Title: Self-Management education for adults with poorly controlled epILEpsy (SMILE) A Randomised Controlled Trial
Funder: Department of Health (England)

Abstract: DESIGN: Parallel group randomised controlled trial comparing the effects of SMILE plus treatment as usual (TAU) versus TAU. At the end of the Trial we will offer SMILE to the TAU group.SETTING: RCT recruiting from secondary care specialist epilepsy clinics in the South East region. Initial piloting of SMILE will be completed with volunteer members with poorly controlled epilepsy from the user group EA.TARGET POPULATION: Collaborating specialist epilepsy services staff will identify adults aged 16+ with epilepsy who are prescribed anti-epileptic drugs (AEDs) who have had 2+ seizures in the previous 12 months (i.e. the ~40% of people with the poorest epilepsy control) and are able to provide informed consent participate in the workshops and complete the questionnaires in English. Exclusion criteria include: acute symptomatic seizures due to acute neurological illness or substance misuse: severe current psychiatric or medical illness; Potentially eligible patients will receive a letter about the study from their epilepsy specialist telling them that a research worker (RW) will contact them with more information. Unless they return a form to opt-out of receiving further information within 2 weeks a RW will explain the study and verify eligibility. Based on prior cohort and trial data and self-management interventions in other conditions we estimate 17-20% of eligible adults will agree to participate.HEALTH TECHNOLOGY BEING ASSESSED: SMILE a 2-day group learning course (facilitated by 2 trained health professionals) and workbook; this aims to support people becoming expert in managing their epilepsy. Courses are provided for groups of 8-12 people in users’ locality. In a trial in German-speaking Europe those receiving the intervention demonstrated increased knowledge about and coping with epilepsy improved seizure control and better AED tolerance and fewer AED side effects. MEASUREMENT OF COST & OUTCOMES. Outcomes and cost effectiveness will be measured by validated self-report questionnaires at pre- and 12m post-randomisation. Primary outcome is the QOLIE-31 an epilepsy-specific QoL measure. Secondary outcomes include impact of epilepsy seizure frequency control perceived impact of epilepsy AED compliance and adverse effects anxiety depression stigma and perceptions of control/self efficacy control. We will measure quality-adjusted life years (using EQ5D) and health service use. Qualitative research during the pilot and main trial will describe users’ views on barriers to participation and benefits and how the intervention might be improved.SAMPLE SIZE: The primary ITT analyses will compare 2 equally-sized treatment arms SMILE (+TAU) or TAU alone on the QOLIE-31 at 12 m. Other interventions for those with poorly controlled epilepsy using the QOLIE-31 to measure outcome found an effect size of 0.4. A total sample size of 320 (randomised 1:1) will provide 91% power to detect an effect size of d=0.4 using ANCOVA with 2 sided tests at p<0.05. This allows for standard error inflation due to group effects (SMILE is a group treatment); assuming an average group size of 10 patients and an intra-group correlation between QOLIE-31 scores of ICC=0.025 160 patients in the TAU arm and 16 groups of 10 patients in the SMILE arm would have 91% power to detect an effect of d=0.4 under clustering in 1 trial arm. Inflating the sample size to allow for an estimated 25% attrition requires an initial sample of 428.PROJECT TIMETABLE (INCLUDING RECRUITMENT RATE)(see Study Flow Diagram and uploaded Gantt chart) 0-5 m:Recruitment of epilepsy services train SMILE facilitators pilot SMILE with qualitative evaluation. 5-18 m:Invite and consent participants; baseline assessments (~12 participants p/wk months 6-17) SMILE intervention participants 6 and 12 month follow-ups and nested qualitative phases start; report on internal pilot at 12m. 18-29 m:Quantitative and qualitative evaluation including12m follow-ups; 30-34 m:SMILE for controls. 30-35m:Analysis & dissemination.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL