SAFE: intervention development and pilot RCT.
Research type
Research Study
Full title
‘Seizure first Aid training For Epilepsy’ (SAFE) for people with epilepsy who attend emergency departments, and their family and friends: intervention development and pilot.
IRAS ID
166241
Contact name
Adam J Noble
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
3 years, 1 months, 29 days
Research summary
- Even with treatment, 1/3 individuals with epilepsy continue to have seizures. Seizures can be frightening. Most though, stop by themselves and the person recovers without medical attention.
-The NHS does not offer a epilepsy course that individuals with epilepsy and their informal carers can go on. Consequently, some do not know seizure first-aid, are unsure about seizure effects and are fearful. This leads many to visit A&E when they have a seizure.
- These visits are inconvenient for patients and costly to the NHS.
-We shall develop a short group course called ‘Seizure first Aid training For Epilepsy’ (SAFE).
-SAFE will be based on a ½-day course offered by the Epilepsy Society.
-Their course needs to be adapted so it is relevant to patients attending A&E. To do this, 20 patients from A&E and carers will go on the existing course and asked what changes are needed. To ensure its medical content is correct, we will seek advice from health professionals.
-Once developed, we will complete a pilot trial of SAFE. 80 patients diagnosed with epilepsy will be recruited from 3 Merseyside A&Es.
-Patients and carers will complete a questionnaire about their confidence managing seizures and use of A&E. Patients will then be randomly assigned to one of two groups. Both will continue to take their medications and see their doctors as normal. One group will attend a SAFE course with their carer (the ‘intervention group’). The other (the ‘control group’) will not. We will ask patients and carers to fill in the questionnaire again 6 and 12 months later.
-The pilot trial is a practice-run. It tells us how best to do a bigger trial in the future to test how effective SAFE is.
-At the end of the trial the control group will get to go to SAFE.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0225
Date of REC Opinion
13 Apr 2015
REC opinion
Further Information Favourable Opinion