RESUMEN
OBJECTIVES: To evaluate the effectiveness of a novel digital patient education (PE) programme in improving self-management in patients newly diagnosed with rheumatoid arthritis (RA). METHODS: This was a parallel, open-label, two-armed, randomized controlled trial with superiority design. Patients from five rheumatology clinics were randomized into digital PE (intervention) or face-to-face PE (control). The primary outcome was self-efficacy, measured by average difference in the Rheumatoid Arthritis Self-Efficacy (RASE) score from baseline to month 12. Secondary outcomes were RA knowledge, health literacy, adherence and quality of life. Healthcare utilization data and digital PE programme usage were recorded. Self-efficacy, knowledge and health literacy data were analysed using mixed-effects repeated measures modelling; adherence using logistic regression, and quality of life and healthcare utilization using descriptive statistics with the Wilcoxon rank-sum test. RESULTS: Of the 180 patients randomized (digital PE, n = 89; face-to-face PE, n = 91), 175 had data available for analysis. Median age was 59.0 years and 61% were women. The average difference in self-efficacy between groups from baseline to month 12 was significant by a -4.34 difference in RASE score, favouring the intervention group (95% CI: -8.17 to -0.51; P = 0.026). RA knowledge, health literacy and quality of life showed minor improvements over time but no difference between groups, except out-patient clinic contacts, which were fewer in the intervention group. CONCLUSION: The findings suggest that digital PE is effective in improving self-efficacy and therefore self-management in patients with early RA. This intervention has potential to lower healthcare costs by decreasing out-patient clinic contacts. TRIAL REGISTRATION NUMBER: clinicaltrials.gov, NCT04669340.