Methods

Randomised trial (pilot study) (grant dates April 1st 1994‐March 31 1998)

Participants

Caregivers of stroke survivors recruited from a university medical centre in Rhode Island USA. Caregiver age ranged from 21‐86 years with a mean of 56.8 (16.4). The majority were female (65.3%). Caregivers were spouses (45%), daughters (33%), sons (10%) or other (e.g. sister, partner, mother) (2%). Forty‐nine percent had an annual household income of $15,000‐29,999, 26.5% of $30,000‐49,000, 18.3% of $0‐14,999 and 6.1% had an annual income ≥ $50,000.

Care‐recipients: Stroke survivors were required to be fully oriented and able to follow a 3‐step command and had either evidence of stroke on neuroimaging or were hemiparetic. Stroke survivors were mainly female (65.3%) with an age range of 44‐87 years (mean (SD) 70.1 (11.6)). Fifty‐one percent were married, 42.9% divorced/separated/widowed and 6.1% were single. Annual household income was $0‐14,999 (32.6%), $15,000‐29,999 (46.9%), or $30,000‐49,000 (20.4%).

Interventions

Intervention: Family Intervention: Telephone Tracking (FITT) plus usual care (n = 23)

Aim: The primary goal of FITT is to assist stroke survivors and their caregivers in identifying problems during their transition back home. It consists of two main components: psychoeducation and follow‐up.

Interventionist(s): Four individuals with prior clinical experience of either family therapy or stroke (a psychiatric resident, family therapy graduate students, a stoke rehabilitation nurse, a master’s level family therapist).

Mode of delivery: Telephone

Duration: 6 months: Weekly for 6 weeks, biweekly for next 2 months, for a total of 13 calls to each individual (26 calls per dyad).

Content: FITT focuses on 5 key areas: (1) family functioning, (2) mood, (3) neurocognitive functioning, (4) functional independence, and (5) physical health. Expectations and transitional challenges within each of these areas are discussed. To reinforce attention to these areas, during the calls, participants were asked to rate themselves and their partner in the 5 areas (worse, same, better) using a structured grid. Telephone contacts were designed to identify and address problems in these key areas, provide psychoeducation, facilitate the dyad’s problem‐solving, and provide follow‐up support. No direct treatment of psychiatric or family problems was given, but participants were supported in seeking referrals for special assessment or treatment as required.

Standardisation: All interventionists received didactic instruction, familiarization with the FITT manual, role playing, and group supervision. Therapist adherence and competence was monitored and found to be acceptable.

Comparison group: Standard medical follow‐up (n = 26)

Outcomes

1. Psychological health (depression): 13‐item Geriatric Depression Scale (GDS) Short Form which uses yes/no responses. Higher scores indicate higher levels of depression.

2. Health status and well‐being:

• Physical activity: Activity (Frenchley Activities Index (FAI), a 15‐item self report scale quantifying survivors' activities inside and outside of the home). Higher scores indicate greater levels of activity.

• Physical activity: Therapy hours (physical, occupational, and speech therapy hours) and physician visits; lower number of therapy hours better physical health.

3. Family functioning: The Family Assessment Device (FAD) and the Perceived Criticism Scale (PCS). Higher scores indicate better family functioning.

Outcome data were collected at 3 and 6 months post‐stroke (end of intervention is 6 month time point).

Notes

Unpublished information requested via email but no response received from the contact author. Professor Ivan Miller, a named author on the paper did provide some additional information via email to enable categorisation of the paper. For the outcome physical health, the Frenchay Activity Index mean change scores as reported were used in this review. For family functioning, the global family functioning score was used in the review and reported in Additional Table 4.

Funding source: National Institute for Mental Health (NIMH) grant 1 R21 MH54182‐01 (p.S72).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Urn randomisation (S64)

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

“Data collectors were blinded to group assignment” (S66).

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

11 caregivers left for reasons including stroke survivor death (n = 2), caregiver death (n = 1), self‐withdrawal/repeated failures to return calls (n = 3), permanent nursing home placement of stroke survivor (n = 3), and refusal to complete assessments (n = 2); not differentiated by intervention or control groups (S67).

Selective reporting (reporting bias)

Low risk

All prespecified outcomes were reported (S69).

Other bias

Unclear risk

Caregiver characteristics were not reported separately for each group. "...an urn randomisation procedure was used and this should have balanced our imbalances" (S64).

Methods

Randomised controlled trial (study dates not reported)

Participants

Caregivers were wives of people with dementia recruited from the Michigan Alzheimer’s Disease Research Center (MADRC) and local chapters of the Alzheimer’s Association (AA) in Michigan and Ohio. The average age of the sample was 66.8 years (SD = 9.4), the majority (65.7%) had at least some education beyond high school and described themselves as white/caucasian (92.7%). About one‐fifth (21.9%) were employed part‐ or full‐time.

Interventions

Intervention: Health First (n = 74)

Aim: To assess whether compared with baseline, participants in the Health First showed greater improvements in selected outcomes than the control group

Interventionist(s): Trained behaviour change counsellors who were current or retired health or social service professionals (confirmed by author via email)

Mode of delivery: Telephone

Duration: 14 telephone calls over a 6‐month period (weekly for 2 months, biweekly for 2 months, monthly for 2 months).

Content: During the first two calls, caregivers were directed to complete daily activity logs (to establish baseline levels of physical activity) and to set a realistic long‐term exercise goal that specified the type of exercise as well as duration and frequency. They were encouraged to set a goal that consisted of a minimum of 30 minutes of low to moderate intensity aerobic exercise at least 3 times a week, supplemented with stretching and strength training. During subsequent calls, participants set short‐term goals for exercise and a problem‐solving process was used to address barriers to goal attainment. They also received a Health First video featuring spouse caregivers discussing strategies for fitting physical activity into their daily routine as a way to model desired behaviour, a choice of exercise videos, a copy of the booklet “Pep up our Life”, and a Health First workbook that explains each step of the program.

Standardisation: Counsellors participated in a day‐long training session to address program fidelity that included opportunities for role play and performance feedback to promote appropriate and accurate delivery of the program. A project manager monitored several calls made by each counsellor to confirm that the intervention was being delivered correctly and uniformly.

Comparison group: No intervention/usual care (n = 63).

Outcomes

1. Burden:

• Objective caregiver burden using the Revised Memory and Behavior Problem Checklist (RMBPC) which assesses upset or burden with the presence of 24 memory and behaviour problems. Possible RMBPC scores range from 0‐24, with higher scores indicating more problem behaviours.

• Subjective burden using responses in the ‘bother/upset/questions' asked as part of a modified version of the RMBPC Form. Responses ranged on a 5‐point scale from 'not at all' to 'extremely'. Responses were summed for an overall subjective burden score, with possible scores ranging from 0‐96. Higher scores were associated with being more bothered or upset by the care‐recipient’s problem behaviours.

2. Psychological health (depression): The 11‐item Iowa short form of the Center for Epidemiologic Studies Depression Scale (CES‐D). Participants were asked the frequency with which they experienced symptoms in the past week (hardly ever or never, some of the time, or much or most of the time). Possible scores range from 0 to 22; higher scores were associated with more symptoms.

3. Psychological health (stress): Perceived stress was measured with the 14‐item Cohen Perceived Stress Scale. Participants rate the degree to which events in the past month were perceived as stressful using a 5‐point scale ranging from never (0) to very often (4); higher scores indicating higher levels of perceived stress.

4. Health status and well‐being (self‐efficacy):

• Exercise self‐efficacy was measured by nine items developed for dementia caregivers where participants rated their level of confidence that they could exercise when faced with barriers (e.g. being tired, hectic schedule) using a scale of 1 to 10 (not at all confident to very confident). The ratings were averaged across items for a total exercise self‐efficacy score. Higher scores indicated greater confidence.

• Self‐efficacy for self‐care was assessed by the single item, “How confident do you feel in being able to take care of yourself?” Response choices ranged from not confident at all to very confident using a 5‐point scale.

All outcomes were collected using follow‐up interviews administered at the end of intervention short‐term approximately 6 months and approximately 12 months from baseline.

Notes

For the outcome burden, data from the subjective burden questionnaire was used in our analysis. For the outcome self‐efficacy, the data for self‐efficacy for self‐care was used.

Funding source: A grant from the National institute on Aging to the Michigan Alzheimer’s Disease Research Center (p.172).

Unpublished data sought via email, author responded and all available data were provided.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to assess

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to assess

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

15.9% overall (n = 27) (17 intervention versus 9 control) (p.179)

Selective reporting (reporting bias)

Low risk

All relevant outcomes reported

Other bias

High risk

At baseline, there was a difference between the groups noted in depression scores (intervention 9.4 SD 2.9; control 7.9, SD 2.8) (p.181).

Methods

Randomised controlled trial (pilot study) (September 2009‐September 2015)

Participants

Caregivers of people with multiple sclerosis (PwMS) recruited from 3 neurological sites (n = 70) in the Republic of Ireland. Caregiver mean age was 51.3 years (SD 13.4), range 22‐84 years; 47.1% were male and 52.9% were female. The majority had at least secondary level education (51.5%) or tertiary education (41.4%). The remaining 7.1% had primary education. Twelve (17.1%) were single, 50 (71.4%) were married and 2 (2.9%) were living as married. Three (4.3%) were separated or divorced and three (4.3%) widowed. An average of 8.8 hours (SD 9.04) were spent caring in a 24‐hour period and the average number of years caring for the PwMS was 11 (SD 7.69). Most (60%) were living with the care‐recipient. Twenty‐five (35.3%) were in paid employment with hours ranging from 6 to 90 hours per week. Thirty‐six (51.4%) were not employed.

Interventions

Intervention: Nurse‐led pro‐active telephone support (n = 33)

Aim: To enable nurse specialists in multiple sclerosis (NSMS) help family members and caregivers of PwMS learn problem management skills in order to be better prepared for their role in supporting a person with MS

Interventionist(s): Three NSMS who had completed a postgraduate diploma in clinical practice along with a certificate in MS nursing

Mode of delivery: Telephone

Duration:3 months (four calls; two in month one, one in month two and one in month three)

Content: In advance of receiving the calls, the support persons received the support person guidebook. During the calls, the NSMS referred to the guidebook. The support person guidebook was designed to facilitate the process and enable nominated support persons prepare for the calls from the nurse specialists. Scripted interviews were designed to provide a focus for the telephone contacts and help the NSMS and support persons structure their interaction using a problem management approach.

Standardisation: Standardisation of interventionist training was maximised through the inclusion of a training section in the intervention manual. Training for delivery of the intervention was provided in accordance with the intervention manual. Each NSMS received a minimum of two hours one‐to‐one training.

Comparison group: Usual care (n = 38).

Outcomes

1. Quality of life: WHOQoL BREF instrument ‐ 26 questions covering four domains (physical, psychological, social relations, and environmental). Higher scores indicated better quality of life.

2. Burden: Caregiver Reaction Assessment (CRA), a 24‐item scale, which assesses how caregivers react to caring for an ill person in 5 domains: how caring affects caregivers health, daily schedule (schedule disruption), finances, their sense of self‐worth (self‐esteem), and their family. Higher scores indicated greater burden.

3. Skill acquisition (preparedness to care): using the support person preparedness scale, an 8‐item subscale with a five point rating scale developed as part of The Family Care Inventory in the early 1980s (Archbold 1990). Higher scores indicated greater perceived preparedness to care.

4. Health status and well‐being (self‐efficacy): Self‐Efficacy for Problem‐solving scale, a 4‐item caregiver self‐efficacy in problem management scale and Self‐Efficacy for Obtaining Respite subscale. Higher scores indicated greater self‐efficacy.

5. Satisfaction with the intervention: Client Satisfaction Questionnaire‐8 (CSQ‐8), an 8‐item questionnaire with a four option response ranging from 1‐4, with higher scores indicating greater satisfaction.

Data were collected at the 4‐week time point which was prior to completion of the intervention, and at the 3‐month time point (approximately week 12), which was the end of the intervention time point.

Notes

The term support person (SP) was used for caregivers. Standard deviation data for burden and preparedness to care were obtained from the author.

Following email communication with the originators of the burden instrument (CRA), the subscale result for 'schedule disruption' was used for 'Burden' in the review.

Funding source: Fellowship from the Health Research Board Ireland

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A random list of numbers for the control and intervention groups at each site was generated by a statistician independent of the study (p.174).

Allocation concealment (selection bias)

Low risk

Allocation held by a person independent of the trial and sent via email on enrolment to the trial (p.174)

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Not blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Overall attrition minimal (2 per group) and reasons provided (p.238)

Selective reporting (reporting bias)

Low risk

All prespecified outcomes were reported.

Other bias

High risk

The interventionists who delivered the intervention delivered care to both groups.

Methods

Randomised controlled trial (study dates not reported)

Participants

Informal caregivers of people with dementia whose care‐recipient was admitted to a nursing home in Rhode Island, USA. The mean age of the caregivers (data provided by the author) was 60.26 years (SD = 11.42) for the entire group. The majority of caregivers were adult children, 83% in the intervention group and 72% in the control group. The majority of caregivers were female (87% data provided by author) for the entire group. The mean years of education was 15.17 (SD = 3.03) in the intervention group and 14.82 (SD = 3.54) in the control group. The mean duration in months of caregiving for the intervention group was 49.23 (SD = 37.59), and for the control group 46.30 (SD = 38.11). Twenty‐seven caregivers received the intervention and 26 caregivers received standard care.

Care‐recipients: mean care recipient age in the intervention group was 82.54 (SD = 5.48) and in the control group 82.73 (SD = 9.05). The mean length of time since dementia diagnosis (months) for the intervention group was 41.14 (SD = 30.15) and control group 42.05 (SD = 33.01). Care‐recipients nursing home placement (weeks) for the intervention group was 6.58 (SD = 3.88) and control group 5.50 (SD = 3.64).

Interventions

Intervention: Family Intervention: Telephone Tracking‐Nursing Home (FITT‐NH) plus a resource pack containing local resources and educational material (n = 27)

Aim: The intervention was designed to help caregivers adjust to the new burdens and stresses of nursing home placement in the first few months after placement has occurred.

Interventionist(s): A trained Master’s level therapist (counsellor – confirmed by author via email)

Mode of delivery: Telephone

Duration: 3 months (initial call, followed by 7 weekly follow‐up calls, and 2 biweekly termination calls over the third month. Initial contact lasted 60 minutes and follow‐up and termination calls lasted 35‐45 minutes.

Content: The FITT‐NH was delivered by a standardised method based on a detailed treatment manual that included sample dialogue, a behavioural problems guide to generate solutions with the caregiver, and a specific interventions guide matched to specific caregiver situations. The FITT model assesses caregiver and care‐recipient functioning in key areas (i.e. the caregiver’s emotional functioning, health, social support, family functioning, and communication with staff; care‐recipient’s emotional adjustment, behaviour, and cognition). These key areas are repeatedly assessed throughout the treatment, and particular interventions are applied based on these assessments. Specific interventions include supportive approaches (i.e. empathy, giving permission, normalising, validation, or venting) and active strategies (i.e. bibliotherapy, interpretation, positive reframing, problem‐solving, reference to resource packet, referral, and setting task directive). In the first contact, caregivers are provided with a rationale for the FITT, description of future telephone contacts, an introduction to resource materials, and an assessment of key areas thought to be instrumental in addressing caregiver coping and adjustment. The psychoeducation component reviews information about dementia, specialty care units, and common psychological and physical effects of caregiving. Scheduled telephone contacts identify new problems, discuss positive and negative changes, provide psychoeducation, and caregiver problem‐solving is assisted. The final two calls (biweekly) address termination by anticipating FITT contacts coming to an end and fostering reliance on the support network established in FITT‐NH. This phase reviews caregiver progress and reinforces success, coping strategies, and positive change. The therapist summarised these sessions in a post‐treatment letter sent to the caregiver.

Standardisation: States that it was delivered in a standardised way. The intervention was administered according to the written manual procedures (confirmed by author via email).

Comparison group: Control group (no formal intervention, received a resource pack containing local resources and educational material) (n = 26)

Outcomes

1. Quality of life: SF‐36. Higher scores indicated better quality of life.

2. Burden: Burden Interview (ZBI) a 22‐item inventory assessed caregivers’ subjective feelings of the impact of caregiving on emotional and physical health functioning, social life, and financial status. Higher scores reflected greater burden.

3.Psychological Health (depression): Center for Epidemiology Studies Depression Scale, a 20‐item measure of depressive symptoms. Higher scores reflected higher level of depression.

4. Satisfaction:

• Perceived satisfaction with practical and other supports: Ohio Department of Aging Family Satisfaction Instrument which contains 62 items assessing family members’ satisfaction with the nursing home placement. Higher scores indicated greater perceived satisfaction.

• Satisfaction with the intervention: Caregivers in the intervention group rated their satisfaction with the program on a four‐point Likert scale (1 = not at all to 4 = very much so). Higher scores indicated higher satisfaction.

Outcome data were collected using face‐to‐face assessments with the caregivers at their home or nursing home at the end of intervention (3 months from baseline).

Notes

Outcome data on quality of life and Information on interventionist training was provided by the author via email.

Funding source: Grant from the National Institute on Aging (AG026122; J.Davis, PI) (p.387).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Urn randomised to balance groups to gender relationships and facility type (p.381)

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

A trained research assistant, blind to group membership, conducted face‐to‐face assessments with the caregivers at their home or nursing home at baseline and at the end of the intervention (p.382).

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Overall attrition low (13%) and balanced between groups (3 and 4); reasons for attrition provided (death n = 5; discharge from nursing home n = 1, and withdrawal n = 1) (p.384).

Selective reporting (reporting bias)

High risk

Quality of life was not reported (Table 3, p.385).

Other bias

Low risk

Groups did not differ in caregiver age, education, gender, relationship (spouse versus adult child), and length of caregiving, length of dementia diagnosis or time since placement.(Table 2, p.384, table 3, p.385).

Methods

Randomised clinical trial (Study dates not reported)

Participants

Chinese family caregivers of people with dementia in the San Francisco Bay area, United States of America (USA). All caregivers were female (n = 55, 100%) and were included in the study if they were at least 21 years of age, caring for a family member with significant memory loss or deterioration in cognitive abilities, spending at least 8 hours/week caregiving for at least 6 months, owned a phone, planning to remain in the area for 6 months, and agreed to random assignment to both conditions. Care‐recipients were required to have a score of 23 or less on the Mini‐Mental State Examination (MMSE) and be unable to perform one or more activities of daily living (ADLs) and two or more Instrumental ADL (IADLs), or have a documented dementia diagnosis.

The mean age of the caregivers who completed the study was 59.3 (SD 12.23), were in the USA for 31.13 years (SD ‐20.93), and had a mean number of years in education of 13.42 (SD 4.10). Most were non‐spousal family relationships (mean spouse caregiver in telephone support condition (TSC) (7, SD 30.4), in‐home behavioural management program (IHBMP) (7, SD 31.8); mean non‐spouse caregiver TSC (16, SD 69.6) IHBMP (15, SD 68.2). Average duration of caregiving was roughly four years (TSC (41.26 months, SD 29.77), IHBMP group (48.32 months, SD 42.86)). More than 75% of caregivers were married: TSC (single (n = 2, 8.7%) , married (n = 18, 78.3%), widowed (n = 1 4.3%), divorced (n = 2, 8.7%)); IHBMP group (single (n = 4, 18.2%), married (n = 17, 77.3%), widowed (n = 1, 4.5), divorced (0)). About 80% of them had children: TSC: (n = 18, 78.3%), IHBMP (n = 18, 81.8%)). At least 75% reported that they had some help with caregiving (n = 20, 87% of the TSC and n = 6, 27.3% of the IHBMP group). About 30% said they were having financial difficulties and over 30% said that they assumed the primary caregiver role because no one else was available.

Interventions

Intervention: Telephone support groups (n = 28)

Aim: To evaluate the efficacy of an in‐home intervention, based on cognitive behaviour therapy principles, to relieve stress and depression in female Chinese‐American caregivers

Interventionists: Advanced doctoral students in psychology from a local university program

Mode of delivery: Telephone

Duration: 12 weeks (six phone calls at two week intervals)

Content: Calls began with a general inquiry as to caregiver and care‐recipient well‐being, then one or more problems were identified for discussion. Common themes were incontinence, incessant questioning, temper outbursts, and nocturnal awakenings. The interventionist remained empathic and supportive, and at a comfortable moment, indicated that written information was available to help. Consumer‐friendly materials (in Chinese or English) were mailed if requested. The next phone call was scheduled and the session ended with expressions of concern for the welfare of caregiver and care‐recipient.

Standardisation: No detail provided

Comparison group: IHBMP is comprised of six modules that focus on learning new skills to help the caregivers cope with caregiving stress. Each module required one or more 90‐minute sessions; one additional session was used for any module requiring extra time (n = 27).

Outcomes

1. Psychological health (depression): 20‐item Center for Epidemiological Studies Depression scale (CES‐D). Higher scores indicated higher level of depression.

2. Psychological health (stress): The 10‐item Perceived Stress Scale and the Conditional Bother Subscale (CBS) is derived from the Revised Memory and Behavior Problems Checklist (RMBPC). Higher scores indicated higher level of stress.

3. Health status and well‐being (self‐efficacy): The revised self‐efficacy scale (SE). Higher scores indicated better perceived self‐efficacy.

Time point for data collection not stated

Notes

For the outcome 'stress', the results from the 10‐item Perceived Stress Scale were used in the analysis for this review.

Funding source: Research grant from the National office of the Alzheimer’s Association, Chicago – grant IIRG‐01‐3157 to DGT (p.433).

Unpublished data sought via email but not received; author did provide information to enable categorisation of the study during the data screening process.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to assess

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to assess

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Ten of the 55 (18%) participants dropped out either before or in the early stages of treatment — five from each group (p.427).

Selective reporting (reporting bias)

Low risk

Reports on all prespecified outcomes (p.431).

Other bias

Low risk

“The two groups were statistically equivalent at baseline, although the IHBMP appears to be higher than the TSC on CES‐D" (p.431).

Methods

Randomised pilot trial (Study start date: October 2008, end date was not reported but final data collection date for primary outcome was February 2012)

Participants

Informal caregivers of people with dementia recruited from 2 memory disorder clinics, the local Alzheimer’s caregiver organisations, local newspapers, and self‐referral based on information from a friend in Jacksonville‐Tallahassee, USA. Caregivers (CGs) were included if they were 18 years of age and older, provided direct care to their care‐recipients (CR) for a minimum of 6 hours per week for at least 6 months, reported specific caregiving problems amenable to change within a 12‐week intervention frame (e.g. increasing CG social and recreational activities and managing effectively CR agitation and aggressive behaviours), scored a minimum of 10 on the Patient Health Questionnaire‐9 indicating a moderate level of depression, and reported no difficulties in hearing over the phone.The caregivers consisted of husbands (n = 1), wives (n = 5), daughters (n = 4), granddaughter (n = 1) of the care‐recipients. Five of the 7 caregivers randomised to the intervention group completed the intervention and 6 of the 7 randomised to the control group completed the study. The mean age of the caregivers who completed the study was 58.09 (SD = 10.11) years and 1 was male and 10 female. All caregivers had an average of 14.18 (SD = 1.78) years education.

Care‐recipients: All care‐recipients were African‐Americans with mean age in years 76.73 (SD = 6.60) and education (years) 12.27 (SD = 3.80), independence in activity of daily living mean score of 2.64 (SD = 1.91) and independence in instrumental activities of daily living mean score of 20.36 (SD = 2.46). Care‐recipients were required to have a medical diagnosis of possible Alzheimer’s disease or other type of progressive dementia verified by a physician at a memory disorder clinic approved by the Alzheimer’s Disease Initiative and at least one limitation in basic activities of daily living and 2 dependencies in IADL.

Interventions

Intervention: A cognitive behavioural program (CBT) (group and individual format) (n = 7)

Aim: To assess CGs appraisal of the intervention process and its impact on daily caregiving experiences and to conduct a preliminary analysis of the effects of face‐to‐face and telephone‐based CBT on changes in subjective burden, assistance support, depression, and health status in African‐American dementia CGs.

Interventionist(s): Four African American counsellors, 3 females and 1 male, and were randomly assigned to the groups. All counsellors had a master’s degree in a counselling related profession and at least 1 year of group intervention experience. All 4 regularly used CBT in their practices but none had participated in a formal CBT workshop prior to the study. Average age of counsellors (66 years, SD = 9.2), average years of education (21.5, SD = 1.29), average years in professional practice (30.75, SD = 13.38).

Mode of delivery: Telephone

Duration: Twelve, 1‐hr, weekly sessions

Content: Telephone‐based CBT took place at the CGs’ homes mediated by either a Florida State University or Mayo Clinic Jacksonville teleconferencing system. The intervention program consisted of seven group and five individual CG goal‐setting and implementation sessions. The small group format was used to encourage discussion and clarification about the rationale for and application of fundamental, cognitive–behavioural skills (e.g. assertiveness and effective thinking), as well as to enhance social support among participants. Individual sessions concentrated on the development of problem‐solving skills, beginning with the identification of key caregiving problems and the performance of focused problem histories, followed by goal setting, rehearsal of goal‐related behaviours, goal implementation, and monitoring change over time. Acquisition of such skills was time‐intensive and required tailoring of the intervention to the specific circumstances, characteristics and preferences of the CG, thus necessitating a one‐on‐one format. All participants received a CBT guidebook and a copy of The 36 Hour Day, and information about local dementia care resources prior to the first training session.

Standardisation: Interventionist training consisted of two 6‐hour training workshops performed over a period of 2 months by two of the authors who were doctoral‐level licensed clinicians. The authors concluded that overall findings of treatment fidelity analysis suggested that pilot counsellors adhered to implementation guidelines in conducting the CBT program.

Comparison group: Face‐to‐face CBT was performed at a university‐based conference room or in a private, soundproof room at a public library. The structure and contents of the programme were the same as that for the telephone intervention (n = 7).

Outcomes

1. Burden: The subjective burden scale of the Caregiver Appraisal Inventory – a subscale of the Caregiver Appraisal Inventory (CAI). Higher scores indicated greater burden.

2. Psychological health (depression): Center for Epidemiological Studies Survey‐Depression scale (CES‐D) is a 20‐item self‐report scale that assesses depression in non‐clinical community populations. Respondents rate the frequency of a variety of depressive symptoms they have experienced over the past week on a 0 to 3 scale. A total score ranging from 0 to 60 is derived by summing the item scores. Individuals scoring 16 or higher on the CES‐D are generally considered to be at risk for developing clinical depression.

3. Psychological health (stress): The Revised Memory and Behaviour Problem Checklist (RMBPC) ‐ The disruptive behaviour and depression subscales (17 items) measure CG distress associated with CR disruptive behaviours and CR difficulties with depression. Higher scores indicated higher levels of stress.

4. Health status and well‐being (physical health): Physical symptoms subscale of the modified Caregiver Health and Behaviour inventory (CHHB). The modified CG Health and Health Behaviors inventory (CHHB) is a 42‐item scale to assess dementia CG perceived health, sleep quality, unhealthy behaviours, chronic health conditions, and physical symptoms. Two items ask respondents to rate their general health; two items measure quality of sleep; four items assess involvement in unhealthy behaviours such as smoking and drinking alcohol to excess; 15 items assess the presence of CG health problems, such as high blood pressure, diabetes, cancer, and arthritis; and 21 items measure physical symptoms, such as headaches, shortness of breath, heartburn, and sore throat. Higher scores indicated greater physical ill‐health.

Outcome data were collected via the telephone at the end of intervention, approximately 1 week after the 12 week CBT program.

Notes

Funding source: Grants from the National Institute of Mental Health (R34MH078999) Florida State University College of Medicine, and University of South Florida Health Byrd Alzheimer’s Institute (p.124).

Unpublished data sought via email but not received, author did provide information to enable categorisation of the study during the data screening process.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to assess

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"Post treatment assessments were also administered over the telephone by an independent interviewer..." (p.130). "The interviewer was unaware of assignment to treatment condition" (p.130) .

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Minimal attrition (3:1 intervention and control) and reasons provided, p.133

Selective reporting (reporting bias)

High risk

Results for stress not reported (p.134)

Other bias

Low risk

Groups fairly balanced on all baseline characteristics and measures, although Jacksonville CRs had a significantly greater number of years of education than their Tallahassee counterparts (p.134).

Methods

A single‐blinded randomised controlled trial (recruitment February 2011‐March 2012)

Participants

Family caregivers of persons with dementia (PWD) in Hong Kong. Caregivers were the primary caregivers of care‐recipients who had a clinical diagnosis of dementia. The majority of caregivers were in the mean age category of between 41‐50 years (n = 21, 55.2%). The remaining study participant ages in years were 31‐40 (n = 3, 7.89%), 51‐60 (8, 21.05%), 61‐70 (n = 3, 7.89%), 71‐80 (n = 1, 2.63%) and > 80 (n = 2, 5.62%). The majority were female (n = 24, 63.15%) and males accounted for 28.94% (n = 11). The caregivers were children of the care‐recipients (n = 30, 78.9%), spouses (n = 4, 10.52%), grandchild (n = 1, 2.63%), son/daughter in‐law (n = 3, 7.89%). Education ranged from secondary education (n = 27, 71.05%), tertiary (n = 8, 21.05%), primary (n = 2, 5.26%) or Illiterate (n = 1, 2.63%). In the intervention group, caregiver monthly income ranged from $10,000 or less, n = 3 (16.7%), $ 10,001‐$20.000, n = 9 (50%), $20.001‐$30,000, n = 2 (11.1%), $30,001‐$40,000, n = 2 (11.1%), $40,001‐$50,000, n = 2 (11.1%). In the control group, monthly income was $10,000 or less, n = 5 (25%), $10,001‐$20.000, n = 9 (45%), $20.001‐$30,000, n = 2 (10%), $30,001‐$40,000, n = 2 (10%), $40,001‐$50,000, n = 1 (5%), and more than $50,000, n = 1 (5%). Caregivers spent between 1‐9 hours caregiving in the intervention group (1 hour (n = 3, 16.7%), 1‐3 hours (n = 2, 11.1%), 4‐6 hours (n = 6, 33.3%), 7‐9 hours (n = 1, 5.6%), 9 hours (n = 6, 33.3%)). In the control group, caregivers also spent between 1 and 9 hours caregiving (1 hour (n = 1, 5.3%), 1‐3 hours (n = 4, 21.1%), 4‐6 hours (n = 9, 47.7%), 7‐9 hours (n = 1, 5.3%), 9 hours (n = 4, 21.1%)).

Interventions

Intervention: A psychoeducation intervention plus a DVD that contained educational information about dementia caregiving (n = 20; of whom 18 received the intervention)

Aim: To investigate the effectiveness of a telephone‐delivered psychoeducational intervention in supporting dementia caregivers in the community

Interventionist(s): Registered social workers

Mode of delivery: Telephone

Duration:12 weeks (approximately 30 minutes per session, one session per week; the day and time of phone calls were flexible to the agreement between the participants and the social workers).

Content: Participants in the intervention group were educated and given advice on topics related to dementia caregiving, including knowledge of dementia, skills of communicating with the patient, management of behavioural and psychological symptoms of dementia (BPSD), caregivers’ own emotional issues, resources available in the community, and long‐term care plan. The topics covered and the schedule of presentation were similar to typical psychoeducation interventions held 'on site' at community centres. The focus was on providing emotional support; directing caregivers to appropriate resources; encouraging them to attend to their own physical, emotional, and social needs; and educating them on strategies to cope with ongoing problems.

Standardisation: no detail provided

Comparison: Caregivers in the control group were given a DVD containing educational information about dementia caregiving (n = 22, of whom 20 remained as control).

Outcomes

1. Burden: Zarit Burden Interview Chinese version (ZBI) which consisted of 22 items pertaining to dementia caregiving in areas of perceived physical and psychological well‐being, social life, and finances. The participants indicated, on a 5‐point scale (0 = not at all to 4 = nearly always) during pretest and post‐test, how often they experienced distress resulting from caring for a relative with dementia. Higher scores indicated greater burden.

2. Health status and well‐being (self‐efficacy): Chinese version of The Revised Scale for Care giving Self Efficacy: Obtaining respite (SE‐OR), Responding to Disturbing Behaviours (SE‐RDB), Controlling Upsetting Thoughts (SE‐CUT). Higher scores indicated greater self‐efficacy.

Outcome data were collected at the end of intervention i.e. approximately 3 months after the pretest.

Notes

For the outcome self‐efficacy the results for the sub‐scale 'Responding to Disturbing Behaviours (SE‐RDB)' were used in the analysis.

Funding source: none stated

Unpublished information requested and received at the data screening stage

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A "computerised randomisation program" was used (p.1192).

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"...research assistant blind to group assignment" (p.1192)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Overall attrition (for each group; with reasons) very low, and balanced (p.1194)

Selective reporting (reporting bias)

Low risk

All outcomes reported (p.1195, table 4)

Other bias

Low risk

No significant differences at baseline on demographic variables and baseline measures (p.1194, table 2)

Methods

Randomised controlled trial (February 2005‐June 2007 (Final data collection date for primary outcome))

Participants

Caregivers of people with dementia (n = 154), Memphis, USA. Caregiver age in years ranged from 37.9‐86.5 (mean age 65.6, SD 12.4). The sample consisted of 83.3% (n = 129) females and 16.2% (n = 25) males of which n = 38 (24.7%) were employed and n = 132 (85.7%) were married. The majority of the caregivers were white (n = 108, 70.1%), black (n = 45, 29.2%), other (n = 1, 0.6%). Most were married (n = 132, 85.7%); n = 38 (24.7%) were employed and mean years of education were 12.8 (SD = 2.0) (i.e. almost a year beyond high school).

Interventions

Intervention: CONNECT (individual and group delivery, 5‐6 caregivers/group; 15 groups) (n = 77)

Aim: To determine if telephone support groups for dementia caregivers have an effect on bother with patient behaviours, burden, depression, and general well‐being

Interventionist(s): 3 group leaders each with a case load (one with an MSc in divinity, one an MSc in psychology, one an MA in Sociology)

Mode of delivery: Telephone

Duration: One year (biweekly for 2 months and monthly thereafter for a year, for a total of 14 hour‐long sessions)

Content: Content and structure of the intervention were based on the 6‐month REACH II intervention of 12 individual in‐home and by‐telephone sessions and five telephone support group sessions. Session materials consisted of a Caregiver Notebook and commercially available pamphlets. The Notebook, initially developed for a primary care intervention comprised behaviour management chapters and 17 caregiver stress/coping chapters. Each participant received a one‐on‐one introductory telephone call. Like REACH, the multicomponent intervention targeted caregiving risks, including risks associated with emotional and physical well‐being, safety, burden, social support, and patient behaviour management.

Standardisation: Training and certification helped to ensure consistency across group leaders. During the final certifying role play, each prospective Group Leader provided the entire first session and two additional educational presentations. Study investigators evaluated behaviourally anchored ratings of specific procedural techniques (e.g. correct use of forms) and clinical skills (e.g. active listening).

Comparison group: Caregivers received pamphlets on dementia and safety as well as telephone numbers for local resources. At the end of the study, they received the Caregiver Notebook and a workshop focusing on knowledge, safety, health, well‐being, behaviour management, and stress (n = 77).

Outcomes

1. Burden: The 12‐item Zarit Burden Interview (ZBI) assessed caregiver burden. Scoring was 0 (never) to 4 (nearly always); a higher score indicated greater burden.

2. Psychological health (depression): The 10‐item Center for Epidemiological Studies Depression Scale (CES‐D) assessed depressive symptoms within the past week. Scoring was 0 (rarely, none of the time) to 3 (most, almost all the time), for a score of 0 to 30; higher scores indicated greater symptoms.

3. Satisfaction:

• Perceived satisfaction with practical and other supports: Nineteen social support items measured received support and negative interactions, satisfaction, and social networks.The first three social support domains used a scale of 0 (never, not at all) to 3 (very often, very). Social network items used a scale of 0 (none) to 5 (9 or more). Social support items summed to 0 through 69; higher scores indicated more support.

• Satisfaction with the intervention: After final data collection, participants were asked by telephone about their satisfaction with the groups and components (e.g. format, length, information), any difficulties (e.g. talking to unseen members, distractions), and benefits (e.g. confidence, ability to provide care). Responses were scored from 1 (not at all) to 5 (extremely). Higher scores indicated greater satisfaction.

Outcome data were collected at the end of intervention which was the 12‐month post‐discharge time point.

Notes

For the outcome 'satisfaction', the satisfaction scores from the 19‐item social support items were used in the analysis for this review.

The author provided additional information on the interventionist training and outcome data for satisfaction with supports.

Funding source: This work was supported by the Veterans Health Administration, Health Services Research and Development Service, US Department of Veterans Affairs with additional support from the Memphis Veterans Affairs Medical Center (p.47).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to assess

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to assess

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Overall attrition low, n = 15 (9.7%), Reasons for attrition similar for both groups: Intervention group, N = 8 (refused contact, n = 3; not interested n = 2; illness, n = 1; other reasons n = 2); control group, N = 7 (refused contact, n = 2; illness, n = 3; other reasons n = 2) (p.38 figure 1 and p.39).

Selective reporting (reporting bias)

High risk

Physical health outcomes not analysed

Other bias

Low risk

No significant group differences reported at baseline and baseline data on outcome measures was similar for both groups (p.40 table 1 and p.41 table 2).

Methods

A randomised, treatment/comparison, repeated‐measures experimental design (July 2005‐February 2010)

Participants

Spouse/partner caregivers of stroke survivors, Kansas, USA. Caregivers were included if they were aged 55 years or older, married or married equivalent, living with and caring for a spouse or/partner surviving a first‐ever stroke occurring 6‐36 months before enrolment, could participate by telephone and spoke English.

Interventions

Intervention: Self‐Care TALK (detail on number not available)

Mode of delivery: Telephone

Aim: To test the effectiveness of a self‐care intervention for older, spouse caregivers of persons with stroke in reducing caregiving strain, promoting caregiver health and well‐being, self‐efficacy related to health, and in reducing depressive symptoms

Comparison: No intervention (detail on numbers not available)

Outcomes

1. Burden: M‐CSI: modified (caregiver strain)

2. Psychological health (depression): CED‐D (depression)

3. Health status and well‐being (physical health): SF‐36 v2, PCS (perceived physical health)

4. Health status and well‐being (self‐efficacy): SRAHP (self‐efficacy for health)

No detail available on the scoring system for any of the outcomes

Data collection time points: 2 and 6 months post‐enrolment

Notes

The principal investigator Cynthia Teel, University of Kansas School of Nursing, confirmed via email on 27 August 2017 that the trial registration was the only publication for this trial. Study data requested; author replied that no study data were available for inclusion in this review.

Funding sources: none stated

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No detail available

Allocation concealment (selection bias)

Unclear risk

No detail available

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No detail available

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No detail available

Selective reporting (reporting bias)

Unclear risk

No detail available

Other bias

Unclear risk

No detail available

Methods

Randomised controlled trial (recruitment March 2007‐October 2009)

Participants

Caregivers of persons with stroke at two large rehabilitation facilities in the greater metropolitan area of Stuttgart Germany, and from a statutory health insurance program. Consenting participants included 27 men (22.1%, mean age 69.78 years, SD 9.09) and 95 women (77.9%, mean age 65.13, SD 10.01). The sample comprised native Germans (n = 100, 82.0%), ethnic German repatriates from Eastern European states (n = 10, 8.2%), and individuals with various European migration backgrounds (n = 12, 9.8%). At enrolment, participants, n = 23 (18.9%), had worked while providing care. The caregivers were spouses or partners (n= 106, 86.9%), children (n= 15, 12.3%), or grandchildren (n= 1, 0.8%) of the care‐recipient and had been providing care for a mean period of 28 months (SD 33). During the 3 months before enrolment, they provided care and support in activities of daily living for 1.98 hr (SD 1.70) per day on average, additional support (e.g. preparing meals, buying goods, doing the laundry, providing outdoor assistance) for 3.72 hr (SD 2.32), and supervision due to cognitive impairment (e.g. disorientation, impaired memory, poor judgment) for 1.75 hr (SD 3.62). Fifteen caregivers (12.3%) were also responsible for the care of a second person who had not been enrolled in the study.

Care‐recipients included 84 men (68.9%, mean age in years 73.05, SD 7.33) and 38 women (31.1%, mean age in years 73.37, SD 7.89). Thirty‐five stroke survivors (28.7%) had already experienced more than one stroke in the past. Forty‐one care‐recipients (33.6%) had aphasia, 37 (30.3%) had dysphagia symptoms, and 71 (58.2%) were incontinent.

Interventions

Intervention: Problem‐Solving Intervention (PSI) and usual support (n = 60)

Aim: To examine the effectiveness of a problem‐solving intervention (PSI) for stroke caregivers who provided care for at least 6 months and who experienced significant strain in their role

Interventionist(s): Two clinical psychologists experienced in providing cognitive behavioural interventions with older persons conducted the PSI.

Mode of delivery: Telephone

Duration: 12 months (an initial in‐home visit, five weekly (month 1), and four biweekly (months 2 and 3) telephone sessions. In the following maintenance period (months 4–12), the second component consisted of another in‐home visit (month 4) and nine monthly telephone sessions. Each call was 60 minutes.

Content: During the initial in‐home face‐to‐face session, the interventionist explained the purpose of the intervention in detail and gave a short introduction into the principles of problem‐solving and the written problem‐solving guide. The intervention started with capturing the facts and identifying specific burdensome issues the caregiver was willing to change as a basis for a shared agenda. A card sorting task was used to facilitate problem identification. At the end of the card‐sorting task, the caregiver was asked to select and prioritise the burdensome problems that needed immediate attention. The caregiver was instructed to seek all available facts related to the selected problem and was then assisted in articulating a specific, realistic goal to overcome the identified problem and in determining possible obstacles to meeting the established goal. In the following step, the caregiver was instructed to think of as many possible solutions or obstacles to the problem and to write them on a worksheet. Various techniques were offered to increase the number of alternative solutions. After completing a comprehensive list of possible solutions, caregivers were encouraged to consider the potential outcomes of the chosen solutions and weigh the perceived benefit and feasibility of each on a 5‐point rating scale. The final phase in the problem‐solving process was the act of implementing the chosen and carefully planned solution. The PSI group also received the same monthly information leaflets like the information‐only control group.

Standardisation: The therapists were supervised every 6‐8 weeks for 3‐4 hr by the third author, who had access to the protocols of the sessions. During these contacts, all participants in the PSI group were discussed on the basis of the interventionists’ records and in regard to study protocol and adherence, intervention progress, and possible difficulties. If needed, telephone‐based supervision was possible at each point in time.

Comparison group: An information‐only control group and usual support. Participants assigned to this group received monthly information letters with care‐specific topics like relaxation, pain, depression, and nutrition, as well as addresses for supporting services or groups in the region corresponding to available written material offered by health insurances or local information centres. They also received the usual support that was regulated by law and the various benefits provided by the compulsory long‐term care insurance (n = 62).

Outcomes

1. Psychological health (depression): The 20‐item Center for Epidemiological Studies–Depression Scale (CES–D). Total scores range from 0 to 60. A score of 16 or higher was used as an indicator of clinical severity.

2. Skill acquisition (competence): The Sense of Competence Questionnaire (SCQ). The SCQ contains 27 items, each rated on a 4‐point scale. The three domains of the SCQ — satisfaction with the stroke patient as a recipient of care, satisfaction with one’s own performance as a caregiver, and consequences of involvement in care for the personal life of the caregiver — have been confirmed for informal caregivers of older adults with diagnosed stroke. A higher total score indicated a greater sense of competence or with a reversed scaling, a higher burden. Total scores ranged from 27 to 135.

3. Skill acquisition (problem‐solving): The short version of the Social Problem‐Solving Inventory–Revised (SPSI ‐R). The SPSI–R:S has 25 items that are rated on a 5‐point scale ranging from 0 (not very true of me) to 4 (extremely true of me). The total score ranges from 0 to 100. Two constructive dimensions (positive problem orientation (PPO), rational problem‐solving (RPS)) and three dysfunctional dimensions (negative problem orientation (NPO), impulsivity/carelessness style (ICS), and avoidance style (AS)) can be differentiated. The total score serves as a global index of problem‐solving ability. Higher scores indicated better problem‐solving abilities.

4. Health status and well‐being (physical health): Physical complaints were assessed with the Giessen Subjective Complaints List. The intensity of each complaint is rated on a 5‐point scale, ranging from 0 (not existing) to 4 (strong). The scores of the 24 items are summed to a total score (from 0 to 96). Higher scores indicated greater physical ill‐health.

5. Satisfaction:

• Perceived satisfaction with practical and other supports: The Leisure Time Satisfaction questionnaire was used to measure the impact of PSI on the caregiver’s satisfaction with his or her leisure time. Items are rated on a Likert‐type scale ranging from 0 (not at all) to 2 (a lot). The total score ranges from 0 to 12, and higher scores reflected greater satisfaction.

• Satisfaction with the intervention: Satisfaction with the intervention measured using a visual analogue scale form 0 = least satisfied to 100 = most satisfied; higher scores indicated greater satisfaction.

Outcome data were assessed at baseline (T0), following the intensive intervention period at 3 months (end of intervention) and after the maintenance period at 12 months.

Notes

We used the 3‐month outcome data because the maintenance period included a second in‐home visit at month 4 which is not consistent with the review's inclusion criteria.

Funding source: Grants of the GKV‐Spitzenverband (National Association of Statutory Health Insurance Funds) Berlin, Germany (p.628)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated – remote location (p.631)

Allocation concealment (selection bias)

Low risk

Remote randomisation centre provided by an "...independent randomisation center at the University of Tübingen" (p.631)

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome "Assessors were trained research assistants who were blind to the treatment condition ..." (p.631)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Overall attrition low: intervention n = 2 (death of care‐recipient, n = 1, and moved outside the region, n = 1); control n = 4 (death of care‐recipient, n = 1 and discontinued participation, n = 3) (Figure 1, p.630)

Selective reporting (reporting bias)

Low risk

All prespecified outcomes reported (Table 2, p.637)

Other bias

Low risk

"At pretreatment, PSI and control groups evidenced no significant differences (P > .05) on demographic characteristics or primary and secondary outcomes" (see Table 2) (p.636). "More caregivers in the control condition than the PSI group received ambulant therapies like physiotherapy, massage or sports therapy ...and had relatives, friends or neighbours who assisted care‐recipients in ADL‐related tasks ... there was a trend for a greater use of home care services for ADL assistance and a higher rate of aphasia among the care‐recipients in the PSI group ..." (p.636).

Methods

A mixed‐method design with random assignment (pilot study) (Study dates not reported)

Participants

African‐American caregivers of people with heart failure recruited from an outpatient cardiology HF follow‐up clinic in a Midwestern Medical Centre, USA. Caregivers were spouses (65%, N = 13) of patients or were other family members (35%, N = 7), i.e. sister, parent, daughter or granddaughter. Of 20 dyads, 15 (75%) lived in the same household, while 25% (5 dyads) lived separately. Ten caregivers were assigned to the intervention group and 10 to the standard care group. Caregiver age ranged from 40‐78 years with a mean age of 61.4 years (SD 10.0). The majority, n = 17 (85%), were female, 8 (40%) high school or lower, 12 (60%) vocational, college or more. The majority were married, 14 (70%), and employed, 12 (60%). Seven caregivers in the intervention group had vocational or higher education versus 5 in the standard care group. Caregivers reported their chronic health conditions: hypertension (n = 11), myocardial infarction or cardiovascular disease (n = 4), diabetes mellitus (n = 4), osteoarthritis/pain (n = 4), and one caregiver each reported the conditions of depression, thyroid problems, asthma, and HIV.

Interventions

Intervention: The adapted FamHFcare coaching intervention plus standard care (n = 10).

Aim: To test whether a culturally‐sensitive telephone coaching intervention could reduce patients’ HF‐related re‐hospitalisation and family caregiver burden and depression, and increase family caregiver confidence, social support, and preparedness to care

Interventionist(s): Experienced nurse interventionist

Mode of delivery: Telephone

Duration: 4 weeks (weekly calls 60‐90 minutes depending on caregiver questions and need for reinforcement).

Content: FamHFcare includes 4 weeks of post‐hospital coaching via telephone on specific HF home care skills using teach‐back strategies. FamHFcare aligns with all ACCF/AHA clinical guideline based instructions for daily sodium/fluid restrictions, medication adherence, and symptom monitoring and reporting. Prior to the first telephone session, each family received the coaching program materials by mail: (1) two AHA home caregiving guides (symptoms checklist and staying healthy guidelines for caregivers); (2) a list of local support organizations; (3) the national award winning book Comfort of Home for Chronic Heart Failure: A Guide for Caregivers; (4) low‐sodium booklet, and (5) a plastic daily pill organiser. The nurse interventionist engaged each dyad in four weekly FamHFcare coaching sessions scheduled at their convenience.

Standardisation: no details provided

Comparison group: Standard care. This included the education and materials routinely given to all HF patients through hospital discharge planning. The standard medical and nursing clinical care in both groups was not changed for this study. Standard care information is not specific to the needs of African‐Americans or to caregivers (n = 10).

Outcomes

1. Burden: a 17‐item five‐point Likert‐type scale in which higher scores indicated more burden or difficulty in providing caregiving. Response options were: 1 = providing caregiving but the task was not difficult to 5 = extremely difficult. Option “N/A = not applicable” was provided and selected by caregivers who did not provide a specific caregiving task. Higher scores indicated greater perceived burden.

2. Psychological health (depression): The Center for Epidemiologic Studies Depression Scale (CES‐D). A higher score indicated higher level of depression.

3. Skill acquisition (preparedness to care): A one‐item Likert type scale (1 = not at all, 4 = very well prepared); higher scores indicating caregivers felt better prepared.

Outcome data were collected at 6 months (medium‐term follow‐up > 3 to ≤ 6 month time point).

Notes

Author provided detail via email, which was used in the evaluation of the quality of the intervention, for example, detail on monitoring of delivery of the intervention and adherence to trial protocol.

Funding source: Award from Kansas City Life Science Institute, Blue Cross Blue Shield, Kansas City, Kansas (p.466).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make assessment

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make assessment

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"Data collectors were trained research nurses who were blinded to random assignment" (p.468)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Minimal attrition (Intervention: 2 withdrew after completing and evaluating the first two intervention sessions (one was too ill to continue and the other had a busy work schedule); Control group: 1 patient died) (p.470)

Selective reporting (reporting bias)

Low risk

None evident – all caregiver outcomes reported in Table 3 (p.471)

Other bias

Low risk

No statistically significant differences were found for caregivers or patients (p.469).

Methods

A randomised 2‐group design (June 2008‐April 2013)

Participants

Caregivers of adult patients with traumatic brain injury (TBI) from an inpatient rehabilitation unit of a level I trauma centre, Washington, USA. Caregiver age ranged from 19 to 89 years (mean 49.7; SD 13.5). The sample comprised of 82% female, 18% male, of which 79% were of a white non‐Hispanic race and 69% were married. The majority of caregivers had post‐high school education (75%), with employment ranging from working full‐time at time of injury (49%); working part‐time (18%); student (not working) (1%); unemployed (5%) and not in workforce or other (27%). Most were spouses or partners (54%) of the care‐recipient and 35% were parents.

Interventions

Intervention: An individualised education and mentored problem‐solving intervention plus usual care (n = 77).

Aim: To investigate the effect of a solely telephone‐based, individualised, combined education and problem‐solving intervention on the quality of life (QoL) and emotional well‐being of caregivers of persons with moderate to severe TBI.

Interventionist(s): A master’s level social worker with experience in prior studies of TBI and problem‐solving treatment approaches.

Mode of delivery: Telephone

Duration: Planned maximum 10 calls (20 weeks), with a target of 8 calls and 2 additional calls at the caregiver’s discretion.

Content: The experimental intervention combined education and mentored problem‐solving for topics relating to caregiving and TBI recovery and management (in addition to usual care). The focus of the intervention was on self‐management of issues by the caregivers through applied problem‐solving rather than the provision of solutions or direction to resources, or both, by study personnel. The study interventionist began each call by asking open‐ended questions to ascertain what, if any, issues had arisen or had been resolved since the last call. The caregiver was then asked to identify the concern that he or she wished to address on the call. The final choice of the concern(s) to be targeted on each call was left up to the caregiver, with no requirement to address a new issue or a previously targeted one with action plans in progress. The interventionist then mentored the caregiver in a problem‐solving approach aimed at addressing the concern.

Standardisation: No details provided, only one interventionist

Comparison group: Usual care (n = 76)

Outcomes

1. Quality of life: Adapted Bakas Caregiving Outcomes Scale (BCOS), a 15‐item, 7‐point scale that measures change in social functioning, emotional well‐being, and physical health related to caregiving. Higher scores reflected better quality of life.

2. Psychological health (depression): Brief Symptom Inventory (BSI‐18), an 18‐item instrument designed to quantify symptoms of somatisation, depression, and anxiety. Respondents use a 5‐point Likert scale to indicate the extent to which each symptom bothered them over the preceding 2 weeks. Higher scores indicated greater symptoms of depression.

3. Psychological health (coping): Modified Caregiver Appraisal (MCA); higher scores indicated better coping.

4. Health Status and Well‐Being (social activity): The PART‐O (Participation Assessment with Recombined Tools–Objective) as a measure of community participation; higher scores indicated greater social activity.

5. Knowledge and understanding (knowledge): No instrument specified, stated structured interview and Likert ratings; no detail provided on the scoring system

Data were collected at the end of intervention which was 6 months after discharge of the survivor to the community.

Notes

Funding source: Funded by the Department of Education, National Institute on Disability and Rehabilitation Research, TBI Model Systems: University of Washington Traumatic Brain Injury Model System (H133A070032) (p.180).

Author confirmed that the abstract was linked to the study. Additonal information requested from the author but not provided at the time of submission of this review.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated (p.182)

Allocation concealment (selection bias)

Low risk

Password‐protected database, "The study coordinator entered identifying information into the database and was given the group assignment (p.182).

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"An examiner blinded to the group allocation conducted the follow‐up assessments..." (p.182).

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Sample size estimates allowed for a 10% loss to follow‐up. Loss to follow‐up, however, was greater, and there was an imbalance in loss to follow‐up across the groups (23% in the intervention group and 13% in the control group). Withdrawn from the intervention group (n = 4); withdrawn from the control group (n = 0) (Figure 1, p.185).

Selective reporting (reporting bias)

High risk

Unclear how or if the prespecified secondary outcome of knowledge was reported; satisfaction not assessed due to insufficient responses at follow‐up (Table 4, p.187)

Other bias

High risk

Fewer caregivers in the intervention group providing direct financial support which could potentially influence outcome measures of QoL and emotional well‐being (p.185)

Methods

A parallel randomised trial (April 2010‐March 2013)

Participants

Caregivers of consenting people with gastrointestinal cancers receiving treatment at one of four metropolitan hospitals in Sydney, Australia, for a newly diagnosed or recurrent primary upper GI cancer, metastatic liver disease, or stage 4 colorectal cancer. Caregivers were recruited either during the patient’s hospital admission or within 2 weeks of patient discharge. Mean caregiver age in years was 54.18 (SD 13.5) and most were female (n = 93, 73%); male (n = 35, 27%). Relationship to care‐recipient was spouse or partner (n = 89, 69.5%), child (n = 29, 22.6%), parent (n = 3, 2.3%), sibling (n = 3, 2.3%), other family member (n = 1, < 1%), and friend (n = 3, 2.3%). Education ranged from none or primary (n = 6, 4.7%), intermediate certificate year 10 (n = 24, 19%), leaving certificate or year 12 (n = 20, 15.6%), technical certificate or diploma (n = 33, 25.8%), tertiary (n = 45, 35.1%). Most were employed full‐time (n = 56, 43.7%), part‐time (n = 21, 16.4%), retired (n = 28, 21.9%), unemployed (n = 5, 3.9%), or engaged in home duties (n = 18, 14.1%).

Interventions

Intervention: The Family Connect intervention (n = 64)

Aim: To investigate the effectiveness of a standardised, telephone‐based intervention to improve caregivers’ QoL in the first 3 months following a patient’s discharge from hospital. Secondary aims included evaluating the interventions effectiveness in reducing caregivers’ unmet supportive care needs, caregiver burden, and distress. The study also aimed to establish whether a caregiver‐focused intervention could also indirectly reduce patient distress, unmet need, and unplanned hospital presentations to improve overall patient QoL.

Interventionist(s): Experienced healthcare professionals (clinical psychologists with training in clinical aspects of cancer care)

Mode of delivery: Telephone

Duration: 10 weeks (biweekly for the first 3 calls and one month later the final call, mean call length ranged from 32 minutes at 2 weeks to 17 minutes at 10 weeks)

Content: The intervention involved a manualised, standardised assessment of caregiver need across the domains of patient care, maintaining family relationships and emotional and physical self‐care, as well as an assessment of information and practical needs. Within each of these domains, the manual provided a list of resources and strategies that might address identified needs, to guide the health professionals delivering the intervention. The resources provided and the level of discussion that was related to management strategies were tailored to individual caregiver needs. Strategies were based on published evidence and clinical experience.

Standardisation: All intervention calls were recorded. Recordings were used during regular sessions to provide support and further training to intervention staff and for quality assurance purposes to confirm intervention fidelity. The intervention fidelity was assessed throughout the study and remained high

Comparison group: Usual care (n = 64)

Outcomes

1. Quality of life: The Short Form (SF)‐12 v2, a 12‐item QoL questionnaire with two subscales that assesses physical and mental well‐being; higher scores indicated better quality of life.

2. Burden: Caregiver Reaction Assessment (CRA), a 26‐item questionnaire which comprises five subscales (disrupted schedule, financial problems, lack of family support, health impact, and impact on self‐esteem). Higher scores indicated greater burden.

Outcome data were assessed at 3 (end of intervention) and 6 months post‐hospital discharge (short‐term time point ≤ 3 months) using self‐administered mailed questionnaires.

Notes

The study did not specify that the intervention group also received usual care. Usual care was not defined.

Following email communication with the originators of the burden instrument (CRA), the subscale result for 'schedule disruption' was used in the analysis for this review. For the QoL outcome data, the result from the physical health subscale was used.

The authors used a substitution method to impute the data for the entire sample and that is why the number 64 was used (confirmed via email November 2017).

Authors confirmed the study outcome data collection time point and provided further detail on the study and intervention.

Funding source: The study was funded by the National Health Medical Research (NHMRC) Project Grant 632645 (p.594).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"... computer generated randomisation list" (p.587)

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to assess

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition balanced across groups (19% versus 17% at 6 mths; and reasons given (Figure 1, p.589)

Selective reporting (reporting bias)

Low risk

All outcomes reported (Table 3, p.592)

Other bias

Low risk

Baseline characteristics were similar for both groups. Demographic and clinical characteristics for participating and non‐participating patients were similar, although non‐participating patients were slightly older (p.588 and Table 1, p.590), table 2, p.591).

Methods

A randomised controlled trial design (recruitment May 2011‐May 2012)

Participants

Caregivers of people with colorectal cancer recruited from the colorectal cancer clinic of Queen Mary Hospital in Hong Kong. Caregivers were caring for a family member diagnosed with colorectal cancer in the preceding four weeks, were at least 18 years old and spoke Cantonese. Domestic helpers, those who were cognitively impaired, and those who did not speak Cantonese were excluded. Caregivers age ranged from 19‐86 years; mean age in years was 54 (SD = 14.6). Most were females (n = 103, 74%) and 37 men comprised 26% of the sample. Education ranged from Illiterate (n = 14, 10%), primary (n = 37, 26%), secondary (n = 69, 49%), tertiary (n = 19, 14%), doctorates (n = 1, < 1%). Monthly family income in Hong Kong dollars (£) for the entire sample (n = 140) ranged from, less than 10,000 (769) (n = 55, 39.28%), 10,001‐20,000 (770‐1,539) (n = 42, 30%), 20,001‐30,000 (1,540‐2,307) (n = 26, 18.57%), 30,001‐40,000 (2,308‐3,079) (n = 8, 5.71%), 40,001‐50,000 (3,080‐3,846) (n = 9, 6.4%).

Interventions

Intervention: Nurse‐led, telephone, psychoeducation programme plus usual care (n = 70)

Aim: To evaluate the efficacy of the programme in reducing depression, anxiety, stress and burden of care among caregivers of patient with colorectal cancer

Interventionist(s): Colorectal nurse specialist

Mode of delivery: Telephone

Duration: Five weeks (three structured telephone calls to the caregivers at 1, 3, and 5 weeks after discharge. Each call lasted no longer than 45 minutes).

Content: The calls sought to understand the caregivers’ situation and identify their problems so that information, as well as education and psychosocial support, could be provided. The interval between telephone calls and the content of the intervention followed a telecare protocol called individual support condition (Taylor 2008). Each call began with an enquiry about the patient’s and carer’s general condition. Specific caring problems or psychological issues were identified, and related information or psychological support was given to caregivers. The nurse also provided education to caregivers according to the patient’s needs at different recovery stages. Before the end of the call, the nurse asked about any additional problems and ensured that caregivers’ needs had been met.

Standardisation: The content of the telephone checklists and field notes were reviewed regularly to ensure accuracy and consistency and conversations were documented.

Comparison group: Caregivers received routine education on home care on discharge using an information sheet. In addition, a telephone help line number was provided (n = 70).

Outcomes

1. Quality of life: The World Health Organization Quality of Life Measure‐BREF (WHOQoLBREF) Hong Kong (HK) was used to assess quality of life and consists of 28 items covering four domains: physical health, psychological health, social relationships and environment. Higher scores indicated better quality of life.

2. Burden: The Chinese version of the Zarit Burden Scale is a 22‐item, self‐report inventory that measures carer burden. Each question was scored on a five‐point Likert scale, ranging from 0 for ‘never’ to four for ‘nearly always present’. The total score ranged from 0 to 60, with a higher score indicating greater burden.

3. Psychological health (depression, anxiety and stress): The Chinese version of the Depression, Anxiety and Stress Scale‐21 (DASS‐21) (a self‐report instrument that measures a patient’s state over the preceding week). It consists of 21 items, spread equally across three scales: depression, anxiety, and stress. Each item uses a four‐point Likert scale, ranging from 0 (‘did not apply to me at all’) to three (‘applied to me very much, or most of the time’). For depression, a score less than nine was regarded as normal, 10‐13 as mild, 14‐20 as moderate, 21‐27 as severe, and higher than 28 as extremely severe. For anxiety, a score less than seven was regarded as normal, 8‐9 as mild, 10‐14 as moderate, 15‐19 as severe, and higher than 20 as extremely severe. For stress, a score less than 14 was regarded as normal, 15‐18 as mild, 19‐25 as moderate, 26‐33 as severe, and higher than 37 as extremely severe.

Outcome data were collected at week 2 (end of intervention), 4, and 8 weeks (short‐term time point) after the intervention.

Notes

Funding sources: none stated

For the QoL outcome, the physical health subscale result was used in the analysis for this review.

Additional information requested on the published registered trial. The author responded to the queries and emailed the linked published paper. Additional data were requested in October 2018 but these data have not been provided by the author.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"A person not involved in participant recruitment generated the randomisation schedule ..." (p.32) ‐ detail of method not provided.

Allocation concealment (selection bias)

Low risk

"...sequentially numbered, sealed, opaque envelopes..." (p.32)

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"The research nurses responsible for carrying out the interviews were masked to the treatment assignment" (p.32).

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Details not provided in the paper, figure 1 (p.33); attrition minimal and accounted for

Selective reporting (reporting bias)

Low risk

All outcomes reported upon (Page 8, table 2&3)

Other bias

Low risk

No significant differences in baseline characteristics of the caregivers (p.4 and 5, table 1)

Methods

A randomised study (study dates not reported)

Participants

Ninety‐seven caregivers of frail older persons, adult child caregivers (n = 61) and spouse caregivers (n= 36) from a 16‐county area that included urban, suburban, and rural settings, New York, USA. Participants were recruited via newspaper advertisements, direct mailings, appearances before civic and religious organisations, radio announcements and referrals from geriatrics professionals. Caregivers were included if they had a minimum score of 7 or higher on the Caregiver Strain Index. Care‐recipients had to exhibit two or more activities of daily living (ADL)/instrumental activities of daily living (IADL) impairments as reported by the caregiver. Thirty‐one adult child caregivers and 33 spouses received the intervention.

The mean adult child caregiver age in years in the intervention group was 54 and in the control group was 54.9. Years spent in education was 14.3 for the intervention group and 15 for the control group. Most were female (77.4% in the intervention group and 96.7% in the control group). Male caregivers accounted for 22.6% in the intervention group and 3.3% in the control group. Most were of white race or ethnicity (87.7% in the intervention group and 96.7% in the control group); black race or ethnicity accounted for 12.9% of the intervention group and 3.3% of the control group. Relationship status ranged from married (intervention group 35.3%, control group 46.2%), single/never married (intervention group 17.6%, control group 23.1%), divorced (intervention group 29.4%, control group 30.8%), separated (intervention group 11.8%, control group 0%) and widowed (intervention group 5.9%, control group 0%).

The mean spouse caregiver age in years in the intervention group was 70.2 and in the control group was 66.2. Years spent in education was 14.1 for the intervention group and 14.3 for the control group. Most were female (86.4% in the intervention group and 92.9% in the control group). Male caregivers accounted for 13.6% in the intervention group and 7.1% in the control group. Most were of white race or ethnicity (90.5% in the intervention group and 85.7% of the control group); black race/ethnicity accounted for 9.5% of the intervention group and 7.1% of the control group. Relationship status ranged from married (intervention group 95.2%, control group 100%), single/never married, divorced, separated, and widowed (0% across groups) and 'other' accounted for 4.8% of the intervention group and 0% of the control group).

Interventions

Intervention: The telephone support group (TSG) intervention (group‐delivered) (n = 31)

Aim: To evaluate the effectiveness of a telephone support

Interventionist(s): License Master’s prepared social worker (who had several years of clinical geriatric social work experience) led all groups.

Mode of delivery: Telephone

Duration: Weekly for 12 weeks. Each weekly session lasted 90 minutes (15 minutes for hook‐up and 75 for group meeting).

Content: A multicomponent intervention that includes education about the effects of chronic illness and about emotion‐focused coping strategies, problem‐solving, and support. A leader’s manual and a participant workbook was developed. The leader’s manual was used to train the group leader and a workbook was given to each member in the TSG arm of the study. The leader instructed members to turn to the appropriate pages in the workbook each week during telephone meetings and to follow along using the structured agendas and the educational materials provided. The first half of each weekly meeting began with conference call connections using a voice‐over internet provider. After the initial period in which the leader called each member in turn, the group leader gave a brief overview of the previous meeting. Following this was a ‘‘check‐in’’ with group members regarding their progress on target goals between meetings. In order to help group members develop supportive relationships beyond the TSG program, the leader asked each of them to select a telephone buddy to call between group meetings. Conversations between telephone buddies were to focus on caregiving issues and the coping and problem‐solving skills that participants were learning. Emotion‐focused coping strategies were taught and practiced during the first half of each weekly TSG meeting. The group leader introduced problem‐focused coping skills during the second half of each meeting and practised them with the members.

Standardisation: Delivery was monitored, with one interventionist for all groups, and a leaders manual was used to train the group leader.

Comparison group: Usual services offered by the senior services centre (n = 30)

Outcomes

1. Burden: Zarit Burden Interview (ZBI), a 22‐item Likert‐type scale that measures the total strain, role strain, and personal strain that caregivers experience as a result of the impact of the patient’s disabilities on their life. For each item, caregivers indicate how often they have felt a certain way: (0) never, (1) rarely, (2) sometimes, (3) quite frequently, or (4) nearly always. Higher scores signified greater burden.

2. Psychological health (depression): Center for Epidemiologic Studies–Depression Scale (CES‐D). Respondents were asked how frequently they had experienced 20 different events in the past 7 days. These events were indicative of depression. Each event had a score of 0 (happened rarely or not at all) to 3 (most or all of the time). Higher scores indicated more depression.

3. Psychological health (anxiety): State–Trait Anxiety Inventory (STAI) —This scale measures anxiety for caregivers. It presents 20 statements that people use to describe themselves and asks caregivers the extent to which they agree (4) or disagree (1) with each statement. The final score is a summary of the answers to the 20 statements. Higher scores indicated more anxiety.

4. Skill acquisition (problem‐solving): Pressing Problems Index (PPI). Researchers developed the 18‐item PPI in order to assess the extent to which participants’ health and social service problems were being addressed. The PPI contains a list of problems that caregivers frequently encounter when caring for a family member with a chronic illness. For each problem, we asked the caregiver how stressful the problem was, from (0) not at all to (4) extremely; how much their stress had changed, from ‐3 (much worse) to 3 (completely better); how effective they had been in dealing with this problem, from 0 (not at all effective) to 4 (extremely effective); and how much their effectiveness had changed from ‐3 (much worse) to 3 (completely better). Higher scores indicated better problem‐solving.

5. Knowledge and understanding (knowledge): the 'Community Services Inventory' subscales (of services and how to access them); higher scores indicated greater knowledge.

Outcome data were collected at the end of intervention and within 2 weeks of completing the intervention.

Notes

For the outcome 'problem‐solving', the reported results for 'how effective' were used in the analysis for this review.

Mean scores for the two subscales of the 'Community Services Inventory' subscales were used for the analysis.

Unpublished data was requested; the author replied on 11 October 2017 stating that the data was no longer available.

Funding source: Project supported in part by United States Administration on Aging Grant (p.620)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to assess

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"Interviewers remained blind to the participants’ assigned condition ..." (p.622).

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient information on post‐test data to assess

Selective reporting (reporting bias)

High risk

Adult children subsample only, reported as this group ‘drove the overall effects’ (p.625)

Other bias

High risk

Adult child demographics showed significant differences between groups in terms of education with the control group having more years of education than intervention group (table 3, p.626).

Methods

Parallel group, single‐blind, randomised controlled trial (recruitment April 2015‐November 2015)

Participants

Caregivers of older people discharged from the medical assessment unit within a metropolitan tertiary hospital in Western Australia with over 600 beds. Caregivers were recruited in the hospital at the time of patient discharge. A family caregiver was defined as a family member or friend who provides unpaid personal care, support, and assistance. Inclusion criteria for dyads were that they comprised a patient aged 70 years or older being discharged to their home or the home of their family caregiver, plus a family caregiver who could speak and read English. Caregiver mean age in years for the intervention group was 63.1 (12.6 SD) and the control group 61.3 (13.4 SD). Females comprised 74% (n = 104) and males 26% (n = 37). Relationship to care‐recipient was husband (n = 13), wife (n = 29), son (n = 62), daughter (n = 14) and other (n = 104).

Interventions

Intervention: Further Enabling Care at Home (FECH) program and usual discharge care (n = 86).

Aim: The FECH intervention is intended to identify family caregivers of older patients during the hospital admission, help ensure their understanding of discharge information that has implications for the caregiving role, prompt reflection by the caregiver on this role and what is needed to help sustain this, and guide the caregiver as they identify and address prioritised needs for support (information provided by author via email).

Interventionist(s): A nurse with acute care knowledge relevant to the care of older people in poor health, knowledge of how to access local services, understanding of the family caregiver role, the capacity to work flexible hours to fit in with caregivers’ needs, and the skills to support the caregiver during the process of reflection and self‐assessment.

Mode of delivery: Telephone

Duration: Up to 40 days (planned calls were delayed). Planned calls were weekly to biweekly (call 1: within a week post‐discharge, call 2: 7‐10 days post‐discharge, call 3: 14 days after discharge). Actual call delivery: call 1 within and up to 9 (instead of 7), contact 2 within 24 (instead of 10) and contact 3 within 40 (instead of 14), days post‐discharge.

Mean and standard deviation call contact time in minutes was contact 1: 15.4 (9.6), contact 2: 59.7 (24.1) and contact 3: 28.3 (17.7).

Content: The Further Enabling Care at Home program involved the implementation of a strict telephone protocol by the specially trained nurse, using the Carer Support Needs Assessment Tool, which has fourteen items covering: (a) support that enables the caregiver to care for the patient at home, and (b) support for the caregiver in their caring role. There were three, sequential, telephone contacts. Contact 1 was planned to take place within a week post‐discharge. Contact 2 was designated to occur from 7 to 10 days post‐discharge. Contact 3 was planned to follow within 14 days of the discharge.

Standardisation: The delivery of the intervention was monitored at regular meetings with investigators responsible for this issue. Field notes were taken by the FECH nurse during intervention contacts to provide a record that allowed the discussion of cases during these meetings so that fidelity could be assured. Using this process, intervention delivery was as planned and consistent, except with respect to the planned time of the contacts, which were delayed in some instances because of the busy schedules of the caregivers. The selection and preparation of the FECH nurse, plus the use of a pre‐prepared resource manual, also helped to ensure the standardised quality of the intervention (information provided by author via email).

Comparison group: Usual discharge care (n = 89).

Outcomes

1. Burden: Caregiver strain subscale of the Family Appraisal of Caregiving Questionnaire – Palliative Care; higher scores indicated greater burden.

2. Skill acquisition (preparedness to care): Preparedness for Caregiving Scale from the Family Care Inventory; higher scores indicated better perceived preparedness to care.

2. Family functioning: Family Well‐Being subscale of the Family Appraisal of Caregiving Questionnaire – Palliative Care; higher scores indicated better family functioning.

3. Health status and well‐being (physical health): SF‐12 v2 Health Survey used for assessing physical health and not as a QoL outcome (caregiver ratings of their own health and well‐being). Higher scores indicated better physical health.

Cost: No specific instrument (intervention costs recorded include (i) nurse time for the duration of each contact; (ii) nurse time to implement and organise resources; (iii) nurse time to write notes following each contact for each patient‐carer dyad; (iv) cost of training the FECH nurse; (v) telephone charges; and (vi) stationary and postage costs. Costs in the control group were estimates of nurse time for usual discharge procedures). Higher scores indicated greater cost.

Outcome data were collected at Time 1 (within 4 days of discharge), Time 2 (15–21 days after discharge) and Time 3 (end of intervention time point, six weeks after discharge).

Notes

Unpublished mean and standard deviations along with details of the cost data collected were obtained from authors via email. Author confirmed via email that care‐recipients may have included those with an exacerbation of a chronic condition or an additional acute illness or both.

Funding source: A Department of Health Western Australia, SHRAC Research Translation Project grant (p.40).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated list of random allocations prepared prior to the study commencing, using a permuted random blocks strategy (p.35)

Allocation concealment (selection bias)

Low risk

Allocation schedule held by researcher not involved in recruitment (p.35)

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

All researchers involved in quantitative data collection were blinded to the allocation schedule and actual group assignment (p.35).

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition Intervention group 19.5%; control group 8.1% (p.37). “From the 12 dyads withdrawing after randomisation without providing data, most failed to provide a reason but three caregivers had concerns about, or difficulties with, the planned telephone data collection and one experienced a bereavement (p.37)”.

Selective reporting (reporting bias)

High risk

Physical and mental health outcomes not reported

Other bias

Low risk

No significant difference in caregiver characteristics between the groups (p.37)

No significant differences in baseline measures for outcomes (Table 2, p.38; table 3 page 39)

Methods

A randomised controlled trial (study dates not reported)

Participants

Caregivers of people with dementia recruited from memory disorder clinics, support groups, and newspaper or television advertisements in the Southern New England region of the United States of America. Caregivers were aged 21 years or older; lived with a relative with dementia in the community; and provided a minimum of four hours of supervision or direct care per day for at least six months prior to enrolment. Sixty caregivers were enrolled in the study at baseline, with 32 assigned to the treatment condition and 28 assigned to standard care. By the 12‐month assessment point, 33 caregivers had data for analysis, with 16 caregivers in the FITT‐D group and 17 caregivers in standard care. There were 20 spousal caregivers and 13 adult child caregivers. Caregiver age ranged from 41‐87 years with an overall group mean of 63.30 years (SD 11.836). The majority were female (n = 26) and male (n = 7). Both groups were similar in terms of years of education; mean caregiver years of education in the intervention group was 14.22 (3.41) and in the control group 15.88 (2.14).

Interventions

Intervention: Family Intervention: Telephone Tracking – Dementia (FITT‐D) plus a binder containing local resource information (e.g. list of support groups, adult day care centres) and educational material from the Alzheimer’s Association (n = 32)

Aim: To examine the preliminary efficacy of FITT‐D, a multicomponent intervention that is delivered in 23 telephone contacts over 12 months

Interventionist(s): Master’s level therapists (counsellors, nurses, social workers – confirmed by author email)

Mode of delivery: Telephone

Duration: One year (one initial call, then weekly for 6 weeks, 12 additional contacts every 2 weeks and 4 monthly termination calls. Initial contacts lasted 60 minutes, follow‐up contact 15‐30 minutes giving approximately 12 hours of contact between the therapist and caregiver).

Content: The calls focused on providing emotional support, directing caregivers to appropriate resources, encouraging caregivers to attend to their own physical, emotional and social needs, and teaching caregivers strategies to cope with ongoing problems. The intervention addressed a broad range of issues and problems related to caregiving. The FITT method consists of two stages. The initial stage, orientation and psychoeducation, involved providing caregivers with a rationale for the FITT, an introduction to educational and resource materials, a description of what would happen during future phone contacts and an assessment of key areas thought to be instrumental in addressing caregiver burden and mental health (i.e. caregivers’ health, functioning, mood, thinking, and family life). The psychoeducation component of this initial stage involved reviewing information about dementia and common psychological, emotional, psychosocial, and medical effects of caregiving. The second stage, follow‐up, involved weekly and biweekly contacts in which new problems were identified, positive and negative changes in caregivers or care‐recipients were discussed, and psychoeducational information was reviewed and applied for particular situations. The initial and follow‐up calls were structured around assessment of key areas of functioning in both the caregiver and care‐recipient. Specific interventions were applied at therapists’ discretion, including supportive approaches (i.e. empathy, giving permission, normalising, provision of information, validation, or venting) or more active strategies (i.e. bibliotherapy, interpretation, positive reframing, problem‐solving, reference to resource packet, referral, and setting task directives). The final four follow‐up calls (monthly) addressed issues of termination by allowing caregivers to anticipate FITT contacts coming to an end and to foster reliance on the support network established during the intervention.

Standardisation: The two therapists were trained in the FITT‐D procedure and were required to achieve at least 80% correct on a 50‐item multiple choice test about dementia and the FITT treatment manual prior to initiating treatment. Doctoral staff supervised therapists weekly to ensure adherence to the protocol and minimise drift.

Comparison group: No telephone intervention. They received a binder containing local resource information e.g. list of support groups, adult day care centres, and educational material from the Alzheimer’s Association (n = 28).

Outcomes

1. Quality of life: SF‐36 General Health; higher scores indicated better quality of life.

2. Burden:

• Burden Interview (ZBI). This 22‐item inventory assessed caregivers’ subjective feelings of the impact of caregiving on emotional and physical health functioning, social life, and financial status. Higher scores reflected greater burden. The scale has been shown to have good internal consistency, content validity, and test–retest reliability. Higher scores signified greater burden.

• Revised Memory and Behavior Problem Checklist (RMBPC). This 24‐item checklist requires caregivers to rate the frequency of problem behaviours and memory difficulties in patients during the previous week and caregiver ratings of their own reaction to each of the behaviour problems. Ratings are made on a five‐point scale for frequency of behaviour problems (0 = never occurs to 4 = occurs daily or more often) and reactions to these problems (0 = not at all bothered/upset to 4 = extremely). Higher scores indicated greater burden.

3. Psychological health (depression) Geriatric Depression Scale (GDS). The GDS is a 30‐item self‐report yes/no measure that is designed specifically for older adults by excluding somatic signs and symptoms of depression. Total scores range from 0 to 30. Higher scores indicated depression.

4. Knowledge and understanding: Alzheimer’s Disease Knowledge Test; higher scores indicated greater knowledge.

5. Health status and well‐being (self‐efficacy): Self‐Efficacy Scale; higher scores indicated greater self‐efficacy.

6. Satisfaction with the intervention: Treatment satisfaction, caregivers in the FITT‐D group completed a 12‐item treatment satisfaction questionnaire. Higher scores indicated greater satisfaction.

Date were collected at 12 months (end of intervention) via face‐to‐face assessments with caregivers at their homes.

Notes

For the outcome burden, the results from the Revised Memory and Behavior Problem Checklist (RMBPC) are used in this review.

Funding source: Grant from National Institute of Mental Health (MH62561; G.Tremont, PI) (p.516).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Urn randomisation (p.507)

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Research assistants were blinded to group membership (p.507).

Incomplete outcome data (attrition bias)
All outcomes

High risk

Intervention group: n = 15 (47%) (n = 11 due to death of care‐recipient); control group: n = 12 (43%) (n = 4 due to death of care‐recipient) (p.511)

Selective reporting (reporting bias)

High risk

Provided results on the main outcomes (burden and depression) and reported on the additional measure to address secondary goal of the intervention but did not report actual statistics for QoL, self‐efficacy, knowledge, and satisfaction with the intervention (p.513).

Other bias

Low risk

No baseline imbalances (Table 1, p.511). Analysis of differences between those who completed and did not complete the 12‐month assessment and whose care‐recipients had died showed that care‐recipient age was the only statistically significant difference between the groups (p.511).

Methods

Randomised controlled trial (pilot study) (November 2014 ‐December 2015)

Participants

Non‐professional caregivers of people with various conditions recruited from an official register of caregivers maintained by the Ministry of Labor and Welfare of the Government of the Autonomous Community of Galicia to North West Spain. Conditions included: diseases of the musculoskeletal system, connective tissue, cardiovascular and respiratory (19.7%, n = 12), chromosomal, congenital and perinatal abnormalities (23.0%, n = 14), mental disorders, neurological diseases, brain damage (18.0%, n = 11), dementia (39.3%, n = 24). Caregiver mean age was 58.4 (SD 8.0, range 42‐75 years). The majority (93.4%, n = 57) were female and 6.6% (n = 4) were male. Caregivers were caring for either father or mother (n = 21, 34.5%), son or daughter (n = 24, 39.3%) or other (n = 16, 26.2%) and had been involved in caregiving for an average of 12.3 years (SD 5.7) providing an average of 17.1 hours of care per day (SD 2.1). Forty caregivers (65.6%) were couples (married or had partners), 50.8% (n = 31) were of low or low middle social class, 49.2% (n = 30) were from middle, middle high or high social class. The majority (65.6%, n = 40) were literate or had a primary education; 34.4% (n = 21) had high school or university education. Most (63.9%, n = 39) had responsibility for housework and 36.1% (n = 22) were retired, employed or unemployed.

Interventions

Intervention: A cognitive behavioural intervention via group conference call (CBC) (n = 20) and a behavioural activation intervention through group conference call (BAC) (n = 22) (group delivered conference calls, approximately 5/group)

Aim: To assess the feasibility/acceptability of a preventive cognitive‐behavioural intervention implemented via conference call for caregivers, and to conduct a preliminary assessment of the efficacy of the behavioural activation component alone compared to the complete cognitive behavioural intervention

Interventionist(s): Four psychologists

Mode of delivery: Telephone

Duration: 5 weeks (weekly 90‐minute sessions)

Content: Prior to the study, CBC and BAC intervention protocols were developed.

The CBC intervention was based on a multifactorial integrative model of depression and was adapted from a proven indicated prevention program for depression previously implemented as a face‐to‐face group format.

The BAC intervention was also adapted from prior work but in this case the intervention focused solely on the behavioural activation component.

Standardisation: Training consisted of 35 hours for each of the interventions including contents, viewing videos, and role‐playing exercises and was administered by two clinical experts in both therapies, each with over 20 years of experience. Each intervention session was audio‐taped and protocol adherence was evaluated by one of two experienced clinicians. These clinicians also provided weekly therapist supervision. Therapist protocol adherence was 93% for CBC and 95% for BAC, indicating that the primary elements of the protocol were all administered.

Comparison group: No intervention (n = 19)

Outcomes

1. Psychological health (depression)

• The Structured Clinical Interview for DSM‐IV Axis I Disorders Clinician Version (SCIDCV) IInstrument was used to assess Axis 1 disorders including major depressive disorders.

• The Center for Epidemiologic Studies Depression Scale (CES‐D‐Spanish version), which consists of 20 items with four Likert scale answer choices ranging from 0 (rarely or never) to 3 (most of the time). The total score ranges from 0 to 60, with a higher score corresponding to greater depressive symptomatology.

2. Satisfaction with the intervention: Client Satisfaction Questionnaire [CSQ‐8]. The CSQ‐8 is an 8‐item scale with 4 response options and a total score ranging from 8 to 32, with a higher score indicating greater satisfaction with the service received.

Outcome data were collected at the end of intervention.

Notes

For the outcome depression, the reported results for 'The Center for Epidemiologic Studies Depression Scale (CES‐D‐Spanish version)' were used in the analysis for this review.

On behalf of the principal investigator, Prof. Fernando L. Vázquez , Patricia Otero, PhD advised via email on the 6th August 2017 that at the time of this review a doctoral thesis was being finalised in which the efficacy of the clinical trial was being analysed. The pilot study for the trial which was published is included in this review for analysis. Patricia Otero PhD advised that the findings of the doctoral thesis are in the line with the pilot study. Details of the pilot study in terms of characteristics of the care‐recipients, the adaptation of the intervention, and intervention monitoring for the pilot study linked to this registered trial were provided by the study authors.

Funding source: Work supported by the Ministry of Economy and Competitiveness of Spain (2012‐PN162 (PSI2012‐37396)) (p.594).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

An independent statistician randomly assigned participants to groups using the table of random numbers (p.939).

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"All pre‐ and post‐treatment assessments were conducted face‐to‐face by trained interviewers not directly involved in the research study and who were blind to the group to which each participant had been assigned" (p.940).

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Minimal attrition (2:2:1); balanced across groups and reasons provided (Figure 1, p.939)

Selective reporting (reporting bias)

Low risk

All relevant outcomes reported (p.943)

Other bias

Low risk

No remarkable or clinically relevant baseline differences, suggesting that randomisation had resulted in a balanced pilot study (p.940)

Methods

Randomised controlled trial (October 20018‐July 2010)

Participants

Informal caregivers of people with dementia recruited mainly from the areas of Berlin/Brandenburg and Thuringia, Germany. Most of the caregivers were recruited via print media (80%). Some participants learned about the study via the internet (6%), cooperating institutions (5%), relatives and friends (4%), practitioners (2%), television (2%), or radio (1%).

Caregivers were included if they had the main responsibility for caregiving for a patient with a diagnosis of Alzheimer’s disease and a Global Deterioration Score > 3 as rated by the screening person based on the caregiver’s report. Caregivers were also required to have no simultaneous psychotherapy, no obvious cognitive impairment (estimated in the comprehensive screening procedure through assessor’s evaluation), and no severe acute mental and/or physical illness.

Mean caregiver age was 62.01 years (SD = 9.33) and females comprised 82.2% (n = 157) of the sample. Most were spouses or partners (n = 76, 39.8%) and daughters or daughters‐in law (n = 75, 39.3%) of the care‐recipients. Of the male participants, more partners (n = 21, 11%) than sons or sons‐in‐law (n = 12, 6.3%) were included.

Interventions

Intervention: CBT (n = 50)

Aim: To analyse whether caregivers of the intervention group reported better well‐being and health post‐treatment than caregivers of an untreated control group and an attention control group (treated with progressive muscle relaxation (PMR)), and whether these benefits were maintained at 6‐month follow‐up

Interventionist(s): Six experienced clinical therapists (Master’s Degree)

Mode of delivery: Telephone

Duration: 3 months

Content: This is a multicomponent intervention focused on managing the behaviour problems and personality changes of the care‐recipient, reduction of social isolation, assisting in utilization of professional and informal support, stress reduction, emotion regulation, reinforcement of positive activities, and supporting acceptance of role change and loss. The intervention included a therapeutic manual consisting of five CBT intervention modules, matched to the needs of the caregivers of people with dementia.

Standardisation: Interventionists attended intensive pre‐intervention training with twice‐monthly supervision during the delivery of the intervention, which was carefully monitored based on intervention documentation (date, duration, content) and audiotaping of each session.

Comparison group: Untreated control group (n = 50)

Outcomes

1. Psychological health (depression) German version of the 20‐item Center for Epidemiologic Studies Depression Scale (CES‐D). Higher scores indicated greater symptoms of depression.

2. Satisfaction with the intervention: A 5‐point Likert scale (where 1 = very good, 2 = good, 3 = average, 4 = below average, 5 = unsatisfactory). Lower scores indicated greater satisfaction.

Data were collected at the end of intervention and at 6 months, the medium‐term follow‐up time point.

Notes

In this study, a second 'selected' non‐randomised experimental group was created where all sessions were delivered by telephone. This non‐randomised arm of the study did not fulfil our inclusion criteria. The study was deemed as meeting our inclusion criteria because the findings from the randomised experimental group were provided by the author. The attention‐only arm was excluded from our review as it was administered over the phone.

Funding source: The study was supported by a grant from the German Federal Ministry of Health (LTDEMENZ‐44‐092) (p.43).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

An independent data management and biometry centre was involved to ensure blinded randomisation. The random number generator Random.org was used for randomisation (p.30).

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to assess

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

An independent data management and biometry centre was involved for blinded assessment (p.30).

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

The experimental group to which the reported loss to follow‐up related was not specified.

Selective reporting (reporting bias)

Low risk

All prespecified outcomes for this review were reported (p.38 and 39).

Other bias

High risk

Significant differences between untreated control group and experimental group in terms of perceived health (p.31)

Methods

A randomised, controlled, 2‐group design (study dates not reported)

Participants

Female caregivers of community‐dwelling individuals with dementia from Philadelphia in United States of America. Caregivers were included in the study if they were female, 50 years of age or older, providing care for a minimum of 6 months to a relative with a physician’s diagnosis of Alzheimer’s disease or related disorders (ADRD), and having weekly access to a telephone for at least 1 hour. Caregiver mean age was 66.6 years (SD = 9.1; range, 51‐86); 68.3% were white, and the remaining caregivers were African‐American. Most were educated beyond high school (51.0%), 35.6% were high school graduates, and 10.6% had less than 12 years of education. Wives constituted 57.7% of the sample.

Interventions

Intervention: Telesupport groups (group delivered teleconference, approximately 5/group) (n = 58)

Aim: To enhance caregiver ability to manage daily stressors by providing emotional support and validation

Duration: 6 months (weekly for one hour)

Interventionist(s): Trained social workers

Mode of delivery: Telephone

Content: Caregivers used their own telephones with no charge. Initially, facilitators focus on developing group cohesion. As groups progress, disclosure of intimate problems and personal conflicts emerge. Caregivers express emotions and share coping strategies including cognitive reframing and practical approaches to organising care routines. They also assist each other in problem‐solving and share educational resources. The mutual support and validation provided by group members normalise experiences and provide a supportive social network, core to the service model.

Standardisation: No detail provided

Comparison group: Usual care (n = 45)

Outcomes

1. Burden: The 22‐item Zarit Burden scale. Caregivers report the extent of agreement on a scale ranging from 0 (never/not at all) to 4 (always/extremely) in accordance with the scale item. Responses were summed to produce a total score ranging from 0 to 88, with high scores indicating greater burden.

2. Psychological health (depression): The 20‐item Centers for Epidemiological Studies–Depression Scale (CES‐D). The response format for each item is 0 (never or rarely) to 4 (always). Scores were summed, with higher scores indicating greater depression and a score of 16 or higher indicative of depressive symptoms.

3. Skill acquisition (competence): The 6‐item scale adapted from Kaye’s Gain Through Group Involvement Scale to assess the extent to which caregivers perceive personal gains over the past few months in new friendships, knowing what to do when lonely, how to handle the blues, how to handle stress, how to find health care or other resources, and ability to deal with family relationships. Responses to each item were not at all (1), a little (2), or a great deal (3). The sum of the 6 items was calculated, yielding a possible range from 6 to 18. The actual range was 7. Higher scores indicated greater competence.

Outcome data were collected at 6 months from baseline i.e. the end of intervention.

Notes

Funding source: Funds from the Alzheimer’s Association awarded to Laura N. Gitlin, PhD (p.391).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to assess

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to assess

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Just stated that 94 (91.3%) were available for the 6‐month telephone interviews. Among these, 81 were still caregiving at home; the remaining had placed their relative in nursing home facilities or were bereaved (p.393).

Selective reporting (reporting bias)

Low risk

All outcomes reported (p.394 table 2)

Other bias

High risk

Those randomised to the experimental group were significantly older than those in the control group. Control group subjects scored slightly higher than the treatment group on gains (p.393 and table 1).

Methods

A prospective 2 × 3 randomised control group design (September 2005‐April 2007)

Participants

Spouse or partner caregivers of veterans with moderate‐to‐severe dementia identified via (a) the Veterans Information System Technology Architecture Patient Care database activity indicating an encounter coded for a dementia diagnosis, (b) clinician referral, (c) self or family referral in response to information and publicity about the study. The study was conducted in New York, United States of America. Caregivers were primary caregivers who lived with the person for at least one year, and exhibited at least a moderate level of caregiving strain as defined by a score of 7 or more. Caregivers mean age was 73.94 years (SD not reported). Mean years of caregivers education in the intervention group was 12.69 (SD 3.04) and in the control group 12.34 (SD 2.40). Mean monthly income (US dollars) was similar across the two groups; intervention group (2784.22, SD 1351.47) and control group (2420.75, SD 1376.32).

Interventions

Intervention: The Telehealth Education Program (TEP) (group‐delivered, up to 8/group) (n = 83)

Aim: To address major areas that can be problematic for caregivers who want to continue to take care of the veteran with dementia at home: (a) verbal and nonverbal communication, (b) effective structuring of caregiver–patient interactions, (c) management of challenging behavioural problems, and (d) accessing resources and planning for the future.

Interventionist(s): Four trained group leaders (three masters‐prepared social workers and one nurse dementia care manager) with expertise in geriatrics led the support groups.

Mode of delivery: Telephone

Duration: 10 weeks (group format in groups of up to 8, 1 hour telephone meetings)

Content: A TEP participant workbook and leader manual were developed for the project. Caregiver participants followed a TEP participant work­book at each of the sessions and weekly homework assignments were included. The TEP group intervention protocol included three primary components: (a) education about dementia and its symptoms and about caregiving skills and resources to address these symptoms, (b) emotion‐focused (such as relaxation and self‐care strategies) and problem‐focused coping strategies (such as problem‐solving and caregiving skills), and (c) group support. TEP content was designed to address major areas that can be problematic for caregivers who want to continue to take care of the veteran with dementia at home: (a) verbal and nonverbal communication, (b) effective structuring of caregiver–patient interactions, (c) management of challenging behavioural problems, and (d) accessing resources and planning for the future.

Standardisation: No detail provided

Comparison group: Usual care (n = 75)

Outcomes

Cost: No specific instruments. Veteran health care cost and utilisation data were collected from national abstracts of the VA’s Decision Support System (DSS) and the fee basis files hosted at the VA Austin Automation Center (AAC).

For each participant, all cost and utilisation data were summed over 6‐month time intervals, resulting in a total value for each of three data collection periods: baseline (0–6 months before the intervention), short‐term follow‐up time point (from intervention start to 6 months following the start of the intervention), and medium‐term follow‐up time point (from 6 to 12 months after the start of the intervention).

Notes

The information reported was from a paper linked to the registered trial.

VA and VMCA were not explained but they appear to be the names or linked to the name of the health care centres/organisations.

Additional unpublished results requested via email in October 2017; results not received at the time of submission of this review

Funding source: Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (IIR 03‐076‐01) (p.631)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to assess

Allocation concealment (selection bias)

Unclear risk

Insufficient information to assess

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Unable to blind due to nature of the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Stated that “…data were extracted by one of the investigators (Jian Gao) who was blind to the participants’ group membership” (p.626)

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient information to assess

Selective reporting (reporting bias)

Low risk

All stated outcomes reported

Other bias

Unclear risk

Insufficient information to assess. Stated “no statistically significant differences between participants in the two conditions at baseline” (p.627). This referred to caregivers only but results were based on patient hospitalisation and this may have impacted on outcomes.