Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process :

NCT02299154 | Unknown

• 1 other identifier: 2014-A00156-41
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Disorders; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Psychometric properties of the french adaptation of the Ilness Perceptions Questionnaire - Memory (IPQ-M, Hurt et al. 2010)

  Baseline, 1 month later and 6 months after diagnosis disclosure

• Impact of the memory problems perceptions on mood and well-being

  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

Study Arms (2)

Patient with memory disorders

EXPERIMENTAL

psychological questionnaires

Behavioral: Psychological questionnaires

Accompanier

EXPERIMENTAL

psychological questionnaires

Behavioral: Psychological questionnaires

Interventions

Psychological questionnaires BEHAVIORAL

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

Accompanier; Patient with memory disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• France Alzheimer: collaborator
• Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France: collaborator

Study Sites (1)

University Hospital of Nancy ,CHU Brabois, France

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Memory Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christine Perret-Guillaume, PhD, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

christine perret-guillaume, PhD, MD

CONTACT

+33383153322; c.perret-guillaume@chu-nancy.fr

anaick besozzi, M's D

CONTACT

+33383157099; a.besozzi@chu-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

FR (1)