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

NCT ID: NCT06783101

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2025-04-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Standard asthma education arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Uses smart inhaler daily for 8 weeks

Group Type: EXPERIMENTAL

Use of smart inhaler to enhance asthma inhaler proficiency

Intervention Type: BEHAVIORAL

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

Interventions

Use of smart inhaler to enhance asthma inhaler proficiency

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Larry Yin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry Yin, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sophia Park, MD

Role: CONTACT

soppark@chla.usc.edu

323-669-2534

Alexis Deavenport-Saman, DrPH, MPH

Role: CONTACT

adeavenport@chla.usc.edu

323-361-2994

Facility Contacts

Sophia Park, MD

Role: primary

soppark@chla.usc.edu

323-669-2534

Other Identifiers

CHLA-24-00064

Identifier Type: -

Identifier Source: org_study_id