Self-management for People with Epilepsy and a History of Negative Health Events (SMART): Targeting Rural and Underserved People with Epilepsy

In spite of advances in biological therapies, many people with epilepsy have poor outcomes including negative health events (NHEs), such as frequent seizures, accidents, and emergency department visits, and low quality of life. Risk factors for poorly controlled epilepsy include limited social supports, poor medication adherence, and comorbidities like mental illnesses. People with epilepsy who live in rural or under-served communities face additional challenges such as social isolation, limited access to care, and low levels of epilepsy awareness. The Managing Epilepsy Well (MEW) Network has been a national leader in developing, testing and disseminating evidence-based epilepsy self-management programs. One of these, Self-management for people with epilepsy and a history of negative health events (SMART), is a remotely-delivered group-format program that has been demonstrated to reduce NHEs and improve quality of life and physical and mental health functioning in individuals with epilepsy.

This 5-year prospective randomized controlled trial (RCT), written in response to Special Interest Project (SIP) 19-003 Managing Epilepsy Well (MEW) Network 2.0 Collaborating Center, will investigate the effects of the SMART program among people with epilepsy who have had recent NHEs vs. a 6-month wait-list control. Phase 1 is intended to set the stage for a successful RCT that will inform future dissemination and implementation efforts should RCT findings be positive. Qualitative evaluation of barriers and facilitators to participation in a self-management program as well as input from informed and committed local stakeholders will help develop a robust recruitment strategy and set of practices that will maximize engagement and retention. Phase 2, the RCT will be conducted in Iowa, led by a team from the University of Iowa, in Iowa City, Iowa in collaboration with local and regional epilepsy care stakeholders and partners. This new partnership will substantially strengthen representation of the U.S. "heartland"/Midwestern states in the MEW Network, increasing overall generalizability of MEW Network programs. Key foci of the study are to replicate the efficacy findings of the original SMART study and to obtain new information on how SMART is perceived among people with epilepsy, their families, clinicians and other stakeholders in rural and underserved communities. We hypothesize that at 6-month follow-up, SMART will be associated with a reduction in NHEs compared to wait-list control. We also expect that SMART will be associated with improved quality of life and functioning, and reduced depression, with improvement maintained at 18-month follow-up. An additional component of the proposed project is the continued development of the MEW database to supplement site-specific data and provide a source for secondary analyses including identification of patient-level and other factors that may identify individuals who may have difficulty engaging in and sustaining participation in evidence-based epilepsy self-management programs.

The University of Iowa will serve as the Institutional Review Board (IRB) of Record over one relying site, Case Western Reserve University (CWRU).

Phase 1 Procedure:

Phase 1 is intended to set the stage for a successful RCT that will inform future dissemination and implementation efforts should RCT findings be positive. Qualitative evaluation of barriers and facilitators to participation in a self-management program as well as input from informed and committed local stakeholders will help develop a robust recruitment strategy and set of practices that will maximize engagement and retention.