Self-management for people with epilepsy and a history of negative health events (SMART): A randomized controlled effectiveness trial.

OBJECTIVES

This 2-site, 6-month randomized controlled trial of an epilepsy self-management (ESM) curriculum (SMART) vs. 6-month waitlist (WL) control assessed effects on epilepsy outcomes in 160 people with epilepsy (PWE).

METHODS

PWE had at least 1 negative health event (NHE) defined as a seizure, emergency department visit, hospitalization or self-harm attempt in the last 6 months. Primary outcomes were differences in proportions of PWE with reductions in NHEs from baseline to 6 months follow up and change in NHE/seizure counts between SMART and WL. Secondary outcomes included the Patient Health Questionnaire (PHQ-9), 36-Item Short Form Survey (SF-36), Quality of Life in Epilepsy (QOLIE-31), Epilepsy Self-Management Scale (ESMS), Epilepsy Stigma Scale (ESS), Multidimensional Scale of Perceived Social Support (MSPSS) and Epilepsy Self-Efficacy Scale (ESES).

RESULTS

Mean age was 39.4 (SD 12.2), 66.9 % (N = 107) women, and 31 % (N = 50) rural. Mean PHQ-9 of 10.5 (SD 7) suggested mild/moderate depression. Seizures were the most common NHE with mean baseline past 6-month seizure count of 20.6 (SD 41.0). SMART was significantly associated with a 2-fold increase in odds of having at least 10-30 % improvement in NHEs vs. WL (p < 0.05). SMART was associated with significant seizure reduction (p < 0.05), significantly improved PHQ-9 (p = 0.014), QOLIE-31 seizure worry (p = <0.001) and social functioning (p = 0.021), ESES (p = 0.046) and ESMS (p < 0.001).

SIGNIFICANCE

Compared to WL, SMART participants had improvement in NHEs and seizures, depressive symptoms, self-management competency and self-efficacy and selected elements of quality of life. Inclusion of effective ESMs into a comprehensive care of model for PWE may be warranted.