Scholarlink

Background <p>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.</p> Objective <p>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.</p> Study design <p>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&#xa0;months, with the first 6&#xa0;months followed by monthly sessions for the next 6&#xa0;months. The control group will continue to receive all aspects of standard care offered by healthcare providers (public or private).</p> Methods <p>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.</p> Discussion <p>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.</p> Trial registration <p>The registration number for this trial is CTRI/2024/01/061939.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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)

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年11月6日

查看全文
  • Pooja Reddy,
  • Anuja Jha,
  • Harshal Gupta,
  • Vivek Verma,
  • Dinesh Kumar,
  • Avi Kumar Bansal,
  • Smita Mahapatra,
  • Tanveer Rehman,
  • Sudhira Kumar Parida,
  • Mamata Jena,
  • A. Charles Pon Ruban,
  • Shantaraman Kalyanaraman,
  • K. Sunitha,
  • Jerin Cherian,
  • Tanu Anand,
  • Denny John

摘要

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.