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

NCT ID: NCT01891214

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Ulcerative Colitis Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ulcerative Colitis and Crohn's Disease

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Bouguen

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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CHRU de Nancy

Nancy, , France

Site Status

Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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LOC/12-17 Bouguen F-IBDQ

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A00144-41

Identifier Type: -

Identifier Source: org_study_id

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