Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33,995
- 试验地点
- 1
- 主要终点
- Primary Outcome of Phase 1: Hypertension control rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome Assessment Committee members will be blinded to outcome assignment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Primary Outcome of Phase 1: Hypertension control rate
时间窗: 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
时间窗: 36 months after baseline
Record the occurrence of newly diagnosed composite cardiovascular disease
Primary Outcome of Phase 3: All-cause dementia
时间窗: 48 months after baseline
Record all-cause dementia
Primary Outcome of Extension Study: Composite cardiovascular disease outcome
时间窗: Year 7 after baseline
Record the occurrence of newly diagnosed composite cardiovascular disease
Primary Outcome of Phase 1: Hypertension control rate
时间窗: 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
时间窗: 36 months after baseline
Record the occurrence of newly diagnosed composite cardiovascular disease
Primary Outcome of Phase 3: All-cause dementia
时间窗: 48 months after baseline
Record all-cause dementia
Primary Outcome of Extension Study: Composite cardiovascular disease outcome
时间窗: Year 7 after baseline
Record the occurrence of newly diagnosed composite cardiovascular disease
次要结局
- Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes(18 months after baseline)
- Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm)(18 months after baseline)
- Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate(18 months after baseline)
- Secondary Outcome of Phase 2: Stroke(36 months after baseline)
- Secondary Outcome of Phase 2: Myocardial infarction(36 months after baseline)
- Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment(36 months after baseline)
- Secondary Outcome of Phase 2: Cardiovascular disease death(36 months after baseline)
- Secondary Outcome of Phase 2: All-cause death(36 months after baseline)
- Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes(36 months after baseline)
- Secondary Outcome of Phase 3: Cognitive impairment no dementia(48 months after baseline)
- Secondary Outcome of Phase 3: Composite outcome of dementia and cognitive impairment no dementia(48 months after baseline)
- Secondary Outcome of Phase 3: Death from all causes(48 months after baseline)
- Secondary Outcome of Phase 3: 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)(48 months after baseline)
- Secondary Outcome of Phase 3: 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(48 months after baseline)
- Secondary Outcome of Extension Study: Stroke(Year 7 after baseline)
- Secondary Outcome of Extension Study: Myocardial infarction(Year 7 after baseline)
- Secondary Outcome of Extension Study: Heart failure requiring hospitalization or treatment(Year 7 after baseline)
- Secondary Outcome of Extension Study: Cardiovascular disease death(Year 7 after baseline)
- Secondary Outcome of Extension Study: All-cause death(Year 7 after baseline)
- Secondary Outcome of Extension Study: All-cause dementia(Year 7 after baseline)
- Secondary Outcome of Extension Study: Cognitive impairment no dementia(Year 7 after baseline)
- Secondary Outcome of Extension Study: Mean systolic and diastolic pressure changes(Year 7 after baseline)
- Secondary Outcome of Extension Study: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg)(Year 7 after baseline)
- Secondary Outcome of Extension Study: Adherence to antihypertensive medication rate(Year 7 after baseline)
- Secondary Outcome of Extension Study: All-cause death(Year 7 after baseline)
- Secondary Outcome of Extension Study: All-cause dementia(Year 7 after baseline)
- Secondary Outcome of Extension Study: Cardiovascular disease death(Year 7 after baseline)
- Secondary Outcome of Extension Study: Heart failure requiring hospitalization or treatment(Year 7 after baseline)
- Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes(18 months after baseline)
- Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm)(18 months after baseline)
- Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate(18 months after baseline)
- Secondary Outcome of Phase 2: Stroke(36 months after baseline)
- Secondary Outcome of Phase 2: Myocardial infarction(36 months after baseline)
- Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment(36 months after baseline)
- Secondary Outcome of Phase 2: Cardiovascular disease death(36 months after baseline)
- Secondary Outcome of Phase 2: All-cause death(36 months after baseline)
- Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes(36 months after baseline)
- Secondary Outcome of Phase 3: Cognitive impairment no dementia(48 months after baseline)
- Secondary Outcome of Phase 3: Composite outcome of dementia and cognitive impairment no dementia(48 months after baseline)
- Secondary Outcome of Phase 3: Death from all causes(48 months after baseline)
- Secondary Outcome of Phase 3: 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)(48 months after baseline)
- Secondary Outcome of Phase 3: 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(48 months after baseline)
- Secondary Outcome of Extension Study: Composite outcome of dementia and cognitive impairment no dementia(Year 7 after baseline)
- Secondary Outcome of Extension Study: Stroke(Year 7 after baseline)
- Secondary Outcome of Extension Study: Myocardial infarction(Year 7 after baseline)
- Secondary Outcome of Extension Study: Cognitive impairment no dementia(Year 7 after baseline)
- Secondary Outcome of Extension Study: Mean systolic and diastolic pressure changes(Year 7 after baseline)
- Secondary Outcome of Extension Study: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg)(Year 7 after baseline)
- Secondary Outcome of Extension Study: Adherence to antihypertensive medication rate(Year 7 after baseline)
研究者
Yingxian Sun
Chief of Department of Cardiology in First Hospital of China Medical University
First Hospital of China Medical University