Back to results

Assessing the Use of Mobile Technology in Adult Asthma Patients

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BreatheSmart

About this trial

This is an interventional health services research trial for Asthma focused on measuring Patient adherence, Mobile application, Mobile health, Digital therapeutics, Digital health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Cohero mHealth HerotrackerTM
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)

Sites / Locations

Cohero Health, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BreatheSmart

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Change in rescue medication usage

Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months.

Secondary Outcome Measures

Change in controller medication adherence

Obtain medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline to 3 months.

Acceptability of BreatheSmart system

Acceptability questionnaire (delivered through the BreatheSmart mobile application) that includes subjects' opinion on the platform, features, usability, and usefulness.

Full Information

NCT ID

NCT03103880

First Posted

March 28, 2017

Last Updated

September 7, 2023

Sponsor

CoheroHealth

1. Study Identification

Unique Protocol Identification Number

NCT03103880

Brief Title

Assessing the Use of Mobile Technology in Adult Asthma Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

April 21, 2017 (Actual)

Primary Completion Date

August 29, 2018 (Actual)

Study Completion Date

August 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CoheroHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Patient adherence, Mobile application, Mobile health, Digital therapeutics, Digital health

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BreatheSmart

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

BreatheSmart

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in asthma control

Description

Determine change in the asthma control test (ACT), a validated asthma test, in subjects using the BreatheSmart system from baseline to 3 months.

Time Frame

3 months

Title

Change in rescue medication usage

Description

Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change in controller medication adherence

Description

Obtain medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline to 3 months.

Time Frame

3 months

Title

Acceptability of BreatheSmart system

Description

Acceptability questionnaire (delivered through the BreatheSmart mobile application) that includes subjects' opinion on the platform, features, usability, and usefulness.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Tam, MPH

Organizational Affiliation

Cohero Health, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Cohero Health, Inc.

City

New York

State/Province

New York

ZIP/Postal Code

10017

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19183166

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.

Results Reference

background

PubMed Identifier

25840665

Citation

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.

Results Reference

background

PubMed Identifier

19767070

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.

Results Reference

background

PubMed Identifier

23058645

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.

Results Reference

background

PubMed Identifier

22401649

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.

Results Reference

background

PubMed Identifier

22123375

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.

Results Reference

background

PubMed Identifier

29071077

Citation

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.

Results Reference

derived

Learn more about this trial

Assessing the Use of Mobile Technology in Adult Asthma Patients

We'll reach out to this number within 24 hrs