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

被引：3

作者：

Silberman, Jordan ^{[1
]}

Sarlati, Siavash ^{[1
,2
]}

Harris, Bronwyn ^{[3
,11
]}

Bokhari, Warris ^{[1
,12
]}

Boushey, Homer ^{[4
]}

Chesnutt, Asha ^{[3
]}

Zhu, Peter ^{[3
]}

Sitts, Kelly ^{[1
,13
]}

Taylor, Thomas H. ^{[5
]}

Willey, Vincent J. ^{[6
]}

Fuentes, Emmanuel ^{[1
]}

LeKrey, Matthew ^{[1
]}

Hou, Evan ^{[1
]}

Kaur, Manpreet ^{[1
]}

Niyonkuru, Christian ^{[1
]}

Muscioni, Guido ^{[7
]}

Bianchi, Matt T. ^{[3
]}

Bota, Daniela A. ^{[8
,9
]}

Lee, Richard A. ^{[10
]}

机构：

[1] Elevance Hlth, Carelon Digital Platforms, Palo Alto, CA USA

[2] Univ Calif San Francisco, Sch Med, Dept Emergency Med, San Francisco, CA USA

[3] Apple Inc, Cupertino, CA 95014 USA

[4] Univ Calif San Francisco, Sch Med, San Francisco, CA USA

[5] Univ Calif Irvine, Dept Epidemiol, Irvine, CA USA

[6] HealthCore Inc, Wilmington, DE USA

[7] Elevance Hlth, Carelon Digital Platforms, Chicago, IL USA

[8] UC Irvine Sch Med, UCI Ctr Clin Res, Irvine, CA USA

[9] UC Irvine Sch Med, Dept Neurol, Irvine, CA USA

[10] UC Irvine Sch Med, Dept Med, Div Pulm Dis & Crit Care Med, Irvine, CA USA

[11] Carbon Hlth Technol Inc, Oakland, CA USA

[12] Amazon Web Serv, HCLS Global Accounts, Los Angeles, CA USA

[13] GRAIL, San Francisco, CA USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2022年 / 122卷

关键词：

Asthma; Digital health; Digital therapeutics; Wearable electronic devices; ADHERENCE; PARTICIPATION; EXACERBATIONS; QUESTIONNAIRE; PRODUCTIVITY; CHILDREN; OUTCOMES; WORK; RISK;

D O I：

10.1016/j.cct.2022.106902

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Asthma self-management can improve symptom control, but adherence to established self-management behav-iors 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 TestTM scores. Findings may inform decisions around adoption of digital tools for asthma self-management.Trial registration:clinicaltrials.gov identifier: NCT04609644. Registered: Oct 30, 2020.

引用

页数：9

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