Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2
19 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
1080
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kai-Chia Cheng, PhD
- Número de telefone: 51169 +886-5-6204000
- E-mail: kccheng@nhri.edu.tw
Locais de estudo
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Yunlin City
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Huwei, Yunlin City, Taiwan, 632007
- Recrutamento
- National Center for Geriatrics and Welfare Research, National Health Research Institute
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Contato:
- Kai-Chia Cheng, PhD
- Número de telefone: 51169 +886-5-6204000
- E-mail: kccheng@nhri.edu.tw
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Physical activity level (step count)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Activities of daily living (Scale title: Activities of Daily Living)
Prazo: Baseline (0 week) and after intervention (8 weeks)
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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)
Prazo: 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)
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Chueh-Ho Lin, PhD, National Health Research Institutes, Taiwan
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
20 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de maio de 2026
Primeira postagem (Real)
12 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de agosto de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EC1140702
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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