Effect of a Novel Digital Leakage Notification System (Heylo) for Ostomy Care on Quality of Life and Burden of Living With an Intestinal Ostomy: The ASSISTER Trial, A Randomized Controlled Cross-Over Trial

Abstract

Objective: To investigate the effect of a novel digital leakage notification system (Heylo) on quality of life (QoL) and burden of living with an intestinal ostomy. Patients and Methods: A randomized, controlled, open-label, cross-over trial was conducted in Germany with people having intestinal ostomies, who were cared for by 13 ostomy care specialists. Participants with fecal leakage problems were randomized by a centralized system to either Heylo + Standard of Care (SoC) or SoC alone for 8 weeks, whereafter participants crossed over to the opposite treatment for an additional 8 weeks. Primary and secondary end points were: Emotional impact domain score of the Ostomy Leak Impact tool and Participation domain score of the WHO Disability Assessment Schedule 2.0, respectively. Primary comparisons between Heylo and SoC were evaluated using linear mixed models, taking time and study period into account. The trial is registered with ClinicalTrials.gov, NCT05200416. Results: A total of 144 participants were allocated to a treatment sequence after giving informed consent (safety population). Analyses included randomized participants who had been exposed to at least 1 product and with information on at least 1 end point (intention-to-treat population, n=139). Both the Emotional impact and Participation domain scores improved significantly after 8 weeks use of Heylo compared with SoC (LS mean difference of 11.4; 95% CI, 7.8-15.0; P<.001 and −4.2; 95% CI, −6.7 to −1.6; P=.001, respectively). Few adverse events related to Heylo were reported (n=5, 3.5%; all related to skin irritation). Conclusion: Use of Heylo reported positive effects on quality of life and the overall burden of living with an intestinal ostomy.