TOD-IBD: Empowering Patients On-Demand

Launched by FRANCISCUS GASTHUIS · Dec 19, 2023

Keywords

ClinConnect Summary

The TOD-IBD clinical trial is studying how on-demand telemonitoring can help manage Inflammatory Bowel Diseases (IBD), such as Crohn's disease and Ulcerative Colitis. Instead of following a fixed schedule for check-ins, patients will use a mobile app to report their symptoms whenever they feel it's necessary. The main goal of the study is to see if this approach can reduce the number of ongoing flare-ups over a year compared to standard telemonitoring, where patients check in regularly. The trial will be looking at various outcomes, including the need for unplanned healthcare visits and how patients feel about their health and quality of life.

To be eligible for this trial, you must be over 18 years old and have a confirmed diagnosis of IBD that is currently stable and well-managed with medication. You should not have experienced any changes in your treatment in the past three months, and your symptoms should be in remission. The trial excludes individuals with certain surgical procedures, those participating in other trials that could interfere, or those who do not have the necessary technology or language skills to use the app. If you decide to participate, you will help researchers understand if this new way of monitoring can empower patients and improve their overall healthcare experience.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.