Asthma Under Artificially Intelligent Robot (AIR) Control: Robotic Support for Pediatric Education
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Miami
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Child Inhaler Technique Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention
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.
Intervention: Standard Asthma Education (Behavioral)
Standard Asthma Education (Control)
Participants in this arm will receive one standard asthma education session during their hospital admission lasting approximately 10 minutes.
Intervention: Standard Asthma Education (Behavioral)
Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention
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.
Intervention: Artificially Intelligent Robot (AIR) Control Intervention (Behavioral)
Outcomes
Primary Outcomes
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-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.
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.
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.
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.
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.
Secondary Outcomes
- Pulmonary function (FEV1/FVC)(Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.)
- Pulmonary function (Forced Expiratory Volume in 1 second/ Forced Vital Capacity )(Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.)
Investigators
Cynthia Foronda
Professor of Clinical Nursing
University of Miami