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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02825732

Collaborator

(none)

1,300

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Neurocognitive Disorders

Study Design

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 :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Jan 1, 2016

Outcome Measures

Primary Outcome Measures

Evolution of caregiver burden [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

Caregiver burden [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

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