Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)

Alzheimer Disease Clinical Trial

Official title:

Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351453
• Other study ID #: 2011/24
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: January 29, 2015
• Start date: August 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2011
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	The increase formal home help services (measured by a standardized questionnaire and coded as a binary variable)	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.	No
Secondary	The delay of institutionalization of AD patients (assessed by a standardized questionnaire and expressed in number of days)	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.	No