China Rural Hypertension Control Project (CRHC)

China Medical University

Status: Active, not recruiting

Conditions: Hypertension

Treatments: Other: Village-doctor-led multifaceted intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03527719

KLS20181582

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33,995 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility criteria for study villages:

• The village has a regular village doctor who is willing to participate in the hypertension control project
• The village does not plan to merge with other villages within 3 years
• The village is at least 2 kilometers away from other participating villages
• The village participates in the China New Rural Cooperative Medical Scheme

Eligibility criteria of study participants:

• Men or women aged ≥40 years
• Mean untreated systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg or mean treated systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg for individuals without a history of clinical CVD; or mean treated/untreated systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg for individuals with a history of clinical coronary heart disease, heart failure, stroke, diabetes, or chronic kidney disease
• Have lived in a participating village for at least 6 months
• No intention to migrate within next 3 years
• Taking part in the New Rural Cooperative Medical Scheme
• Not pregnant or planning to become pregnant
• No malignant tumors and life expectancy ≥3 years
• Willing to participate and able to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33,995 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Village-doctor-led multifaceted intervention

Treatment:

Other: Village-doctor-led multifaceted intervention

Control Group

No Intervention group

Description:

Village doctors in usual care group will not receive hypertension management training or support. However, they will be trained in standardized BP measurement. Participants in control group will receive their usual care from village doctors or primary care physicians in township hospitals