Clinical trial NCT06904664: An APP That Can Provide Early Warning of Temperature Health Risks and Give Protective Suggestions or Personalized Suggestions Based on Patients' Own Secondary Prevention Risk Factors Was Applied to Intervene, and the Intervention Effect of APP on Stroke Recurrence Risk Was Analyzed
Official title: Individualized Temperature Health Risk Early Warning and Risk Factor Management App for Reducing the Recurrence Risk of Stroke: a Multicenter, Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 10184
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 1-year recurrence rate of stroke
timeFrame: Intervention at the 1-year
Secondary outcomes:
measure: 3-month, 6-month, 9-month recurrence rate of stroke
timeFrame: Intervention at 3-month, 6-month, 9-month
measure: Cardiovascular system function indicators
timeFrame: Intervention at 3-month, 6-month, 9-month and 1-year
measure: Hematological indices
timeFrame: Intervention at 3-month, 6-month, 9-month and 1-year
measure: Modified Rankin Scale
timeFrame: Intervention at 3-month, 6-month, 9-month and 1-year
measure: European five-dimensional five-level Health Scale score
timeFrame: Intervention at 3-month, 6-month, 9-month and 1-year
measure: Risk perception of stroke recurrence
timeFrame: Intervention at 3-month, 6-month, 9-month and 1-year
measure: Environmental Risk Perception Score
timeFrame: Intervention at 3-month, 6-month, 9-month and 1-year
measure: Stroke health literacy score
timeFrame: Intervention at 3-month, 6-month, 9-month and 1-year
measure: Compliance
timeFrame: Intervention at 3-month, 6-month, 9-month and 1-year
Other outcomes:
measure: Incidence of adverse cerebrovascular events
timeFrame: Intervention at the 1-year
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