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
ABSTRACT
Epilepsy and other seizure disorders have a significant impact in Germany. Timely diagnosis and accurate treatment are crucial, and the management of these disorders needs improvement. Outpatient long-term video EEGs (ALVEEGs) have shown potential to aid in 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 Germany and to assess their effectiveness compared to the current inpatient-monitoring gold standard.
METHODS
The ALVEEG study is a prospective, multicenter, randomized controlled trial involving five epilepsy centers in eastern Germany. It will include 688 patients, continuously recruited over the trial. Patients will be randomized into either the intervention group (IG) or the control group (CG). 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, patients’ health status, quality of life, and number and form of epilepsy-related events and epileptiform activity. A process implementation and health economic evaluation will also be conducted alongside the trial.
DISCUSSION
This study’s comprehensive evaluation, including an implementation and health economic assessment, will provide valuable information for health policy decision-makers to optimize neurological care delivery for patients with epilepsy and other seizure disorders in Germany.
TRIAL REGISTRATION
German Clinical Trials Register (DRKS00032220), date registered: December 11, 2023.
