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

St. John's Research Institute

Status

Not yet enrolling

Conditions

Cardiovascular Diseases

ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Treatments

Behavioral: Patients will Enhanced Usual Care (EUC)

Behavioral: FDC and TLC and medication adherance

Study type

Interventional

Funder types

Other

Identifiers

NCT06836661

293/2023

Details and patient eligibility

About

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.

Full description

Cardiovascular diseases (CVD) are the leading cause of death worldwide, responsible for approximately 17.9 million deaths each year, which accounts for 31% of all global deaths. The majority of these deaths-about 85%-are due to heart attacks and strokes. In India, CVD has contributed to 28·1% of the total deaths and 14·1% of the total DALYs. There is a remarkably high burden of CVD in India, with an age-standardised death rate of 282 deaths/100,000 (264-293) compared with global levels (233 deaths per 100,000 (229-236). Ischemic heart disease and stroke have been identified as the top two causes of mortality in the country, highlighting the urgent need for effective interventions.

Evidence supports the effectiveness of fixed dose combination treatments and the use of Non-Physician Health Workers (NPHWs) in primary and secondary prevention of CVD. India's healthcare system faces the dual challenge of rising CVD mortality and a lack of integrated preventive and management strategies for CVD at both the primary and secondary care levels. NPHWs play a major role in reducing CVD risk factors.

Despite the growing burden of CVD, there is a notable lack of evidence in India that evaluate comprehensive CVD management strategies across multiple levels, particularly focusing on hard clinical endpoints such as mortality, myocardial infarction (MI), stroke, and cardiovascular hospitalisations. To fill these gaps, we need a robust implementation trial that evaluates the effectiveness of multiple proven interventions in diverse settings on hard clinical endpoints. Such a trial, likely the first of its kind, would provide key evidence to guide policy decisions to improve CVD management strategies in India.

Enrollment

1,560 estimated patients

Sex

All

Ages

40 to 99 years old

Volunteers

No Healthy Volunteers

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, <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.

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,560 participants in 2 patient groups

Intervention arm - FDC and TLC and medication adherance

Experimental group

Description:

NPHW enabled education and counseliing along with prescribing combination therapies and TLC and availability of low cost rational FDC at hospital pharmacy

Treatment:

Behavioral: FDC and TLC and medication adherance

Control arm - Patients will Enhanced Usual Care (EUC)

Experimental group

Description:

Enhanced Usual Care (EUC) with periodic follow ups.

Treatment:

Behavioral: Patients will Enhanced Usual Care (EUC)