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

Study Overview
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Brief Summary
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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
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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.

Official Title
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COmprehensive Management of High-risk PopuLatIon of Stroke bAsed oN soCial nEtwork: a Multicenter, Parallel and Randomized Controlled sTudy

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

Intervention / Treatment
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* Behavioral: Post-hospital management based on WeChat applet
* Behavioral: Routine post-hospital follow-up management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard group<br>Patients are managed according to the routine methods after enrollment. | Behavioral: Routine post-hospital follow-up management<br>* 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.<br>|
| Experimental: Experimental group<br>Patients are managed by the social network platform. | Behavioral: Post-hospital management based on WeChat applet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good compliance rate of stroke prevention drugs at 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. | 12 months after discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good compliance rate of stroke prevention drugs at 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. | 1 month, 3 months and 6 months after discharge. | 
| 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. | 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 | 1 month, 3 months, 6 months and 12 months after discharge | 
| Knowledge of stroke | Measured by The Knowledge questionnaire on prevention and treatment of stroke | 1 month, 3 months, 6 months and 12 months after discharge | 
| Personal motivation | Measured by The Stroke Attitude Questionnaire | 1 month, 3 months, 6 months and 12 months after discharge | 
| Stroke health behavior improvement | Measured by The Stroke Prevention Health Behavior Scale | 1 month, 3 months, 6 months and 12 months after discharge | 
| Social motivation | Measured by Perceived Social Support Scale | 1 month, 3 months, 6 months and 12 months after discharge | 
| Health-related quality of life | Measured by The 5-level EQ-5D | 1 month, 3 months, 6 months and 12 months after discharge | 
| Incidence of anxiety | Measured by Generalized Anxiety Disorder-7 | 1 month, 3 months, 6 months and 12 months after discharge | 
| Incidence of depression | Measured by Patient Health Questionnaire-9 | 1 month, 3 months, 6 months and 12 months after discharge | 
| Self efficacy | Measured by Chronic Disease Self-Efficacy Scale | 1 month, 3 months, 6 months and 12 months after discharge | 
| Incidence of major cardiovascular events including stroke, acute coronary syndrome, and vascular death | 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 | 1 month, 3 months, 6 months and 12 months after discharge | 
| Delayed behavioral intention before hospitalization after stroke | Measured by Prehospital Delayed Behavior Intention Scale for Stroke | 1 month, 3 months, 6 months and 12 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Management, Social Networks