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

July 7, 2016 updated by: Hospices Civils de Lyon

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villeurbanne, France, 69100
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The caregiver burden will be measured at baseline (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 4, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0437

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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