Clinical trial NCT06783049: Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack with an Intelligent Management System
Official title: Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack with an Intelligent System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Transient Ischemic Attack (TIA)
Keywords: ischemic stroke
secondary prevention
digital health
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tsinghua Chang Gung Hospital
name: Xiangya Hospital of Zhongnan University
name: The affiliated Hospital of Shihezi University
name: The First Hospital of Jilin University
name: First People's Hospital of Foshan
name: The Second Affiliated Hospital of Fujian Medical University
name: BOE Technology Group Co. Ltd.
First posted: 2025-01-20
Enrollment: 4490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vascular events and all-causes death
timeFrame: From enrollment to 1 year follow-up
measure: Risk factor control rate
timeFrame: From enrollment to 1 year follow-up
Secondary outcomes:
measure: Readmission to hospital within 1 year
timeFrame: From enrollment to 1 year follow-up
measure: Stroke-related readmission
timeFrame: From enrollment to 1 year follow-up
measure: Direct medical costs
timeFrame: From enrollment to 1 year follow-up
measure: Rate of good adherence to secondary prevention medicine
timeFrame: From enrollment to 1 year follow-up
measure: Adverse drug reaction
timeFrame: From enrollment to 1 year follow-up
measure: Body mass index
timeFrame: From enrollment to 1 year follow-up
measure: Waist circumstance
timeFrame: From enrollment to 1 year follow-up
measure: Frequency of blood pressure monitoring
timeFrame: From enrollment to 1 year follow-up
measure: Frequency of blood glucose monitoring
timeFrame: From enrollment to 1 year follow-up
measure: Blood lipid levels
timeFrame: From enrollment to 1 year follow-up
measure: Rehabilitation
timeFrame: From enrollment to 1 year follow-up
measure: Smoking
timeFrame: From enrollment to 1 year follow-up
measure: Alcohol
timeFrame: From enrollment to 1 year follow-up
measure: Regular exercise
timeFrame: From enrollment to 1 year follow-up
measure: Overall physical activity level
timeFrame: From enrollment to 1 year follow-up
measure: Fatigue
timeFrame: From enrollment to 1 year follow-up
Other outcomes:
Locations:
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University
state: Xinjiang
city: Beijing
country: China
facility: Beijing Tiantan Hospital
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: 北京市
Study officials:
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