China Rural Hypertension Control Project

Hypertension Clinical Trial

— CRHC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03527719
• Other study ID #: KLS20181582
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: First Hospital of China Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 33995
• Est. completion date: June 30, 2024
• Est. primary completion date: March 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Village-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

Locations

Country	Name	City	State
China	The First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (9)

Lead Sponsor	Collaborator
First Hospital of China Medical University	Chaoyang Central Hospital, Disease Control and Prevention Centre of Chaoyang City, Disease Control and Prevention Centre of Liaoning Province, First Affiliated Hospital Xi'an Jiaotong University, Hanzhong People's Hospital, Shengjing Hospital, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Tulane University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Primary Outcome of Phase 2: Composite cardiovascular disease outcome	Record the occurrence of newly diagnosed composite cardiovascular disease	36 months after baseline
Primary	Primary Outcome of Phase 3: All-cause dementia	Record all-cause dementia	48 months after baseline
Secondary	Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes	Mean systolic and diastolic pressure changes of participants	18 months after baseline
Secondary	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	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	Secondary Outcome of Phase 2: Stroke	Number of newly diagnosed stroke	36 months after baseline
Secondary	Secondary Outcome of Phase 2: Myocardial infarction	Number of newly diagnosed myocardial infarction	36 months after baseline
Secondary	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	Secondary Outcome of Phase 2: Cardiovascular disease death	Number of cardiovascular disease death	36 months after baseline
Secondary	Secondary Outcome of Phase 2: All-cause death	Number of all-cause death	36 months after baseline
Secondary	Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes	Mean systolic and diastolic pressure changes of participants	36 months after baseline
Secondary	Secondary Outcome of Phase 3: Cognitive impairment no dementia	Record cognitive impairment no dementia	48 months after baseline
Secondary	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	Secondary Outcome of Phase 3: Death from all causes	Record death from all causes	48 months after baseline
Secondary	Secondary Outcome of Phase 3: Composite outcome of dementia or deaths	Record the composite outcome of dementia or deaths	48 months after baseline
Secondary	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	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	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