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NCT04212806 Clinical Trial

French Validation of Axial Spondyloarthritis Questionnaires (Val-SpA)

Ankylosing Spondylitis Clinical Trial

— Val-SpA  

Official title:
French Linguistic Validation of Questionnaires for Patients With Axial Spondyloarthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04212806
Other study ID # 38RC19.291
Secondary ID 2019-A02508-49
Status Completed
Phase
First received
Last updated
Start date January 27, 2020
Est. completion date December 31, 2020

Study information
Verified date November 2022
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Axial spondyloarthritis (SpA) is a chronic rheumatic diseases affecting axial skeleton and sacro-iliac joints. SpA can have functional consequences, often assessed with the Bath Ankylosing Spondylitis Functional Index (BASFI), the Dougados functional index, or more globally with the Bath Ankylosing Spondylitis Global (BAS-G). If these questionnaires are validated in English, there are not validated in French. The aim is to do a french linguistic validation of these questionnaires. A translation, reconciliation and retro-translation will be conducted for each of the questionnaires by two bilingual translators. The last version of each questionnaire will be then validated by clinicians experts in SpA. The version will be further validated by 5 patients. If necessary and if changes occured on the version of the questionnaire, another version will be validated by 5 other patients until full understanding is obtained.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date December 31, 2020
Est. primary completion date September 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients diagnosed with axial spondyloarthritis or ankylosing spondylitis Exclusion Criteria: - Patients who do not understand French - Patients with cognitive impairments - People protected by law - People who do not want to participate

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Grenoble Alpes Grenoble
France Chu Grenoble Alpes Grenoble Cedex 9

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Grenoble University Grenoble Alps

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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