Developing a Childhood Asthma Risk Passive Digital Marker

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.

Study Overview

• Status: Terminated
• Conditions: Pediatric Asthma
• Intervention / Treatment: Other: Childhood Asthma Passive Digital Marker

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Practicing pediatricians within the IU Health Network

Exclusion Criteria:

• Non-practicing pediatricians within the IU Health Network

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Clinicians - post test only; 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.
Experimental: PDM Intervention Clinicians - post test only; 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.	Other: Childhood Asthma Passive Digital Marker; A childhood asthma Passive Digital Marker (PDM) is an ML algorithm that is able to retrieve and synthesize pre-existing "passively" collected mother/child dyad prognostic data in "digital" electronic health record (EHR) to provide an objective and quantifiable "marker" of a child's risk (probability) and associated pathophysiological phenotype to inform clinician decision-making at point-of-care.; Other Names: Passive Screening Test (PDM)
No Intervention: Control Clinicians - pre and post test; 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.
Active Comparator: PDM Intervention Clinicians - pre and post test; 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.	Other: Childhood Asthma Passive Digital Marker; A childhood asthma Passive Digital Marker (PDM) is an ML algorithm that is able to retrieve and synthesize pre-existing "passively" collected mother/child dyad prognostic data in "digital" electronic health record (EHR) to provide an objective and quantifiable "marker" of a child's risk (probability) and associated pathophysiological phenotype to inform clinician decision-making at point-of-care.; Other Names: Passive Screening Test (PDM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived PDM acceptance	Perceived PDM acceptance will be measured using a Behavioral Intention scale (BIS).	8 to 12 months
Perceived PDM usability	Perceived Usability will be measured using a modified Simplified System Usability Scale (SUS).	8 to 12 months
Study feasibility	Percent of successful study enrollment of eligible clinicians (>80%)	8 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic accuracy	% correct clinician predictions at pre and post test	3 to 12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Screening; Risk Factors; Pediatric Asthma; Early Detection; Passive Digital Marker
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 15873; K01HL166436 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No