Clinical trial NCT02299154: Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process :
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
Overall status: UNKNOWN
Phase: NA
Conditions: Memory Disorders
Alzheimer Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: France Alzheimer
name: Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France
First posted: 2014-11-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Memory problems perceptions of patients and next of kin during diagnosis process
timeFrame: Baseline and 6 months after diagnosis disclosure
Secondary outcomes:
measure: Psychometric properties of the french adaptation of the Ilness Perceptions Questionnaire - Memory (IPQ-M, Hurt et al. 2010)
timeFrame: Baseline, 1 month later and 6 months after diagnosis disclosure
measure: Impact of the memory problems perceptions on mood and well-being
timeFrame: Baseline and 6 months after diagnosis disclosure
measure: Differences of memory problems perceptions and coping according to level of cognitive disorder at the Mini-Mental State Examination (MMSE)
timeFrame: Baseline and 6 months after diagnosis disclosure
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: University Hospital of Nancy ,CHU Brabois, France
Study officials:
affiliation: Central Hospital, Nancy, France
name: Christine Perret-Guillaume, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: