Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Nov 4, 2020
Date Accepted: Feb 15, 2021
Date Submitted to PubMed: Apr 7, 2021
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
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 (RCT) 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, and Hom and colleagues’ (2020) 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 in-person to a web-based platform, 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 transitioning their research programs to a web-based format during the pandemic and beyond.
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