Telemonitoring with TECCU of active Inflammatory Bowel Disease is Not Inferior to Standard Care: Short-term Results of a Multicentre Randomized Controlled Trial of GETECCU (Preprint)

BACKGROUND Telemonitoring is not consistently superior to standard care for inflammatory bowel disease (IBD), yet non-inferiority may be an acceptable outcome if remote care is more efficient. OBJECTIVE To compare the remission time and quality of life of patients with an active IBD controlled by standard care or through the TECCU App (Telemonitoring of Crohn´s Disease and Ulcerative Colitis). METHODS A 2-arm, randomized, multicentre trial with a non-inferiority design was performed at 24 Spanish hospitals on adult patients with IBD who initiated immunosuppressant or biological therapy. Patients were randomized into telemonitoring or standard care groups, and the primary outcome was time in remission after 12-week, with quality of life, medication adherence, adverse events and patient satisfaction as secondary outcomes. RESULTS Of 169 patients enrolled, 158 were randomized and analysed: telemonitoring (n=74); control (n=84). After 12-week, the time in clinical remission was not inferior after telemonitoring (4.20 ±3.73 weeks) to that in the controls (4.32 ±3.28 weeks), with a mean difference between arms of -0.12 weeks (95% CI -1.25-,1.01), non-inferiority p=0.017). There was a similar reduction in faecal calprotectin and C-reactive protein, and an improvement in quality of life and medication adherence in both groups. Satisfaction remained stable around 90%, although non-inferiority was not demonstrated for secondary outcomes. CONCLUSIONS Telemonitoring patients with active IBD is not inferior to standard care to achieve and maintain short-term remission. TECCU may be an alternative follow-up tool if the improved health outcomes and costs are confirmed in the long-term. CLINICALTRIAL The trial is registered at ClinicalTrials.gov with the identifier NCT06031038; https://classic.clinicaltrials.gov/ct2/show/NCT06031038 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.9639