Leone Ridsdale1, Alison McKinlay1, Gabriella Wojewodka1, Emily J Robinson2, Iris Mosweu3, Sarah J Feehan1, Adam J Noble4, Myfanwy Morgan5, Stephanie Jc Taylor6, Paul McCrone3, Sabine Landau2, Mark Richardson1, Gus Baker7, Laura H Goldstein8. 1. Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. 2. Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. 3. King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. 4. Department of Psychological Sciences, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK. 5. Institute of Pharmaceutical Science, King's College London, London, UK. 6. Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Centre for Primary Care and Public Health, London, UK. 7. Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. 8. Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Abstract
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.
RCT Entities:
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 epilepticseizures 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.
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