Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease
F-IBDQ
2 other identifiers
observational
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2013
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 3, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 15, 2017
February 1, 2017
2.3 years
June 17, 2013
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Internal validity, scale F-IBDQ
Chronbach's alpha coefficient, measured at the first visit and at the second visit.
Day1 and Month4
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
Discriminant ability, disease activity indexes
Correlation with disease activity indexes, measured at the first visit and at the second visit.
Day1 and Month4
Reliability, disease outcomes
Correlation with disease outcomes, measured at the first visit and at the second visit.
Day1 and Month4
Study Arms (1)
Ulcerative Colitis and Crohn's Disease
Interventions
Eligibility Criteria
Patient with definite diagnosis of UC or CD for at least 6 months
You may qualify if:
- men and women ≥ 18 years of age,
- patient with definite diagnosis of UC or CD for at least 6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHRU de Nancy
Nancy, France
Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux
Rennes, 35033, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillaume Bouguen
Rennes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
July 3, 2013
Study Start
December 1, 2013
Primary Completion
April 1, 2016
Study Completion
January 1, 2017
Last Updated
February 15, 2017
Record last verified: 2017-02