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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Asthma Education (Control) | Active Comparator | Participants in this arm will receive one standard asthma education session during a single clinic visit lasting approximately 5 minutes. |
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| Standard Education Plus Artificially Intelligent Robot (AIR) Support Intervention (Experimental) | Experimental | Participants in this arm will receive standard asthma education plus one artificially intelligent robot supported education session during a single clinic visit lasting approximately 15 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Asthma Education | Behavioral | 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Human Support Robot: Enrollment Rate | 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. | Immediately after robotic session and up to 3 months afterwards via recordings and documentation. |
| Feasibility of the Human Support Robot: Completion Rate | 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. | Immediately after robotic session and up to 3 months afterwards via recordings and documentation. |
| Feasibility of the Human Support Robot: Session Length | 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. | Immediately after robotic session and up to 3 months afterwards via recordings and documentation. |
| Feasibility of the Human Support Robot: Number of Technical Issues | 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. | Immediately after robotic session and up to 3 months afterwards via recordings and documentation. |
| Measure | Description | Time Frame |
|---|---|---|
| Child Engagement (PROMIS) | 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia L Foronda, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Batchelor Children's Research Institute | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Pasternak K, Foronda C, Downs C, Visser U. Social robots for pediatric asthma education: A pilot study. In: Staffa M, et al., eds. Social Robotics + AI. ICSR+AI 2025. Lecture Notes in Computer Science. Vol 16131. Singapore: Springer; 2026. doi:10.1007/978-981-95-2379-5_35 | ||
| Background | Foronda CL, Susas T, Castaño Cubillos N, Pasternak K, Downs CA, Visser U. Preparing nurses for the technological future: Robotic integration in nursing education. Teaching and Learning in Nursing. 2025. doi:10.1016/j.teln.2025.11.034 | ||
| 38746721 | Background | 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. |
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| ID | Term |
|---|---|
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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| Artificially Intelligent Robot (AIR) Support Intervention | Behavioral | Participants will receive a single 15-minute robotic asthma education session delivered by the Artificially Intelligent Robot/Human Support Robot (AIR/HSR). |
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| Acceptability of the Human Support Robot or Acceptability of the Robot-Supported Education Session | 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. | Immediately after the robotic session (same clinic visit) and up to 3 months afterwards via recordings and documentation. |
| Day 1 |
| Child inhaler technique (Coaching Tool) | 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. | Day 1 |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |