Individualized Temperature Health Risk Early Warning and Risk Factor Management App for Reducing the Recurrence Risk of Stroke: A Multicenter, Randomized Controlled Trial Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 10,184
- Primary Endpoint
- 1-year recurrence rate of stroke
Study Overview
Brief Summary
This study employs individualized temperature health risk early warning and risk factor management interventions for stroke, and explores their actual intervention effects. This enables patients to promptly understand their own risk levels and take corresponding protective measures, thereby enhancing the management outcomes and quality of life. The study also promotes the interdisciplinary integration of environmental epidemiology and clinical intervention management, providing new ideas and methodological support for future relevant research.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 40 to 80, with no gender restrictions;
- •Acute ischemic stroke inpatients within 2 weeks of onset, where the onset time is the time when stroke symptoms appear or the last known normal time of the patient (when it is an onset during sleep or the symptom onset time cannot be accurately obtained due to aphasia, impaired consciousness, etc.); ③ Confirmed diagnosis of ischemic stroke by CT or MRI of the brain within 2 weeks after symptom onset;
- •Local residents (residing for ≥6 months); ⑤ Patients who voluntarily participate in the study, have high compliance, and can sign the informed consent form;
- •Patients who own a smartphone or other smart devices.
Exclusion Criteria
- •Patients diagnosed with other cerebrovascular diseases (hemorrhagic stroke, transient ischemic attack, cerebral venous sinus thrombosis, etc.) or non-cerebrovascular diseases;
- •Known pregnant or lactating women, or those who tested positive on a pregnancy test before cluster randomization;
- •Patients with other conditions that may affect participation in the trial (e.g., refractory hypertension, severe aphasia, etc.);
- •Patients undergoing psychiatric/psychological treatment that may contaminate the results; ⑤ Patients with a life expectancy of less than one year (e.g., coexisting malignant tumors, severe cardiopulmonary diseases, etc.); ⑥ Patients already participating in other interventional clinical studies that may influence the outcome assessment; ⑦ Patients for whom the investigator deems unsuitable for participation in this study or who may pose significant risks to the patients (e.g., cognitive impairment preventing understanding and/or compliance with the study procedures and/or follow-up).
Arms & Interventions
Temperature health risk early warning group
Receive individualized temperature health risk warning through the application
Intervention: Temperature health risk early warning (Other)
Risk factor management group
Receive individualized prevention risk factor management information for stroke through the application
Intervention: Risk factor management (Other)
Enhanced intervention group
Receive individualized temperature health risk warning and prevention risk factor management information for stroke through the application
Intervention: Individualized temperature health risk early warning and risk factor management (Other)
Routine education group
Only receive routine health education, without receiving individualized temperature health risk warning or prevention risk factor management information for stroke through the application
Outcomes
Primary Outcomes
1-year recurrence rate of stroke
Time Frame: Intervention at the 1-year
Secondary Outcomes
- 3-month, 6-month, 9-month recurrence rate of stroke(Intervention at 3-month, 6-month, 9-month)
- Cardiovascular system function indicators(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
- Laboratory examination(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
- Modified Rankin Scale(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
- European five-dimensional five-level Health Scale score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
- Risk perception scale of stroke recurrence(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
- Environmental temperature health risk perception assessment 1uestionnaire(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
- Stroke health literacy score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
- Health status score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
- System usability scale(Intervention at 3-month, 6-month, 9-month and 1-year)