China Rural Hypertension Control Project

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: Village-doctor-led multifaceted intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Village-doctor-led multifaceted intervention | Other: Village-doctor-led multifaceted intervention<br>* 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<br>|
| No Intervention: Control Group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome of Phase 1: Hypertension control rate | The proportion of participants with controlled blood pressure（< 130/80 mm Hg） | 18 months after baseline | 
| Primary Outcome of Phase 2: Composite cardiovascular disease outcome | Record the occurrence of newly diagnosed composite cardiovascular disease | 36 months after baseline | 
| Primary Outcome of Phase 3: All-cause dementia | Record all-cause dementia | 48 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes | Mean systolic and diastolic pressure changes of participants | 18 months after baseline | 
| Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm) | The proportion of participants with controlled blood pressure（< 140/90 mm Hg） | 18 months after baseline | 
| Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate | Use questionnaires to assess the proportion of participants who adhere to antihypertensive drugs | 18 months after baseline | 
| Secondary Outcome of Phase 2: Stroke | Number of newly diagnosed stroke | 36 months after baseline | 
| Secondary Outcome of Phase 2: Myocardial infarction | Number of newly diagnosed myocardial infarction | 36 months after baseline | 
| Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment | Number of patients with newly diagnosed heart failure requiring hospitalization or treatment | 36 months after baseline | 
| Secondary Outcome of Phase 2: Cardiovascular disease death | Number of cardiovascular disease death | 36 months after baseline | 
| Secondary Outcome of Phase 2: All-cause death | Number of all-cause death | 36 months after baseline | 
| Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes | Mean systolic and diastolic pressure changes of participants | 36 months after baseline | 
| Secondary Outcome of Phase 3: Cognitive impairment no dementia | Record cognitive impairment no dementia | 48 months after baseline | 
| Secondary Outcome of Phase 3: Composite outcome of dementia and cognitive impairment no dementia | Record the composite outcome of dementia and cognitive impairment no dementia | 48 months after baseline | 
| Secondary Outcome of Phase 3: Death from all causes | Record death from all causes | 48 months after baseline | 
| Secondary Outcome of Phase 3: Composite outcome of dementia or deaths | Record the composite outcome of dementia or deaths | 48 months after baseline | 
| Secondary Outcome of Phase 3: Composite and individual cardiovascular disease (myocardial infarction, stroke, heart failure requiring hospitalization or treatment, and cardiovascular death) | Record the composite and individual cardiovascular disease (myocardial infarction, stroke, heart failure requiring hospitalization or treatment, and cardiovascular death) | 48 months after baseline | 
| Secondary Outcome of Phase 3: Changes in mean systolic and diastolic blood pressure from baseline to 48 months | Record changes in mean systolic and diastolic blood pressure from baseline to 48 months | 48 months after baseline | 
| Secondary Outcome of Phase 3: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months | Record the proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months | 48 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Cardiovascular disease, Dementia, China, Protocol-based treatment, Stroke