Clinical trial NCT03527719: China Rural Hypertension Control Project
Official title: Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Cardiovascular disease
Dementia
China
Protocol-based treatment
Stroke
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: Tulane University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Tongji Hospital
name: Disease Control and Prevention Centre of Liaoning Province
name: Chaoyang Central Hospital
name: Hanzhong People's Hospital
name: Disease Control and Prevention Centre of Chaoyang City
name: Shengjing Hospital
First posted: 2018-05-17
Enrollment: 33995
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Primary Outcome of Phase 1: Hypertension control rate
timeFrame: 18 months after baseline
measure: Primary Outcome of Phase 2: Composite cardiovascular disease outcome
timeFrame: 36 months after baseline
measure: Primary Outcome of Phase 3: All-cause dementia
timeFrame: 48 months after baseline
Secondary outcomes:
measure: Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes
timeFrame: 18 months after baseline
measure: Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm)
timeFrame: 18 months after baseline
measure: Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate
timeFrame: 18 months after baseline
measure: Secondary Outcome of Phase 2: Stroke
timeFrame: 36 months after baseline
measure: Secondary Outcome of Phase 2: Myocardial infarction
timeFrame: 36 months after baseline
measure: Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment
timeFrame: 36 months after baseline
measure: Secondary Outcome of Phase 2: Cardiovascular disease death
timeFrame: 36 months after baseline
measure: Secondary Outcome of Phase 2: All-cause death
timeFrame: 36 months after baseline
measure: Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes
timeFrame: 36 months after baseline
measure: Secondary Outcome of Phase 3: Cognitive impairment no dementia
timeFrame: 48 months after baseline
measure: Secondary Outcome of Phase 3: Composite outcome of dementia and cognitive impairment no dementia
timeFrame: 48 months after baseline
measure: Secondary Outcome of Phase 3: Death from all causes
timeFrame: 48 months after baseline
measure: Secondary Outcome of Phase 3: Composite outcome of dementia or deaths
timeFrame: 48 months after baseline
measure: Secondary Outcome of Phase 3: Composite and individual cardiovascular disease (myocardial infarction, stroke, heart failure requiring hospitalization or treatment, and cardiovascular death)
timeFrame: 48 months after baseline
measure: Secondary Outcome of Phase 3: Changes in mean systolic and diastolic blood pressure from baseline to 48 months
timeFrame: 48 months after baseline
measure: Secondary Outcome of Phase 3: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months
timeFrame: 48 months after baseline
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Yingxian Sun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.