About the SMILE Study
The SMILE trial is an NIHR funded randomized control trial in collaboration with Kings College Health Care Partners, London. It aims to assess the effectiveness of a course called “Self-Management education for adults with Epilepsy (SMILE-UK)” in helping those with poorly controlled epilepsy to deal with their seizures.
The course is delivered in the form of a two day workshop and consists of 9 topics. The workshops help people achieve a better understanding of the causes of epilepsy and its treatments, and identify factors that can help or hinder their own self-management. People become more able to recognise patterns in the occurrence of their seizures and better able to deal with some of the stressful aspects of having epilepsy. People also have the opportunity to hear about and learn from the experiences of other attendees with epilepsy, and are given a course book containing the information from the workshop. The project is in collaboration with Epilepsy Action, the leading epilepsy charity in the UK. Their involvement helps ensure the project engages people with epilepsy in a significant way.
Epilepsy is a long-term neurological condition with a prevalence of up to 1% in the UK. Following diagnosis, approximately 40% of patients continue to have two or more seizures per year. This puts them at greater risk of injury, psychological distress and perceived stigmatization. Poor epilepsy control is associated with unnecessary hospital admissions and epilepsy ranks highest of all chronic neurological conditions for repeat emergency department visits within a year. Six out of seven admissions for epilepsy are on an emergency basis. Though emergency care for epilepsy can be important, most emergency department visits by people with epilepsy are unnecessary. With the right training, most seizures can be safely managed by patients and their families within the community.
When an individual is diagnosed with diabetes, they are offered group education (e.g. Diabetes Education and Self-Management for Ongoing and Newly Diagnosed, DESMOND). It is now thought that similar group education for those with epilepsy could help in improving the quality of life of those with poorly controlled epilepsy reducing unnecessary emergency admissions as well as seizure frequency. This trial aims to investigate whether the SMILE course will have the same effectiveness and positive impact on patients with epilepsy.
Development of the SMILE course
The SMILE course is adapted from an intervention developed in Germany called Modular Service Package in Epilepsy (MOSES), which has been delivered to small groups in some European countries for thirteen years. It was found that this course reported improved knowledge about the condition, enhanced control of seizures, and better acceptance of anti-epileptic medications. Based on this finding, the intervention was adapted for use in the UK, with collaboration from Epilepsy Action, and is referred to here as the SMILE-UK (Self-Management education for adults with poorly controlled epILEpsy) trial.
The purpose of the project is to evaluate the effectiveness of self-management education to improve the quality of life in adults with poorly controlled epilepsy. Its primary objective is to establish if taking part in the SMILE course leads to improved quality of life measured at 12 months following attendance. Secondary aims include reducing the amount of seizures, improvement in perceived impact of epilepsy, improved adherence to medication, reduction in emotional distress and improved self-management. Some participants are being interviewed to find out their views of the course and whether it was useful for them. The study also aims to measure whether attending the course is cost-effective with analysis from a team of health economists. The trial is comparing the effects of SMILE plus treatment as usual (TAU) versus TAU alone.
Eligibility criteria required a documented diagnosis of epilepsy (all epilepsy syndromes and seizure types permitted), currently on AEDs, aged 16 years or over, able to provide informed consent, participate in the workshops and complete questionnaires in English and to have had at least 2 seizures in the previous 12 months (as reported by the patient).
Participants randomized to the SMILE group will be invited to attend a two-day interactive training course and will receive a workbook to take home for future reference. There will be 8 to 12 participants in each group. Teams of two health professionals (one epilepsy nurse specialist and one EEG technician) facilitate the courses. Each facilitator has completed a formalized SMILE training programme. The facilitators use a power point presentation and flipcharts to go through each topic in the SMILE course within a predefined timetable (9.30am – 5.30pm on both days).
Excerpts from Laybourne, R., Morgan, M., Watkins, S. H., Lawton, R., Ridsdale, L. & Goldstein, L. (2015). Self-management for people with poorly controlled epilepsy: Participants' views of the UK Self-Management in epILEpsy (SMILE) program. Epilepsy & Behaviour (52) 159-164.
“It was really interesting to see a variety of perspectives based on personal experiences.” (Participant 9)
“It was good to meet somebody else [on the course] who has been through surgery and to be able to talk about it, how it made her feel.” (Participant 7)
“When I see epilepsy nurses and neurologist and consultants in the future, instead of just hoping to give them small answers…you can give them more detailed and structured answers. And you'll probably get a better sort of answer out of the person you're speaking to.” (Participant 2)
“Oh the confidence to talk, yeah. Because it has given me more, more confidence, because I know a little bit more …and it was meeting other people as well and being able to talk about it” (Participant 7)
“It's inspired me in that respect to question and not actually just to accept what the doctor says” (Participant 3)