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

27. august 2026 opdateret af: Larry Yin, Children's Hospital Los Angeles

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

34

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90027
        • Rekruttering
        • Children's Hospital Los Angeles
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Comparator
Standard asthma education arm and passive smart inhaler every day for 8 weeks in the home setting.
Adfærdsmæssigt: Use of passive remote smart inhaler in the home setting
The application of the passive remote smart inhaler to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.
Eksperimentel: Intervention
Uses active smart inhaler daily for 8 weeks in the home setting.
Adfærdsmæssigt: Use of active remote smart inhaler in the home setting
The application of the remote smart inhaler in active setting to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of smart inhaler device for remote home management
Tidsramme: Weeks 1-8
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
Tidsramme: Weeks 4 and 8
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
Tidsramme: Weeks 4 and 8
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fractional exhaled nitric oxide (FeNO) levels
Tidsramme: Weeks 1,4,8
Examine changes in FeNO levels from FeNO test, measured in parts per billion (ppb).
Weeks 1,4,8
Change in forced expiratory volume in 1 second (FEV1)
Tidsramme: Weeks 1,4,8
Examine changes in FEV1 using a spirometer, measured in liters/minute (l/m)
Weeks 1,4,8
Change in peak expiratory flow (PEF)
Tidsramme: Weeks 1,4,8
Examine changes in PEF using a spirometer, measured in liters/minute (l/m)
Weeks 1,4,8
Correlation of change in Inhaler proficiency score and medication adherence
Tidsramme: Weeks 1, 4, 8
Validated 9-step Inhaler Proficiency Scale (IPS), measured from a score of 0-9 (min=0, max=9) and correlation with medication use, with 1= yes and 0=1, (min=0, max=1) for each day of use.
Weeks 1, 4, 8

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation of change in medication adherence and lung function.
Tidsramme: Weeks 1,4,8
Examine change in association of medication use, with 1= yes and 0=1, (min=0, max=1) for each day of use, and correlation with lung function, measured by FeNO levels or parts per billion (ppb).
Weeks 1,4,8
Correlation of change in Inhaler proficiency score and forced expiratory volume in 1 second (FEV1).
Tidsramme: Weeks 1,4,8
Validated 9-step Inhaler Proficiency Scale (IPS), measured from a score of 0-9 (min=0, max=9) and correlation with FEV1, measured in liters/minute (l/m).
Weeks 1,4,8
Correlation of change in Inhaler proficiency score and peak expiratory flow (PEF)
Tidsramme: Weeks 1,4,8
Validated 9-step Inhaler Proficiency Scale (IPS), measured from a score of 0-9 (min=0, max=9) and correlation with PEF, measured in liters/minute (l/m).
Weeks 1,4,8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Hospital Los Angeles

Efterforskere

  • Ledende efterforsker: Larry Yin, MD, MSPH, Children's Hospital Los Angeles

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. august 2026

Primær færdiggørelse (Anslået)

9. august 2027

Studieafslutning (Anslået)

9. august 2027

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

30. juli 2026

Først opslået (Faktiske)

5. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHLA-26-00026

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