Self-Management education for adults with poorly controlled epILEpsy (SMILE (UK)): a randomised controlled trial protocol

BACKGROUND: Teaching people with epilepsy to identify and manage seizure triggers, implement strategies to remember to take antiepileptic drugs, implement precautions to minimize risks during seizures, tell others what to do during a seizure and learn what to do during recovery may lead to better self-management. No teaching programme exists for adults with epilepsy in the United Kingdom although a number of surveys have shown patients want more information. METHODS/DESIGN: This is a multicentre, pragmatic, parallel group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a two-day Self-Management education for epILEpsy (SMILE (UK)), which was originally developed in Germany (MOSES). Four hundred and twenty eight adult patients who attended specialist epilepsy outpatient clinics at 15 NHS participating sites in the previous 12 months, and who fulfil other eligibility criteria will be randomised to receive the intervention (SMILE (UK) course with treatment as usual- TAU) or to have TAU only (control). The primary outcome is the effect on patient reported quality of life (QoL). Secondary outcomes are seizure frequency and psychological distress (anxiety and depression), perceived impact of epilepsy, adherence to medication, management of adverse effects from medication, and improved self-efficacy in management (mastery/control) of epilepsy. Within the trial there will be a nested qualitative study to explore users’ views of the intervention, including barriers to participation and the perceived benefits of the intervention. The cost-effectiveness of the intervention will also be assessed. DISCUSSION: This study will provide quantitative and qualitative evidence of the impact of a structured self management programme on quality of life and other aspects of clinical and cost effectiveness in adults with poorly controlled epilepsy. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN57937389.