Trials. 2025 Nov 6;26(1):473. doi: 10.1186/s13063-025-09209-7.
ABSTRACT
BACKGROUND: According to the WHO, more than 50% of patients do not take their medications as prescribed. Nonadherence is caused by several variables, including social and economic factors, issues with the healthcare team and system, problems related to specific diseases, characteristics of those diseases, and their treatments.
OBJECTIVE: To study the effectiveness of the PARTICIPATE intervention at the community level regarding medication adherence among adults with diabetes and/or hypertension in rural India.
STUDY DESIGN: This is a multicentre cluster randomised trial implemented across 4 blocks (64 villages) of 4 districts in East, West, North, and South India, covering 2880 randomly selected participants. A nested economic evaluation will measure the effectiveness of community-based participatory research (CBPR). The intervention will be delivered by peer educators identified from the community for a duration of 12 months, with the first 6 months followed by monthly sessions for the next 6 months. The control group will continue to receive all aspects of standard care offered by healthcare providers (public or private).
METHODS: The measure of drug adherence for hypertension and/or diabetes, as determined by the self-reported Morisky Medication Adherence Scale (MMAS-8) at baseline, midterm, and end, is the study’s outcome variable. The independent variables, namely socio-economic status, number of antihypertensive and/or antidiabetic drugs, their duration, self-perceived health status, systolic and diastolic blood pressure, and/or HbA1c, will be controlled for during the analysis. Secondary outcomes include improvement in health literacy using the All Aspects of Health Literacy Scale (AAHS), clinical outcomes, quality of life using the EURO-QoL (EQ-5D), cost-effectiveness, and return on investment (ROI). Process evaluations will be conducted with a sub-sample of participants to examine engagement in various intervention components. The fidelity of intervention will be monitored using the Normalisation Process Theory framework.
DISCUSSION: To the best of our knowledge, this is the first multi-centre cluster randomised controlled trial in India to assess the effectiveness of the CBPR approach for improving medication adherence among diabetics and hypertensive patients. The results of this study will contribute to the evidence base for scaling up peer-educator models for diabetes and hypertension management in India and similar low- and middle-income countries.
TRIAL REGISTRATION: The registration number for this trial is CTRI/2024/01/061939.
PMID:41199367 | DOI:10.1186/s13063-025-09209-7
