Albuterol Integrated Adherence Monitoring in Children With Asthma

Study Overview
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Brief Summary
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The investigators propose to evaluate whether an integrated electronic adherence monitoring albuterol rescue inhaler can improve proper use in a mostly minority and inner-city population of children treated for asthma at the Children's Hospital of Los Angeles

Detailed Description
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This study is designed to (1) determine whether an integrated EAM albuterol rescue inhaler can increase proper use (2) determine if the monitoring capabilities of the device (flow rate, warnings) and/or increased proper use from having the device correlate with better outcomes. The investigators will also have patients perform at-home gamified spirometry (Aluna ©) to (3) determine if at-home spirometry can predict albuterol use or change outcomes.

Official Title
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Albuterol Integrated Adherence Monitoring in Children With Asthma

Conditions
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Asthma in Children

Intervention / Treatment
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* Device: Digihaler Albuterol Device by TEVA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 8 to <19 years of age with a diagnosis of asthma as ICD-9 code 493 or ICD-10 code J45 seen in the allergy clinic at CHLA who have an albuterol rescue inhaler already prescribed and access to a personal smartphone will be eligible for recruitment. Exclusion Criteria: Patients unable to use device, unable to use albuterol (i.e. must use levalbuterol) or Age < 4 (ProAir® Digihaler only approved for Subjects 4 years and older). Patients with other chronic lung disease besides asthma or other significant comorbidities that could affect lung function/asthma (e.g. significant heart defects, immunodeficiency, cystic fibrosis, etc).

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients 8 to <19 years of age with a diagnosis of asthma<br>Patients 8 to <19 years of age with a diagnosis of asthma as ICD-9 code 493 or ICD-10 code J45 seen in the allergy clinic at CHLA who have an albuterol rescue inhaler already prescribed and access to a personal smartphone will be eligible for recruitment. | Device: Digihaler Albuterol Device by TEVA<br>* Patient with asthma will have their regular albuterol rescue inhaler replaced with Digihaler, they will also be asked to perform gamified spirometry (Aluna) at home<br>* Other names: Electronic Adherence Monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Outcomes | Severity by NHLBI EPR3 Guidelines | 3 months | 
| Asthma Adherence | 4-item Morisky Medication Adherence Scale (MMAS-4) | 3 months | 
| Asthma Adherence | Test of Adherence to Inhalers (TAI) | 3 months | 
| Asthma Outcomes | Composite Asthma Severity Index (CASI) | 3 months | 
| Asthma Outcomes | Asthma Control Test (ACT) | 3 months | 
| Albuterol Use | Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry | Aluna at home gamified spirometer, measures full spirometry FEV1, FVC, FEV1/FVC, Peak Flow. | 3 months | 
| Lung Function | Microlife FEV1, measures FEV1 | 3 months | 
| Asthma Quality of Life | PedsQL (Pediatric Quality of Life Inventory) | 3 months |