Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process :

Alzheimer Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02299154
• Other study ID #: 2014-A00156-41
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2014
• Last updated: March 7, 2016
• Start date: December 2014
• Est. completion date: November 2017

Study information

• Verified date: March 2016
• Source: Central Hospital, Nancy, France
• Contact: christine perret-guillaume, PhD, MD
• Phone: +33383153322
• Email: c.perret-guillaume[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Memory Disorders

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Nancy ,CHU Brabois, France	Vandoeuvre les Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France, Union des associations France Alzheimer et maladies apparentées, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No