Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process :

NCT ID: NCT02299154

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-11-30

Brief Summary

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This study aims to prospectively examine the memory problem perceptions of patients with memory complaints \[MCs\] and their accompaniers during the diagnostic process.

Detailed Description

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Through the french adaptation of the "illness perception questionnaire memory", this study aims to prospectively examine the memory problem perceptions of patients with memory complaints \[MCs\] and their accompaniers during the diagnostic process. The investigators plan to recruit 125 patients with MCs who come for the first time at the Research and Resources Memory Center in Nancy, France. Participants have to express MCs and must be free of dementia diagnosis at the first visit. Participants also need to be accompanied by an accompanier and both have to be fluent in French. This study has been approved by our local Ethics Committee (Committee for the Protection of Persons) and the French Health Security Agency. After giving their informed consent, patients and accompaniers are followed up throughout the diagnostic process with three visits : at their first visit, at one month after the first visit, and at six months after the diagnosis disclosure.

Conditions

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Memory Disorders Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with memory disorders

psychological questionnaires

Group Type EXPERIMENTAL

Psychological questionnaires

Intervention Type BEHAVIORAL

Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping

Accompanier

psychological questionnaires

Group Type EXPERIMENTAL

Psychological questionnaires

Intervention Type BEHAVIORAL

Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping

Interventions

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Psychological questionnaires

Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

For patients with memory complaints:

* Age over 18 years
* Have a memory complaints with a QPC score greater than or equal to 3
* Be accompanied by a next of kin
* Folstein MMSE greater than or equal to 15/30
* Have given their written consent after receiving clear and intelligible oral and written information
* Social security coverage

For Accompaniers :

* Age over 18 years
* Consent to participate at the study with the patient
* Have given their written consent after receiving clear and intelligible oral and written information
* Social security coverage
* Be in contact with the patient at least 8 hours per week. It could be physical contact or telephone contact.

Exclusion Criteria

For patients with memory complaints:

* Sensory deficit interfering with the completion of the questionnaires
* Level of French insufficient to complete the questionnaires
* Legally protected person
* Diagnosis of neurocognitive disorders already established
* Treatment for Alzheimer Disease
* Refusal or inability to obtain written informed consent form from the patient
* Included in another experimental study at inclusion visit

For Accompaniers:

* Sensory deficit interfering with the completion of the questionnaires
* Level of French insufficient to complete the questionnaires
* Refusal or inability to obtain written informed consent form from the accompanier
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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France Alzheimer

OTHER

Sponsor Role collaborator

Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France

UNKNOWN

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Perret-Guillaume, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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University Hospital of Nancy ,CHU Brabois, France

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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christine perret-guillaume, PhD, MD

Role: CONTACT

+33383153322

anaick besozzi, M's D

Role: CONTACT

+33383157099

Other Identifiers

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2014-A00156-41

Identifier Type: -

Identifier Source: org_study_id

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