Assessing the Use of Mobile Technology in Adult Asthma Patients

September 7, 2023 updated by: CoheroHealth

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10017
        • Cohero Health, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BreatheSmart

104 subjects will be provided with the BreatheSmart platform, which consists of:

  1. HeroTracker sensor that monitors real-time asthma medication adherence
  2. Mobile spirometer that offer remote clinical-grade lung function monitoring
  3. BreatheSmart mobile application that provides patients with real-time alerts, environmental information (weather, pollution, etc.), and the ability to complete questionnaires / surveys.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoheroHealth

Investigators

  • Study Director: Anne Tam, MPH, Cohero Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2017

Primary Completion (Actual)

August 29, 2018

Study Completion (Actual)

August 29, 2018

Study Registration Dates

First Submitted

March 28, 2017

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017 Observational Study 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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