Abstract：
BACKGROUND: During the COVID-19 pandemic, individuals with a positive viral test were enrolled in a study, within 48 hours, to remotely monitor their vital signs to characterize disease progression and recovery. A virtual trial design was adopted to reduce risks to participants and the research community in a study titled Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization (RiskSEARCH). The Food and Drug Administration-cleared Current Health platform with a wearable device is a continuous remote patient monitoring technology that supports hospital-at-home care and is used as a data collection tool. Enrolled participants wore the Current Health wearable device continuously for up to 30 days and took a daily symptom survey via a tablet that was provided. A qualitative substudy was conducted in parallel to better understand virtual trial implementation, including barriers and facilitators for participants.
OBJECTIVE: This study aimed to understand the barriers and facilitators of the user experience of interacting with a virtual care platform and research team, while participating in a fully virtual study using qualitative and quantitative data.
METHODS: Semistructured interviews were conducted to understand participants\' experience of participating in a virtual study during a global pandemic. The schedule included their experience of enrollment and their interactions with equipment and study staff. A total of 3 RiskSEARCH participants were interviewed over telephone, and transcriptions were inductively coded and analyzed using thematic analysis. Themes were mapped onto the Theoretical Domains Framework (TDF) to identify and describe the factors that influenced study adherence. Quantitative metrics, including adherence to wearable and scheduled tasks collected as part of the RiskSEARCH main study, were paired with the interviews to present an overall picture of participation.
RESULTS: All participants exceeded our definition of a fully adherent participant and reported that participation was feasible and had a low burden. The symptoms progressively resolved during the trial. Inductive thematic analysis identified 13 main themes from the interview data, which were deductively mapped onto 11 of the 14 TDF domains, highlighting barriers and facilitators for each.
CONCLUSIONS: Participants in the RiskSEARCH substudy showed high levels of adherence and engagement throughout participation. Although participants experienced some challenges in setting up and maintaining the Current Health kit (eg, charging devices), they reported feeling that the requirements of participation were both reasonable and realistic. We demonstrated that the TDF can be used for inductive thematic analysis. We anticipate expanding this work in future virtual studies and trials to identify barriers and enabling factors for implementation.
OBJECTIVE: This study aimed to understand the barriers and facilitators of the user experience of interacting with a virtual care platform and research team, while participating in a fully virtual study using qualitative and quantitative data.
METHODS: Semistructured interviews were conducted to understand participants\' experience of participating in a virtual study during a global pandemic. The schedule included their experience of enrollment and their interactions with equipment and study staff. A total of 3 RiskSEARCH participants were interviewed over telephone, and transcriptions were inductively coded and analyzed using thematic analysis. Themes were mapped onto the Theoretical Domains Framework (TDF) to identify and describe the factors that influenced study adherence. Quantitative metrics, including adherence to wearable and scheduled tasks collected as part of the RiskSEARCH main study, were paired with the interviews to present an overall picture of participation.
RESULTS: All participants exceeded our definition of a fully adherent participant and reported that participation was feasible and had a low burden. The symptoms progressively resolved during the trial. Inductive thematic analysis identified 13 main themes from the interview data, which were deductively mapped onto 11 of the 14 TDF domains, highlighting barriers and facilitators for each.
CONCLUSIONS: Participants in the RiskSEARCH substudy showed high levels of adherence and engagement throughout participation. Although participants experienced some challenges in setting up and maintaining the Current Health kit (eg, charging devices), they reported feeling that the requirements of participation were both reasonable and realistic. We demonstrated that the TDF can be used for inductive thematic analysis. We anticipate expanding this work in future virtual studies and trials to identify barriers and enabling factors for implementation.
摘要：
背景：在COVID-19大流行期间，病毒检测呈阳性的个体参加了一项研究，48小时内,远程监测他们的生命体征，以表征疾病进展和恢复。在一项名为“关于COVID-19住院的风险分层和早期警报”（RiskSEARCH）的研究中，采用了虚拟试验设计，以降低参与者和研究界的风险。食品和药物管理局批准的带有可穿戴设备的CurrentHealth平台是一种连续的远程患者监测技术，可支持医院的家庭护理，并用作数据收集工具。注册参与者连续佩戴CurrentHealth可穿戴设备长达30天，并通过提供的平板电脑进行每日症状调查。并行进行了定性子研究，以更好地了解虚拟试验的实施，包括参与者的障碍和促进者。
目的：本研究旨在了解与虚拟护理平台和研究团队进行交互的用户体验的障碍和促进因素，同时使用定性和定量数据参与完全虚拟的研究。
方法：进行了半结构化访谈，以了解参与者在全球大流行期间参与虚拟研究的经验。时间表包括他们的注册经验以及与设备和研究人员的互动。共有3名RiskSEARCH参与者通过电话接受了采访，并使用主题分析对转录进行感应编码和分析。将主题映射到理论域框架（TDF）上，以识别和描述影响研究依从性的因素。定量指标，包括对作为RiskSEARCH主要研究的一部分收集的可穿戴和计划任务的依从性，与访谈配对，以呈现参与的整体情况。
结果：所有参与者都超出了我们对完全坚持参与者的定义，并报告说参与是可行的并且负担较低。试验期间症状逐渐缓解。归纳主题分析从访谈数据中确定了13个主要主题，它们被演绎地映射到14个TDF域中的11个，突出每个人的障碍和促进者。
结论：RiskSEARCH子研究的参与者在整个参与过程中表现出高水平的依从性和参与度。尽管参与者在设置和维护当前健康工具包方面遇到了一些挑战(例如，充电设备)，他们报告说，参与的要求既合理又现实。我们证明了TDF可用于归纳主题分析。我们预计在未来的虚拟研究和试验中扩大这项工作，以确定实施的障碍和有利因素。
目的：本研究旨在了解与虚拟护理平台和研究团队进行交互的用户体验的障碍和促进因素，同时使用定性和定量数据参与完全虚拟的研究。
方法：进行了半结构化访谈，以了解参与者在全球大流行期间参与虚拟研究的经验。时间表包括他们的注册经验以及与设备和研究人员的互动。共有3名RiskSEARCH参与者通过电话接受了采访，并使用主题分析对转录进行感应编码和分析。将主题映射到理论域框架（TDF）上，以识别和描述影响研究依从性的因素。定量指标，包括对作为RiskSEARCH主要研究的一部分收集的可穿戴和计划任务的依从性，与访谈配对，以呈现参与的整体情况。
结果：所有参与者都超出了我们对完全坚持参与者的定义，并报告说参与是可行的并且负担较低。试验期间症状逐渐缓解。归纳主题分析从访谈数据中确定了13个主要主题，它们被演绎地映射到14个TDF域中的11个，突出每个人的障碍和促进者。
结论：RiskSEARCH子研究的参与者在整个参与过程中表现出高水平的依从性和参与度。尽管参与者在设置和维护当前健康工具包方面遇到了一些挑战(例如，充电设备)，他们报告说，参与的要求既合理又现实。我们证明了TDF可用于归纳主题分析。我们预计在未来的虚拟研究和试验中扩大这项工作，以确定实施的障碍和有利因素。
