China Rural Hypertension Control Project (CRHC)

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

Tulane University, First Affiliated Hospital Xi'an Jiaotong University, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, 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

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.

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.

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

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

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)

Secondary Outcome of Phase 3: Changes in mean systolic and diastolic blood pressure from baseline to 48 months

Secondary Outcome of Phase 3: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months

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

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.