Simplified Cardiovascular Management in India and China Study (SimCard)
This project aims to develop, pilot test, and evaluate a highly simplified but guideline-based program for cardiovascular management in resource-scarce settings. The specific aim is to evaluate the effects of implementing a simple low-cost cardiovascular management program for high-risk individuals, delivered by primary care providers and community healthcare workers (CHWs), on the proportion of patients appropriately treated with diuretics as well as a number of secondary outcomes.
Methods
This project will be a cluster-randomised controlled interventional trial conducted in the rural areas in China and India as a large pilot study. In India, 16 villages will be selected to be randomised to receive the intervention (eight villages) or usual care (eight villages). In Tibet, China, a total of 32 villages from 14 townships in 2 counties will participate. Due to the road access constrains and after careful consideration in terms of feasibility, only 27 villages will be randomised to the intervention group or the control group (14 villages in intervention group and 13 villages in the control group).
The main intervention is a simplified cardiovascular management program for high-risk individuals delivered by village CHWs with support of PCPs (township physicians). Each country will follow identical standardised operating procedures to train research personnel, implement and monitor the interventions, and assess study outcomes. All outcome assessments will be done in exactly the same way in every village, regardless of their assignment to intervention or control. Before the intervention begins, a village-wide screening will be done to identify and measure high-risk individuals in all villages.
A post-intervention assessment of all high-risk individuals will also be conducted. The primary outcome is the net difference in post-intervention changes from baseline in the proportion of high-risk patients treated with diuretics between intervention and control villages. A number of secondary outcomes including process and economic evaluations will also be included.
Status
All enrolment in China site finished in July 2012. A total of 1064 subjects were identified and participated in the study. Intervention is currently undergoing and expected to finish in July, 2013. Enrolment in India is expected to finish by 10 February, 2013, 1050 participants have been enrolled into the study till date. Intervention is expected to finish by December, 2013.
