Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial.
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BACKGROUND: The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China. METHODS: The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, will be assigned to either intervention (60 villages) or control (60 villages). Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify, treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village. The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years. We will draw two different (independent) random samples, before and after the intervention, 20 men aged≥50 years and 20 women aged≥60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level. The primary outcome will be the pre-post difference in mean systolic blood pressure, analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect. Secondary outcomes will include monthly clinic visits, provision of lifestyle advice, use of antihypertensive medications and use of aspirin. Process and economic evaluations will also be conducted. DISCUSSION: This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease. The results are expected to provide important information (effectiveness, cost-effectiveness, feasibility and acceptability) to guide policy making for rural China as well as other resource-limited countries. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT01259700). Date of initial registration is December 13, 2010.
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Published Version (Please cite this version)10.1186/1471-2458-14-345
Publication InfoYan, LL; Fang, W; DeLong, Elizabeth Ray; Neal, B; Peterson, Eric David; Huang, Y; ... Wu, Y (2014). Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial. BMC Public Health, 14. pp. 345. 10.1186/1471-2458-14-345. Retrieved from http://hdl.handle.net/10161/15015.
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Professor of Biostatistics and Bioinformatics
Developing methods for assessing, comparing, and validating statistical models of short and long term outcomes. Developing and testing methods for evaluating comparative effectiveness in observational data.
Fred Cobb, M.D. Professor of Medicine
Dr Peterson is the Fred Cobb Distinguished Professor of Medicine in the Division of Cardiology, a DukeMed Scholar, and the Past Executive Director of the Duke Clinical Research Institute (DCRI), Durham, NC, USA. Dr Peterson is the Principal Investigator of the National Institute of Health, Lung and Blood Institute (NHLBI) Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT) Trial He is also the Principal I
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