Reducing Stress and Fatigue among Patients with Inflammatory Bowel Disease via Sidekick Health Digital Therapeutics (Preprint)

Abstract

BACKGROUND Fatigue is one of the most prominent and disabling symptoms reported by adult patients with inflammatory bowel disease (IBD). Also, stress is perceived as one of the leading causes of IBD flare-ups. Therapeutic guidelines call for effective disease assessment, early intervention, and personalized care using a treat-to-target approach which may be hard to achieve through typical time- and resource-constrained standard care. Providing patients with a digital therapeutic intervention incorporating helpful self-management features and patient support to complement standard care may be optimal for improving fatigue and reducing stress. OBJECTIVE The objective of this study was to perform an analysis of engagement and the preliminary effectiveness of a newly developed 16-week digital therapeutic intervention (SK-311, SK-321) for IBD patients. METHODS Adults with IBD were recruited for participation in a real-world, live, digital therapeutic intervention via Finnish IBD patient association websites and social media. No inclusion/exclusion criteria were applied for this study. Baseline characteristics were entered by participants upon signup. Platform engagement was measured by tracking participants' event logs. The outcome measures stress, energy levels (fatigue), and quality of sleep were reported by participants through the platform. RESULTS Out of 444 adults who registered for the digital therapeutic, 205 adults were included in an intention-to-treat (ITT) sample. The ITT participants, logged events on average 41 times per week (5.9 times/day) during the weeks in which they were active on the digital therapeutic platform. More women than men took part in the intervention (88.7%). The mean participant age was 40.3 years (standard deviation (SD) 11.5), and their mean body mass index was 27.9 (SD 6.0). Eighty people provided the required outcome measures during weeks 12-16 (completers). Analysis of the ITT sample showed significant improvements in ratings of stress (t(204) = 3.49; p < 0.01, percentage change = -9.52%), and energy levels (t(204) = -2.38; p < 0.05, percentage change = 4.60%). No significant difference was observed in quality of sleep (t(204) = -1.37; p = 0.173). For completers (n=80), significant improvements were observed for stress (t(79) = 4.57; p < 0.01, percentage change = -23.26%) and energy levels (t(79) = -2.44; p < 0.05, percentage change = 9.48%) but not for quality of sleep (t(79) = -1.32; p = 0.191). CONCLUSIONS These results indicate that a digital therapeutic intervention for IBD patients (SK-311, SK-321) has significant positive effects on patient-reported stress and energy levels in a real-world setting. These findings are promising and provide initial support for using the Sidekick Health digital therapeutic to supplement standard care for IBD patients.