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This is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids.
The study consists of one interventional group and all 104 subjects will be included in this group. All subjects will be provided with the HeroTracker package, which includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreatheSmart | Experimental | 104 subjects will be provided with the BreatheSmart platform, which consists of:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreatheSmart | Device | BreatheSmart is a comprehensive asthma monitoring system that combines a medical device and mobile application that are designed for use with Apple and Android mobile devices. The medical device connects to the mobile application using Bluetooth to facilitate the collection of controlled medication adherence, rescue medication usage, and asthma control. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in asthma control | Determine change in the asthma control test (ACT), a validated asthma test, in subjects using the BreatheSmart system from baseline to 3 months. | 3 months |
| Change in rescue medication usage | Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in controller medication adherence | Obtain medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline to 3 months. | 3 months |
| Acceptability of BreatheSmart system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Tam, MPH | Cohero Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cohero Health, Inc. | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19183166 | Background | Lasmar L, Camargos P, Champs NS, Fonseca MT, Fontes MJ, Ibiapina C, Alvim C, Moura JA. Adherence rate to inhaled corticosteroids and their impact on asthma control. Allergy. 2009 May;64(5):784-9. doi: 10.1111/j.1398-9995.2008.01877.x. Epub 2009 Jan 21. | |
| 25840665 | Background | Chan AH, Harrison J, Black PN, Mitchell EA, Foster JM. Using electronic monitoring devices to measure inhaler adherence: a practical guide for clinicians. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):335-49.e1-5. doi: 10.1016/j.jaip.2015.01.024. Epub 2015 Apr 1. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
Acceptability questionnaire (delivered through the BreatheSmart mobile application) that includes subjects' opinion on the platform, features, usability, and usefulness.
| 3 months |
| 19767070 | Background | Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19. |
| 23058645 | Background | Jia CE, Zhang HP, Lv Y, Liang R, Jiang YQ, Powell H, Fu JJ, Wang L, Gibson PG, Wang G. The Asthma Control Test and Asthma Control Questionnaire for assessing asthma control: Systematic review and meta-analysis. J Allergy Clin Immunol. 2013 Mar;131(3):695-703. doi: 10.1016/j.jaci.2012.08.023. Epub 2012 Oct 8. |
| 22401649 | Background | Melosini L, Dente FL, Bacci E, Bartoli ML, Cianchetti S, Costa F, Di Franco A, Malagrino L, Novelli F, Vagaggini B, Paggiaro P. Asthma control test (ACT): comparison with clinical, functional, and biological markers of asthma control. J Asthma. 2012 Apr;49(3):317-23. doi: 10.3109/02770903.2012.661008. Epub 2012 Mar 9. |
| 22123375 | Background | Korn S, Both J, Jung M, Hubner M, Taube C, Buhl R. Prospective evaluation of current asthma control using ACQ and ACT compared with GINA criteria. Ann Allergy Asthma Immunol. 2011 Dec;107(6):474-9. doi: 10.1016/j.anai.2011.09.001. Epub 2011 Oct 5. |
| 29071077 | Derived | Melvin E, Cushing A, Tam A, Kitada R, Manice M. Assessing the use of BreatheSmart(R) mobile technology in adult patients with asthma: a remote observational study. BMJ Open Respir Res. 2017 Aug 16;4(1):e000204. doi: 10.1136/bmjresp-2017-000204. eCollection 2017. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |