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NCT Number: NCT07738016

Artificially Intelligent Robotic Control

The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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 age 4-11 with asthma.

Inclusion criteria

for Children:

  • 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.

Exclusion 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 who is age 4-11.

Exclusion criteria

for Children:

  • 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.

Treatment and study plan

Artificially Intelligent Robot (AIR) Control Intervention

Behavioral

Participants will receive a single 10-minute robotic asthma education session delivered by the Artificially Intelligent Robot (AIR) during their hospital admission.

Standard Asthma Education

Behavioral

Participants will receive the standard asthma education provided by their healthcare provider during their hospital admission.

Primary outcomes

  1. 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.

  2. Medication Adherence (Neuro-QoL 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 (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.

  3. Asthma Control (Childhood Asthma Control Test (C-ACT)

    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.

  4. Caregiver Illness Burden (PROMIS 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.

  5. 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.

Secondary outcomes

  1. Pulmonary function (FEV1/FVC)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia L Foronda, PhD

CONTACT

[email protected]

305-284-1525

Ubbo Visser, PhD

CONTACT

[email protected]

305-284-2254

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Asthma Under Artificially Intelligent Robotic (AIR) Control: Robotic Support for Pediatric Education

Acronym: AIR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

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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