Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack With an Intelligent Management System (SPIRIT)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age ≥ 18 years.
- Patients diagnosed with acute ischemic stroke or transient ischemic attack.
- Time from onset to enrollment ≤ 14 days.
- Presence of at least one modifiable risk factor (hypertension, diabetes).
- Ability to independently use a smartphone to complete system tasks upon discharge, or with the assistance of family members.
- Signed informed consent by the patient or their family members.
Exclusion criteria
- Patients already enrolled in other stroke-related healthcare quality improvement projects or clinical trials.
- Patients or family members who refuse to sign the informed consent form.
- Pregnant or breastfeeding women.
Trial design
Primary purpose
Allocation
Interventional model
Masking
4,490 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Zhiyuan Feng, MD; Chunjuan Wang, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal