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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders
• Interventions: Behavioral: Routine post-hospital follow-up management; Behavioral: Post-hospital management based on WeChat applet

• Registration Number: NCT05963828
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study First Submitted: 2023-04-14
• Study Start: 2023-07-18
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-07-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard group	Routine post-hospital follow-up management	Patients are managed according to the routine methods after enrollment.
Experimental group	Post-hospital management based on WeChat applet	Patients are managed by the social network platform.

Primary Outcome Measures

Name	Time	Method
Patient's medication adherence to five evidence-based secondary prevention drugs for stroke at 12 months after discharge	12 months after discharge	Compliance is defined when patients take all evidence-based secondary preventive drugs (antihypertensive, hypoglycemic, lipid-regulating, anticoagulant and antiplatelet drugs) for more than 24 days in 12 months after discharge, that is, the drug taking rate is \> 80% (\> 24/30 days). If the patient adjusts the drug or stops taking the drug by himself, it will be regarded as "non-compliance". If the patient stops taking the drug according to the doctor's advice, it will be regarded as compliance. If the drug is adjusted according to the doctor's advice, it is necessary to continue to ask about the number of days of taking the drug in the past month. If the number of days of taking the drug exceeds 24 days, it will be regarded as compliance.

Secondary Outcome Measures

Name	Time	Method
Stroke health behavior improvement	1 month, 3 months, 6 months and 12 months after discharge	Measured by The Stroke Prevention Health Behavior Scale
Health-related quality of life	1 month, 3 months, 6 months and 12 months after discharge	Measured by The 5-level EQ-5D
Self efficacy	1 month, 3 months, 6 months and 12 months after discharge	Measured by Chronic Disease Self-Efficacy Scale
Knowledge of stroke	1 month, 3 months, 6 months and 12 months after discharge	Measured by The Knowledge questionnaire on prevention and treatment of stroke
Incidence of anxiety	1 month, 3 months, 6 months and 12 months after discharge	Measured by Generalized Anxiety Disorder-7
Incidence of depression	1 month, 3 months, 6 months and 12 months after discharge	Measured by Patient Health Questionnaire-9
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.	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
Personal motivation	1 month, 3 months, 6 months and 12 months after discharge	Measured by The Stroke Attitude Questionnaire
Social motivation	1 month, 3 months, 6 months and 12 months after discharge	Measured by Perceived Social Support Scale
The rate of good compliance with stroke prevention drugs among patients 1 month, 3 months, 6 months and 12 months after discharge	1 month, 3 months，6 months and 12 months after discharge.	Measured by Morisky Medication Adherence Scale 8 item; Morisky Medication Adherence Scale 8 item
Incidence of major cardiovascular events including stroke, acute coronary syndrome, and vascular death	1 month, 3 months, 6 months and 12 months after discharge	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

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China