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

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 to 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 Fifty patients were randomized (23 control, 27 intervention). In per protocol (PP) analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT fatigue (34% absolute improvement for intervention group vs -1% for control group, P<.001), BPI-SF-pain interference (25% vs 0%, P=.016), LupusQoL-planning (17% vs 0%, P=.004), LupusQoL-pain (13% vs 0%, P=.004), LupusQoL-emotional health (21% vs 4%, P=.016), and LupusQoL-fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-pain severity (13% vs -6%, P=0.049), LupusQoL-physical health (17% vs 3%, P=.049), and LupusQoL-burden to others (33% vs 4%, P=.035) 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. CLINICALTRIAL ClinicalTrials.gov (NCT03426384)