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

NCT06783101 | Recruiting

• 1 other identifier: CHLA-24-00064
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children; Intellectual Disabilities (F70-F79); Developmental Disability; Autism Spectrum Disorder (ASD)

Keywords

smart inhaler; asthma; inhaler proficiency; children; intellectual disability; developmental disability

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control

NO INTERVENTION

Standard asthma education arm

Intervention

EXPERIMENTAL

Uses smart inhaler daily for 8 weeks

Behavioral: Use of smart inhaler to enhance asthma inhaler proficiency

Interventions

Use of smart inhaler to enhance asthma inhaler proficiency BEHAVIORAL

The application of the smart inhaler technology to enhance asthma inhaler proficiency

Intervention

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Intellectual Disability; Developmental Disabilities; Autism Spectrum Disorder; Asthma

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Larry Yin, MD, MSPH

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Park, MD

CONTACT

323-669-2534; soppark@chla.usc.edu

Alexis Deavenport-Saman, DrPH, MPH

CONTACT

323-361-2994; adeavenport@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: August 13, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)