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

Health Technology Assessment

Stephanie JC Taylor¹  Alison McKinlay²  Mark Richardson²  Gabriella Wojewodka²  Sarah J Feehan²  Leone Ridsdale²  Sabine Landau³  Emily J Robinson³  Gus Baker⁴  Adam J Noble⁵  Laura H Goldstein⁶  Myfanwy Morgan⁷  Iris Mosweu⁸  Paul McCrone⁸ 

[1] Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Centre for Primary Care and Public Health, London, UK;Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK;Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK;Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK;Department of Psychological Sciences, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK;Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK;Institute of Pharmaceutical Science, King’s College London, London, UK;King’s Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK;

关键词: epilepsy;    self-management;    group education;    smile (uk);    anxiety;    depression;    stigma;    quantitative;    qualitative;    health economics;    cost-effectiveness;    fidelity;   

DOI  :  10.3310/hta22210

来源: DOAJ

【 摘 要 】

Background: 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. Objectives: To determine the effectiveness and cost-effectiveness of Self-Management education for people with poorly controlled epILEpsy [SMILE (UK)]. Design: A parallel pragmatic randomised controlled trial. Setting: Participants were recruited from eight hospitals in London and south-east England. Participants: Adults aged ≥ 16 years with epilepsy and two or more epileptic seizures in the past year, who were currently being prescribed antiepileptic drugs. Intervention: A 2-day group self-management course alongside treatment as usual (TAU). The control group received TAU. Main outcome measures: 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. Randomisation: A 1 : 1 ratio between trial arms using fixed block sizes of two. Blinding: 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. Results: The trial completed successfully. A total of 404 participants were enrolled in the study [SMILE (UK), n = 205; TAU, n = 199] with 331 completing the final follow-up at 12 months [SMILE (UK), n = 163; TAU, n = 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 course increased confidence by sharing with others and improved self-management behaviours. Conclusions: 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. Future work: More research is needed on self-management courses, with psychological components and integration with routine monitoring. Trial registration: Current Controlled Trials ISRCTN57937389. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 21. See the NIHR Journals Library website for further project information.

【 授权许可】

Unknown