Developing a Childhood Asthma Risk Passive Digital Marker

Not Applicable

Terminated

• Conditions: Pediatric Asthma

• Registration Number: NCT05826561
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-24
• Study Start: 2024-06-01
• Primary Completion: 2025-06-16
• Study Completion: 2025-06-16
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Practicing pediatricians within the IU Health Network

Exclusion Criteria

• Non-practicing pediatricians within the IU Health Network

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Prognostic accuracy	3 to 12 months	% correct clinician predictions at pre and post test

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States