A randomized controlled trial of medication adherence and management of risk factors for secondary prevention of stroke (MaMoRS) using a smartphone-based application

Abstract

Background: There are little data on the use of smartphone-based applications for medication adherence and risk-factor control for the secondary prevention of stroke in low-and-middle-income countries (LMICs). Aims: The aim was to determine whether a smartphone-based app improved medication adherence, risk-factor control, and provided health education to stroke survivors for lifestyle and behavioral modifications. Methods: An unblinded, single-center randomized controlled double arm trial with 1:1 allocation among stroke survivors was performed in South India. The primary outcome was medication adherence, with co-primary outcomes of lifestyle and behavioral factors and control of vascular risk factors, at 3 and 6 months. Results: Among 351 stroke survivors screened, 209 were recruited. The mean (standard deviation (SD)) age of the intervention (n = 105) group was 60 (12) years and that of the control (n = 104) group was 60 (10) years. In the primary outcome, mean medication adherence significantly improved in the intervention group with a between group difference of 0.735 (95% confidence interval (CI) = 0.419 to 1.050), p < 0.001. Being in intervention group (OR = 4.5; 95% CI = 2.3 to 8.9), stroke recurrence (OR = 3.3 (95% CI = 1.9 to 7.8)), and regular physician visits (OR = 2.1; 95% CI = 1.0 to 4.4) were significant predictors of good medication adherence. Considering the co-primary outcomes, compared to the control group, participants in the intervention group had a greater improvement in self-reported healthy diet intake (p = 0.003), intake of fruits (p = 0.005), and were physically more active (p = 0.001). At 6 months, mean fasting blood sugar (p = 0.005) and high-density lipoprotein cholesterol higher (p = 0.024) in the intervention group. Conclusions: The use of a mobile app is an effective method to improve medication adherence and risk-factor control in stroke survivors and is feasible in LMICs like India. Data access statement: Data used during the study are available from the corresponding author on request. Trial registration: The study is registered in Clinical Trial Registry of India (CTRI/2022/06/042980).