Assessing the Use of Mobile Technology in Adult Asthma Patients

Overview

This is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids.

Full Title of Study: “Assessing the Use of Digital Therapeutic in Adult Asthma Patients: A Remote Observational Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 29, 2018

Detailed Description

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: 1. HeroTracker sensor that counts dosage and monitors real-time medication adherence 2. Mobile spirometer that offer remote clinical-grade lung function monitoring 3. BreatheSmart mobile application that sends subjects real-time alerts and allows patients respond to questionnaires / surveys.

Interventions

  • Device: BreatheSmart
    • BreatheSmart is a comprehensive asthma monitoring system that combines a medical device, mobile application, and mobile spirometry designed for use with iOS and Android operating systems. Using Bluetooth to connect, the devices sync with the mobile application to facilitate the collection of controlled medication adherence, rescue medication usage, lung function data, and asthma control.

Arms, Groups and Cohorts

  • Experimental: BreatheSmart
    • 104 subjects will be provided with the BreatheSmart platform, which consists of: HeroTracker sensor that monitors real-time asthma medication adherence Mobile spirometer that offer remote clinical-grade lung function monitoring BreatheSmart mobile application that provides patients with real-time alerts, environmental information (weather, pollution, etc.), and the ability to complete questionnaires / surveys.

Clinical Trial Outcome Measures

Primary Measures

  • Change in asthma control
    • Time Frame: 3 months
    • Determine change in the asthma control test (ACT), a validated asthma test, in subjects using the BreatheSmart system from baseline to 3 months.
  • Change in rescue medication usage
    • Time Frame: 3 months
    • Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months.

Secondary Measures

  • Change in controller medication adherence
    • Time Frame: 3 months
    • Obtain medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline to 3 months.
  • Acceptability of BreatheSmart system
    • Time Frame: 3 months
    • Acceptability questionnaire (delivered through the BreatheSmart mobile application) that includes subjects’ opinion on the platform, features, usability, and usefulness.

Participating in This Clinical Trial

Inclusion Criteria

  • Ability to provide written informed consent – Male and female adults (aged ≥ 18 years) – Diagnosis of asthma for at least 6 months – ICS (inhaled corticosteroid) use for at least 3 months – Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker – Possess a compatible smartphone (iOS 8.0 or higher and Android 4.3 or higher) Exclusion Criteria:

  • Currently pregnant or planning to become pregnant during the study period – Primary language other than English (BreatheSmart mobile app is currently available only in English)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CoheroHealth
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne Tam, MPH, Study Director, Cohero Health, Inc.

References

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.

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.

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.

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.

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.

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.

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