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Clinical Trials/NCT07097428
NCT07097428Not yet recruitingNot Applicable

Individualized Temperature Health Risk Early Warning for Reducing the Recurrence Risk of Stroke:A Multicenter, Randomized Controlled Trial Study

Xuanwu Hospital, Beijing0 sites5,092 target enrollmentStarted: September 1, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
5,092
Primary Endpoint
1-year recurrence rate of stroke
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study applied an application to provide early warnings and advice for stroke patients and explored the impact of this intervention on reducing the risk of stroke recurrence

Detailed Description

This study applied an application that provides individualized environmental temperature-related health risk warnings and recommendations to stroke patients, enabling them to promptly understand their risk levels and take corresponding protective measures. And explore the effect of this actual intervention on reducing the risk of stroke recurrence after one year, as well as changes in other health-related indicators.

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.);
  • •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

Experimental

Receive individualized temperature health risk warning through the application

Intervention: Temperature health risk early warning (Other)

Routine education

No Intervention

Only receive routine health education, without receiving individualized temperature health risk warning through the application

Outcomes

Primary Outcomes

1-year recurrence rate of stroke

Time Frame: Intervention at the 1-year

Secondary Outcomes

  • Electrocardiogram (ECG) parameters(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Blood pressure(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Environmental temperature health risk perception assessment questionnaire(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Lipid Profile (Total Cholesterol, LDL-C, HDL-C, and Triglycerides)(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Fasting blood glucose(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Coagulation parameters (Prothrombin Time, aPTT, INR, Fibrinogen, Platelet Count and D-dimer)(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • C-reactive protein(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Modified rankin scale score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • NIH stroke scale score(Baseline)
  • European five-dimensional five-level health scale score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Minimum mental state examination(Baseline; Intervention at 6-month and 1-year)
  • Social support rate scale score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Depression anxiety stress scales - 21 score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Blood pressure(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Electrocardiogram (ECG) parameters(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Environmental temperature health risk perception assessment questionnaire(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • System usability scale score(Intervention at 3-month, 6-month, 9-month and 1-year)
  • Lipid Profile (Total Cholesterol, LDL-C, HDL-C, and Triglycerides)(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Fasting blood glucose(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Coagulation parameters (Prothrombin Time, aPTT, INR, Fibrinogen, Platelet Count and D-dimer)(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • C-reactive protein(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • NIH stroke scale score(Baseline)
  • Modified rankin scale score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Social support rate scale score(Baseline; Intervention at 3-month, 6-month, 9-month and 1-year)
  • Depression anxiety stress scales - 21 score(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)
  • Minimum mental state examination(Baseline; Intervention at 6-month and 1-year)
  • 3-month, 6-month, 9-month recurrence rate of stroke(Intervention at 3-month, 6-month, 9-month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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