- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02351453
Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Angers, Francia, 49933
- University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Date of institutionalization of AD patients (standardized questionnaire)
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The increase formal home help services (measured by a standardized questionnaire and coded as a binary variable)
Lasso di tempo: 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)
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Olivier Beauchet, MD, PhD, University Hospital, Angers
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2011/24
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .