | This study was funded by the Health Research Board, Ireland | |
| Conflicts of interest | NR | |
| Notes | *2041 initially randomised, but 94 final diagnosis was not ACS and 3 had no baseline data available | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computerised random number generator was used to devise random sequences for the five tertiary hospitals |
| Allocation concealment (selection bias) | Low risk | The study numbers were allocated sequentially and group assignment was concealed until after baseline data were collected |
| Blinding of outcome assessment (detection bias) | High risk | Blinding of outcome assessors is not described |
| Incomplete outcome data (attrition bias) | Low risk | Intervention: 35/972 (3.6%) lost to follow‐up Control: 27/972 (2.8%) lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods are reported |
| Were groups balanced at baseline? | High risk | There were some significant differences between characteristics and prognostic factors of the two groups at baseline e.g. age |
| Intention to treat analysis | Low risk | Although ITT analysis is not described, data from patients lost to follow‐up were included in the analyses |
| Did both groups receive comparable care? | Low risk | Both control and intervention groups received usual in‐hospital care |
| Study characteristics | ||
| Methods | Study design: Single centre RCT When randomised: Before hospital discharge | |
| Participants | Inclusion criteria: Patients aged 18 to 80 years admitted for ACS (with or without ST segment elevation) or for ischemic stroke Ischemic Cardiopathy: intervention: 64.5% ; comparator:66.7% Stroke: intervention: 35.5%; comparator: 33.3% Age (mean ± SD): total: NR; intervention: 64.89 ± 11.53 years; comparator: 65.60 ± 14.3 years | |
| Interventions | Description of intervention: The patients received health education informing them of their disease and the importance of carrying out correct treatment. Subsequently, visits were programmed at 2, 5, 12, 24, and 36 months after the acute episode, with the possibility of more visits if considered appropriate. Patients could consult with other specialists related to their cardiovascular disease. Each visit consisted of a nursing intervention (health education, lifestyle modifications, evaluation of adherence to treatment) and a medical assessment (clinical evaluation and modification of treatment, if appropriate) Components: Education Delivered by: Trained nurse Setting (home/centre): Centre Teaching modalities: Individual Involvement of family: NR Time of start after event: NR Dose: Length of session: NR Frequency/number of sessions: At least 5 sessions Total duration: 3 years Follow‐up further re‐inforcement: NR Theoretical basis for intervention: NR Co‐interventions: NR Comparator: Usual follow‐up in cardiology or neurology and/or primary care consulting offices Co‐interventions: NR | |
| Outcomes | Total mortality Cardiovascular mortality Non‐cardiovascular mortality Total cardiovascular events Fatal and/or non‐fatal MI Other fatal and/or non‐fatal cardiovascular events | |
| Source of funding | NR | |
| Conflicts of interest | “None declared” | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “randomisation by blocks…assigned each patient to either the intervention group or the control group using a computer generated list” |
| Allocation concealment (selection bias) | Low risk | “…using a computer generated list, with a different person in charge of this task than of the previous tasks” |
| Blinding of outcome assessment (detection bias) | Low risk | “The evaluation was carried out by a non‐blinded member of the research team” |
| Incomplete outcome data (attrition bias) | High risk | Intervention: 3/121 (2.5%) lost to follow‐up Control: 5/126 (4.0%) lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes described in methods are reported |
| Were groups balanced at baseline? | Low risk | There were no significant differences between characteristics or prognostic factors |
| Intention to treat analysis | Low risk | “Data analysis was carried out based on intention to treat” |
| Did both groups receive comparable care? | Low risk | Neither group received any co‐interventions |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (4 sites); 3 groups When randomised: 30 to 60 days post MI | |
| Participants | Inclusion criteria: MI < 65 years N randomised: total: 182; intervention: 60; comparator I "Counselling programme": 61; comparator II "Usual care": 61 Age (mean): total: 50.3 years; intervention: 51 years; comparator I: 51 years; comparator II: 49 years | |
| Interventions | Description of intervention: Recommendations were given about control of cardiovascular risk factors and physical standardised exercise. Patients were also seen privately by the cardiologist in charge of the programme for a full medical examination and personal adjustment of the recommendations Components: Education Delivered by: Cardiologist Setting (home/centre): Centre Teaching modalities: One group session, plus individual session with Cardiologist Involvement of family: Spouse/partner encouraged to attend Time of start after event: NR Dose: Length of session: NR Frequency/number of sessions: One Total duration: NR Follow‐up further re‐inforcement: No Theoretical basis for intervention: No Co‐interventions: There was no restriction or recommendation in the three groups for any other concomitant therapies Comparator: Patients randomised to a counselling programme attended a group session with a cardiologist, a psychiatrist, a nutritionist and a physiotherapist whenever possible. Patients in the usual care group were just referred to their usual private practitioner and/or cardiologist. Co‐interventions: There was no restriction or recommendation in the three groups for any other concomitant therapies | |
| Outcomes | Mortality Cardiovascular events | |
| Source of funding | Institut National de la Santé et de la Recherche Médicale, by the Hospices Civils de Lyon and by the Association pour la Promotion et la Réalisation d'Essais Thérapeutiques | |
| Conflicts of interest | NR | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | NR |
| Allocation concealment (selection bias) | Unclear risk | NR |
| Blinding of outcome assessment (detection bias) | Unclear risk | NR |
| Incomplete outcome data (attrition bias) | Low risk | Reasons for exclusions pre‐randomisation given. "Exclusion of women and men above the age of 65 alone contributed to almost 60% of all reasons for non‐eligibility...the reasons for non‐inclusion in the other patients were either inability to perform the exercise test or major ECG abnormalities." "No patient was lost to follow‐up" but number actually completing interventions not reported. Results for all those randomised, reported for non‐fatal events and mortality outcomes |
| Selective reporting (reporting bias) | Low risk | All outcomes listed in methods reported in results |
| Were groups balanced at baseline? | Low risk | "No statistically significant differences were observed among the treatment groups for any of the tested variable" |
| Intention to treat analysis | Low risk | "The analysis followed the intention‐to‐treat principle; patients were counted in the groups in which they were allocated" |
| Did both groups receive comparable care? | Low risk | Intervention and control group received identical care other than the intervention stated |
| Study characteristics | ||
| Methods | Study design: Single centre RCT When randomised: After baseline measures | |
| Participants | Inclusion criteria: (i) Patients from 18 to 70 years of age with first hospitalisation diagnosed with either angina pectoris or MI and who had scheduled PCI; (ii) Willing to participate in this study; and (ii) Able to speak, read and write Korean. N randomised: total: 63; intervention: 31; comparator: 32 Angina:intervention: 20.0 comparator: 3228.6 Myocardial:intervention: infarction 80.0 comparator: 3271.4 Age (mean ± SD): total: NR; intervention: 57.89 ± 7.96 years; comparator: 58.27 ± 8.56years | |
| Interventions | Description of intervention: The 12‐week psycho‐educational intervention consisted of individual face‐to‐face education using a tailored resource package and telephone ‐delivered health coaching. It began with a risk factor assessment, focusing on lifestyle changes related to the risk factors and some biological risk indicators for CAD and was performed using individual face‐to‐face education. Next, the patients made guided choices about which risk factors they wanted to lower and participated in goal setting informed by current national targets for the chosen risk factors. They selected the management options they would use to lower the risks and were provided with a tailored resource package that was developed in consultation with clinical experts. In addition, patients in the intervention group received up to six telephone delivered health coaching (every other week) throughout the 12‐week period. This biweekly telephone delivered health coaching helped patients to develop management plans that included giving advice and information for specific concerns or problems, reinforced education, and for counselling/support. Components: Education Delivered by: NR Setting (home/centre): Centre then home (telephone call) Teaching modalities: Individual Involvement of family: NR Time of start after event: NR Dose: Initial face‐to face meeting plus telephone‐delivered health coaching: Length of session: 10 to 40 minutes Frequency/number of sessions: Every other week (6 sessions) Total duration: 12 weeks Follow‐up further re‐inforcement: NR Theoretical basis for intervention: NR Co‐interventions: NR Comparator: Standard care from the medical team. Patients were provided with a short booklet on general guidelines related to CAD and were instructed to contact their medical team to continue with follow‐up care Co‐interventions: NR | |
| Outcomes | Total cardiovascular events Withdrawals | |
| Source of funding | Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology | |
| Conflicts of interest | NR | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “Random assignment was based on the last digit of the patient’s identification number, with even numbers assigned to the intervention group and odd numbers assigned to the control group.” |
| Allocation concealment (selection bias) | High risk | Allocation concealment not described |
| Blinding of outcome assessment (detection bias) | High risk | Blinding of outcome assessors is not described |
| Incomplete outcome data (attrition bias) | Low risk | Intervention: 3/31 (9.7%) lost to follow‐up Control: 2/32 (6.3%) lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods are reported |
| Were groups balanced at baseline? | Low risk | “There were no significant differences in the sociodemographic and disease/treatment‐related characteristics between the two groups.” |
| Intention to treat analysis | High risk | ITT analysis is not described and data from patients lost to follow‐up were not included in the analyses |
| Did both groups receive comparable care? | High risk | Intervention includes psychological support and counselling |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (15 sites) When randomised: NR | |
| Participants | Inclusion and exclusion criteria: "Each program was allowed to define within broad boundaries its own target population and exclusion criteria, and designed its intervention accordingly." 10/15 sites required a hospital admission within the previous year, 4/15 sites excluded < 65 years old and 14/15 excluded "terminal illness and conditions that affected their ability to learn self management" Recruitment from: Eligible‐fee for service Medicare patients from 15 care co‐ordination programs N randomised: total: 18,402; intervention: 9,427; comparator: 8,975 Congestive heart failure: 48% Age (mean ± SD): total: NR; intervention: NR; comparator: NR | |
| Interventions | Description of intervention: The care coordination interventions of the 15 programs differed widely. All of the programs assigned patients to a care coordinator.Nurses provided patient education and monitoring. All but one of the programs educated patients to improve adherence to medication, diet, exercise, and self‐care regimens,mostly through the nurses conveying factual information. Seven programs also used behaviour change models such as the transtheoretical approach or techniques such as motivational interviewing. Components: Education and behaviour change Delivered by: Care co‐ordinator. Licensed or registered nurses (4 programs required a BSc level qualification in nursing studies) Setting (home/centre): NR Teaching modalities: All programs contacted patients primarily by telephone; however, 4 programs contacted patients in person nearly once a month as well. Involvement of family: NR Time of start after event: NR Dose: Length of session: NR Frequency/number of sessions: 11 programs: 1 to 2.5 times/month: 3 programs 4 to 8 times/month. Other programs did not record contact frequency Total duration: On average 30 months eligibility (range 18 to 31 months) Follow‐up further re‐inforcement: NR Theoretical basis for intervention: NR Co‐interventions: Seven programs also used behaviour change models such as the transtheoretical approach or techniques such as motivational interviewing Comparator: Not described Co‐interventions: NR | |
| Outcomes | Hospitalisations HRQoL Cost analysis ‐ monthly Medicare expenditure | |
| Source of funding | Centers for Medicare & Medicaid Services. There were no industry sponsors of this study. The writing of the manuscript was funded solely by Mathematica Policy Research Inc | |
| Conflicts of interest | The authors are all salaried employees of Mathematica Policy Research Inc and receive no compensation from any other source. They do not own stock in any of the programs being evaluated or stand to profit in any way, directly or indirectly, from particular findings in this article | |
| Notes | The following paper produced from the results of the same trial were used to inform the data collected: Brown 2008 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly generated concealed 4‐digit "strings" |
| Allocation concealment (selection bias) | Low risk | Randomised assignment was returned via the trial web site |
| Blinding of outcome assessment (detection bias) | High risk | "Because of the nature of the intervention, no individuals were blinded to which group participants were randomised." Peikes 2009 |
| Incomplete outcome data (attrition bias) | Unclear risk | "Observations are weighted by the number of months in the follow‐up period that the same member meets eligibility requirements." Peikes 2009. A full breakdown of periods that patients were eligible is not given |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in the methods are reported in the results |
| Were groups balanced at baseline? | Low risk | "Across all of the 15 programs and the baseline characteristics the treatment and control groups differed significantly on only 11 of the 255 comparisons at the p<0.05 level, less than the expected number of statistical significant differences that would be observed by chance." Peikes 2009 |
| Intention to treat analysis | Low risk | "Effects were calculated using...an intention to treat design." Peikes 2009 |
| Did both groups receive comparable care? | High risk | "7 of the programs used behaviour change models. 14 programs attempted to improve communication between patients and physicians." Peikes 2009 Education was not the only intervention that the treatment groups received |
| Study characteristics | ||
| Methods | Study design: Single centre RCT When randomised: NR | |
| Participants | Inclusion criteria: Diagnosis of CHD, stable angina, age < 65 years N randomised: total: 100; intervention: 50; comparator: 50 Angina: 100% Post MI: intervention: 52%; comparator: 48% Post CABG: intervention: 14%; comparator:8% Post PCI: intervention: 18%; comparator: 14% Age (mean ± SD): total: 59.9 ± 0.4 years; intervention: 59.3 ± 0.69 years; comparator: 60.5 ± 0.48 years | |
| Interventions | Description of intervention: A course at the "Health school for CHD patients"; Structured programme of 6 sessions (90 min each, twice a week), during which 1 or 2 risk factors were discussed. Evaluation of knowledge about the disease and risk factors after the course. Components: Education Delivered by: Outpatient doctors Setting (home/centre): Centre Teaching modalities: Group Involvement of family: NR Time of start after event: NR Dose: Length of session: 90 minutes Frequency/number of sessions: twice a week (6 sessions total) Total duration: 3 weeks Follow‐up further re‐inforcement: NR Theoretical basis for intervention: Organisation of Health Schools for CHD patients in practical health‐care setting. Organisational‐methodical letter. Appendix 2. M 2003 Co‐interventions: NR Comparator: Usual care (for all patients) consisted of three visits during a 12 months follow‐up. First visit ‐ evaluating inclusion criteria, giving informed consent, randomisation, evaluation of knowledge about the disorder and risk factors; clinical examination; blood test for lipids and glucose; psychological survey. Second and third visits ‐ 6 and 12 months after the start of the study; consisted of clinical examination (blood test for lipids and glucose), evaluation of knowledge and psychological survey Co‐interventions: NR | |
| Outcomes | HRQoL: SF36 | |
| Source of funding | NR | |
| Conflicts of interest | NR | |
| Notes | NA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | NR |
| Allocation concealment (selection bias) | Unclear risk | NR |
| Blinding of outcome assessment (detection bias) | Unclear risk | NR |
| Incomplete outcome data (attrition bias) | Unclear risk | Likely, description of the results in text indicates missing data but no breakdown given |
| Selective reporting (reporting bias) | Low risk | All outcomes are accounted for in the results in either table, graphical or text format |
| Were groups balanced at baseline? | Low risk | Groups at baseline were comparable |
| Intention to treat analysis | Unclear risk | NR |
| Did both groups receive comparable care? | Low risk | Control group received standard care only |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT When randomised: NR | |
| Participants | Inclusion criteria: Diagnosis of CHD or CHF or both. Approval of either primary care physician or cardiologist. Need access to the Internet Exclusion criteria: NR N randomised: total: 104; intervention: 53; comparator: 51 CHD, or congestive heart failure or both Breakdown not reported. Age (mean ± SD): total: 61.8 ± 10.6 years; intervention: 62.8 ± 10.6 years; comparator: 62.3 ± 10.6 years | |
| Interventions | Description of intervention: Log in to the site at least once a week for 30 min, communicating with a case manager through a secure form of e‐mail, completing education modules assigned by the case manager, and entering data into progress graphs. Participants had the opportunity to use an on‐line discussion group. There were material incentives for active participation. Also dietary input Components: Education Delivered by: "Case Managers” and dieticians Setting (home/centre): Home Teaching modalities: Interactive, multiple choice, self tests followed by feedback Involvement of family: NR Time of start after event: NA Dose: Length of session: at least 30 min Frequency/number of sessions: one/week Total duration: 6 months Follow‐up further re‐inforcement: No Theoretical basis for intervention: NR Co‐interventions: NR Comparator: Usual care (details not explicitly stated) Co‐interventions: NR | |
| Outcomes | Total cardiovascular Events (fatal/nonfatal MI and other fatal/nonfatal cardiovascular event) Total revascularisations (PCI) Hospitalisations HRQoL ‐ Dartmouth COOP QoL Cost analysis | |
| Source of funding | The Agency for Healthcare Research and Quality | |
| Conflicts of interest | NR | |
| Notes | NB. Included heart failure not just CHD patients; percentage with just heart failure not clear; the breakdown table shows "multiple diagnoses". Included a proportion of patients who had previously received cardiac rehabilitation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomly assigned to SI or UC on the basis of a computer‐generated random number.” ”study population was stratified on the basis of minority status, participation in cardiac rehabilitation, and acute status (time since event)” |
| Allocation concealment (selection bias) | Unclear risk | NR |
| Blinding of outcome assessment (detection bias) | High risk | Case managers collected number of outcomes (height, weight, blood pressure) at follow up and were not blind to intervention or control. |
| Incomplete outcome data (attrition bias) | Low risk | "Of the 104 subjects randomised to the study, 6‐month follow‐up data was obtained on 100. Four subjects were lost to follow up evaluation." Details of withdrawals/loss to follow up reported. |
| Selective reporting (reporting bias) | High risk | Dartmouth COOP QoL taken at entry and exit. Results reported on entry but not at exit |
| Were groups balanced at baseline? | Low risk | Table of demographics and baseline outcome values presented and baseline statistical analysis did not demonstrate any differences |
| Intention to treat analysis | Low risk | Although not explicitly stated, there groups appear to have been analysed according to initial random allocation |
| Did both groups receive comparable care? | Unclear risk | Not clear if intervention group received same usual care as control arm |
| Study characteristics | ||
| Methods | Study design: Multicentre RCT (2 sites) When randomised: NR | |
| Participants | Inclusion criteria: Recent CAD; MI and/or PCI and/or CABG N randomised: total: 207; intervention: 104; comparator: 103 Post MI: 40.5% MI and/or post CABG: 22% MI and/or post PCI: 37% Age (mean ± SD): total: 59 ± 7 years; intervention: 59 ± 7 years; comparator: 59 ± 7 years | |
| Interventions | Description of intervention: The PBL programme was run within CR at the two participating hospitals. The first meeting focused on information about the pedagogic model of learning, the content of the programme, and the role of the tutor. Real‐life situations or scenarios were presented, consisting of pictures, press cuttings, or short texts about exercise, food, drugs, smoking, and cholesterol. They were produced in accordance with the planned curriculum for the programme, which included manifestations of CAD and its symptoms, psychological reactions to the disease, psychosocial factors, stress, smoking, metabolic factors, food and alcohol, physical exercise, sex life, revascularisation procedures, and drug treatment. During the second group meeting, the participants were presented with a scenario chosen to illustrate the whole life situation for patients with CAD. They then decided which particular aspects they would choose to focus on, and a priority list of problem areas was made. A structured problem solving process was used to facilitate the work in tutorial groups and to stimulate self‐directed learning. Every group member was given a diary in which to write down goals for learning and for own lifestyle changes. Components: Education Delivered by: Tutor ‐ member of rehabilitation team, trained to take the role of the facilitator Setting (home/centre): Centre Teaching modalities: Groups of 6 to 8 people Involvement of family: NR Time of start after event: NR Dose: Length of session: 1.5 hours Frequency/number of sessions: 13 group sessions (weekly for the first month, every other week for the next month and the spread over the year) Total duration: 1 year Follow‐up further re‐inforcement: NR Theoretical basis for intervention: Schmidt seven step model of problem solving Co‐interventions: Participants were offered standard treatment by the rehabilitation team, including visits to a nurse and physician. All patients were also offered the possibility of taking part in physical exercise groups, smoking cessation groups, and individual counselling by a dietician Comparator: Standard treatment by the rehabilitation team, including visits to a nurse and physician Co‐interventions: All patients were also offered the possibility of taking part in physical exercise groups, smoking cessation groups and individual counselling by a dietician | |
| Outcomes | HRQoL ‐ Ladder of Life, Self‐Rated Health, SF‐36, Cardiac Health Profile Withdrawal from intervention group | |
| Source of funding | Vardal Foundation, the Swedish Heart‐ and Lung Association and the Swedish Heart‐ and Lung Foundation | |
| Conflicts of interest | NR | |
| Notes | High attendance rate to the educational sessions. Mean 9.4 (median 11) out of 13 sessions | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Not reported in the study itself but from communication with the author it was confirmed that sealed envelopes were randomly organised by a person outside of the research team |
| Allocation concealment (selection bias) | Low risk | Not reported in the study. However, from communication with the author a sealed envelope method was used |
| Blinding of outcome assessment (detection bias) | High risk | Not reported in the study. Confirmed by communication with author |
| Incomplete outcome data (attrition bias) | Low risk | QUORUM trial flow diagram reported with exclusions and attrition documented and reasons given |
| Selective reporting (reporting bias) | Low risk | All stated outcomes in methods are reported in results at pre and post tests. Although the self rated health score was not reported in detail |
| Were groups balanced at baseline? | Low risk | Table of baseline characteristics showed no statistically differences |
| Intention to treat analysis | Low risk | Confirmed by communication with the author. "For all analyses intention to treat was used." |
| Did both groups receive comparable care? | Low risk | "both groups were offered standard treatment by the rehabilitation team..." |
Abbreviations:
ACS: acute coronary syndrome; AMI: acute myocardial infarction; CABG: coronary artery bypass graft; CAD: coronary artery disease; CHD: coronary heart disease; CR: cardiac rehabilitation; HRQoL: health related quality of life; ITT: intention to treat; MI: myocardial infarction; NR: not reported; PCI: percutaneous coronary intervention; pts: participants; RCT: randomised controlled trial; SD: standard deviation; SF‐36: Short Form 36; STEMI: ST segment elevation myocardial infarction; USA: United States of America
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| No outcomes of interest | |
| No outcomes of interest | |
| Identifed from Lie 2009. Review not a RCT | |
| Systematic Review: 21 references identified and reviewed as being of potential interest to this review | |
| Education not primary aim of intervention. (Risk Factor intervention clinic) | |
| Follow‐up less than 6 months | |
| Performance bias, intervention included exercise as well as education. | |
| Education not primary aim of intervention. (Psychological Counselling) | |
| An observational retrospective study | |
| Education not primary aim of intervention | |
| "quasi‐experimental" investigating patient satisfaction with teaching. | |
| Performance bias: education only part of the intervention. | |
| Education not primary aim of intervention: symptom management intervention (pain management / incremental physical exercise.) | |
| Performance bias: education only part of the intervention. | |
| No outcomes of interest | |
| Identified from Clark 2007. Not RCT. | |
| A review of a meta‐analysis Dusseldorp 1999 | |
| Systematic Review: 2 references identified and reviewed as being of potential interest to this review | |
| Identified from Clark 2005. Education not primary aim of intervention (Exercise based intervention). | |
| Not education: exercise intervention. | |
| Not a RCT. | |
| No outcomes of interest | |
| Performance bias, intervention included exercise as well as education. Not a RCT compared with historical controls. | |
| Performance bias, intervention included exercise as well as education. | |
| Education not primary aim of intervention. Psychological ‐ "Rational Emotive behavioural therapy". | |
| Education not primary aim of intervention (nurse intervention clinic). | |
| Education not primary aim of intervention (nurse intervention clinic). | |
| Review of implementation of Acute Coronary Syndrome patient pathway. Not an intervention. | |
| Education not primary aim of intervention | |
| No relevant outcomes ‐ self care questionnaires. | |
| Identified from Eshah 2009. Not RCT: Prospective pre‐test / post‐test design. | |
| Education not primary aim of intervention | |
| No specified follow‐up period. | |
| Follow‐up was "two weeks after discharge. " | |
| Comment paper | |
| Systematic Review: 45 references identified and reviewed as being of potential interest to this review | |
| Systematic Review: 35 references identified and reviewed as being of potential interest to this review | |
| Systematic Review: 3 references identified and reviewed as being of potential interest to this review | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention ‐ multidisciplinary interventional clinic. | |
| Entrance into study after cardiac rehabilitation. | |
| Population doesn't have CHD | |
| Identifed from Hanssen 2007. Review not an RCT | |
| Not an RCT design | |
| Education not primary aim of intervention. Nurse led intervention. | |
| Education not primary aim of intervention ‐ a nurse led intervention clinic. | |
| Education not primary aim of intervention | |
| Comment article | |
| Systematic Review: 12 references identified and reviewed as being of potential interest to this review | |
| Commentary on a meta‐analysis: Dusseldorp 1999 | |
| Comparator group received education | |
| Performance bias: Intervention multifactorial involves exercise and psychological therapy. | |
| Performance bias: Intervention multifactorial involves exercise and psychological therapy. | |
| Performance bias: Intervention multifactorial involves exercise and psychological therapy. | |
| Performance bias: Intervention multifactorial involves exercise and psychological therapy. | |
| Identified from Beranova 2007. Not relevant outcomes. | |
| Systematic Review: 8 references identified and reviewed as being of potential interest to this review | |
| Population doesn't have CHD | |
| A non‐equivalent control group pretest–post‐test design was used. | |
| A non‐equivalent control group pretest–post‐test design was used. | |
| Education not primary aim of intervention‐ Performance bias | |
| No outcomes of interest | |
| Education not primary aim of intervention: Exercise intervention | |
| Intervention cognitive behavioural therapy compared with standard cardiac rehabilitation (including education). | |
| Education not primary aim of intervention: Individualised psychological intervention. | |
| Individualised educational intervention in CABG patients: Study designed to investigate the time of delivery of education ‐ both groups received the same intervention | |
| Systematic Review: 7 references identified and reviewed as being of potential interest to this review | |
| Comparator group received education | |
| Education not primary aim of intervention | |
| Not relevant outcomes (patients recruited between 1977 and 79). | |
| Education not primary aim of intervention | |
| Not education, exercise is the primary focus post CABG. | |
| Commentary: paper excluded education not primary intervention. | |
| Follow‐up period only 3 months post discharge from CABG. | |
| Education not primary aim of intervention | |
| Commentary on meta‐analysis Clark, A.M., et al., Meta‐analysis: Secondary prevention programs for patients with coronary artery. Annals of Internal Medicine, 2005. 143(9): p. 659‐672+I87. | |
| Identified from Clark 2007. Education not primary aim of intervention | |
| ID from 2011 update: No outcomes of interest | |
| Follow up less than 6 months and no outcomes of interest | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention ‐ Performance bias. | |
| Education not primary aim of intervention ‐ Performance bias. | |
| Not RCT "experimental design" | |
| Follow‐up only 5 days after intervention | |
| Editorial referring to Shuldham 2002, Pre‐CABG education. No relevant outcomes investigated. | |
| Follow‐up only 6 weeks | |
| No outcomes of interest | |
| No outcomes of interest | |
| Systematic Review: 0 references identified | |
| Comparator group received education | |
| Identified from Clark 2009. No relevant outcomes. | |
| Identifed from Beranova 2007. Outcomes; Effectiveness of education package in promoting learning only. | |
| Not education, psycho‐social intervention, post MI. | |
| No outcomes of interest | |
| Education not primary aim of intervention. Nurse led clinic. | |
| Education not primary aim of intervention | |
| Identified from Eshah 2009. Education not primary aim of intervention (diet and stress management and social support). | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention | |
| No outcomes of interest | |
| Education not primary aim of intervention: computer support group ‐ comparison of moderated and unmoderated access. | |
| No outcomes of interest | |
| Comparator group received education | |
| Education not primary aim of intervention | |
| Systematic Review: 0 references identified | |
| ID from 2011 update: Follow‐up only 3 months | |
| Education not primary aim of intervention: Psychological intervention ‐ cognitive behavioural therapy. | |
| Education not primary aim of intervention‐Psychological intervention | |
| Education not primary aim of intervention | |
| Quasi‐experimental, sequential cohort design study | |
| No outcomes of interest | |
| Intervention included counseling and no outcomes of interest and | |
| Follow‐up only 3 months and no outcomes of interest | |
| Identified from Fredericks 2009. Education not primary aim of intervention. Symptom management program using audiotapes. | |
| No outcomes of interest | |
| Intervention included counseling and no outcomes of interest and | |
| Duplicate of Dolan 1992; Systematic Review: 0 references identified (all pre1990) | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention: secondary prevention clinic. | |
| Education not primary aim of intervention: secondary prevention clinic. | |
| ID from 2011 update: Education not primary aim of intervention | |
| Education not primary aim of intervention | |
| Follow‐up less than 6 months | |
| Systematic Review: 11 references identified and reviewed as being of potential interest to this review | |
| Identified from Clark 2007. Education not primary aim of intervention (exercise and low fat diet) | |
| Education not primary aim of intervention: psychological intervention | |
| No outcomes of interest | |
| Education not primary aim of intervention: case management ‐ not relevant outcomes (only risk factor modification). | |
| Education not primary aim of intervention; no outcomes of interest (protocol) | |
| Education not primary aim of intervention; no outcomes of interest | |
| No outcomes of interest | |
| Education not primary aim of intervention: psychological intervention. | |
| Education not primary aim of intervention | |
| Identified from Clark 2007. Education not primary aim of intervention | |
| Education not primary aim of intervention: lifestyle regime | |
| Education not primary aim of intervention: nurse managed cholesterol control program. | |
| Education not primary aim of intervention | |
| No relevant outcomes | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention | |
| Non‐standard RCT design with non‐randomised control group. | |
| Not RCT. "True experimental post‐test only, control group design, including the process of randomisation." | |
| Commentary on a Systematic Review, subsequently reviewed and demonstrated: 9 references identified and reviewed as being of potential interest to this review | |
| Education not primary aim of intervention | |
| Follow up less than 6 months | |
| Transcendental Meditation Intervention vs health education (control) | |
| Education not primary aim of intervention | |
| Comparator group received education | |
| No outcomes of interest | |
| Education not primary aim of intervention, combined with psychological counselling and no relevant outcomes. | |
| Follow‐up only 30 days after leaving hospital. | |
| Systematic Review: 0 references identified | |
| pre‐CABG education. No relevant outcomes investigated. | |
| Follow‐up only 100 days. | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention | |
| Identified from Hanssen 2007. Review not an RCT | |
| Identified from Hanssen 2007. Review not an RCT | |
| Education not primary aim of intervention, telephone nurse management. | |
| Cost analysis of Khunti 2007; Education not primary aim of intervention | |
| Follow‐up only 3 months | |
| Not an RCT; follow‐up only 3 months post‐discharge | |
| Education not primary aim of intervention: Program is a risk factor targeted prompting of treatment. | |
| No relevant outcomes. | |
| Not RCT ‐" quasi‐experimental pre‐test / post test control group design." | |
| Follow‐up only 8 weeks | |
| Population doesn't have CHD | |
| Identified from Eshah 2009. Not RCT: Retrospective Study | |
| Dietary intervention, Education not primary aim of intervention. | |
| Education not primary aim of intervention | |
| Education not primary aim of intervention | |
| No outcomes of interest | |
| No outcomes of interest | |
| Systematic Review: 0 references identified. | |
| Listed under "Studies awaiting assessment" in 2011 update: Unable to find full publication | |
| Follow‐up only 3 months and no outcomes of interest | |
| No outcomes of interest | |
| No outcomes of interest | |
| Comparator group received education | |
| No relevant outcomes. | |
| Education not primary aim of intervention‐Performance bias | |
| No outcomes of interest | |
| Comparator group received education | |
| Identified from Neubeck 2009. No relevant outcome measures |
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | Not available |
| Participants | Not available |
| Interventions | Not available |
| Outcomes | Not available |
| Notes | Published in IIOAB but cannot access any of this journal's web pages |
| Methods | RCT |
| Participants | 355 patients (mean age 59 ± 9 years; 258 male) consecutively admitted for control exercise stress test after PCI |
| Interventions | Education on lifestyle modification regarding dietary habits, physical activity, stress management, smoking status, lipid status, fasting blood glucose, blood pressure and adherence to treatment |
| Outcomes | Primary outcome was a change in risk factor management |
| Notes | Unable to find full text or trace authors |
| Methods | RCT |
| Participants | 1850 post MI patients |
| Interventions | MI educational program: Patients participated in a 30 min weekly education session for eight weeks. Follow up telephone calls after another 4 weeks. |
| Outcomes | Smoking cessation; overweight; diet modifications; physical activity |
| Notes | Unable to find full text or trace authors |
| Methods | RCT; 3 groups: usual care (G1, 214 patients); phone follow‐up group (G2, 193 patients), intensive long‐term intervention group (G3, 204 patients). |
| Participants | 611 patients (57 ± 9 year), following an acute coronary event |
| Interventions | The G2 patients were called every month by a nurse to reinforce adherence to medical treatment and physical activity recommended and to check progress regarding lifestyle and other risk factors changes; the G3 patients underwent, every 3 months, 2 hours of a risk factors ‐ education counselling session managed by nurse |
| Outcomes | Total and cardiovascular mortality; MI; hospitalisations; LDL cholesterol; adherence to medical treatment; adherence to physical activity; blood pressure |
| Notes | Unable to find full text or trace authors |
| Methods | Not available |
| Participants | Not available |
| Interventions | Not available |
| Outcomes | Not available |
| Notes | Unable to find full text or abstract, or trace authors |
Characteristics of ongoing studies [ordered by study ID]
| Study name | Investigating whether patients with ACS who receive a secondary‐prevention educational resource have greater attendance at cardiac rehabilitation compared to patients who receive usual inpatient education |
| Methods | RCT |
| Participants | Patients aged over 18 years with a diagnosis of ACS and eligible for cardiac rehabilitation. |
| Interventions | Patients will receive an educational booklet produced by the Heart Foundation Australia. The resource aims to support patients with coronary heart disease to understand and better manage their cardiac condition. |
| Outcomes | Hospital admissions |
| Starting date | May 2013 |
| Contact information | Dr Alison Beauchamp, Faculty of Health Deakin University Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125, Australia, [email protected] |
| Notes |
| Study name | TEXT messages to improve MEDication adherence & Secondary prevention in patients with acute coronary syndrome ‐ TEXTMEDS |
| Methods | Parallel RCT |
| Participants | Acute coronary syndrome, a planned return to the community, ability to provide informed consent, own an operational mobile telephone and sufficient skill in English language to read and send text messages. |
| Interventions | The intervention group will receive secondary prevention support program delivered via mobile phone text message and an opportunity to communicate with a health counsellor over a 12 month period. The messages will provide education, support, motivation and reminders with respect to medications and lifestyle. |
| Outcomes | Major vascular event (cardiovascular death, non‐fatal AMI, stroke or hospital admission with unstable angina or congestive heart failure), coronary revascularisation (coronary artery bypass graft surgery or percutaneous coronary intervention), Death, hospital readmission |
| Starting date | July 2013 |
| Contact information | Assoc Prof Clara Chow, The George Institute for Global Health PO Box M201 Missenden Road NSW 2050, Australia, [email protected] |
| Notes | http://www.anzctr.org.au/ACTRN12613000793718.aspx |
| Study name | SMARTphone‐based, early cardiac REHABilitation in patients with acute coronary syndromes: A Randomised Controlled Trial Protocol (SMART‐REHAB Trial) |
| Methods | RCT |
| Participants | Adults with acute coronary syndromes with documented coronary artery disease |
| Interventions | The smartphone‐based secondary prevention program delivered over 8 weeks starting at time of discharge from hospital through a smartphone application (App). This is a multi‐faceted intervention with particular emphasis on early mobilisation. The app provides a platform to deliver a comprehensive secondary prevention program. |
| Outcomes | Major adverse cardiovascular events (combination of death, mortality, stroke and unplanned revascularisation), HRQoL, hospital readmissions |
| Starting date | 04/04/2016 |
| Contact information | Dr Matias Yudi, Austin Health Cardiology Department 145 Studley Road PO BOX 5555 Heidelberg, VIC 3084, Australia; [email protected] |
| Notes | Multi‐faceted intervention, and not clear if the follow‐up will extend beyond the duration of the 8 week intervention |
| Study name | The Use of Virtual World‐Based Cardiac Rehabilitation to Encourage Healthy Lifestyle Choices Among Cardiac Patients: Intervention Development and Pilot Study Protocol |
| Methods | In Phase 1: Patients will participate in a 12‐week, virtual world health education program which will provide feedback on the feasibility, usability, and design of the intervention. During Phase 2: A 2‐arm, parallel group, single‐centre, randomised controlled trial (RCT). Patients will be randomised at a 1:1 ratio to adjunct virtual world‐based CR with conventional CR or conventional CR only. |
| Participants | Patients recently hospitalised for an ACS (unstable angina, ST‐segment elevation MI, non‐ST‐segment elevation MI) or who recently underwent elective PCI at Mayo Clinic Hospital, Rochester Campus in Rochester, Minnesota with at least one modifiable, lifestyle risk factor target (sedentary lifestyle, unhealthy diet, and current smoking) |
| Interventions | Adjunct virtual world‐based CR with conventional CR or conventional CR only. |
| Outcomes | The primary outcome is a composite including at least one of the following (1) at least 150 minutes of physical activity per week, (2) daily consumption of five or more fruits and vegetables, and (3) smoking cessation. Patients will be assessed at 3, 6, and 12 months. |
| Starting date | NR |
| Contact information | Stephen Kopecky, Mayo Clinic College of Medicine, Department of Medicine, 200 First Street SW, Rochester, MN, 55905, United States, Phone: 1 507 284 9601, Fax: 1 507 266 0228, Email: [email protected]. |
| Notes |
| Study name | Telephone‐based health coaching for chronically ill patients |
| Methods | The study is a prospective randomised controlled trial comparing the effects of telephone‐based health coaching with usual care during a 4‐year time period. Data are collected at baseline and after 12, 24 and 36 months. Patients are selected based on one of the following chronic conditions: diabetes, coronary artery disease, asthma, hypertension, heart failure, COPD, chronic depression or schizophrenia. The statistical analyses includes intention‐to‐treat and as‐treated principles |
| Participants | Approximately 12,000 insurants will be enrolled |
| Interventions | The health coaching intervention is carried out by trained nurses employed by a German statutory health insurance. The frequency and the topics of the health coaching are manual‐based but tailored to the patients' needs and medical condition, following the concepts of motivational interviewing, shared decision‐making and evidence‐based‐medicine |
| Outcomes | Primary outcome is the time until hospital readmission within two years after enrolling in the health coaching, assessed by routine data. Secondary outcomes are patient‐reported outcomes like changes in quality of life, depression and anxiety and clinical values assessed with questionnaires. Additional secondary outcomes are further economic evaluations like health service use as well as costs and hospital readmission rates |
| Starting date | The recruitment will be completed in September 2014 |
| Contact information | Sarah Dwinger. Department of Medical Psychology, University Medical Center Hamburg‐Eppendorf, Martinistr 52, Hamburg 20246, Germany. [email protected] |
| Notes |
| Study name | The effects of application of Prochaska's stages of change model in education of coronary artery bypass grafting patients on quality of life, lipid profile & some psychological complications of CABG |
| Methods | RCT |
| Participants | Patients aged 40 to 75 who have received CABG |
| Interventions | Intervention group receive education based on stages of change model of Prochaska, for 8 weeks, immediately after discharge. Control group received "routine education" |
| Outcomes | Quality of life |
| Starting date | February 2013 |
| Contact information | Dr Marzieh Moattari, Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Islamic Republic of Iran, [email protected] |
| Notes |
| Study name | A randomised controlled trial of the effectiveness of a self‐help psycho‐education programme on outcomes of outpatients with coronary heart disease |
| Methods | Single centre RCT |
| Participants | Patients aged 21 or more with a diagnosis of CHD, lives at home and does not intend to attend hospital‐based rehabilitation programme |
| Interventions | Intervention group will receive a self‐help psycho‐education programme, which includes an education booklet, an accompanying DVD and an education session conducted by a member of the research team. Control group will receive usual care |
| Outcomes | Hospital admissions, HRQoL |
| Starting date | January 2015 |
| Contact information | Wenru Wang, Alice Lee Centre for Nursing Studies Yong Loo Lin School of Medicine National University of Singapore 10, Medical Drive, Block MD11 Clinical Research Centre, Level 2 117597 Singapore [email protected] |
| Notes |
| Study name | COR‐PRIM study NCT01462799 |
| Methods | RCT |
| Participants | 165 patients with CHD |
| Interventions | All patients will receive conventional care from their general practitioner and other care providers. The intervention consists of a patient education program in PHC by trained district nurses (tutors) who will apply PBL to groups of 6‐9 patients meeting on 13 occasions for two hours over one year. Patients in the control group will not attend a PBL group but will receive home‐sent patient information on 11 occasions during the year |
| Outcomes | The primary outcome is empowerment to reach self‐care goals. Data collection will be performed at baseline at hospital and after one, three and five years in PHC using quantitative and qualitative methodologies involving questionnaires, medical assessments, interviews, diaries and observations |
| Starting date | September 2011 |
| Contact information | [email protected]; Department of Social and Welfare studies (HAV), Linköping University, Linköping, Sweden |
| Notes | "The first finding of the COR‐PRIM study will become available in 2014, and the first results of the main study around 2015" |
| Study name | Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention |
| Methods | 2‐group, parallel, superiority, double‐blinded randomised controlled trial |
| Participants | 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery |
| Interventions | Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control) |
| Outcomes | The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision‐making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. |
| Starting date | First received 26 Augst 2015 |
| Contact information | Veronica Lai Ka Wai, [email protected] |
| Notes |
| Study name | LC‐REHAB NCT01668394 |
| Methods | Open parallel randomised controlled trial conducted in three hospital units in Denmark |
| Participants | Patients recently discharged with ischemic heart disease or heart failure |
| Interventions | Patients are allocated to either the intervention group with learning and coping strategies incorporated into standard care in cardiac rehabilitation or the control group who receive the usual cardiac rehabilitation program. Learning and coping consists of two individual clarifying interviews, participation of experienced patients as educators together with health professionals and theory based, situated and inductive teaching. Usual care is characterised by a structured deductive teaching style with use of identical pre‐written slides in all hospital units. In both groups, cardiac rehabilitation consists of training three times a week and education once a week over eight weeks. |
| Outcomes | Adherence to cardiac rehabilitation, morbidity and mortality,quality of life (SF‐12, Health education impact questionnaire and Major Depression Inventory) and lifestyle and risk factors (Body Mass Index, waist circumference, blood pressure, exercise work capacity, lipid profile and DXA‐scan). |
| Starting date | 30th of November 2010 |
| Contact information | [email protected]; Regional Hospital West Jutland, Cardiovascular Research Unit, Herning, Denmark |
| Notes |
| Study name | Feeding Education in Patients Submitted to Coronary Angioplasty (PTCA‐Nutri) |
| Methods | Open label RCT |
| Participants | Patients submitted for PTCA |
| Interventions | The intervention group will receive 4x 1 hour group meetings of food education, including Investigation, Contextualisation, Awareness and Strengthening the nutritional concepts.The control group will have access to the nutritionist |
| Outcomes | Cardiovascular event (new PTCA, CABG, ischemic acute syndrome, MI) and mortality (all causes) at 1 and 3 years |
| Starting date | April 2008 |
| Contact information | Moacyr Roberto Cucê Nobre, Heart Institute, São Paulo University |
| Notes |
| Study name | Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications. Is a Picture Really Worth a Thousand Words? |
| Methods | RCT |
| Participants | Adults undergoing PCI for any clinical indication |
| Interventions | The investigators will show half of the patients their before and after images of their heart arteries where the narrowing occurred and was treated. The other half of the patients will not be shown these images. |
| Outcomes | Occurrence of major adverse cardiovascular events |
| Starting date | December 2010 |
| Contact information | Janet Karol [email protected] |
| Notes |
| Study name | Intensive Education on Lipid Management |
| Methods | RCT |
| Participants | Patients ≥18 years, admitted with a diagnosis of ACS |
| Interventions | Multi‐channel intensive patient education versus usual care |
| Outcomes | Major adverse cardiovascular events at 24 weeks follow up |
| Starting date | August 2013 |
| Contact information | Bingqing Huang huang.bingqing@zs‐hospital.sh.cn |
| Notes |
| Study name | Interactive Education of Patients With Coronary Heart Disease (INSERT) |
| Methods | RCT |
| Participants | Patients ≥18 years with cardiovascular disease |
| Interventions | Using an Audience Response System (ARS) during oral presentations in rehabilitation centers to improve the learning effect of patients. Patients will receive motivating telephone calls in the follow‐up. |
| Outcomes | HRQoL, MI |
| Starting date | May 2014 |
| Contact information | Paracelsus Harz Clinic Bad Suderode, Quedlinburg, Saxony‐Anhalt, Germany, 06485 |
| Notes |
| Study name | Evaluation Program “Coaching patients On Achieving Cardiovascular Health” (COACH) |
| Methods | Single site RCT |
| Participants | Patients with CHD (AMI or chronic/unstable angina), treated with a CABG, PCI or with medication and have finished the hospital's rehabilitation programme |
| Interventions | Trained professionals coach patients achieving targets of the influential risk factors, while focusing on lifestyle factors and drug use. Each session contains education, assertiveness training and goal setting. |
| Outcomes | HRQoL |
| Starting date | June 2010 |
| Contact information | Chantal Leemrijse, Postbus 1568 3500 BN Utrecht The Netherlands, [email protected] |
| Notes | http://www.trialregister.nl/trialreg/admin/rctview.asp?TC = 2388 |
| Study name | SPRITE NCT00901277 |
| Methods | 3‐arm RCT |
| Participants | 450 patients with a recent MI and hypertension |
| Interventions | Telephone‐based, nurse‐administered disease management program. The first arm (N = 150) will receive home blood pressure (BP) monitors plus a nurse‐delivered, telephone‐based tailored patient education intervention and will be enrolled into HealthVault, a Microsoft electronic health record platform. The second arm (N = 150) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault. However, the patient education intervention will be delivered by a Web‐based program and will cover topics identical to those in the nurse‐delivered intervention. Both arms will be compared with a control group receiving standard care (N = 150) |
| Outcomes | BP, LDL cholesterol, body weight, and glycosylated haemoglobin (in diabetic subjects), adherence to evidence‐based therapies and improvement in health behaviours |
| Starting date | NR |
| Contact information | Bimal R. Shah, MD, MBA, Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705; [email protected] |
| Notes |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Total mortality at the end of the follow up period Show forest plot | 13 | 10075 | Risk Ratio (M‐H, Random, 95% CI) | 0.80 [0.60, 1.05] |
| Analysis 1.1  Comparison 1: Education versus no education, Outcome 1: Total mortality at the end of the follow up period | ||||
| 1.1.1 Studies with 12 months or less follow‐up | 6 | 4063 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.35, 1.78] |
| 1.1.2 Studies with more than 12 months follow‐up | 7 | 6012 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.60, 1.02] |
| 1.2 Fatal and/or non‐fatal MI Show forest plot | 2 | 209 | Risk Ratio (M‐H, Random, 95% CI) | 0.63 [0.26, 1.48] |
| Analysis 1.2  Comparison 1: Education versus no education, Outcome 2: Fatal and/or non‐fatal MI | ||||
| 1.3 Other fatal and/or non‐fatal cardiovascular events Show forest plot | 2 | 310 | Risk Ratio (M‐H, Random, 95% CI) | 0.36 [0.23, 0.56] |
| Analysis 1.3  Comparison 1: Education versus no education, Outcome 3: Other fatal and/or non‐fatal cardiovascular events | ||||
| 1.4 Total revascularisations (including CABG and PCI) Show forest plot | 3 | 456 | Risk Ratio (M‐H, Random, 95% CI) | 0.58 [0.19, 1.71] |
| Analysis 1.4  Comparison 1: Education versus no education, Outcome 4: Total revascularisations (including CABG and PCI) | ||||
| 1.5 Hospitalisations Show forest plot | 5 | 14849 | Risk Ratio (M‐H, Random, 95% CI) | 0.93 [0.71, 1.21] |
| Analysis 1.5  Comparison 1: Education versus no education, Outcome 5: Hospitalisations | ||||
| 1.6 Withdrawals Show forest plot | 17 | 10972 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.88, 1.22] |
| Analysis 1.6  Comparison 1: Education versus no education, Outcome 6: Withdrawals | ||||
| 1.6.1 Studies with 12 months or less follow‐up | 10 | 4960 | Risk Ratio (M‐H, Random, 95% CI) | 1.18 [0.93, 1.49] |
| 1.6.2 Studies with more than 12 months follow‐up | 7 | 6012 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.80, 1.20] |
PRISMA flow diagram
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Funnel plot of comparison: 4 Education versus no education, outcome: 4.1 Total mortality at the end of the follow up period.
Funnel plot of comparison: 1 Education versus no education, outcome: 1.6 Withdrawals.
Comparison 1: Education versus no education, Outcome 1: Total mortality at the end of the follow up period
Comparison 1: Education versus no education, Outcome 2: Fatal and/or non‐fatal MI
Comparison 1: Education versus no education, Outcome 3: Other fatal and/or non‐fatal cardiovascular events
Comparison 1: Education versus no education, Outcome 4: Total revascularisations (including CABG and PCI)
Comparison 1: Education versus no education, Outcome 5: Hospitalisations
Comparison 1: Education versus no education, Outcome 6: Withdrawals
| Patient education for the management of coronary heart disease | ||||||
| Patient or population: patients with coronary heart disease | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Control | Patient education | |||||
| Total mortality at the end of the follow‐up period | Study population | RR 0.80 | 10075 | ⊕⊕⊕⊝ | ||
| 46 per 1000 | 37 per 1000 | |||||
| Moderate population | ||||||
| 43 per 1000 | 34 per 1000 | |||||
| Fatal and/or non‐fatal MI at the end of the follow up period | Study population | RR 0.63 | 209 | ⊕⊝⊝⊝ | ||
| 118 per 1000 | 74 per 1000 | |||||
| Moderate population | ||||||
| 106 per 1000 | 67 per 1000 | |||||
| Other fatal and/or non‐fatal cardiovascular events | Study population | RR 0.36 | 310 | ⊕⊕⊝⊝ | ||
| 386 per 1000 | 139 per 1000 (89 to 216) | |||||
| Moderate population | ||||||
| 324 per 1000 | 117 per 1000 | |||||
| Total revascularisations (including CABG and PCI) | Study population | RR 0.58 | 456 | ⊕⊝⊝⊝ | ||
| 35 per 1000 | 20 per 1000 | |||||
| Moderate population | ||||||
| 33 per 1000 | 19 per 1000 | |||||
| Hospitalisations (cardiac‐related)at end of follow up period | Study population | RR 0.93 | 14849 | ⊕⊝⊝⊝ | ||
| 79 per 1000 | 74 per 1000 | |||||
| Moderate population | ||||||
| 141 per 1000 | 131 per 1000 | |||||
| All cause withdrawal at follow‐up | Study population | RR 1.04 | 10972 | ⊕⊕⊝⊝ | ||
| 92 per 1000 | 96 per 1000 | |||||
| Moderate population | ||||||
| 70 per 1000 | 73 per 1000 | |||||
| HRQoL | Not measurable | Not measurable | Not measurable | 4393 | ⊕⊕⊕⊝ | HRQoL in intervention > HRQoL in comparator, in then 9/99 domains |
| ¹ 95% CIs include both no effect and appreciable benefit (i.e. CI < 0.75) | ||||||
| Outcome or subgroup | Studies | Participants | Effect estimate (random‐effect) RR (M‐H, random, 95% CI) | Effect estimate (fixed‐effect) RR (M‐H, fixed, 95% CI) |
|---|---|---|---|---|
| 1.1 Total mortality at the end of the follow up period | 13 | 10,075 | 0.80 [0.60, 1.05] | 0.80 [0.66, 0.97] |
| 1.1.1 Studies with 12 months or less follow‐up | 6 | 4063 | 0.78 [0.35, 1.78] | 0.87 [0.56, 1.36] |
| 1.1.2 Studies with more than 12 months follow‐up | 7 | 6012 | 0.78 [0.60, 1.02] | 0.79 [0.64, 0.97] |
| 2.1 Myocardial Infarction at the end of the follow‐up period | 2 | 209 | 0.63 [0.26, 1.48] | 0.59 [0.25, 1.38] |
| 2.2 Total revascularisations | 3 | 456 | 0.58 [0.19, 1.71] | 0.58 [0.20, 1.69] |
| 2.3 Other fatal and/or non‐fatal cardiovascular events | 2 | 310 | 0.36 [0.23, 0.56] | 0.36 [0.23, 0.56] |
| 3.1 Cardiac hospitalisations at end of follow‐up period | 5 | 14,849 | 0.93 [0.71, 1.21] | 1.02 [0.90, 1.15] |
| 4.1 All cause withdrawal or drop‐out at follow‐up | 17 | 10,972 | 1.04 [0.88, 1.22] | 0.98 [0.88, 1.10] |
| 4.1.1 Studies with 12 months or less follow‐up | 10 | 4960 | 1.18 [0.93, 1.49] | 1.18 [0.94, 1.49] |
| 4.1.2 Studies with more than 12 months follow‐up | 7 | 6012 | 0.98 [0.80, 1.20] | 0.92 [0.81, 1.05] |
| Study ID | Description of Intervention | Theoretical basis | Tailored | Duration | One‐to‐one | Group | Face‐ to‐face | Telephone | Internet | Notes |
|---|---|---|---|---|---|---|---|---|---|---|
| Text message‐based prevention program delivering regular semi‐personalised messages providing advice, motivation, and information to improve diet, increase physical activity, and encourage smoking cessation | NR | Y | 4 messages per week for 24 weeks | Y | N | N | Y (text messages) | N | Content for each participant was selected using a prespecified algorithm dependent on key baseline characteristics | |
| *PRIDE | Y | Y | Once weekly for 4 weeks | Y | Y | Taught by health educator. Videotape and workbook aids | ||||
| *PRIDE | Y | Y | Once weekly for 4 weeks | Y | Y | Taught by health educator. Videotape and workbook aids | ||||
| *PRIDE | Y | Y | Once weekly for 6 weeks | Y | Y | Y | 3 groups (self‐directed and group intervention and a control) | |||
| "House of Education" with individualised consultations with e.g. smoking cessation nurse | NR | Y | At least 6 sessions in 12 months | Y | N | Y | N | N | Consultations content was individualised according to a patient’s risk factors | |
| Practical tailored advice on cardiovascular risk factors and appropriate health education | NR | Y | 3 times a year for 2 years | Y | Y | Delivered at home by health visitor | ||||
| Patients received education on ACS, anticipated emotional issues and social factors that could affect delay | Y | Y | 55 mins (40 min face‐to‐face plus 15 min follow‐up call) | Y | N | Y | N | N | Delivered by a nurse with expertise in cardiology | |
| Predesigned scripts to provide education on various aspects of care, geared to personalised clinical goals | NR | Y | Average 1.1 contacts per month for 18 months | Y | Y | Y | Nurse case manager, primarily by telephone but also face‐to‐face | |||
| Three booklets and three telephone follow‐up calls aimed at helping patient understand his cardiac condition, PCI and how to cope with CAD | Y | N | 2 face to face sessions and 3 telephone calls over 16 weeks | Y | N | Y | Y | N | The first booklet was discussed with participants before undergoing PCI procedure | |
| Individualised education from a menu of topics to be covered | Y | Y | 6 months (8 sessions in total) | Y | Y | Structured element and an on‐call element | ||||
| Outpatient clinic visits to a cardiovascular nurse | NR | Y | 6 months (4 sessions) | NR | NR | Y | N | N | Nurse‐coordinated: provided general lifestyle advice, and individual counselling | |
| A psycho‐educative intervention. Structured information and psychological support | NR | N/S | 2 visits (1 hour each) | Y | Y | Critical care nurse, home based | ||||
| Health education and achievement of behavioural change | NR | Y | 4 week residential then 11 month one‐to‐one individual sessions | Y | Y | Y | Trained nurses (personal coaches). Seminars, lectures, discussion and skills sessions | |||
| Lesson materials consisted of a patient brochure, teaching cards and curriculum poster/wall chart set | NR | N | NR | Y | N | Y | N | N | Patients were given an exercise diary to enable them to document their daily physical activity | |
| Education intervention aimed at reducing total prehospital delay time | Y | Y | 6 months (1 face‐to‐face session, 1 telephone call and one reinforcement letter at 6 months) | Y | N | Y | Y | N | Research nurses used preprinted flip charts and prescriptive scripts as educational aids | |
| Health education on the meaning of patients' disease and the importance of treatment | NR | NR | 3 years (at least 5 sessions) | Y | N | Y | N | N | Each visit consisted of a nursing intervention and a medical assessment | |
| Education and counselling on management of cardiovascular risk factors and exercise | NR | Y | 1 group session, 1 individual session with cardiologist | Y | Y | Y | Multidisciplinary input to group. Cardiologist tailors therapy | |||
| Psycho‐educational intervention comprising tailored face‐to‐face education and telephone‐delivered health coaching | NR | Y | 12 weeks (6 sessions) | Y | N | Y | Y | N | Patients made choices about risk factors they wanted to lower and participated in goal setting | |
| Variable ‐ nurse provision of patient education | NR | NR | 1 to 2.5 times a month for an average of 30 months | Y | Y | 15 different programs, majority telephone, one‐to‐one | ||||
| Structured program addressing different risk factors in each session | Y | NR | 6 sessions (twice weekly, 90 min) | Y | Y | |||||
| Modular internet sessions, Interactive multiple choice and self tests followed by feedback | NR | NR | Once weekly for 6 months (at least 30 min) | Y | Y | Y | Communication with case manager and online discussion group | |||
| Problem based rehabilitation to teach a planned curriculum | Y | NR | 13 sessions over 1 year | Y | Y | Trained facilitator | ||||
| PRIDE = Problem Identification, Researching one's routine, Identifying a management goal, Developing a plan to reach it, Expressing one's reactions and Establishing rewards for making progress. Y = Yes; N = No; NR = not reported | ||||||||||
| Study ID | Number randomised | Number lost at follow‐up* | Notes | |
|---|---|---|---|---|
| Intervention | 352 | 33 | 20 excluded from analysis, 9 unable to contact, 4 died | |
| Control | 358 | 25 | 21 excluded from analysis, 3 unable to contact, 1 died | |
| Intervention | 309 | 51 | 36 withdrew, 14 died, 1 data missing | |
| Control | 262 | 42 | 33 withdrew, 8 died, 1 data missing | |
| Intervention | 201 | 37 | Self‐directed program; 33 withdrew, 4 died | |
| Intervention | 190 | 24 | Group format; 19 withdrew, 5 died | |
| Control | 184 | 23 | 15 withdrew, 8 died | |
| Intervention | 251 | 48 | 6 did not meet inclusion criteria, 7 died, 23 follow‐up refusal, 10 lost to follow‐up, 2 in another protocol | |
| Control | 251 | 36 | 4 did not meet inclusion criteria, 7 died, 13 follow‐up refusal, 12 lost to follow‐up | |
| Intervention | 342 | 92 | 45 defaulted, 47 died; 21 defaulted at 2 years | |
| Control | 346 | 109 | 44 defaulted, 65 died; 25 defaulted at 2 years | |
| Intervention | 1777 | 197 | 89 lost to follow‐up, 41 withdrawn, 67 died | |
| Control | 1745 | 238 | 94 lost to follow‐up, 69 withdrawn, 75 died | |
| Intervention | 34 | 4 | 4 unable to contact by telephone at follow‐up (90 participants were originally randomised (45 in each group), but 24 participants were excluded immediately after randomisation as they were indicated for surgery or enrolled in another study) | |
| Control | 32 | 2 | 2 did not return for 6 month follow‐up | |
| Intervention | 156 | 55 | 40 withdrew, 7 died, 8 missing data | |
| Control | 132 | 38 | 21 withdrew, 7 died, 10 missing data | |
| Intervention | 375 | 23 | 9 did not receive intervention, 3 died, 2 had early discontinuation of intervention, 9 had incomplete data | |
| Control | 379 | 35 | 12 were excluded from the study, 10 died, 1 lost to follow‐up, 7 didn't attend 12 month follow‐up, 5 had incomplete data | |
| Intervention | 101 | 8 | 6 withdrew, 2 medical exclusions | |
| Control | 102 | 10 | 5 withdrew, 5 medical exclusions | |
| Intervention | 202 | 21 | "patients were exclude (for example, because of missed training appointments)" | |
| Control | 205 | 19 | "patients were excluded (for example, because of missed training appointments)" | |
| Intervention | 972 | 35 | 14 withdrew, 21 died | |
| Control | 972 | 27 | 10 withdrew, 17 died | |
| Intervention | 121 | 3 | 3 lost to follow‐up, 0 died | |
| Control | 126 | 5 | 5 lost to follow‐up, 0 died | |
| Intervention | 60 | 0 | Counseling program without exercise | |
| Intervention | 61 | 0 | Comprehensive cardiac rehabilitation | |
| Control | 61 | 0 | Usual care | |
| Intervention | 31 | 3 | 3 withdrew, 0 died | |
| Control | 32 | 2 | 2 withdrew, 0 died | |
| Intervention | 53 | 4 | Reasons for drop‐out stated: relocation, dietary intervention instead, psychiatric diagnosis, loss of interest | |
| Control | 51 | 0 | ||
| Intervention | 104 | 3 | 7 lost to follow‐up: 2 died, 5 did not attend | |
| Control | 103 | 4 | ||
| Combined results | Intervention | 5692 | 641 | 11.3% |
| Control | 5341 | 615 | 11.5% | |
| * All causes of drop out from follow0up included (including mortality) | ||||
| Sickness Impact Profile+++ at 12 months | ||||
|---|---|---|---|---|
| Absolute mean outcome values at follow‐up++ | Comparison | |||
| Education | Comparator | Between group P value | ||
| Clark 1997(12 months) | ||||
| Total score | 7.26 | 8.09 | NS | Education = comparator |
| Psychosocial dimension | 5.52 | 7.05 | ≤ 0.05 | Education > comparator |
| Physical dimension | 5.89 | 6.00 | NS | Education = comparator |
| Sickness Impact Profile+++ at 18 months | ||||
| Absolute mean outcome values at follow‐up++ | Comparison | |||
| Education | Comparator | Between group P value | ||
| Total score | 7.93 | 7.41 | NS | Education = comparator |
| Psychosocial dimension | 6.05 | 6.23 | NS | Education = comparator |
| Physical dimension | 6.40 | 5.25 | NS | Education = comparator |
| ++ for mean scores at follow‐up (adjusted for baseline scores) NS: No significant difference demonstrated | ||||
| Sickness Impact Profile at 12 months | ||||
|---|---|---|---|---|
| Clark 2000(12 months) | Absolute means at follow‐up++ | Comparison | ||
| Education | Comparator | Between group P value | ||
| Psychosocial dimension | 5.15 | 5.91 | 0.144 | Education = comparator |
| Physical dimension | 7.09 | 7.66 | 0.05 | Education > comparator |
| Means were adjusted to take account of baseline values NS: No significant difference demonstrated | ||||
| Sickness Impact Profile at 12 months | |||||
|---|---|---|---|---|---|
| Absolute means (SD) at follow‐up | Comparison | ||||
| Education | Education self directed | Comparator | Between group P value | ||
| Total score | 8.13 (8.63) | 9.79 (10.17) | 9.49 (9.46) | NS | Education = comparator |
| Psychosocial dimension | 5.84 (8.02) | 7.31 (10.74) | 6.75 (9.39) | NS | Education = comparator |
| Physical dimension | 8.07 (9.63) | 9.46 (10.11) | 9.85 (10.79) | NS | Education = comparator |
| Sickness Impact Profile at 18 months | |||||
| Total score | 8.44 (9.13) | 8.98 (10.29) | 9.64 (9.45) | NS | Education = comparator |
| Psychosocial dimension | 5.74 (9.68) | 6.16 (8.20) | 7.17 (10.40) | NS | Education = comparator |
| Physical dimension | 8.27 (10.02) | 8.98 (9.33) | 9.65 (10.19) | NS | Education = comparator |
| Note: analysis of these data was reported, but the individual results were not. These were obtained by contacting the author directly NS: No significant difference demonstrated | |||||
| SF‐12 (Short Form 12 item survey) at 6 months | ||||
|---|---|---|---|---|
| Mean (SD) outcome values at follow‐up | Between group P value | Comparison | ||
| Education | Comparator | |||
| Mental component summary | 47.5 (11.2) | 47.7 (11.2) | 0.43 | Education = comparator |
| Physical component summary | 47.5 (9.3) | 47.3 (9.4) | 0.44 | Education = comparator |
| Negative baseline‐follow‐up difference favours intervention and positive favours control NS: No significant difference demonstrated | ||||
| Nottingham Health Profile+ at 24 months | |||
|---|---|---|---|
| MD (95% CI) between groups in change from baseline at follow‐up | Between group P value | Comparison | |
| Emotional reaction | 0.0 (‐5.2 to 5.2) | NS | Education = comparator |
| Energy | 0.5 (‐7.8 to 8.8) | NS | Education = comparator |
| Physical mobility | ‐0.4 (‐5.2 to 4.5) | NS | Education = comparator |
| Pain | 0.5 (‐4.7 to 5.6) | NS | Education = comparator |
| Sleep | 3.0 (‐4.0 to 9.9) | NS | Education = comparator |
| Social isolation | ‐2.2 (‐6.6 to 2.1) | P < 0.05 | Education > comparator |
| Nottingham Health Profile+ at 60 months | |||
| MD (95% CI) between groups in change from baseline at follow‐up | Between group P value | Comparison | |
| Emotional reaction | ‐2.1 (‐7.5 to 3.3) | NS | Education = comparator |
| Energy | ‐4.7 (‐13.2 to 3.7) | NS | Education = comparator |
| Physical mobility | ‐1.3 (‐6.3 to 3.6) | < 0.05 | Education > comparator |
| Pain | ‐3.4 (‐9.2 to 2.3) | < 0.05 | Education > comparator |
| Sleep | ‐2.4 (‐9.3 to 4.5) | NS | Education = comparator |
| Social isolation | 0.0 (‐4.3 to 4.3) | NS | Education = comparator |
| + Higher scores reflect poorer quality of life NS: No significant difference demonstrated | |||
| Participant' self assessment of quality of life on a five‐point scale at 24 months | ||||||
|---|---|---|---|---|---|---|
| Initial scores | Follow‐up scores | Between group P value | Comparison | |||
| Education | Comparator | Education | Comparator | |||
| P < 0.03 | Education > comparator | |||||
| Poor | 6.3 | 5.3 | 6.9 | 8.3 | ||
| Fair | 27.8 | 23.3 | 18.9 | 21.7 | ||
| Average | 35 | 39 | 33.1 | 33.7 | ||
| Good | 22.7 | 22.7 | 29.3 | 25.3 | ||
| Very good | 8.2 | 9.7 | 11.7 | 11 | ||
| Note: the between group P value represents the overall "comparison of change in individuals' assessment for intervention and control groups" the significant difference being in favour of the intervention group NS: No significant difference demonstrated | ||||||
| SF‐12* (Short Form 12 item survey) at 6 months | ||||
|---|---|---|---|---|
| Mean (SD) outcome values at follow‐up | Between group P value | Comparison | ||
| Education | Comparator | |||
| Mental component summary | 51.7 (9.5) | 48.4 (9.2) | 0.73 | Education = comparator |
| Physical component summary | 43.3 (10.6) | 41.0 (11.0) | 0.28 | Education = comparator |
| SF‐36* (Short Form 36 item survey) | ||||
| Mean (SD) outcome values at follow‐up | Between group P value | Comparison | ||
| Education | Comparator | |||
| Social functioning | 79.2 (25.1) | 64.2 (28.4) | 0.1 | Education = comparator |
| Mental health | 70.9 (22.7) | 70.1 (19.1) | 0.98 | Education = comparator |
| Physical functioning | 72.5 (23.9) | 64.5 (27.8) | 0.2 | Education = comparator |
| General health | 66.1 (19.8) | 63.9 (20.0) | 0.61 | Education = comparator |
| Vitality | 69.7 (20.6) | 62.5 (20.7) | 0.52 | Education = comparator |
| Bodily pain | 63.8 (28.5) | 55.7 (24.2) | 0.22 | Education = comparator |
| Role–emotional | 77.8 (36.4) | 64.4 (36.0) | 0.72 | Education = comparator |
| Role–physical | 52.5 (40.7) | 50.0 (44.0) | 0.96 | Education = comparator |
| *Negative baseline ‐ follow‐up difference favours intervention; positive difference favours control NS: No significant difference demonstrated | ||||
| SF‐36* (Short Form 36 item survey) at 6 months | |||
|---|---|---|---|
| Between group difference in mean change from baseline | Between group P value | Comparison | |
| Overall physical | ‐2.33 (‐4.54 to ‐0.12) | 0.039 | Education = comparator |
| Physical functioning | ‐1.16 (‐3.28 to 0.95) | 0.28 | Education = comparator |
| Role physical | ‐1.84 (‐5.32 to 1.64) | 0.299 | Education = comparator |
| Bodily pain | ‐1.74 (‐4.54 to 1.05) | 0.22 | Education = comparator |
| General health | ‐0.36 (‐2.64 to 1.91) | 0.752 | Education = comparator |
| Overall mental | 1.07 (‐1.71 to 3.86) | 0.447 | Education = comparator |
| Vitality | ‐0.07 (‐2.23 to 2.10) | 0.951 | Education = comparator |
| Social functioning | 0.36 (‐2.96 to 3.67) | 0.832 | Education = comparator |
| Role‐emotional | 0.78 (‐3.29 to to 4.84) | 0.706 | Education = comparator |
| Mental health | 0.4 (‐1.81 to 2.60) | 0.723 | Education = comparator |
| SF‐36* (Short Form 36 item survey) at 18 months | |||
| Between group difference in mean change from baseline | Between group P value | Comparison | |
| Overall physical | ‐1.44 (‐3.89 to 1.02) | 0.25 | Education = comparator |
| Physical functioning | ‐0.79 (‐3.06 to 1.48) | 0.491 | Education = comparator |
| Role physical | ‐0.94 (‐4.76 to 2.88) | 0.627 | Education = comparator |
| Bodily pain | ‐0.77 (‐4.00 to 2.47) | 0.641 | Education = comparator |
| General health | 0.25 (‐2.15 to 2.64) | 0.838 | Education = comparator |
| Overall mental | 1.65 (‐1.35 to 4.65) | 0.28 | Education = comparator |
| Vitality | 0.58 (‐1.95 to 3.12) | 0.65 | Education = comparator |
| Social functioning | 0.55 (‐3.95 to 2.85) | 0.751 | Education = comparator |
| Role‐emotional | 2.59 (‐1.58 to 6.77) | 0.221 | Education = comparator |
| Mental health | 0.31 (‐2.11 to 2.73) | 0.8 | Education = comparator |
| *Negative baseline ‐ follow‐up difference favours intervention; positive difference favours control NS: No significant difference demonstrated | |||
| Seattle Angina Questionnaire at 6 months | |||||
|---|---|---|---|---|---|
| Absolute mean (SD) outcome values at follow‐up | Comparison | ||||
| Education | P value | Comparator | P value | ||
| Physical limitation | 86.4 (15.6) | P < 0.001 | 83.2 (18.7) | P < 0.001 | Education = comparator |
| Angina frequency | 91.7 (16.6) | P < 0.001 | 90.8 (18.9) | P < 0.001 | Education = comparator |
| Treatment satisfaction | 89.2 (15.4) | NS | 88.0 (16.1) | NS | Education = comparator |
| Disease perception | 77.8 (20.2) | P < 0.001 | 73.9 (24.2) | P < 0.001 | Education = comparator |
| SF‐36 (Short Form 36 item survey) at 6 months | |||||
| Absolute mean (SD) outcome values at follow‐up | Comparison | ||||
| Education | P value | Comparator | P value | ||
| Overall physical | 47.4 (9.6) | P < 0.001 | 47 (10) | P < 0.001 | Education = comparator |
| Physical functioning | 82.2 (19.2) | P < 0.001 | 82.3 (19.8) | P < 0.001 | Education = comparator |
| Role physical | 64 (41.2) | P < 0.001 | 57.2 (43.3) | P < 0.001 | Education = comparator |
| Bodily pain | 77.2 (22.3) | P < 0.001 | 78.5 (25.2) | P < 0.001 | Education = comparator |
| General health | 69.9 (23.3) | NS | 65.7 (27.2) | NS | Education = comparator |
| Overall mental | 52.1 (10.7) | P < 0.05 | 50.5 (10.8) | NS | Favours education |
| Vitality | 61.9 (23.9) | P < 0.001 | 60.5 (21.6) | P < 0.001 | Education = comparator |
| Social functioning | 86.3 (21.4) | P < 0.001 | 84.3 (21.9) | P < 0.001 | Education = comparator |
| Role‐ emotional | 73.3 (38.2) | P < 0.01 | 67.4 (41.6) | P < 0.01 | Education = comparator |
| Mental health | 81.9 (17.3) | P < 0.001 | 78.5 (21) | P < 0.01 | Education = comparator |
| Higher scores indicate better HRQoL NS: No significant difference demonstrated | |||||
| Angina Pectoris ‐ Quality of Life Questionnaire (AP‐QLQ) at 24 months | ||||
|---|---|---|---|---|
| Mean (SD) score at follow‐up | Between group P value | Comparison | ||
| Education | Comparator | |||
| QLQ (total) | 4.7 (0.8) | 4.3 (1.0) | NS | Education = comparator |
| Somatic symptoms | 4.8 (1.0) | 4.3 (1.1) | NS | Education = comparator |
| Physical activity | 4.8 (1.0) | 4.1 (1.2) | NS | Education = comparator |
| Emotional distress | 4.8 (0.8) | 4.6 (1.1) | NS | Education = comparator |
| Life satisfaction | 4.2 (1.0) | 3.9 (1.2) | NS | Education = comparator |
| Figures quoted represent absolute scores on a self‐rating scale NS: No significant difference demonstrated | ||||
| MacNew Heart Disease Quality of Life Questionnaire (MacNew) at 220 days | ||||
|---|---|---|---|---|
| Mean (SD) outcome values at follow‐up | Between group P value | Comparison | ||
| Education | Comparator | |||
| Rank sum | 5.75 (0.87) | 5.74 (0.83) | 0.056 | Education = comparator |
| NS: No significant difference demonstrated | ||||
| Seattle Angina Questionnaire‐Korean (SAQ‐K) at 6 months | ||||
|---|---|---|---|---|
| Mean (SD) outcome values at follow‐up | Between group P value | Comparison | ||
| Education | Comparator | |||
| Physical symptoms | ||||
| Physical limitation | 90.77 (9.97) | 85.74 (15.37) | 0.901 | Education = comparator |
| Angina stability | 78.57 (20.09) | 64.17 (23.38) | 0.037 | Education > comparator |
| Angina frequency | 94.29 (7.90) | 89.33 (14.84) | 0.543 | Education = comparator |
| Treatment satisfaction | 86.38 (12.15) | 73.13 (16.09) | 0.021 | Education > comparator |
| Diseases perception | 74.40 (16.03) | 52.78 (15.98) | 0.005 | Education > comparator |
| Higher scores indicate better HRQoL NS: No significant difference demonstrated | ||||
| SF‐36 (Short Form 36 item survey) at 12 months | |||
|---|---|---|---|
| Mean change from baseline P value | Comparison | ||
| Education | Comparator | ||
| Overall physical | P > 0.05 | P ≤ 0.05 | Favours education |
| Physical functioning | P > 0.05 | P ≤ 0.05 | Favours education |
| Bodily pain | P > 0.05 | P ≤ 0.05 | Favours education |
| Overall mental | P > 0.05 | P ≤ 0.05 | Favours education |
| Vitality | P > 0.05 | P ≤ 0.05 | Favours education |
| Social functioning | P > 0.05 | P ≤ 0.05 | Favours education |
| Mental health | P > 0.05 | P ≤ 0.05 | Favours education |
| There were no significant changes demonstrated in the control group but no statistical comparison of the mean change between groups was reported NS: No significant difference demonstrated | |||
| SF‐36* (Short Form 36 item survey) at 12 months | ||||
|---|---|---|---|---|
| Mean change from baseline (SD) | Between group P value+ | Comparison | ||
| Education | Comparator | |||
| Physical functioning | 3.6 (17.6) | 4.4 (15.1) | 0.749 | Education = comparator |
| Role physical | 38.2 (46.9) | 33.8 (42.4) | 0.504 | Education = comparator |
| Bodily pain | 5.69 (31.1) | 6.18 (29.1) | 0.911 | Education = comparator |
| General health | 1.4 (15.9) | 1.8 (16.3) | 0.862 | Education = comparator |
| Vitality | 5.3 (22.7) | 4.9 (21.8) | 0.921 | Education = comparator |
| Social functioning | 9.7 (24) | 9.1 (25.3) | 0.869 | Education = comparator |
| Role emotional | 15.8 (48.1) | 16.5 (41.1) | 0.913 | Education = comparator |
| Mental health | 2.9 (16.6) | 4.2 (17.8) | 0.566 | Education = comparator |
| *Positive values indicate improvement in HRQL from baseline NS: No significant difference demonstrated | ||||
| Variable | ||||||||
|---|---|---|---|---|---|---|---|---|
| Follow‐up | 24 months | 24 months | 6 months | 7 to 12 months | 12 months | 18 months | 6 months | 25 months |
| Year | 2000 | NR | 2005 to 2006 | NR | 2002 to 2005 | |||
| Currency | USD | GBP | USD | USD | USD | |||
| Mean cost of cardiac rehabilitation program per patient | ||||||||
| Total costs | USD 187 | GBP 49.72 | USD 162 | USD 453 | USD 196 | |||
| Costs considered | Personnel, instructional materials, telephone supplies, ongoing staff training | Direct costs by health visitors (staff time), Travel Costs | Average monthly fee paid to the program per member | Nurse salary Overheads Subscription costs | Average monthly fee paid to the program per member | |||
| Comments | Participating site overheads were not measured, a "conservatively high" estimate of these was taken to double the treatment cost to USD 374 | Costs of the health visitor also included time spent recording data collection for the study | Cost varied among the 15 included studies. Negotiated locally with Medicare and Medicaid Services. (Range USD 50 to USD 444) | |||||
| Mean total healthcare costs per patient | ||||||||
| Total cost (intervention) | USD ~3300 (calc) | GBP 1801 | USD 1627 | USD 2356 | USD 2288 | USD 1793 | USD 635 | USD 1283* |
| Total cost (control) | USD ~6500 | GBP 1812 | USD 1632 | USD 2464 | USD 2372 | USD 1818 | USD 2053 | USD 1314* |
| Between group difference | USD ~1800* | GBP 9.60 | USD 5 | USD 107 | USD 84 | USD 25 | USD 1418 | USD 144 (80% CI 99 to 188) |
| P value | NR | NS | 0.895 | 0.077 | 0.132 | 0.365 | NR | < 0.001 |
| Cost saving per pt (when cost of intervention taken into account§) | USD ~1610 or USD ~1420 if estimated overheads were included | GBP 40 | USD ‐157 | USD ‐55 | USD ‐78 | USD ‐137 | USD 965 | USD ‐52 |
| Additional healthcare costs considered | Number of admissions (heart related), number of inpatient days, In patient cost' emergency department costs | Prescription of drugs, GP visits, visits to hospital as inpatients and outpatients, all tests investigations and treatments carried out | Medicare medical claims | Cardiovascular‐related emergency department visits and hospitalisations | ||||
| Comments | Expenditure was calculated from differences in % utilisation of hospital services. i.e. hospital charges for participants were on average 49% lower and the average annual expenditure was USD 6500. * There was a calculated saving of a hospital charge of USD 3200, the ratio of payments to charges was 0.56 therefore USD 1800 actual saving | There was a difference in the drug usage at baseline which is not accounted for in these figures although this would make minimal impact to the results. The intervention group were more costly for drugs, procedures and service use | Claims quoted are per member per month | *Expenditure/pt/month enrolled Overall costs were increased by 11% when the care coordination fees were taken into account | ||||
| Summary difference between groups | Favours Rx | Rx = Control | Rx = control (for all time periods studied) | Favours Rx | Favours control | |||
| § = Negative mean difference indicates a net cost of the intervention group | ||||||||
| Explanatory variable (n trials) | Exp(slope)* | 95% CI univariate; | Proportion of variation explained | Interpretation |
|---|---|---|---|---|
| Case mix (% myocardial infarction patients) (n = 11) | RR = 1.004 | 0.988 to 1.020 | ‐190.36% | No evidence that RR is associated with case mix |
| Age of participants (n = 13) | RR = 1.005 | 0.940 to 1.074 | ‐28.26% | No evidence that RR is associated with the age of participants |
| Percentage of male participants (n = 13) | RR = 0.991 | 0.986 to 1.012 | ‐25.27% | No evidence that RR is associated with the percentage of male participants |
| Type of CR (education only vs. education plus e.g. exercise or psychological intervention) (n = 13) | RR = 0.181 | 0.014 to 2.321 | 28.25% | No evidence that RR is associated with type of CR |
| Method of structured educational delivery (one‐to‐one vs. group versus combination) (n = 13) | RR = 1.010 | 0.728 to 1.401 | ‐28.28% | No evidence that RR is associated with method of delivery |
| Duration of intervention (n = 12) | RR = 0.978 | 0.948 to 1.010 P = 0.152 | 3.69% | No evidence that RR is associated with duration of intervention |
| Theoretical vs. no theoretical basis to educational intervention (n = 13) | RR = 1.473 | 0.750 to 2.895 | ‐0.31% | No evidence that RR is associated with theoretical basis |
| Involvement of significant others (e.g. spouse, family member) in the education programme (n = 13) | RR = 1.245 | 0.890 to 1.722 P = 0.166 | 7.06% | No evidence that RR is associated with family involvement |
| Study location (n = 13) | RR = 1.050 | 0.714 to 1.543 | ‐59.78% | No evidence that risk ratio is associated with study location |
| Setting (centre vs. home) (n = 13) | RR = 1.171 | 0.773 to 1.774 | ‐44.55% | No evidence that RR is associated with centre status |
| Length of follow‐up (n = 13) | RR = 0998 | 0.964 to 1.033 | ‐22.64% | No evidence that RR is associated with length of follow‐up |
| CR ‐ cardiac rehabilitation; RR ‐ risk ratio | ||||
| Explanatory variable (n trials) | Exp(slope)* | 95% CI univariate P value | Proportion of variation explained | Interpretation |
|---|---|---|---|---|
| Case mix (% myocardial infarction patients) (n = 12) | RR = 1.002 | 0.992 to 1.013 | ‐9.25% | No evidence that RR is associated with case mix |
| Age of participants (n = 17) | RR = 0.998 | 0.963 to 1.034 | ‐15.62% | No evidence that RR is associated with the age of participants |
| Percentage of male participants (n = 17) | RR = 0.999 | 0.992 to 1.005 | ‐28.64% | No evidence that RR is associated with the percentage of male participants |
| Type of CR (education only vs. education plus e.g. exercise or psychological intervention) (n = 17) | RR = 0.752 | 0.260 to 2.174 | ‐16.99% | No evidence that RR is associated with type of CR |
| Method of structured educational delivery (one‐to‐one vs. group versus combination) (n = 17) | RR = 1.033 | 0.860 to 1.242 | ‐29.18% | No evidence that mortality risk is associated with method of delivery |
| Duration of intervention (n = 16) | RR = 0.993 | 0.964 to 1.023 | ‐25.06% | No evidence that mortality risk is associated with duration of intervention |
| Theoretical vs. no theoretical basis to educational intervention (n = 17) | RR = 1.031 | 0.690 to 1.541 | ‐24.70% | No evidence that RR is associated with theoretical basis |
| Involvement of significant others (e.g. spouse, family member) in the education (n = 17) | RR = 1.016 | 0.829 to 1.245 | ‐33.62% | No evidence that RR is associated with family involvement |
| Study location (n = 17) | RR = 0.942 | 0.801 to 1.109 | 24.47% | No evidence that RR is associated with study location |
| Setting (centre vs. home) (n = 17) | RR = 1.096 | 0.873 to 1.374 | ‐13.38% | No evidence that RR is associated with centre status |
| Length of follow‐up (n = 17) | RR = 0.976 | 0.955 to 0.998 | 90.79% | Significant evidence that risk of withdrawal is increased in studies with a shorter follow‐up |
| CR ‐ cardiac rehabilitation; RR ‐ risk ratio | ||||
| Explanatory variable (n trials) | Exp(slope)* | 95% CI univariate P value | Proportion of variation explained | Interpretation |
| Year of publication (n = 13) | RR = 0.998 | 0.950 to 1.047 | ‐61.7% | No evidence that RR is associated with year of publication |
| Risk of bias (low risk in ≥ 5 items vs. < 5 items) (n = 13) | RR = 1.105 | 0.421 to 3.831 | ‐84.29% | No evidence that RR is associated with risk of bias |
| RR ‐ risk ratio | ||||
| Explanatory variable (n trials) | Exp(slope)* | 95% CI univariate P value | Proportion of variation explained | Interpretation |
|---|---|---|---|---|
| Year of publication (before 2000 vs. 2000 or later) (n = 17) | RR = 1.017 | 0.982 to 1.052 | ‐7.02% | No evidence that RR is associated with year of publication |
| Risk of bias (low risk in ≥ 5 items vs. < 5 items) (n = 17) | RR = 1.437 | 1.069 to 1.931 | 15.35% | Significant evidence that risk of withdrawal is increased in studies with higher risk of bias |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Total mortality at the end of the follow up period Show forest plot | 13 | 10075 | Risk Ratio (M‐H, Random, 95% CI) | 0.80 [0.60, 1.05] |
| 1.1.1 Studies with 12 months or less follow‐up | 6 | 4063 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.35, 1.78] |
| 1.1.2 Studies with more than 12 months follow‐up | 7 | 6012 | Risk Ratio (M‐H, Random, 95% CI) | 0.78 [0.60, 1.02] |
| 1.2 Fatal and/or non‐fatal MI Show forest plot | 2 | 209 | Risk Ratio (M‐H, Random, 95% CI) | 0.63 [0.26, 1.48] |
| 1.3 Other fatal and/or non‐fatal cardiovascular events Show forest plot | 2 | 310 | Risk Ratio (M‐H, Random, 95% CI) | 0.36 [0.23, 0.56] |
| 1.4 Total revascularisations (including CABG and PCI) Show forest plot | 3 | 456 | Risk Ratio (M‐H, Random, 95% CI) | 0.58 [0.19, 1.71] |
| 1.5 Hospitalisations Show forest plot | 5 | 14849 | Risk Ratio (M‐H, Random, 95% CI) | 0.93 [0.71, 1.21] |
| 1.6 Withdrawals Show forest plot | 17 | 10972 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.88, 1.22] |
| 1.6.1 Studies with 12 months or less follow‐up | 10 | 4960 | Risk Ratio (M‐H, Random, 95% CI) | 1.18 [0.93, 1.49] |
| 1.6.2 Studies with more than 12 months follow‐up | 7 | 6012 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.80, 1.20] |
