Esplorhem: Evaluation of Spanish Experience of Using Florio® Haemo Digital Medical Device for Treatment Monitoring in Hemophilia Patients. a Preliminary Report

Background: Current treatment for hemophilia is mainly based on the infusion of factor concentrates and is carried out at home by patients or caregivers. This practice involves extensive recording of infusions, frequency of bleeding and other adverse events. However, compliance with these records, which are usually kept on paper, is poor in most cases, making it very difficult to monitor and optimize patients’ treatment. The implementation of the digital medical device florio® HAEMO in the clinical routine of hemophilia patients could lead to an improvement in patient follow-up, allowing home treatment in a more controlled and independent manner from the physician. florio HAEMO is a mobile phone application (app), where patients can record bleeding and infusion details and share them with their doctor in real time. The current COVID-19 health crisis has further highlighted the advantages of using these digital tools, reducing the need for patients to go to their referral centers, thus limiting visits to those that are strictly necessary.

Aims: To evaluate the impact of florio HAEMO on adherence to treatment and Annualised Bleeding Rate (ABR) of patients.

Patients and Methods: Preliminary analysis from eSPLORHEM study "Evaluation of Spanish experience of using florio HaEMo digital medical device in monitoring the treatment of hemophilia patients". To date, a total of 23 patients from three Spanish centers have been recruited bispectively with a minimum follow-up period of 6 months in florio HAEMO. Adherence to treatment was calculated based on the prescribed treatment and concentrates collected at the pharmacy by the patient. ABR was calculated by the number of bleedings for one year. Student's t-test or Mann-Whitney U-test were used for comparison of medians using SPSS software.

Results: Twenty-one were patients with hemophilia A and 2 with hemophilia B. All of them with severe hemophilia, except for one case of moderate hemophilia A. All patients were on prophylactic treatment with extended half-life clotting factor concentrates, except for three, who were on standard half-life clotting factors. The median age of the patients at the time of initiation of florio HAEMO was 20 years (range, 5-56 years). Nine of them were younger than 12 years old and recordings were performed by a caregiver. Median follow-up was 13 months (range, 6-24 months). Three patients discontinued use of the application due to their inclusion in a phase 2 clinical trial. Although there was no change in patients’ adherence to treatment before and after the use of florio HAEMO [median 94% (38-100) vs 93% (21-100), P=0.918; respectively], a decrease in ABR was observed after the use of the application [median 1 (0-8) vs. 0 (0-5.3), P=0.009]. The percentage of patients with a zero-bleed rate increased from 26.1% (N=6) to 56.5% (N=13) (P=0.036). The number of records was consistent between the first and last month of florio HAEMO use [median 11.5 (3-26) vs. 10 (2-20), P=0.104]. During the follow-up period, 60.9% of patients recorded at least some pain. In addition, 56.5% of patients recorded their physical activity in the app through daily step counts or by reporting more specific activities such as swimming or cycling.

Conclusion: The results of the preliminary analysis show that the use of florio HAEMO achieves a significant reduction in the annualized rate of bleeds, as well as an increase in the percentage of patients with zero bleeds. These data suggest that florio HAEMO is a very useful tool that allows patients and clinicians to better manage their disease.

No relevant conflicts of interest to declare.