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Testing a Low-Cost Program to Reduce Heart Disease in India: A Cluster Randomized TriaL

Effect, cost, and sustainability of a synergistic, multipronged, customized, low-cost intervention package to reduce cardiovascular burden across India a cluster RCT-ENABLE - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078262
Enrollment
1560
Registered
2024-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I210- ST elevation (STEMI) myocardial infarction of anterior wall

Interventions

Intervention1: Multilevel Interventions : Level 1: Patient 1. Rational FDCs 2. NPHWs and PMs mediated therapeutic lifestyle changes 3. Texts/ WhatsApp reminders Level 2: Physician 1. Reinforcing t

Sponsors

Indian Council of Medical Research Â
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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, 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.

Exclusion criteria

Exclusion criteria: We will exclude patients with any ONE of the following: a. Severe cognitive impairment of any aetiology and have no reliable caregivers. b. Medical conditions with a survival prognosis of less than 12 months. c. Unable to follow-up for the study period

Design outcomes

Primary

MeasureTime frame
a) Composite of death, myocardial infarction, stroke and CVD-related hospitalisations at three years Timepoint: 3 years

Secondary

MeasureTime frame
b) The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP c) Key Fidelity Metrics â?? 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)Timepoint: 3 years

Countries

India

Contacts

Public ContactDr Deepa S

St Johns Medical College and Research InstituteÂ

denis.xavier@stjohns.in08049466141

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026