Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)
1 other identifier
observational
207
1 country
1
Brief Summary
The primary objective of AID study is to identify the medico-neuropsychological, socio-economic and environmental baseline characteristics of dyads associated with the institutionalization of AD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 30, 2015
CompletedJanuary 30, 2015
November 1, 2011
1.5 years
January 13, 2015
January 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Date of institutionalization of AD patients (standardized questionnaire)
Date of entrance in institution was collected by a standardized questionnaire.
This outcome is assessed at 12 months.
Secondary Outcomes (2)
The increase formal home help services (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)
This outcome is assessed at baseline and 12 months.
Eligibility Criteria
AD patients and their spouses were recruited in each memory clinic by a physician during the annual follow-up consultation of AD patient based on eligibility criteria.
You may qualify if:
- 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,
- Being affiliated to the French health insurance,
- Living at home,
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Angers, 49933, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Beauchet, MD, PhD
University Hospital, Angers
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 30, 2015
Study Start
August 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
January 30, 2015
Record last verified: 2011-11