# Study protocol: A randomized controlled trial of a community-based intervention on clinical parameters, health literacy, medication adherence, and quality of life among individuals with coexisting diabetes and hypertension

## TL;DR

This study tests a community-based program to improve health outcomes for people with both diabetes and hypertension in urban slums.

## Contribution

The study introduces a novel community-based intervention combining yoga, counseling, and home monitoring for coexisting diabetes and hypertension.

## Key findings

- The intervention is expected to improve clinical parameters like blood sugar and blood pressure.
- Health literacy and medication adherence are anticipated to increase in the intervention group.
- Quality of life is projected to improve among participants receiving the community-based intervention.

## Abstract

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Ms Krishna Kumari Samantaray:
•
Dr Sasmita Das and Dr Krushna Chandra Sahoo:
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Dr N. Siva:

Ms Krishna Kumari Samantaray:

Dr Sasmita Das and Dr Krushna Chandra Sahoo:

Dr N. Siva:

Diabetes and hypertension are prevalent chronic conditions that often coexist and contribute significantly to morbidity and mortality. Effective management requires patient-centred interventions that integrate lifestyle modification, health education, and self-monitoring.

This study aims to evaluate the effectiveness of Community-Based Intervention (CBI) on clinical parameters, health literacy, medication adherence, and quality of life among Individuals with coexisting diabetes and hypertension in urban slum settings.

A randomized controlled trial (RCT) will be conducted among 120 eligible participants aged between 30–60 years. Participants will be randomly assigned to either the intervention or control group using block randomization (12 blocks, each containing 5 participants per group) with allocation concealment. The intervention group will receive a 6-week CBI consisting of pre-intervention orientation, yoga-based lifestyle modification, nurse-led counseling, and home-based monitoring, in addition to standard care. The control group will receive standard care, with informational materials provided after the intervention period.

Data on blood sugar, blood pressure, health literacy, medication adherence, and quality of life will be collected at baseline, 2 months, 3 months, and 6 months. The intervention is expected to improve clinical outcomes, enhance health literacy, increase medication adherence, and promote better quality of life.

Image, graphical abstract