MedPath

Remote monitoring of IBD

Conditions
Inflammatory bowel disease
Crohn's disease
ulcerative colitis
Registration Number
NL-OMON21966
Lead Sponsor
M
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
286
Inclusion Criteria

Established diagnosis of CD or UC according to ECCO guidelines
- Scheduled for an ileocolonoscopy at the endoscopy ward of the MUMC+ (regardless of indication)
- Aged 18 years or older
- Smartphone with internet access (for use of QOC home test)

Exclusion Criteria

- Unclassified IBD
- Ileostomy, colostomy, ileoanal pouch anastomosis or ileorectal anastomosis
- Insufficient knowledge of Dutch language

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The main study endpoint is the diagnostic test accuracy of the below listed remote monitoring tools, using ileocolonoscopy as reference:<br>- MIAH questionnaire with QOC test<br>- Mobile health Index with QOC test<br>- Manitoba IBD index with QOC test<br>- IBD-control with QOC test<br>- QOC test (without questionnaire)
Secondary Outcome Measures
NameTimeMethod
- Agreement between fecal calprotectin levels measured by QOC tests and by routine MUMC+ laboratory tests<br>- Association between the questions used in the various patient based disease activity scores and endoscopic disease activity
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