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.
None
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
Parallel
FDC and TLC and medication adherance
BehavioralLevel 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)
BehavioralPatients will Enhanced Usual Care (EUC) with periodic follow ups
Composite of death, myocardial infarction, stroke and CVD-related hospitalisations at three years
The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP
b) The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP c) Key Fidelity Metrics - utilisation rates of fixed-dose combinations, adherence to drug therapy at 12 months, proportion monitoring BP at home, adherence to different components of TLC and optimal referral. d) Key Implementation Metrics using the Reach Effectiveness-Adoption Implementation and Maintenance (RE-AIM) framework (Implementation research metric/ framework)
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St. John's Research Institute
Lead sponsor
Assam Medical College, Dibrugarh, India
Collaborator
SRM Medical College Hospital & Research Centre
Collaborator
Jawaharlal Institute of Postgraduate Medical Education & Research
Collaborator
Indian Council of Medical Research
Collaborator
All India Institute of Medical Sciences, Bhopal
Collaborator
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