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

Neurocognitive Disorders Clinical Trial

— MEMORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825732
• Other study ID #: 69HCL16_0437
• Status: Completed
• Phase: N/A
• First received: July 4, 2016
• Last updated: July 7, 2016
• Start date: November 2011
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: January 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 100 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Disease
• Neurocognitive Disorders

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of caregiver burden	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.	No
Secondary	Caregiver burden	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)	No