One-year follow-up of a remotely delivered epilepsy self-management program in high-risk people with epilepsy.

Objective: "Self-management for people with epilepsy and a history of negative health events" (SMART) is a novel group-format epilepsy self-management intervention demonstrated to reduce negative health events (NHEs) such as accidents, emergency department visits, and seizures in adults with epilepsy in a 6-month prospective randomized controlled trial (RCT); SMART also reduced depressive symptoms and improved health functioning and quality of life. This report describes the longer-term (12-month) post-efficacy RCT outcomes in adults with epilepsy who received SMART.

Methods: After completing a 6-month, prospective RCT that demonstrated efficacy of SMART vs 6-month waitlist control (WL), adults ≥18 years of age with epilepsy were followed for an additional 12 months. Individuals originally randomized to WL received the 8-week SMART intervention immediately following the conclusion of the RCT. For this long-term extension analysis, assessments were conducted at 24 weeks (the 6-month primary outcome time-point of the efficacy RCT), at 32 weeks for individuals originally randomized to WL, and at 48 weeks and 72 weeks for all individuals. Outcomes assessed included past 6-month NHE counts, depressive symptoms assessed with the 9-item Patient Health Questionnaire (PHQ-9) and Montgomery-Asberg Depression Rating Scale (MADRS), and quality of life assessed with the 10-item Quality of Life in Epilepsy (QOLIE-10).

Results: At the beginning of this long-term observational period (24-week follow-up time point for the original RCT), there were 50 individuals in the group originally randomized to SMART and 52 originally randomized to WL. Mean age was 41.4 years, 70% women (N = 71), 64% (N = 65) African-American, and 8% Hispanic (N = 8). Study attrition from week 24 to week 72 was 8% in the arm originally randomized to SMART and 17% in the arm originally randomized to WL. During the 12-month observation period (24 weeks to 72 weeks), there were a total of 44 serious adverse events and 4 deaths, none related to study participation. There was no significant change in total past 6-month NHE counts in the group originally randomized to SMART, although the group had significantly reduced 6-month seizure counts. The group originally randomized to WL, who received SMART during this observational period, had a reduction in total NHE counts. The group originally randomized to SMART had relatively stable levels on other outcome variables except for a trend for improved MADRS (p = 0.08). In the group originally randomized to WL, there were significant improvements in PHQ-9 (p = 0.01), MADRS (p ≤ 0.01), and QOLIE-10 (p = 0.004).

Conclusions: This post-RCT extension study suggests that adults with epilepsy who participate in the SMART intervention sustain clinical effects at 1-year follow-up and may have incremental improvements in seizure frequency and mood. Future research needs to identify opportunities for scale-up and outreach to other high-risk groups with epilepsy.