Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Web-based systems provide safe and well-accepted management of mild to moderate inflammatory bowel disease (IBD) patients, with potential cost savings. However, the efficacy of different eHealth applications on disease outcomes is inconsistent between studies and data are lacking in complex IBD. Objective: To compare the impact on health outcomes and healthcare use of remote monitoring with a web system, TECCU (Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa [Telemonitoring of Crohn’s Disease and Ulcerative Colitis]) in complex IBD patients vs standard care and telephone care. Methods: We performed a 3-arm randomized controlled trial (ClinicalTrials.gov identifier: NCT02943538). Adult IBD patients who initiated immunosuppressant and/or biological agents were recruited from the specialized IBD Unit of a public university hospital and then randomized to receive remote monitoring (G_TECCU), nurse-assisted telephone care (G_NT) or standard care with in-person visits (G_control). All patients attended study visits at baseline and at 12 and 24 weeks, in addition to each type of intervention. The primary outcome was the percentage of patients in remission at 24 weeks. Secondary health outcomes were quality of life, medication adherence, adverse effects, satisfaction and social activities. The number of outpatient visits and telephone calls, emergency visits, hospitalizations, IBD-related surgeries and corticosteroid courses were also collected. Results: In total, 63 patients were selected (21 in each group). During the study period, 90,5% of patients (19/21) in G_control, 95,2% of patients in G_AT (20/21) and 85,7% of patients in G_TECCU (18/21) were compliant to the intervention. After 24 weeks, the percentage of patients in remission was higher in G_TECCU (81%) compared with G_NT (66,7%) and G_control (71.4%), with a higherimprovement in disease activity in G_TECCU vs G_control both considering Harvey-Bradshaw/Mayo (OR= 0.12 [95% CI 0.003 to 2.162]; p=0.189) and Harvey-Bradshaw/Walmsley indexes (OR= 0.11 [95% CI 0.004 to 1.55]; p=0.126). Disease activity improvement was also associated to a higher reduction in fecal calprotectine values in G_TECCU vs G_control (estimated intervention effect -0.90 [95% CI -1.96 to 0.16]; p= 0.106) at the end of the study. All completer patients adhered to treatment in G_TECCU andquality of life, social activities and satisfaction improved in the 3 groups. The number of outpatient visits and telephone calls was lower in G_TECCU, with similar safety profile compared with G_NT and G_control. Conclusions: This pilot clinical trial suggests that TECCU is a safe strategy for improving health outcomes in complex IBD patients, with less frequent use of health care resources. Clinical Trial: ClinicalTrials.gov: NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/6y4DQdmt8).