OP26 Impact of telemonitoring on the management of Inflammatory Bowel Disease in Spain: a multicenter TECCU clinical trial

Abstract

Abstract Background Telemedicine is not consistently superior to standard care in the management of inflammatory bowel disease (IBD). Non-inferiority is an acceptable outcome if telemedicine improves the efficacy and efficiency of care. Owing to the positive results of the TECCU app (Telemonitoring of Crohn’s Disease [CD] and Ulcerative Colitis [Au]) in a pilot trial1, we aimed to evaluate the time in remission and quality of life (QoL) of IBD patients controlled by telemonitoring (G_TECCU), compared to standard care (G_Control) after 12 weeks. 1Del Hoyo J et al. J Med Internet Res. 2018;20(11):e11602. Methods A 2-arm randomized multicenter study with a non-inferiority design was performed in 29 IBD centers in Spain. Adult IBD patients who initiated therapy with immunosuppressant or biological agents for disease activity were included. Exclusion criteria were: patients with ileorectal/ileo-pouch anal anastomosis, stoma, active perianal disease, no Internet access. Time in remission was evaluated with Harvey-Bradshaw/Walmsley indexes (according to CD]/UC, respectively), fecal calprotectin (FC) and reactive C protein (RCP). QoL was assessed with IBDQ-9, medication adherence with Morisky-Green index and patient satisfaction with a questionnaire derived from CSQ-8. Results We included 157 patients, and 126 were analyzed after 12 weeks of follow-up. The demographic and clinical variables are listed in Table 1. The time in remission was not inferior in patients who used the TECCU app (mean 4.2 weeks [SD 3.8]) compared with patients who received standard care (mean 4.2 weeks [SD 3.2]; difference 0.03 [95%CI -1.21 to 1.27]; p=0.017) (Figure 1). In patients with UC, disease activity improved significantly in both TECCU (mean SCCAI improvement -3.60 [SD 3.25]; p= 0.001) and standard care groups (-3.89 [SD 4.56]; p=0.001;). In patients with CD, clinical activity also improved significantly in both groups (mean Harvey-Bradshaw improvement -1.65 [SD 2.51]; p=0.001 in TECCU; -2.24 [SD 4.15]; p=0.001 in standard care group). Similarly, FC and CRP values improved significantly in both groups (Figure 2). Considering QoL, the IBDQ-9 score improved significantly in TECCU (mean 11.29 [SD15.8]; p<0.001) and standard care groups (16.59 [SD 22.1]; p<0.001). Medication adherence improved significantly in TECCU group and it was superior compared with standard care (Figure 3). Patient satisfaction was superior to 90% in both groups at week 12. Conclusion In IBD patients who initiate biological agents or immunomodulators, TECCU app is not inferior to standard care to maintain remission in the short-term. Telemonitoring with TECCU app associated a higher improvement in medication adherence and an increase in QoL. Long-term results are needed to confirm it.