Rosa Michaelis (Bochum / DE), Susanne Knake (Marburg / DE), Felix Rosenow (Frankfurt a. M. / DE), Wenke Grönheit (Bochum / DE), Hajo M. Hamer (Erlangen / DE), Bettina Schmitz (Berlin / DE), Ilka Immisch (Marburg / DE), Lena Habermehl (Marburg / DE), Johann Philipp Zöllner (Frankfurt a. M. / DE), Catrin Mann (Frankfurt a. M. / DE), Tim Wehner (Bochum / DE), Jörg Wellmer (Bochum / DE), Jeanne Cuny (Erlangen / DE), Stephanie Gollwitzer (Erlangen / DE), Florian-Phillip Losch (Berlin / DE), Kirsten Krämer (Berlin / DE), Kevin Steffen Voss (Spaichingen / DE), Gerd Heinen (Berlin / DE), Adam Strzelczyk (Frankfurt a. M. / DE)
Abstract-Text (inklusive Referenzen und Bildunterschriften)
Introduction
Health-related quality of life (HRQoL) is more severely impaired in epilepsy than in other chronic conditions. Self-efficacy has shown to increase resilience in epilepsy and self-management interventions have shown promising results. However, their implementation is often impaired in the real-world due to several barriers. Digital interventions may help to overcome some of these barriers and improve patient autonomy, HRQoL and other health-related outcomes. In light of this, we developed the Helpilepsy Self-Action Program, a stand-alone smartphone-delivered self-care treatment program for adults with epilepsy. This program is delivered through the Neuroventis Platform, a certified medical device (under EU/MDD Class I, and EU/MDR grace period), consisting of mobile applications for people with neurological conditions and a web application for healthcare professionals.
Objectives
To assess the effect sizes of this Helpilepsy Program in improving epilepsy-related outcomes including patient autonomy, HRQoL, and psychiatric symptoms.
Methods
The 12-week intervention is evaluated through a randomized controlled trial with waiting-list control group, and outcome measurement at baseline and at 12 weeks. The primary endpoint is patient autonomy (EASE, recently developed in Germany), and secondary endpoints include HRQoL (QOLIE-31-P), Health Literacy Questionnaire, anxiety and depression symptions (HADS), Epilepsy Knowledge Scale, Seizure Frequency and Seizure Severity. We aimed at recruiting 100 patients, main inclusion criteria comprise active epilepsy and the ability to use a smartphone.
Results
The recruitment is finalized. Ninety-five (95) patients have been included (48 in intervention group, 47 in waiting-list control). Characteristics of 76 patients have been evaluated: 36 in the intervention group and 40 in control (38% male, median age 30 years old (range: 18-70 years)). The majority of these patients (64%) have pharmacoresistant epilepsy, with a median duration of epilepsy diagnosis of 12 years (16% were diagnosed in 2022). Seventy-five percent (75%) have at least 1 seizure per month (33% at least one bilateral tonic-clonic seizure, 47% at least 1 focal seizure per month). Fifty percent (50%) of patients have at least 1 comorbidity. As the post-intervention outcome assessment is likely to be completed by March next year, we will share the status of the interim analysis at the time of the congress in March 2022.
Conclusion
So far, this ongoing study shows promising insights into the feasibility of implementing a digital self-management intervention.