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

19 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

1080

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Taiwan
    • Yunlin City
      • Huwei, Yunlin City, Taiwan, 632007
        • Werving
        • National Center for Geriatrics and Welfare Research, National Health Research Institute
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical activity level (step count)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Activities of daily living (Scale title: Activities of Daily Living)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Health Research Institutes, Taiwan

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

20 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

19 augustus 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EC1140702

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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