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The effectiveness of a group self-management education course for adults with poorly controlled epilepsy, SMILE (UK): a randomised controlled trial

Research output: Contribution to journalArticle

Original languageEnglish
Pages (from-to)1048-1061
JournalEpilepsia
Volume59
Issue number5
Early online date16 Apr 2018
DOIs
StatePublished - May 2018

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King's Authors

Abstract

Objective
Epilepsy is one of the most common neurological conditions affecting about 1% of adults. Up to 40% of people with epilepsy (PWE) report recurring seizures while on medication. And optimal functioning requires good self-management. Our objective was to evaluate a group self-management education course for people with epilepsy and drug-resistant seizures by means of a multicentre, pragmatic, parallel group randomised controlled trial.
Methods
We recruited adults with epilepsy, having ≥ 2 seizures in the prior 12 months, from specialist clinics. Consenting participants were randomised 1:1 to a group course or treatment as usual. The primary outcome measure was quality of life 12 months after randomisation using QOLIE-31-P. Secondary outcome measures were seizure frequency and recency, psychological distress, impact and stigma of epilepsy, self-mastery, medication adherence and adverse effects. Analysis of outcomes followed the intention-to-treat principle using mixed-effects regression models.
Results
We enrolled 404 participants (intervention: n=205, control: n=199) with 331 (82%) completing 12-month follow-up (intervention: n=163, control: n=168). Mean age was 41.7 years, ranging from 16 to 85, 54% were female and 75% were white. From the intervention arm, 73.7% attended all or some of the course. At 12-month follow-up, there were no statistically significant differences between trial arms in QOLIE-31-P (intervention mean: 67.4, SD: 13.5; control mean: 69.5, SD 14.8) or in secondary outcome measures.
Significance
This is the first pragmatic trial of group education for people with poorly controlled epilepsy. Recruitment, course attendance and follow-up rates were higher than expected. The results show that the primary outcome, quality of life, did not differ between the trial arms after 12 months. We found a high prevalence of felt-stigma and psychological distress in this group of people with drug-resistant seizures. To address this, social and psychological interventions require evaluation, and may be necessary before or alongside self-management-education courses.

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