Health-Related Quality of Life Improvements in Systemic Lupus Erythematosus Derived from a Digital Therapeutic Plus Tele-Health Coaching Intervention: Randomized Controlled Pilot Trial

Abstract

Background Systemic lupus erythematosus (SLE), a systemic autoimmune disease with no known cure, remains poorly understood and patients suffer from many gaps in care. Recent work has suggested that dietary and other lifestyle factors play an important role in triggering and propagating SLE in some susceptible individuals. However, the magnitude of influence of these triggers, how to identify pertinent triggers in individual patients, and whether removing these triggers confers clinical benefit is unknown. Objective To demonstrate that a digital therapeutic intervention, utilizing a mobile app that allows self-tracking of dietary, environmental, and lifestyle triggers, paired with telehealth coaching, added to usual care, improves quality of life in patients with SLE compared with usual care alone. Methods In this randomized controlled pilot study, adults with SLE were assigned to a 16-week digital therapeutic intervention plus usual care or usual care alone. Primary outcome measures were changes from baseline to 16 weeks on 3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL). Results A total of 50 patients were randomized (23 control, 27 intervention). In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs –1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs –6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level. Conclusions A digital therapeutic intervention that pairs self-tracking with telehealth coaching to identify and remove dietary, environmental, and lifestyle symptom triggers resulted in statistically significant, clinically meaningful improvements in HRQoL when added to usual care in patients with SLE. Trial Registration ClinicalTrials.gov NCT03426384; https://clinicaltrials.gov/ct2/show/NCT03426384

Review and Analysis of German Mobile Apps for Inflammatory Bowel Disease Management Using the Mobile Application Rating Scale: Systematic Search in App Stores and Content Analysis

“…An increasing body of evidence supports the use of mobile apps in IBD, as in other chronic diseases [ 15 , 16 ], to increase quality of life and medication adherence, to improve patient outcomes, and to decrease health care costs in chronic diseases such as type 2 diabetes [ 17 ], chronic obstructive pulmonary disease [ 18 , 19 ], and chronic heart failure [ 20 , 21 ]. In IBD, mobile health (mHealth) interventions to monitor patients have been shown to reduce health care visits by 33% and reduce hospital admissions without increasing disease activity or decreasing patient satisfaction [ 22 ].…”

Effectiveness of remote care interventions: a systematic review informing the 2022 EULAR Points to Consider for remote care in rheumatic and musculoskeletal diseases

“…Five studies revealed better outcomes with remote monitoring, especially an improved quality of life,11 13 fatigue and pain,13 higher numbers of patients reaching remission,16 lower number of patient visits14 and reduced travel distance 21 22. Five studies found no differences between the investigated remote intervention and the comparator group11 12 14 15 17 18 (Berdal et al only for patient beliefs).…”

“…In the 12 studies on efficacy, outcomes investigated were highly heterogeneous. Eleven different patient-reported outcome measures (PROMs) were reported, assessing generic quality of life,11–15 disease severity14 16 and activity,17 function,12 14 fatigue,13 pain13 and patient beliefs 11. Disease activity was captured by composite scores in five studies 12 14–17.…”

Patient-Reported Outcomes for Quality of Life in SLE: Essential in Clinical Trials and Ready for Routine Care

“…Moreover, a Phase 4 multi-centre RCT examining the efficacy and safety of Acthar Gel in persistently active SLE patients demonstrated significant and clinically meaningful improvements in LupusQoL scores for the pain, planning, and fatigue domains in those who had higher disease activity levels [36]. Lastly, the remaining two clinical trials found that upper limb exercises [37] and a digital therapeutic plus telehealth coaching intervention [38] led to significant and clinically meaningful improvements in HRQoL as measured by LupusQoL scores. LupusQoL was not designed for use in the clinical setting and has not been studied as a PRO for use in routine care.…”