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

BMC Public Health

Lijing L Yan³  Dorairaj Prabhakaran²  Anand Krishnan¹  Nikhil Tandon⁶  Mohammed K Ali⁸  Danzeng Dunzhu⁴  Xian Li³  Yangfeng Wu⁷  Hao Chen⁵  Maoyi Tian³  Vamadevan S Ajay² 

[1] Department of Community Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India;Centre for Chronic Disease Control, 4th Floor, Plot # 47, Sector-44, Gurgaon, New Delhi 122002, India;The 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;Tibet University, Jiangsu Road, Chengguan District, Lhasa 850000, China;Department of Cardiology, Beijing Hospital, No. 1 Dahua Road, Dongcheng District, Beijing 100730, China;Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India;Department of Epidemiology and Biostatistics, Peking University School of Public Health, No. 38 Xueyuan Road, Haidian District, Beijing 100083, China;Rollins School of Public Health, Emory University, 1518 Clifton Road, Atlanta, GA 30322, USA

关键词: Electronic decision support system;    Risk reduction;    Community health workers;    Rural population;    Developing countries;    Research design;    Cardiovascular diseases prevention and control;   

Others  :  1127973
DOI  :  10.1186/1471-2458-14-924

 received in 2014-08-28, accepted in 2014-09-02,  发布年份 2014

【 摘 要 】

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 isNCT01503814.

【 授权许可】

   
2014 Ajay et al.; licensee BioMed Central Ltd.

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