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NCT Number: NCT07579832

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

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.

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Key information

Conditions

Disabled Persons Activities of Daily Living Aged Behavior Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Center for Geriatrics and Welfare Research, National Health Research Institute

Huwei, Yunlin City, 632007, Taiwan

Location contact

Kai-Chia Cheng, PhD

CONTACT

[email protected]

+886-5-6204000 ext. 51169

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Smart Wearable Wristband-Based Monitoring System

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai-Chia Cheng, PhD

CONTACT

[email protected]

+886-5-6204000 ext. 51169

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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