The effectiveness of text messages support for diabetes self-management: protocol of the TEXT4DSM study in the democratic Republic of Congo, Cambodia and the Philippines.

Background: People with diabetes find it difficult to sustain adequate self-management behaviour. Self-Management Support strategies, including the use of mobile technology, have shown potential benefit. This study evaluates the effectiveness of a mobile phone support intervention on top of an existing strategy in three countries, DR Congo, Cambodia and the Philippines to improve health outcomes, access to care and enablement of people with diabetes, with 480 people with diabetes in each country who are randomised to either standard support or to the intervention. Design/methods: The study consists of three sub-studies with a similar design in three countries to be independently implemented and analysed. The design is a two-arm Randomised Controlled Trial, in which a total of 480 adults with diabetes participating in an existing DSME programme will be randomly allocated to either usual care in the existing programme or to usual care plus a mobile phone self-management support intervention. Participants in both arms complete assessments at baseline, one year and two years after inclusion. Glycosylated haemoglobin blood pressure, height, weight, waist circumference will be measured. Individual interviews will be conducted to determine the patients’ assessment of chronic illness care, degree of self-enablement, and access to care before implementation of the intervention, at intermediate moments and at the end of the study. Analyses of quantitative data including assessment of differences in changes in outcomes between the intervention and usual care group will be done. A probability of <0.05 is considered statistically significant. Outcome indicators will be plotted over time. All data are analysed for confounding and interaction in multivariate regression analyses taking potential clustering effects into account. Differences in outcome measures will be analysed per country and realistic evaluation to assess processes and context factors that influence implementation in order to understand why it works, for whom, under which circumstances. A costing study will be performed. Discussion: The intervention addresses the problem that the greater part of diabetes management takes place without external support and that many challenges, unforeseen problems and questions occur at moments in between scheduled contacts with the support system, by exploiting communication technology. (aut.ref.

The effect of text message support on diabetes self-management in developing countries: a randomised trial.

Objective: mHealth interventions have the potential to facilitate self-management. This TEXT4DSM study implemented a mobile phone intervention in existing diabetes programmes in three low- and middleincome countries (Democratic Republic of Congo, Cambodia, and the Philippines). Research design and methods: Sub-studies with a similar randomised controlled trial design were conducted in three different countries. Each sub-study included 480 adults with diabetes. Subjects were randomised to receive either routine care or routine care plus text message self-management support. The primary outcome was the difference in the proportion of subjects with well-controlled diabetes after 2 years. Results: Baseline and 2-year HbA1c measurements were available for 781 individuals. After 2 years, the proportion of subjects with controlled HbA1c was 2.8% higher in the intervention group than in the control group (difference not statistically significant). In the logistic regression model, the odds ratio for having controlled diabetes after the intervention was 1.1, after adjusting for baseline HbA1c level, sex, receiving insulin treatment, and participating in the routine programme. The HbA1c dynamics over time differed between programmes; the number of people with controlled diabetes tended to increase in DR Congo and decrease in Cambodia. Conclusion: This study was the first to test the same mHealth intervention in different countries. The finding that text messages did not show an additional effect on diabetes control implied that expectations about mHealth should be cautious. The degree of coverage, the quality of the routine programme, and the progression of disease can interfere with the expected impact. Trial registration: ISRCTN registry (86247213). (aut. ref.