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临床试验/NCT05826561
NCT05826561终止不适用

Developing a Childhood Asthma Risk Passive Digital Marker

Indiana University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年6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
终止
入组人数
34
试验地点
2
主要终点
Perceived PDM acceptance

研究概览

简要总结

Underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. Current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical settings and hence are not widely used in practice.

The objective of the study is to determine the usability, acceptability, feasibility, and preliminary efficacy of the childhood asthma passive digital marker (PDM) among pediatricians. The study will include practicing pediatricians within the IU Health Network.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Care Provider)

入排标准

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

入选标准

  • Practicing pediatricians within the IU Health Network

排除标准

  • Non-practicing pediatricians within the IU Health Network

研究组 & 干预措施

Control Clinicians - post test only

No Intervention

N=25 control pediatric clinicians, who will receive the post test only. Each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years.

PDM Intervention Clinicians - post test only

Experimental

N=25 intervention pediatric clinicians, who will receive the post test only. Using the PDM, each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years.

干预措施: Childhood Asthma Passive Digital Marker (Other)

Control Clinicians - pre and post test

No Intervention

N=25 control pediatric clinicians, who will receive the pre and post test. Each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years.

PDM Intervention Clinicians - pre and post test

Active Comparator

N=25 intervention pediatric clinicians, who will receive the pre and post test. Using the PDM, each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years.

干预措施: Childhood Asthma Passive Digital Marker (Other)

结局指标

主要结局

Perceived PDM acceptance

时间窗: 8 to 12 months

Perceived PDM acceptance will be measured using a Behavioral Intention scale (BIS).

Perceived PDM usability

时间窗: 8 to 12 months

Perceived Usability will be measured using a modified Simplified System Usability Scale (SUS).

Study feasibility

时间窗: 8 to 12 months

Percent of successful study enrollment of eligible clinicians (\>80%)

Perceived PDM Acceptance

时间窗: 8 to 12 months

Mean Perceived PDM acceptance measured using a Behavioral Intention scale (BIS) with a score Likert scale score of 0-5. Here, higher score values represent a higher acceptability of the PDM (i.e., better outcome).

Perceived PDM Usability

时间窗: 8 to 12 months

Mean Perceived Usability measured using a modified Simplified System Usability Scale (SUS) with a score Likert scale of 0-5. Here, higher score values represent a higher perceived usability of the PDM (i.e., better outcome).

Study Feasibility

时间窗: 8 to 12 months

Percent of successful study enrollment of eligible clinicians (\>80%)

次要结局

  • Prognostic accuracy(3 to 12 months)
  • Prognostic Accuracy(3 to 12 months)

研究者

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

Arthur H. Owora, MPH, PhD

Associate Professor

Indiana University

研究点 (2)

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