- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299154
Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process : (REMAD)
March 7, 2016 updated by: Central Hospital, Nancy, France
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: christine perret-guillaume, PhD, MD
- Phone Number: +33383153322
- Email: c.perret-guillaume@chu-nancy.fr
Study Contact Backup
- Name: anaick besozzi, M's D
- Phone Number: +33383157099
- Email: a.besozzi@chu-nancy.fr
Study Locations
-
-
-
Vandoeuvre les Nancy, France, 54511
- Recruiting
- University Hospital of Nancy ,CHU Brabois, France
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient with memory disorders
psychological questionnaires
|
Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping
|
Experimental: Accompanier
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
Time Frame: Baseline and 6 months after diagnosis disclosure
|
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)
Time Frame: Baseline, 1 month later and 6 months after diagnosis disclosure
|
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
Time Frame: Baseline and 6 months after diagnosis disclosure
|
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)
Time Frame: Baseline and 6 months after diagnosis disclosure
|
Baseline and 6 months after diagnosis disclosure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Perret-Guillaume, PhD, MD, Central Hospital, Nancy, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- 2014-A00156-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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