Artificial Intelligence, Asthma in Children, Caregiver Burden
Conditions
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.
Interventions
BEHAVIORALArtificially Intelligent Robot (AIR) Control Intervention
Participants will receive a single 10-minute robotic asthma education session delivered by the Artificially Intelligent Robot (AIR) during their hospital admission.
BEHAVIORALStandard Asthma Education
Participants will receive the standard asthma education provided by their healthcare provider during their hospital admission.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
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 4-11.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Inhaler Technique Score | 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) | 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) | 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) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function (Forced Expiratory Volume in 1 second/ Forced Vital Capacity ) | 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. |
Countries
United States
Contacts
CONTACTCynthia L Foronda, PhD
CONTACTUbbo Visser, PhD
PRINCIPAL_INVESTIGATORCynthia L Foronda, PhD
University of Miami
Outcome results
None listed