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

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.

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Key information

Conditions

Neurocognitive Disorders Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurodegenerative Diseases Stress, Psychological Tauopathies

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MEMORA

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2016
First posted: Jul 7, 2016
Registry last updated: Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed