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Trial registered on ANZCTR


Registration number
ACTRN12609000059268
Ethics application status
Approved
Date submitted
18/11/2008
Date registered
23/01/2009
Date last updated
20/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sydney Epilepsy Incidence Study To Measure Illness Consequences
Scientific title
Sydney Epilepsy Incidence Study To Measure Illness Consequences (SEISMIC) - A cohort study of people newly diagnosed with epilepsy and the associated psychosocial, educational and economic sequelae
Secondary ID [1] 253172 0
None
Universal Trial Number (UTN)
Trial acronym
SEISMIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 3992 0
Condition category
Condition code
Neurological 4191 4191 0 0
Epilepsy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Epilepsy is one of the most common serious brain disorders in Australia. The fundamental characteristic of epilepsy is recurrent unprovoked seizures; a clinical manifestation presumed to
result from an abnormal and excessive discharge of a set of neurons in the brain. In this study people with newly diagnosed epilepsy will be assessed at three time points: 28 days (baseline), 4 and 12 months following first diagnosis for the associated psychosocial, educational and
economic sequelae of epilepsy.
Intervention code [1] 3717 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5085 0
Psychosocial factors: Family functioning assessed by The Family APGAR Score; perceptions and social support (from Quality of Life in Newly Diagnosed Epilepsy Instrument (NEWQoL)); Carer and patient psychological distress assessed by General Health Questionnaire (GHQ-12) and Hospital Anxiety and Depression Scale (HADS); Disability (World health organisation Disability Assessment Schedule (WHODAS-12)' Quality of Life (Visual Analogue Scale); Childhood behaviour (Childhood behabviour Checklist); Coping and Resilience (illness Perception Questionnaire).
Timepoint [1] 5085 0
Baseline; 4 months; 12 months.
Secondary outcome [1] 8541 0
Economic Hardship: will be measured as a dichotomous variable based on a series of questions about failure to make household payments and whether there was help provided by any organistation or individual. A family reporting one or more failures to make payments or the need for help in making payments will be identified as a case of economic hardship. This will be measured at baseline for the 3 months prior to the diagnosis of epilepsy and at each follow-up visit. An advantage of this measure is that it is sensitive to the possibility that individuals do prioritise certain payments (e.g. default on power bills to pay rent). The basis for these questions is the US Census Survey of Income and Program Participation.
Timepoint [1] 8541 0
Baseline; 4 months; 12 months.

Eligibility
Key inclusion criteria
New diagnosis of epilepsy meeting International League Against Epilepsy (ILAE) diagnostic criteria;
Aged over 44 weeks post conception;
Residing within the Sydney South West Area Health Service (SSWAHS) Eastern Zone geographical boudaries for the past month.
Minimum age
4 Weeks
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Seizures due to acute cerebral insult or reversible metabolic courses.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4183 0
Government body
Name [1] 4183 0
Australian Research Council (ARC)
Address [1] 4183 0
GPO Box 2702
Canberra ACT 2601
Country [1] 4183 0
Australia
Funding source category [2] 258142 0
Government body
Name [2] 258142 0
NHMRC
Address [2] 258142 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 258142 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The George Institute for International Health
Address
PO Box M201
Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 3758 0
Other Collaborative groups
Name [1] 3758 0
Epilepsy Action, Australia
Address [1] 3758 0
GPO Box 9878
Sydney NSW 2001
Country [1] 3758 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6238 0
Sydney South West Area Health Service Human Research Ethics Committee (HREC)
Ethics committee address [1] 6238 0
Royal Prince Alfred Hospital (RPAH)
Missenden Rd
Camperdown NSW 2050
Ethics committee country [1] 6238 0
Australia
Date submitted for ethics approval [1] 6238 0
Approval date [1] 6238 0
10/07/2008
Ethics approval number [1] 6238 0
08/RPAH/258

Summary
Brief summary
SEISMIC is a population based incidence study of epilepsy to be conducted in the Sydney South West Area Health Service (Eastern Zone). It is a 3 year cohort study of people newly diagnosed with epilepsy and the associated psychosocial, educational and economic sequelae. Participants are enrolled over 24 months and they, or their carer/proxy/guardian, will be interviewed at three time points: 28 days (Baseline), 4 and 12 months following first diagnosis of epilepsy. The aim is to identify modifiable factor that enhance resilience and reduce vulnerability to the socioeconomic impact of epilepsy in an Australian population.
Trial website
Trial related presentations / publications
1. Hackett ML, Glozier NS, Martiniuk AL, Jan S, Anderson CS. Sydney Epilepsy Incidence Study to Measure Illness Consequences: the SEISMIC observational epilepsy study protocol. BMC Neurology 2011, 11:3
2. Essue BM, Jan S, Hackett ML, Bleasel A, Ireland C, Berkovic S, Anderson CS. Action to improve awareness, participation, care and support for people with epilepsy. A national policy forum to connect researchers, clinicians, advocates, consumers and policy makers around a common goal. Medical Journal of Australia, 2011;194:7-9
Public notes

Contacts
Principal investigator
Name 29141 0
Prof Craig Anderson
Address 29141 0
The George Institute
PO Box M201
Missenden Rd
Camperdown
NSW 2050
Country 29141 0
Australia
Phone 29141 0
+61 2 9993 4500
Fax 29141 0
Email 29141 0
canderson@georgeinstitute.org.au
Contact person for public queries
Name 12298 0
A/Prof Maree Hackett
Address 12298 0
The George Institute
PO Box M201
Missenden Rd
Camperdown
NSW 2050
Country 12298 0
Australia
Phone 12298 0
+61 2 9993 4593
Fax 12298 0
+61 2 9993 4502
Email 12298 0
mhackett@georgeinstitute.org.au
Contact person for scientific queries
Name 3226 0
A/Prof Maree Hackett
Address 3226 0
The George Institute
PO Box M201
Missenden Rd
Camperdown
NSW 2050
Country 3226 0
Australia
Phone 3226 0
+61 2 9993 4541
Fax 3226 0
+ 61 2 9993 4502
Email 3226 0
mhackett@georgeinstitute.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary