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

Not Applicable

Not yet recruiting

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT06904664
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Study Start: 2025-07-01
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10184

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1-year recurrence rate of stroke	Intervention at the 1-year

Secondary Outcome Measures

Name	Time	Method
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	Such as blood pressure, various electrocardiogram indicators and other examination results that can reflect cardiovascular function
Laboratory examination	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year	Such as results of laboratory tests including lipid profiles, blood glucose, coagulation, and other laboratory indicators.
Modified Rankin Scale	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year	The Modified Rankin Scale (mRS) is a scale used to assess the neurological recovery status and disability level in stroke patients. The scale ranges from zero to six, divided into seven levels, with higher grades indicating worse conditions.
European five-dimensional five-level Health Scale score	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year	The scale includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension containing five levels. It also includes a 0-100 scale, where a lower score indicates worse condition.
Risk perception scale of stroke recurrence	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year	The scale uses a Likert three-point scoring method, assigning values of 1, 2, and 3 for the responses "disagree," "uncertain," and "agree," respectively. A higher score indicates a higher level of perceived ability.
Environmental temperature health risk perception assessment 1uestionnaire	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year	Here are multiple questions related to environmental risk factors and health risks, each using a 0-100 scale where a higher score indicates greater understanding
Stroke health literacy score	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year	The scale uses a five-point scoring method, with a higher score indicating a higher level of stroke health literacy.
Health status score	Baseline; Intervention at 3-month, 6-month, 9-month and 1-year	Such as barthel index (BI) and other scoring scales for evaluating patients' disease recovery, physical condition and other abilities
System usability scale	Intervention at 3-month, 6-month, 9-month and 1-year