NCT07387718

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

January 22, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

January 22, 2026

Last Update Submit

March 13, 2026

Conditions

Asthma in ChildrenArtificial Intelligence

Outcome Measures

Primary Outcomes (5)

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (2)

  • Child Engagement (PROMIS)

    Day 1

  • Child inhaler technique (Coaching Tool)

    Day 1

Study Arms (2)

Standard Asthma Education (Control)

ACTIVE COMPARATOR

Participants in this arm will receive one standard asthma education session during a single clinic visit lasting approximately 5 minutes.

Behavioral: Standard Asthma Education

Standard Education Plus Artificially Intelligent Robot (AIR) Support Intervention (Experimental)

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.

Behavioral: Standard Asthma EducationBehavioral: Artificially Intelligent Robot (AIR) Support Intervention

Interventions

Standard Asthma EducationBEHAVIORAL

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..

Standard Asthma Education (Control)Standard Education Plus Artificially Intelligent Robot (AIR) Support Intervention (Experimental)
Artificially Intelligent Robot (AIR) Support InterventionBEHAVIORAL

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

Standard Education Plus Artificially Intelligent Robot (AIR) Support Intervention (Experimental)

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Batchelor Children's Research Institute

Miami, Florida, 33136, United States

Location

Related Publications (3)

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 38746721BACKGROUND

MeSH Terms

Interventions

Air

Intervention Hierarchy (Ancestors)

AtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Cynthia L Foronda, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Dean for Innovation and Clinical Scholarship

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 4, 2026

Study Start

February 10, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)