A randomized controlled trial of self-management for people with epilepsy and a history of negative health events (SMART) targeting rural and underserved people with epilepsy: a methodologic report

Trials

Gena R. Ghearing¹  Farren Briggs²  Carol Blixen³  Martha Sajatovic⁴  Kristin Cassidy⁴  Michael Privitera⁵ 

[1] Department of Neurology, Carver College of Medicine and University of Iowa Health Center, Iowa City, IA, USA;Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, OH, USA;Department of Psychiatry & Neurological and Behavioral Outcomes Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA;Department of Psychiatry & of Neurology, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA;UC Gardner Neuroscience Institute, University of Cincinnati College of Medicine, Cincinnati, OH, USA;

关键词: Epilepsy;    Seizure;    Self-management;    Rural;    Hospitalizations;    Emergency room;   

DOI  :  10.1186/s13063-021-05762-z

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY