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Clinical Trials/NCT04212806
NCT04212806
Completed
N/A

French Linguistic Validation of Questionnaires for Patients With Axial Spondyloarthritis

University Hospital, Grenoble2 sites in 1 country5 target enrollmentJanuary 27, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Axial Spondyloarthritis
Sponsor
University Hospital, Grenoble
Enrollment
5
Locations
2
Primary Endpoint
BAS-G validity in French
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 27, 2020
End Date
December 31, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

BAS-G validity in French

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (2)

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