An Application 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

Capital Medical University

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke

Treatments: Other: Temperature health risk early warning; Other: Individualized temperature health risk early warning and risk factor management; Other: Risk factor management

Study type: Interventional

Funder types: Other

Identifiers

NCT06904664

[2024]444-003-1-3

Details and patient eligibility

About

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.

Enrollment: 10,184 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,184 participants in 4 patient groups

Enhanced intervention group

Experimental group

Description:

Receive individualized temperature health risk warning and prevention risk factor management information for stroke through the application

Treatment:

Other: Individualized temperature health risk early warning and risk factor management

Temperature health risk early warning group

Experimental group

Description:

Receive individualized temperature health risk warning through the application

Treatment:

Other: Temperature health risk early warning

Risk factor management group

Experimental group

Description:

Receive individualized prevention risk factor management information for stroke through the application

Treatment:

Other: Risk factor management

Routine education group

No Intervention group

Description:

Only receive routine health education, without receiving individualized temperature health risk warning or prevention risk factor management information for stroke through the application