- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03527719
China Rural Hypertension Control Project (CRHC)
October 21, 2023 updated by: Yingxian Sun, First Hospital of China Medical University
Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
33995
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
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Shenyang, Liaoning, China, 110001
- The First Hospital of China Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Village-doctor-led multifaceted intervention
|
|
No Intervention: Control Group
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Outcome of Phase 1: Hypertension control rate
Time Frame: 18 months after baseline
|
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
Time Frame: 36 months after baseline
|
Record the occurrence of newly diagnosed composite cardiovascular disease
|
36 months after baseline
|
Primary Outcome of Phase 3: All-cause dementia
Time Frame: 48 months after baseline
|
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
Time Frame: 18 months after baseline
|
Mean systolic and diastolic pressure changes of participants
|
18 months after baseline
|
Secondary Outcome of Phase 1: Hypertension control rate(<140/90 mm)
Time Frame: 18 months after baseline
|
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
Time Frame: 18 months after baseline
|
Use questionnaires to assess the proportion of participants who adhere to antihypertensive drugs
|
18 months after baseline
|
Secondary Outcome of Phase 2: Stroke
Time Frame: 36 months after baseline
|
Number of newly diagnosed stroke
|
36 months after baseline
|
Secondary Outcome of Phase 2: Myocardial infarction
Time Frame: 36 months after baseline
|
Number of newly diagnosed myocardial infarction
|
36 months after baseline
|
Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment
Time Frame: 36 months after baseline
|
Number of patients with newly diagnosed heart failure requiring hospitalization or treatment
|
36 months after baseline
|
Secondary Outcome of Phase 2: Cardiovascular disease death
Time Frame: 36 months after baseline
|
Number of cardiovascular disease death
|
36 months after baseline
|
Secondary Outcome of Phase 2: All-cause death
Time Frame: 36 months after baseline
|
Number of all-cause death
|
36 months after baseline
|
Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes
Time Frame: 36 months after baseline
|
Mean systolic and diastolic pressure changes of participants
|
36 months after baseline
|
Secondary Outcome of Phase 3: Cognitive impairment no dementia
Time Frame: 48 months after baseline
|
Record cognitive impairment no dementia
|
48 months after baseline
|
Secondary Outcome of Phase 3: Composite outcome of dementia and cognitive impairment no dementia
Time Frame: 48 months after baseline
|
Record the composite outcome of dementia and cognitive impairment no dementia
|
48 months after baseline
|
Secondary Outcome of Phase 3: Death from all causes
Time Frame: 48 months after baseline
|
Record death from all causes
|
48 months after baseline
|
Secondary Outcome of Phase 3: Composite outcome of dementia or deaths
Time Frame: 48 months after baseline
|
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)
Time Frame: 48 months after baseline
|
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
Time Frame: 48 months after baseline
|
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
Time Frame: 48 months after baseline
|
Record the proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months
|
48 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yingxian Sun, MD, PhD, First Hospital of China Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sun Y, Mu J, Wang DW, Ouyang N, Xing L, Guo X, Zhao C, Ren G, Ye N, Zhou Y, Wang J, Li Z, Sun G, Yang R, Chen CS, He J; CRHCP Study Group. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial. Lancet. 2022 May 21;399(10339):1964-1975. doi: 10.1016/S0140-6736(22)00325-7. Epub 2022 Apr 29.
- Sun Y, Li Z, Guo X, Zhou Y, Ouyang N, Xing L, Sun G, Mu J, Wang D, Zhao C, Wang J, Ye N, Zheng L, Chen S, Chang Y, Yang R, He J. Rationale and Design of a Cluster Randomized Trial of a Village Doctor-Led Intervention on Hypertension Control in China. Am J Hypertens. 2021 Aug 9;34(8):831-839. doi: 10.1093/ajh/hpab038.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2018
Primary Completion (Actual)
March 26, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
April 22, 2018
First Submitted That Met QC Criteria
May 4, 2018
First Posted (Actual)
May 17, 2018
Study Record Updates
Last Update Posted (Actual)
October 24, 2023
Last Update Submitted That Met QC Criteria
October 21, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KLS20181582
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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