MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint (MEMORA)
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|ClinicalTrials.gov Identifier: NCT02825732|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 11, 2016
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|
|Study Type :||Observational|
|Actual Enrollment :||1300 participants|
|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|
- 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.
- 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.
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
|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|
|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|