Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- Rennes University Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- External validity, questionnaire SF36
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
- •malignancy
Outcomes
Primary Outcomes
External validity, questionnaire SF36
Time Frame: 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
Time Frame: Day1 and Month4
Correlation with disease activity indexes, measured at the first visit and at the second visit.
Reliability, disease outcomes
Time Frame: Day1 and Month4
Correlation with disease outcomes, measured at the first visit and at the second visit.
Internal validity, scale F-IBDQ
Time Frame: Day1 and Month4
Chronbach's alpha coefficient, measured at the first visit and at the second visit.