Effectiveness of a Self-Management Program to Improve Cognition and Quality of Life in Epilepsy: A Pragmatic, Randomized, Multicenter Trial

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OBJECTIVE: To determine the effectiveness of HOBSCOTCH (Home-based self-management and cognitive training changes lives) in a real-world setting, and to assess feasibility of a virtual intervention, we conducted a multi-site, pragmatic replication trial at four New England epilepsy centers. METHODS: HOBSCOTCH is an 8-session intervention addressing cognitive impairment and quality of life (QOL) for people with epilepsy (PWE). Participants were recruited from epilepsy centers in four states and block-randomized into the following groups: in-person HOBSCOTCH (H-IP), virtual HOBSCOTCH (H-V), and waitlist control. Outcome measures were assessed for all groups at baseline, 3-months, and 6-months; intervention groups received long-term follow-up at 9- and 12-months. RESULTS: A total of 108 participants were recruited, of which 85 were included in this analysis (age at baseline 47.5 ± 11.5 years; 68% female). Participants completing the in-person intervention (H-IP) had a 12.4-point improvement in QOL score compared to controls ( < 0.001). Pairwise comparisons found a 6.2-point treatment effect for subjective cognition in the H-IP group ( < 0.001). There were no meaningful group differences in objective cognition or healthcare utilization at any timepoints, and the treatment effect for QOL diminished by 6-months. The virtual intervention demonstrated feasibility, but did not significantly improve outcomes compared to controls. Within-group analysis found improvements in QOL for both H-V and H-IP. CONCLUSIONS: This study replicated the effectiveness of the HOBSCOTCH program in improving QOL for PWE. The study was conducted prior to the COVID-19 pandemic, but the distance-delivered intervention may be particularly well-suited for the current environment. Future research will explore modifications designed to improve the efficacy of H-V and the sustainability of HOBSCOTCH's treatment effect. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that in-person HOBSCOTCH delivery improved subjective measures of cognition in persons with epilepsy.The study was registered and listed on ClinicalTrials.gov (NCT02394509).