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Smart Inhaler and Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities
NCT07746921 · Children's Hospital Los Angeles
In plain English
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Official title
A Pilot Randomized Controlled Trial: Utilizing a Digital Inhaler Cap to Support for Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities
About this study
The study is a single-blinded randomized-controlled pilot trial with a goal of 34 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 active smart inhalers for remote home management daily for 8 weeks, and the control group receives standard asthma education and passive smart inhalers for remote home management.
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, medication reminders, 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. Fractional exhaled nitric oxide (FeNO), which measures the amount of nitric oxide exhaled from a breath in parts per billion, will be measured by a FeNO device. 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:
* Adolescents ages 10-17 years
* Diagnosis of mild-to-moderate intellectual disability (ID) ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89; (Diagnosis of ID and/or autism in the EMR may be used to reach out to potential families).
* Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma or diagnosis indicated in the EMR: ICD-10: J45.40-J45.909; (Diagnosis of ID and/or autism in the EMR may be used to reach out to potential families).
* Parent/legal guardian has a smartphone and is willing to download an application associated with the CapMedic device, is assigned to the intervention group.
* 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 currently 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) as maintenance inhaled corticosteroids (ICS): Advair HFA, Flovent HFA, Symbicort HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA.
Exclusion Criteria:
* Health status or any clinical conditions: limited life expectancy and complex respiratory pathologies (e.g., tracheostomy, restrictive lung disease, bronchopulmonary dysplasia, cystic fibrosis) to prevent confounding in asthma treatment outcomes.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Study design
Enrollment target: 34 participants
Allocation: randomized
Masking: single
Age groups: child
Timeline
Starts: 2026-08-10
Estimated completion: 2027-08-09
Last updated: 2026-08-31
Interventions
Behavioral: Use of active remote smart inhaler in the home settingBehavioral: Use of passive remote smart inhaler in the home setting
Primary outcomes
- • Feasibility of smart inhaler device for remote home management (Weeks 1-8)
- • Acceptability of smart inhaler for remote home management (Weeks 4 and 8)
- • Usability of smart inhaler for remote home management (Weeks 4 and 8)
Sponsor
Children's Hospital Los Angeles · other
Contacts & investigators
ContactAlexis Deavenport-Saman, DrPH, MPH · contact · adeavenport@chla.usc.edu · 323-361-2994
InvestigatorLarry Yin, MD, MSPH · principal_investigator, Children's Hospital Los Angeles
All locations (1)
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States