Ulcerative ColitisF-IBDQNCT01891214
Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease
An observational study of Ulcerative Colitis and Crohn's Disease, run by Rennes University Hospital at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2013to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with definite diagnosis of UC or CD for at least 6 months
Who may be able to join
- men and women ≥ 18 years of age,
- patient with definite diagnosis of UC or CD for at least 6 months
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Nancy
Nancy
Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux
Rennes, 35033
About this study
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.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)
- Keywords
- Inflammatory bowel diseases, Inflammatory Bowel Disease Questionnaire (IBDQ)
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)Other
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis and Crohn's Disease | Not described Receives: Other: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal validity, scale F-IBDQ
Chronbach's alpha coefficient, measured at the first visit and at the second visit.
Measured: Day1 and Month4
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.
Measured: Day1 and Month4
Discriminant ability, disease activity indexes
Correlation with disease activity indexes, measured at the first visit and at the second visit.
Measured: Day1 and Month4
Reliability, disease outcomes
Correlation with disease outcomes, measured at the first visit and at the second visit.
Measured: Day1 and Month4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Bouguen, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891214
- Sponsor's protocol ID
- 2013-A00144-41
- Other IDs
- LOC/12-17 Bouguen F-IBDQ
- Acronym
- F-IBDQ
- Status last verified
- Feb 2017
- First submitted
- 17 Jun 2013
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease
- ClinicalTrials.gov ID
- NCT01891214
- Acronym / sponsor ID
- F-IBDQ / 2013-A00144-41
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Inflammatory bowel diseases, Inflammatory Bowel Disease Questionnaire (IBDQ)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis and Crohn's Disease | – | Other: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with definite diagnosis of UC or CD for at least 6 months
Key inclusion criteria (2 listed)
- men and women ≥ 18 years of age,
- patient with definite diagnosis of UC or CD for at least 6 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) | Other | Ulcerative Colitis and Crohn's Disease |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Bouguen principal investigator
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn's Disease, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal validity, scale F-IBDQ (time frame: Day1 and Month4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.