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:
- 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?
- Whether the intervention can increase physical activity levels and improve overall care quality, while reducing caregiver burden and enhancing satisfaction?
Participants will:
- Wear a smart wearable wristband continuously for 8 weeks to record physical activity data, including step count, activity level, heart rate, and fatigue index.
- 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).
- Provide data on caregiver stress, satisfaction, and service utilization for the analysis of care quality.
調査の概要
研究の種類
介入
入学 (推定)
1080
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Kai-Chia Cheng, PhD
- 電話番号：51169 +886-5-6204000
- メール：kccheng@nhri.edu.tw
研究場所
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Yunlin City
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Huwei、Yunlin City、台湾、632007
- 募集
- National Center for Geriatrics and Welfare Research, National Health Research Institute
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コンタクト：
- Kai-Chia Cheng, PhD
- 電話番号：51169 +886-5-6204000
- メール：kccheng@nhri.edu.tw
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical activity level (step count)
時間枠：Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Physical activity level (heart rate)
時間枠：Baseline (0 week) and after intervention (8 weeks)
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Heart rate in older adults with disabilities will be measured using a smart wearable wristband before and after the 8-week intervention.
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Baseline (0 week) and after intervention (8 weeks)
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Physical activity level (fatigue index)
時間枠：Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Caregivers stress (Scale title: Caregiver Burden/stress Scale)
時間枠：Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Satisfaction with smart wearable wristband system
時間枠：Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Activities of daily living (Scale title: Activities of Daily Living)
時間枠：Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Instrumental activities of daily living (Scale title: Instrumental Activities of Daily Living scale)
時間枠：Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Intrinsic capacity (Title: Integrated Care for Older People)
時間枠：Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Self-reported physical activity (Scale title: Chinese Version of the Physical Activity Scale for the Elderly)
時間枠：Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Chueh-Ho Lin, PhD、National Health Research Institutes, Taiwan
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年4月20日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月21日
QC基準を満たした最後の更新が送信されました
2026年8月19日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。