The NINR-funded RCT tested the effectiveness of a 6-week intervention (Heart Up!) on increasing physical activity and decreasing hopelessness in adults with ischemic heart disease (IHD). Prior to the COVID-19 mitigation and containment efforts in March 2020, 43 participants had been enrolled. The RCT collected multiple key variables (hopelessness, depression, suicidal ideation, anxiety, perceived social support, study enrollment motivation, quality of life, well-being, and physical activity) at three time points over 6 months to improve understanding of how the RCT’s intervention could change the impact of shelter-in-place/physical distancing measures on important mental, social, and behavioral health outcomes in a vulnerable population.

At the time of shelter-in-place/physical distancing, rather than pausing the protocol, the delivery of in-person data collection and intervention components was modified to remote (phone and video conferencing). The team received IRB approval to resume enrollment of hospitalized patients either in person or remotely, resulting in a COVID-19-compatible RCT. Enrollment resumed on May 29. Based on current information about the pandemic, adults with IHD were at higher risk for severe illness and death from COVID-19.

Given the high-risk population, remote intervention, key variables already being collected, longitudinal design, and timing of the study launch, the project was in an excellent position to contribute new knowledge about important mental, social, and behavioral health characteristics of the pandemic that might be positively impacted by the RCT’s intervention.