Background The SARS-CoV-2 (COVID-19) pandemic may accelerate the adoption of digital, decentralized clinical trials. Conceptual recommendations for digitalized and remote clinical studies and technology are available to enable digitalization. Fully remote studies may break down some of the participation barriers in traditional trials. However, they add logistical complexity and offer fewer opportunities to intervene following a technical failure or adverse event. Objective Our group designed an end-to-end digitalized clinical study protocol, using the Food and Drug Administration (FDA)–cleared Current Health (CH) remote monitoring platform to collect symptoms and continuous physiological data of individuals recently infected with COVID-19 in the community. The purpose of this work is to provide a detailed example of an end-to-end digitalized protocol implementation based on conceptual recommendations by describing the study setup in detail, evaluating its performance, and identifying points of success and failure. Methods Primary recruitment was via social media and word of mouth. Informed consent was obtained during a virtual appointment, and the CH-monitoring kit was shipped directly to the participants. The wearable continuously recorded pulse rate (PR), respiratory rate (RR), oxygen saturation (SpO2), skin temperature, and step count, while a tablet administered symptom surveys. Data were transmitted in real time to the CH cloud-based platform and displayed in the web-based dashboard, with alerts to the study team if the wearable was not charged or worn. The study duration was up to 30 days. The time to recruit, screen, consent, set up equipment, and collect data was quantified, and advertising engagement was tracked with a web analytics service. Results Of 13 different study advertisements, 5 (38.5%) were live on social media at any one time. In total, 38 eligibility forms were completed, and 19 (50%) respondents met the eligibility criteria. Of these, 9 (47.4%) were contactable and 8 (88.9%) provided informed consent. Deployment times ranged from 22 to 110 hours, and participants set up the equipment and started transmitting vital signs within 7.6 (IQR 6.3-10) hours of delivery. The mean wearable adherence was 70% (SD 19%), and the mean daily survey adherence was 88% (SD 21%) for the 8 participants. Vital signs were in normal ranges during study participation, and symptoms decreased over time. Conclusions Evaluation of clinical study implementation is important to capture what works and what might need to be modified. A well-calibrated approach to online advertising and enrollment can remove barriers to recruitment and lower costs but remains the most challenging part of research. Equipment was effectively and promptly shipped to participants and removed the risk of illness transmission associated with in-person encounters during a pandemic. Wearable technology incorporating continuous, clinical-grade monitoring offered an unprecedented level of detail and ecological validity. However, study planning, relationship building, and troubleshooting are more complex in the remote setting. The relevance of a study to potential participants remains key to its success.

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.

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ObjectiveTo describe the healthcare provider (HCP) experience of launching a COVID-19 remote patient monitoring (CRPM) program during the global COVID-19 pandemic.MethodsWe conducted qualitative, semi-structured interviews with eight HCPs involved in deploying the CRPM pilot program in the Military Health System (MHS) from June to December 2020. Interviews were thematically audio recorded, transcribed, and analyzed using an inductive approach. We then deductively mapped themes from interviews to the updated Consolidated Framework for Implementation Research (CFIR).ResultsWe identified the following main themes mapped to CFIR domains listed in parentheses: external and internal environments (outer and inner settings), processes around implementation (implementation process domain), the right people (individuals domain), and program characteristics (innovation domain). Participants believed that buy-in from leadership and HCPs was critical for successful program implementation. HCP participants showed qualities of clinical champions and believed in the CRPM program.ConclusionThe MHS deployed a successful remote patient monitoring pilot program during the global COVID-19 pandemic. HCPs found the CRPM program and the technology enabling the program to be acceptable, feasible, and usable. HCP participants exhibited characteristics of clinical champions. Leadership engagement was the most often-cited key factor for successful program implementation.

BACKGROUND During the COVID-19 pandemic, individuals with a positive viral test were enrolled within 48 hours in a study to remotely monitor their vital signs to characterise disease progression and recovery. A virtual trial design was adopted to reduce risks to participants and the research community. The Current Health platform with wearable device, which enables hospital level care at home, including continuous remote patient monitoring (CRPM) was used as a data collection tool. Enrolled participants wore the Current Health wearable continuously for up to 30 days and took a daily symptom survey via a provided tablet. A qualitative sub-study was conducted in parallel to better understand virtual trial implementation, including the barriers and facilitators for participants. OBJECTIVE This study aims to understand the barriers and facilitators around 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 Semi-structured interviews were conducted to understand the participant experience of participating in a virtual study during a global pandemic. The schedule included their experience of enrolment, and their interactions with equipment and study staff. Three RiskSEARCH participants were interviewed by phone and transcriptions were inductively coded and analysed using thematic analysis. Themes were mapped onto the Theoretical Domains Framework (TDF) to identify and describe factors that influenced study adherence. Quantitative metrics, including adherence for the 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 low burden. Their 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 sub-study showed high levels of adherence and engagement throughout participation. While participants experienced some challenges in setting up and maintaining the Current Health kit (e.g., charging devices), they reported feeling like the requirements of participation were both reasonable and realistic. We have 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 around implementation. CLINICALTRIAL US National Library of Medicine (clinicaltrials.gov) NCT04709068