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/m2. 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 (t79=4.57; P<.001; percentage change=−23.26%) and energy levels (t79=−2.44; P=.017; percentage change=9.48%); however, no significant improvements were observed for quality of sleep (t79=−1.32; P=.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.
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.
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.
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