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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| Veröffentlicht in: | Contemporary clinical trials 2022-11, Vol.122, p.106902-106902, Article 106902 |
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| creator | 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. |
| description | 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. |
| doi_str_mv | 10.1016/j.cct.2022.106902 |
| format | Article |
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Trial registration:clinicaltrials.gov identifier: NCT04609644. Registered: Oct 30, 2020.</description><identifier>ISSN: 1551-7144</identifier><identifier>EISSN: 1559-2030</identifier><identifier>DOI: 10.1016/j.cct.2022.106902</identifier><identifier>PMID: 36049674</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>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</subject><ispartof>Contemporary clinical trials, 2022-11, Vol.122, p.106902-106902, Article 106902</ispartof><rights>2022 The Authors</rights><rights>Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c396t-97ec5da7319dca89f8b32599c3c035f7dc76e52f308cc7e94e1a0627cd41f62c3</citedby><cites>FETCH-LOGICAL-c396t-97ec5da7319dca89f8b32599c3c035f7dc76e52f308cc7e94e1a0627cd41f62c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1551714422002282$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36049674$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Silberman, Jordan</creatorcontrib><creatorcontrib>Sarlati, Siavash</creatorcontrib><creatorcontrib>Harris, Bronwyn</creatorcontrib><creatorcontrib>Bokhari, Warris</creatorcontrib><creatorcontrib>Boushey, Homer</creatorcontrib><creatorcontrib>Chesnutt, Asha</creatorcontrib><creatorcontrib>Zhu, Peter</creatorcontrib><creatorcontrib>Sitts, Kelly</creatorcontrib><creatorcontrib>Taylor, Thomas H.</creatorcontrib><creatorcontrib>Willey, Vincent J.</creatorcontrib><creatorcontrib>Fuentes, Emmanuel</creatorcontrib><creatorcontrib>LeKrey, Matthew</creatorcontrib><creatorcontrib>Hou, Evan</creatorcontrib><creatorcontrib>Kaur, Manpreet</creatorcontrib><creatorcontrib>Niyonkuru, Christian</creatorcontrib><creatorcontrib>Muscioni, Guido</creatorcontrib><creatorcontrib>Bianchi, Matt T.</creatorcontrib><creatorcontrib>Bota, Daniela A.</creatorcontrib><creatorcontrib>Lee, Richard A.</creatorcontrib><title>A digital approach to asthma self-management in adults: Protocol for a pragmatic randomized controlled trial</title><title>Contemporary clinical trials</title><addtitle>Contemp Clin Trials</addtitle><description>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.</description><subject>Adult</subject><subject>Asthma</subject><subject>Asthma - therapy</subject><subject>Critical Care</subject><subject>Digital health</subject><subject>Digital therapeutics</subject><subject>Humans</subject><subject>Mobile Applications</subject><subject>Monitoring, Physiologic</subject><subject>Pragmatic Clinical Trials as Topic</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Self-Management - methods</subject><subject>Wearable electronic devices</subject><issn>1551-7144</issn><issn>1559-2030</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEtvFDEQhC0EIiHwA7ggH7nM4sfYXsMpinhJkeAAZ6vT7tl45Rkvthcp_HombODIqaulqpLqY-ylFBsppH2z3yD2jRJKrb_1Qj1i59IYPyihxeM_Wg5OjuMZe9baXghtjTVP2Zm2YvTWjecsX_KYdqlD5nA41AJ4y3vh0PrtDLxRnoYZFtjRTEvnaeEQj7m3t_xrLb1gyXwqlQM_VNjN0BPyCkssc_pFkWNZei05r7LXBPk5ezJBbvTi4V6w7x_ef7v6NFx_-fj56vJ6QO1tH7wjNBGclj4ibP20vdHKeI8ahTaTi-gsGTVpsUV05EeSIKxyGEc5WYX6gr0-9a6Dfhyp9TCnhpQzLFSOLSgnvBulUW61ypMVa2mt0hQONc1Q74IU4R5y2IcVcriHHE6Q18yrh_rjzUzxX-Iv1dXw7mSgdeTPRDU0TLQgxVRpLYsl_af-Nz9xjdQ</recordid><startdate>202211</startdate><enddate>202211</enddate><creator>Silberman, Jordan</creator><creator>Sarlati, Siavash</creator><creator>Harris, Bronwyn</creator><creator>Bokhari, Warris</creator><creator>Boushey, Homer</creator><creator>Chesnutt, Asha</creator><creator>Zhu, Peter</creator><creator>Sitts, Kelly</creator><creator>Taylor, Thomas H.</creator><creator>Willey, Vincent J.</creator><creator>Fuentes, Emmanuel</creator><creator>LeKrey, Matthew</creator><creator>Hou, Evan</creator><creator>Kaur, Manpreet</creator><creator>Niyonkuru, Christian</creator><creator>Muscioni, Guido</creator><creator>Bianchi, Matt T.</creator><creator>Bota, Daniela A.</creator><creator>Lee, Richard A.</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202211</creationdate><title>A digital approach to asthma self-management in adults: Protocol for a pragmatic randomized controlled trial</title><author>Silberman, Jordan ; 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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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36049674</pmid><doi>10.1016/j.cct.2022.106902</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1551-7144 |
| ispartof | Contemporary clinical trials, 2022-11, Vol.122, p.106902-106902, Article 106902 |
| issn | 1551-7144 1559-2030 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| 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 |
| title | A digital approach to asthma self-management in adults: Protocol for a pragmatic randomized controlled trial |
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