Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-12-20
Brief Title:
Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD
Sponsor:
EPSTEIN Jonathan
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD Crohns Disease Hemorrhagic Rectocolitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Flare-IBD
Brief Summary:
Validating two questionnaires for measuring relapse in IBD Crohns UC
Detailed Description:
IBD Chronic Inflammatory Bowel Diseases includes Crohns disease and ulcerative colitis UC In France an estimated 300000 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 projects deliverable will therefore be two validated questionnaires for measuring relapse from the patients 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
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 projects deliverable will therefore be two validated questionnaires for measuring relapse from the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None