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

May 6, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1080

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity level (step count)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of daily living (Scale title: Activities of Daily Living)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC1140702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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