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

NCT07579832 | Not Yet Recruiting

• 1 other identifier: EC1140702
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Whether the intervention can increase physical activity levels and improve overall care quality, while reducing caregiver burden and enhancing satisfaction?
3. 3.Wear a smart wearable wristband continuously for 8 weeks to record physical activity data, including step count, activity level, heart rate, and fatigue index.
4. 4.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).
5. 5.Provide data on caregiver stress, satisfaction, and service utilization for the analysis of care quality.

Conditions

Disabled Persons; Activities of Daily Living; Aged; Motor Activity

Outcome Measures

Primary Outcomes (5)

• Physical activity level (step count)

  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)

  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)

  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)

  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

  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 Outcomes (4)

• Activities of daily living (Scale title: 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)

  Baseline (0 week) and after intervention (8 weeks)

• Intrinsic capacity (Title: Integrated Care for Older People)

  Baseline (0 week) and after intervention (8 weeks)

• Self-reported physical activity (Scale title: Chinese Version of the Physical Activity Scale for the Elderly)

  Baseline (0 week) and after intervention (8 weeks)

Study Arms (1)

Smart Wearable Wristband Intervention

EXPERIMENTAL

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

Interventions

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.

Smart Wearable Wristband Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

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

Huwei, Yunlin City, 632007, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chueh-Ho Lin, PhD

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai-Chia Cheng, PhD

CONTACT

+886-5-6204000; kccheng@nhri.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 12, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)