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

Sponsor
Changhai Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05963828
Collaborator
(none)
720
1
2
14
51.4

Study Details

Study Description

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
  • Behavioral: Post-hospital management based on WeChat applet
  • Behavioral: Routine post-hospital follow-up management
N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. Good compliance rate of stroke prevention drugs at 12 months after discharge [12 months after discharge.]

    Measured by The 8-Item Medication Adherence Scale ;The score of Morisky-8 medication compliance scale is greater than 6 as "good compliance".

Secondary Outcome Measures

  1. Good compliance rate of stroke prevention drugs at 1 month, 3 months and 6 months after discharge [1 month, 3 months and 6 months after discharge.]

    Measured by The 8-Item Medication Adherence Scale ;The score of Morisky-8 medication compliance scale is greater than 6 as "good compliance".

  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. [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 [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 [1 month, 3 months, 6 months and 12 months after discharge]

    Measured by The Stroke Attitude Questionnaire

  5. Stroke health behavior improvement [1 month, 3 months, 6 months and 12 months after discharge]

    Measured by The Stroke Prevention Health Behavior Scale

  6. Social motivation [1 month, 3 months, 6 months and 12 months after discharge]

    Measured by Perceived Social Support Scale

  7. Health-related quality of life [1 month, 3 months, 6 months and 12 months after discharge]

    Measured by The 5-level EQ-5D

  8. Incidence of anxiety [1 month, 3 months, 6 months and 12 months after discharge]

    Measured by Generalized Anxiety Disorder-7

  9. Incidence of depression [1 month, 3 months, 6 months and 12 months after discharge]

    Measured by Patient Health Questionnaire-9

  10. Self efficacy [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 [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

  12. Delayed behavioral intention before hospitalization after stroke [1 month, 3 months, 6 months and 12 months after discharge]

    Measured by Prehospital Delayed Behavior Intention Scale for Stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Changhai Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

  • Study Director: Zhang lingjuan, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changhai Hospital
ClinicalTrials.gov Identifier:
NCT05963828
Other Study ID Numbers:
  • COMPLIANCE-MT
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Changhai Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023