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China Rural Hypertension Control Project (CRHC)

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ClinicalTrials.gov Identifier: NCT03527719
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Yingxian Sun, 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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Strengthen the performance appraisal system Other: Establishing a chronic disease management system Other: Simulating medical insurance reform Other: Enhancing village doctors'ability. Other: Establishing a supervision mechanism for the effect Other: Establishing a hierarchical management system for patients Behavioral: Enhancing the awareness of blood pressure self-management Behavioral: Establishing a self-management group Other: Establishing patient encouragement system Not Applicable

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 stroke events.The investigators will select a total of 332 villages in China: 232 in the northeastern, 40 in eastern, 40 in central, and 20 in western China.The investigators will recruit 36,520 participants with hypertension (110 participants per village) who are aged 40-years and older. The study villages will be randomly assigned to the standard protocol treatment group (166 villages) or the usual management group (166 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 measurement every six months. The project will have two phases. The first one will last for 12 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome Assessment Committee members will be blinded to intervention assignment.
Primary Purpose: Treatment
Official Title: Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.

  1. Strengthen the performance appraisal system for primary hypertension management
  2. Establishing a chronic disease management system
  3. Simulating medical insurance reform
  4. Enhancing village doctors'ability for standardized diagnosis and treatment of hypertension.
  5. Establishing a supervision mechanism for the effect of hypertension management
  6. Establishing a hierarchical management system for patients
  7. Enhancing the awareness of blood pressure self-management
  8. Establishing a self-management group for patients
  9. 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,enhancing the active awareness of hypertension prevention and control of, and cooperating with the village doctor 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,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 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 above hospitals - county hospitals - village doctors. Three levels of doctors in the management system sign contracted management. Each city-level and above hospital doctor signs three county-level hospital doctors. Each county-level hospital doctor signs up with ten village doctors and established 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 was established in each of the study village. They will participate in a group activity every quarter to learn about healthy lifestyles and self-tested blood pressure, the hazards of hypertension, to 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, and rewards will be based on quarterly and annual points to cultivate and enhance participants' initiative consciousness of self-management of blood pressure.

No Intervention: Control Group
All participants in the routine management groups will receive the current management program.



Primary Outcome Measures :
  1. Primary Outcome of Phase 1: Hypertension control rate [ Time Frame: 12 months after baseline ]
    The proportion of participants with controlled blood pressure(< 130/80 mm Hg)

  2. Primary Outcome of Phase 2: Composite cardiovascular disease outcome [ Time Frame: 36 months after baseline ]
    Record the occurrence of newly diagnosed composite cardiovascular disease


Secondary Outcome Measures :
  1. Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes [ Time Frame: 12 months after baseline ]
    Mean systolic and diastolic pressure changes of participants

  2. Secondary Outcome of Phase 1:Hypertension control rate(<140/90 mm) [ Time Frame: 12 months after baseline ]
    The proportion of participants with controlled blood pressure(< 140/90 mm Hg)

  3. Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate [ Time Frame: 12 months after baseline ]
    Use questionnaires to assess the proportion of participants who adhere to antihypertensive drugs

  4. Secondary Outcome of Phase 2: Stroke [ Time Frame: 36 months after baseline ]
    Number of newly diagnosed stroke

  5. Secondary Outcome of Phase 2: Myocardial infarction [ Time Frame: 36 months after baseline ]
    Number of newly diagnosed myocardial infarction

  6. 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

  7. Secondary Outcome of Phase 2: Newly diagnosed cancer [ Time Frame: 36 months after baseline ]
    Number of newly diagnosed cancer

  8. Secondary Outcome of Phase 2: Aortic dissection [ Time Frame: 36 months after baseline ]
    Number of newly diagnosed aortic dissection

  9. Secondary Outcome of Phase 2:Cardiovascular disease death [ Time Frame: 36 months after baseline ]
    Number of cardiovascular disease death

  10. Secondary Outcome of Phase 2:All-case death [ Time Frame: 36 months after baseline ]
    Number of all-case death

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527719


Contacts
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Contact: Liying Xing, PhD +86 13998878063 xly1983sy@163.com

Locations
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China, Liaoning
The First Affiliated Hospital of China Medical University Recruiting
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
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Principal Investigator: Yingxian Sun, MD, PhD First Hospital of China Medical University

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Responsible Party: Yingxian Sun, Chief of Department of Cardiology in First Hospital of China Medical University, First Hospital of China Medical University
ClinicalTrials.gov Identifier: NCT03527719     History of Changes
Other Study ID Numbers: KLS20181582
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yingxian Sun, First Hospital of China Medical University:
Hypertension
Stroke
China
Protocol-based treatment
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases