This trial is active, not recruiting.

Conditions ulcerative colitis, crohn's disease
Treatment validation of the french version of the inflammatory bowel disease questionnaire (ibdq)
Sponsor Rennes University Hospital
Start date October 2013
End date January 2016
Trial size 100 participants
Trial identifier NCT01891214, 2013-A00144-41, LOC/12-17 Bouguen F-IBDQ


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
validation of the french version of the inflammatory bowel disease questionnaire (ibdq)

Primary Outcomes

Internal validity, scale F-IBDQ
time frame: Day1 and Month4
External validity, questionnaire SF36
time frame: Day1 and Month4
Discriminant ability, disease activity indexes
time frame: Day1 and Month4
Reliability, disease outcomes
time frame: Day1 and Month4

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease
Principal investigator Guillaume Bouguen
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Rennes University Hospital.