Assessing the Use of Mobile Technology in Adult Asthma Patients

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

Detailed Description
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Device: BreatheSmart


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BreatheSmart<br>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. | Device: BreatheSmart<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| Change in rescue medication usage | 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 | 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 | Acceptability questionnaire (delivered through the BreatheSmart mobile application) that includes subjects' opinion on the platform, features, usability, and usefulness. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient adherence, Mobile application, Mobile health, Digital therapeutics, Digital health