Comprehensive Management of High-risk PopuLatIon for Stroke Based on Social Network

NCT05963828 | Completed DMC

• 1 other identifier: COMPLIANCE-MT
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Keywords

Stroke; Management; Social Networks

Outcome Measures

Primary Outcomes (1)

• Good Medication Adherence to all guideline-recommended vascular prevention medications at 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 Outcomes (12)

• Proportion of good medication adherence to stroke prevention drugs post-discharge

  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.

  1 month, 3 months, 6 months and 12 months post-discharge

• Health-related quality of life (HRQoL)

  1 month, 3 months, 6 months and 12 months post-discharge

• Anxiety symptom severity

  1 month, 3 months, 6 months and 12 months post-discharge

• Depressive symptom severity

  1 month, 3 months, 6 months and 12 months post-discharge

Study Arms (2)

conventional care group

OTHER

Patients are managed according to the conventional methods after enrollment.

Behavioral: conventional care

Social network-based intervention group

EXPERIMENTAL

Patients are managed according to to the integrated digital platform

Behavioral: Social network-based intervention

Interventions

conventional care BEHAVIORAL

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.

conventional care group

Social network-based intervention BEHAVIORAL

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.

Social network-based intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (31)

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MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhang lingjuan

  Changhai Hospital Affiliated to Naval Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: July 27, 2023
• Study Start: July 19, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• 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.

Locations

CN (1)