Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial
ENABLE
Effect, Cost, and sustaiNability of a Synergistic, Multipronged, Customized, Low-cost Intervention Package to Reduce cArdiovascular Burden Across India: a cLustEr RCT
1 other identifier
interventional
1,560
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2025
CompletedFirst Posted
Study publicly available on registry
February 20, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
May 18, 2025
February 1, 2025
3.6 years
February 1, 2025
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of death, myocardial infarction, stroke and CVD-related hospitalisations at three years
3 years
Secondary Outcomes (1)
The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP
3 years
Study Arms (2)
Intervention arm - FDC and TLC and medication adherance
EXPERIMENTALNPHW enabled education and counseliing along with prescribing combination therapies and TLC and availability of low cost rational FDC at hospital pharmacy
Control arm - Patients will Enhanced Usual Care (EUC)
EXPERIMENTALEnhanced Usual Care (EUC) with periodic follow ups.
Interventions
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
Patients will Enhanced Usual Care (EUC) with periodic follow ups
Eligibility Criteria
You may qualify if:
- \- 1. High-risk primary prevention A. Patients aged more than 40years of any gender without a CVD event (MI, Stroke) with at least two of the following risk factors, A to E with a 10 year documented evidence OF (a to d) a. Diabetes Mellitus b. Hypertension c. Dyslipidaemia d. Microalbuminuria e. Family history of premature CVD event (MI, stroke or CVD-related death under 55 years) B. Patients aged above 50years of any gender without a CVD event (MI, Stroke) with at least one year of documented disease, at least two A to D (Above) 2. High-risk secondary prevention Patients aged above 40 years or above, with a CVD event with any one of the following: options a. MI or stroke less than three months, \<br/\> b. MI or stroke, more than three months, but less than one year with at least one comorbid condition, that is A to E (Above).
- c. Patients aged above 60 years or above with MI or stroke greater than three months BUT less than one year, without any comorbid condition. These patients are expected to have a moderate to high risk of a CVD event or death in the next three years.
You may not qualify if:
- We will exclude patients with any ONE of the following:
- Severe cognitive impairment of any aetiology and have no reliable caregivers.
- Medical conditions with a survival prognosis of less than 12 months.
- Unable to follow-up for the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. John's Research Institutelead
- Assam Medical College, Dibrugarh, Indiacollaborator
- SRM Medical College Hospital & Research Centrecollaborator
- Jawaharlal Institute of Postgraduate Medical Education & Researchcollaborator
- Indian Council of Medical Researchcollaborator
- All India Institute of Medical Sciences, Bhopalcollaborator
Study Sites (1)
Division of Clinical Research and training St. John's Research Institute Koramangala , - , India
Bangalore, Karnataka, 560034, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denis Xavier, Dr.
St. John's Medical College and research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2025
First Posted
February 20, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
May 18, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
Individual participant data that underlie the results reported in specific publication arising out of the trial, after de-identification (text, tables, figures, and appendices).