Assessing the Use of Mobile Technology in Adult Asthma Patients

NCT ID: NCT03103880

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2018-08-29

Brief Summary

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

Detailed Description

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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. BreatheSmart mobile application that sends subjects real-time alerts and allows patients respond to questionnaires / surveys.

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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BreatheSmart

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.

Group Type EXPERIMENTAL

BreatheSmart

Intervention Type 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.

Interventions

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BreatheSmart

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CoheroHealth

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Tam, MPH

Role: STUDY_DIRECTOR

Cohero Health, Inc.

Locations

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Cohero Health, Inc.

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19183166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25840665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19767070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23058645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22401649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22123375 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29071077 (View on PubMed)

Other Identifiers

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2017 Observational Study 1.0

Identifier Type: -

Identifier Source: org_study_id

NCT05712863

Identifier Type: -

Identifier Source: nct_alias

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