Abstract
BackgroundMany people living with epilepsy (PLWE) reside in rural communities, and epilepsy self-management may help address some of the gaps in epilepsy care for these communities. A prior randomized control trial of a remotely delivered, Web-based group format 12-week self-management program (SMART) conducted in Northeast Ohio, a primarily urban and suburban community, demonstrated improved outcomes in negative health events such as depression symptoms and quality of life. However, there is a paucity of research addressing the needs of PLWE in rural settings.MethodsThe present study leverages collaboration between investigators from 2 mid-western US states (Ohio and Iowa) to replicate testing of the SMART intervention and prioritize delivery to PLWE in rural and semi-rural communities. In phase 1, investigators will refine the SMART program using input from community stakeholders. A Community Advisory Board will then be convened to help identify barriers to trial implementation and strategies to overcome barriers. In phase 2, the investigators will conduct a 6-month prospective randomized control trial of the SMART program compared to 6-month waitlist controls, with the primary outcome being changes in negative health events defined as seizure, self-harm attempt, emergency department visit, or hospitalization. Additional outcomes of interest include quality of life and physical and mental health functioning. The study will also assess process measures of program adopters and system end-users to inform future outreach, education, and self-management strategies for PLWE.DiscussionThe method of this study employs lived experience of PLWE and those who provide care for PLWE in rural and underserved populations to refine a remotely delivered Web-based self-management program, to improve recruitment and retention, and to deliver the intervention. Pragmatic outcomes important to PLWE, payers, and policymakers will be assessed. This study will provide valuable insights on implementing future successful self-management programs.Trial registrationClinicalTrials.gov NCT04705441. Registered on January 12, 2021
Highlights
Many people living with epilepsy (PLWE) reside in rural communities, and epilepsy self-management may help address some of the gaps in epilepsy care for these communities
Two focus groups composed of PLWE and their family members from rural communities in Iowa and two focus groups composed of rural health providers, social services agency administrators/staff, or other professionals working in rural health will be convened to collect information on perceived barriers and facilitators to participation in an epilepsy self-management program, as well as impressions of the SMART self-management curriculum
Focus groups will be conducted via Zoom technology, last 60–90 min, and use a semistructured interview guide adapted from previous studies in self-management of neurological conditions conducted by the Case Western Reserve University (CWRU) investigators [11, 12]
Summary
In addition to demographic and clinical information (age, gender, ethnicity, self-reported cumulative medical illness [19, 20]), health literacy will be assessed [21] to detect persons with limited or marginal health literacy For both the SMART and the WL groups, research assessments will be done at screening (to establish study eligibility), at baseline, and at 13 weeks, 6 months, 12 months, and 18 months after randomization. The 13-week NHE measurement will reflect the time period following baseline (when individuals participating in SMART will be having their “intensive” group sessions), and it will be used to assess for within-subject differences from baseline to 13-week and 13-week to 6-month time periods. A 2-sided type I error rate of 5% will be considered significant
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