Ischemic Stroke, Transient Ischemic Attack (TIA)
Conditions
Keywords
ischemic stroke, secondary prevention, digital health
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.
Interventions
BEHAVIORALCerebrovascular Disease Secondary Prevention Smart Management System
The continuous post-discharge intervention for patients was conducted using the Cerebrovascular Disease Secondary Prevention Smart Management System. This system, integrated with a WeChat-based applet, records patients' basic information and connects with mobile IoT devices such as blood pressure monitors and glucose meters. This allows patients to self-monitor their risk factors post-discharge. Based on international guidelines, high-level evidence, and the clinical expertise of cerebrovascular specialists, a comprehensive clinical decision-making tree was developed. This serves as the foundation for an AI feedback system that provides intelligent feedback on risk factor control and predicts the risk of recurrence.
Sponsors
Beijing Tiantan Hospital
Beijing Tsinghua Chang Gung Hospital
Xiangya Hospital of Zhongnan University
The affiliated Hospital of Shihezi University
The First Hospital of Jilin University
First People's Hospital of Foshan
The Second Affiliated Hospital of Fujian Medical University
BOE Technology Group Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
CONTACTZhiyuan Feng, MD
CONTACTChunjuan Wang, MD
Outcome results
None listed