An Application Provides Temperature-related Health Risk Warnings and Protective Recommendations on Stroke

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Temperature health risk early warning
  Receive individualized temperature health risk warning through the application

Первичные конечные точки

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

Вторичные конечные точки (12)

• 3-month, 6-month, 9-month recurrence rate of stroke [Срок оценки: Intervention at 3-month, 6-month, 9-month]
• Blood pressure [Срок оценки: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
• Electrocardiogram (ECG) parameters [Срок оценки: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
• Environmental temperature health risk perception assessment questionnaire [Срок оценки: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
• System usability scale score [Срок оценки: Intervention at 3-month, 6-month, 9-month and 1-year]
• Lipid Profile (Total Cholesterol, LDL-C, HDL-C, and Triglycerides) [Срок оценки: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
• Fasting blood glucose [Срок оценки: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
• Coagulation parameters (Prothrombin Time, aPTT, INR, Fibrinogen, Platelet Count and D-dimer) [Срок оценки: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
• C-reactive protein [Срок оценки: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
• Modified rankin scale score [Срок оценки: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
• NIH stroke scale score [Срок оценки: Baseline]
• European five-dimensional five-level health scale score [Срок оценки: Baseline; 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.);

• 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: NCT07097428 · [2024]444-003-1-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗