Assessing the Use of Mobile Technology in Adult Asthma Patients

Asthma Clinical Trial

Official title:

Assessing the Use of Digital Therapeutic in Adult Asthma Patients: A Remote Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103880
• Other study ID #: 2017 Observational Study 1.0
• Status: Completed
• Phase: N/A
• Start date: April 21, 2017
• Est. completion date: August 29, 2018

Study information

• Verified date: September 2023
• Source: CoheroHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT05712863

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Cohero Health, Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
CoheroHealth

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in rescue medication usage	Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months.	3 months
Secondary	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
Secondary	Acceptability of BreatheSmart system	Acceptability questionnaire (delivered through the BreatheSmart mobile application) that includes subjects' opinion on the platform, features, usability, and usefulness.	3 months