Clinical trial NCT05978245: Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12
Official title: Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12, Translate From English for Use in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Physical Medicine and Rehabilitation
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: French-language linguistic and cultural validation of caregiver burden questionnaires (Zarit-12) in a population of neurological patients
timeFrame: two days (day one and day fourteen)
measure: French-language linguistic and cultural validation of caregiver burden questionnaires (CBI) in a population of neurological patients
timeFrame: two days (day one and day fourteen)
Secondary outcomes:
measure: Identifying populations at higher risk of burden (ZARIT-12)
timeFrame: two days (day one and day fourteen)
measure: Identifying populations at higher risk of burden (CBI)
timeFrame: two days (day one and day fourteen)
measure: Identification of risk factors for caregiver's burden (ZARIT-12)
timeFrame: two days (day one and day fourteen)
measure: Identification of risk factors for caregiver's burden (CBI)
timeFrame: two days (day one and day fourteen)
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Hôpital Delafontaine
state: Seine Saint Denis
Study officials:
References: