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

Stroke Clinical Trial

— COMPLIANCE-MT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963828
• Other study ID #: COMPLIANCE-MT
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Changhai Hospital
• Contact: Qiao mengting
• Phone: 15039464902
• Email: pour7788[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Post-hospital management based on WeChat applet
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.
• Routine post-hospital follow-up management
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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good compliance rate of stroke prevention drugs at 12 months after discharge	Measured by The 4-Item Medication Adherence Scale ;The score of Morisky-4	12 months after discharge
Secondary	Good compliance rate of stroke prevention drugs at 1 month, 3 months and 6 months after discharge	Measured by The 4-Item Medication Adherence Scale ;The score of Morisky-4	1 month, 3 months and 6 months after discharge.
Secondary	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
Secondary	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
Secondary	Personal motivation	Measured by The Stroke Attitude Questionnaire	1 month, 3 months, 6 months and 12 months after discharge
Secondary	Stroke health behavior improvement	Measured by The Stroke Prevention Health Behavior Scale	1 month, 3 months, 6 months and 12 months after discharge
Secondary	Social motivation	Measured by Perceived Social Support Scale	1 month, 3 months, 6 months and 12 months after discharge
Secondary	Health-related quality of life	Measured by The 5-level EQ-5D	1 month, 3 months, 6 months and 12 months after discharge
Secondary	Incidence of anxiety	Measured by Generalized Anxiety Disorder-7	1 month, 3 months, 6 months and 12 months after discharge
Secondary	Incidence of depression	Measured by Patient Health Questionnaire-9	1 month, 3 months, 6 months and 12 months after discharge
Secondary	Self efficacy	Measured by Chronic Disease Self-Efficacy Scale	1 month, 3 months, 6 months and 12 months after discharge
Secondary	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: ?typical clinical symptoms (such as chest pain, heart failure, etc.) accompanied by typical electrocardiogram (ECG) abnormalities; ? typical clinical symptoms with troponin elevated more than 2 times the upper limit of normal;? or Non-specific symptoms with elevated troponin more than 2 times the upper limit of normal; ?Asymptomatic 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