Implementation of a comprehensive intervention for patients at high risk of cardiovascular disease in rural China: A pragmatic cluster randomized controlled trial

PLoS One. 2017 Aug 16;12(8):e0183169. doi: 10.1371/journal.pone.0183169. eCollection 2017.


Objective: This study aims to assess whether a standard intervention package of cardiovascular disease (CVD) care was being delivered effectively, and if it was associated with improved lifestyle and biomedical indicators.

Methods: In rural China, we implemented a pragmatic cluster randomized controlled trial for 12 months, randomized at the township hospital level, and compared with usual care. Intervention case management guideline, training and performance monitoring meeting and patient support activities were designed to fit within the job description of family doctors in the township hospitals and comprised: 1) prescription of a standardised package of medicines targeted at those with hypertension or diabetes; 2) advice about specific lifestyle interventions; and 3) advice about medication adherence. Participants were 50-74 years old, had hypertension and CVD risk scores >20% or diabetes, but were excluded if a history of severe CVD events. We also randomly selected 100 participants from six selected clusters per arm as a panel to collect intermediate biomedical indicators over time.

Results: A total of 28,130 participants, in 33 intervention and 34 control township hospitals, were recruited. Compared with the control arm, participants in the intervention arm had substantially improved prescribing rates of anti-hypertensives, statins and aspirin (P<0.001), and had higher medication taking rates of aspirin and statins (P<0.001). Mean systolic and diastolic blood pressures were similar across both arms (0.15 mmHg, P = 0.79, and 0.52 mmHg, P = 0.05, respectively). In the panel, (950) rates of smoking (OR = 0.23, P = 0.02) and salt intake (OR = 2.85, P = 0.03) were significantly reduced in the intervention versus control arms, but there were no statistically significant improvement over the 12 month follow-up period in biomedical indicators (P>0.05).

Conclusion: Implementation of the package by family doctors was feasible and improved prescribing and some lifestyle changes. Additional measures such as reducing medication costs and patient education are required.

Trial registration: Current Controlled Trials ISRCTN58988083.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antihypertensive Agents / therapeutic use
  • Blood Pressure / drug effects
  • Cardiovascular Diseases / drug therapy*
  • Cardiovascular Diseases / prevention & control
  • China
  • Diabetes Mellitus / drug therapy
  • Diabetes Mellitus / prevention & control
  • Female
  • Humans
  • Hypertension / drug therapy
  • Hypertension / prevention & control
  • Male
  • Medication Adherence
  • Middle Aged


  • Antihypertensive Agents

Grant support

This study was partly funded by COMDIS-HSD, a research consortium funded by UK aid from the UK government: however, the views expressed do not necessarily reflect the UK government’s official policies. The study also received funding from Zhejiang Provincial Government, China through the Zhejiang Centre for Disease Control and Prevention (CDC) and the Dalla Lana School of Public Health at the University of Toronto. The funders had no role in research design, data collection, interpretation of the data, writing or submitting the manuscript.