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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nancy, Nancy, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

Internal validity, scale F-IBDQ

Time frame: Day1 and Month4

Chronbach's alpha coefficient, measured at the first visit and at the second visit.
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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: F-IBDQ

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: Jul 3, 2013
Registry last updated: Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed