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Protocol for a clinical trial of telehealth-based social communication skills training for people with traumatic brain injury and their communication partners
Brain Impairment ( IF 1.1 ) Pub Date : 2019-05-29 , DOI: 10.1017/brimp.2019.9
Rachael Rietdijk , Emma Power , Melissa Brunner , Leanne Togher

Background: A previous clinical trial of training communication partners of people with traumatic brain injury (TBI) demonstrated positive outcomes [Togher, Power, McDonald, Tate, & Rietdijk (2009). Brain Impairment, 10(2), 188-204]. Adapting communication partner training for delivery via telehealth could improve access to this intervention.Objectives: To compare outcomes across in-person communication partner training, telehealth communication partner training and a control groupMethod: Protocol for a partially randomised controlled trial. People with moderate-severe TBI will be allocated to either an in-person or telehealth-based training program. Comparison data will be drawn from the original trial control group, which was recruited using the same eligibility criteria as this protocol. Outcomes after training will be compared between the in-person training group, the telehealth training group and the historical control group.Discussion: This protocol uses specific design features with the aim of maximising the study’s power, including a partially randomised allocation process and a historical control group. The results will inform about the feasibility and effectiveness of delivering TBI rehabilitation via telehealth.Trial registration: Australian and New Zealand Clinical Trials Registry: ACTRN12615001024538.

中文翻译:

为创伤性脑损伤患者及其交流伙伴进行基于远程医疗的社会交流技能培训的临床试验方案

背景:先前对创伤性脑损伤 (TBI) 患者的沟通伙伴进行培训的临床试验显示出积极的结果 [Togher、Power、McDonald、Tate 和 Rietdijk (2009)。脑损伤,10(2),188-204]。通过远程医疗调整通信合作伙伴培训可以改善获得这种干预的机会。目标:比较面对面交流合作伙伴培训、远程医疗交流合作伙伴培训和对照组的结果方法:部分随机对照试验的方案。中重度 TBI 患者将被分配到面对面或基于远程医疗的培训计划。比较数据将从使用与本方案相同的资格标准招募的原始试验对照组中提取。培训后的结果将在面对面培训组、远程医疗培训组和历史对照组之间进行比较。讨论:该协议使用特定的设计功能,旨在最大限度地提高研究的能力,包括部分随机分配过程和历史对照组。结果将告知通过远程医疗提供 TBI 康复的可行性和有效性。试用注册:澳大利亚和新西兰临床试验注册中心:ACTRN12615001024538。
更新日期:2019-05-29
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