Smartwatch-Guided Secondary Prevention After Stroke

Официальное название

WATCH-STEP : Pilot Trial: Smartwatch-Guided Secondary Prevention After Stroke Randomized Trial of Nurse-led Program With Active vs Passive Smartwatch in Minor Stroke. A Randomized Controlled Trial Evaluating a Nurse-led Secondary Prevention and Physical Activity Program Supported by Either an Active Smartwatch (Structured Feedback) or Passive Smartwatch in Patients With Minor Stroke.

Обзор

After a first stroke or transient ischemic attack (TIA), the risk of recurrence is high in the weeks and months following the initial event. There are several modifiable risk factors that can reduce this risk, such as blood pressure, diet, physical activity, and smoking. Many stroke patients (NIHSS \< 5) have a low daily step count during the early recovery period, despite a good functional prognosis. Active smartwatches provide real-time feedback, track progress, and set personalized walking goals, thereby boosting motivation and adherence to physical activity recommendations. The combination of advice provided by nurses and active behavioral coaching supported by a smartwatch, compared to passive monitoring, could significantly increase daily step counts over a 12-week period. The results of this research will help guide future large-scale secondary prevention strategies integrating digital health and structured nursing support.

Подробное описание

To meet the study's objectives, 50 patients who have recently suffered a stroke or a transient ischemic attack (TIA) (\< 30 days) will be recruited at Brest University Hospital.

Participation in this study will last 12 weeks. It consists of 3 visits, described below:

=\> Visit #1: Enrollment (hospital)

Enrollment will take place during a routine hospital visit. The investigator will obtain the patient's written consent. Randomization will then be performed to assign the patient to a group ("active" or "passive" watch).

For all patients ("active" and "passive" watch groups):

* Program led by nurses, conducted as part of routine care following a recent ischemic stroke or TIA (secondary prevention). * Issuance of a smartwatch and a smartphone * Data collection (sociodemographic information, medical history, current treatments, risk factors) * Questionnaires * Clinical examination, neurological examination, and blood draw.

For patients in the "passive" smartwatch group:

o The smartwatch will collect data passively, without notifications.

For patients in the "active" smartwatch group:

* Setting daily step goals and assessing potential obstacles * Scheduling regular calls (twice a week) for the duration of the study.

* Visit #2: Phone call

For all patients (both "active" and "passive" watch):

* Phone contact to collect data on changes in risk factors and the occurrence of events of interest (stroke, TIA, and cardiovascular events). * Questionnaires

* Visit #3: End of study (hospital)

The end-of-study visit will take place at the hospital during a scheduled routine care appointment:

* Assessment with a nurse as part of the secondary prevention program (routine care) * Data collection (risk factors) * Questionnaires * Clinical examination, neurological examination, and blood draw * Return of the smartwatch and smartphone

Вмешательства

• Другое Smartwatch-Guided Secondary Prevention after Stroke
  Setting daily walking goals, assessing obstacles Regular phone calls (twice a week) to review progress, adjust goals, and provide support

Первичные конечные точки

• To determine whether the addition of an active smartwatch providing structured feedback to a nurse-led activity program produces a significantly greater increase in daily step count over 12 weeks compared with the same program paired with a passive smart [Срок оценки: Week 12]

Вторичные конечные точки (12)

• To evaluate feasibility to smartwatch wear [Срок оценки: Week 6 and Week 12]
• To evaluate adherence to smartwatch wear [Срок оценки: Week 6 and Week 12]
• To evaluate acceptability of digital feedback. [Срок оценки: Week 6 and Week 12]
• To assess the impact of active smartwatch feedback on sedentary time. [Срок оценки: day 1 to week 12]
• To assess the impact of active smartwatch feedback on gait-related activity patterns. [Срок оценки: day 1 to week 12]
• To assess the impact of active smartwatch feedback on blood pressure. [Срок оценки: day 1 to week 12]
• To monitor falls [Срок оценки: day 1 to week 12]
• To monitor cardiovascular events (atrial fibrillation, AF), [Срок оценки: day 1 to week 12]
• To examine effects on quality of life [Срок оценки: day 1 to week 12]
• To examine effects on risk factors [Срок оценки: Day 1, week 6 and week 12]
• Recurrence and cardiovascular events [Срок оценки: day 1 to week 12]
• To examine effects on fatigue [Срок оценки: day 1 to week 12]

Критерии участия

Критерии включения

• Age ≤ 40-75
• Patients with recent minor ischemic stroke or TIA, initial NIHSS ≤5 (< 30 days)
• mRS ≤2 before stroke and on discharge
• Patient with Wifi access (for data transmission)
• Able to understand smartwatch instructions
• Written informed consent
• Ambulatory ≥10 meters without assistance and without walking aid
• Expected to live at home during the study period.

Критерии исключения

• Patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded
• Not affiliated to social security
• Patient under legal protection or deprived of liberty by a judicial or administrative decision
• Patient whose follow-up will be impossible
• Cognitive impairment interfering with participation (e.g., MoCA <20).
• Unstable cardiac conditions preventing walking goals.
• Major visual or upper limb impairment preventing use of the smartwatch.
• Life expectancy <1 year.
• Already highly active (>10,000 steps/day, or about 1.5 hours of walking).
• Participation in competing interventional trials.

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

Профилактика

Центры проведения

Франция · 1 центр

• CHU Brest — Brest

Идентификаторы

NCT: NCT07640360 · 29BRC23.0208

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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