Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack with an Intelligent Management System

Not Applicable

Recruiting

• Conditions: Ischemic Stroke; Transient Ischemic Attack (TIA)

• Registration Number: NCT06783049
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

The purpose of this study is to develop a digital health-based intelligent management system for the secondary prevention of ischemic stroke and to evaluate its effectiveness through a multicenter randomized controlled trial, assessing its health economic value.

Participants will receive usual care after discharge (control group) or be managed with a WeChat-based intelligent management system after discharge (intervention group).

At one year, all patients will undergo face-to-face follow-up to assess clinical events, medication adherence, and the achievement of target risk factor levels.

Detailed Description

Before discharge, patients receive standard education on the secondary prevention of ischemic stroke from their physician, covering topics such as secondary prevention medications, risk factor management, lifestyle modifications, and rehabilitation. Additionally, the "Intelligent Management System," a WeChat-based applet, is activated for each patient. The system records basic patient information and integrates with mobile IoT devices, such as blood pressure monitors and glucose meters, allowing for self-monitoring of risk factors post-discharge. Based on international guidelines, high-level evidence, and the expertise of stroke specialists, a comprehensive clinical decision-making tree is established. This serves as the foundation for an AI feedback system that provides intelligent feedback on risk factor control and predicts recurrence risk. The patient interface includes educational content on ischemic stroke, risk factor management, lifestyle adjustments, and follow-up schedules post-discharge.

The system also features a physician interface, which enables attending doctors to offer online consultations, schedule face-to-face follow-up appointments, and manage patients long-term. Each patient is assigned to an "Online Stroke Care Team," which includes a "Health Management Officer" responsible for facilitating communication between the patient and the physician and providing basic health guidance. Additionally, an "Online Doctor" is available to answer stroke-related medical questions.

The Health Management Officer monitors patients' health data and arranges online or in-person consultations for those with poor adherence or suboptimal target achievement. Patient management is guided by the theory of health empowerment, creating an integrated online and offline ischemic stroke management intervention model.

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Status Verified: 2025-02
• Study Start: 2025-03-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4490

Inclusion Criteria

1. Age ≥ 18 years.
2. Patients diagnosed with acute ischemic stroke or transient ischemic attack.
3. Time from onset to enrollment ≤ 14 days.
4. Presence of at least one modifiable risk factor (hypertension, diabetes).
5. Ability to independently use a smartphone to complete system tasks upon discharge, or with the assistance of family members.
6. Discharge to home rather than to a community hospital, rehabilitation facility, or other professional medical institution.
7. Signed informed consent by the patient or their family members.

Exclusion Criteria

1. Patients already enrolled in other stroke-related healthcare quality improvement projects or clinical trials.
2. Patients or family members who refuse to sign the informed consent form.
3. Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vascular events and all-causes death	From enrollment to 1 year follow-up	Vascular and all-cause mortality events were collected for one year post-enrollment through face-to-face follow-ups and patient self-reports. Vascular events included stroke recurrence, transient ischemic attacks, myocardial infarction, vascular interventions or surgeries, and systemic embolism. If a patient experienced both a vascular event and death, only one event was recorded. In cases of multiple vascular events, only the first event was documented.
Risk factor control rate	From enrollment to 1 year follow-up	Risk factor control was defined as achieving glycated hemoglobin (HbA1c) ≤7% or blood pressure below the target set at discharge. If a patient had both hypertension and diabetes at enrollment, meeting the criteria for both conditions was considered two achieved targets. If the patient had only hypertension or diabetes at enrollment, meeting the target for the respective condition was considered one achieved target.

Secondary Outcome Measures

Name	Time	Method
Readmission to hospital within 1 year	From enrollment to 1 year follow-up
Stroke-related readmission	From enrollment to 1 year follow-up
Direct medical costs	From enrollment to 1 year follow-up
Rate of good adherence to secondary prevention medicine	From enrollment to 1 year follow-up
Adverse drug reaction	From enrollment to 1 year follow-up
Body mass index	From enrollment to 1 year follow-up
Waist circumstance	From enrollment to 1 year follow-up
Frequency of blood pressure monitoring	From enrollment to 1 year follow-up	calculated as time/week
Frequency of blood glucose monitoring	From enrollment to 1 year follow-up	calculated as time/week
Blood lipid levels	From enrollment to 1 year follow-up	Included total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceridee
Rehabilitation	From enrollment to 1 year follow-up
Smoking	From enrollment to 1 year follow-up
Alcohol	From enrollment to 1 year follow-up
Regular exercise	From enrollment to 1 year follow-up
Overall physical activity level	From enrollment to 1 year follow-up	Assessed by IPAQ-S, calculated as MET-min/week
Fatigue	From enrollment to 1 year follow-up	Assessed by Fatigue Severity Scale (FSS). Fatigue was defined as total FSS score ≥36

Trial Locations

Locations (3)

The First Affiliated Hospital of Shihezi University; 🇨🇳 Shihezi, Xinjiang, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, 北京市, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, China