Leveraging Telehealth to Overcome Research Implementation and Data Collection Challenges in the Era of COVID-19

项目摘要 在2019冠状病毒病大流行的时代， 在世界各地开展健康研究。保健系统、保健提供者和病人 同样受到封锁，旅行限制，社会需求的负面影响， 远距离，缺乏个人防护设备等。符合新要求 已导致方案调整和实地研究操作中的意外费用。的 行政补充资金申请的动机是我们的团队致力于完成数据 收集，以获得具有足够统计学显著性把握度的样本量。母研究 方案要求在基线期间研究人员和患者之间进行密切的面对面互动 入组和随访。基线入组访视包括面对面的研究筛选 合格性、获得书面知情同意书、临床评估、基线问卷和培训 作为试验的一部分，VDOT干预部门的患者使用智能手机应用程序。后续 包括3次亲自访问和在诊所的后续访问。到目前为止，母研究时间轴将于4月到期 截至2021年12月30日，只有30.6%的研究参与者完成了研究。的目标 补充是修改研究实施方案，以增加远程保健的使用， 效率、安全性和完成随访。本项目的目标将得以实现 通过以下具体目标。

Project Summary In the era of the COVID-19 pandemic there has been an unprecedented scale of disruption in implementation of health research around the world. Health systems, health providers and patients alike have been negatively impacted by the lockdowns, restrictions to travel, the need for social distancing, the lack of personal protective equipment among others. Compliance to new requirements has resulted in protocol adjustments and unexpected expenses in the field research operations. The administrative supplemental funding request is motivated by our team’s commitment to complete data collection to achieve a sample size with adequate power for statistical significance. The parent study protocol required close in-person interactions between research staff and patients during the baseline enrollment and follow up visits. The baseline enrollment visit involves face-to-face screening for study eligibility, obtaining written informed consent, clinical assessment, a baseline questionnaire and training patients in the VDOT intervention arm to use of a smartphone app as part of the trial. The follow-up involves 3 in-person visits follow up visits at the clinics. To-date, the parent study timeline expires April 30th 2021, yet only 30.6% of the study participants have completed the study. The goal of the supplement is to modify study implementation protocols to increase use of telehealth to enhance efficiency, safety and completion of follow up visits. The goal of this project will be accomplished through the following specific aims.