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

A Pilot Randomized Controlled Trial: Utilizing a Digital Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children; Developmental Disability; Autism Spectrum Disorder (ASD); Intellectual Disabilities (F70-F79)
• Intervention / Treatment: Behavioral: Use of smart inhaler to enhance asthma inhaler proficiency

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophia Park, MD; Phone Number: 323-669-2534; Email: soppark@chla.usc.edu
• Study Contact Backup: Name: Alexis Deavenport-Saman, DrPH, MPH; Phone Number: 323-361-2994; Email: adeavenport@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Sophia Park, MD; Phone Number: 323-669-2534; Email: soppark@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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/or diagnosis 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 study procedures 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 not necessary 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 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-existing disease or other characteristics that precludes appropriate diagnosis, treatment, or follow-up in the trial.
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard asthma education arm
Experimental: Intervention; Uses smart inhaler daily for 8 weeks	Behavioral: Use of smart inhaler to enhance asthma inhaler proficiency; The application of the smart inhaler technology to enhance asthma inhaler proficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of smart inhaler device	Feasibility will be determined by data completeness: Ratio of days on which there are valid smart inhaler data out of the total number of days	Weeks 1-8
Acceptability of smart inhaler	Acceptability will be measured by response rate on user satisfaction survey.	Weeks 4 and 8
Usability of smart inhaler	Usability will be measured by ease of use smart inhaler survey.	Weeks 4 and 8

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Larry Yin, MD, MSPH, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: children; asthma; developmental disability; intellectual disability; smart inhaler; inhaler proficiency
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Immune System Diseases; Respiratory Tract Diseases; Neurobehavioral Manifestations; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Asthma; Developmental Disabilities; Intellectual Disability
• Other Study ID Numbers: CHLA-24-00064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No