Albuterol Integrated Adherence Monitoring in Children With Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Asthma Adherence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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).
Arms & Interventions
Patients 8 to <19 years of age with a diagnosis of asthma
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.
Intervention: Digihaler Albuterol Device by TEVA (Device)
Outcomes
Primary Outcomes
Asthma Adherence
Time Frame: 3 months
4-item Morisky Medication Adherence Scale (MMAS-4)
Asthma Outcomes
Time Frame: 3 months
Severity by NHLBI EPR3 Guidelines
Albuterol Use
Time Frame: 3 months
Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc.
Secondary Outcomes
- Spirometry(3 months)
- Asthma Quality of Life(3 months)
- Lung Function(3 months)
Investigators
Neema Izadi
Assistant Professor
Children's Hospital Los Angeles