Pivoting during a pandemic: lessons learned from transitioning a multisite randomized controlled trial to a remote protocol in response to COVID-19

Transl Behav Med. 2021 Dec 14;11(12):2187-2193. doi: 10.1093/tbm/ibab103.

Abstract

THR1VE! is an ongoing multisite randomized clinical trial of a positive psychology intervention designed to treat diabetes distress and improve glycemic outcomes in teens with type 1 diabetes. Due to the COVID-19 pandemic restrictions on clinical research and changes in diabetes clinical care, THR1VE! was adapted from an in-person enrollment protocol to a remote protocol through a series of development and testing strategies. We discuss the process of transitioning the protocol and the demonstrated feasibility of ongoing recruitment, enrollment, and retention outcomes. These findings offer support for a remotely transitioned protocol that has larger applications for ongoing and future clinical research.

Keywords: COVID-19; Clinical trial; Protocol; Remote protocol; Type 1 diabetes.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • COVID-19*
  • Humans
  • Multicenter Studies as Topic
  • Pandemics*
  • Randomized Controlled Trials as Topic