A multicenter randomized controlled feasibility trial of a digital self-management intervention for adults with epilepsy
- PMID: 38689518
- PMCID: PMC11145620
- DOI: 10.1002/epi4.12933
A multicenter randomized controlled feasibility trial of a digital self-management intervention for adults with epilepsy
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.
Keywords: Helpilepsy; health literacy; mobile health; patient autonomy; quality of life.
© 2024 The Authors. Epilepsia Open published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.
Conflict of interest statement
R. Michaelis and G. Heinen receive royalties for the workbooks “Selbst‐Handeln bei Anfällen”, published by Pabst and Hippocampus. S. Knake reports speaker's honoraria from Angelini Pharma, Bial, Desitin Arzneimittel, Eisai, Jazz (GW) Pharmaceuticals, Kanso, Merck Serono, Precisis and UCB (Zogenix) Pharma. F. Rosenow has served as a paid consultant od speaker for Angelini Pharma, Desitin Arzneimittel, Eisai, Jazz Pharmaceuticals, Roche Pharma, Takeda, UCB (Zogenix) Pharma and received support from the German Research Foundation (DFG), BMBF – ERAPerMed Programme, European Union (FP7), Hessisches Ministerium für Wissenschaft und Kunst (LOEWE‐Programme), Hessisches Ministerium für Soziales und Integration, and the Detlev‐Wrobel‐Fonds for Epilepsy Research Frankfurt, the Reiss‐Stiftung, the Dr. Senckenbergische‐Stiftung, the Ernst Max von Grunelius‐Stiftung, the Chaja Foundation, Dr. Schär Deutschland GmbH, Vitaflo Deutschland GmbH, Nutricia Milupa GmbH, and Desitin Pharma, Hamburg, outside the submitted work. W. Grönheit reports speaker fees and travel grants from Desitin, Eisai, Bial, UCB. H.M. Hamer has served on the scientific advisory board of Angelini, Corlieve, Eisai, GW/Jazz, Sandoz, UCB Pharma, UNEEG and UCB/Zogenix. He served on the speakers' bureau of or received unrestricted grants from Ad‐Tech, Alnylam, Angelini, Bracco, Desitin, Eisai, GW, Micromed, Nihon Kohden, Novartis, Pfizer, and UCB Pharma. A. Accarie reports working full time for Neuroventis. P. Dedeken is a consultant to Neuroventis and has received consultancy fees from Merck, UCB Pharma, Pfizer, and Novartis. L. Habermehl reports traveling expenses and training costs from Zogenix International Limited, Angelini Pharma and GW Pharma (Germany). J.P. Zöllner has received support from Jazz (GW) Pharmaceuticals. C. Mann reports speakers' honoraria from Eisai and travel support from GW Pharmaceuticals and Zogenix, outside of the submitted work. T. Wehner has received speaker fees and travel costs from Bial, Eisai, GW/Jazz, Precisis, and UCB. J. Wellmer has received speakers' honoraria or support for self‐organized educational courses by Desitin, Eisai, Jazz (GW) Pharmaceuticals, Angelini Pharma, UCB Pharma, Natus, and Nightwatch. J.Cuny reports no conflict of interest to disclose. F. Losch reports no conflict of interest to disclose. K.S.Voss has served as a paid consultant to Neuroventis. A. Strzelczyk reports personal fees and grants from Angelini Pharma, Biocodex, Desitin Arzneimittel, Eisai, Jazz (GW) Pharmaceuticals, Marinus Pharma, Precisis, Takeda, UCB (Zogenix) Pharma, and UNEEG Medical. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.
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References
-
- Wang J, Wang Y, Wang LB, Xu H, Zhang XL. A comparison of quality of life in adolescents with epilepsy or asthma using the short‐form health survey (SF‐36). Epilepsy Res. 2012;101(1–2):157–165. - PubMed
-
- Tellez‐Zenteno JF, Patten SB, Jetté N, Williams J, Wiebe S. Psychiatric comorbidity in epilepsy: a population‐based analysis. Epilepsia. 2007;48(12):2336–2344. - PubMed
-
- Jacoby A, Baker GA. Quality‐of‐life trajectories in epilepsy: a review of the literature. Epilepsy Behav. 2008;12(4):557–571. - PubMed
-
- Velissaris SL, Saling MM, Newton MR, Berkovic SF, Wilson SJ. Psychological trajectories in the year after a newly diagnosed seizure. Epilepsia. 2012;53(10):1774–1781. - PubMed