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Asthma in ChildrenNCT07387718

AIR Support: Artificially Intelligent Robot (AIR) Support for Pediatric Asthma Education

A study testing Standard Asthma Education and Artificially Intelligent Robot (AIR) Support Intervention in people with Asthma in Children and Artificial Intelligence, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 3 years and older
Conditions the study is for
Asthma in Children, Artificial Intelligence
What is being tested?
Standard Asthma Education and Artificially Intelligent Robot (AIR) Support Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteUnited States
Study dates
10 Feb 2026to 17 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • The participant must be at least 3 years old - 17 years old with asthma.
  • The participant must assent to participation.
Show all 11Show fewer
  • The participant's guardian must have consented.
  • 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.

Who cannot join

  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Batchelor Children's Research Institute

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: 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.

Being tested
Standard Asthma Education, Artificially Intelligent Robot (AIR) Support Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Asthma EducationBehavioural

    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..

  • Artificially Intelligent Robot (AIR) Support InterventionBehavioural

    Participants will receive a single 15-minute robotic asthma education session delivered by the Artificially Intelligent Robot/Human Support Robot (AIR/HSR).

Study groups in NCT07387718
Study groupRoleWhat they receive
Standard Asthma Education (Control)Active comparatorParticipants in this arm will receive one standard asthma education session during a single clinic visit lasting approximately 5 minutes.
Receives: Behavioral: Standard Asthma Education
Standard Education Plus Artificially Intelligent Robot (AIR) Support Intervention (Experimental)ExperimentalParticipants 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.
Receives: Behavioral: Standard Asthma Education; Behavioral: Artificially Intelligent Robot (AIR) Support Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the Human Support Robot: Enrollment Rate

    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.

    Measured: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.

  2. Feasibility of the Human Support Robot: Completion Rate

    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.

    Measured: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.

  3. Feasibility of the Human Support Robot: Session Length

    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.

    Measured: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.

  4. Feasibility of the Human Support Robot: Number of Technical Issues

    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.

    Measured: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.

  5. Acceptability of the Human Support Robot or Acceptability of the Robot-Supported Education Session

    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.

    Measured: Immediately after the robotic session (same clinic visit) and up to 3 months afterwards via recordings and documentation.

Secondary outcomes (2)

  1. Child Engagement (PROMIS)

    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.

    Measured: Day 1

  2. Child inhaler technique (Coaching Tool)

    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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start10 Feb 2026
  3. Primary completion17 Jun 2026
  4. Study completion17 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07387718
Sponsor's protocol ID
20251352
Status last verified
Jun 2026
First submitted
22 Jan 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 38746721

Questions about this trial

What is this clinical trial studying?

A study testing Standard Asthma Education and Artificially Intelligent Robot (AIR) Support Intervention in people with Asthma in Children and Artificial Intelligence, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the Human Support Robot: Enrollment Rate (time frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07387718, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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