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临床试验/NCT07387718
NCT07387718已完成不适用

Artificially Intelligent Robot (AIR) Support for Pediatric Asthma Education

University of Miami1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2026年2月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Feasibility of the Human Support Robot: Enrollment Rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion (Eligibility) 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 with asthma.
  • Exclusion (Eligibility) 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.
  • Inclusion (Eligibility) Criteria for Children:
  • The participant must be at least 3 years old - 17 years old with asthma.
  • The participant must assent to participation.
  • The participant's guardian must have consented.
  • Exclusion (Eligibility) Criteria for Children:
  • The participant is younger than 3 years old.
  • The participant does not have asthma.
  • The participant is unwilling to participate in the study.
  • The participant's guardian did not consent.
  • Inclusion (Eligibility) Criteria for Healthcare Providers:
  • The participant must be at least 18 years old.
  • The participant must be willing and able to participate.
  • The participant can read English and is able to fill out survey instruments by themselves.
  • The participant must view a robotic education session.

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Standard Asthma Education (Behavioral)

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.

干预措施: Standard Asthma Education (Behavioral)

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.

干预措施: Artificially Intelligent Robot (AIR) Support Intervention (Behavioral)

结局指标

主要结局

Feasibility of the Human Support Robot: Enrollment Rate

时间窗: 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.

Feasibility of the Human Support Robot: Completion Rate

时间窗: 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.

Feasibility of the Human Support Robot: Session Length

时间窗: 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.

Feasibility of the Human Support Robot: Number of Technical Issues

时间窗: 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.

Acceptability of the Human Support Robot or Acceptability of the Robot-Supported Education Session

时间窗: 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.

次要结局

  • Child Engagement (PROMIS)(Day 1)
  • Child inhaler technique (Coaching Tool)(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Foronda

Assistant Dean for Innovation and Clinical Scholarship

University of Miami

研究点 (1)

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