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

Changhai Hospital720 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

720

Conditions

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

Interventions

conventional careBEHAVIORAL

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.

Social network-based interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

Time frame: 12 months post-discharge

Secondary Outcomes

Proportion of good medication adherence to stroke prevention drugs 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.

Time frame: 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.

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

Time frame: 1 month, 3 months, 6 months and 12 months post-discharge

Data from ClinicalTrials.gov

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