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

Ulcerative Colitis Clinical Trial

— F-IBDQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891214
• Other study ID #: 2013-A00144-41
• Secondary ID: LOC/12-17 Bougue
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: February 14, 2017
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy
France	Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Internal validity, scale F-IBDQ	Chronbach's alpha coefficient, measured at the first visit and at the second visit.	Day1 and Month4
Primary	External validity, questionnaire SF36	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.	Day1 and Month4
Primary	Discriminant ability, disease activity indexes	Correlation with disease activity indexes, measured at the first visit and at the second visit.	Day1 and Month4
Primary	Reliability, disease outcomes	Correlation with disease outcomes, measured at the first visit and at the second visit.	Day1 and Month4