- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02351453
Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
In order to reduce Alzheimer Disease (AD) adverse impacts at individual level as well as in terms of expenditures, the development of efficient strategies based on the identification and the correction of risk factors of institutionalization of AD patients proves necessary.
While it has been identified that institutionalization date depends on patients' health characteristics, the role of social, economic and environmental factors still remains few known.
The investigators hypothesized that institutionalization of AD patients could be related not only to medico-neuropsychological patients' characteristics but also to socio-economic and environmental characteristics of dyad (i.e., AD patient and spouse carer), that could modify the delay of institutionalization.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Angers, Francia, 49933
- University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Eligibility criteria for AD patients were:
- Over age 65,
- Diagnosis of AD according to the NINCDS-ADRDA ( National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria,
- Last memory center consultation between 6 and 12 months before the inclusion,
- Being affiliated to the French health insurance,
- Living at home,
- Having a caregiver with inclusion criteria,
- Agreement of General Practitioner (GP) of AD patient to participate in the study and affiliation of the GP to the national "Association pour le Développement de l'Information Médicalisée" (ADIM) French network.
Eligibility criteria for spouse carers were:
- Over age 65,
- Being the spouse and the caregiver of AD patient,
- Being affiliated to the French health insurance,
- Living at home with AD patient.
Exclusion Criteria:
Non inclusion criteria for AD patients and spouse carers were:
- An inability to understand and speak French,
- Acute disease in the past month of baseline assessment,
- Expected moving outside the recruitment area during the follow-up period
- Concomitant participation in a clinical trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Date of institutionalization of AD patients (standardized questionnaire)
Periodo de tiempo: This outcome is assessed at 12 months.
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Date of entrance in institution was collected by a standardized questionnaire.
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This outcome is assessed at 12 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The increase formal home help services (measured by a standardized questionnaire and coded as a binary variable)
Periodo de tiempo: This outcome is assessed at baseline and 12 months.
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The use of formal home help services was measured by a standardized questionnaire and coded as a binary variable.
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This outcome is assessed at baseline and 12 months.
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The delay of institutionalization of AD patients (assessed by a standardized questionnaire and expressed in number of days)
Periodo de tiempo: This outcome is assessed at baseline and 12 months.
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The delay of institutionalization was assessed by a standardized questionnaire and expressed in number of days.
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This outcome is assessed at baseline and 12 months.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Olivier Beauchet, MD, PhD, University Hospital, Angers
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2011/24
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