An interventional study of Smart Wearable Wristband-Based Monitoring System in Disabled Persons, Activities of Daily Living and Aged, sponsored by National Health Research Institutes, Taiwan. Recruiting at 1 site in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by National Health Research Institutes, Taiwan · Not applicable, Interventional, and Treatment
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:
Participants will:
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This study's planned enrollment of 1,080 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
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Older adults with disabilities:
Family caregivers:
Multidisciplinary rehabilitation professionals:
Exclusion Criteria:
Older adults with disabilities:
Family caregivers:
Multidisciplinary rehabilitation professionals:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
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)
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)
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)
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.
Time frame: Baseline (0 week) and after intervention (8 weeks)
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)
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)
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)
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)
Plan to share: No
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