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CompletedNCT01891214F-IBDQUpdated Feb 15, 2017

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

An observational study in Ulcerative Colitis and Crohn's Disease, sponsored by Rennes University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-15.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Ulcerative Colitis
  • Crohn's Disease

Keywords

  • Inflammatory bowel diseases
  • Inflammatory Bowel Disease Questionnaire (IBDQ)
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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 100 is close to the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • men and women ≥ 18 years of age,
  • patient with definite diagnosis of UC or CD for at least 6 months

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Ulcerative Colitis and Crohn's Disease

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

Interventions

  • OtherValidation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)
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What researchers measure

Primary outcomes

  1. Internal validity, scale F-IBDQ

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

    Time frame: Day1 and Month4

  2. 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.

    Time frame: Day1 and Month4

  3. Discriminant ability, disease activity indexes

    Correlation with disease activity indexes, measured at the first visit and at the second visit.

    Time frame: Day1 and Month4

  4. Reliability, disease outcomes

    Correlation with disease outcomes, measured at the first visit and at the second visit.

    Time frame: Day1 and Month4

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01891214
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Jul 3, 2013
Start date
Dec 2013
Primary completion
Apr 2016
Completion
Jan 2017
Last update
Feb 15, 2017

Study contacts

Guillaume Bouguen
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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