Asthma in Children
Conditions
Brief summary
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
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.
Interventions
DEVICEDigihaler Albuterol Device by TEVA
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
Sponsors
Teva Pharmaceuticals USA
Children's Hospital Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Outcomes | 3 months | Severity by NHLBI EPR3 Guidelines |
| Asthma Adherence | 3 months | 4-item Morisky Medication Adherence Scale (MMAS-4) |
| Albuterol Use | 3 months | Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spirometry | 3 months | Aluna at home gamified spirometer, measures full spirometry FEV1, FVC, FEV1/FVC, Peak Flow. |
| Lung Function | 3 months | Microlife FEV1, measures FEV1 |
| Asthma Quality of Life | 3 months | PedsQL (Pediatric Quality of Life Inventory) |
Countries
United States
Outcome results
None listed