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Developing a Childhood Asthma Risk Passive Digital Marker

Sponsor
Indiana University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05826561
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
100
Enrollment
4
Arms
37
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Childhood Asthma Passive Digital Marker
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Screening
Official Title:
Developing a Childhood Asthma Risk Passive Digital Marker
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Perceived PDM acceptance [8 to 12 months]

      Perceived PDM acceptance will be measured using a Behavioral Intention scale (BIS).

    2. Perceived PDM usability [8 to 12 months]

      Perceived Usability will be measured using a modified Simplified System Usability Scale (SUS).

    3. Study feasibility [8 to 12 months]

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

    Secondary Outcome Measures

    1. Prognostic accuracy [3 to 12 months]

      % correct clinician predictions at pre and post test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Practicing pediatricians within the IU Health Network

    Exclusion Criteria:

    • Non-practicing pediatricians within the IU Health Network

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arthur H. Owora, MPH, PhD, Associate Professor, Indiana University
    ClinicalTrials.gov Identifier:
    NCT05826561
    Other Study ID Numbers:
    • 15873
    • K01HL166436
    First Posted:
    Apr 24, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arthur H. Owora, MPH, PhD, Associate Professor, Indiana University
    Pediatric Asthma
    Early Detection
    Screening
    Passive Digital Marker
    Risk Factors
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Apr 28, 2023