Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2

Обзор

The goal of this clinical trial is to evaluate whether a smart wearable wristband-based care system can improve the quality of care and physical activity levels among older adults with disabilities receiving home-based care. The study population includes older adults with disabilities, their family caregivers, and multidisciplinary rehabilitation service providers. The main questions it aims to answer are: 1. Whether the use of a smart wearable wristband can improve functional performance, as measured by Activities of Daily Living (ADLs), Instrumental Activities of Daily Living (IADLs), and Integrated Care for Older People (ICOPE) assessments? 2. Whether the intervention can increase physical activity levels and improve overall care quality, while reducing caregiver burden and enhancing satisfaction? Participants will: 1. Wear a smart wearable wristband continuously for 8 weeks to record physical activity data, including step count, activity level, heart rate, and fatigue index. 2. Undergo assessments at baseline and after the 8-week intervention, including Activities of Daily Living (ADLs), Instrumental Activities of Daily Living (IADLs), Integrated Care for Older People (ICOPE), and the Chinese Version of the Physical Activity Scale for the Elderly (PASE-C). 3. Provide data on caregiver stress, satisfaction, and service utilization for the analysis of care quality.

Вмешательства

• Устройство Smart Wearable Wristband-Based Monitoring System
  The intervention consists of an 8-week use of a smart wearable wristband device. The device continuously collects physiological and physical activity data, including step count, activity level, heart rate, and fatigue index. The system provides feedback on activity patterns and supports care coordination among older adults with disabilities, family caregivers, and multidisciplinary professionals through a digital communication system. Data collected from the device will be used to monitor change

Первичные конечные точки

• Physical activity level (step count) [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]
• Physical activity level (heart rate) [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]
• Physical activity level (fatigue index) [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]
• Caregivers stress (Scale title: Caregiver Burden/stress Scale) [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]
• Satisfaction with smart wearable wristband system [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]

Вторичные конечные точки (4)

• Activities of daily living (Scale title: Activities of Daily Living) [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]
• Instrumental activities of daily living (Scale title: Instrumental Activities of Daily Living scale) [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]
• Intrinsic capacity (Title: Integrated Care for Older People) [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]
• Self-reported physical activity (Scale title: Chinese Version of the Physical Activity Scale for the Elderly) [Срок оценки: Baseline (0 week) and after intervention (8 weeks)]

Критерии участия

Критерии включения

• Older adults with disabilities:

• Aged ≥ 65 years.
• Classified as CMS level 2-6 under Taiwan Long-Term Care Need Assessment.
• Currently receiving at least one Long-Term Care 2.0 service (e.g., home care, home-based rehabilitation, or respite care).
• Have normal cognitive function, or a Mini-Mental State Examination (MMSE) score ≥ 23 when cognitive screening is performed.
• Own and are able to use a smartphone.
• Willing to participate and provide written informed consent.
• Family caregivers:

• Have normal cognitive function, or a Mini-Mental State Examination (MMSE) score ≥ 23 when cognitive screening is performed.
• Own and are able to use a smartphone.
• Willing to participate and provide written informed consent.
• Multidisciplinary rehabilitation professionals:

• Employed or contracted by a home-based long-term care institution with at least three professional disciplines (e.g., physical therapists, occupational therapists, nurses, social workers).
• Own and are able to use a smartphone.
• Willing to participate and provide written informed consent.

Критерии исключения

• Older adults with disabilities:

• Severe acute medical conditions or unstable physiological status.
• Severe cognitive impairment without a caregiver capable of assisting with questionnaires.
• Not currently receiving any long-term care services.
• Family caregivers:

• Severe acute medical conditions or unstable physiological status.
• Severe cognitive impairment without ability to complete questionnaires.
• Not currently involved in long-term care services.
• Multidisciplinary rehabilitation professionals:

• Providing services exclusively in non-home-based settings (e.g., institutional or hospital-only care).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Center for Geriatrics and Welfare Research, National Health Research Institute — Huwei

Идентификаторы

NCT: NCT07579832 · EC1140702

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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