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

2021 ◽  
Author(s):  
Saemundur Jon Oddsson ◽  
Thrudur Gunnarsdottir ◽  
Lilja Gudrun Johannsdottir ◽  
Maria Lovisa Amundadottir ◽  
Arna Frimannsdottir ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Real World ◽  
Therapeutic Intervention ◽  
Standard Care ◽  
Energy Levels ◽  
Percentage Change ◽  
Quality Of Sleep ◽  
Inflammatory Bowel ◽  
Reducing Stress

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.

scholarly journals P376 Improving stress and fatigue in a real-world setting among patients with Inflammatory Bowel Disease through a digital platform

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S391-S392
Author(s):  
S Oddsson ◽  
T Gunnarsdottir ◽  
L Johannsdottir ◽  
M Amundadottir ◽  
A Frimannsdottir ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Standard Care ◽  
Energy Levels ◽  
Percentage Change ◽  
Quality Of Sleep ◽  
Digital Platform ◽  
Significant Difference ◽  
Inflammatory Bowel

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 by these patients as one of the main 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 standard care. Providing patients with effective self-management strategies and patient support programs (PSPs) via a digital platform to complement standard care, may be optimal for improving fatigue and reducing stress. The objective of this study was to perform a preliminary test of engagement and effectiveness of a newly developed 16-week PSP delivered via the digital platform Sidekick Health. Methods Participants were recruited via Finnish IBD patient association websites and social media (advertisements through Facebook and Instagram). Participants entered baseline characteristics upon program signup. Platform engagement was automatically tracked, and participants reported stress, energy levels (fatigue), and quality of sleep through the platform. Results An intention to treat (ITT) sample included 205 participants. Eighty people completed the required outcome measures during weeks 12-16 (completers). More women than men took part (61.5%) with the average age of 40.3 years (mean, SD=11.5) and average BMI of 27.9 (mean, SD=6.0). ITT analyses showed significant improvements in ratings of stress (t(204)=3.488; p&lt;0.01, percentage change=-9.52%), and energy levels (t(204)=-2.381; p&lt;0.05, percentage change=4.60%). No significant difference was observed in quality of sleep (t(204)=-1.368; p=0.173). For completers (n=80), significant improvements were observed for stress (t(79)=4.574; p&lt;0.01, percentage change=-23.26%) and energy levels (t(79)=-2.440; p&lt;0.05, percentage change=9.48%) but not for quality of sleep (t(79)=-1.319; p=0.191). Conclusion These results indicate that participation in the Sidekick Health PSP for IBD has significant positive effects on patient-reported stress and energy levels. These findings are promising and provide initial support for using this digital platform for supplementing standard care for IBD patients.

scholarly journals Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

2021 ◽  
Vol 14 ◽  
pp. 175628482110106
Author(s):  
Fabio Salvatore Macaluso ◽  
Marcello Maida ◽  
Mauro Grova ◽  
Federica Crispino ◽  
Giulia Teresi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Randomized Controlled Trials ◽  
Real World ◽  
Bowel Disease ◽  
Quality Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Therapeutic Algorithms ◽  
Inflammatory Bowel

During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

scholarly journals Evaluation of Home Polysomnography Findings, Quality of Sleep, and Fatigue in Inflammatory Bowel Disease: A Case Series

2019 ◽  
Vol 15 (01) ◽  
pp. 39-45 ◽  
Author(s):  
Deise Luna Paixão ◽  
Dalva Poyares ◽  
Marta Sevilha de Paula ◽  
Joselmo Willamys Duarte ◽  
Paula Midori Castelo ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Case Series ◽  
Quality Of Sleep ◽  
Inflammatory Bowel

Quality of Sleep and Coexistent Psychopathology Have Significant Impact on Fatigue Burden in Patients With Inflammatory Bowel Disease

2018 ◽  
Vol 52 (5) ◽  
pp. 423-430 ◽  
Author(s):  
Jana G. Hashash ◽  
Claudia Ramos-Rivers ◽  
Ada Youk ◽  
Wai Kan Chiu ◽  
Kyle Duff ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Quality Of Sleep ◽  
Inflammatory Bowel

scholarly journals TELEmedicine for Patients With Inflammatory Bowel Disease (TELE-IBD) Does Not Improve Depressive Symptoms or General Quality of Life Compared With Standard Care at Tertiary Referral Centers

2020 ◽  
Vol 2 (1) ◽  
Author(s):  
Matthew Schliep ◽  
Kenechukwu Chudy-Onwugaje ◽  
Ameer Abutaleb ◽  
Patricia Langenberg ◽  
Miguel Regueiro ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Inflammatory Bowel Disease ◽  
Depressive Symptoms ◽  
Bowel Disease ◽  
Standard Care ◽  
Text Message ◽  
Tertiary Referral ◽  
Inflammatory Bowel ◽  
The Impact

Abstract Background Depression is common in patients with inflammatory bowel disease (IBD) and contributes to poor quality of life (QoL). The use of information technology for the remote management of patients with IBD is growing, but little is known about its impact on depressive symptoms (DS) and QoL. We aimed to evaluate the impact of telemedicine on DS and generic QoL in IBD patients. Methods We analyzed data from the Telemedicine for Patients with IBD (TELE-IBD) study. During this 12-month clinical trial, patients were randomized to receive text message-based telemedicine weekly (TELE-IBD W), every other week (TELE-IBD EOW), or to standard care. Depressive symptoms and QoL were assessed over time with the Mental Health Inventory 5 (MHI-5) and the Short Form 12 (SF-12), respectively. We compared the change in MHI-5 and SF-12 (with separate physical (PCS) and mental component summary (MCS) scores) between the study arms. Results A total of 217 participants were included in this analysis. After 1 year, there was no significant difference in the change in MHI-5 (TELE-IBD W +3.0 vs TELE-IBD EOW +0.7 vs standard care +3.4; P = 0.70), MCS (TELE-IBD W +1.4 vs TELE-IBD EOW +1.0 vs standard care +2.5; P = 0.89), and PCS scores (TELE-IBD W +0.4 vs TELE-IBD EOW +0.6 vs standard care +3.7; P = 0.06) between the groups. Conclusions Text message-based telemedicine does not improve DS or QoL when compared with standard care in IBD patients treated at tertiary referral centers. Further studies are needed to determine whether telemedicine improves DS or QoL in settings with few resources.

scholarly journals P233 Sleep Disorders and Chronic Inflammatory Bowel Disease: What’s the Connection?

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S281-S281
Author(s):  
A Hassine ◽  
A Hamami ◽  
W Dahmani ◽  
W Ben Ameur ◽  
N Elleuch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Sleep Disorders ◽  
Bowel Disease ◽  
Quality Of Sleep ◽  
Inflammatory Bowel ◽  
The Mean ◽  
Chronic Inflammatory Bowel

Abstract Background The quality of sleep is a major determinant of quality of life, which has become a therapeutic target in the management of Chronic Inflammatory Bowel Diseases (IBD). The relationship between IBD and sleep disorders is still unclear. Although poor quality sleep is believed to be strongly linked to disruptions to clinical disease activity, IBD patients are reported to experience sleep disturbance even when the disease is clinically inactive. The objective of this work was to assess the prevalence and risk factors of sleep disorders as well as their impact on the quality of life of patients with IBD. Methods We conducted a cross-sectional study, including all patients followed for IBD, who presented to our consultation during the three months preceding our study. The quality of sleep was assessed by the Pittsburgh Sleep Quality Index (PSQI). The quality of sleep is impaired when the PSQI score&gt; 5. The activity of Crohn’s disease (CD) was evaluated by the Harvey-Bradshaw index (HBI), that of ulcerative colitis (UC), by the Clinical Mayo score. Quality of life was assessed by the Short Inflammatory Bowel Disease Questionnaire (S-IBDQ). Results We included 100 patients, mean age 42.18 ± 15.71 years with a predominance of men (sex ratio M / F = 1.5). The mean course of IBD was 9.02 ± 6.57 years. Sixty eight patients (68%) had CD, the location was ileal in 32 patients (47%), ileocolonic in 22 patients (32.4%), and colonic in 14 cases (20.6%). Ano-perineal manifestations were present in 38.2% of cases. Severe disease activity was noted in 14 patients (20.6%). Thirty two patients (32%) had UC. Pancolitic involvement was noted in 14 patients (43.7%) UC activity was severe in 10 patients (31.3%). The mean PSQI score was 8.2 ± 4.42. A PSQI score&gt; 5 was noted in 68% of patients. There is a significant association between the PSQI score and disease activity in both patients with CD (p = 0.003) and those with UC (p = 0.026). The quality of sleep was altered in 44.4% of patients in remission vs. 81.25% of patients in relapse, with a statistically significant difference (p &lt;0.001). There was a strong negative correlation between the PSQI score and the S-IBDQ (p &lt;0.001, r = -0.61). Conclusion Our study showed that 68% of patients with IBD suffer from impaired quality of sleep. This disturbance was strongly correlated with the deterioration in the quality of life of these patients, requiring multidisciplinary management.

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