Smart Inhaler and Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities

NCT07746921 | Not Yet Recruiting

• 1 other identifier: CHLA-26-00026
• Study Type: interventional
• Target: 34
• 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 for remote home use. This study aims to investigate whether daily application of smart inhalers (1) is feasible, acceptable and usable in the IDD population for remote asthma management, (2) improves the rate of medication use and correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population for remote home use.

Conditions

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

Keywords

smart inhaler; asthma; remote home management; medication adherence; intellectual disability; developmental disability

Outcome Measures

Primary Outcomes (3)

• Feasibility of smart inhaler device for remote home management

  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 for remote home management

  Acceptability will be measured by response rate on user satisfaction survey item, measured on a 5-pt Likert type scale, ranging from very unsatisfied to very satisfied, with a score of 1-5 (min=1, max= 5).

  Weeks 4 and 8

• Usability of smart inhaler for remote home management

  Usability will be measured by an "ease of use" smart inhaler survey item, and will be measured on a 5-pt Likert type scale, ranging from very hard to very easy, with a score of 1-5 (min=1, max= 5).

  Weeks 4 and 8

Secondary Outcomes (4)

• Change in fractional exhaled nitric oxide (FeNO) levels

  Weeks 1,4,8

• Change in forced expiratory volume in 1 second (FEV1)

  Weeks 1,4,8

• Change in peak expiratory flow (PEF)

  Weeks 1,4,8

• Correlation of change in Inhaler proficiency score and medication adherence

  Weeks 1, 4, 8

Other Outcomes (3)

• Correlation of change in medication adherence and lung function.

  Weeks 1,4,8

• Correlation of change in Inhaler proficiency score and forced expiratory volume in 1 second (FEV1).

  Weeks 1,4,8

• Correlation of change in Inhaler proficiency score and peak expiratory flow (PEF)

  Weeks 1,4,8

Study Arms (2)

Comparator

EXPERIMENTAL

Standard asthma education arm and passive smart inhaler every day for 8 weeks in the home setting.

Behavioral: Use of passive remote smart inhaler in the home setting

Intervention

EXPERIMENTAL

Uses active smart inhaler daily for 8 weeks in the home setting.

Behavioral: Use of active remote smart inhaler in the home setting

Interventions

Use of active remote smart inhaler in the home setting BEHAVIORAL

The application of the remote smart inhaler in active setting to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.

Intervention

Use of passive remote smart inhaler in the home setting BEHAVIORAL

The application of the passive remote smart inhaler to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.

Comparator

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 (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Intellectual Disability; Developmental Disabilities; Autism Spectrum Disorder; Asthma; Medication Adherence

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; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Larry Yin, MD, MSPH

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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: Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 5, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): August 9, 2027
• Study Completion (Estimated): August 9, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)