Abstract
BackgroundIn resource-poor areas of China and India, the cardiovascular disease burden is high, but availability of and access to quality healthcare is limited. Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management. The study aims to develop, implement, and evaluate the feasibility and effectiveness of a simplified, evidence-based cardiovascular management program delivered by community healthcare workers in resource-constrained areas in Tibet, China and Haryana, India.Methods/designThis yearlong cluster-randomized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana. Randomization of villages to usual care or intervention will be stratified by country. High cardiovascular disease risk individuals (aged 40 years or older, history of heart disease, stroke, diabetes, or measured systolic blood pressure of 160 mmHg or higher) will be screened at baseline. Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified ‘2 + 2’ intervention model involving two lifestyle recommendations and the appropriate prescription of two medications. A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management. Baseline and follow-up surveys will be conducted in a standardized fashion in all villages. The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention. Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure. Process and economic evaluations will also be conducted.DiscussionTo our knowledge, this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients. If effective, this intervention strategy can serve as a model that can be implemented, where applicable, in rural China, India, and other resource-constrained areas.Trial registrationThe trial was registered in the clinicaltrials.gov database on 30 December, 2011 and the registration number is NCT01503814.
Highlights
In resource-poor areas of China and India, the cardiovascular disease burden is high, but availability of and access to quality healthcare is limited
To our knowledge, this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients
To the best of our knowledge, SimCard is the first study to incorporate an electronic decision support (EDS) system delivered by the Community health worker (CHW) for cardiovascular disease (CVD) management in these two countries
Summary
CVD is a global problem that affects developed and developing countries alike. Areas with constrained economic or healthcare resources face an even tougher challenge as the awareness of CVD is lacking and trained healthcare professionals are limited. Despite there being well-established national guidelines and policies on effective strategies to prevent and control CVD in China and India, its uptake into routine medical care remains very limited in resource constrained areas. This is primarily due to the complexity of the guideline, the lack of awareness of the guidelines by the CHWs and CHW’s limited capacity to implement the guidelines. We incorporate the smartphone or tablet based EDS system into the intervention aiming to help the CHWs better follow-up and manage their high CVD risk patients Such a study is needed in both rural China and India where the prevalence of hypertension and CVD has been increasing rapidly and has reached epidemic proportions.
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