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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients 8 to <19 years of age with a diagnosis of asthma | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digihaler Albuterol Device by TEVA | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neema Izadi, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
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|
| 3 months |
| Asthma Quality of Life | PedsQL (Pediatric Quality of Life Inventory) | 3 months |