Authors :
Presenting Author: Vasilios Kimiskidis, MD, PhD – First Department of Neurology, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece
Magdalena Bosak, MD, PhD – Neurology Clinical Department, University Hospital Krakow, Krakow, Poland
Milan Brazdil, PhD – Department of Neurology, St Anne's University Hospital, Brno, Czechia
Andras Fogarasi, MD, PhD – Epilepsy Center, Bethesda Children's Hospital, Budapest, Hungary
Stylianos Gatzonis, MD – First Department of Neurosurgery, National and Kapodistrian University of Athens, Athens, Greece
Sofia Markoula, MBChB, PhD – Department of Neurology, University of Ioannina, Greece
Dionysios Pandis, MD – First Department of Neurology, Eginitio Hospital, National and Kapodistrian University of Athens, Athens, Greece
Jana Zarubova, MD – Department of Neurology, 2nd Faculty of Medicine, Charles University and University Hospital Motol - Motol Epilepsy Center, Prague, Czechia
Alison Accarie, PhD – Neuroventis, Overijse, Belgium
Ludovic Ampe, MSc – Neuroventis, Overijse, Belgium
Susanne Mueller-Scholtz, PhD – UCB, Monheim am Rhein, Germany
Dita Fiserova, MVDr – UCB, Prague, Czech Republic
Iryna Leunikava, MSc – UCB, Monheim am Rhein, Germany
Susanne Knake, MD – Rhoen Hospital, Giessen and Marburg University Hospital, Marburg, Germany
Rationale:
Digital health solutions are becoming integral to clinical practice, creating new information sharing capabilities for patients and physicians. These tools facilitate data collection and consultations, enabling novel patient-physician interactions. The BRIVA-Reg study, an observational study conducted across 6 Central and Eastern European countries, and the BRITOBA study, an observational study conducted across 4 European countries and Canada, integrated the use of Helpilepsy (www.helpilepsy.com), a certified medical device consisting of a mobile health assistant for patients and a web-based dashboard for physicians. During those studies, participants and physicians used the Helpilepsy platform to share epilepsy-related data and complete patient-reported outcomes (PROs). The current analysis is aimed to summarize participants' experience using the app, compliance, and demographics across both studies.Methods:
In both studies, participants or their legal representant (caregivers of minors [4–17 years old] in BRIVA-Reg) could answer PROs via the Helpilepsy app. This analysis assessed the proportion of Helpilepsy users, their characteristics, and PRO response rates by country, age and gender. Feedback from physicians was also gathered through post-study sessions organised by UCB and Neuroventis during the 2024 European Epilepsy Congress. Results:
In BRITOBA and BRIVA-Reg studies, 137/403 participants enrolled (34%) and 280/801 participants enrolled (35%) respectively agreed to use the Helpilepsy app. In both studies, the proportion of participants using the Helpilepsy app varied across countries: Bulgaria (32%), Canada (25%), Czech Republic (50%), France (62%), Germany (19%), Greece (44%), Hungary (25%), Italy (44%), Poland (28%), Romania (24%) and Spain (4%). The PRO response rates varied between countries as well, with an average of 53% in BRITOBA and 40% in BRIVA-Reg (Table 1). Demographics of Helpilepsy app users are detailed in Table 1.
Post study interviews conducted by Neuroventis and UCB highlighted that physicians found the app valuable, noting it enhanced doctor-patient interactions when patients actively input data. They emphasized the increasing role of digital tools in managing epilepsy and suggested future improvements. Personalization, simplicity, AI integration, and additional features like period tracking for women were recommended for further development. Connected devices like NightWatch and hospital system integration were deemed beneficial, though the latter may face institutional challenges.
Conclusions:
These two real-world studies provided valuable data on the usage of the Helpilepsy app. These data allow us to identify the patient groups most likely to engage with the app in its current form for this type of studies. These insights are contributing to the development of a new generation of electronic clinical outcome assessments (eCOA) platforms for the epilepsy population, aimed at enhancing protocol compliance and providing benefits to both patients and investigators.Funding: Both studies were funded by UCB