Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint (MEMORA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02825732
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

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.


Condition or disease
Neurocognitive Disorders

Layout table for study information
Study Type : Observational
Actual Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint
Study Start Date : November 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Caregiver burden [ Time Frame: The caregiver burden will be measured at baseline (Day 0) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825732


Locations
Layout table for location information
France
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, France, 69100
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Pierre Krolak-Salmon, Pr 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02825732    
Other Study ID Numbers: 69HCL16_0437
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
Alzheimer's disease or related disorder
Comorbidity
Charlson comorbidity index
Caregiver burden
Cohort
Dementia
Behavioral disorders
Functional dependency
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Neurocognitive Disorders
Pathologic Processes
Mental Disorders