Neurocognitive DisordersMEMORANCT02825732
MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint
An observational study of Neurocognitive Disorders, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The investigators will investigate which patients' characteristics are associated with caregivers burden and its evolution for outpatients visiting a memory clinic, in particular how functional autonomy, behavioral and psychological symptoms as well as patients comorbidities can influence caregiver burden. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Neurocognitive Disorders
- How many people
- 1,300 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Jan 2016
- Phase
- Observational
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes a sample of consecutive dyads of patient-caregiver consulting a neurologist or a geriatrician for a cognitive complaint between November 2011 and December 2014 at the Memory Clinic of the Hospital Charpennes, Villeurbanne, France.
Who may be able to join
- patients with a cognitive complaint, either expressed by the patient or one of their relatives,
- patients at any stage of disease (cognitive complaint, mild cognitive impairment (MCI) or dementia),
- patients living in the community,
- patients having an informal caregiver who will complete the questionnaire to assess the caregiver burden.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical and Research Memory Centre of Lyon (CMRR); Geriatrics Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France - Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon
Villeurbanne, 69100
About this study
The investigators will investigate which patients' characteristics are associated with caregivers burden and its evolution for outpatients visiting a memory clinic, in particular how functional autonomy, behavioral and psychological symptoms as well as patients comorbidities can influence caregiver burden.
The study will be conducted among outpatients with progressive cognitive complaint followed in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers experience a higher burden due to disease symptoms such as impairment of functional autonomy, behavioral and cognitive impairment, whatever the aetiology of the cognitive decline.
- Conditions
- Neurocognitive Disorders
- Keywords
- Alzheimer's disease or related disorder, Comorbidity, Charlson comorbidity index, Caregiver burden, Cohort, Dementia, Behavioral disorders, Functional dependency
- Medical subject headings
- Neurocognitive Disorders, Alzheimer Disease, Caregiver Burden, Dementia, Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of caregiver burden
The caregiver burden change will be assessed using two repeated measures of the validated short version of the ZBI.
Measured: Two measured of the caregiver burden at baseline and at follow-up during current care, at 6 months to 12 months of follow-up.
Secondary outcomes (1)
Caregiver burden
The caregivers burden will be assessed using the validated short version of the Zarit Burden Inventory (ZBI), which was previously developed for routine medical care. The score is noted as a continuous variable ranging from 0 (no burden) to 7 (higher burden). The questionnaire includes 7 questions for which the caregivers could answer "never", "sometimes" or "nearly always": Does the fact of caring for your relative lead to 1. Difficulties in your family life, 2. Difficulties in your relationship with friends, hobbies, or in your work, 3. An impact on your health, 4. Do you have the feeling of no longer recognizing your relative? 5. Are you concerned for the future of your relative? 6. Do you feel you need more help to take care of your relative? 7. Do you feel a burden in taking care of your relative? The questionnaire of ZBI will be sent at home and completed by the caregiver before the patient's consultation at the memory centre.
Measured: The caregiver burden will be measured at baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Krolak-Salmon, Pr, Principal investigator, Clinical and Research Memory Centre of Lyon (CMRR); Geriatrics Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France - Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825732
- Sponsor's protocol ID
- 69HCL16_0437
- Acronym
- MEMORA
- Status last verified
- Jul 2016
- First submitted
- 4 Jul 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Dauphinot V, Ravier A, Novais T, Delphin-Combe F, Mouchoux C, Krolak-Salmon P. Risk Factors of Caregiver Burden Evolution, for Patients With Subjective Cognitive Decline or Neurocognitive Disorders: A Longitudinal Analysis. J Am Med Dir Assoc. 2016 Nov 1;17(11):1037-1043. doi: 10.1016/j.jamda.2016.07.003. Epub 2016 Aug 26.
PubMed 27575984
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint
- ClinicalTrials.gov ID
- NCT02825732
- Acronym / sponsor ID
- MEMORA / 69HCL16_0437
- Conditions
- Neurocognitive Disorders
- Keywords
- Alzheimer's disease or related disorder, Comorbidity, Charlson comorbidity index, Caregiver burden, Cohort, Dementia, Behavioral disorders, Functional dependency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Jul 2016 (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.
The investigators will investigate which patients' characteristics are associated with caregivers burden and its evolution for outpatients visiting a memory clinic, in particular how functional autonomy, behavioral and psychological symptoms as well as patients comorbidities can influence caregiver burden.
The study will be conducted among outpatients with progressive cognitive complaint followed in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers experience a higher burden due to disease symptoms such as impairment of functional autonomy, behavioral and cognitive impairment, whatever the aetiology of the cognitive decline.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes a sample of consecutive dyads of patient-caregiver consulting a neurologist or a geriatrician for a cognitive complaint between November 2011 and December 2014 at the Memory Clinic of the Hospital Charpennes, Villeurbanne, France.
Key inclusion criteria (4 listed)
- patients with a cognitive complaint, either expressed by the patient or one of their relatives,
- patients at any stage of disease (cognitive complaint, mild cognitive impairment (MCI) or dementia),
- patients living in the community,
- patients having an informal caregiver who will complete the questionnaire to assess the caregiver burden.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of caregiver burden
Time frame: Two measured of the caregiver burden at baseline and at follow-up during current care, at 6 months to 12 months of follow-up.
The caregiver burden change will be assessed using two repeated measures of the validated short version of the ZBI.
1 secondary outcome
Caregiver burden
Time frame: The caregiver burden will be measured at baseline (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Derived from this study: PubMed 27575984Dauphinot V, Ravier A, Novais T, Delphin-Combe F, Mouchoux C, Krolak-Salmon P. Risk Factors of Caregiver Burden Evolution, for Patients With Subjective Cognitive Decline or Neurocognitive Disorders: A Longitudinal Analysis. J Am Med Dir Assoc. 2016 Nov 1;17(11):1037-1043. doi: 10.1016/j.jamda.2016.07.003. Epub 2016 Aug 26.
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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.
Pierre Krolak-Salmon, Pr principal investigator
Clinical and Research Memory Centre of Lyon (CMRR); Geriatrics Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France - Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders, run by Hospices Civils de Lyon 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of caregiver burden (time frame: Two measured of the caregiver burden at baseline and at follow-up during current care, at 6 months to 12 months of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825732, which also lists 1 linked publication.
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 11 Jul 2016; AzTrials last refreshed its copy on 8 Nov 2026.