Abstract
BACKGROUND: Hematological malignancies 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 a medical device (SaMD) offer potential solutions by facilitating telemedicine visits and supporting patients in managing their treatment. OBJECTIVE: The aim of this study was to evaluate the performance and safety of RITA SaMD in improving patient adherence to treatment protocols for hematological malignancies. METHODS: This prospective clinical investigation enrolled patients with hematological malignancies at Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo in Milan, Italy. The RITA SaMD group used the RITA platform, while the control group comprised historical patients. The primary end point was average therapeutic adherence to the prescribed drug treatment, measured as at least the 80% of the relative dose intensity, at month 3. Secondary end points were based on comparisons between the RITA SaMD group and the control group and included the average therapeutic adherence to the prescribed drug treatment at months 1 and 2, number of emergency room visits for minor and severe complications, and the average hospital stay. 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). At multivariable analysis, the probability of being adherent to treatment at month 3 in the RITA SaMD group was significantly higher than that in the control group (odds ratio 3.0, 95% CI 1.0-8.8; P=.04). A total of 1476 self-reported adverse events (AEs) were collected through RITA SaMD usage, the majority (N=1080) being grade 1 events. During the study visits, 20 AEs were 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 serious AEs (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 RITA SaMD, patients with hematological malignancies had 3 times higher odds ratio of being adherent to the prescribed treatment than the control group. The use of RITA SaMD facilitated the reporting of AEs, 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. TRIAL REGISTRATION: ClinicalTrials.gov CTI05260203; https://clinicaltrials.gov/study/NCT05260203.