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

May 6, 2026 updated by: Changhai Hospital

COmprehensive Management of High-risk PopuLatIon for Stroke bAsed oN soCial nEtwork: A Multicenter Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Hospitalized patients at high risk of stroke are those who have at least three of the following risk factors: hypertension, dyslipidemia, diabetes, atrial fibrillation/valvular disease, smoking history, overweight/obesity, physical inactivity, or family stroke history; or those with a history of prior transient ischemic attack (TIA) or stroke.12
  • modified Rankin Scale (mRS) score ≤2.
  • Smartphone/WeChat access (patient or caregiver).
  • Informed consent obtained.
  • Active long-term therapy: ≥1 medication (antihypertensive, hypoglycemic, lipid-lowering, anticoagulant, antiplatelet).

Exclusion Criteria:

  • Inability to operate smartphones (patient or caregiver).
  • Comorbidities potentially confounding outcome assessments, including Advanced malignancies (life expectancy <12 months); Documented dementia; Severe psychiatric disorders (e.g., schizophrenia, major depressive disorder).
  • Residence in areas with unreliable internet access.
  • Concurrent participation in other clinical trials.
  • Any condition deemed by investigators to preclude safe trial participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: conventional care group
Patients are managed according to the conventional methods after enrollment.
Behavioral: conventional care
Patients in conventional care group will receive standardized education based on ASA/AHA 2021 guidelines prior to discharge,2 delivered verbally by a certified Brain-Heart Health Manager (BHHM) and supplemented with an expert-reviewed booklet. Content will cover medication adherence, risk factor control, stroke recognition, emergency response, and follow-up plans. A contact number will be provided for post-discharge support. A baseline archive will document demographics, lifestyle, and cardiovascular risk factors.
Experimental: Social network-based intervention group
Patients are managed according to to the integrated digital platform
Behavioral: Social network-based intervention
Participants in Social network-based intervention group are onboard to the integrated digital platform. BHHMs facilitate the activation of the digital interface via a unique QR code, assist in the creation of a comprehensive electronic health record (EHR), and guide participants through an interactive tutorial to ensure technical proficiency in data entry and communication features.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Good Medication Adherence to all guideline-recommended vascular prevention medications at 12 months post-discharge
Time Frame: 12 months post-discharge

Adherence is assessed using self-reported data, with participants asked to indicate the number of days they missed taking a dose for each medication class during the preceding 30 days. This evaluation is conducted separately for each of the five evidence-based secondary prevention drug classes: antihypertensives, hypoglycemics, lipid-lowering agents, anticoagulants, and antiplatelets. Good adherence for each class is defined as taking the prescribed medication on more than 24 days out of the previous 30 days (corresponding to an adherence rate >80%). To meet the primary endpoint, a participant must achieve this >80% adherence threshold simultaneously across all five medication classes at the 12-month follow-up.

Any self-directed cessation or adjustment of the regimen without medical consultation is categorized as non-adherence. Conversely, patients who cease or adjust their medications according to medical advice will be considered adherent. For those who adjust their medications base
12 months post-discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of good medication adherence to stroke prevention drugs post-discharge
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Morisky-8 Medication Adherence Scale [MMAS-8]. Good adherence is defined as an MMAS-8 score greater than 6.The lowest score is 0, and the highest score is 8. A higher score indicates better adherence.
1 month, 3 months, 6 months and 12 months post-discharge
Risk factor control, including blood glucose(mmol/L), blood pressure(mmHg), lipid profile(mmol/L), body mass index (BMI) (kg/m ^ 2), waist circumference(cm), hip circumference(cm), and smoking status post-discharge.
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge

The method of measurement is as follows:

Blood lipids(mmol/L): fasting blood sampling measurement Blood glucose(mmol/L): fasting fingertip blood glucose Blood pressure(mmHg): using a sphygmomanometer to measure BMI (kg/m ^ 2): weight(kg) / height (m ^ 2) Waist circumference(cm), Hip circumference(cm), Smoking: Patient self-report
1 month, 3 months, 6 months and 12 months post-discharge
Health-related quality of life (HRQoL)
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L),including visual analog scale (score range of 0-100, higher score indicates better health status) and utility score (score range of[ -0.391,1], higher score indicates better quality of life for patients)
1 month, 3 months, 6 months and 12 months post-discharge
Anxiety symptom severity
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
assessed using the 7-item Generalized Anxiety Disorder Scale (GAD-7),the score range is 0-21 points, with higher scores indicating greater levels of anxiety.
1 month, 3 months, 6 months and 12 months post-discharge
Depressive symptom severity
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the 9-item Patient Health Questionnaire (PHQ-9),the score range is 0-27 points, with higher scores indicating more severe depression.
1 month, 3 months, 6 months and 12 months post-discharge
Stroke prevention knowledge scores
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Stroke Prevention Knowledge Questionnaire,the score range is 0-36 points, with higher scores indicating better mastery of stroke related knowledge.
1 month, 3 months, 6 months and 12 months post-discharge
Personal motivation for stroke prevention
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Stroke Attitude Questionnaire,the total score is the sum of 16 items, and the higher the score, the better the cognitive attitude.
1 month, 3 months, 6 months and 12 months post-discharge
Perceived social support
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Perceived Social Support Scale (PSSS),there are a total of 12 items, with each item assigned a score of 1-7, for a total score of 12-84. The higher the score, the higher the individual's level of social support.
1 month, 3 months, 6 months and 12 months post-discharge
Stroke prevention-related health behavior scores
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Stroke Prevention Health Behavior Scale,the scale consists of 25 items and uses the Likert 4-point scoring method. The higher the total score, the higher the level of healthy behavior.
1 month, 3 months, 6 months and 12 months post-discharge
Self-efficacy for chronic disease management
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Chronic Disease Self-Efficacy Scale,the scale consists of 6 items, with each item rated on a scale of 1-10. The average score is taken, and the higher the average score, the stronger the self-efficacy.
1 month, 3 months, 6 months and 12 months post-discharge
Intentions regarding prehospital delay in stroke emergency care
Time Frame: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Prehospital Delay Behavior Intention Scale for Stroke,the scale consists of 27 items and uses the Likert 5-point scoring method, with a score range of 27-135 points. The higher the score, the stronger the intention and likelihood of delaying medical treatment.
1 month, 3 months, 6 months and 12 months post-discharge
Incidence of major adverse cerebrovascular and cardiovascular events (MACCE)
Time Frame: 1month, 3months, 6months and 12-months post-discharge
Including stroke, acute coronary syndrome, and vascular death
1month, 3months, 6months and 12-months post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Study Director: Zhang lingjuan, Changhai Hospital Affiliated to Naval Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPLIANCE-MT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual, de-identified participant data used in these analyses will be shared by request from any qualified investigator following approval of a protocol and signed data access agreement via both the trial steering committee.

IPD Sharing Time Frame

Data sharing will be available from 12 months after the publication of the main results.

IPD Sharing Access Criteria

1.The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2.The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3.Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4.Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5.The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on conventional care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe