Chronic Inflammatory Bowel DiseasesFlare-IBDNCT06214299
Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD
An observational study of Chronic Inflammatory Bowel Diseases, run by EPSTEIN Jonathan.
Trial summary
Validating two questionnaires for measuring relapse in IBD (Crohn's / UC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Bowel Diseases
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Mar 2024
- 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: The population is all patients who are members of the AFA Crohn RCH and belong to their mailing list.
Who may be able to join
- Patient member of the AFA Crohn RCH, and registered in the mailing list
- Person having received full information on the organization of the research and not having objected to his/her participation and to the use of his/her data.
Who cannot join
- There were no non-inclusion criteria.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD (Crohn's Disease / Hemorrhagic Rectocolitis)
Validating two questionnaires for measuring relapse in IBD (Crohn's / UC)
Read the detailed description
IBD (Chronic Inflammatory Bowel Diseases) includes Crohn's disease and ulcerative colitis (UC). In France, an estimated 300,000 people suffer from IBD (source afa Crohn RCH France).
To our knowledge, there are no Patient Reported Outcomes (PROs) validated in French to measure the relapse phenomenon in IBD. Such an instrument would complement the available indicators and enable clinicians to detect treatment response at an early stage, as well as failure to respond to treatment, as manifested by the resumption or increased frequency of relapses, and thus enable rapid adjustment of the proposed therapeutic strategy.
Two questionnaires have been developed, their psychometric properties need to be studied.
The project's deliverable will therefore be two validated questionnaires for measuring relapse from the patient's perspective in IBD for routine use. For this reason, the questionnaires will be short, simple to use, easy to interpret and designed to integrate online applications for patient self-monitoring of IBD disease activity.
- Conditions
- Chronic Inflammatory Bowel Diseases
- Keywords
- Psychometric properties, Patient-Reported Outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural validity evaluated by a confirmatory factor analysis, thresholds: comparative fit index (CFI)>0.90, Tucker-Lewis index (TLI)>0.90, root mean square error of approximation (RMSEA)<0.08
Psychometric properties measurable in a cross-sectional study as described by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), using classical test theory and item response theory
Measured: day 0
Secondary outcomes (1)
Reproducibility evaluated by answers to respondents' questions according to declared status corresponding to current absence of relapse. Measured by intraclass correlation coefficient (ICC), a value above 0.70 is expected for acceptable reproducibility
Reproductibility
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EPSTEIN Jonathan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, EPSTEIN Jonathan, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214299
- Sponsor's protocol ID
- 2023PI116
- Acronym
- Flare-IBD
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricci L, Toussaint Y, Becker J, Najjar H, Renier A, Choukour M, Buisson A, Devos C, Epstein J, Peyrin Biroulet L, Guillemin F. Web-based and machine learning approaches for identification of patient-reported outcomes in inflammatory bowel disease. Dig Liver Dis. 2022 Apr;54(4):483-489. doi: 10.1016/j.dld.2021.09.005. Epub 2021 Sep 26.
PubMed 34588153
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD (Crohn's Disease / Hemorrhagic Rectocolitis)
- ClinicalTrials.gov ID
- NCT06214299
- Acronym / sponsor ID
- Flare-IBD / 2023PI116
- Conditions
- Chronic Inflammatory Bowel Diseases
- Keywords
- Psychometric properties, Patient-Reported Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- EPSTEIN JonathanUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 19 Jan 2024 (actual)
- 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.
Validating two questionnaires for measuring relapse in IBD (Crohn's / UC)
Detailed description
IBD (Chronic Inflammatory Bowel Diseases) includes Crohn's disease and ulcerative colitis (UC). In France, an estimated 300,000 people suffer from IBD (source afa Crohn RCH France).
To our knowledge, there are no Patient Reported Outcomes (PROs) validated in French to measure the relapse phenomenon in IBD. Such an instrument would complement the available indicators and enable clinicians to detect treatment response at an early stage, as well as failure to respond to treatment, as manifested by the resumption or increased frequency of relapses, and thus enable rapid adjustment of the proposed therapeutic strategy.
Two questionnaires have been developed, their psychometric properties need to be studied.
The project's deliverable will therefore be two validated questionnaires for measuring relapse from the patient's perspective in IBD for routine use. For this reason, the questionnaires will be short, simple to use, easy to interpret and designed to integrate online applications for patient self-monitoring of IBD disease activity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is all patients who are members of the AFA Crohn RCH and belong to their mailing list.
Key inclusion criteria (2 listed)
- Patient member of the AFA Crohn RCH, and registered in the mailing list
- Person having received full information on the organization of the research and not having objected to his/her participation and to the use of his/her data.
Key exclusion criteria (1 listed)
- There were no non-inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Structural validity evaluated by a confirmatory factor analysis, thresholds: comparative fit index (CFI)>0.90, Tucker-Lewis index (TLI)>0.90, root mean square error of approximation (RMSEA)<0.08
Time frame: day 0
Psychometric properties measurable in a cross-sectional study as described by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), using classical test theory and item response theory
1 secondary outcome
Reproducibility evaluated by answers to respondents' questions according to declared status corresponding to current absence of relapse. Measured by intraclass correlation coefficient (ICC), a value above 0.70 is expected for acceptable reproducibility
Time frame: day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 34588153Ricci L, Toussaint Y, Becker J, Najjar H, Renier A, Choukour M, Buisson A, Devos C, Epstein J, Peyrin Biroulet L, Guillemin F. Web-based and machine learning approaches for identification of patient-reported outcomes in inflammatory bowel disease. Dig Liver Dis. 2022 Apr;54(4):483-489. doi: 10.1016/j.dld.2021.09.005. Epub 2021 Sep 26.
- Web-based and machine learning approaches for identification of patient-reported outcomes in inflammatory bowel diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Bowel Diseases, run by EPSTEIN Jonathan.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANDREIA CARVALHO DE FREITAS (0383859305, a.carvalhodefreitas@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural validity evaluated by a confirmatory factor analysis, thresholds: comparative fit index (CFI)>0.90, Tucker-Lewis index (TLI)>0.90, root mean square error of approximation (RMSEA)<0.08 (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06214299, which also lists 1 linked publication.
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 19 Jan 2024.