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You can access this
clinical trial
if you have
Coronary Heart Disease
and you are
between 18 and 80
years old
-
The phase for this study is not defined.
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The purpose

The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in individuals with family history of premature coronary heart disease (CHD). This care model involves: 1. screening for cardiovascular risk factors, 2. providing lifestyle interventions for prevention and management of cardiovascular risk factors, 3. providing a framework for linkage to appropriate primary health care facility and 4. active follow-up of intervention adherence. Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package (for example, context specific ways to enhance physical activity and to reduce prolonged sitting time, ways to improve diet etc.) and feedback on the intervention strategies (lifestyle education, care and linkage coordination). Then a randomized controlled trial involving ~700 families and 1400 participants will be used to determine whether an integrated care model is effective in reducing or halting the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic and qualitative lenses to estimate value and acceptability. Scalability will be informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.

Provided treatments

  • Behavioral: Integrated cardiovascular disease risk management.
Tris trial is registered with FDA with number: NCT02771873. The sponsor of the trial is Public Health Foundation of India and it is looking for 1678 volunteers for the current phase.
Official trial title:
A Family Based Randomized Controlled Trial of Cardiovascular Risk Reduction in Individuals With Family History of Premature Coronary Heart Disease in India