1. A digital approach to asthma self-management in adults: Protocol for a pragmatic randomized controlled trial
- Author
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Jordan Silberman, Siavash Sarlati, Bronwyn Harris, Warris Bokhari, Homer Boushey, Asha Chesnutt, Peter Zhu, Kelly Sitts, Thomas H. Taylor, Vincent J. Willey, Emmanuel Fuentes, Matthew LeKrey, Evan Hou, Manpreet Kaur, Christian Niyonkuru, Guido Muscioni, Matt T. Bianchi, Daniela A. Bota, and Richard A. Lee
- Subjects
Adult ,Critical Care ,Self-Management ,Pragmatic Clinical Trials as Topic ,Humans ,Pharmacology (medical) ,General Medicine ,Mobile Applications ,Asthma ,Monitoring, Physiologic ,Randomized Controlled Trials as Topic - Abstract
Asthma self-management can improve symptom control, but adherence to established self-management behaviors is often poor. With adult asthma uncontrolled in over 60% of U.S. cases, there is a need for scalable, cost-effective tools to improve asthma outcomes. Here we describe a protocol for the Asthma Digital Study, a 24-month, decentralized, pragmatic, open-label, randomized controlled trial investigating the impact of a digital asthma self-management (DASM) program on asthma outcomes in adults. The program leverages consumer-grade devices with a smartphone app to provide "smart nudges," symptom logging, trigger tracking, and other features. Participants are recruited (target N = 900) from throughout the U.S., and randomized to a DASM or control arm (1:1). Co-primary outcomes at one year are a) asthma-associated costs for acute care and b) change from baseline in Asthma Control Test™ scores. Findings may inform decisions around adoption of digital tools for asthma self-management. Trial registration:clinicaltrials.gov identifier: NCT04609644. Registered: Oct 30, 2020.
- Published
- 2022