Actively Recruiting
Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities: A Pilot Randomized Controlled Trial
Led by Children's Hospital Los Angeles · Updated on 2025-01-20
30
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of smart inhalers to support asthma management in adolescents aged 10 to 17 years who have intellectual and developmental disabilities (IDD) along with moderate-to-severe asthma. The study aims to determine if smart inhalers are feasible and acceptable for this group, whether they improve correct medication use, and if they help improve lung function. This pilot trial addresses the challenges faced by children with IDD in using inhalers correctly and seeks to promote better asthma control in this vulnerable population. The trial is a single-blinded randomized controlled pilot study involving 30 participants recruited from specialty clinics and a primary care center at a large urban children's hospital. Participants are divided into two groups: one group uses smart inhalers daily for 8 weeks, while the control group receives standard asthma education. The smart inhalers provide guidance and immediate feedback on inhaler techniques to enhance proficiency. Participants attend three visits over the 8-week study period, each visit spaced four weeks apart. Researchers assess feasibility and acceptability through data completeness and satisfaction surveys, while inhaler proficiency is measured by both the smart inhaler and trained observers. Lung function is tested using spirometry measuring Forced Expiratory Volume in one second (FEV1) and Peak Expiratory Flow (PEF). Data analysis will consider participant variability using specialized statistical models.
CONDITIONS
Official Title
Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents ages 10-17 years
- Diagnosis of mild-to-moderate intellectual disability (ICD-10: F70-F71) or developmental disability including autism (ICD-10: F80-89)
- Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma (ICD-10: J45.40-J45.909)
- Parent or legal guardian willing to answer questions about their child
- Parent or legal guardian and adolescent able to understand and comply with study procedures for the entire study
- English or Spanish-speaking participants
- Not currently involved in other studies using digital inhalers
- Males and females of reproductive capability (contraception not required)
- Use of one of the following MDIs: Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, or Asmanex HFA
You will not qualify if you...
- Limited life expectancy or co-existing disease that prevents proper diagnosis, treatment, or follow-up in the trial
- Inability or unwillingness of the individual or legal guardian to give written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
Research Team
S
Sophia Park, MD
A
Alexis Deavenport-Saman, DrPH, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here