- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05986825
Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER) (QUALIVER)
July 22, 2024 updated by: University Hospital, Brest
Validation of the French Version of the Score on Quality of Life in Hidradenitis Suppurativa.
The French HiSQOL will be completed by 60 patients with hidradenitis suppurativa a first time, and a second time 1 week later.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brest, France, 29200
- CHU Brest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with Verneuil disease
Description
Inclusion Criteria:
- Age ≥18 years
- Patient with Verneuil disease
- Beneficiary of or affiliated to a social security insurance
- Participation agreement
Exclusion Criteria:
- Patients physically or mentally unable to complete questionnaires.
- Refusal to participate
- Patient under legal protection (guardianship, curatorship) or deprived of liberty
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Experimental
Patients with Verneuil disease
|
Request patient to Complete the questionnaire for validation of the French version
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Validation of the questionnaire
Time Frame: During the visit and 1 week later
|
During the visit and 1 week later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2023
Primary Completion (Actual)
December 22, 2023
Study Completion (Actual)
December 22, 2023
Study Registration Dates
First Submitted
August 3, 2023
First Submitted That Met QC Criteria
August 3, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
July 23, 2024
Last Update Submitted That Met QC Criteria
July 22, 2024
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC22.0225 (QUALIVER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
All collected data that underlie results in a publication
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH.
Requestors will be required to sign and complete a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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