A multicenter randomized controlled feasibility trial of a digital self-management intervention for adults with epilepsy

Michaelis R, Knake S, Rosenow F, Grönheit W, Hamer H, Schmitz B, Accarie A, Dedeken P, Immisch I, Habermehl L, Zöllner JP, Mann C, Wehner T, Wellmer J, Cuny J, Gollwitzer S, Losch F, Krämer K, Voss KS, Heinen G, Strzelczyk A (2024)

Publication Type: Journal article

Publication year: 2024

Journal

Epilepsia Open Wiley

Book Volume: 9

Pages Range: 1021-1033

Journal Issue: 3

DOI: 10.1002/epi4.12933

Abstract

Objective: Self-management interventions may enhance health-related quality of life (HRQoL) in epilepsy. However, several barriers often impair their implementation in the real world. Digital interventions may help to overcome some of these barriers. Considering this, the Helpilepsy Plus Prototype was developed as a prototype smartphone-delivered self-care treatment program for adults with epilepsy. Methods: The 12-week Helpilepsy Plus Prototype was evaluated through a randomized controlled feasibility trial with a waiting-list control (WLC) group. Outcome measurement at baseline and at 12 weeks assessed adherence to the prototype intervention and changes in epilepsy-related outcomes. The primary endpoint was patient autonomy measured with EASE, and secondary endpoints included HRQoL measured with QOLIE-31, health literacy measured with HLQ, anxiety, and depression symptoms measured with HADS. Semi-structured interviews were conducted with a heterogeneous sample of participants to assess user-friendliness and usefulness. The prototype program was delivered through the Neuroventis Platform (Neuroventis, BV, Overijse, Belgium), a certified medical device (under EU/MDD Class I, and EU/MDR grace period). Results: Ninety-two patients were included (46 in the intervention group, 46 in WLC). Most participants (63%, 58/92 women, median age 30 years) had pharmacoresistant epilepsy (61%, 56/92). Only 22% of participants (10/46) in the intervention group completed at least half of all intervention sessions. No significant differences between the intervention group and WLC were observed. Although there was a larger proportion of patients in the intervention group with meaningful improvements in HRQoL compared to WLC (19/46 versus 11/46), the difference was not significant (p = 0.119). Qualitative feedback showed that participants would appreciate more personalization, such as adaptation of the content to their current epilepsy knowledge level, a more interactive interface, shorter text sections, and interaction through reminders and notifications. Significance: Digital interventions should allow sufficient scope for personalization and interaction to increase patient engagement and enable benefits from self-care apps. Feedback loops allow the participatory development of tailored interventions. Plain Language Summary: In this study, we investigated the effectiveness of an app-based self-help intervention. Study participants were either randomly assigned to a group that had access to the app or a group that received access to the app after the end of the study. Although a larger proportion of participants in the intervention group showed a relevant improvement in quality of life, the difference between the two groups was not statistically significant. Less than one-fifth of participants in the intervention group attended at least half of all intervention sessions; patient feedback showed that patients required more personalization and interactive options.

Authors with CRIS profile

Hajo Hamer Professur für Epileptologie Stephanie Gollwitzer Medizinische Fakultät

Involved external institutions

Universitätsklinikum Gießen und Marburg (UKGM) DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) Vivantes - Netzwerk für Gesundheit GmbH DE Germany (DE) Neuroventis BE Belgium (BE) Universitätsklinikum Knappschaftskrankenhaus Bochum DE Germany (DE) VOSS CONSULTING GmbH DE Germany (DE)

How to cite

APA:

Michaelis, R., Knake, S., Rosenow, F., Grönheit, W., Hamer, H., Schmitz, B.,... Strzelczyk, A. (2024). A multicenter randomized controlled feasibility trial of a digital self-management intervention for adults with epilepsy. Epilepsia Open, 9(3), 1021-1033. https://doi.org/10.1002/epi4.12933

MLA:

Michaelis, Rosa, et al. "A multicenter randomized controlled feasibility trial of a digital self-management intervention for adults with epilepsy." Epilepsia Open 9.3 (2024): 1021-1033.

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