A mobile app to support self-management and remotely monitor disease impact in rheumatoid arthritis: the randomized controlled AEGORA trial.

Abstract

The aim of this work was to determine whether smartphone applications could support the self-management of RA and to investigate engagement and potential negative psychological effects with app-use. App-based Education and GOal-setting in RA (AEGORA) was a multicentre randomized controlled trial with 2:1:1 allocation to usual care or two versions of an app-based self-management intervention for RA. The 16-week programme involved patient education, goal-setting and remote monitoring of the Rheumatoid Arthritis Impact of Disease (RAID) instrument, either weekly or monthly depending on randomization. The primary end point was improvement in the Arthritis Self-Efficacy Scale (ASES) after 16 weeks. Secondary endpoints included non-inferiority regarding the Pain Catastrophizing Scale (PCS) and superiority regarding patient-reported physical activity, sleep quality and RAID. App engagement and RAID scores were analysed descriptively. Overall, 122 patients were included: mean (s.d.) disease duration 12 (9) years, age 58 (11), 68% female, DAS28-CRP 2.4 (0.9). The intervention did not improve the ASES score over usual care (β 0.44, P = 0.87). Non-inferiority was established for the PCS (β -0.95 [95% CI -3.30, +1.40] favouring the intervention). Other predefined outcomes did not differ. App retention steadily declined to 43% by 16 weeks. Although the RAID remained stable over time overall, 35% of app users reported ≥1 episode of clinically relevant worsening over 16 weeks. This app-based self-management intervention was not superior to usual care regarding self-efficacy improvement. However, remote symptom monitoring provided valuable insight and did not increase pain catastrophizing, alleviating concerns regarding the psychological impact of remote monitoring with apps. clinicaltrials.gov, NCT05888181.