Batchelor Children's Research Institute
Miami, Florida, 33136, United States
NCT Number: NCT07387718
The purpose of this prevention study is to evaluate the design and usability of a newly developed asthma education protocol with the Human Support Robot (HSR) for children with asthma.
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Notify Me3 year and older
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion (Eligibility) Criteria for Caregivers or Parents:
Exclusion (Eligibility) Criteria for Caregivers or Parents:
Inclusion (Eligibility) Criteria for Children:
Exclusion (Eligibility) Criteria for Children:
Inclusion (Eligibility) Criteria for Healthcare Providers:
Participants will receive the usual asthma education provided by their healthcare provider during the clinic visit, including asthma action plan and metered dose inhaler and spacer teaching..
Participants will receive a single 15-minute robotic asthma education session delivered by the Artificially Intelligent Robot/Human Support Robot (AIR/HSR).
Time frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
Feasibility will be assessed by measuring the enrollment rate for the study involving the Human Support Robot. Enrollment rate will be calculated as the number of participants enrolled divided by the number of eligible participants approached, expressed as a percentage. Higher percentages indicate greater feasibility of implementation.
Time frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
Feasibility will be evaluated by measuring the completion rate for the study procedures involving the Human Support Robot. Completion rate will be calculated as the number of enrolled participants who complete all required study procedures - including the education session, survey, inhaler-use demonstration, and interview - divided by the total number of participants enrolled, expressed as a percentage. Higher percentages indicate greater feasibility of implementation.
Time frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
Feasibility will be measured by recording the duration in minutes of the robot education session. More consistent and shorter session durations indicate better feasibility for clinic workflow and integration of the Human Support Robot.
Time frame: Immediately after robotic session and up to 3 months afterwards via recordings and documentation.
Feasibility will be assessed by recording the number and type of technical issues occurring during the robot-supported education session, including hardware malfunctions, software errors, or disruptions requiring staff assistance. Fewer technical issues indicate greater feasibility of implementing the Human Support Robot in a clinic setting.
Time frame: Immediately after the robotic session (same clinic visit) and up to 3 months afterwards via recordings and documentation.
Acceptability of the robot will be evaluated by using the Technology Acceptance Model Questionnaire. The questionnaire includes items assessing perceived usefulness and perceived ease of use, each rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). Scores will be averaged to produce subscale scores ranging from 1 to 7, with higher scores indicating greater acceptability.
Time frame: Day 1
Child engagement will be evaluated using a slightly adapted Patient-Reported Outcomes Measurement Information System (PROMIS) Early Childhood Parent Engagement measure. This questionnaire includes items assessing the child's attention, interest, and participation during activities. Each item is rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("always"). Item responses are summed and converted to a standardized T-score (mean = 50, standard deviation = 10). Higher T-scores indicate greater engagement.
Time frame: Day 1
Child knowledge will be assessed using the Inhaler Technique Coaching Tool, a structured checklist evaluating each step of proper inhaler use. The research assistant will score each step as correct (1) or missed or done improperly (0). Scores will be summed to produce a total score ranging from 0 - 6, with higher scores indicating more accurate inhaler technique and greater knowledge of inhaler use.
University of Miami
Other
Artificially Intelligent Robot (AIR) Support for Pediatric Asthma Education
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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