Prospective Regional Epilepsy Database

Recruiting

• Conditions: Epilepsy
• Interventions: Other: Seizure status; Diagnostic Test: Tests; Other: Epilepsy; Other: Demographics and psychosocial; Other: Health care

• Registration Number: NCT04559919
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

PREDICT is an observational study following adults with an unprovoked seizure or epilepsy in the health care region of western Sweden. The objective is to identify biomarkers and/or genetic predisposition of relevance for diagnosis and/or treatment of epilepsy and study the long-term prognosis and consequences of epilepsy.

Detailed Description

Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in the health care region of western Sweden (VGR) at the time of inclusion.

Baseline data and outcome variables are collected from several patient registries: the electronic medical records system in the health care region VGR and Swedish National Registers of healthcare, income, and employment managed by The National Board of Health and Welfare or Statistics Sweden, both of which are government agencies.

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Study Start: 2020-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Over 18 years of age
• An unprovoked seizure within the last year or a diagnosis of epilepsy according to the current International League Against Epilepsy definition (epilepsy with seizure in the last ten or antiepileptic drug treatment in the last five years)

Exclusion Criteria

• Expected survival less than two years
• Inability to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with epilepsy	Seizure status	Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in VGR at the time of inclusion. Languages available: Swedish, English, Arabic. Based on the clinical information, patients can be categorized into relevant groups; single seizure, seizure-free with epilepsy, and drug-resistant epilepsy. Subgroups may also be selected based on age, sex, epilepsy sub-diagnosis, cause of epilepsy, use of a particular antiepileptic drug, or experience of a particular side effect.
Adults with epilepsy	Tests	Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in VGR at the time of inclusion. Languages available: Swedish, English, Arabic. Based on the clinical information, patients can be categorized into relevant groups; single seizure, seizure-free with epilepsy, and drug-resistant epilepsy. Subgroups may also be selected based on age, sex, epilepsy sub-diagnosis, cause of epilepsy, use of a particular antiepileptic drug, or experience of a particular side effect.
Adults with epilepsy	Epilepsy	Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in VGR at the time of inclusion. Languages available: Swedish, English, Arabic. Based on the clinical information, patients can be categorized into relevant groups; single seizure, seizure-free with epilepsy, and drug-resistant epilepsy. Subgroups may also be selected based on age, sex, epilepsy sub-diagnosis, cause of epilepsy, use of a particular antiepileptic drug, or experience of a particular side effect.
Adults with epilepsy	Demographics and psychosocial	Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in VGR at the time of inclusion. Languages available: Swedish, English, Arabic. Based on the clinical information, patients can be categorized into relevant groups; single seizure, seizure-free with epilepsy, and drug-resistant epilepsy. Subgroups may also be selected based on age, sex, epilepsy sub-diagnosis, cause of epilepsy, use of a particular antiepileptic drug, or experience of a particular side effect.
Adults with epilepsy	Health care	Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in VGR at the time of inclusion. Languages available: Swedish, English, Arabic. Based on the clinical information, patients can be categorized into relevant groups; single seizure, seizure-free with epilepsy, and drug-resistant epilepsy. Subgroups may also be selected based on age, sex, epilepsy sub-diagnosis, cause of epilepsy, use of a particular antiepileptic drug, or experience of a particular side effect.

Primary Outcome Measures

Name	Time	Method
epilepsy	baseline and years 1,2,3,4,5,6,7,8,9,10	more than one seizure after first seizure
seizure status	baseline and years 1,2,3,4,5,6,7,8,9,10	the number of seizures in last two months and overall
drug resistant epilepsy	baseline and years 1,2,3,4,5,6,7,8,9,10	epilepsy that has not responded to two antiepileptic drugs
severe side effects of antiepileptic drug	baseline and years 1,2,3,4,5,6,7,8,9,10
psychosocial outcomes	baseline and years 1,2,3,4,5,6,7,8,9,10	employment, marital status, income, sick leave

Secondary Outcome Measures

Name	Time	Method
received health care	baseline and years 1,2,3,4,5,6,7,8,9,10	the number of visits for epilepsy, missed appointments, time intervals between visits

Trial Locations

Locations (3)

Södra Älvsborgs Sjukhus; 🇸🇪 Borås, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Sjukhusen i Väster; 🇸🇪 Gothenburg, Sweden