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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 1-year recurrence rate of stroke [Срок оценки: Intervention at the 1-year]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06904664 · [2024]444-003-1-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗