Comparison of patient reported disease activity scores combined with calprotectin home tests for remote monitoring of IBD patients: a cross-sectional cohort study
Recruiting
- Conditions
- inflammatory bowel diseases10017969
- Registration Number
- NL-OMON54092
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
- Established diagnosis of CD or UC based on ECCO guidelines
- CD or UC patients scheduled for an ileocolonoscopy, or UC patients scheduled
for an sigmoidoscopy at the endoscopy ward of one of the participating centers
(regardless of indication)
- Aged 18 years or older
- Smartphone with internet access (for use of fecal calprotectin home test)
Exclusion Criteria
- Unclassified IBD
- Ileostomy, colostomy, ileoanal pouch anastomosis or ileorectal anastomosis
- Isolated upper gastro-intestinal CD, or isolated peri-anal disease
- Insufficient knowledge of Dutch language
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is prediction of mucosal inflammation in daily clinical<br /><br>practice, using the below listed PROMs (with and without FC home test),<br /><br>relative to the gold standard ileocolonoscopy:<br /><br>- MIAH<br /><br>- Mobile health Index<br /><br>- Manitoba IBD index<br /><br>- IBD-control<br /><br>- p-HBI / p-SCCAI<br /><br><br /><br>In addition, redeveloped and optimized PROMs are a primary endpoint. </p><br>
- Secondary Outcome Measures
Name Time Method