- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02351453
Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
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Angers, France, 49933
- University Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Date of institutionalization of AD patients (standardized questionnaire)
Délai: This outcome is assessed at 12 months.
|
Date of entrance in institution was collected by a standardized questionnaire.
|
This outcome is assessed at 12 months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The increase formal home help services (measured by a standardized questionnaire and coded as a binary variable)
Délai: This outcome is assessed at baseline and 12 months.
|
The use of formal home help services was measured by a standardized questionnaire and coded as a binary variable.
|
This outcome is assessed at baseline and 12 months.
|
|
The delay of institutionalization of AD patients (assessed by a standardized questionnaire and expressed in number of days)
Délai: This outcome is assessed at baseline and 12 months.
|
The delay of institutionalization was assessed by a standardized questionnaire and expressed in number of days.
|
This outcome is assessed at baseline and 12 months.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Olivier Beauchet, MD, PhD, University Hospital, Angers
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2011/24
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