Skip to main content
OpenTrials
Completed

NCT Number: NCT03103880

Assessing the Use of Mobile Technology in Adult Asthma Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Behavior Bronchial Diseases Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Patient Acceptance of Health Care Patient Compliance Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cohero Health, Inc.

New York, 10017, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BreatheSmart

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

CoheroHealth

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.