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.
【저자키워드】 COVID-19, Type 1 diabetes, clinical trial, protocol, Remote protocol, 【초록키워드】 Type 1 diabetes, randomized clinical trial, feasibility, COVID-19 pandemic, Intervention, diabetes, outcome, Clinical research, outcomes, clinical, Research, remote, clinical care, recruitment, distress, Support, Positive psychology, Enrollment, treat, offer, IMPROVE, changes in, demonstrated, diabete, glycemic, multisite, transitioned, 【제목키워드】 Randomized controlled trial, multisite,