A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale
Related Experiment Video
Updated: Apr 24, 2026
A Rat Model of Central Fatigue Using a Modified Multiple Platform Method
Published on: August 14, 2018
Vamadevan S Ajay, Maoyi Tian, Hao Chen
1The George Institute for Global Health at Peking University Health Science Center, Suite 1801, Tower B, Horizon Tower, No, 6 Zhichun Road, Haidian District, Beijing 100088, China. lyan@georgeinstitute.org.cn.
Insights
This study shows a simplified cardiovascular management program improved medication adherence in high-risk patients in rural China and India. This community health worker-led intervention offers a scalable model for resource-limited settings.
Area of Science:
- Global Health
- Cardiovascular Disease Management
- Community Health
Background:
- High cardiovascular disease burden in resource-poor areas of China and India.
- Limited access to quality healthcare in these regions.
- Need for sustainable, localized management strategies.
Purpose of the Study:
- To develop, implement, and evaluate a simplified, evidence-based cardiovascular management program.
- To assess the feasibility and effectiveness of community healthcare worker (CHW) delivery.
- To address cardiovascular disease prevention and management in resource-constrained settings.
Main Methods:
- Yearlong cluster-randomized controlled trial in Tibet, China, and Haryana, India.
- Screening of high cardiovascular disease risk individuals (aged 40+).
- CHW training on a '2+2' model (2 lifestyle recommendations, 2 medications) with electronic decision support.
Main Results:
- Primary outcome: net difference in antihypertensive medication uptake.
- Secondary outcomes: aspirin use and blood pressure changes.
- Process and economic evaluations conducted.
Conclusions:
- First study evaluating a CHW-delivered, simplified management program with electronic decision support for high cardiovascular disease risk patients.
- Potential model for implementation in rural China, India, and other resource-limited areas.
- Highlights the role of CHWs in improving cardiovascular health outcomes.
Background:
In 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/Design:
This 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.
Discussion:
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. 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 Registration:
The trial was registered in the clinicaltrials.gov database on 30 December, 2011 and the registration number is NCT01503814.
