Memory DisordersREMADNCT02299154
Memory Problems Perceptions Among Patients and Accompaniers During Diagnosis Process :
A study testing Psychological questionnaires in people with Memory Disorders and Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Memory Disorders, Alzheimer Disease
- What is being tested?
- Psychological questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Nancy ,CHU Brabois, France
Vandœuvre-lès-Nancy, 54511
About this study
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
This study aims to prospectively examine the memory problem perceptions of patients with memory complaints [MCs] and their accompaniers during the diagnostic process.
Read the 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.
- Conditions
- Memory Disorders, Alzheimer Disease
- Being tested
- Psychological questionnaires
- Medical subject headings
- Memory Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological questionnairesBehavioural
Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping
| Study group | Role | What they receive |
|---|---|---|
| Patient with memory disorders | Experimental | psychological questionnaires Receives: Behavioral: Psychological questionnaires |
| Accompanier | Experimental | psychological questionnaires Receives: Behavioral: Psychological questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Psychometric properties of IPQ-M by a traditional approach and by comparison to another french memory complaint questionnaire
Measured: Baseline, 1 month later and 6 months after diagnosis disclosure
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.
Measured: 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)
Measured: Baseline and 6 months after diagnosis disclosure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- France Alzheimer, Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France
- Responsible party
- Sponsor
- Investigators
- Christine Perret-Guillaume, PhD, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299154
- Sponsor's protocol ID
- 2014-A00156-41
- Acronym
- REMAD
- Status last verified
- Mar 2016
- First submitted
- 20 Nov 2014
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02299154
- Acronym / sponsor ID
- REMAD / 2014-A00156-41
- Conditions
- Memory Disorders, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- France Alzheimer, Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France
- Study start
- Dec 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with memory disorders | Experimental | Behavioral: Psychological questionnairespsychological questionnaires |
| Accompanier | Experimental | Behavioral: Psychological questionnairespsychological questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological questionnairesPsychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping | Behavioural | Accompanier, Patient with memory disorders |
Primary outcome
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
3 secondary outcomes
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
Impact of the memory problems perceptions on mood and well-being
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Perret-Guillaume, PhD, MD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological questionnaires in people with Memory Disorders and Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact christine perret-guillaume, PhD, MD (+33383153322, c.perret-guillaume@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory problems perceptions of patients and next of kin during diagnosis process (time frame: Baseline and 6 months after diagnosis disclosure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016; AzTrials last refreshed its copy on 26 Oct 2026.