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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01891214 |
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Date of registration:
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17/06/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease |
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Date of first enrolment:
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December 2013 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01891214 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Guillaume Bouguen |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rennes University Hospital |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Crohn's Disease
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Intervention(s)
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Other: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)
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Primary Outcome(s)
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Discriminant ability, disease activity indexes
[Time Frame: Day1 and Month4]
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Internal validity, scale F-IBDQ
[Time Frame: Day1 and Month4]
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Reliability, disease outcomes
[Time Frame: Day1 and Month4]
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External validity, questionnaire SF36
[Time Frame: Day1 and Month4]
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Secondary ID(s)
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2013-A00144-41
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LOC/12-17 Bouguen F-IBDQ
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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