China Rural Hypertension Control Project

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

Sponsors

Lead Sponsor: First Hospital of China Medical University

Collaborator: Tulane University
Soochow University
Huazhong University of Science and Technology
Health Science Center of Xi'an Jiaotong University
Liaoning Center for Disease Control and Prevention

Source First Hospital of China Medical University
Brief Summary

China Rural Hypertension Control (CRHC) Project is a cluster randomized trial which will test the effectiveness of a standardized protocol-based treatment program on hypertension control and cardiovascular events among hypertensive patients in rural China.

Detailed Description

China Rural Hypertension Control (CRHC) Project is a cluster randomized trial to test the effectiveness of a standard treatment protocol on hypertension control and cardiovascular events.The investigators will select a total of 326 villages in China: 282 in the northeastern, 25 in central, and 19 in western China.The investigators will recruit 33,995 participants with hypertension who are aged 40-years and older. The study villages will be randomly assigned to the standard protocol treatment group (163 villages) or the usual management group (163 villages). The village doctors in the intervention group will be trained to manage hypertension using a standard protocol based on the new hypertension treatment guideline and those in the control group will not receive training on the standard treatment protocol. The standard treatment protocol is based on the 2017 ACC(American College of Cardiology)/AHA(American Heart Association) hypertension treatment guideline and our previous experience in hypertension management and treatment strategies in rural China. Blood pressure and other clinical outcomes will be followed up every six months. The project has two phases. The first one will last for 18 months and blood pressure control is the primary outcome. The phase 2 will last for 36 months and cardiovascular event rate is the primary outcome.

Overall Status Active, not recruiting
Start Date 2018-05-08
Completion Date 2022-12-31
Primary Completion Date 2021-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary Outcome of Phase 1: Hypertension control rate 18 months after baseline
Primary Outcome of Phase 2: Composite cardiovascular disease outcome 36 months after baseline
Secondary Outcome
Measure Time Frame
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: Newly diagnosed cancer 36 months after baseline
Secondary Outcome of Phase 2: Aortic dissection 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
Enrollment 33995
Condition
Intervention

Intervention Type: Other

Intervention Name: Strengthen the performance appraisal system

Description: In accordance with the performance evaluation standards for the management of hypertension patients in national basic public health services and on the basis of routine management such as blood pressure monitoring and lifestyle guidance, medication rate, medication compliance, control rate and patient follow-up rate of participants in the intervention group will be included in the performance assessment index system and a complete performance appraisal evaluation and reward and punishment system will be established.

Arm Group Label: Experimental Group

Intervention Type: Other

Intervention Name: Establishing a chronic disease management system

Description: Assigning a professional staff for the propaganda and treatment of chronic disease prevention and management for each study village, who is responsible for supervising participants taking medicine according to doctor's prescription, regularly measuring blood pressure, promoting healthy lifestyles, and regularly organizing hypertensive participants to carry out self-management group activities, enhance the active awareness of hypertension prevention and control. They will cooperate with the village doctors to manage blood pressure control of hypertensive patients.

Arm Group Label: Experimental Group

Intervention Type: Other

Intervention Name: Simulating medical insurance reform

Description: Through the provision of preferential anti-hypertensive drugs to the participants in the intervention group, the increase of Medicare reimbursement proportion for hypertension is simulated to provide affordable, effective free antihypertensive drugs to the participants with poor economic conditions in the management population. Through the measures above, the participants' compliance with medication will be improved. The project will select the best antihypertensive drugs for rural patients, and to implement preferential policies for buying gifts. At the same time, inexpensive and effective free antihypertensive drugs including nitrendipine tablets, captopril tablets and indapamide tablets will be supplied to the impoverished hypertensive patients free of charge.

Arm Group Label: Experimental Group

Intervention Type: Other

Intervention Name: Enhancing village doctors'ability.

Description: Standardizing training programs for village doctors in hypertension prevention, control, management ,diagnosis and treatment capabilities, including clinical norms of hypertension medication, professional knowledge about commonly used antihypertensive drugs'adverse reactions, contraindications and drug adjustment strategies and disposal principles, will improve the rationality of managing drug treatment programs for participants, and comprehensively improve participants' compliance and blood pressure control rate. At the same time, a quarterly evaluation and assessment system for the medical treatment capacity of village doctors for hypertension will be established.

Arm Group Label: Experimental Group

Intervention Type: Other

Intervention Name: Establishing a supervision mechanism for the effect

Description: Establish a hypertension management effect monitoring team composed of the county (district) health commission, the disease prevention and control center, and the township prevention and protection station to remind and urge village doctors to strengthen the management of blood pressure in participants who do not meet the standard and to increase the compliance rate. Periodically form a paper work record and report to the provincial project team's quality control center.

Arm Group Label: Experimental Group

Intervention Type: Other

Intervention Name: Establishing a hierarchical management system for patients

Description: Establish a hierarchical management system for participants at the municipal level and superior hospitals - county hospitals - village doctors. Three levels of doctors in the management system sign contracted management. Each city-level and superior hospital doctor signs up with three county-level hospital doctors, and each county-level hospital doctor signs up with ten village doctors. They will establish a three-level doctors WeChat (Chinese mainstream social software) communication group to ensure the rationality of the program and the participants' safety during the diagnosis and treatment.

Arm Group Label: Experimental Group

Intervention Type: Behavioral

Intervention Name: Enhancing the awareness of blood pressure self-management

Description: Electronic sphygmomanometer will be uniformly distributed among the participants in the intervention group to promote the self-tested blood pressure habits of the participants. The participants will be encouraged to communicate with the village doctors actively to enhance their self-management consciousness of blood pressure.

Arm Group Label: Experimental Group

Intervention Type: Behavioral

Intervention Name: Establishing a self-management group

Description: A self-management group for participants will be established in each of the study village. They will participate in a group activity every quarter to learn about healthy lifestyles, methods on self-tested blood pressure and the risk of hypertension. They will communicate with other patients about the experience in the treatment process and give feedback to village doctors about the treatment process for the enhancement of the confidence for long-term medication.

Arm Group Label: Experimental Group

Intervention Type: Other

Intervention Name: Establishing patient encouragement system

Description: A self-administration point encouragement system for participants' blood pressure will be established to accumulate points according to the participants' self-blood pressure measurement, medication compliance, follow-up compliance, and self-management team participation. Rewards will be based on quarterly and annual points to cultivate and enhance participants' initiative consciousness of self-management of blood pressure.

Arm Group Label: Experimental Group

Eligibility

Criteria:

Inclusion Criteria: - 40 years and older - Uncontrolled blood pressure (patients with mean treated systolic blood pressure [SBP] ≥130 mm Hg and/or diastolic blood pressure [DBP] ≥80 mm Hg or mean untreated SBP ≥140 mm Hg and/or DBP ≥90 mm Hg; or patients with complications (coronary heart disease, heart failure, stroke, diabetes, chronic kidney disease) and with a mean treated/untreated SBP ≥130 mm Hg and/or DBP ≥80 mm Hg) - Living in the current residence at least 6 months - No intention to move within next 3 years; - Taking part in the New National Rural Cooperative Scheme - Voluntarily participating in the study and signing an informed consent - With an estimated life expectancy of more than 3 years - Not pregnant and do not intend to become pregnant in next 36 months Exclusion Criteria: - Patients with malignant tumors and life expectancy <3 years; - Pregnant women or trying to conceive

Gender:

All

Minimum Age:

40 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yingxian Sun, MD, PhD Principal Investigator First Hospital of China Medical University
Location
Facility: The First Hospital of China Medical University
Location Countries

China

Verification Date

2020-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: First Hospital of China Medical University

Investigator Full Name: Yingxian Sun

Investigator Title: Chief of Department of Cardiology in First Hospital of China Medical University

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental Group

Type: Experimental

Description: All participants of intervention groups will receive a new comprehensive evidence-based medicine (EBM) management program including nine intervention measures. Strengthen the performance appraisal system for primary hypertension management. Establishing a chronic disease management system. Simulating medical insurance reform. Enhancing village doctors'ability for standardized diagnosis and treatment of hypertension. Establishing a supervision mechanism for the effect of hypertension management. Establishing a hierarchical management system for patients. Enhancing the awareness of blood pressure self-management. Establishing a self-management group for patients. Establishing patient encouragement system.

Label: Control Group

Type: No Intervention

Description: All participants in the routine management groups will receive the current management program.

Acronym CRHC
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: Outcome Assessment Committee members will be blinded to outcome assignment.

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