Methods

RCT (3 arms, study duration 12 months)

Participants

Paediatric patients (aged 8 to 18 years) with Type 1 Diabetes Mellitus receiving conventional insulin therapy attending a clinic in Tayside, Scotland. A total of 92 patients were randomised, of which 89 received their allocated interventions and data were analysed for 90 patients (Group 1 n = 27; Group 2 n = 32; Group 3 n = 31).

Interventions

Participants were randomly assigned to one of three groups: 1) Conventional Insulin Therapy (CIT); 2) CIT with SweetTalk intervention; or 3) Intensive Insulin Therapy (IIT) with SweetTalk intervention. We excluded the third arm from this review.

Sweet Talk is an automated, scheduled text‐messaging system designed to offer regular support to patients with diabetes to optimise their self‐management and diabetes control. Patients contract personal diabetes self‐management goals during the diabetes consultation and, based on these goals and patients' age, sex and diabetes regimen, SweetTalk schedules the automated delivery of a series of appropriately‐tailored text messages, including a weekly reminder of the goal set in clinic, and a daily message providing tips, information or reminders to reinforce this goal. In addition, patients receive occasional text newsletters regarding topical diabetes issues.

Outcomes

Primary outcomes:

• Glycaemic control, assessed by HbA1c.

• Behavioural change, measured by a series of validated psychological measures including: self‐efficacy for diabetes score (SED), diabetes knowledge score (DKN), and the diabetes social support interview (DSSI).

Secondary outcomes:

• Episodes of diabetic ketoacidosis (DKA).

• Severe hypoglycaemia.

• Body mass index.

• Health service utilisation.

Outcome measures were determined at baseline and at the end of the study (12 months).

Notes

Mobile phones and ongoing technical support for the study were provided by Orange.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A computer‐generated allocation sequence was used to assign participants to one of three groups.

Allocation concealment (selection bias)

Low risk

Allocation is said to have been concealed.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

At the end of the study (12 months) 4/27 patients were missing from Group 1 (3 discontinued therapy for clinical reasons, 1 withdrew), 6/33 missing from Group 2 (5 discontinued therapy for clinical reasons, 1 moved away), and 5/29 missing from Group 3 (5 discontinued therapy for clinical reasons). The number of patients who discontinued the intervention is comparable in all 3 groups and relatively small. Unlikely to influence results.

Selective reporting (reporting bias)

Unclear risk

Study protocol was not available but data presented match the outcome measures described in the methods section. Likely free of selective reporting.

Other bias

Low risk

Intervention and control groups were comparable at baseline; no other sources of bias were identified.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Blinding of participants was not possible due to nature of the intervention. Blinding of researchers was not discussed, but likely not done. Unlikely to influence outcome measures.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information on blinding of outcome assessment.

Methods

RCT (2 arms, study duration 3 months)

Participants

Diabetes patients (aged 12 to 25 yrs) on insulin treatment (n = 40).

Interventions

The Computerized Automated Reminder Diabetes System (CARDS) includes a web‐based module and a messaging/reminder module designed to run autonomously. Participants log into the system via a secure website where they can customize their schedule for reminder messages, and view, edit, and print their blood glucose (BG) diaries. Participants can opt to receive two daily factoids: one related to diabetes education/nutrition and one with trivia. At a pre‐set time, CARDS sends a reminder to check the BG either by cell phone text message (intervention) or by email (control). After a user submits a BG value, regardless of the result, (s)he receives positive feedback. If the submitted BG value is out of range, CARDS provides a warning to take appropriate action according to the healthcare team's recommendations, and then recheck the BG.

Outcomes

Primary outcomes: Number of BG results submitted.

Secondary outcomes: HbA1c (%).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Participants were "randomized to receive reminders either via cell phone text messaging or by e‐mail". No further information on the method or randomisation was presented.

Allocation concealment (selection bias)

Unclear risk

No information on concealment.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Data presented for all patients randomised. Presumably no loss to follow‐up.

Selective reporting (reporting bias)

Unclear risk

Study protocol was not available but data presented match the outcome measures described in the methods section. Likely free of selective reporting.

Other bias

Low risk

There were no significant differences between the email (control) and cell phone (intervention) groups at baseline; no other sources of bias were identified.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Blinding of participants was not possible due to nature of the intervention. Blinding of researchers was not discussed, but likely not done. Unlikely to influence outcome measures.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information on blinding of outcome assessment.

Methods

RCT (2 arms, study duration 24 weeks, cluster randomisation)

Participants

Ambulatory hypertension (HT) patients (aged over 18 yrs) whose HT was not well uncontrolled with monotherapy, and who were eligible for treatment with a combination of a single‐dose angiotensin II antagonist and a diuretic (n=67).

Excluded were patients: a) on treatment with 2 or more antihypertensive drugs; b) with secondary HT; c) with known contra‐indications for any of the antihypertensive drugs to be used; d) whose clinical condition might have interfered with the study; e) who were participating in other research studies; f) who lived with a person who was being treated with the same antihypertensive drug; or g) who were unable to give their informed consent.

Interventions

Patients in the intervention group were subscribed to an SMS alerting system programmed to generate random messages. The aim of the messages was to provide information on HT, promote compliance, and good health and dietary habits, and remind patients to take their medication. Two messages were sent per week on randomly chosen weekdays during the 6‐month study period. Receipt of the messages was free to participants in the study and independent of their telephone service operator.

Outcomes

Primary outcomes:

• Percentage compliance (PC)

• • Monthly;

  • At the end of the study;

  • Cumulative at the end of follow‐up;

  • Change from one follow‐up visit to the next.

Secondary outcomes:

• Blood pressure;

• Body weight.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Researchers were randomised to 1 of the 2 groups with a random number table.

Allocation concealment (selection bias)

Unclear risk

No information on concealment.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

After 24 weeks data for 3/36 patients were missing from the control group and 2/36 missing from the intervention group due to lack of record of the number of tablets consumed. The reasons for loss to follow‐up are similar in both groups and unlikely to affect the results.

Selective reporting (reporting bias)

Unclear risk

Study protocol was not available but data presented match the outcome measures described in the methods section. Likely free of selective reporting.

Other bias

Low risk

Intervention and control groups were comparable at baseline; no other sources of bias were identified.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Blinding of participants was not possible due to nature of the intervention. Blinding of researchers was not discussed, but likely not done. Unlikely to influence outcome measures.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information on blinding of outcome assessment.

Methods

RCT (2 arms, study duration 16 weeks)

Participants

Patients with moderate persistent asthma for at least 6 months and being treated with inhaled corticosteroids and long acting beta agonist at a general hospital clinic in Zagreb, Croatia (n=16).

Interventions

Patients in the intervention group were instructed to send their Peak Expiratory Flow (PEF) results daily via text message to a mobile telephone connected to a computer running the Asthma Center 0.90 Software. The software automatically computed maximal, minimal, and mean PEF, PEF variability, and compliance. Patients also received weekly instructions by text message from an asthma specialist on adjustments of therapy and recommended follow‐up based on the PEF values received by text message. Patients in both the intervention and control groups were treated according to GINA guidelines and kept paper asthma diaries.

Outcomes

Pulmonary Function Test results (Forced Expiratory Volume in the first second (FEV1), PEF variability, Forced Vital Capacity); compliance with PEF measurements; asthma symptoms (cough, night symptoms, wheezing, limitation of activity); daily consumption of inhaled medicine and; cost to patient and provider.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Patients were randomised by computer into either the SMS study group or the control group. Although it is not explicitly mentioned, this suggests use of a random number sequence.

Allocation concealment (selection bias)

Unclear risk

No information on concealment.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No patient withdrew from the study after enrolment.

Selective reporting (reporting bias)

Unclear risk

Study protocol was not available but data presented match the outcome measures described in the methods section. Likely free of selective reporting.

Other bias

Unclear risk

Intervention and control groups comparable at baseline. However, the study "is limited by the small number of patients and by the particulars of the population studied. The follow‐up period may not have been sufficiently long to reveal all significant differences between the groups."

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "The study was not blinded, but this, we believe, has not influenced the outcome. First, compliance was not significantly different in the two groups. Second, the patients in both groups were managed by the same current guidelines."

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information on blinding of outcome assessment.