French Validation of Axial Spondyloarthritis Questionnaires (Val-SpA)

NCT ID: NCT04212806

Last Updated: 2022-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-27

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Axial Spondyloarthritis Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Grenoble Alps

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Grenoble Alpes

Grenoble, , France

Site Status

CHU Grenoble Alpes

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36043728 (View on PubMed)

Other Identifiers

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2019-A02508-49

Identifier Type: OTHER

Identifier Source: secondary_id

38RC19.291

Identifier Type: -

Identifier Source: org_study_id

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