NCT05978245

Brief Summary

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

  • 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 22, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

July 20, 2023

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Delafontaine

Saint-Denis, Seine Saint Denis, 93200, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 7, 2023

Study Start

November 22, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations