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Comprehensive Management of High-risk PopuLatIon of Stroke Based on Social Network (COMPLIANCE-MT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05963828
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
Changhai Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effectiveness of social network in improving drug compliance and risk factors control rate of stroke high-risk population after discharge.

Condition or disease Intervention/treatment Phase
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Behavioral: Post-hospital management based on WeChat applet Behavioral: Routine post-hospital follow-up management Not Applicable

Detailed Description:

Stroke is the leading cause of death among residents in China, with the characteristics of high morbidity, high mortality, high disability rate, high recurrence rate and so on, which brings huge economic burden to the patients' families and society. Strengthening the comprehensive management of the high-risk population of stroke, improving the medication compliance of patients and the control rate of stroke risk factors play a key role in reducing stroke recurrence.

This study is a multicenter, prospective, randomized, single-blind study, which aims to use the tool of WeChat Mini Programs to realize the post-hospital follow-up management of the high-risk population of stroke. The follow-up time is 12 months. The main measurement result was the change of patients' medication compliance after comprehensive management.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: COmprehensive Management of High-risk PopuLatIon of Stroke bAsed oN soCial nEtwork: a Multicenter, Parallel and Randomized Controlled sTudy
Actual Study Start Date : August 8, 2023
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : June 30, 2025
Arms and Interventions
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Arm Intervention/treatment
Standard group
Patients are managed according to the routine methods after enrollment.
 Behavioral: Routine post-hospital follow-up management
The brain and mental health managers routinely followed up the patients in the standard group for 1, 3, 6 and 12 months by telephone or outpatient follow-up, the main content of which was to inquire about the medication of patients and the management of stroke risk factors. Targeted health education was carried out according to the risk factors of patients.
Experimental: Experimental group
Patients are managed by the social network platform.
 Behavioral: Post-hospital management based on WeChat applet
The brain and heart health manager uses the exclusive QR code in the WeChat applet to receive and manage patients. Patients can register and use the WeChat applet by scanning the QR code. The functions of WeChat applet include making medication plan for patients, daily medication reminder, targeted health education, health index monitoring, online consultation and so on.


Outcome Measures
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Primary Outcome Measures :
  1. Good compliance rate of stroke prevention drugs at 12 months after discharge [ Time Frame: 12 months after discharge ]
    Measured by The 4-Item Medication Adherence Scale ;The score of Morisky-4


Secondary Outcome Measures :
  1. Good compliance rate of stroke prevention drugs at 1 month, 3 months and 6 months after discharge [ Time Frame: 1 month, 3 months and 6 months after discharge. ]
    Measured by The 4-Item Medication Adherence Scale ;The score of Morisky-4

  2. The attainment rate of stroke risk factors (blood glucose, blood pressure, blood lipid, BMI, waist circumference, hip circumference, smoking) at 1 month, 3 months, 6 months and 12 months after discharge. [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]

    The method of measurement is as follows:

    Blood lipids: fasting blood sampling measurement Blood glucose: fasting fingertip blood glucose Blood pressure: using a sphygmomanometer to measure BMI: weight (kg) / height (m) ^ 2 Waist circumference, Hip circumference, Smoking: Patient self-report


  3. Knowledge of stroke [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]
    Measured by The Knowledge questionnaire on prevention and treatment of stroke

  4. Personal motivation [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]
    Measured by The Stroke Attitude Questionnaire

  5. Stroke health behavior improvement [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]
    Measured by The Stroke Prevention Health Behavior Scale

  6. Social motivation [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]
    Measured by Perceived Social Support Scale

  7. Health-related quality of life [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]
    Measured by The 5-level EQ-5D

  8. Incidence of anxiety [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]
    Measured by Generalized Anxiety Disorder-7

  9. Incidence of depression [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]
    Measured by Patient Health Questionnaire-9

  10. Self efficacy [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]
    Measured by Chronic Disease Self-Efficacy Scale

  11. Incidence of major cardiovascular events including stroke, acute coronary syndrome, and vascular death [ Time Frame: 1 month, 3 months, 6 months and 12 months after discharge ]

    Stroke: cerebral blood supply disorder caused by acute (focal) neurological syndrome, there is ischemic or hemorrhagic lesion in the corresponding area on brain imaging, or clinical evidence shows negative ischemic lesion on imaging, and the symptoms last longer than 24 hours.

    Acute coronary syndrome: ①typical clinical symptoms (such as chest pain, heart failure, etc.) accompanied by typical electrocardiogram (ECG) abnormalities; ② typical clinical symptoms with troponin elevated more than 2 times the upper limit of normal;③ or Non-specific symptoms with elevated troponin more than 2 times the upper limit of normal; ④Asymptomatic myocardial infarction diagnosed by follow-up ECG compared with baseline ECG combined with corresponding results of echocardiography or coronary angiography.

    Vascular death: including death within 30 days after stroke, death within 7 days after acute coronary syndrome, non-cerebral hemorrhage or necrotic death after peripheral artery occlusion or



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • High-risk population of stroke for hospitalization
  • Modified Rankin Scale score≤ 2
  • Patients or primary caregiver have smart phone and wechat accounts
  • Patients take at least one drug for a long time (antihypertensive, hypoglycemic, lipid-lowering, anticoagulant, antiplatelet drugs)
  • Written informed consent

Exclusion Criteria:

  • Patients and their families are unable to operate smartphones
  • Having other diseases that interfere with clinical follow-up assessment (such as cancer, dementia, severe mental illness, etc.)
  • Life expectancy is less than 12 months
  • Patients living in the absence of network conditions
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05963828


Contacts
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Contact: Qiao mengting 15039464902 pour7788@163.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Qiao mengting    15039464902    pour7788@163.com   
Sponsors and Collaborators
Changhai Hospital
Investigators
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Study Director: Zhang lingjuan Changhai Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Changhai Hospital
ClinicalTrials.gov Identifier: NCT05963828    
Other Study ID Numbers: COMPLIANCE-MT
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: March 27, 2024
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Changhai Hospital:
Stroke
Management
Social Networks
Additional relevant MeSH terms:
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Stroke
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
 Cerebrovascular Disorders
Cardiovascular Diseases
Vascular Diseases