Study to Determine the Impact of BreatheSmart on Asthma Control in Adult Asthmatics

January 26, 2023 updated by: CoheroHealth

A Prospective, Observational Study to Assess Changes in Asthma Control in Adults With Asthma Managed on BreatheSmart

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, observational study of adults with persistent asthma who are managed on inhaled corticosteroids (ICS). 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 offers remote clinical-grade lung function monitoring
  • BreatheSmart mobile application that sends subjects real-time alerts and allow patients to enter quality of life data.

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
      • Mount Kisco, New York, United States, 10549
        • North Westchester Hospital

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and/or female adults (aged ≥ 18 years)
  • Ability to provide written informed consent
  • Owns a compatible smartphone (iOS 8.0 or higher, or Android 4.3 or higher) and is familiar with the download and management of software applications

  • Diagnosis of persistent asthma for at least 6 months duration with evidence of poorly controlled disease defined as having at least one of the following within 12 months prior to consent:

    • exacerbation of asthma symptoms requiring pulse of corticosteroids
    • acute asthma event that resulted in an emergency department or urgent care visit
    • hospitalization for asthma related care
  • Managed on inhaled corticosteroid (ICS) medication for at least 3 months prior to enrollment. Stable dose of oral corticosteroids and/or biologic therapy is also permissable
  • Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker
  • Non-smoker, or ≤ 10 pack/year history of tobacco use and abstinence for at least 1 year

Exclusion Criteria:

  • Presence of other significant chronic lung disease or condition such as chronic obstructive pulmonary disease, cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, primary pulmonary hypertension, or presence of tracheostomy
  • Presence of other chronic medical conditions such as congenital heart disease or immunodeficiency,
  • Presence of other comorbidities that, in the opinion of the investigator, will interfere with the collection of study procedures, or limit life expectancy to < 1 year
  • Currently pregnant/breast feeding or planning to become pregnant during the study period
  • Primary language other than English or Spanish

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BreatheSmart Intervention

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

  • HeroTracker asthma sensor that counts asthma dosage and monitors real-time medication adherence
  • Mobile Spirometer that offers remote clinical-grade lung function monitoring
  • BreatheSmart mobile application that provides patients with real-time alerts and allows patients to complete quality of life surveys
Device: BreatheSmart
BreatheSmart is a comprehensive asthma monitoring system combining medical devices and a mobile application 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 medication adherence and lung function data.

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 using 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
We plan to obtain the medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline, 1 month post-baseline, 2-months post-baseline, and 3-months post-baseline. We will then display the monthly averaged medication treatment adherence and calculate the difference in medication adherence between baseline and 3-months post-baseline, which will be expressed as a percentage increase or decrease.
3 months

Collaborators and Investigators

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

Sponsor

CoheroHealth

Collaborators

Databean

Investigators

  • Study Director: Anne Tam, Consultant

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

January 15, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (ACTUAL)

February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-001

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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