Research Article
A Decentralized Clinical Trial of a Digital Intervention with Multiple Health Trackers for Heart Failure: Early Learnings and Practical Considerations
@INPROCEEDINGS{10.1007/978-3-031-59717-6_15, author={Rachel Tunis and Tom Baranowski and Angelica Rangel and James Custer and Edison Thomaz and Paul Rathouz and Jay Bartroff and Christine Julien and Grace Lee and Matthew O’Hair and Miyong Kim and Kavita Radhakrishnan}, title={A Decentralized Clinical Trial of a Digital Intervention with Multiple Health Trackers for Heart Failure: Early Learnings and Practical Considerations}, proceedings={Pervasive Computing Technologies for Healthcare. 17th EAI International Conference, PervasiveHealth 2023, Malm\o{}, Sweden, November 27-29, 2023, Proceedings}, proceedings_a={PERVASIVEHEALTH}, year={2024}, month={6}, keywords={Heart Failure Self-Management Remote Monitoring Decentralized Trials Digital Health}, doi={10.1007/978-3-031-59717-6_15} }- Rachel Tunis
Tom Baranowski
Angelica Rangel
James Custer
Edison Thomaz
Paul Rathouz
Jay Bartroff
Christine Julien
Grace Lee
Matthew O’Hair
Miyong Kim
Kavita Radhakrishnan
Year: 2024
A Decentralized Clinical Trial of a Digital Intervention with Multiple Health Trackers for Heart Failure: Early Learnings and Practical Considerations
PERVASIVEHEALTH
Springer
DOI: 10.1007/978-3-031-59717-6_15
Abstract
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.
