Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities

Last updated: January 14, 2025
Sponsor: Children's Hospital Los Angeles
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Williams Syndrome

Asthma

Treatment

Use of smart inhaler to enhance asthma inhaler proficiency

Clinical Study ID

NCT06783101
CHLA-24-00064
  • Ages 10-17
  • All Genders

Study Summary

Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population. This study aims to investigate whether daily application of smart inhalers (1) is feasible and acceptable in the IDD population, (2) improves the rate of correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population.

Eligibility Criteria

Inclusion

Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in this study:

  • Adolescents ages 10-17 years

  • Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/ordiagnosis of 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/legal guardian is willing to answer questions about their child.

  • Parent/legal guardian and adolescent must have the ability to understand studyprocedures and to comply with them for the entire length of the study

  • English or Spanish-speaking participants

  • Not involved in other studies using digital inhalers

  • Males and females of reproductive capability will be enrolled: contraception is notnecessary or required.

  • Participants must use any of the following MDIs (as indicated by the 510(k):Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA,Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA.

Exclusion

Exclusion Criteria: All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:

  • Health status or any clinical conditions: Limited life expectancy, co-existingdisease or other characteristics that precludes appropriate diagnosis, treatment, orfollow-up in the trial.

  • Inability or unwillingness of individual or legal guardian/representative to givewritten informed consent.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Use of smart inhaler to enhance asthma inhaler proficiency
Phase:
Study Start date:
August 13, 2024
Estimated Completion Date:
April 30, 2025

Study Description

The study is a single-blinded randomized-controlled pilot trial with a goal of 30 participants ages 10-17 years diagnosed with IDD and moderate-to-severe asthma. Subjects are recruited from subspecialty clinics and a primary care FQHC at a large, urban academic children's hospital. Participants in the intervention group are assigned to use smart inhalers daily for 8 weeks, and the control group receives standard asthma education.

All participants attend three visits over 8 weeks, each scheduled four weeks apart. Primary outcomes, feasibility and acceptability, are assessed by data completeness and satisfaction surveys. Secondary outcomes, the Inhaler Proficiency Scales, are measured by the smart inhaler and by a trained observer and analyzed by Spearman's correlation test. Tertiary outcomes, Forced Expiratory Volume (FEV1) in one second, and Peak Expiratory Flow (PEF), are measured by a spirometer. Demographics and outcomes are reported as frequencies (%), mean (SD), or median (IQR). Analyses will utilize generalized linear mixed-effects models to account for the within-participant correlation.

Connect with a study center

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

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