Assessing the Use of Mobile Technology in Adult Asthma Patients

NCT03103880 | Completed FDA Device

• 1 other identifier: 2017 Observational Study 1.0
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Patient adherence; Mobile application; Mobile health; Digital therapeutics; Digital health

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Change in controller medication adherence

  3 months

• Acceptability of BreatheSmart system

  3 months

Study Arms (1)

BreatheSmart

EXPERIMENTAL

104 subjects will be provided with the BreatheSmart platform, which consists of: 1. HeroTracker sensor that monitors real-time asthma medication adherence 2. BreatheSmart mobile application that provides patients with real-time alerts, environmental information (weather, pollution, etc.), and the ability to complete questionnaires / surveys.

Device: BreatheSmart

Interventions

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.

BreatheSmart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• CoheroHealth: lead

Study Sites (1)

Cohero Health, Inc.

New York, New York, 10017, United States

Location

Related Publications (7)

• 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.

  PMID: 19183166 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.

  PMID: 25840665 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.

  PMID: 19767070 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.

  PMID: 23058645 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.

  PMID: 22401649 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.

  PMID: 22123375 BACKGROUND

• 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.

  PMID: 29071077 DERIVED

MeSH Terms

Conditions

Asthma; Patient Compliance

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anne Tam, MPH

  Cohero Health, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 6, 2017
• Study Start: April 21, 2017
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)