Mobile App for Multidimensional Monitoring of Immune-Mediated Inflammatory Diseases: A Multicenter Prospective Study (Preprint)

BACKGROUND Immune-mediated inflammatory diseases (IMIDs) require long-term treatment with biologic therapies or targeted small molecules. Although these therapies have improved outcomes, routine care still faces important challenges, including medication adherence, early recognition and management of adverse events (AEs), and systematic collection of patient-reported outcome measures (PROMs). Mobile health (mHealth) tools may facilitate multidimensional follow-up between scheduled visits. OBJECTIVE To assess the feasibility and real-world use of the eMidCare mobile app among IMID outpatients initiating a new biologic or targeted small-molecule therapy, focusing on medication adherence monitoring, AE reporting, health-related quality of life and mental health PROMs, patient-health care professional communication, app usability, and patient satisfaction. METHODS We conducted a prospective, multicenter observational study across 10 Spanish hospitals. Adult IMID outpatients who initiated a new biologic or targeted small-molecule therapy between May and October 2025 installed eMidCare during pharmacist-led onboarding. Outcomes were derived from routinely captured in-app data: medication recording and Morisky-Green questionnaire (adherence), AE self-reporting (safety), EQ-5D-5L and Hospital Anxiety and Depression (HAD) scale (PROMs), and in-app messaging (communication). Usability was assessed using Google Analytics for Firebase and backend logs. Group comparisons across specialties used appropriate nonparametric and categorical tests, with significance set at P65% at later follow-up points, and backend logs showed no recorded errors with all Application Programming Interface (API) calls (N=67,237) successfully completed. Median overall satisfaction was 9 (9, 10). CONCLUSIONS In real-world, multicenter practice, eMidCare was feasible and well accepted for longitudinal follow-up of IMID outpatients initiating a new biologic or targeted small-molecule therapy. The app supported adherence monitoring and AE reporting, enabled PROM collection, and facilitated patient-initiated messaging (including out-of-hours contact) with high user satisfaction.