Comparison of patient reported disease activity scores combined with calprotectin home tests for remote monitoring of IBD patients: a cross-sectional cohort study

Comparison of patient reported disease activity scores combined with calprotectin home tests for remote monitoring of IBD patients: a cross-sectional cohort study - Remote monitoring of IBD.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54092

Enrollment

400

Registered

2021-03-05

Start date

2022-06-07

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory bowel diseases

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary outcome is prediction of mucosal inflammation in daily clinical practice, using the below listed PROMs (with and without FC home test), relative to the gold standard ileocolonoscopy: - MIAH - Mobile health Index - Manitoba IBD index - IBD-control - p-HBI / p-SCCAI In addition, redeveloped and optimized PROMs are a primary endpoint.	—

Secondary

Measure	Time frame
- Prediction of mucosal inflammation in a strict trial setting using PROMs with and without FC home test, relative to the gold standard ileocolonoscopy - Agreement between fecal calprotectin levels measured by calprotectin home tests and by routine laboratory tests in the participating centers - Association between abdominal pain and histologic disease activity - A validated profile of VOCs that predicts endoscopic and/or histological disease activity in IBD - The relation of oxylipins to IBD mucosal inflammation and the relation to VOCs - Association between fatigue, persistent abdominal complaints and endoscopic and/or histological disease activity - Association between anxiety and depression, persistent abdominal complaints and endoscopic and/or and histological disease activity - Association between altered quality of life, medical consumption and work productivity in relation to persistent abdominal complaints and endoscopic disease activity.	—

Measure

Time frame

- Prediction of mucosal inflammation in a strict trial setting using PROMs with and without FC home test, relative to the gold standard ileocolonoscopy - Agreement between fecal calprotectin levels measured by calprotectin home tests and by routine laboratory tests in the participating centers - Association between abdominal pain and histologic disease activity - A validated profile of VOCs that predicts endoscopic and/or histological disease activity in IBD - The relation of oxylipins to IBD mucosal inflammation and the relation to VOCs - Association between fatigue, persistent abdominal complaints and endoscopic and/or histological disease activity - Association between anxiety and depression, persistent abdominal complaints and endoscopic and/or and histological disease activity - Association between altered quality of life, medical consumption and work productivity in relation to persistent abdominal complaints and endoscopic disease activity.

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Countries

Netherlands

Outcome results