French Validation of Axial Spondyloarthritis Questionnaires (Val-SpA)

Completed

• Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis

• Registration Number: NCT04212806
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-30
• Study Start: 2020-01-27
• Primary Completion: 2020-09-07
• Study Completion: 2020-12-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BAS-G validity in French	Day 0	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.
BASFI validity in French	Day 0	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.
Dougados validity in French	Day 0	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.

Trial Locations

Locations (2)

Chu Grenoble Alpes; 🇫🇷 Grenoble Cedex 9, France

CHU Grenoble Alpes; 🇫🇷 Grenoble, France