NCT02351453

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
Last Updated

January 30, 2015

Status Verified

November 1, 2011

Enrollment Period

1.5 years

First QC Date

January 13, 2015

Last Update Submit

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

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Olivier Beauchet, MD, PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

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

Locations