Wilroy Jereme, Lai Byron, Currie Madison, Young Hui-Ju, Thirumalai Mohanraj, Mehta Tapan, Giannone John, Rimmer James
University of Alabama at Birmingham, Birmingham, AL, United States.
JMIR Form Res. 2021 Nov 18;5(11):e29799. doi: 10.2196/29799.
The Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) initiative is a large randomized controlled study that aims to overcome logistical barriers to exercise via telehealth for people with physical disabilities. However, at the start of the COVID-19 pandemic, enrollment was halted due to limited operations at the testing site, which included no onsite visits that involved participant data collection. In response to the limited operations, a modified data collection protocol was developed for virtual enrollment of study participants.
This paper presents feasibility data on using teleassessments to enroll people with mobility impairment into a home-based exercise trial.
The modified protocol replaced onsite enrollment and data collection visits with teleassessments using a computer tablet and testing equipment that was shipped to the participants' home address prior to the synchronous teleassessments conducted by an exercise physiologist through Zoom. The participants were mailed a teleassessment toolkit that included a digital blood pressure cuff, spirometer, hand dynamometer, mini disc cone, and measuring tape (to complete standardized testing). The teleassessment measures included resting blood pressure and heart rate, forced vital capacity, grip strength, Five Times Sit to Stand, and Timed Up and Go. Feasibility metrics included technological effectiveness, efficiency, and safety. The technological effectiveness of the telehealth assessment was determined by the percentage of sessions completed without technical issues with ≥90% criteria set a priori. Efficiency was measured by a session duration of ≤2 hours. Safety was measured by the number of adverse events related to the teleassessments reported.
Data from 36 participants were included in this feasibility study, and 34 (94%) participants completed all teleassessments without technical issues. For efficiency, the teleassessment sessions were completed in a mean time of 65 minutes and a maximum session length of 110 minutes. There were no adverse events reported to indicate concerns with the safety of teleassessments.
The modified teleassessment protocol, in response to COVID-19 restrictions, may be a feasible process for enrolling adults with mobility impairment into a home exercise trial who otherwise would have not been able to participate.
ClinicalTrials.gov NCT03024320; https://clinicaltrials.gov/ct2/show/NCT03024320.
扩大规模项目评估对家庭锻炼和生活方式远程医疗的反应性(SUPER-HEALTH)倡议是一项大型随机对照研究,旨在克服身体残疾者通过远程医疗进行锻炼的后勤障碍。然而,在新冠疫情开始时,由于测试地点的运营受限,招募工作暂停,其中包括没有涉及参与者数据收集的现场访问。针对运营受限的情况,制定了一种修改后的数据收集方案,用于虚拟招募研究参与者。
本文介绍了使用远程评估将行动不便者纳入家庭锻炼试验的可行性数据。
修改后的方案用远程评估取代了现场招募和数据收集访问,使用平板电脑和测试设备,在运动生理学家通过Zoom进行同步远程评估之前,将这些设备运送到参与者的家庭住址。向参与者邮寄了一个远程评估工具包,其中包括一个数字血压袖带、肺活量计、握力计、迷你圆盘锥体和卷尺(用于完成标准化测试)。远程评估措施包括静息血压和心率、用力肺活量、握力、五次坐立试验和定时起立行走试验。可行性指标包括技术有效性、效率和安全性。远程医疗评估的技术有效性由在无技术问题的情况下完成的疗程百分比确定,预先设定的标准为≥90%。效率通过疗程持续时间≤2小时来衡量。安全性通过报告的与远程评估相关的不良事件数量来衡量。
36名参与者的数据被纳入这项可行性研究,34名(94%)参与者在没有技术问题的情况下完成了所有远程评估。在效率方面,远程评估疗程的平均完成时间为65分钟,最长疗程为110分钟。没有报告不良事件表明对远程评估的安全性存在担忧。
针对新冠疫情限制而修改的远程评估方案,对于将行动不便的成年人纳入家庭锻炼试验可能是一个可行的过程,否则这些成年人可能无法参与。
ClinicalTrials.gov NCT03024320;https://clinicaltrials.gov/ct2/show/NCT03024320 。