A new Digital Therapeutic Intervention for Patients with Inflammatory Bowel Disease: Program Evaluation (Preprint)

BACKGROUND Inflammatory bowel disease (IBD) causes chronic inflammation of the gastrointestinal tract. IBD is characterized by an unpredictable disease course that varies greatly between individuals and alternates between periods of relapse and remission. 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 the disease course. OBJECTIVE We performed a program evaluation, analyzing engagement and 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 the 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). The treatment completion was strongly predicted by the number of active days during week one. Analysis of the completers (n=80) showed significant improvements 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 support the feasibility of a digital therapeutic intervention for IBD patients (SK-311, SK-321) and suggest that treatment completion might have a significant positive effect 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.