Pugmire Juliana, Lever Taylor Jessie, Wilkes Matt, Wolfberg Adam, Zahradka Nicole
Current Health Ltd, Edinburgh, United Kingdom.
Current Health Inc, Boston, MA, United States.
JMIR Form Res. 2022 Jul 5;6(7):e37567. doi: 10.2196/37567.
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.
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.
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.
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.
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.
在新冠疫情期间，病毒检测呈阳性的个体在48小时内被纳入一项研究，以远程监测他们的生命体征，从而描述疾病的进展和康复情况。在一项名为“关于新冠住院的风险分层与早期预警”（RiskSEARCH）的研究中，采用了虚拟试验设计，以降低对参与者和研究群体的风险。经美国食品药品监督管理局批准的带有可穿戴设备的Current Health平台是一种持续的远程患者监测技术，可支持居家住院护理，并用作数据收集工具。登记的参与者连续30天佩戴Current Health可穿戴设备，并通过提供的平板电脑进行每日症状调查。同时开展了一项定性子研究，以更好地了解虚拟试验的实施情况，包括参与者面临的障碍和促进因素。
本研究旨在利用定性和定量数据，了解在参与一项完全虚拟的研究时，与虚拟护理平台和研究团队互动的用户体验中的障碍和促进因素。
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体验。访谈内容包括他们的入组体验以及与设备和研究人员的互动。通过电话对3名RiskSEARCH参与者进行了访谈，并对访谈记录进行归纳编码，采用主题分析法进行分析。将主题映射到理论领域框架（TDF）上，以识别和描述影响研究依从性的因素。将作为RiskSEARCH主要研究一部分收集的包括可穿戴设备依从性和预定任务依从性在内的定量指标与访谈结果相结合，以呈现参与情况的全貌。
所有参与者都超出了我们对完全依从参与者的定义，并表示参与是可行的，且负担较轻。在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，这些主题被演绎映射到14个TDF领域中的11个，突出了每个领域的障碍和促进因素。
RiskSEARCH子研究的参与者在整个参与过程中表现出高度的依从性和参与度。尽管参与者在设置和维护Current Health套件（如充电设备）方面遇到了一些挑战，但他们表示觉得参与要求既合理又现实。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展这项工作，以确定实施的障碍和促成因素。
