China Rural Hypertension Control Project
- Conditions
- Hypertension
- Interventions
- Other: Village-doctor-led multifaceted intervention
- Registration Number
- NCT03527719
- Lead Sponsor
- First Hospital of China Medical University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 33995
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Village-doctor-led multifaceted intervention Village-doctor-led multifaceted intervention
- Primary Outcome Measures
Name Time Method Primary Outcome of Phase 1: Hypertension control rate 18 months after baseline The proportion of participants with controlled blood pressure（\< 130/80 mm Hg）
Primary Outcome of Phase 2: Composite cardiovascular disease outcome 36 months after baseline Record the occurrence of newly diagnosed composite cardiovascular disease
Primary Outcome of Phase 3: All-cause dementia 48 months after baseline Record all-cause dementia
- Secondary Outcome Measures
Name Time Method Secondary Outcome of Phase 3: Cognitive impairment no dementia 48 months after baseline Record cognitive impairment no dementia
Secondary Outcome of Phase 3: Death from all causes 48 months after baseline Record death from all causes
Secondary Outcome of Phase 3: Changes in mean systolic and diastolic blood pressure from baseline to 48 months 48 months after baseline Record changes in mean systolic and diastolic blood pressure from baseline to 48 months
Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes 18 months after baseline Mean systolic and diastolic pressure changes of participants
Secondary Outcome of Phase 2: Cardiovascular disease death 36 months after baseline Number of cardiovascular disease death
Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm) 18 months after baseline The proportion of participants with controlled blood pressure（\< 140/90 mm Hg）
Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate 18 months after baseline Use questionnaires to assess the proportion of participants who adhere to antihypertensive drugs
Secondary Outcome of Phase 2: Myocardial infarction 36 months after baseline Number of newly diagnosed myocardial infarction
Secondary Outcome of Phase 3: Composite outcome of dementia or deaths 48 months after baseline Record the composite outcome of dementia or deaths
Secondary Outcome of Phase 3: Composite and individual cardiovascular disease (myocardial infarction, stroke, heart failure requiring hospitalization or treatment, and cardiovascular death) 48 months after baseline Record the composite and individual cardiovascular disease (myocardial infarction, stroke, heart failure requiring hospitalization or treatment, and cardiovascular death)
Secondary Outcome of Phase 3: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months 48 months after baseline Record the proportion of hypertension control (BP \<130/80 mm Hg or \<140/90 mmHg) at 48 months
Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment 36 months after baseline Number of patients with newly diagnosed heart failure requiring hospitalization or treatment
Secondary Outcome of Phase 2: All-cause death 36 months after baseline Number of all-cause death
Secondary Outcome of Phase 3: Composite outcome of dementia and cognitive impairment no dementia 48 months after baseline Record the composite outcome of dementia and cognitive impairment no dementia
Secondary Outcome of Phase 2: Stroke 36 months after baseline Number of newly diagnosed stroke
Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes 36 months after baseline Mean systolic and diastolic pressure changes of participants
Trial Locations
- Locations (1)
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China