G40
Conditions
Interventions
Group 1: Control Arm:
Overview:
Duration for subject: 2 weeks
Study treatment: regular outpatient treatment without use of the EDITH-CDSS.
Visit 1 will take place at inclusion, and a telephone visi
Sponsors
University Hospital Tübingen,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with a confirmed or probable diagnosis of epilepsy (ICD-10 G40.-) as determined by the investigator who have not received antiepileptic medication in monotherapy or combination therapy in the past six months, Legal capacity, Presence of a written informed consent from the participant.
Exclusion criteria
Exclusion criteria: 1. persons who are in a dependent / employment relationship with the sponsor or investigator, 2. placement in an institution due to court or administrative order, 3. known psychogenic non-epileptic seizures, 4. current symptoms of G41 (ICD10 GM) status epilepticus, 5. any other acute illness with current persistent symptoms, 6. concurrent participation in other study-related trials (last study participation must be at least 3 months prior to inclusion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is an Absolute Risk Reduction (ARR) in the error rate of diagnosis and therapy by using the CDSS EDITH of 50%. The following values are assumed: Without CDSS, diagnosis and therapy are correct in only 25% of cases overall; with CDSS, they are correct in 75% of cases. A decision for diagnosis is grouped into correct (complete diagnosis including seizure origin [generalized, focal, unclassified] and seizure type [motor, non-motor] correctly classified), partially correct (one indication missing or incorrect in content) or incorrect (both indications missing or incorrect in content). A decision is considered correct for therapy if a 1st/2nd choice medication was used, partially correct (if it is not a 1st/2nd choice agent but a drug approved in the indication). If the decision is not correct, it is a drug that is not approved or contraindicated in the indication. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study objective is to test the usability of the system in clinical practice by using the System Usability Scale, and to investigate user acceptance | — |
Countries
Germany
Contacts
Public ContactJosua Kegele
Universitätsklinikum Tübingen
Outcome results
None listed