- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01689948
Alzheimer Disease : Rehabilitation's Intervention at Home (pré MATAPA)
Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.
Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its prevalence and its medical and social consequences, AD represents a dual challenge to public health and society. The elderly want to stay in their homes even when their lives are altered by a chronic progressive disease. Their caregivers claim in turn a support at home. But this desire is questioned because of the characteristics of the disease, e.g. the altered relational function by the cognitive impairment and the behavioural disorders associated.
Outpatients non-drug therapies represent a potential support that adapts to patient with an AD or mixed dementia, especially in their milder forms.
The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention at home and its acceptability by both the patient and the caregiver.
The study of its efficiency in terms of autonomy will be the next step.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The protocol is based on weekly rehabilitation's intervention at home. All home visits and assessments of the patient and his caregiver will be made by the rehabilitation's therapist himself.
Twelve weekly interventions at home are planed. The first five are needed to define a realistic and achievable goal of treatment which is accepted by the dyad and the therapist. The following seven interventions will achieve this goal by rehabilitation's intervention (e.g. occupational therapy, psychomotor approach).
Four filmed sessions for dyad's assessment are planned (at inclusion, at weeks 5 and 12 after inclusion and 3 months after the last intervention).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Nantes, Francia, 44093
- Bellier Hospital, CHU of Nantes
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Patient's inclusion criteria:
- Aged 65 and over
- AD or mixed dementia (DSM IV TR criteria), documented by a neuropsychological assessment and a brain imaging
- Living at home
- Having a caregiver (more than 2 visits per week)
- Agreement for the study
Caregiver's inclusion criteria :
- More than 2 patient's visits per week
- Agreement for the study
Patient's exclusion criteria:
- Life expectancy less than 1 year
- Guardianship
- Already having a rehabilitation program's therapy
- Participation in a pharmacological study
Caregiver's exclusion criteria:
- Medical condition requiring regular care
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Home rehabilitation therapy
12 weekly sessions of Home rehabilitation therapy
|
12 sessions of home rehabilitation therapy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Periodo de tiempo: 27 weeks
|
The main objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
|
27 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Periodo de tiempo: 5 weeks
|
This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the fifth weekly session of at home rehabilitation therapy).
|
5 weeks
|
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Periodo de tiempo: 13 weeks
|
This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy).
|
13 weeks
|
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Periodo de tiempo: 27 weeks
|
This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
|
27 weeks
|
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Periodo de tiempo: 5 weeks
|
This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy).
|
5 weeks
|
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Periodo de tiempo: 13 weeks
|
This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 12 weeks later (meaning after the last of the twelfth weekly session of at home rehabilitation therapy).
|
13 weeks
|
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Periodo de tiempo: 13 weeks
|
This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy).
|
13 weeks
|
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Periodo de tiempo: 27 weeks
|
This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
|
27 weeks
|
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Periodo de tiempo: 5 weeks
|
This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy).
|
5 weeks
|
Alcohol consumption for the patient and the caregiver
Periodo de tiempo: 27 weeks
|
This objective is to compare the alcohol consumption for the patient and the caregiver observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
|
27 weeks
|
Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment)
Periodo de tiempo: 27 weeks
|
This objective is to compare the mean scores of Mini Mental State Examination (MMSE) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
|
27 weeks
|
Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver)
Periodo de tiempo: 27 weeks
|
This objective is to compare the mean scores of Goal Attainment Scales (GAS) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
|
27 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gilles Berrut, Pr, Bellier Hospital, CHU of Nantes
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RC12_0080
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