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.
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.
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.
Parallel
Use of active remote smart inhaler in the home setting
BehavioralThe application of the remote smart inhaler in active setting to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.
Use of passive remote smart inhaler in the home setting
BehavioralThe application of the passive remote smart inhaler to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.
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
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).
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).
Change in fractional exhaled nitric oxide (FeNO) levels
Examine changes in FeNO levels from FeNO test, measured in parts per billion (ppb).
Change in forced expiratory volume in 1 second (FEV1)
Examine changes in FEV1 using a spirometer, measured in liters/minute (l/m)
Change in peak expiratory flow (PEF)
Examine changes in PEF using a spirometer, measured in liters/minute (l/m)
Correlation of change in Inhaler proficiency score and medication adherence
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.
Correlation of change in medication adherence and lung function.
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).
Correlation of change in Inhaler proficiency score and forced expiratory volume in 1 second (FEV1).
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).
Correlation of change in Inhaler proficiency score and peak expiratory flow (PEF)
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).
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