Clinical trial NCT05963828: Comprehensive Management of High-risk PopuLatIon of Stroke Based on Social Network
Official title: COmprehensive Management of High-risk PopuLatIon of Stroke bAsed oN soCial nEtwork: a Multicenter, Parallel and Randomized Controlled sTudy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Keywords: Stroke
Management
Social Networks
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient's medication adherence to five evidence-based secondary prevention drugs for stroke at 12 months after discharge
timeFrame: 12 months after discharge
Secondary outcomes:
measure: The rate of good compliance with stroke prevention drugs among patients 1 month, 3 months, 6 months and 12 months after discharge
timeFrame: 1 month, 3 months，6 months and 12 months after discharge.
measure: 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.
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Knowledge of stroke
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Personal motivation
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Stroke health behavior improvement
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Social motivation
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Health-related quality of life
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Incidence of anxiety
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Incidence of depression
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Self efficacy
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
measure: Incidence of major cardiovascular events including stroke, acute coronary syndrome, and vascular death
timeFrame: 1 month, 3 months, 6 months and 12 months after discharge
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhang lingjuan
role: STUDY_DIRECTOR
References: