Artificially Intelligent Robotic Control

NCT07738016 | Not Yet Recruiting

• 1 other identifier: 20260782
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma in Children; Artificial Intelligence; Caregiver Burden

Outcome Measures

Primary Outcomes (5)

• 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.

  Within 1 hour following completion of the education session

• Medication Adherence (Neuro-QoL Medication Adherence Short Form 6a Score)

  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.

  Baseline, 2-4 months, and 5-7 months post-intervention

• Asthma Control (Childhood Asthma Control Test (C-ACT)

  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.

  Baseline, 2-4 months, and 5-7 months post-intervention

• Caregiver Illness Burden (PROMIS 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.

  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.

  Baseline, 2-4 months, and 5-7 months post-intervention

Secondary Outcomes (1)

• Pulmonary function (FEV1/FVC)

  Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.

Study Arms (2)

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 supported education session lasting approximately 10 minutes during their hospital admission.

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.

Behavioral: Standard Asthma Education

Interventions

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 Plus Artificially Intelligent Robot (AIR) Control Intervention

Standard Asthma Education BEHAVIORAL

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

Standard Asthma Education (Control); Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Holtz Children's Hospital

Miami, Florida, 33136, United States

Location

Related Publications (4)

• 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: 38746721 BACKGROUND

• Foronda 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.

  PMID: 32299726 BACKGROUND

• Prather 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.

  PMID: 32653828 BACKGROUND

• Foronda 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.

  PMID: 34913268 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden

Interventions

Air

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Cynthia L Foronda, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia L Foronda, PhD

CONTACT

305-284-1525; c.foronda@miami.edu

Ubbo Visser, PhD

CONTACT

305-284-2254; ubbo.visser@gmail.com

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: Professor of Clinical Nursing

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)