Asthma
Conditions
Keywords
Patient adherence, Mobile application, Mobile health, Digital therapeutics, Digital health
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.
Interventions
DEVICEBreatheSmart
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.
Sponsors
CoheroHealth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in rescue medication usage | 3 months | Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed