Real-world feasibility and clinical engagement of a digital remote monitoring device in routine psychiatric care for mood disorders

Major depressive disorder (MDD) and bipolar disorder (BD) are among the most prevalent and disabling psychiatric conditions worldwide, associated with high symptom burden, frequent relapse, significant functional impairment, and substantial socioeconomic costs. A challenge in the long-term management of these conditions is the limited visibility clinicians have into patients’ symptom trajectories between consultations. This monitoring gap can result in delayed detection of clinical deterioration, suboptimal treatment adjustment, and preventable relapse or hospitalisation.

Digital remote patient monitoring (RPM) offers a promising approach to bridge this gap by enabling continuous, structured surveillance outside clinical settings, directly from patients’ daily environments. RPM tools can facilitate early detection of warning signs, support treatment adherence, and foster data-driven clinical decision-making. However, despite growing interest in digital health solutions for psychiatric care, real-world evidence on patient engagement, and clinician responsiveness in routine psychiatric practice remains scarce. Most existing studies have been conducted within controlled research frameworks, leaving substantial uncertainty about the feasibility and clinical utility of RPM tools in everyday care.

Edra PRO is a CE-marked medical device designed for patients with mood disorders. It collects weekly electronic patient-reported outcomes (ePROs) assessing core symptom domains including depressive and anxiety symptoms, treatment-emergent side effects, and treatment adherence. When responses exceed predefined clinical thresholds, the platform automatically generates alerts, enabling a structured escalation pathway from case manager to treating psychiatrist. Understanding the real-world performance of this tool — in terms of both patient engagement and clinical responsiveness — is essential to inform wider adoption and to support regulatory and reimbursement decision-making.

This study evaluates the real-world feasibility and clinical engagement of Edra PRO in adults with MDD or BD followed in routine psychiatric care across diverse clinical settings in France.

This observational analysis includes all patients with MDD or BD enrolled on the Edra PRO platform outside of clinical research, across hospitals, university medical centres, private practices, and clinics in France. Patients completed ePROs via a mobile application covering mood symptoms, side effects, and treatment adherence. An automated alert system escalated clinically significant responses from case manager to psychiatrist as required. Feasibility outcomes included digital onboarding rates, ePRO completion rates, questionnaire response time, alert generation rates, alert treatment rates, and clinician engagement metrics. Symptom profiles were derived from alert data categorized by domain and severity.

At the time of submission, enrollment is ongoing across participating centres. Final figures — including total patients enrolled, survey completion rates, care team engagement metrics, and symptom domain distributions — will be reported at the time of presentation, reflecting the complete dataset available at poster submission.

Real-world deployment of Edra PRO in routine psychiatric care demonstrates strong patient engagement and clinician adoption across diverse clinical settings. High ePRO completion rates, rapid alert treatment rates, and short response times support the clinical viability of digital remote patient monitoring in MDD and BD beyond research settings. Final outcome data, to be presented at the time of the poster, will further characterise the clinical impact of continuous remote monitoring in everyday psychiatric practice

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