title: Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang.
abstract: BACKGROUND
  Cardiovascular disease (CVD) is a major cause of death in China. Despite government efforts, the majority of hypertensive and diabetic patients in China do not receive proper treatment. Reducing CVD events requires long-term care that is proactive, patient-centred, community-based, and sustainable. We have designed a package of interventions for patients at high risk of CVD to be implemented by family doctors based in township hospitals (providers of primary care) in rural Zhejiang, China. This trial aims to determine whether the systematic CVD risk reduction package results in reduced CVD events among patients at risk of CVD compared with usual care, and whether the package is cost-effective and suitable for routine implementation and scale-up.
  
  
  METHODS
  This is a prospective, open-label, cluster randomized controlled trial (RCT) with blinded data analysis. The trial will randomize 67 township hospitals with 31,708 participants in three counties in Zhejiang Province. Participants will be identified from existing health records and will comprise adults aged 50 to 74 years, with a calculated 10-year CVD risk of 20% or higher, or diabetes. In the intervention arm, participants will receive a package of interventions including: 1) healthy lifestyle counseling (smoking cessation, and salt, oil, and alcohol reduction); 2) prescription of a combination of drugs (antihypertensives, aspirin, and statin); and 3) adherence support for drug compliance and healthy lifestyle change. In the control arm, participants will receive usual care for hypertension and diabetes management at individual clinicians' discretion. The primary outcome is the incidence of severe CVD events over 24 months of follow-up. All CVD events will be defined according to the World Health Organization (WHO) monitoring of trends and determinants in cardiovascular disease (MONICA) definitions, diagnosed at the county hospital or higher level, and reported by the Zhejiang surveillance system. Secondary outcomes include: mean systolic and diastolic blood pressure, blood glucose, serum total cholesterol (TC), and adherence to appointments, and drugs and lifestyle changes.
  
  
  CONCLUSIONS
  This trial focuses on risk reduction of CVD rather than specific diseases. It is not designed to compare therapeutic and healthy lifestyle interventions, but rather their combined effects in primary care settings. Through the trial, we intend to understand the effectiveness of the comprehensive CVD reduction package in routine practice. We also intend to understand the barriers and facilitators to implementing the package, and thus to advise on policy and practice change.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN58988083.
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Wei
authors.forename: Guanyang
authors.initials: G
authors.lastname: Zou
authors.forename: Weiwei
authors.initials: W
authors.lastname: Gong
authors.forename: Jia
authors.initials: J
authors.lastname: Yin
authors.forename: Yunxian
authors.initials: Y
authors.lastname: Yu
authors.forename: John
authors.initials: J
authors.lastname: Walley
authors.forename: Zhitong
authors.initials: Z
authors.lastname: Zhang
authors.forename: Rebecca
authors.initials: R
authors.lastname: King
authors.forename: Kun
authors.initials: K
authors.lastname: Chen
authors.forename: Marc Ka Chun
authors.initials: MK
authors.lastname: Chong
authors.forename: Benny Chung Ying
authors.initials: BC
authors.lastname: Zee
authors.forename: Su
authors.initials: S
authors.lastname: Liu
authors.forename: Jinling
authors.initials: J
authors.lastname: Tang
authors.forename: Sian
authors.initials: S
authors.lastname: Griffiths
authors.affiliation: Zhejiang Centre for Disease Control and Prevention, Hangzhou, Zhejiang, China. myu@cdc.zj.cn.
authors.forename: Min
authors.initials: M
authors.lastname: Yu
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000191:economics / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D002681:China / Q000453:epidemiology; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D011314:Preventive Health Services / Q000191:economics / Q000379:methods*; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D019035:Rural Health Services / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents