Evaluation of a digital treatment platform (CDSS) for outpatient and trans-sectoral care for epilepsy patients: EDITH (Epilepsie richtig Diagnostizieren und Therapieren)

Not Applicable

Recruiting

Conditions: G40
Epilepsy

Registration Number: DRKS00031299

Lead Sponsor: niversity Hospital Tübingen,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

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

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).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is an Absolute Risk Reduction (ARR) in the error rate of diagnosis and therapy by using the CDSS EDITH of 50%. <br><br>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.<br><br><br>

Secondary Outcome Measures

Name	Time	Method
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