A digital approach to asthma self-management in adults: Protocol for a pragmatic randomized controlled trial

• DOI: 10.1016/j.cct.2022.106902
• Publication Date: 2022-08-30T01:38:05Z
• Authors: 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; Richard A. Lee
• Keywords: Adult; 03 medical and health sciences; Critical Care; Self-Management; Pragmatic Clinical Trials as Topic; Humans; 0305 other medical science; Mobile Applications; Asthma; Monitoring, Physiologic; Randomized Controlled Trials as Topic; 3. Good health

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.