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

2026年8月27日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

34

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90027
        • 募集
        • Children's Hospital Los Angeles
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Comparator
Standard asthma education arm and passive smart inhaler every day for 8 weeks in the home setting.
行動：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.
実験的：Intervention
Uses active smart inhaler daily for 8 weeks in the home setting.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Feasibility of smart inhaler device for remote home management
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in fractional exhaled nitric oxide (FeNO) levels
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Correlation of change in medication adherence and lung function.
時間枠：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).
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Children's Hospital Los Angeles

捜査官

  • 主任研究者：Larry Yin, MD, MSPH、Children's Hospital Los Angeles

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月10日

一次修了 (推定)

2027年8月9日

研究の完了 (推定)

2027年8月9日

試験登録日

最初に提出

2026年7月13日

QC基準を満たした最初の提出物

2026年7月30日

最初の投稿 (実際)

2026年8月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月27日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CHLA-26-00026

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いいえ

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