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. 2024 Aug 27;24(1):994.
doi: 10.1186/s12913-024-11076-y.

Effect evaluation of outpatient long-term video EEGs for people with seizure disorders - study protocol of the ALVEEG project: a randomized controlled trial in Germany

Pauline Sarah Münchenberg #  1 , Ricarda Sophia Schulz #  2 , Kerstin Wainwright  2 , Imke Mayer  2 , Martin Holtkamp  3 , Christian Meisel #  3   4   5   6   7 , Tobias Kurth #  2 ; ALVEEG Consortium
Collaborators, Affiliations

Effect evaluation of outpatient long-term video EEGs for people with seizure disorders - study protocol of the ALVEEG project: a randomized controlled trial in Germany

Pauline Sarah Münchenberg et al. BMC Health Serv Res. .

Abstract

Background: Epilepsy and other seizure disorders account for a high disease burden in Germany. As a timely diagnosis and accurate treatment are crucial, improving the management of these disorders is important. Outside of Germany, outpatient long-term video EEGs (ALVEEGs) have demonstrated the potential to support the diagnosis and management of epilepsy and other seizure disorders. This study aims to evaluate the implementation of ALVEEGs as a new diagnostic pathway in eastern parts of Germany to diagnose epilepsy and other seizure disorders and to assess if ALVEEGs are equally effective as the current inpatient-monitoring gold standard, which is currently only available at a limited number of specialized centers in Germany.

Methods: ALVEEG is a prospective, multicenter, randomized controlled equivalence trial, involving five epilepsy centers in the eastern states of Germany. Patients will be randomized into either intervention (IG) or control group (CG), using a permuted block randomization. The sample size targeted is 688 patients, continuously recruited over the trial. The IG will complete an ALVEEG in a home setting, including getting access to a smartphone app to document seizure activity. The CG will receive care as usual, i.e., inpatient long-term video-EEG monitoring. The primary outcome is the proportion of clinical questions being solved in the IG compared to the CG. Secondary outcomes include hospital stays, time until video EEG, time until diagnosis and result discussion, patients' health status, quality of life and health competence, and number and form of epilepsy-related events and epileptiform activity. Alongside the trial, a process implementation and health economic evaluation will be conducted.

Discussion: The extensive evaluation of this study, including an implementation and health economic evaluation, will provide valuable information for health policy decision-makers to optimize future delivery of neurological care to patients affected by epilepsy and other seizure disorders and on the uptake of ALVEEG into standard care in Germany.

Trial registration: German Clinical Trials Register (DRKS00032220), date registered: December 11, 2023.

Keywords: Epilepsy; Equivalence trial; Healthcare management; Outpatient long-term video EEGs; Randomized controlled trial; Seizure disorders; Statutory health insurance.

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Conflict of interest statement

During the last three years, MH has received personal fees from Angelini, Bial, Desitin, Eisai, Jazz Pharma, and UCB. Outside of the submitted work, TK reports to have received research grants from the Bundesministerium für Gesundheit (BMG – Federal Ministry of Health, Germany). He further has received personal compensation from Eli Lilly, the BMJ, and Frontiers. All the remaining authors report no competing interests.

Figures

Fig. 1
Fig. 1
Participant timeline throughout the course of the study
See this image and copyright information in PMC

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