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Published in: BMC Public Health 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: Lijing L Yan, Weigang Fang, Elizabeth Delong, Bruce Neal, Eric D Peterson, Yining Huang, Ningling Sun, Chen Yao, Xian Li, Stephen MacMahon, Yangfeng Wu

Published in: BMC Public Health | Issue 1/2014

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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.
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Metadata
Title
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
Authors
Lijing L Yan
Weigang Fang
Elizabeth Delong
Bruce Neal
Eric D Peterson
Yining Huang
Ningling Sun
Chen Yao
Xian Li
Stephen MacMahon
Yangfeng Wu
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2014
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-14-345

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