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Developing a Childhood Asthma Risk Passive Digital Marker

NCT05826561 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-07-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-06-16
Completion
2025-06-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826561 on ClinicalTrials.gov