Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease

Completed

• Conditions: Crohn's Disease; Ulcerative Colitis
• Interventions: Other: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)

• Registration Number: NCT01891214
• Lead Sponsor: Rennes University Hospital

Brief Summary

The purpose of the study is to develop a validated French version of the IBDQ in a cohort of patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative Colitis.

Detailed Description

Importance of measuring subjective aspects of the patient's health, often referred to as quality of life (QoL), become increasingly recognized and integrated into healthcare. For this purpose, The Inflammatory Bowel Disease Questionnaire (IBDQ) is a widely used questionnaire for QoL assessment specific for patients who suffer from inflammatory bowel diseases. However, the IBDQ was originally developed in a cohort of Canadian patients in English language. Since QoL is impacted by underlying cultural trends, any translation of the IBDQ should be reassessed in relation to its validity, reliability, and sensitivity to detect change in the new language and cultural context. While the linguistic French translation of the original IBDQ has been validated, the French IBDQ has never been tested adequately on a French cohort of patient that we aim to perform.

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-07-03
• Study Start: 2013-12
• Primary Completion: 2016-04
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• men and women ≥ 18 years of age,
• patient with definite diagnosis of UC or CD for at least 6 months

Exclusion Criteria

• adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
• inability to comprehend or complete the self-administered questionnaire
• psychiatric diagnosis that prevents participation (many pts will have anxiety or depression and should not be excluded)
• stoma
• malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ulcerative Colitis and Crohn's Disease	Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)	-

Primary Outcome Measures

Name	Time	Method
External validity, questionnaire SF36	Day1 and Month4	Correlation with the French validated SF-36 and disease activity indexes (Harvey Bradshaw index for Crohn's disease and Simple Colitis Activity Index for ulcerative colitis, measured at the first visit and at the second visit.
Discriminant ability, disease activity indexes	Day1 and Month4	Correlation with disease activity indexes, measured at the first visit and at the second visit.
Reliability, disease outcomes	Day1 and Month4	Correlation with disease outcomes, measured at the first visit and at the second visit.
Internal validity, scale F-IBDQ	Day1 and Month4	Chronbach's alpha coefficient, measured at the first visit and at the second visit.

Trial Locations

Locations (2)

CHRU de Nancy; 🇫🇷 Nancy, France

Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux; 🇫🇷 Rennes, France