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

NCT06836661 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Assam Medical College, Dibrugarh, India

    collaborator UNKNOWN

  • SRM Medical College Hospital & Research Centre

    collaborator UNKNOWN

  • Jawaharlal Institute of Postgraduate Medical Education & Research

    collaborator OTHER_GOV

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences, Bhopal

    collaborator OTHER

  • St. John's Research Institute

    lead OTHER

Principal Investigators

  • Denis Xavier, Dr. · St. John's Medical College and research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06836661 on ClinicalTrials.gov