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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests smart inhalers for home asthma care in children ages 10–17 with intellectual or developmental disabilities. Smart inhalers give tips and quick feedback on inhaler use. The study checks whether they are easy to use and help children take medicine correctly and improve how their lungs work.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 10–17 years old.
  • Have mild-to-moderate intellectual disability, which affects learning and understanding, and/or a developmental disability, including autism.
  • Have moderate-to-severe asthma.
  • Use one of these daily steroid inhalers for asthma: Advair HFA, Flovent HFA, Symbicort HFA, Alvesco HFA, Dulera HFA, or Asmanex HFA.
  • A parent or legal guardian must have a smartphone and be willing to download the CapMedic app if placed in the group using the device.
  • A parent or legal guardian must be willing to answer questions about their child. Both must understand and follow study steps for the whole study.
  • Speak English or Spanish.
  • Not be in another study using digital inhalers.

Who can't join

  • Have a health condition that limits how long you are expected to live, or a complex breathing condition that could affect asthma treatment results. Examples include a breathing opening in the neck, disease that limits lung expansion, long-term lung damage from early birth, or cystic fibrosis.
  • You or your legal guardian cannot or will not give written consent to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

CA