RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-13
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06783101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Adolescents ages 10-17 years
  2. * Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89
  3. * Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma: ICD-10: J45.40-J45.909
  4. * Parent/legal guardian is willing to answer questions about their child.
  5. * 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
  6. * English or Spanish-speaking participants
  7. * Not involved in other studies using digital inhalers
  8. * Males and females of reproductive capability will be enrolled: contraception is not necessary or required.
  9. * 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.
  1. * 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.
  2. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Contacts and Locations

Study Contact

Sophia Park, MD
CONTACT
323-669-2534
soppark@chla.usc.edu
Alexis Deavenport-Saman, DrPH, MPH
CONTACT
323-361-2994
adeavenport@chla.usc.edu

Principal Investigator

Larry Yin, MD, MSPH
PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

  • Larry Yin, MD, MSPH, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13
Study Completion Date2025-04

Study Record Updates

Study Start Date2024-08-13
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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