- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02351453
Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Angers, France, 49933
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Date of institutionalization of AD patients (standardized questionnaire)
Time Frame: 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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The increase formal home help services (measured by a standardized questionnaire and coded as a binary variable)
Time Frame: 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)
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier Beauchet, MD, PhD, University Hospital, Angers
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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