Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT06836661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial
Sponsor:
St. John's Research Institute
Organization:
Study Overview
Official Title:
Effect, Cost, and sustaiNability of a Synergistic, Multipronged, Customized, Low-cost Intervention Package to Reduce cArdiovascular Burden Across India: a cLustEr RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENABLE
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: