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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02299154
Other study ID # 2014-A00156-41
Secondary ID
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


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
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