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Clinical Trials/NCT05978245
NCT05978245RecruitingNot Applicable

Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12, Translate From English for Use in France

Centre Hospitalier de Saint-Denis1 site in 1 country264 target enrollmentStarted: November 22, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
264
Locations
1
Primary Endpoint
French-language linguistic and cultural validation of caregiver burden questionnaires (CBI) in a population of neurological patients
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several stages:

  1. translation stage : during this stage there will be a meeting of experts to Validate the test version in French by 4 Bilingual translators of the French and English mother tongue.
  2. pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.
  3. Validation stage : the two questionnaires have been validated, in this stage there should be a recruitment of 264 participants for the CBI questionnaire and 120 participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver to the participant on the same day.
  • The first questionnary will have to be filled the day they get the questionnary (day 1).
  • The second one must be completed and sent fourteen days later (day 14).

Detailed Description

To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several stages:

  1. translation stage : during this stage there will be a meeting of experts to Validate the test version in French by 4 Bilingual translators of the French and English mother tongue.
  2. pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.
  3. Validation stage : the two questionnaires have been validated, in this stage there should be a recruitment of 264 participants for the CBI questionnaire and 120 participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver to the participant on day 1. The first questionnary will have to be filled on day 1 and the second one must be completed and sent fourteen days later (so on day 14)

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Caregivers (family or friend) of patients followed for a central neurological pathology (MS, BM, Parkinson's, stroke, congenital (Spina...)) or peripheral (ponytail, peripheral neuropathies)
  • •Adult caregivers (age ≥ 18 years), regardless of the patient's age
  • •Francophone caregivers (ability to read, write and understand French)
  • •Caregivers who did not object to the use of their data or the patient's data for research

Exclusion Criteria

  • •- Professional caregivers
  • •caregivers of patients being cared for with a pathology other than neurological
  • •Minor caregivers (age ≤ 17 years)
  • •Caregivers with no or poor French language skills
  • •Caregivers who refused to participate in the research

Outcomes

Primary Outcomes

French-language linguistic and cultural validation of caregiver burden questionnaires (CBI) in a population of neurological patients

Time Frame: two days (day one and day fourteen)

CBI questionnaire

French-language linguistic and cultural validation of caregiver burden questionnaires (Zarit-12) in a population of neurological patients

Time Frame: two days (day one and day fourteen)

ZARIT-12

Secondary Outcomes

  • Identifying populations at higher risk of burden (ZARIT-12)(two days (day one and day fourteen))
  • Identifying populations at higher risk of burden (CBI)(two days (day one and day fourteen))
  • Identification of risk factors for caregiver's burden (ZARIT-12)(two days (day one and day fourteen))
  • Identification of risk factors for caregiver's burden (CBI)(two days (day one and day fourteen))

Investigators

Sponsor
Centre Hospitalier de Saint-Denis
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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