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Alzheimer Disease : Rehabilitation's Intervention at Home (pré MATAPA)

14 de octubre de 2014 actualizado por: Nantes University Hospital

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

Terminado

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

Intervencionista

Inscripción (Actual)

17

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.

Ubicaciones de estudio

  • Francia
      • Nantes, Francia, 44093
        • Bellier Hospital, CHU of Nantes

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

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

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: 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
Conductual: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Nantes University Hospital

Investigadores

  • Investigador principal: Gilles Berrut, Pr, Bellier Hospital, CHU of Nantes

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

1 de octubre de 2012

Finalización primaria (Actual)

1 de mayo de 2014

Finalización del estudio (Actual)

1 de septiembre de 2014

Fechas de registro del estudio

Enviado por primera vez

18 de septiembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

20 de septiembre de 2012

Publicado por primera vez (Estimar)

21 de septiembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de octubre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

14 de octubre de 2014

Última verificación

1 de octubre de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RC12_0080

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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