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

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 Asthm...

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Published inContemporary clinical trials Vol. 122; p. 106902
Main Authors Silberman, Jordan, Sarlati, Siavash, Harris, Bronwyn, Bokhari, Warris, Boushey, Homer, Chesnutt, Asha, Zhu, Peter, Sitts, Kelly, Taylor, Thomas H., Willey, Vincent J., Fuentes, Emmanuel, LeKrey, Matthew, Hou, Evan, Kaur, Manpreet, Niyonkuru, Christian, Muscioni, Guido, Bianchi, Matt T., Bota, Daniela A., Lee, Richard A.
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.11.2022
Subjects
Adult
Asthma
Asthma - therapy
Critical Care
Digital health
Digital therapeutics
Humans
Mobile Applications
Monitoring, Physiologic
Pragmatic Clinical Trials as Topic
Randomized Controlled Trials as Topic
Self-Management - methods
Wearable electronic devices
RCT
ACT
PROs
FIPS
DASM
NIST
Digital health
Wearable electronic devices
Digital therapeutics
Asthma
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Summary: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.
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ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2022.106902