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

2026년 5월 6일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

1080

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Kai-Chia Cheng, PhD
  • 전화번호: 51169 +886-5-6204000
  • 이메일: kccheng@nhri.edu.tw

연구 장소

  • 대만
    • Yunlin City
      • Huwei, Yunlin City, 대만, 632007
        • National Center for Geriatrics and Welfare Research, National Health Research Institute
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Physical activity level (step count)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Activities of daily living (Scale title: Activities of Daily Living)
기간: 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)
기간: 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)
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Health Research Institutes, Taiwan

수사관

  • 수석 연구원: Chueh-Ho Lin, PhD, National Health Research Institutes, Taiwan

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 15일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • EC1140702

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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