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Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process : (REMAD)

Primary Purpose

Memory Disorders, Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychological questionnaires
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Memory Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Nancy ,CHU Brabois, FranceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient with memory disorders

Accompanier

Arm Description

psychological questionnaires

psychological questionnaires

Outcomes

Primary Outcome Measures

Memory problems perceptions of patients and next of kin during diagnosis process
How patients and accompaniers perceive memory problems at the first visit in a Memory Center to 6 months after the diagnosis disclosure, with the Illness Perception Questionnaire Memory

Secondary Outcome Measures

Psychometric properties of the french adaptation of the Ilness Perceptions Questionnaire - Memory (IPQ-M, Hurt et al. 2010)
Psychometric properties of IPQ-M by a traditional approach and by comparison to another french memory complaint questionnaire
Impact of the memory problems perceptions on mood and well-being
Correlation between memory problems perceptions at the IPQ-M, levels of anxiety (STAI-Y), depression (MADRS), quality of life (WHOQOL-BREF) and coping strategies.
Differences of memory problems perceptions and coping according to level of cognitive disorder at the Mini-Mental State Examination (MMSE)

Full Information

First Posted
November 20, 2014
Last Updated
March 7, 2016
Sponsor
Central Hospital, Nancy, France
Collaborators
France Alzheimer, Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France
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1. Study Identification

Unique Protocol Identification Number
NCT02299154
Brief Title
Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process :
Acronym
REMAD
Official Title
Study of Memory Problems Perceptions With the French Adaptation of the Illness Perception Questionnaire Memory, Among Patients Who Come for the First Time at a Memory Center Until Diagnosis Disclosure Post-visit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
France Alzheimer, Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders, Alzheimer Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with memory disorders
Arm Type
Experimental
Arm Description
psychological questionnaires
Arm Title
Accompanier
Arm Type
Experimental
Arm Description
psychological questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Psychological questionnaires
Intervention Description
Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping
Primary Outcome Measure Information:
Title
Memory problems perceptions of patients and next of kin during diagnosis process
Description
How patients and accompaniers perceive memory problems at the first visit in a Memory Center to 6 months after the diagnosis disclosure, with the Illness Perception Questionnaire Memory
Time Frame
Baseline and 6 months after diagnosis disclosure
Secondary Outcome Measure Information:
Title
Psychometric properties of the french adaptation of the Ilness Perceptions Questionnaire - Memory (IPQ-M, Hurt et al. 2010)
Description
Psychometric properties of IPQ-M by a traditional approach and by comparison to another french memory complaint questionnaire
Time Frame
Baseline, 1 month later and 6 months after diagnosis disclosure
Title
Impact of the memory problems perceptions on mood and well-being
Description
Correlation between memory problems perceptions at the IPQ-M, levels of anxiety (STAI-Y), depression (MADRS), quality of life (WHOQOL-BREF) and coping strategies.
Time Frame
Baseline and 6 months after diagnosis disclosure
Title
Differences of memory problems perceptions and coping according to level of cognitive disorder at the Mini-Mental State Examination (MMSE)
Time Frame
Baseline and 6 months after diagnosis disclosure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
christine perret-guillaume, PhD, MD
Phone
+33383153322
Email
c.perret-guillaume@chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
anaick besozzi, M's D
Phone
+33383157099
Email
a.besozzi@chu-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Perret-Guillaume, PhD, MD
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Nancy ,CHU Brabois, France
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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