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

2026年8月19日 更新者：National Health Research Institutes, Taiwan

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1080

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Kai-Chia Cheng, PhD
  • 电话号码：51169 +886-5-6204000
  • 邮箱：kccheng@nhri.edu.tw

学习地点

  • 台湾
    • Yunlin City
      • Huwei、Yunlin City、台湾、632007
        • 招聘中
        • National Center for Geriatrics and Welfare Research, National Health Research Institute
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Smart Wearable Wristband Intervention
Participants will receive an 8-week smart wearable wristband-based intervention. The wearable device continuously records physical activity data, including step count, activity level, heart rate, and fatigue index. The intervention also includes a digital care coordination and feedback system to support communication between older adults with disabilities, family caregivers, and multidisciplinary rehabilitation professionals. Outcomes are assessed before and after the intervention.
设备：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 changes in physical activity among older adults with disabilities and to evaluate changes in care quality for family caregivers and multidisciplinary professionals before and after the intervention.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Physical activity level (step count)
大体时间：Baseline (0 week) and after intervention (8 weeks)
Step count in older adults with disabilities will be measured using a smart wearable wristband to assess changes in physical activity before and after the 8-week intervention.
Baseline (0 week) and after intervention (8 weeks)
Physical activity level (heart rate)
大体时间：Baseline (0 week) and after intervention (8 weeks)
Heart rate in older adults with disabilities will be measured using a smart wearable wristband before and after the 8-week intervention.
Baseline (0 week) and after intervention (8 weeks)
Physical activity level (fatigue index)
大体时间：Baseline (0 week) and after intervention (8 weeks)
Fatigue index in older adults with disabilities will be calculated using the algorithm embedded in the smart wearable wristband system and assessed before and after the 8-week intervention.
Baseline (0 week) and after intervention (8 weeks)
Caregivers stress (Scale title: Caregiver Burden/stress Scale)
大体时间：Baseline (0 week) and after intervention (8 weeks)
Caregiver stress in family caregivers will be assessed using a validated caregiver burden/stress scale. The total score ranges from 0 to 36 and will be transformed to a 0-100 scale for analysis. A higher score indicates greater caregiver burden and stress.
Baseline (0 week) and after intervention (8 weeks)
Satisfaction with smart wearable wristband system
大体时间：Baseline (0 week) and after intervention (8 weeks)
Satisfaction with the smart care system will be assessed among multidisciplinary professionals using a structured satisfaction questionnaire. The questionnaire evaluates multiple domains, including usability, applicability, service quality, sustainability, and motivation. Responses are rated using a 5-point Likert scale ranging from very dissatisfied to very satisfied, with higher scores indicating greater satisfaction.
Baseline (0 week) and after intervention (8 weeks)

次要结果测量

结果测量
措施说明
大体时间
Activities of daily living (Scale title: Activities of Daily Living)
大体时间：Baseline (0 week) and after intervention (8 weeks)
Functional status in older adults with disabilities will be assessed using the Activities of Daily Living (ADL) scale. Scores range from 0 to 100, with higher scores indicating greater ability to perform activities of daily living.
Baseline (0 week) and after intervention (8 weeks)
Instrumental activities of daily living (Scale title: Instrumental Activities of Daily Living scale)
大体时间：Baseline (0 week) and after intervention (8 weeks)
Functional independence in older adults with disabilities will be assessed using the Instrumental Activities of Daily Living (IADL) scale. Scores range from 0 to 34 and will be converted to a standardized 0-100 scale for analysis. Higher scores indicate better ability to perform instrumental activities of daily living.
Baseline (0 week) and after intervention (8 weeks)
Intrinsic capacity (Title: Integrated Care for Older People)
大体时间：Baseline (0 week) and after intervention (8 weeks)
Intrinsic capacity in older adults with disabilities will be assessed using the Integrated Care for Older People (ICOPE) framework. The assessment includes cognitive function, mobility, nutritional status, vision, hearing, and depressive symptoms. Higher levels of impairment indicate greater decline in intrinsic capacity.
Baseline (0 week) and after intervention (8 weeks)
Self-reported physical activity (Scale title: Chinese Version of the Physical Activity Scale for the Elderly)
大体时间：Baseline (0 week) and after intervention (8 weeks)
Self-reported physical activity in older adults with disabilities will be assessed using the Chinese Version of the Physical Activity Scale for the Elderly (PASE-C). Scores are calculated by weighting different physical activities according to their frequency and duration of performance. Higher scores indicate higher levels of physical activity.
Baseline (0 week) and after intervention (8 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Health Research Institutes, Taiwan

调查人员

  • 首席研究员：Chueh-Ho Lin, PhD、National Health Research Institutes, Taiwan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年4月20日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • EC1140702

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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