- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04180345
Development of a Questionnaire Based on Patients' Messages on an Internet Forum for Flare Detection in IBD (FLARE_IBD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jonathan Epstein, MD, PhD
- Phone Number: 0033382852342
- Email: j.epstein@chru-nancy.fr
Study Contact Backup
- Name: Laetitia Ricci, PhD
- Phone Number: 0033382852342
- Email: l.ricci@chru-nancy.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Validation of the questionnaire
Items reduction, ajustment and psychometric validation of the questionnaire
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scale calibration of the new developped questionnaire
Time Frame: About 30 minutes
|
Weighing scale calibration
|
About 30 minutes
|
Construct validity of the new developped questionnaire
Time Frame: About 30 minutes
|
Exploratory factor analysis, discriminant validity by Kruskal-Wallis tests
|
About 30 minutes
|
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
|
about 30 minutes
|
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.
|
Up to 8 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A01520-57
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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