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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01891214
Acronym
F-IBDQ
Enrollment
100
Registered
2013-07-03
Start date
2013-12-31
Completion date
2017-01-31
Last updated
2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Inflammatory bowel diseases, Inflammatory Bowel Disease Questionnaire (IBDQ)

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.

Interventions

OTHERValidation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Internal validity, scale F-IBDQDay1 and Month4Chronbach's alpha coefficient, measured at the first visit and at the second visit.
External validity, questionnaire SF36Day1 and Month4Correlation 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 indexesDay1 and Month4Correlation with disease activity indexes, measured at the first visit and at the second visit.
Reliability, disease outcomesDay1 and Month4Correlation with disease outcomes, measured at the first visit and at the second visit.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026