Research Summary

A family based randomized controlled trial of cardiovascular risk reduction in individuals with family history of premature coronary heart disease in India

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 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 ~900 families and 1800 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.

Figure Legend: The study flow chart (Randomized Controlled Trial Design)