Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2
19 de agosto de 2026 actualizado por: 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:
- 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?
- Whether the intervention can increase physical activity levels and improve overall care quality, while reducing caregiver burden and enhancing satisfaction?
Participants will:
- Wear a smart wearable wristband continuously for 8 weeks to record physical activity data, including step count, activity level, heart rate, and fatigue index.
- 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).
- Provide data on caregiver stress, satisfaction, and service utilization for the analysis of care quality.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
1080
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kai-Chia Cheng, PhD
- Número de teléfono: 51169 +886-5-6204000
- Correo electrónico: kccheng@nhri.edu.tw
Ubicaciones de estudio
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Yunlin City
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Huwei, Yunlin City, Taiwán, 632007
- Reclutamiento
- National Center for Geriatrics and Welfare Research, National Health Research Institute
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Contacto:
- Kai-Chia Cheng, PhD
- Número de teléfono: 51169 +886-5-6204000
- Correo electrónico: kccheng@nhri.edu.tw
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical activity level (step count)
Periodo de tiempo: Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Physical activity level (heart rate)
Periodo de tiempo: Baseline (0 week) and after intervention (8 weeks)
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Heart rate in older adults with disabilities will be measured using a smart wearable wristband before and after the 8-week intervention.
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Baseline (0 week) and after intervention (8 weeks)
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Physical activity level (fatigue index)
Periodo de tiempo: Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Caregivers stress (Scale title: Caregiver Burden/stress Scale)
Periodo de tiempo: Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Satisfaction with smart wearable wristband system
Periodo de tiempo: Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Activities of daily living (Scale title: Activities of Daily Living)
Periodo de tiempo: 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.
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Baseline (0 week) and after intervention (8 weeks)
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Instrumental activities of daily living (Scale title: Instrumental Activities of Daily Living scale)
Periodo de tiempo: Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Intrinsic capacity (Title: Integrated Care for Older People)
Periodo de tiempo: Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Self-reported physical activity (Scale title: Chinese Version of the Physical Activity Scale for the Elderly)
Periodo de tiempo: Baseline (0 week) and after intervention (8 weeks)
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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.
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Baseline (0 week) and after intervention (8 weeks)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Chueh-Ho Lin, PhD, National Health Research Institutes, Taiwan
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de agosto de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EC1140702
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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