OBJECTIVE: We sought to determine whether a novel mHealth intervention is useful in enhancing antihypertensive therapy adherence and treatment outcomes among patients with hypertension in a low- to middle-income country.

METHODS: A 6-month parallel, single-blinded, superiority randomized controlled trial recruited 439 patients with hypertension with poor adherence to antihypertensive therapy and access to smartphones. An innovative, multifaceted mHealth intervention (Multi-Aid-Package), based on the Health Belief Model and containing reminders (written, audio, visual), infographics, video clips, educational content, and 24/7 individual support, was developed for the intervention group; the control group received standard care. The primary outcome was self-reported medication adherence measured using the Self-Efficacy for Appropriate Medication Adherence Scale (SEAMS) and pill counting; the secondary outcome was systolic blood pressure (SBP) change. Both outcomes were evaluated at baseline and 6 months. Technology acceptance feedback was also assessed at the end of the study. A generalized estimating equation was used to control the covariates associated with the probability of affecting adherence to antihypertensive medication.

METHODS: We chose a double-blinded pragmatic randomized-controlled with factorial design for this investigation. The trial is going to recruit 1648 hypertensive patients with coronary artery disease at the age of 21 to 70 years. All participants will already be on anti-hypertensive medication and own a smartphone. They will be randomized into four groups with each having 412 participants. The first group will only receive standard care; while the second group, in addition to standard care, will receive monthly Ed-counselling (educational booklets with animated infographics and peer counseling); the third group will receive daily written and voice reminders and an education-led video once weekly together with standard care; while the fourth one gets both interventions given to second and third groups respectively. All groups will be followed-up for 1 year (0, 6, and 12 months). The primary outcome will be the change in systolic blood pressure while secondary outcomes include health-related quality of life and changes in medication adherence. For measuring changes in systolic blood pressure (SBP) and adherence scores difference at 0, 6, and 12 months between and within the group, parametric (ANOVA/repeated measure ANOVA) and non-parametric tests (Kruskal-Wallis test/Friedman test) will be used. By using the general estimating equation (GEE) with negative binomial regression, at 12 months, the covariates affecting primary and secondary outcomes will be determined and controlled. The analysis will be intention-to-treat. All the outcomes will be analyzed at 0, 6, and 12 months; however, the final analysis will be at 12 months from baseline.