Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorNational Health Research Institutes, Taiwan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Severe acute medical conditions or unstable physiological status.
Trial design
Design model
Single group
Treatments tested in this trial
Smart Wearable Wristband-Based Monitoring System
DeviceThe 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.
Treatment groups
1,080 Participants
are divided into 1 treatment groupGroup A: Smart Wearable Wristband InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (0 week) and after intervention (8 weeks)2
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.
Time frame
Baseline (0 week) and after intervention (8 weeks)3
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.
Time frame
Baseline (0 week) and after intervention (8 weeks)4
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.
Time frame
Baseline (0 week) and after intervention (8 weeks)Secondary outcomes
1
Activities of daily living (Scale title: Activities of Daily Living)
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.
Time frame
Baseline (0 week) and after intervention (8 weeks)2
Instrumental activities of daily living (Scale title: Instrumental Activities of Daily Living scale)
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.
Time frame
Baseline (0 week) and after intervention (8 weeks)3
Intrinsic capacity (Title: Integrated Care for Older People)
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.
Time frame
Baseline (0 week) and after intervention (8 weeks)4
Self-reported physical activity (Scale title: Chinese Version of the Physical Activity Scale for the Elderly)
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.
Time frame
Baseline (0 week) and after intervention (8 weeks)Sponsors and contacts
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Source ClinicalTrials.gov