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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Feasibility of smart inhaler device for remote home management [Срок оценки: Weeks 1-8]
• Acceptability of smart inhaler for remote home management [Срок оценки: Weeks 4 and 8]
• Usability of smart inhaler for remote home management [Срок оценки: Weeks 4 and 8]

Вторичные конечные точки (4)

• Change in fractional exhaled nitric oxide (FeNO) levels [Срок оценки: Weeks 1,4,8]
• Change in forced expiratory volume in 1 second (FEV1) [Срок оценки: Weeks 1,4,8]
• Change in peak expiratory flow (PEF) [Срок оценки: Weeks 1,4,8]
• Correlation of change in Inhaler proficiency score and medication adherence [Срок оценки: Weeks 1, 4, 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07746921 · CHLA-26-00026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗