{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T04:43:55Z","timestamp":1789879435380,"version":"4.0.1"},"reference-count":188,"publisher":"National Institute for Health and Care Research","issue":"21","license":[{"start":{"date-parts":[[2018,4,1]],"date-time":"2018-04-01T00:00:00Z","timestamp":1522540800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["09\/165\/01"],"award-info":[{"award-number":["09\/165\/01"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>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.<\/jats:p><\/jats:sec>Objectives<\/jats:title>To determine the effectiveness and cost-effectiveness of Self-Management education for people with poorly controlled epILEpsy [SMILE (UK)].<\/jats:p><\/jats:sec>Design<\/jats:title>A parallel pragmatic randomised controlled trial.<\/jats:p><\/jats:sec>Setting<\/jats:title>Participants were recruited from eight hospitals in London and south-east England.<\/jats:p><\/jats:sec>Participants<\/jats:title>Adults aged \u2265\u200916 years with epilepsy and two or more epileptic seizures in the past year, who were currently being prescribed antiepileptic drugs.<\/jats:p><\/jats:sec>Intervention<\/jats:title>A 2-day group self-management course alongside treatment as usual (TAU). The control group received TAU.<\/jats:p><\/jats:sec>Main outcome measures<\/jats:title>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.<\/jats:p><\/jats:sec>Randomisation<\/jats:title>A 1\u2009:\u20091 ratio between trial arms using fixed block sizes of two.<\/jats:p><\/jats:sec>Blinding<\/jats:title>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.<\/jats:p><\/jats:sec>Results<\/jats:title>The trial completed successfully. A total of 404 participants were enrolled in the study [SMILE (UK),n<\/jats:italic>\u2009=\u2009205; TAU,n<\/jats:italic>\u2009=\u2009199] with 331 completing the final follow-up at 12 months [SMILE (UK),n<\/jats:italic>\u2009=\u2009163; TAU,n<\/jats:italic>\u2009=\u2009168]. 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 course increased confidence by sharing with others and improved self-management behaviours.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>For people with epilepsy and persistent seizures, a 2-day self-management education course is cost-saving, but does not improve QoL after 12-months or reduce anxiety or depression symptoms. A psychological intervention may help with anxiety and depression. Interviewed participants reported attending a group course increased their confidence and helped them improve their self-management.<\/jats:p><\/jats:sec>Future work<\/jats:title>More research is needed on self-management courses, with psychological components and integration with routine monitoring.<\/jats:p><\/jats:sec>Trial registration<\/jats:title>Current Controlled Trials ISRCTN57937389.<\/jats:p><\/jats:sec>Funding<\/jats:title>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment<\/jats:italic>; Vol. 22, No. 21. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta22210","type":"journal-article","created":{"date-parts":[[2018,5,2]],"date-time":"2018-05-02T10:03:02Z","timestamp":1525255382000},"page":"1-142","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":32,"title":["Self-Management education for adults with poorly controlled epILEpsy [SMILE (UK)]: a randomised controlled trial"],"prefix":"10.3310","volume":"22","clinical-trial-number":[{"clinical-trial-number":"isrctn57937389","registry":"10.18810\/isrctn","type":"results"}],"author":[{"given":"Leone","family":"Ridsdale","sequence":"first","affiliation":[{"name":"Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology and Neuroscience, King\u2019s College London, London, 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