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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02825732
Other study ID # 69HCL16_0437
Secondary ID
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


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
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