Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12 (VALI-CBIZ)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Physical Medicine and Rehabilitation

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 Type: Observational
• Enrollment (Estimated): 264

Contacts and Locations

• Study Contact: Name: TURMEL Nicolas; Phone Number: 0142356140; Email: nicolas.turmel@ch-stdenis.fr

Study Locations

• France
  • Seine Saint Denis
    • Saint-Denis, Seine Saint Denis, France, 93200
      • Recruiting
      • Hopital DELAFONTAINE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients consulted in the hospital wards included in the research and suffering from neurological pathology with the inclusion of caregivers of patients who have had a consultation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
French-language linguistic and cultural validation of caregiver burden questionnaires (Zarit-12) in a population of neurological patients	ZARIT-12	two days (day one and day fourteen)
French-language linguistic and cultural validation of caregiver burden questionnaires (CBI) in a population of neurological patients	CBI questionnaire	two days (day one and day fourteen)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying populations at higher risk of burden (ZARIT-12)	ZARIT-12	two days (day one and day fourteen)
Identifying populations at higher risk of burden (CBI)	CBI questionnaire	two days (day one and day fourteen)
Identification of risk factors for caregiver's burden (ZARIT-12)	ZARIT-12	two days (day one and day fourteen)
Identification of risk factors for caregiver's burden (CBI)	CBI questionnaire	two days (day one and day fourteen)

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Saint-Denis

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CHSD_0027_MPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No