Adaptations to the RVA Breathes clinical trial due to the COVID-19 pandemic.

ABSTRACT

RVA Breathes, a community program to improve asthma management and care coordination among children living in a low-income, urban area, is being evaluated in a randomized clinical trial. In March 2020, RVA Breathes was converted to a remote program due to the COVID-19 pandemic; this report provides an update on the modifications made to the RVA Breathes trial. Additionally, given that families in the program have been disproportionally impacted by both COVID-19 and significant social unrest at both the local and national level, strategies used to enroll and engage families in the trial who bore disproportionately high burdens during this time period are outlined. Remote sessions (telephone or video) for families enrolled in the program prior to the onset of COVID-19 began in April 2020; enrollment of new families began remotely in July 2020 using adapted consent procedures. Baseline, intervention, and follow-up sessions were delivered either via the telephone or video depending upon family preference. Strategies were implemented to engage caregivers and children in completing measures over the telephone or video versus in person. Tangible intervention materials and participant payments were dropped off at family homes using contactless procedures. Our team was able to adapt and safely continue a large, community-based clinical trial, despite the increased health risks and social isolation mandates from the pandemic, by transitioning to a remote format. Challenges remain in determining whether RVA Breathes as a remote program has had the same impact on child asthma as the face-to-face interventions that comprised its original format.