Hypertension
Conditions
Keywords
Hypertension, Cardiovascular disease, Dementia, China, Protocol-based treatment, Stroke
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. 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.
Interventions
OTHERVillage-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
Sponsors
Tulane University
First Affiliated Hospital Xi'an Jiaotong University
Tongji Hospital
Disease Control and Prevention Centre of Liaoning Province
Chaoyang Central Hospital
Hanzhong People's Hospital
Disease Control and Prevention Centre of Chaoyang City
Shengjing Hospital
First Hospital of China Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome Assessment Committee members will be blinded to outcome assignment.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Primary Outcome of Extension Study: Composite cardiovascular disease outcome | Year 7 after baseline | Record the occurrence of newly diagnosed composite cardiovascular disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome of Phase 2: Myocardial infarction | 36 months after baseline | Number of newly diagnosed myocardial infarction |
| 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: Cardiovascular disease death | 36 months after baseline | Number of cardiovascular disease death |
| Secondary Outcome of Phase 2: All-cause death | 36 months after baseline | Number of all-cause death |
| Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes | 36 months after baseline | Mean systolic and diastolic pressure changes of participants |
| Secondary Outcome of Phase 3: Cognitive impairment no dementia | 48 months after baseline | Record cognitive impairment no dementia |
| 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 3: Death from all causes | 48 months after baseline | Record death from all causes |
| 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: 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 Extension Study: Composite outcome of dementia and cognitive impairment no dementia | Year 7 after baseline | Record the composite outcome of dementia and cognitive impairment no dementia |
| Secondary Outcome of Extension Study: Stroke | Year 7 after baseline | Number of newly diagnosed stroke |
| Secondary Outcome of Extension Study: Myocardial infarction | Year 7 after baseline | Number of newly diagnosed myocardial infarction |
| Secondary Outcome of Extension Study: Heart failure requiring hospitalization or treatment | Year 7 after baseline | Number of patients with newly diagnosed heart failure requiring hospitalization or treatment |
| Secondary Outcome of Extension Study: Cardiovascular disease death | Year 7 after baseline | Number of cardiovascular disease death |
| Secondary Outcome of Extension Study: All-cause death | Year 7 after baseline | Number of all-cause death |
| Secondary Outcome of Extension Study: All-cause dementia | Year 7 after baseline | Record all-cause dementia |
| Secondary Outcome of Extension Study: Cognitive impairment no dementia | Year 7 after baseline | Record cognitive impairment no dementia |
| Secondary Outcome of Extension Study: Mean systolic and diastolic pressure changes | Year 7 after baseline | Record changes in mean systolic and diastolic blood pressure |
| Secondary Outcome of Extension Study: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) | Year 7 after baseline | Record the proportion of hypertension control (BP \<130/80 mm Hg or \<140/90 mmHg) |
| Secondary Outcome of Extension Study: Adherence to antihypertensive medication rate | Year 7 after baseline | Use questionnaires to assess the proportion of participants who adhere to antihypertensive drugs |
| 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 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: Stroke | 36 months after baseline | Number of newly diagnosed stroke |
Countries
China
Outcome results
None listed