Menu
Not yet recruiting NCT06904664

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

No phase Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individualized temperature health risk early warning and risk factor management, Temperature health risk early warning, Risk factor management.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Individualized temperature health risk early warning and risk factor management
    Receive individualized temperature health risk warning and prevention risk factor management information for stroke through the application
  • Other Temperature health risk early warning
    Receive individualized temperature health risk warning through the application
  • Other Risk factor management
    Receive individualized prevention risk factor management information for stroke through the application

Primary outcome measures

  • 1-year recurrence rate of stroke [Time frame: Intervention at the 1-year]
Secondary outcome measures (10)
  • 3-month, 6-month, 9-month recurrence rate of stroke [Time frame: Intervention at 3-month, 6-month, 9-month]
  • Cardiovascular system function indicators [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Laboratory examination [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Modified Rankin Scale [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • European five-dimensional five-level Health Scale score [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Risk perception scale of stroke recurrence [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Environmental temperature health risk perception assessment 1uestionnaire [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Stroke health literacy score [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Health status score [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • System usability scale [Time frame: Intervention at 3-month, 6-month, 9-month and 1-year]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06904664 · [2024]444-003-1-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗