Abstract
Supportive couple relationships are associated with reduced risk of chronic illness development, such as cardiovascular disease, as well as improved secondary prevention. Healing Hearts Together (HHT) is an 8-week couples-based intervention designed to improve relationship quality, mental health, quality of life, and cardiovascular health among couples in which one partner has experienced a cardiac event. A randomized controlled trial began in October 2019 to test the efficacy of the in-person, group-based HHT program as compared to usual care. In March of 2020, all recruitment, assessments, and interventions halted due to the COVID-19 pandemic. Guided by optimal virtual care principles, as well as by Hom and colleagues’ four-stage framework—consultation, adaptation, pilot-testing, and test launch—this paper is a tutorial for the step-by-step transition planning and implementation of a clinical research intervention from an in-person to a web-based format, using the HHT program as an example. Clinical and research considerations are reviewed, including (1) privacy, (2) therapeutic aspects of the intervention, (3) group cohesion, (4) research ethics, (5) participant recruitment, (6) assessment measures, (7) data collection, and (8) data analyses. This tutorial can assist clinical researchers in transitioning their research programs to a web-based format during the pandemic and beyond.
Highlights
This tutorial aims to help clinical researchers transition their in-person research programs to a web-based format during the pandemic and beyond
Preliminary results from a proof-of-concept study indicated that couples who participated in the Healing Hearts Together (HHT) program reported significant improvements in relationship quality, mental health, and quality of life [25]
Once the approval was received, a form requesting permission to restart our research study was submitted to our research services department lead by the chief scientific officer of our institution
Summary
This tutorial aims to help clinical researchers transition their in-person research programs to a web-based format during the pandemic and beyond. Preliminary results from a proof-of-concept study indicated that couples who participated in the HHT program reported significant improvements in relationship quality, mental health, and quality of life [25] Based on these promising results and to assess the efficacy of the HHT program on a larger sample with additional cardiovascular outcomes, an RCT was initiated. In June 2020, researchers at the hospital were asked to adapt their research protocols to allow for as much virtual care as possible Following these directives, the HHT research team began to focus on how to do this while following best practices and preserving the integrity of the trial (see Figure 1 for a timeline of the transition to a web-based intervention during COVID-19). J Med Internet Res 2021 | vol 23 | iss. 4 | e25502 | p. 2 (page number not for citation purposes)
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