Assessing the Use of Mobile Technology in Adult Asthma Patients

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Device: BreatheSmart

• Registration Number: NCT03103880
• Lead Sponsor: CoheroHealth

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:

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.

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Study Start: 2017-04-21
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BreatheSmart	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.

Primary Outcome Measures

Name	Time	Method
Change in rescue medication usage	3 months	Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months.
Change in asthma control	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.

Secondary Outcome Measures

Name	Time	Method
Change in controller medication adherence	3 months	Obtain medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline to 3 months.
Acceptability of BreatheSmart system	3 months	Acceptability questionnaire (delivered through the BreatheSmart mobile application) that includes subjects' opinion on the platform, features, usability, and usefulness.

Trial Locations

Locations (1)

Cohero Health, Inc.; 🇺🇸 New York, New York, United States