Spondylo-arthritis Screening Tool Among Patient Suffering From Inflammatory Bowel Disease

NCT06998316 | Not Yet Recruiting

• 1 other identifier: 38RC24.0348
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The QUESAM study aims to translate into French and validate the traduction of 2 screening questionnaires for spondylo-arthritis among people with inflammatory bowel disease. DETAIL (DETection of Arthritis in Inflammatory boweL diseases) and IBIS-Q (Inflammatory Bowel disease Identification of Spondyloarthritis Questionnaire) questionnaires are built to determine which patients might benefit from a rheumatologic consultation, for a potential rheumatologic inflammatory disease. The investigators will translate the 2 questionnaire in french thanks to an external translation company, from english to french, then back to english to make sure the translation is correct. Then, the main question is: is there a conceptual and semantic equivalence beetween the original english questionnaire and the french-translated one. Participant will answer the 2 screening questionnaire, one initial time during a consultation, and a second time after 1 month.

Conditions

Spondylarthritis; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Spondylitis, Ankylosing

Keywords

spondylarthritis; Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases; screening tools

Outcome Measures

Primary Outcomes (1)

• translation and cross-cultural adaptation in french of the questionnaires developped by Di Marco et al (2017) and Variola et al (2020)

  This is a composite criterion combining conceptual equivalence and semantic equivalence of items between the transcultural adaptation of the scale and its original version. Conceptual equivalence will be judged on the results of factorial analysis (exploratory and confirmatory). Semantic equivalence of items will be based on evaluation by a panel of experts.

  13 months

Secondary Outcomes (6)

• acceptability of the instrument via the proportion of missing data for each item

  Baseline and one month later

• Evaluation of the internal consistency assessed by the average inter-item correlation, the average item-result correlation and cronbach's alpha coefficient

  baseline and one month later

• evaluation of the reliability of the questionnaire through an intra-rater reliability with the intra-class correlation.

  Baseline and one month later

• Comparaison of the acceptability of the instrument via the proportion of missing data for each item

  13 months

• Comparaison of internal consistency of the 2 questionnaires

  13 months

Study Arms (1)

People with inflammatory bowel disease

Patient followed in gastro-enterology for an inflammatory bowel disease. These represent every-patient in our study.

Other: Screening questionnaire

Interventions

Screening questionnaire OTHER

Every patient will answer the 2 screening questionnaires given to them, once at baseline and a second time after 1 month.

People with inflammatory bowel disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is people with inflammatory bowel disease

You may qualify if:

• Patient with an inflammatory bowel disease according to gastroenterologist

You may not qualify if:

• Difficulty for understanding or reading french
• Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code
• Patients with no social security coverage.
• Patients refusing to participate voluntarily.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinique des Cèdres, Echirolles: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, France

Location

MeSH Terms

Conditions

Spondylarthritis; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis

Central Study Contacts

Xavier R university hospital practitioner, PhD

CONTACT

04 76 76 54 58; xromand@chu-grenoble.fr

Rejane R ARC, nursing diploma

CONTACT

04 76 76 72 23; Rgruel@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 31, 2025
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)