Abstracts

Rationale: People with epilepsy are more likely to experience negative health events (NHEs) compared to the general population despite significant advances in care. We developed a novel remotely delivered group-format epilepsy self-management program (“Self-management for people with epilepsy and a history of negative health events,” SMART) which was tested in a 6-month randomized controlled trial. At 6 months the SMART study arm compared to the wait-list study arm had significant (p<0.05) decreases in NHEs, and scores for Epilepsy Self-Management Scale (ESMS), Epilepsy Self-Efficacy Scale (ESES), 10-item Quality of Life in Epilepsy (QOLIE), Montgomery-Asberg Depression Rating Scale (MADRS) and 9-item Patient Health Questionnaire (PHQ-9). The objective of this study was to determine whether the causal effect of SMART on improvements in NHEs is direct or mediated by improvements in ESMS, ESES, QOLIE, MADRS, and/or PHQ-9. Methods: Participants were adults (≥18 years) with epilepsy and an NHE (seizure, accident, self-harm attempt, emergency department visit, or hospitalization) within the prior 6 months. There were 60 participants in each study arm (SMART versus wait-list) and assessments were conducted at baseline, 10 weeks, and 24 weeks (6 months). At baseline the study arms did not differ by age, sex, race/ethnicity, education, income, NHEs in the prior 6 months, nor baseline scores for ESMS, ESES, QOLIE, MADRS, and PHQ-9. In this secondary data analysis from our SMART randomized controlled trial, NHEs were categorized into two groups (0=increased or no change in the number of NHEs, 1=decrease in the number of NHEs) and the mediators of interest, ESMS, ESES, QOLIE, MADRS, and PHQ-9 scores were also categorized into two groups (0=worsening or no change, 1=improvement). Causal mediation analyses were conducted using medeff as implemented in STATA v13.1 (StataCorp, TX) to quantify the effect of SMART that operates through particular mechanisms. Results: At 6 months, using the categorical NHE and other standardized rating scale groupings, subjects receiving SMART compared to those on a wait-list experienced a reduction in NHEs (odds ratio [OR]=3.2, p=0.015) and improvements in ESMS (OR=2.6, p=0.027) and QOLIE (OR=3.5, p=0.0037). SMART was marginally associated with improvements in ESES (OR=2.2, p=0.079) and MADRS (OR=2.1, p=0.085) but not PHQ-9 (OR=1.2, p=0.59). There was no statistical evidence to suggest the causal effect of SMART on NHE reduction was mediated by improvements in ESMS, ESES, MADRS, or PHQ-9. However, improvements in QOLIE indirectly mediated 22.5% (95% CI: 9.6%, 88.9%) of the effect of SMART on NHE reduction. Conclusions: SMART had a significant impact on the reduction of NHEs experienced by persons with epilepsy, and a portion of the impact was positively mediated by improvements in quality of life. Change in self-management, self-efficacy, and depressive symptom severity did not appear to mediate NHE. Larger and more diverse samples of people with epilepsy receiving epilepsy self-management interventions, such as SMART, are needed to replicate these mediational findings. Funding: The project was supported in part by the Cooperative Agreement Number 1U48DP005030 from the Centers for Disease Control and Prevention (CDC).