NCT03527719

China Rural Hypertension Control Project

Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33,995 (estimated)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

China Rural Hypertension Control (CRHC) Project is a cluster randomized trial that will test the effectiveness of a village doctor-led multifaceted intensive blood pressure intervention on hypertension control in 18 months (Phase 1), cardiovascular disease risk in 36 months (Phase 2), and all-cause dementia in 48 months (Phase 3) among patients with hypertension in rural China. An extended observational follow-up, the CRHCP post-intervention observational follow-up study, will be conducted at Year 7 to evaluate long-term effects.

Detailed description

The overall objective of the CRHC Project is to develop an effective, adoptable, and sustainable implementation strategy to achieve more intensive blood pressure (BP) control among rural residents in China. Moreover, this effectiveness-implementation trial will test the effectiveness of a lower BP target (\<130/80 mmHg) on cardiovascular disease (CVD) and all-cause dementia. Specifically, we will test the effectiveness of a village doctor-led multifaceted intervention, compared with usual care, on BP control, CVD, and dementia among rural residents with hypertension in China. This cluster randomized trial is conducted in 326 villages from three provinces in mainland China. A total of 163 villages was randomly assigned to a village doctor-led multifaceted intervention and 163 villages to usual care, stratified by provinces, counties, and townships. A total of 33,995 individuals aged ≥40 years with uncontrolled hypertension were recruited into the study. The village doctor-led multifaceted intervention is designed to overcome barriers at the healthcare system, provider, patient, and community levels. Study participants are followed every 6 months for BP, CVD, and other study outcomes. The primary outcome is BP control (\<130/80 mm Hg) at 18 months in phase 1, CVD events over 36 months in phase 2, and all-cause dementia at 48 months in phase 3. In addition, an extended observational follow-up will be conducted at Year 7 without further active intervention, to evaluate long-term outcomes including major cardiovascular events, dementia or cognitive outcomes, all-cause mortality, renal outcomes, and the sustainability of implementation fidelity.

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	Village-doctor-led multifaceted intervention	* Establishing a network including hypertension specialists at city/county hospitals, primary care physicians at township hospitals, and village doctors to collaboratively manage hypertension * Using hypertension control rate as one of the metrics for incentive supplements to village doctors * Providing discounted or free antihypertensive medications to patients with hypertension * Training village doctors to measure blood pressure according to a standard protocol * Training village doctors to use a simple stepwise protocol for hypertension treatment * Training village doctors to conduct health coaching on lifestyle change (e.g., lowering sodium and alcohol intake) and medication adherence * Providing free blood-pressure monitor and training to patients for home blood pressure measurement * Encouraging lifestyle change and medication adherence * Connecting patients through WeChat or telephone for group social support

Timeline

• Start date: 2018-05-08
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2018-05-17
• Last updated: 2025-12-18

Locations

1 site across 1 country: China