PREDICT: Prospective Regional Epilepsy Database
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Adults with 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. 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
We will collect information on first seizure ever, last seizure ever, number of seizure in last two months.
Diagnostic Test: Tests
We will collect results from imaging, electroencephalogram, and laboratory tests.
Other: Epilepsy
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.
Other: Demographics and psychosocial
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.
Other: Health care
We will collect information on received health care; visit dates, caregiver, dispensation dates of antiepileptic drugs
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Södra Älvsborgs Sjukhus | Borås | Sweden | ||
| 2 | Sahlgrenska University Hospital | Gothenburg | Sweden | 41345 |
Sponsors and Collaborators
- Sahlgrenska University Hospital, Sweden
Investigators
- Principal Investigator: Johan Zelano, MD PhD, Sahlgrenska University Hospital, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-00853