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Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease (F-IBDQ)
This study has been completed.
Sponsor:
Rennes University Hospital
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01891214
First received: June 17, 2013
Last updated: February 14, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Ulcerative Colitis Crohn's Disease | Other: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease |
Resource links provided by NLM:
Further study details as provided by Rennes University Hospital:
Primary Outcome Measures:
- 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.
| Enrollment: | 100 |
| Actual Study Start Date: | December 2013 |
| Study Completion Date: | January 2017 |
| Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Ulcerative Colitis and Crohn's Disease | Other: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | 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
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01891214
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891214
Locations
| France | |
| CHRU de Nancy | |
| Nancy, France | |
| Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux | |
| Rennes, France, 35033 | |
Sponsors and Collaborators
Rennes University Hospital
Investigators
| Principal Investigator: | Guillaume Bouguen | Rennes University Hospital |
More Information
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01891214 History of Changes |
| Other Study ID Numbers: |
2013-A00144-41 LOC/12-17 Bouguen F-IBDQ ( Other Identifier: Rennes University Hospital ) |
| Study First Received: | June 17, 2013 |
| Last Updated: | February 14, 2017 |
Keywords provided by Rennes University Hospital:
|
Inflammatory bowel diseases Inflammatory Bowel Disease Questionnaire (IBDQ) |
Additional relevant MeSH terms:
|
Crohn Disease Colitis Ulcer Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on July 27, 2017