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Идёт набор NCT07321587

Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise

Без фазы С лечением Mild Dementia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ACTIVE Intervention.
Кому может быть актуально
Состояния в реестре: Mild Dementia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise (ACTIVE) Intervention Among Older Adults With and Without Mild Dementia

Обзор

This is a multi-methods two-arm, crossover, analyst-blinded randomized controlled trial with embedded qualitative interviews, enrolling 50 dyads (older adult-care partner). Participants will receive the ACTIVE intervention, which includes a Fitbit smartwatch, motivational text messages to engage in walking exercise, instructional educational videos, and virtual physical therapy sessions. Intervention components will be delivered over 3 weeks, with continuous monitoring of physical activity via Fitbit data, read receipts of the motivational text messages, and log of engagement in the virtual physical therapy and educational videos.

Вмешательства

  • Поведенческое ACTIVE Intervention
    The ACTIVE Intervention comprises the following components: * Fitbit Smartwatch-Based Activity Tracking * Care Partner Co-Participation * Motivational Text Messaging * Instructional Education Videos * Virtual Physical Therapy * Exercise (Walking Exercise)

Первичные конечные точки

  • Adoption [Срок оценки: Up to Week 7 (End of Week 1 of Intervention Period)]
  • Feasibility: Smartwatch [Срок оценки: Up to Week 8]
  • Feasibility: Motivational Texts [Срок оценки: Up to Week 8]
  • Feasibility: Virtual Physical Therapy [Срок оценки: Up to Week 8]
  • Feasibility: Instructional Education Videos [Срок оценки: Up to Week 8]
  • Acceptability: System Usability Scale (SUS) [Срок оценки: Up to Week 10]
  • Acceptability: Perceived Usefulness (PU): Smartwatch [Срок оценки: Up to Week 10]
  • Acceptability: Perceived Usefulness (PU): Motivational Texts [Срок оценки: Up to Week 10]
  • Acceptability: Perceived Usefulness (PU): Instructional Education Videos [Срок оценки: Up to Week 10]
  • Acceptability: Perceived Usefulness (PU): Virtual Physical Therapy [Срок оценки: Up to Week 10]

Критерии участия

Критерии включения

Older Adults:

  • Age ≥65 years.
  • With or without mild dementia.
  • Willing to consent to participate in the study or have an LAR that is willing to consent for their participation in the study
  • Willing to wear a Fitbit smartwatch, receive text messages, watch intervention-related videos, participate in physical therapy, and walking exercise.
  • No contraindications to engaging in physical activity.

Care Partners:

  • Age ≥18 years.
  • Met criteria for survey participation.
  • Person being cared for is recruited in the study.
  • Willing to consent to participation
  • Willing to wear a Fitbit smartwatch, receive text messages, watch intervention-related videos, participate in physical therapy, and walking exercise.
  • No contraindications to engaging in physical activity.

Критерии исключения

Older Adults:

  • Severe cardiac, neurologic, or musculoskeletal condition (including but not limited to recent or untreated fracture in any part of the body)
  • limiting participation in daily walking or Fitbit smartwatch use.
  • Moderate to severe dementia (using the clinical dementia rating scale of 2 or higher
  • Inability to operate or manage a Fitbit smartwatch device (even with care partner support).
  • No phone or phone not capable of receiving text messages or watching videos.
  • No internet for watching videos

Care Partners:

  • Severe cardiac, neurologic, or musculoskeletal condition limiting participation in daily walking or Fitbit smartwatch use.
  • Pregnant care partners
  • Any level of dementia or cognitive impairment among care partners
  • Inability to operate or manage a Fitbit smartwatch device.
  • Inability to co-participate in intervention tasks with older adult
  • No phone or phone not capable of receiving text messages or watching videos.
  • No internet for watching videos

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • NYU Langone Health — New York

Идентификаторы

NCT: NCT07321587 · 25-01158

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗