An interventional study of Artificially Intelligent Robot (AIR) Control Intervention and Standard Asthma Education in Asthma in Children, Artificial Intelligence and Caregiver Burden, sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Miami · Not applicable, Interventional, and Prevention
The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.
500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
This study's planned enrollment of 80 is above the median of 71 across 402 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Caregivers or Parents:
Inclusion Criteria for Children:
Exclusion Criteria for Caregivers or Parents:
Exclusion Criteria for Children:
Participants in this arm will receive the standard asthma education plus one Artificially Intelligent Robot (AIR) supported education session lasting approximately 10 minutes during their hospital admission.
Behavioral: Artificially Intelligent Robot (AIR) Control Intervention · Behavioral: Standard Asthma Education
Participants in this arm will receive one standard asthma education session during their hospital admission lasting approximately 10 minutes.
Behavioral: Standard Asthma Education
Participants will receive a single 10-minute robotic asthma education session delivered by the Artificially Intelligent Robot (AIR) during their hospital admission.
Participants will receive the standard asthma education provided by their healthcare provider during their hospital admission.
Child Inhaler Technique Score
Measured using the Children's Hospital Colorado Inhaler Technique Coaching Tool. The tool uses a 0-10 point scale, where 0 indicates no correct steps and 10 indicates all steps performed correctly. Higher scores indicate better technique.
Time frame: Within 1 hour following completion of the education session
Medication Adherence (Neuro-Quality of Life Medication Adherence Short Form 6a Score)
Medication adherence will be assessed using the Neuro-Quality of Life Medication Adherence Short Form 6a, a 6-item patient-reported outcome measure. Scores range from 6-30. Scores are reported as standardized T scores. Higher T scores indicate better medication adherence.
Time frame: Baseline, 2-4 months, and 5-7 months post-intervention
Asthma Control (Childhood Asthma Control Test)
Asthma control will be assessed using the Childhood Asthma Control Test (C-ACT) for children 4 to 11 years), a 7-item patient-reported measure. The C-ACT produces a total score ranging from 0 to 27. Item responses are summed with higher scores indicating better asthma control.
Time frame: Baseline, 2-4 months, and 5-7 months post-intervention
Caregiver Illness Burden (Patient-Reported Outcomes Measurement Information System Illness Burden - Short Form 6a)
Caregiver illness burden will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Illness Burden - Short Form 6a, a 6-item patient-reported measure. Scoring ranges from 6-30. Item responses are summed and converted to a standardized T-score (mean = 50, standard deviation = 10) with higher T-scores indicating greater illness burden.
Time frame: Baseline, 2-4 months, and 5-7 months post-intervention
Healthcare Utilization
Healthcare utilization will be assessed using the Healthcare Utilization Survey, a 4-item caregiver-reported measure, ranging from 4-20. Healthcare utilization is assessed as the number of times the child has visited a healthcare facility (total number of visits indicated by the caregiver), with higher values indicating higher healthcare utilization.
Time frame: Baseline, 2-4 months, and 5-7 months post-intervention
Pulmonary function (Forced Expiratory Volume in 1 second/ Forced Vital Capacity )
Pulmonary function will be assessed using Forced Expiratory Volume in 1 second/ Forced Vital Capacity (FEV1/FVC) extracted from the electronic health record. This ratio compares the volume of air exhaled in the first second (FEV1) to the total amount of air exhaled (FVC). FVC is interpreted by using a z score or Lower Limit of Normal (LLN) from the Global Lung Function Initiative (GLI) 2012 reference equations. A score of ≥80% predicted or z-score of-1.64 or higher is considered normal pulmonary function with higher scores indicating higher pulmonary function. A score of \<80% predicted or z-score of -1.64 or lower is considered poor pulmonary function.
Time frame: Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.
Plan to share: No — Individual participant data (IPD) will not be shared publicly. De-identified, aggregate-level data may be made available upon reasonable request to the Principal Investigator after study completion, contingent on approval by the Institutional Review Board (IRB), execution of a data use agreement, and confirmation that the proposed use is consistent with the informed consent and applicable privacy regulations. No direct identifiers will be shared. Data will be retained and managed in accordance with institutional policies and federal regulations.
Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.
Of 282 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 9 months is below that.
Counting every sponsor, half of 291 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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