Status:
ENROLLING_BY_INVITATION
TOD-IBD: Empowering Patients On-Demand
Lead Sponsor:
Franciscus Gasthuis
Collaborating Sponsors:
Jeroen Bosch Ziekenhuis
Conditions:
Inflammatory Bowel Diseases
Telemonitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Crohn's disease and Ulcerative Colitis, collectively known as Inflammatory Bowel Disease (IBD), impose a significant burden on patients and healthcare systems due to their chronic nature and complex t...
Detailed Description
Rationale: Crohn's disease and Ulcerative Colitis (Inflammatory Bowel Disease (IBD)) are chronic intestinal inflammations with significant impact on quality of life. Due to their chronic nature and co...
Eligibility Criteria
Inclusion
- Aged \>18 years.
- Confirmed IBD diagnosis according to current standards (37).
- Provided informed consent.
- Maintenance therapy with no medication changes in the last 3 months.
- Remission (17, 38)
- Crohn's disease: Faecal calprotectin (FCP) \< 100 µg/g and Harvey Bradshaw Index (HBI) \< 5 or MIAH-CD \< 0.3623618
- Ulcerative Colitis: Faecal calprotectin (FCP) \< 250 µg/g and Simple Clinical Colitis Activity Index scores (SCCAI) \< 3 or MIAH-CU \< 0.354215
Exclusion
- Presence of a stoma.
- Presence of an ileo-anal pouch or ileorectal anastomosis.
- Participating in another prospective clinical trial that interferes with this trial.
- Have insufficient knowledge of the Dutch language to use the application.
- Do not have a smartphone or tablet with an internet connection.
Key Trial Info
Start Date :
March 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT06179563
Start Date
March 26 2025
End Date
March 1 2028
Last Update
August 21 2025
Active Locations (2)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands, 5223GZ
2
Franciscus
Rotterdam, South Holland, Netherlands, 3045PM