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临床试验/NCT07738016
NCT07738016尚未招募不适用

Asthma Under Artificially Intelligent Robot (AIR) Control: Robotic Support for Pediatric Education

University of Miami1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Child Inhaler Technique Score

研究概览

简要总结

The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.

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
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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-
  • Exclusion Criteria for Children:
  • The participant is younger than 4 years old, over 11 years old, or does not have asthma.
  • The child does not speak English or Spanish.
  • The participant is unwilling to participate in the study.
  • The participant's guardian did not consent.

研究组 & 干预措施

Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention

Experimental

Participants in this arm will receive the standard asthma education plus one Artificially Intelligent Robot (AIR) supported education session lasting approximately 10 minutes during their hospital admission.

干预措施: Standard Asthma Education (Behavioral)

Standard Asthma Education (Control)

Active Comparator

Participants in this arm will receive one standard asthma education session during their hospital admission lasting approximately 10 minutes.

干预措施: Standard Asthma Education (Behavioral)

Standard Asthma Education Plus Artificially Intelligent Robot (AIR) Control Intervention

Experimental

Participants in this arm will receive the standard asthma education plus one Artificially Intelligent Robot (AIR) supported education session lasting approximately 10 minutes during their hospital admission.

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

结局指标

主要结局

Child Inhaler Technique Score

时间窗: 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-QoL Medication Adherence Short Form 6a Score)

时间窗: Baseline, 2-4 months, and 5-7 months post-intervention

Medication adherence will be assessed using the Neuro-Quality of Life (QoL) 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 (C-ACT)

时间窗: 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 (PROMIS Illness Burden - Short Form 6a)

时间窗: 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

时间窗: 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.

Medication Adherence (Neuro-Quality of Life Medication Adherence Short Form 6a Score)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • Pulmonary function (FEV1/FVC)(Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.)
  • Pulmonary function (Forced Expiratory Volume in 1 second/ Forced Vital Capacity )(Baseline, 2-4 months post-intervention, and 5-7 months post-intervention.)

研究者

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

Cynthia Foronda

Professor of Clinical Nursing

University of Miami

研究点 (1)

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