COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
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DOI：
10.2196/18415
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发表时间：
2020-07-01
影响因子：
1.7
通讯作者：
Rimmer, James
中科院分区：
文献类型：
--
作者：
Lai, Byron;Chiu, Chia-Ying;Rimmer, James
背景资料：为多发性硬化症患者提供全面的运动和康复服务仍然是一项重大挑战，特别是在农村低收入地区。因此，远程运动和多发性硬化症（TEAMS）研究旨在通过对MS成人实施为期12周的补充和替代医学（CAM）干预，提供以患者为中心的协调护理。2020年3月中旬，位于伯明翰的亚拉巴马大学宣布了一种有限的商业模式，停止所有需要现场访问的非必要研究，其中包括TEAMS研究。根据就地避难政策和检疫指南，制定了修改后的测试和培训方案，以允许参与者继续研究。方法：修改后的协议取代了现场数据收集和培训程序，包括远程评估包（平板电脑、血压袖带、手部测力计、迷你盘锥、卷尺、8”台阶，和一张8”x 11”的大印刷纸，带有标尺和墙上安全胶带）以及用于治疗师和参与者之间的同步交互式训练的虚拟会议平台。远程评估措施包括静息血压和心率，握力，五次坐站，定时起身和走，和贝格平衡量表。远程训练部分包括20个同步训练课程，包括为一系列功能水平设计和定制的双重任务、瑜伽和普拉提练习。远程训练持续12周，参与者被指示继续行使posttraining期间的9 months.Results：协议修改的支持与补充资金（从以患者为中心的成果研究所），并批准了大学机构审查委员会为人类使用。在大学停止非必要的研究访问时，有759人参加了基线测试，占我们基线测试完成目标的92.5%（N=820）。具体而言，325名参与者完成了为期12周的干预和随访测试访问，289名参与者需要完成干预或随访评估。修改后的分析计划将包括敏感性分析，以确保在存在不确定性和方案偏离的情况下研究结果的稳健性。研究结果预计将于2021年发表。结论：这种修改后的远程远程评估/远程培训方案将影响大量MS参与者，否则他们将退出研究。
Background: Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study.Objective: In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study.Methods: The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8" step, and a large-print 8" x 11" paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months.Results: The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021.Conclusions: This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study.