Developing a Childhood Asthma Risk Passive Digital Marker

NCT05826561 | Terminated Results

• 2 other identifiers: 15873K01HL166436
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Asthma

Keywords

Pediatric Asthma; Early Detection; Screening; Passive Digital Marker; Risk Factors

Outcome Measures

Primary Outcomes (3)

• Perceived PDM Acceptance

  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).

  8 to 12 months

• Perceived PDM Usability

  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).

  8 to 12 months

• Study Feasibility

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

  8 to 12 months

Secondary Outcomes (1)

• Prognostic Accuracy

  3 to 12 months

Study Arms (4)

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.

Other: Childhood Asthma Passive Digital Marker

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.

Other: Childhood Asthma Passive Digital Marker

Interventions

Childhood Asthma Passive Digital Marker OTHER

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.

Also known as: Passive Screening Test (PDM)

PDM Intervention Clinicians - post test only; PDM Intervention Clinicians - pre and post test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Practicing pediatricians within the IU Health Network

You may not qualify if:

• Non-practicing pediatricians within the IU Health Network

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Owora AH, Jiang B, Shah Y. Effect of an electronic health record-integrated machine learning asthma risk marker on pediatrician prognostic accuracy during preschool age: a pilot randomized clinical trial. Sci Rep. 2026 Jun 18;16(1):20753. doi: 10.1038/s41598-026-57759-w.

  PMID: 42315888 DERIVED

Results Point of Contact

• Title: Arthur H Owora
• Organization: Indiana University School of Medicine

ahowora@iu.edu

3172749109

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: June 1, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: July 21, 2026
• Results First Posted: July 21, 2026

Record last verified: 2026-06

Locations

US (1)