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

Epilepsy is a common neurological condition resulting in recurrent seizures. Research evidence in long-term conditions suggests that patients benefit from self-management education and that this may improve quality of life (QoL). Epilepsy self-management education has yet to be tested in a UK setting. To determine the effectiveness and cost-effectiveness of Self-Management education for people with poorly controlled epILEpsy [SMILE (UK)]. A parallel pragmatic randomised controlled trial. Participants were recruited from eight hospitals in London and south-east England. Adults aged ≥ 16 years with epilepsy and two or more epileptic seizures in the past year, who were currently being prescribed antiepileptic drugs. A 2-day group self-management course alongside treatment as usual (TAU). The control group received TAU. The primary outcome is QoL in people with epilepsy at 12-month follow-up using the Quality Of Life In Epilepsy 31-P (QOLIE-31-P) scale. Other outcomes were seizure control, impact of epilepsy, medication adverse effects, psychological distress, perceived stigma, self-mastery and medication adherence. Cost-effectiveness analyses and a process evaluation were undertaken. A 1 : 1 ratio between trial arms using fixed block sizes of two. Participants were not blinded to their group allocation because of the nature of the study. Researchers involved in data collection and analysis remained blinded throughout. The trial completed successfully. A total of 404 participants were enrolled in the study [SMILE (UK), = 205; TAU, = 199] with 331 completing the final follow-up at 12 months [SMILE (UK), = 163; TAU, = 168]. In the intervention group, 61.5% completed all sessions of the course. No adverse events were found to be related to the intervention. At baseline, participants had a mean age of 41.7 years [standard deviation (SD) 14.1 years], and had epilepsy for a median of 18 years. The mean QOLIE-31-P score for the whole group at baseline was 66.0 out of 100.0 (SD 14.2). Clinically relevant levels of anxiety symptoms were reported in 53.6% of the group and depression symptoms in 28.0%. The results following an intention-to-treat analysis showed no change in any measures at the 12-month follow-up [QOLIE-31-P: SMILE (UK) mean: 67.4, SD 13.5; TAU mean: 69.5, SD 14.8]. The cost-effectiveness study showed that SMILE (UK) was possibly cost-effective but was also associated with lower QoL. The process evaluation with 20 participants revealed that a group co