Developing a Childhood Asthma Risk Passive Digital Marker

Pediatric Asthma Clinical Trial

Official title:

Developing a Childhood Asthma Risk Passive Digital Marker

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05826561
• Other study ID #: 15873
• Secondary ID: K01HL166436
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Practicing pediatricians within the IU Health Network

Exclusion Criteria:

• Non-practicing pediatricians within the IU Health Network

Related Conditions & MeSH terms

• Asthma
• Pediatric Asthma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived PDM acceptance	Perceived PDM acceptance will be measured using a Behavioral Intention scale (BIS).	8 to 12 months
Primary	Perceived PDM usability	Perceived Usability will be measured using a modified Simplified System Usability Scale (SUS).	8 to 12 months
Primary	Study feasibility	Percent of successful study enrollment of eligible clinicians (>80%)	8 to 12 months
Secondary	Prognostic accuracy	% correct clinician predictions at pre and post test	3 to 12 months