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

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

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

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease; Memory Disorders
• Intervention / Treatment: Behavioral: Psychological questionnaires

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les Nancy, France, 54511
    • Recruiting
    • University Hospital of Nancy ,CHU Brabois, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with memory disorders; psychological questionnaires	Behavioral: Psychological questionnaires; Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping
Experimental: Accompanier; psychological questionnaires	Behavioral: Psychological questionnaires; Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and 6 months after diagnosis disclosure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 1 month later and 6 months after diagnosis disclosure
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.	Baseline and 6 months after diagnosis disclosure
Differences of memory problems perceptions and coping according to level of cognitive disorder at the Mini-Mental State Examination (MMSE)		Baseline and 6 months after diagnosis disclosure

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: France Alzheimer; Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France
• Investigators: Principal Investigator: Christine Perret-Guillaume, PhD, MD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 20, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Memory Disorders
• Other Study ID Numbers: 2014-A00156-41