Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

Study Overview
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Brief Summary
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This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control

Detailed Description
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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.

Official Title
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Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Electronic sensor and OW education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic sensor and OW education<br>MDI sensor-generated alerts will be relayed and responded to (e.g. outreach worker contacts the participant 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 asthma education over the phone | Behavioral: Electronic sensor and OW education<br>* 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<br>|
| No Intervention: Usual Care<br>Usual care group will receive the electronic tracker but the sensor-generated alerts will not be delivered. If the usual care group rescue inhaler data reveals frequent use of rescue medication (daily use for >3 days) investigators will reach out (via app or phone call) to advise the participant to see their physician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Test | validated asthma control measure | change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | measured by electronic sensor | change from baseline to 6 months | 
| Health care utilization | ED visits and hospitalizations will be assessed via electronic health records | change from baseline to 6 months |