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

Kralj-Hans, Ines; Noble, Adam; Landau, Sabine; Magill, Nicholas; McCrone, Paul; Baker, Gus A.; Morgan, Myfanwy; Richardson, Mark P.; Taylor, Stephanie J C; Ridsdale, Leone

doi:10.1186/1471-2377-14-69

Cited by 32 publications

(39 citation statements)

References 33 publications

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“…Exclusion criteria were having non-epileptic seizures only, having seizures related to an acute illness or substance overuse, having a serious psychiatric condition or terminal illness, and participating in other epilepsy-related studies [12]. …”

Section: Methodsmentioning

confidence: 99%

Characteristics associated with quality of life among people with drug-resistant epilepsy

Ridsdale¹,

Wojewodka²,

Robinson

et al. 2017

J Neurol

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Quality of Life (QoL) is the preferred outcome in non-pharmacological trials, but there is little UK population evidence of QoL in epilepsy. In advance of evaluating an epilepsy self-management course we aimed to describe, among UK participants, what clinical and psycho-social characteristics are associated with QoL. We recruited 404 adults attending specialist clinics, with at least two seizures in the prior year and measured their self-reported seizure frequency, co-morbidity, psychological distress, social characteristics, including self-mastery and stigma, and epilepsy-specific QoL (QOLIE-31-P). Mean age was 42 years, 54% were female, and 75% white. Median time since diagnosis was 18 years, and 69% experienced ≥10 seizures in the prior year. Nearly half (46%) reported additional medical or psychiatric conditions, 54% reported current anxiety and 28% reported current depression symptoms at borderline or case level, with 63% reporting felt stigma. While a maximum QOLIE-31-P score is 100, participants’ mean score was 66, with a wide range (25–99). In order of large to small magnitude: depression, low self-mastery, anxiety, felt stigma, a history of medical and psychiatric comorbidity, low self-reported medication adherence, and greater seizure frequency were associated with low QOLIE-31-P scores. Despite specialist care, UK people with epilepsy and persistent seizures experience low QoL. If QoL is the main outcome in epilepsy trials, developing and evaluating ways to reduce psychological and social disadvantage are likely to be of primary importance. Educational courses may not change QoL, but be one component supporting self-management for people with long-term conditions, like epilepsy.

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Section: Methodsmentioning

confidence: 99%

Characteristics associated with quality of life among people with drug-resistant epilepsy

Ridsdale¹,

Wojewodka²,

Robinson

et al. 2017

J Neurol

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“…The trial was conducted and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. A detailed description of the trial design, interventions, and outcome measures can be found in the published trial protocol . Here we provide a brief overview.…”

Section: Methodsmentioning

confidence: 99%

“…Randomization was provided by an online system managed by the King's Clinical Trials Unit, maintaining full allocation concealment . Randomization occurred in blocks of 2 (1:1 intervention: control) and was stratified by treatment center.…”

Section: Methodsmentioning

confidence: 99%

“…A detailed description of the trial design, interventions, and outcome measures can be found in the published trial protocol. 13 Here we provide a brief overview.…”

Section: Methodsmentioning

confidence: 99%

“…Randomization was provided by an online system managed by the King's Clinical Trials Unit, maintaining full allocation concealment. 13,14 Randomization occurred in blocks of 2 (1:1 intervention: control) and was stratified by treatment center. Research staff who completed follow-up assessments and the patients' healthcare providers were blinded to treatment allocation.…”

Section: Randomization and Blindingmentioning

confidence: 99%

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

et al. 2018

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SummaryObjectiveEpilepsy 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 courses for people with epilepsy and drug‐resistant seizures by means of a multicenter, pragmatic, parallel group, randomized controlled trial.MethodsWe recruited adults with epilepsy, having ≥2 seizures in the prior 12 months, from specialist clinics. Consenting participants were randomized 1:1 to a group course or treatment as usual. The primary outcome measure was quality of life 12 months after randomization using Quality of Life 31‐P (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.ResultsWe 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, standard deviation [SD]: 13.5; control mean: 69.5, SD 14.8) or in secondary outcome measures.SignificanceThis 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 and 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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Neuropsychological and psychological interventions for people with newly diagnosed epilepsy

Jackson

Makin

Baker

2015

Cochrane Database of Systematic Reviews

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Meta-analysis was not possible as we identified only two studies and they utilised different interventions and outcome measures.Previous research has highlighted the impact of psychological and neuropsychological difficulties experienced by people with epilepsy and the negative effect this has on their quality of life. The main finding of this review is that there is a paucity of research assessing possible neuropsychological and psychological interventions for adults with newly diagnosed epilepsy.

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

Cited by 32 publications

References 33 publications

Characteristics associated with quality of life among people with drug-resistant epilepsy

Characteristics associated with quality of life among people with drug-resistant epilepsy

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

Neuropsychological and psychological interventions for people with newly diagnosed epilepsy

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