A New Digital Health Program for Patients With Inflammatory Bowel Disease: Preliminary Program Evaluation (Preprint)
Authors: Oddsson Saemundur Jon , Gunnarsdottir Thrudur , Johannsdottir Lilja Gudrun , Amundadottir Maria Lovisa , Frimannsdottir Arna , Molander Pauliina , Ylanne Anna Karoliina , Islind Anna Sigridur , Oskarsdottir Maria , Thorgeirsson Tryggvi 
Published: May 2022

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 the periods of relapse and remission. A low energy level (fatigue) is a common symptom, whereas stress and reduced sleep quality may be the triggering factors. Therapeutic guidelines call for effective disease assessment, early intervention, and personalized care using a treat-to-target approach, which may be difficult to achieve through typical time- and resource-constrained standard care. Providing patients with a digital health program that incorporates helpful self-management features and patient support to complement standard care may be optimal for improving the disease course.

OBJECTIVE

This study aimed to perform a preliminary program evaluation, analyzing engagement and preliminary effectiveness and the effect on participants’ energy levels (fatigue), stress, and sleep quality, of a newly developed 16-week digital health program (SK-311 and SK-321) for patients with IBD.

METHODS

Adults with IBD were recruited to participate in a real-world, live, digital health program via Finnish IBD patient association websites and social media. No inclusion or exclusion criteria were applied for this study. Baseline characteristics were entered by the participants upon sign-up. Platform engagement was measured by tracking the participants’ event logs. The outcome measures of stress, energy levels (fatigue), and quality of sleep were reported by participants through the platform.

RESULTS

Of the 444 adults who registered for the digital health program, 205 (46.2%) were included in the intention-to-treat sample. The intention-to-treat participants logged events on average 41 times per week (5.9 times per day) during the weeks in which they were active on the digital platform. More women than men participated in the intervention (126/205, 88.7%). The mean age of the participants was 40.3 (SD 11.5) years, and their mean BMI was 27.9 (SD 6.0) kg/m<sup>2</sup>. In total, 80 people provided the required outcome measures during weeks 12 to 16 (completers). Treatment completion was strongly predicted by the number of active days in week 1. Analysis of the completers (80/205, 39%) showed significant improvements for stress (<i>t</i><sub>79</sub>=4.57; <i>P</i>&lt;.001; percentage change=−23.26%) and energy levels (<i>t</i><sub>79</sub>=−2.44; <i>P</i>=.017; percentage change=9.48%); however, no significant improvements were observed for quality of sleep (<i>t</i><sub>79</sub>=−1.32; <i>P</i>=.19).

CONCLUSIONS

These results support the feasibility of a digital health program for patients with IBD (SK-311 and SK-321) and suggest that treatment completion might have a substantial 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 health program to supplement standard care for patients with IBD.