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NOT YET RECRUITING
NCT06836661
NA

Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial

Sponsor: St. John's Research Institute

View on ClinicalTrials.gov

Summary

The ICRAG-2 project aims to assess the impact, cost-effectiveness, and sustainability of a low-cost, multipronged intervention package to reduce cardiovascular disease (CVD) burden in India. Given the high CVD mortality rate in India, this study addresses the urgent need for scalable, evidence-based solutions. The project will unfold in three steps: first, formative research including systematic reviews, cross-sectional studies, and qualitative studies will identify key barriers, facilitators, and refine interventions. Next, a matched-pair cluster randomized controlled trial (CRCT) across 26 clusters will evaluate the intervention's impact on CVD outcomes over three years, focusing on therapeutic lifestyle changes, fixed-dose medications, and task-sharing with non-physician health workers. Finally, the project will engage stakeholders through policy dialogues to support potential national-scale implementation. This trial offers a promising model to reduce CVD incidence through customized, sustainable interventions targeting patients, providers, and the health system.

Official title: Effect, Cost, and sustaiNability of a Synergistic, Multipronged, Customized, Low-cost Intervention Package to Reduce cArdiovascular Burden Across India: a cLustEr RCT

Key Details

Gender

All

Age Range

40 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

1560

Start Date

2025-06-01

Completion Date

2029-06-30

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

BEHAVIORAL

FDC and TLC and medication adherance

Level 1: Patient 1. Rational FDCs 2. NPHWs and PMs mediated therapeutic lifestyle changes 3. Texts/ WhatsApp reminders Level 2:Physician 1. Reinforcing task sharing 2. Providing evidence on FDCs 3. Theory based behavior modification Level 3: Health administrators 1. Pharmacy - Update drug formulary FDCs 2. CV health days 3. Facility strengthening

BEHAVIORAL

Patients will Enhanced Usual Care (EUC)

Patients will Enhanced Usual Care (EUC) with periodic follow ups

Locations (1)

Division of Clinical Research and training St. John's Research Institute Koramangala , - , India

Bangalore, Karnataka, India