Artificially Intelligent Robot Control
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4+
SponsorUniversity of Miami
About this trial
The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Artificially Intelligent Robot (AIR) Control Intervention
BehavioralParticipants will receive a single 10-minute robotic asthma education session delivered by the Artificially Intelligent Robot (AIR) during their hospital admission.
Standard Asthma Education
BehavioralParticipants will receive the standard asthma education provided by their healthcare provider during their hospital admission.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control InterventionExperimental treatment 2 interventions
Group B: Standard Asthma Education (Control)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 1 hour following completion of the education session2
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.
Time frame
Baseline, 2-4 months, and 5-7 months post-intervention3
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.
Time frame
Baseline, 2-4 months, and 5-7 months post-intervention4
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.
Time frame
Baseline, 2-4 months, and 5-7 months post-interventionSecondary 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.
Time frame
Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: