A Decentralized Clinical Trial of a Digital Intervention with Multiple Health Trackers for Heart Failure: Early Learnings and Practical Considerations
摘要
DT4HF (Digital Tools for Heart Failure) is carrying out, to the best of our knowledge, the only fully decentralized randomized clinical trial assessing an intervention for heart failure self-management. Participants in the study use a smart scale and activity tracker to monitor important self-management behaviors, and those in the Intervention Group also play a digital game to help further motivate adherence to these behaviors. All study activities take place remotely. In this paper, we describe our experiences recruiting and enrolling participants during the first six months of the study. We also discuss themes and challenges that are unique to decentralized trials and contribute to existing literature by describing how we have dealt with these issues and what considerations might be relevant to other researchers executing decentralized trials. While completing screening, enrollment, and installation entirely remotely presents challenges, we have already begun to see some of the benefits of the decentralized design and the positive impact the study is having on participants.