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French Validation of Axial Spondyloarthritis Questionnaires (Val-SpA)

French Linguistic Validation of Questionnaires for Patients With Axial Spondyloarthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04212806
Acronym
Val-SpA
Enrollment
5
Registered
2019-12-30
Start date
2020-01-27
Completion date
2020-12-31
Last updated
2022-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Axial Spondyloarthritis

Keywords

Validation, BASFI, Dougados Functional Index, BAS-G

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.

Interventions

None listed

Sponsors

University Grenoble Alps
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BASFI validity in FrenchDay 0The 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.
BAS-G validity in FrenchDay 0The 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.
Dougados validity in FrenchDay 0The 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026