Holtz Children's Hospital
Miami, Florida, 33136, United States
NCT Number: NCT07738016
The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.
Trial opening soon.
Get Notified4 year and older
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Caregivers or Parents:
Inclusion criteria
for Children:
Exclusion criteria
for Caregivers or Parents:
Exclusion criteria
for Children:
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.
Time frame: Within 1 hour following completion of the education session
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: Baseline, 2-4 months, and 5-7 months post-intervention
Medication adherence will be assessed using the Neuro-Quality of Life (QoL) 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 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 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 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 post-intervention, and 5-7 months post-intervention.
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.
Contact information is provided by the study sponsor or research team.
Cynthia L Foronda, PhD
CONTACT
Ubbo Visser, PhD
CONTACT
University of Miami
Other
Asthma Under Artificially Intelligent Robotic (AIR) Control: Robotic Support for Pediatric Education
Acronym: AIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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