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.
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.
复制标题
DOI：
10.1186/s13063-021-05762-z
复制
发表时间：
2021-11-20
期刊：
影响因子：
2.5
通讯作者：
Sajatovic M
中科院分区：
文献类型：
--
作者：
Ghearing GR;Briggs F;Cassidy K;Privitera M;Blixen C;Sajatovic M
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癫痫护理方面的一些差距。先前在俄亥俄州东北部（主要是城市和郊区社区）进行的一项基于网络的远程小组形式的 12 周自我管理计划 (SMART) 的随机对照试验表明，抑郁症状和生活质量等负面健康事件的结果有所改善。然而，针对农村地区 PLWE 需求的研究却很少。本研究利用美国中西部两个州（俄亥俄州和爱荷华州）的研究人员之间的合作来复制 SMART 干预措施的测试，并优先向农村和半农村社区的 PLWE 提供服务。在第一阶段，调查人员将根据社区利益相关者的意见完善 SMART 计划。然后将召开社区咨询委员会，帮助确定试验实施的障碍以及克服障碍的策略。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、急诊科就诊或住院治疗。其他令人感兴趣的结果包括生活质量以及身心健康功能。该研究还将评估项目采用者和系统最终用户的流程衡量标准，为 PLWE 未来的推广、教育和自我管理策略提供信息。本研究的方法利用 PLWE 以及为农村和服务欠缺人群中的 PLWE 提供护理的人员的生活经验来完善远程交付的基于网络的自我管理计划，以改善招募和保留，并提供干预措施。对 PLWE、付款人和政策制定者重要的务实成果将得到评估。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。 ClinicalTrials.gov NCT04705441。注册日期：2021年1月12日
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. 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. 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. ClinicalTrials.gov NCT04705441. Registered on January 12, 2021
登录
查看更多内容
影响因子：
9.9
作者：
Dall, Timothy M.;Storm, Michael V.;Vidic, Thomas R.
通讯作者：
Vidic, Thomas R.
影响因子：
2.2
作者：
Cramer, JA;Arrigo, C;Bromfield, EB
通讯作者：
Bromfield, EB
影响因子：
2.6
作者：
DiIorio, C;Shafer, PO;Yeager, K
通讯作者：
Yeager, K
影响因子：
3
作者：
Chaudhry, S;Jin, L;Meltzer, D
通讯作者：
Meltzer, D
影响因子：
5.6
作者：
Hawley, Suzanne R.;Paschal, Angelia M.;Molgaard, Craig A.
通讯作者：
Molgaard, Craig A.