Asthma
Conditions
Brief summary
This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control
Detailed description
This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx. Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.
Interventions
BEHAVIORALElectronic sensor and OW education
MDI sensor-generated alerts will be relayed via app platform on participant's phone and responded to (e.g. outreach worker contacts the patient for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide education over the phone
Sponsors
Stony Wold-Herbert Fund, Inc.
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma * Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year * Use of daily controller inhaler medications * Adult non-smokers, or lifetime use \<5 pack years with no smoking in last 1 yr * Smartphone required * English or Spanish speaking
Exclusion criteria
* No smartphone * Use of oral corticosteroids in prior 4 weeks * Pregnancy * Psychiatric conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test | change from baseline to 6 months | validated asthma control measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | change from baseline to 6 months | measured by electronic sensor |
| Health care utilization | change from baseline to 6 months | ED visits and hospitalizations will be assessed via electronic health records |
Countries
United States
Outcome results
None listed