Inflammatory Bowel DiseasesFLARE_IBDNCT04180345
Development of a Questionnaire Based on Patients' Messages on an Internet Forum for Flare Detection in IBD
An observational study of Inflammatory Bowel Diseases, run by Central Hospital, Nancy, France.
Trial summary
Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD) are chronic disabling conditions characterized by flares followed by periods of remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Psychometric validation of the questionnaire
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Feb 2021
- 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: Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease are chronic disabling conditions characterized by flares followed by periods of remission. To the current state of knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in inflammatory bowel disease. This study aimed to use an innovative methodology to collect messages posted by patients in an Internet forum for developing and validating a PRO measuring flare in inflammatory bowel disease.
Who may be able to join
- Every patient consulting the gastroenterology unit of Nancy University Hospital with a confirmed IBD diagnosis, regardless of the patient's state or treatment will be considered for inclusion
Who cannot join
- patients with a diagnosis < 3 months.
- Protected persons (minors, adults under guardianship, pregnant or breastfeeding women, people living in a public health or social institution, patients in an emergency situation, incarcerated individuals)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Flare_IBD: Development and Validation of a Questionnaire Based on Patients' Messages on an Internet Forum for Early Detection of Flare in Inflammatory Bowel Disease
Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD) are chronic disabling conditions characterized by flares followed by periods of remission. However, IBD patients are seen every 3 to 6 months in the outpatient clinic, and the occurrence of a flare between two outpatient visits is not captured. In the current state of knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in IBD. This study aimed to use an innovative methodology to collect messages posted by patients in an Internet forum for developing and validating a PRO measuring flare in IBD.
The design involves 1) Engineering sciences for scraping extraction of messages posted in an Internet forum and for Identification of messages related to flare, 2) Qualitative methods for thematic content analyze of the messages posted, for candidate items generation, for items selection (Delphi process) and for items adjustment ("think aloud" interviews), 3) Quantitative methods for psychometric validation of the PRO.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Psychometric validation of the questionnaire
- Keywords
- Flare, Inflammatory Bowel Diseases, Questionnaire, Internet, Mixed methods
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric validation of the questionnaireOther
Delph Process : expert panel will include HCPs and patients. They will evaluate the relevance of items on a Likert scale (HCPs N = 25 ; Patients N = 25 ) "Think aloud" interviews (N = 10 patients) Psychometric validation ( N = 200 patients)
| Study group | Role | What they receive |
|---|---|---|
| Validation of the questionnaire | Items reduction, ajustment and psychometric validation of the questionnaire Receives: Other: Psychometric validation of the questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale calibration of the new developped questionnaire
Weighing scale calibration
Measured: About 30 minutes
Construct validity of the new developped questionnaire
Exploratory factor analysis, discriminant validity by Kruskal-Wallis tests
Measured: About 30 minutes
Convergence proprieties of the new developped questionnaire
Convergence test of Flare-IBD scores with objective biological markers and clinical markers used in routine clinical practice
Measured: about 30 minutes
Reproductibility of the new developped questionnaire
Investigation of test-retest reliability with a second questionnaire administered 8 days later.
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study startJan 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionFeb 2021 (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 Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Association François Aupetit, Paris, France, University of Lorraine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180345
- Sponsor's protocol ID
- 2019-A01520-57
- Acronym
- FLARE_IBD
- Status last verified
- Sep 2019
- First submitted
- 23 Oct 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricci L, Epstein J, Buisson A, Devos C, Toussaint Y, Peyrin-Biroulet L, Guillemin F. Flare-IBD: development and validation of a questionnaire based on patients' messages on an internet forum for early detection of flare in inflammatory bowel disease: study protocol. BMJ Open. 2020 Jul 1;10(7):e037211. doi: 10.1136/bmjopen-2020-037211.
PubMed 32611745
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flare_IBD: Development and Validation of a Questionnaire Based on Patients' Messages on an Internet Forum for Early Detection of Flare in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04180345
- Acronym / sponsor ID
- FLARE_IBD / 2019-A01520-57
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Flare, Inflammatory Bowel Diseases, Questionnaire, Internet, Mixed methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Association François Aupetit, Paris, France, University of Lorraine
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 27 Nov 2019 (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.
Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD) are chronic disabling conditions characterized by flares followed by periods of remission. However, IBD patients are seen every 3 to 6 months in the outpatient clinic, and the occurrence of a flare between two outpatient visits is not captured. In the current state of knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in IBD. This study aimed to use an innovative methodology to collect messages posted by patients in an Internet forum for developing and validating a PRO measuring flare in IBD.
The design involves 1) Engineering sciences for scraping extraction of messages posted in an Internet forum and for Identification of messages related to flare, 2) Qualitative methods for thematic content analyze of the messages posted, for candidate items generation, for items selection (Delphi process) and for items adjustment ("think aloud" interviews), 3) Quantitative methods for psychometric validation of the PRO.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation of the questionnaire | – | Other: Psychometric validation of the questionnaireItems reduction, ajustment and psychometric validation of the questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease are chronic disabling conditions characterized by flares followed by periods of remission. To the current state of knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in inflammatory bowel disease. This study aimed to use an innovative methodology to collect messages posted by patients in an Internet forum for developing and validating a PRO measuring flare in inflammatory bowel disease.
Key inclusion criteria (1 listed)
- Every patient consulting the gastroenterology unit of Nancy University Hospital with a confirmed IBD diagnosis, regardless of the patient's state or treatment will be considered for inclusion
Key exclusion criteria (2 listed)
- patients with a diagnosis < 3 months.
- Protected persons (minors, adults under guardianship, pregnant or breastfeeding women, people living in a public health or social institution, patients in an emergency situation, incarcerated individuals)
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 |
|---|---|---|
| Psychometric validation of the questionnaireDelph Process : expert panel will include HCPs and patients. They will evaluate the relevance of items on a Likert scale (HCPs N = 25 ; Patients N = 25 ) "Think aloud" interviews (N = 10 patients) Psychometric validation ( N = 200 patients) | Other | Validation of the questionnaire |
Primary outcome
Scale calibration of the new developped questionnaire
Time frame: About 30 minutes
Weighing scale calibration
Construct validity of the new developped questionnaire
Time frame: About 30 minutes
Exploratory factor analysis, discriminant validity by Kruskal-Wallis tests
Convergence proprieties of the new developped questionnaire
Time frame: about 30 minutes
Convergence test of Flare-IBD scores with objective biological markers and clinical markers used in routine clinical practice
Reproductibility of the new developped questionnaire
Time frame: Up to 8 days
Investigation of test-retest reliability with a second questionnaire administered 8 days later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Derived from this study: PubMed 32611745Ricci L, Epstein J, Buisson A, Devos C, Toussaint Y, Peyrin-Biroulet L, Guillemin F. Flare-IBD: development and validation of a questionnaire based on patients' messages on an internet forum for early detection of flare in inflammatory bowel disease: study protocol. BMJ Open. 2020 Jul 1;10(7):e037211. doi: 10.1136/bmjopen-2020-037211.
- 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 Inflammatory Bowel Diseases, run by Central Hospital, Nancy, 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 1 inclusion and 2 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 27 Nov 2019. 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 Jonathan Epstein, MD, PhD (0033382852342, j.epstein@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale calibration of the new developped questionnaire (time frame: About 30 minutes). 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?
On the ClinicalTrials.gov record for NCT04180345, 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 27 Nov 2019.