Validation of the French Version of the Score on Quality... | NCT05986825

Studies
Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)

NCT05986825

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Jul 23, 2024Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Hidradenitis Suppurativa

Interventions

Verneuil questionnaire Validation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2023Actual

Primary Completion Date

Dec 22, 2023Actual

Completion Date

Dec 22, 2023Actual

First Submitted Date

Aug 3, 2023

First Submission Date that Met QC Criteria

Aug 3, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2024

Last Update Posted Date

Jul 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental		Patients with Verneuil disease	Other: Verneuil questionnaire Validation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Verneuil questionnaire Validation	Other	Request patient to Complete the questionnaire for validation of the French version	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validation of the questionnaire		During the visit and 1 week later

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Verneuil disease

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU Brest		Brest		29200	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

All collected data that underlie results in a publication

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017497	Hidradenitis Suppurativa

Ancestor Terms

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided