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

February 14, 2017 updated by: Rennes University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • CHRU de NANCY
      • Rennes, France, 35033
        • Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with definite diagnosis of UC or CD for at least 6 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ulcerative Colitis and Crohn's Disease
Other: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal validity, scale F-IBDQ
Time Frame: Day1 and Month4
Chronbach's alpha coefficient, measured at the first visit and at the second visit.
Day1 and Month4
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.
Day1 and Month4
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.
Day1 and Month4
Reliability, disease outcomes
Time Frame: Day1 and Month4
Correlation with disease outcomes, measured at the first visit and at the second visit.
Day1 and Month4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Guillaume Bouguen, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00144-41
  • LOC/12-17 Bouguen F-IBDQ (Other Identifier: Rennes University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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