- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05260476
The Effect of Reablement Service of Long-term Care on Physical Mobility and Quality of Life in Disable People
To Investigate the Effect of Rreablement Service of Long-term Care on Physical Mobility and Quality of Life in Disable People
The long-term care 2.0 policy has been launched at 2017 by Taiwanese government to respond the rate of aging population reached to14% and estimated to 20% in 2025, becoming a "super-aged society" in Taiwan. As aging society, the ratio of chronic disease and disability has reasonably raised. The home reablement and care of this policy are not only to prevent and delay disability but provide daily care for the elderly who needed. As the implementation of the policy, there is still insufficient research to investigate and compare the effects on physical mobility and quality of life among the individual after using these different types of the service. Therefore, the aim of the study is to compare the effects on physical function and quality of life of the frail and disabled individual with and without receiving the home reablement services.
The participants will be enrolled from the long-term care service units registered in local government at Hualien county, Taiwan. The recruited participants will be assigned to two groups in a convenient method (receiving and non-receiving the home reablement service). All participants will be assessed by a professional physical therapist at three time points, before the reablement, at 1-3 months after receiving the reablement, then follow-up after 3 months
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jia-Ching Chen
- Número de teléfono: 2493 886-3-8565301
- Correo electrónico: chenjiaching0608@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Lian-Cing Yan
- Número de teléfono: 2493 886-3-8565301
- Correo electrónico: 110331102@gms.tcu.edu.tw
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
- Aged from 50-90 years old
- The disability grade level 2 to 8 according to the grading with long-term care case-mix system, approximately to 20 to 80 of Barthel Index score.
Descripción
Inclusion Criteria:
- Aged from 50-90 years old
- Be able to follow the command and cooperate with the assessor
- The disability grade level 2 to 8 according to the grading with long-term care case-mix system, approximately to 20 to 80 of Barthel Index score.
- Receiving the reablement services at least 3 times/a set.
Exclusion Criteria:
- Using the outpatient rehabilitation service during the study period
- Transferring or delivering to institution
- Re-admission to hospital during using the service
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Reablement group
The home reablement program will be implemented by a physical therapist according to "Long-term Care Reablement Operational Guidelines" announced by the Ministry of Health and Welfare of Taiwanese government
|
The service provider customizes a training plan and formulates training goals based on the patient's level of disability, family environment, and the needs of the patient and the caregiver.
|
Non-reablement group
This group will only receive general home care service without the reablement program.
|
The service provider customizes a training plan and formulates training goals based on the patient's level of disability, family environment, and the needs of the patient and the caregiver.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Short Physical Performance Battery, SPPB
Periodo de tiempo: 15 minutes
|
The SPPB is one of the most commonly used instruments for measuring physical performance in population studies of aging.
The SPPB consists of three subtests: a hierarchical test of balance, a short walk at usual pace and standing up from a chair five times consecutively.
Low scores on the SPPB have a high predictive value for a wide range of health consequences including disability in Activities of Daily Living.
|
15 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Barthel index, BI
Periodo de tiempo: 10 minutes
|
The total score is from 0 to 100, each item is divided into 2-4 levels according to complete independence, need assistance and complete dependence.
The lower the score, the higher the dependent level.
|
10 minutes
|
Instrumental Activities of Daily Living, IADL
Periodo de tiempo: 5 minutes
|
There are eight domains of function measured with the Lawton IADL scale.
Evaluators are scored according to their highest level of functioning in that category.
A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
|
5 minutes
|
EuroQol Five Dimensions Questionnaire, EQ-5D
Periodo de tiempo: 5 minutes
|
The quality of life was assessed using 5 items: Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression.
This questionnaire asks respondents to choose the option that best suits them based on their health status.
|
5 minutes
|
Elderly Mobility Scale, EMS
Periodo de tiempo: 15 minutes
|
The EMS is a 7-item objective measure designed to assess mobility and function in elderly adults.
Divided into bedside mobility and functional mobility (lying to sitting, sitting to lying, standing, and balance and walking).
The total score is 0 to 20 points.
The higher the score, the better performance.
|
15 minutes
|
Handheld dynamometer to measure muscle strength
Periodo de tiempo: 5 minutes
|
Grip strength will be measured twice on the left and right sides of the elderly in a standard sitting position with elbow 90 degree and shoulder in neutral position, and the average value will be taken.
|
5 minutes
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jia-Ching Chen, Department of physical therapy, Tzu Chi University
- Director de estudio: Lian-Cing Yan, Department of physical therapy, Tzu Chi University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IRB110-277-B
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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