Implementation of a Home Monitoring System for COPD Patients During the SARS-CoV-2 Pandemic: A Feasibility Study

M. Rydberg, A. McDaniel-Harper, K. Hardy, P. Burkett, E. Johnson, M. B. Drummond
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Abstract

RATIONALE: Remote monitoring of COPD patients has the potential to improve clinical outcomes. The ability to successfully deploy home monitoring technologies to COPD patients remotely without in-person encounters is of particular interest during the SARS-CoV-2 pandemic. We present interim results from a prospective implementation study of a home monitoring system in COPD patients at-risk for frequent acute exacerbations of COPD (AECOPD). METHODS: We recruited non-hospitalized individuals aged 40-80 years with spirometryconfirmed COPD and increased AECOPD risk (one hospitalization or two outpatient AECOPD in the prior year). The home system includes: a GoHome™ Data Collection Platform and GoSpiro® spirometer (Monitored Therapeutics, Dublin, OH), and a 3230 pulse oximeter (Nonin Medical, Plymouth, MN). The tablet-based GoHome™ has an auto-start system requiring no computer skills for operation. Eligible participants were contacted via phone, and if interested, were sent a participation kit containing informed consent and the home system. After remotely collecting ICF, participants completed device setup and baseline spirometry using Avatar coaching. At set times, the device collects responses for an automated COPD Action Plan and displays reminders for the patient to use the integrated Bluetooth® spirometer and pulse oximeter. The GoSpiro® measures slow vital capacity (SVC) and forced vital capacity (FVC) using an Avatar-assisted technology coach on the GoHome™ (Figure). The Avatar coaches the patient through each measurement following ATS recommendations for instructions and coaching, followed by error identification and maneuver error correction without human intervention. Patients are engaged daily with the COPD Action Plan. Automated scores return immediate patient guidance along with appropriate clinician alerts. Results are cellular or Wi-Fi uploaded to a cloud server for realtime investigator review. Following demonstrated proficiency, daily measurements of spirometry (FVC Tuesday/Thursday, SVC all other days), daily pulse oximetry and COPD Action Plan were performed. Participant study duration was three months. RESULTS: To date, seven of 12 planned participants have been enrolled. All enrolled participants have successfully activated all device components and performed FVC maneuvers meeting ATS acceptability standards. All participants were able to complete collection and transmission of daily pulse oximetry and COPD Action Plan data. One participant requested study withdrawal after three weeks and six participants remain on study. CONCLUSIONS: Deployment of a COPD home telemonitoring system platform including daily spirometry, pulse oximetry and electronic questionnaire without in-person contact is feasible. This technology may be useful in settings where in-person visits are not feasible due to patient safety, remote location or access-related issues. .
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在SARS-CoV-2大流行期间实施COPD患者家庭监测系统的可行性研究
理由:对慢性阻塞性肺病患者进行远程监测有可能改善临床结果。在SARS-CoV-2大流行期间,成功地将家庭监测技术远程部署到COPD患者而无需亲自接触的能力特别值得关注。我们报告了一项前瞻性实施研究的中期结果,该研究是针对有COPD频繁急性加重(AECOPD)风险的COPD患者的家庭监测系统。方法:我们招募了年龄在40-80岁之间的非住院患者,经肺量测定确诊为COPD,且AECOPD风险增加(前一年住院一次或两次门诊AECOPD)。家庭系统包括:GoHome™数据收集平台和GoSpiro®肺活量计(Monitored Therapeutics, Dublin, OH)和3230脉搏血氧计(Nonin Medical, Plymouth, MN)。基于平板电脑的GoHome™具有自动启动系统,无需计算机技能即可操作。通过电话联系符合条件的参与者,如果感兴趣,将发送一份包含知情同意书和家庭系统的参与工具包。在远程收集ICF后,参与者使用Avatar指导完成设备设置和基线肺活量测定。在设定的时间,该设备收集自动COPD行动计划的响应,并显示提醒,提醒患者使用集成的蓝牙®肺活量计和脉搏血氧计。GoSpiro®使用GoHome™上的avatar辅助技术教练测量慢速肺活量(SVC)和强制肺活量(FVC)(图)。Avatar按照ATS的指导和指导建议指导患者完成每项测量,然后在没有人为干预的情况下进行错误识别和操作错误纠正。患者每天都参与COPD行动计划。自动评分返回即时的患者指导以及适当的临床医生警报。结果通过蜂窝或Wi-Fi上传到云服务器上,供实时调查人员审查。在证明熟练程度后,每日测量肺活量(周二/周四FVC,其他所有天SVC),每日脉搏血氧饱和度和COPD行动计划。参与者的研究时间为三个月。结果:到目前为止,12名计划参与者中有7名已入组。所有参与者都成功激活了所有设备组件,并执行了符合ATS可接受标准的FVC操作。所有参与者都能够完成每日脉搏血氧仪和COPD行动计划数据的收集和传输。一名参与者在三周后要求退出研究,六名参与者继续进行研究。结论:部署COPD家庭远程监测系统平台,包括每日肺活量测定、脉搏血氧仪和电子问卷,无需面对面接触是可行的。在由于患者安全、位置偏远或访问相关问题而无法亲自就诊的情况下,这项技术可能会很有用。
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