JMIR Publications

ABSTRACT

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. Clinical Trial: US National Library of Medicine (clinicaltrials.gov) NCT04709068