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.
Abstract
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.
Type
Journal articleSubject
Blood PressureCardiology
Cardiovascular Diseases
China
Community Health Workers
Cost-Benefit Analysis
Female
General Practitioners
Humans
Linear Models
Male
Middle Aged
Risk Factors
Rural Population
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https://hdl.handle.net/10161/15015Published Version (Please cite this version)
10.1186/1471-2458-14-345Publication Info
Yan, Lijing L; Fang, Weigang; Delong, Elizabeth; Neal, Bruce; Peterson, Eric D; Huang,
Yining; ... Wu, Yangfeng (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 https://hdl.handle.net/10161/15015.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Elizabeth Ray DeLong
Professor Emeritus 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.
Eric David Peterson
Fred Cobb, M.D. Distinguished 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
This author no longer has a Scholars@Duke profile, so the information shown here reflects
their Duke status at the time this item was deposited.
Lijing Yan
Professor of Global Health at Duke Kunshan University
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