Use of a Digital Medical Device to Improve Therapeutic Adherence in Patients with Hematological Malignancies: the MargheRITA Study (Preprint)

BACKGROUND Oncological conditions are a global health challenge, with a substantial number of deaths each year. Treatment adherence is crucial for improving patient outcomes in patients with hematological malignancies, but resource limitations and logistical challenges hinder optimal outpatient management. Digital health solutions, such as the Remote Intelligence for Therapeutic Adherence (RITA) software as medical device (SaMD), offer potential solutions by facilitating telemedicine visits and supporting patients in managing their treatment. OBJECTIVE To evaluate the performance and safety of RITA SaMD in improving patient adherence to treatment protocols for hematological malignancies. METHODS This prospective clinical investigation involved patients with hematological malignancies at ASST Santi Paolo e Carlo in Milan, Italy. The RITA SaMD Group used the RITA platform, while the Control Group comprised historical patients. The primary endpoint was therapeutic adherence to the prescribed drug treatment, defined as at least 80% of the prescribed dose intensity, at Month 3. Secondary endpoints included therapeutic adherence to the prescribed drug treatment at Month 1 and 2, emergency room (ER) visits, adverse events (AEs), and patient-reported outcomes (PROs). Multivariable logistic regression models were used to evaluate the effectiveness of RITA. RESULTS Between July and December 2022, 119 patients were included in the analysis (57 in the RITA SaMD Group and 62 in the Control Group). The probability of being adherent to treatment tended to be higher at all time points in the RITA SaMD Group compared with the Control Group (82.1% vs 80.7% at Month 1, 81.1% vs 76.3% at Month 2, and 85.2% vs 77.1% at Month 3). Multivariable analysis confirmed significantly improved adherence in the RITA SaMD Group at Month 3 [odds ratio (OR): 3.0, 95% confidence interval (CI): 1.0–8.8, P=0.042]. A total of 1476 self-reported AEs were collected through RITA SaMD usage, the majority (N=1080) being Grade 1 events. During the study visits, a total of 20 AEs was recorded by the study physician, 16 in the RITA SaMD Group and 4 in the Control Group. Of the recorded AEs during study visits, 14 were SAEs (11 in the RITA SaMD Group and 3 in the Control Group). None of the reported AEs was considered related to RITA SaMD usage. CONCLUSIONS The MargheRITA clinical investigation showed that after 3 months of using the RITA SaMD, patients with hematological malignancies had 3 times higher OR of being adherent to the prescribed treatment than the Control Group. The use of RITA SaMD facilitated the reporting of AEs and PROs, reinforcing the role of mobile health apps and software in optimizing patient outcomes. Further research is needed to fully understand its interdisciplinary potential and long-term impact on patient outcomes. CLINICALTRIAL ClinicalTrials.gov Identifier NCT05260203