Rationale and design of the Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a factorial, cluster-randomized trial of 2 practical cardiovascular disease prevention strategies developed for rural Andhra Pradesh, India

Abstract

Background: Developing countries are experiencing increasing levels of cardiovascular disease (CVD). Although there is a good understanding of how to deliver CVD prevention programs in developed countries, there are few data regarding strategies for CVD prevention in resource-poor settings. This study aimed to implement and evaluate a CVD prevention program in a rural area of India.

Methods: The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion campaign. A factorial, cluster-randomized trial design will be used to evaluate these, in which villages will be exposed to one, both, or neither of the interventions for a period of about 12 months. Surveys of households in every village will be used to assess outcomes in all high-risk individuals and a sample of the general adult population.

Results: The primary outcome of the algorithm-based component of this study will be the percentage of high-risk individuals that have been "identified"-defined as having received a cardiovascular-risk assessment in the last 12 months. The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk (green-leafy vegetables, fruits, oily foods, salt, smoking, physical activity). Secondary outcomes include a range of measures defining uptake of different preventive strategies.

Conclusions: This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically designed for delivery in a resource-poor area in India.

Trial registration: ClinicalTrials.gov NCT00263393.