Abstract
Background and objectives: We conducted a multisite, pragmatic replication trial at 4 New England epilepsy centers to determine the effectiveness of Home-Based Self-Management and Cognitive Training Changes Lives (HOBSCOTCH) in a real-world setting and to assess feasibility of a virtual intervention.
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 4 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 whom 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 with controls ( p < 0.001). Pairwise comparisons found a 6.2-point treatment effect for subjective cognition in the H-IP group ( p < 0.001). There were no meaningful group differences in objective cognition or health care utilization at any time points and the treatment effect for QoL diminished by 6 months. The virtual intervention demonstrated feasibility but did not significantly improve outcomes compared with controls. Within-group analysis found improvements in QoL for both H-V and H-IP.
Discussion: 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.
Trial registration information: ClinicalTrials.gov ( NCT02394509 ).
Classification of evidence: This study provides Class III evidence that in-person HOBSCOTCH delivery improved subjective measures of cognition in persons with epilepsy.
【초록키워드】 Treatment, Efficacy, Trial, feasibility, COVID-19 pandemic, Intervention, classification, outcome, epilepsy, Replication, improvement, Health, female, Research, Effectiveness, Control, Cognitive impairment, age, Quality of life, group, England, change, Care, Evidence, Analysis, Pragmatic, Long-term follow-up, training, intervention group, measure, participant, class, Pairwise comparison, Modification, Future, controls, IMPROVE, significantly, recruited, conducted, provide, determine, demonstrated, replicated, New, baseline, multisite, were assessed, 【제목키워드】 Cognition, Program, Quality, life,