- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387718
AIR Support: Artificially Intelligent Robot (AIR) Support for Pediatric Asthma Education
March 13, 2026 updated by: Cynthia Foronda, University of Miami
Artificially Intelligent Robot (AIR) Support for Pediatric Asthma Education
The purpose of this prevention study is to evaluate the design and usability of a newly developed asthma education protocol with the Human Support Robot (HSR) for children with asthma.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Batchelor Children's Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion (Eligibility) Criteria for Caregivers or Parents:
- The participant must be at least 18 years old.
- The participant must be willing and able to participate.
- The participant can read English or Spanish and is able to fill out survey instruments by themselves or with assistance.
- The participant cares for a child with asthma.
Exclusion (Eligibility) Criteria for Caregivers or Parents:
- The participant is younger than 18 years old.
- The participant is unwilling to participate in the study.
- The participant is unable to complete survey instruments.
- The participant does not care for a child with asthma.
Inclusion (Eligibility) Criteria for Children:
- The participant must be at least 3 years old - 17 years old with asthma.
- The participant must assent to participation.
- The participant's guardian must have consented.
Exclusion (Eligibility) Criteria for Children:
- The participant is younger than 3 years old.
- The participant does not have asthma.
- The participant is unwilling to participate in the study.
- The participant's guardian did not consent.
Inclusion (Eligibility) Criteria for Healthcare Providers:
- The participant must be at least 18 years old.
- The participant must be willing and able to participate.
- The participant can read English and is able to fill out survey instruments by themselves.
- The participant must view a robotic education session.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Standard Asthma Education (Control)
Participants in this arm will receive one standard asthma education session during a single clinic visit lasting approximately 5 minutes.
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Participants will receive the usual asthma education provided by their healthcare provider during the clinic visit, including asthma action plan and metered dose inhaler and spacer teaching..
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Experimental: Standard Education Plus Artificially Intelligent Robot (AIR) Support Intervention (Experimental)
Participants in this arm will receive standard asthma education plus one artificially intelligent robot supported education session during a single clinic visit lasting approximately 15 minutes.
|
Participants will receive the usual asthma education provided by their healthcare provider during the clinic visit, including asthma action plan and metered dose inhaler and spacer teaching..
Participants will receive a single 15-minute robotic asthma education session delivered by the Artificially Intelligent Robot/Human Support Robot (AIR/HSR).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the Human Support Robot: Enrollment Rate
Time Frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
|
Feasibility will be assessed by measuring the enrollment rate for the study involving the Human Support Robot.
Enrollment rate will be calculated as the number of participants enrolled divided by the number of eligible participants approached, expressed as a percentage.
Higher percentages indicate greater feasibility of implementation.
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Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
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Feasibility of the Human Support Robot: Completion Rate
Time Frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
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Feasibility will be evaluated by measuring the completion rate for the study procedures involving the Human Support Robot.
Completion rate will be calculated as the number of enrolled participants who complete all required study procedures - including the education session, survey, inhaler-use demonstration, and interview - divided by the total number of participants enrolled, expressed as a percentage.
Higher percentages indicate greater feasibility of implementation.
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Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
|
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Feasibility of the Human Support Robot: Session Length
Time Frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
|
Feasibility will be measured by recording the duration in minutes of the robot education session.
More consistent and shorter session durations indicate better feasibility for clinic workflow and integration of the Human Support Robot.
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Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
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Feasibility of the Human Support Robot: Number of Technical Issues
Time Frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
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Feasibility will be assessed by recording the number and type of technical issues occurring during the robot-supported education session, including hardware malfunctions, software errors, or disruptions requiring staff assistance.
Fewer technical issues indicate greater feasibility of implementing the Human Support Robot in a clinic setting.
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Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
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Acceptability of the Human Support Robot or Acceptability of the Robot-Supported Education Session
Time Frame: Immediately after the robotic session (same clinic visit) and up to 3 months afterwards via recordings and documentation.
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Acceptability of the robot will be evaluated by using the Technology Acceptance Model Questionnaire.
The questionnaire includes items assessing perceived usefulness and perceived ease of use, each rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Scores will be averaged to produce subscale scores ranging from 1 to 7, with higher scores indicating greater acceptability.
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Immediately after the robotic session (same clinic visit) and up to 3 months afterwards via recordings and documentation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Engagement (PROMIS)
Time Frame: Day 1
|
Child engagement will be evaluated using a slightly adapted Patient-Reported Outcomes Measurement Information System (PROMIS) Early Childhood Parent Engagement measure.
This questionnaire includes items assessing the child's attention, interest, and participation during activities.
Each item is rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("always").
Item responses are summed and converted to a standardized T-score (mean = 50, standard deviation = 10).
Higher T-scores indicate greater engagement.
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Day 1
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Child inhaler technique (Coaching Tool)
Time Frame: Day 1
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Child knowledge will be assessed using the Inhaler Technique Coaching Tool, a structured checklist evaluating each step of proper inhaler use.
The research assistant will score each step as correct (1) or missed or done improperly (0).
Scores will be summed to produce a total score ranging from 0 - 6, with higher scores indicating more accurate inhaler technique and greater knowledge of inhaler use.
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia L Foronda, PhD, University of Miami
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pasternak K, Foronda C, Downs C, Visser U. Social robots for pediatric asthma education: A pilot study. In: Staffa M, et al., eds. Social Robotics + AI. ICSR+AI 2025. Lecture Notes in Computer Science. Vol 16131. Singapore: Springer; 2026. doi:10.1007/978-981-95-2379-5_35
- Foronda CL, Susas T, Castaño Cubillos N, Pasternak K, Downs CA, Visser U. Preparing nurses for the technological future: Robotic integration in nursing education. Teaching and Learning in Nursing. 2025. doi:10.1016/j.teln.2025.11.034
- Foronda C, Gonzalez JM, Snowden K, Prather S, Majilton C, Weisman A, Parmeter S, Herrera A, Gattamorta KA, Gonzalez JE, Downs C, Hooshmand M, Cardenas M. Improving knowledge and decreasing depressive symptoms in caregivers of children with asthma through the asthma academy: A randomized controlled trial. Int J Nurs Stud Adv. 2021 Oct 9;3:100047. doi: 10.1016/j.ijnsa.2021.100047. eCollection 2021 Nov.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
January 22, 2026
First Submitted That Met QC Criteria
January 29, 2026
First Posted (Actual)
February 4, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20251352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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