Clinical trial NCT06783101: Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities
Official title: A Pilot Randomized Controlled Trial: Utilizing a Digital Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of smart inhaler device
timeFrame: Weeks 1-8
measure: Acceptability of smart inhaler
timeFrame: Weeks 4 and 8
measure: Usability of smart inhaler
timeFrame: Weeks 4 and 8
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Larry Yin, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: