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

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT02351453
• Lead Sponsor: University Hospital, Angers

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.

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 Timeline

• Study Start: 2011-08
• Status Verified: 2011-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-29
• Last Update Submitted: 2015-01-29
• Study First Posted: 2015-01-30
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Date of institutionalization of AD patients (standardized questionnaire)	This outcome is assessed at 12 months.	Date of entrance in institution was collected by a standardized questionnaire.

Secondary Outcome Measures

Name	Time	Method
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 use of formal home help services was measured by a standardized questionnaire and coded as a binary variable.
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.	The delay of institutionalization was assessed by a standardized questionnaire and expressed in number of days.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France