Asthma in ChildrenAIRNCT07738016
Artificially Intelligent Robot Control
A study testing Standard Asthma Education in people with Asthma in Children and Artificial Intelligence, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Asthma in Children, Artificial Intelligence, Caregiver Burden
- What is being tested?
- Standard Asthma Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 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 age 4-11 with asthma.
- The participant must be at least 4 years old - 11 years old with asthma.
- The child can speak English or Spanish.
- The participant must assent to participation.
- The participant's guardian must have consented.
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 who is age 4-11.
- The participant is younger than 4 years old, over 11 years old, or does not have asthma.
- The child does not speak English or Spanish.
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site
Holtz Children's Hospital
Miami, Florida, 33136
Bridgette Johnson, PhD, 954-562-6480, Bridgette.Johnson@jhsmiami.org
About this study
Official title: Asthma Under Artificially Intelligent Robot (AIR) Control: Robotic Support for Pediatric Education
The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.
- Being tested
- Artificially Intelligent Robot (AIR) Control Intervention, Standard Asthma Education
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificially Intelligent Robot (AIR) Control InterventionBehavioural
Participants will receive a single 10-minute robotic asthma education session delivered by the Artificially Intelligent Robot (AIR) during their hospital admission.
Standard Asthma EducationBehavioural
Participants will receive the standard asthma education provided by their healthcare provider during their hospital admission.
| Study group | Role | What they receive |
|---|---|---|
| Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention | Experimental | 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. Receives: Behavioral: Artificially Intelligent Robot (AIR) Control Intervention; Behavioral: Standard Asthma Education |
| Standard Asthma Education (Control) | Active comparator | Participants in this arm will receive one standard asthma education session during their hospital admission lasting approximately 10 minutes. Receives: Behavioral: Standard Asthma Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2-4 months, and 5-7 months post-intervention
Secondary outcomes (1)
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.
Measured: Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startOct 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Foronda, University of Miami
- Investigators
- Cynthia L Foronda, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738016
- Sponsor's protocol ID
- 20260782
- Acronym
- AIR
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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 38746721Foronda CL, Kelley CN, Nadeau C, Prather SL, Lewis-Pierre L, Sarik DA, Muheriwa SR. Psychological and Socioeconomic Burdens Faced by Family Caregivers of Children With Asthma: An Integrative Review. J Pediatr Health Care. 2020 Jul-Aug;34(4):366-376. doi: 10.1016/j.pedhc.2020.02.003. Epub 2020 Apr 14.
PubMed 32299726Prather SL, Foronda CL, Kelley CN, Nadeau C, Prather K. Barriers and Facilitators of Asthma Management as Experienced by African American Caregivers of Children with Asthma: An Integrative Review. J Pediatr Nurs. 2020 Nov-Dec;55:40-74. doi: 10.1016/j.pedn.2020.06.012. Epub 2020 Jul 10.
PubMed 32653828Foronda C, Prather S, Snowden K, Gonzalez JM, Gattamorta KA, Lee J, Gonzalez JE, Cardenas M. Asthma academy: A student nurse-led telehealth education program for low-income family caregivers of children with asthma. Nurs Open. 2022 Mar;9(2):1486-1496. doi: 10.1002/nop2.1123. Epub 2021 Dec 16.
PubMed 34913268
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Under Artificially Intelligent Robot (AIR) Control: Robotic Support for Pediatric Education
- ClinicalTrials.gov ID
- NCT07738016
- Acronym / sponsor ID
- AIR / 20260782
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention | Experimental | Behavioral: Artificially Intelligent Robot (AIR) Control Intervention, Behavioral: Standard Asthma EducationParticipants 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. |
| Standard Asthma Education (Control) | Active comparator | Behavioral: Standard Asthma EducationParticipants in this arm will receive one standard asthma education session during their hospital admission lasting approximately 10 minutes. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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 age 4-11 with asthma.
- The participant must be at least 4 years old - 11 years old with asthma.
Key exclusion criteria (8 listed)
- 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 who is age 4-11.
- The participant is younger than 4 years old, over 11 years old, or does not have asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificially Intelligent Robot (AIR) Control InterventionParticipants will receive a single 10-minute robotic asthma education session delivered by the Artificially Intelligent Robot (AIR) during their hospital admission. | Behavioural | Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention |
| Standard Asthma EducationParticipants will receive the standard asthma education provided by their healthcare provider during their hospital admission. | Behavioural | Standard Asthma Education (Control), Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention |
Primary outcome
Child Inhaler Technique Score
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.
Medication Adherence (Neuro-Quality of Life Medication Adherence Short Form 6a Score)
Time frame: Baseline, 2-4 months, and 5-7 months post-intervention
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.
Asthma Control (Childhood Asthma Control Test)
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.
Caregiver Illness Burden (Patient-Reported Outcomes Measurement Information System Illness Burden - Short Form 6a)
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.
Healthcare Utilization
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.
1 secondary outcome
Pulmonary function (Forced Expiratory Volume in 1 second/ Forced Vital Capacity )
Time frame: Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 38746721Foronda 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.
- Background: PubMed 32299726Foronda CL, Kelley CN, Nadeau C, Prather SL, Lewis-Pierre L, Sarik DA, Muheriwa SR. Psychological and Socioeconomic Burdens Faced by Family Caregivers of Children With Asthma: An Integrative Review. J Pediatr Health Care. 2020 Jul-Aug;34(4):366-376. doi: 10.1016/j.pedhc.2020.02.003. Epub 2020 Apr 14.
- Background: PubMed 32653828Prather SL, Foronda CL, Kelley CN, Nadeau C, Prather K. Barriers and Facilitators of Asthma Management as Experienced by African American Caregivers of Children with Asthma: An Integrative Review. J Pediatr Nurs. 2020 Nov-Dec;55:40-74. doi: 10.1016/j.pedn.2020.06.012. Epub 2020 Jul 10.
- Background: PubMed 34913268Foronda C, Prather S, Snowden K, Gonzalez JM, Gattamorta KA, Lee J, Gonzalez JE, Cardenas M. Asthma academy: A student nurse-led telehealth education program for low-income family caregivers of children with asthma. Nurs Open. 2022 Mar;9(2):1486-1496. doi: 10.1002/nop2.1123. Epub 2021 Dec 16.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia L Foronda, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Asthma Education 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 8 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: opening soon, as of the sponsor's last update on 16 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia L Foronda, PhD (305-284-1525, c.foronda@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Inhaler Technique Score (time frame: Within 1 hour following completion of the education session). 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 NCT07738016, which also lists 4 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 16 Sep 2026.