Project Details

PARTICIPATE Project
Ongoing

PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hypertension (PARTICIPATE)

Duration: 3 Years Funding: ICMR Website: Project Link

Project Overview

The 3-year PArticipatory Research model for medicaTion adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) implementation research project is funded under the Safe and Rational Use of Medicines (SRUM) initiative of the Indian Council of Medical Research (ICMR). It assesses the effectiveness, cost-effectiveness, and return of investment of peer-educator led intervention for improving medication adherence for diabetes and hypertensive patients in semi-urban and rural areas of Indore, Madhya Pradesh; Kangra, Himachal Pradesh; Cuttack, Odisha and Tirunelveli, Tamil Nadu in 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.

Participating Institutions

  • Sri Aurobindo Medical College & P.G. Institute
  • Assam University
  • MS Ramaiah University of Applied Sciences
  • SCB Medical College & Hospital
  • Dr R P Government Medical College
  • Directorate of Medical Education & Research TamilNadu
  • Tirunelveli Medical College
  • Adherence Cartography

Publications

Reddy, P., Jha, A., Gupta, H., Verma, V., Kumar, D., Bansal, A. K., … & John, D. (2025). Effectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: study protocol for a multi-centre cluster randomised trial in rural settings across India (PARTICIPATE study). Trials, 26(1)

John, D., Reddy, P., Jha, A., Gupta, H., Kumar, D., Bansal, A. K., … & Anand, T. (2025). Protocol for the economic evaluation alongside the PARTICIPATE (PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion) multicenter cluster randomized trial. BMJ Open, 15(7), e094185