CRHC: China Rural Hypertension Control Project
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group 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. |
Other: Strengthen the performance appraisal system
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.
Other: Establishing a chronic disease management system
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.
Other: Simulating medical insurance reform
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.
Other: Enhancing village doctors'ability.
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.
Other: Establishing a supervision mechanism for the effect
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.
Other: Establishing a hierarchical management system for patients
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.
Behavioral: Enhancing the awareness of blood pressure self-management
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.
Behavioral: Establishing a self-management group
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.
Other: Establishing patient encouragement system
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.
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| No Intervention: Control Group All participants in the routine management groups will receive the current management program. |
Outcome Measures
Primary Outcome Measures
- Primary Outcome of Phase 1: Hypertension control rate [18 months after baseline]
The proportion of participants with controlled blood pressure（< 130/80 mm Hg）
- Primary Outcome of Phase 2: Composite cardiovascular disease outcome [36 months after baseline]
Record the occurrence of newly diagnosed composite cardiovascular disease
Secondary Outcome Measures
- Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes [18 months after baseline]
Mean systolic and diastolic pressure changes of participants
- Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm) [18 months after baseline]
The proportion of participants with controlled blood pressure（< 140/90 mm Hg）
- Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate [18 months after baseline]
Use questionnaires to assess the proportion of participants who adhere to antihypertensive drugs
- Secondary Outcome of Phase 2: Stroke [36 months after baseline]
Number of newly diagnosed stroke
- Secondary Outcome of Phase 2: Myocardial infarction [36 months after baseline]
Number of newly diagnosed myocardial infarction
- Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment [36 months after baseline]
Number of patients with newly diagnosed heart failure requiring hospitalization or treatment
- Secondary Outcome of Phase 2: Newly diagnosed cancer [36 months after baseline]
Number of newly diagnosed cancer
- Secondary Outcome of Phase 2: Aortic dissection [36 months after baseline]
Number of newly diagnosed aortic dissection
- Secondary Outcome of Phase 2: Cardiovascular disease death [36 months after baseline]
Number of cardiovascular disease death
- Secondary Outcome of Phase 2: All-cause death [36 months after baseline]
Number of all-cause death
- Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes [36 months after baseline]
Mean systolic and diastolic pressure changes of participants
Eligibility Criteria
Criteria
Inclusion Criteria:
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40 years and older
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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)
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Living in the current residence at least 6 months
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No intention to move within next 3 years;
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Taking part in the New National Rural Cooperative Scheme
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Voluntarily participating in the study and signing an informed consent
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With an estimated life expectancy of more than 3 years
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Not pregnant and do not intend to become pregnant in next 36 months
Exclusion Criteria:
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Patients with malignant tumors and life expectancy <3 years;
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Pregnant women or trying to conceive
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Hospital of China Medical University | Shenyang | Liaoning | China | 110001 |
Sponsors and Collaborators
- First Hospital of China Medical University
- 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
Investigators
- Principal Investigator: Yingxian Sun, MD, PhD, First Hospital of China Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KLS20181582