一项针对农村和服务不足的癫痫患者的自我管理干预试验（SMART）的方法学报告：针对有负面健康事件史的癫痫患者的随机对照试验。
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.
作者信息
Ghearing Gena R, Briggs Farren, Cassidy Kristin, Privitera Michael, Blixen Carol, Sajatovic Martha
机构信息
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.
出版信息
Trials. 2021 Nov 20;22(1):821. doi: 10.1186/s13063-021-05762-z.
BACKGROUND
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. 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.
METHODS
The 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.
DISCUSSION
The 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 REGISTRATION
ClinicalTrials.gov NCT04705441 . Registered on January 12, 2021.
背景
许多癫痫患者（PLWE）居住在农村社区，癫痫自我管理可能有助于解决这些社区中一些癫痫护理方面的差距。先前在俄亥俄州东北部进行的一项针对远程提供的基于网络的 12 周自我管理计划（SMART）的随机对照试验，该计划采用团体格式，主要针对城市和郊区社区，结果显示抑郁症状和生活质量等负面健康事件的改善。然而，针对农村环境中 PLWE 需求的研究甚少。
方法
本研究利用来自美国中西部两个州（俄亥俄州和爱荷华州）的研究人员之间的合作，复制测试 SMART 干预措施，并优先向农村和半农村社区的 PLWE 提供服务。在第一阶段，研究人员将使用社区利益相关者的反馈来改进 SMART 计划。然后将成立一个社区咨询委员会，以帮助确定试验实施的障碍和克服障碍的策略。在第二阶段，研究人员将对 SMART 计划进行为期 6 个月的前瞻性随机对照试验，与 6 个月的候补对照组进行比较，主要结果是负面健康事件的变化，定义为癫痫发作、自残企图、急诊就诊或住院。其他感兴趣的结果包括生活质量以及身体和心理健康功能。该研究还将评估计划采用者和系统最终用户的过程指标，以为 PLWE 提供未来的外展、教育和自我管理策略。
讨论
本研究方法利用 PLWE 的生活经历以及为农村和服务不足人群中的 PLWE 提供护理的人员的经验来改进远程提供的基于网络的自我管理计划，以提高招募和保留率，并提供干预措施。将评估对 PLWE、支付者和政策制定者重要的实用结果。这项研究将为实施未来成功的自我管理计划提供宝贵的见解。
试验注册
ClinicalTrials.gov NCT04705441。于 2021 年 1 月 12 日注册。
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