Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Nervous System Diseases, Stroke, Vascular Diseases
Conditions
Keywords
Stroke, Management, Social Networks
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.
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.
Interventions
BEHAVIORALconventional 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.
BEHAVIORALSocial 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.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Good Medication Adherence to all guideline-recommended vascular prevention medications at 12 months post-discharge | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of good medication adherence to stroke prevention drugs post-discharge | 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. |
| 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 | 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 |
| Health-related quality of life (HRQoL) | 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) |
| Anxiety symptom severity | 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. |
| Depressive symptom severity | 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. |
| Stroke prevention knowledge scores | 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. |
| Personal motivation for stroke prevention | 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. |
| Perceived social support | 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. |
| Stroke prevention-related health behavior scores | 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. |
| Self-efficacy for chronic disease management | 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. |
| Intentions regarding prehospital delay in stroke emergency care | 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. |
| Incidence of major adverse cerebrovascular and cardiovascular events (MACCE) | 1month, 3months, 6months and 12-months post-discharge | Including stroke, acute coronary syndrome, and vascular death |
Countries
China
Contacts
STUDY_DIRECTORZhang lingjuan
Changhai Hospital Affiliated to Naval Medical University
Outcome results
None listed