Digital tool could help people with hemophilia ‘live their normal life’
Study: Medical device monitors real-world data to support personized care
- Florio HAEMO is a digital tool for people with hemophilia to monitor treatment, symptoms, and physical activity.
- It tracks real-time data like bleeding, pain, and factor levels, enabling personalized care and activity planning.
- Early studies show the device is easy to use, well-accepted, and reduces annualized bleeding rates.
A new digital medical device, called florio HAEMO, may support more personalized care and help people with hemophilia better plan daily activities and live their normal life, a study suggests.
The device helps patients and clinicians monitor real-world, real-time data on treatment and clinical outcomes, including pain, bleeding, well-being, and physical activity levels. Such data “support self-management [and] shared decision-making,” and enable “better care for [people living with hemophilia],” researchers wrote.
The study, “florio HAEMO—A Digital Medical Device for Monitoring of Treatment, Symptoms and Physical Activities for People Living With Haemophilia”, was published in Haemophilia.
Hemophilia treatment goals now include participation in physical activity
Hemophilia is a rare disorder in which the blood doesn’t clot properly because specific clotting factors — factor VIII in hemophilia type A and factor IX in hemophilia type B — are deficient. As a result, people with hemophilia experience unusually easy and prolonged bleeding.
Standard treatment to prevent these bleeds relies on factor replacement therapies that provide a functional form of the missing clotting factor. While these treatments have dramatically reduced bleeding rates, many patients still experience subclinical joint bleeds, pain, and progressive joint damage.
As people with hemophilia increasingly pursue active, normal lives, treatment goals have evolved. Care is now focused not only on preventing bleeds, but also on enabling safe participation in everyday physical activities while preserving joint health. Determining how treatment should be adjusted to match different activity levels, however, remains a challenge.
Although several digital tools and apps have been developed to improve hemophilia care, the researchers noted that most focus on basic event logging, such as recording infusions or bleeds, and do not integrate patient-reported treatment and outcome data with real-time information, “such as factor levels during physical activity and respective outcome.”
“Hence, a need for unbiased, timely and comprehensive real-world information exists to support informed shared decision-making regarding treatment and care,” the researchers wrote, noting that such data are needed to “achieve the best possible care” on an individual level.
Platform consists of app for patients, dashboard for healthcare teams
In this study, a team of international researchers describes florio HAEMO, a digital medical device designed to support patients and care teams in documenting, interpreting, and analyzing patient-reported outcomes to better align treatment with real-world needs.
The platform consists of two components: a smartphone app for people with hemophilia and a secure web-based dashboard for healthcare professionals.
Using the app, patients record information on treatment regimen, infusion frequency, bleeding events, pain levels, well-being, and physical activity. Physical activity data — such as step count and active minutes — can be automatically captured by connected wearable devices and fitness trackers via the phone’s native health application.
Based on an individual’s treatment plan and infusion frequency, florio HAEMO calculates treatment adherence and factor consumption. The platform can also connect with additional devices to estimate personal clotting factor clearance rates. Using planned dosing schedules and personal clearance data, the app then displays the current estimated clotting factor level and predicts future levels until the next scheduled injection.
These estimates are intended to help people with hemophilia better plan daily activities around their preventive regimen.
Healthcare professionals access this information through a web-based dashboard that provides a graphical overview of all recorded data, allowing them to review treatment patterns over time and examine details linked to individual events. These insights can support treatment optimization and individualized care decisions.
Taken together, collection and correlation of parameters, such as pain and bleeds, as well as factor levels and activity levels, with florio HAEMO has the potential to help to further enhance the personalised care and enable [people living with hemophilia] to live their normal life.
Since its launch in March 2020, the platform has been available in 25 countries and 24 languages. A total of 1,558 people with hemophilia are registered across 121 treatment centers in 20 countries. Most users (86%) have hemophilia A, and all are on preventive treatment.
Early studies from Spain and Greece, as well as surveys from six other European countries, suggest that the app is easy to use and well accepted. In one survey, 97% of participants said the app was easy or rather easy to use, and 78.8% reported that it had a positive impact on their lives. Another survey found that Florio HAEMO was preferred over other apps due to its real-time factor level estimates and intuitive design.
Preliminary clinical data are also encouraging. In a small group of Spanish users, the use of florio HAEMO was associated with a significant drop in annualized bleeding rates and a higher proportion of patients reporting zero bleeds, even though treatment adherence remained similar.
“Taken together, collection and correlation of parameters, such as pain and bleeds, as well as factor levels and activity levels, with florio HAEMO has the potential to help to further enhance the personalised care and enable [people living with hemophilia] to live their normal life,” the researchers concluded, while adding that data collected over time may help clarify the factor levels needed for effective bleed and joint protection in real-world settings, from daily life to physical activity.
About the Author
