Comprehensive Management of High-risk PopuLatIon of Stroke Based on Social Network - Clinical Trial for Stroke | NCT05963828

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Post-hospital management based on WeChat applet

Routine post-hospital follow-up management

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Management, Social Networks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard group

Experimental group

Arm Description

Patients are managed according to the routine methods after enrollment.

Patients are managed by the social network platform.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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".

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

Knowledge of stroke

Measured by The Knowledge questionnaire on prevention and treatment of stroke

Personal motivation

Measured by The Stroke Attitude Questionnaire

Stroke health behavior improvement

Measured by The Stroke Prevention Health Behavior Scale

Social motivation

Measured by Perceived Social Support Scale

Health-related quality of life

Measured by The 5-level EQ-5D

Incidence of anxiety

Measured by Generalized Anxiety Disorder-7

Incidence of depression

Measured by Patient Health Questionnaire-9

Self efficacy

Measured by Chronic Disease Self-Efficacy Scale

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

Delayed behavioral intention before hospitalization after stroke

Measured by Prehospital Delayed Behavior Intention Scale for Stroke

Full Information

NCT ID

NCT05963828

First Posted

April 14, 2023

Last Updated

October 19, 2023

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05963828

Brief Title

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

Acronym

COMPLIANCE-MT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 8, 2023 (Actual)

Primary Completion Date

April 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Stroke, Management, Social Networks

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard group

Arm Type

Other

Arm Description

Patients are managed according to the routine methods after enrollment.

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Patients are managed by the social network platform.

Intervention Type

Behavioral

Intervention Name(s)

Post-hospital management based on WeChat applet

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Routine post-hospital follow-up management

Intervention Description

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.

Primary Outcome Measure Information:

Title

Good compliance rate of stroke prevention drugs at 12 months after discharge

Description

Measured by The 8-Item Medication Adherence Scale ;The score of Morisky-8 medication compliance scale is greater than 6 as "good compliance".

Time Frame

12 months after discharge.

Secondary Outcome Measure Information:

Title

Good compliance rate of stroke prevention drugs at 1 month, 3 months and 6 months after discharge

Description

Measured by The 8-Item Medication Adherence Scale ;The score of Morisky-8 medication compliance scale is greater than 6 as "good compliance".

Time Frame

1 month, 3 months and 6 months after discharge.

Title

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.

Description

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

Time Frame