NCT04212806

Brief Summary

The aim is to do a French linguistic validation of three questionnaires used in axial Spondyloarthritis (BASFI, BAS-G, Dougados Functional Index). In order to validate the questionnaires, a prospective, qualitative, observational and monocentric study will be conducted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

November 25, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 25, 2019

Last Update Submit

November 18, 2022

Conditions

Keywords

ValidationBASFIDougados Functional IndexBAS-G

Outcome Measures

Primary Outcomes (3)

  • BASFI validity in French

    The self-administered Bath Ankylosing Spondylitis Functional Index (BASFI) measures functional consequences of axial spondyloarthritis. The score will be validated in French if the clarity and understanding is approved by 5 french native-language patients.

    Day 0

  • BAS-G validity in French

    The self-administered Bath Ankylosing Spondylitis Global (BAS-G) measures global consequences of axial spondyloarthritis on well-being. The score will be validated in French if the clarity and understanding is approved by 5 french native-language patients.

    Day 0

  • Dougados validity in French

    The self-administered Dougados functional Index measures functional capacities of patients with axial spondyloarthritis. The score will be validated in French if the clarity and understanding is approved by 5 french native-language patients.

    Day 0

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with Ankylosing Spondylitis or Axial Spondyloarthritis at any stage of disease evolution followed at the Rhumatology unit of Grenoble University Hospital

You may qualify if:

  • Patients diagnosed with axial spondyloarthritis or ankylosing spondylitis

You may not qualify if:

  • Patients who do not understand French
  • Patients with cognitive impairments
  • People protected by law
  • People who do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

CHU Grenoble Alpes

Grenoble, France

Location

Related Publications (1)

  • Soulard J, Vaillant J, Baillet A, Vuillerme N. Translation and French Linguistic Validation of the Bath Ankylosing Spondylitis Functional Index and the Bath Ankylosing Spondylitis Global Score in Patients with Axial Spondyloarthritis. Curr Rheumatol Rev. 2023;19(4):449-454. doi: 10.2174/1573397118666220829124234.

MeSH Terms

Conditions

Axial SpondyloarthritisSpondylitis, Ankylosing

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Design

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

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 30, 2019

Study Start

January 27, 2020

Primary Completion

September 7, 2020

Study Completion

December 31, 2020

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations