The Healing Hearts Together Randomized Controlled Trial and the COVID-19 Pandemic: A Tutorial for Transitioning From an In-Person to a Web-Based Intervention.

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. ©Kathleen Lalande, Paul S Greenman, Karen Bouchard, Susan M Johnson, Heather Tulloch. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.04.2021.

RCT Entities:   Population Interventions Outcomes