Assessing the Use of Digital Therapeutic in Adult Asthma Patients: A Remote Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Change in rescue medication usage
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
BreatheSmart
104 subjects will be provided with the BreatheSmart platform, which consists of:
- HeroTracker sensor that monitors real-time asthma medication adherence
- BreatheSmart mobile application that provides patients with real-time alerts, environmental information (weather, pollution, etc.), and the ability to complete questionnaires / surveys.
Intervention: BreatheSmart (Device)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change in controller medication adherence(3 months)
- Acceptability of BreatheSmart system(3 months)