Physical Medicine and RehabilitationVALI-CBIZNCT05978245
Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12
An observational study of Physical Medicine and Rehabilitation, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Physical Medicine and Rehabilitation
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Delafontaine
Saint-Denis, Seine Saint Denis, 93200
About this study
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
To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several stages:
- 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.
- pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.
- 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).
Read the detailed description
To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several stages:
- 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.
- pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.
- 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)
- Conditions
- Physical Medicine and Rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
French-language linguistic and cultural validation of caregiver burden questionnaires (Zarit-12) in a population of neurological patients
ZARIT-12
Measured: 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
Measured: two days (day one and day fourteen)
Secondary outcomes (4)
Identifying populations at higher risk of burden (ZARIT-12)
ZARIT-12
Measured: two days (day one and day fourteen)
Identifying populations at higher risk of burden (CBI)
CBI questionnaire
Measured: two days (day one and day fourteen)
Identification of risk factors for caregiver's burden (ZARIT-12)
ZARIT-12
Measured: two days (day one and day fourteen)
Identification of risk factors for caregiver's burden (CBI)
CBI questionnaire
Measured: two days (day one and day fourteen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start22 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Medicine and RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978245
- Sponsor's protocol ID
- CHSD_0027_MPR
- Acronym
- VALI-CBIZ
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05978245
- Acronym / sponsor ID
- VALI-CBIZ / CHSD_0027_MPR
- Conditions
- Physical Medicine and Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several stages:
- 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.
- pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.
- 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:
- 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.
- pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
4 secondary outcomes
Identifying populations at higher risk of burden (ZARIT-12)
Time frame: two days (day one and day fourteen)
Identifying populations at higher risk of burden (CBI)
Time frame: two days (day one and day fourteen)
Identification of risk factors for caregiver's burden (ZARIT-12)
Time frame: two days (day one and day fourteen)
Identification of risk factors for caregiver's burden (CBI)
Time frame: two days (day one and day fourteen)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Medicine and Rehabilitation, run by Centre Hospitalier de Saint-Denis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TURMEL Nicolas (0142356140, nicolas.turmel@ch-stdenis.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.