An interventional study of Use of smart inhaler to enhance asthma inhaler proficiency in Asthma in Children, Intellectual Disabilities (F70-F79) and Developmental Disability, sponsored by Children's Hospital Los Angeles. Recruiting at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
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. This study aims to investigate whether daily application of smart inhalers (1) is feasible and acceptable in the IDD population, (2) improves the rate of correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population.
The study is a single-blinded randomized-controlled pilot trial with a goal of 30 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 smart inhalers daily for 8 weeks, and the control group receives standard asthma education.
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, 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. 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.
387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.
This study's planned enrollment of 30 is below the median of 58 across 248 interventional studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in this study:
Exclusion Criteria: All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard asthma education arm
Uses smart inhaler daily for 8 weeks
Behavioral: Use of smart inhaler to enhance asthma inhaler proficiency
The application of the smart inhaler technology to enhance asthma inhaler proficiency
Feasibility of smart inhaler device
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
Time frame: Weeks 1-8
Acceptability of smart inhaler
Acceptability will be measured by response rate on user satisfaction survey.
Time frame: Weeks 4 and 8
Usability of smart inhaler
Usability will be measured by ease of use smart inhaler survey.
Time frame: Weeks 4 and 8
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Apr 2025, 8 months after the start.
Of 155 non-industry interventional studies with no phase under Intellectual Disability, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 8 months is below that.
Counting every sponsor, half of 158 studies reached it within 19 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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