Prospective Regional Epilepsy Database

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Regional Epilepsy Database and Biobank for Individualized Clinical Treatment

Conditions
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Epilepsy

Intervention / Treatment
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* Other: Seizure status
* Diagnostic Test: Tests
* Other: Epilepsy
* Other: Demographics and psychosocial
* Other: Health care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults with epilepsy<br>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. | Other: Seizure status<br>* We will collect information on first seizure ever, last seizure ever, number of seizure in last two months.<br>Diagnostic Test: Tests<br>* We will collect results from imaging, electroencephalogram, and laboratory tests.<br>Other: Epilepsy<br>* We will collect information on risk factors of epilepsy, cause of epilepsy, epilepsy type/syndrome, medications tried, if the epilepsy is drug resistent, side effects of antiepileptic drugs.<br>Other: Demographics and psychosocial<br>* We will collect information on age, sex, date of death if applicable, marital status, education level, income type, driving status, employment, benefits, sick leave, number of household members.<br>Other: Health care<br>* We will collect information on received health care; visit dates, caregiver, dispensation dates of antiepileptic drugs<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| received health care | the number of visits for epilepsy, missed appointments, time intervals between visits | baseline and years 1,2,3,4,5,6,7,8,9,10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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access to care, seizure, epilepsy, biomarker, quality of care