We aimed to study if smartphone applications could support the self-management of RA, while investigating engagement and potential negative psychological effects with app-use. App-based Education and GOal-setting in RA (AEGORA) was a multicentre randomised 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 randomisation. 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 (SD) disease duration 12 (9) years, mean (SD) age 58(11), 68% female, mean (SD) 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 to + 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 catastrophising, alleviating concerns regarding the psychological impact of remote monitoring with apps. clinicaltrials.gov, NCT05888181.
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