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Developing a Childhood Asthma Risk Passive Digital Marker

Primary Purpose

Pediatric Asthma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Childhood Asthma Passive Digital Marker
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pediatric Asthma focused on measuring Pediatric Asthma, Early Detection, Screening, Passive Digital Marker, Risk Factors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Practicing pediatricians within the IU Health Network Exclusion Criteria: • Non-practicing pediatricians within the IU Health Network

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    No Intervention

    Active Comparator

    Arm Label

    Control Clinicians - post test only

    PDM Intervention Clinicians - post test only

    Control Clinicians - pre and post test

    PDM Intervention Clinicians - pre and post test

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Prognostic accuracy
    % correct clinician predictions at pre and post test

    Full Information

    First Posted
    April 12, 2023
    Last Updated
    July 26, 2023
    Sponsor
    Indiana University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05826561
    Brief Title
    Developing a Childhood Asthma Risk Passive Digital Marker
    Official Title
    Developing a Childhood Asthma Risk Passive Digital Marker
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indiana University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Asthma
    Keywords
    Pediatric Asthma, Early Detection, Screening, Passive Digital Marker, Risk Factors

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Clinicians - post test only
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    PDM Intervention Clinicians - post test only
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Clinicians - pre and post test
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    PDM Intervention Clinicians - pre and post test
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Childhood Asthma Passive Digital Marker
    Other Intervention Name(s)
    Passive Screening Test (PDM)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Perceived PDM acceptance
    Description
    Perceived PDM acceptance will be measured using a Behavioral Intention scale (BIS).
    Time Frame
    8 to 12 months
    Title
    Perceived PDM usability
    Description
    Perceived Usability will be measured using a modified Simplified System Usability Scale (SUS).
    Time Frame
    8 to 12 months
    Title
    Study feasibility
    Description
    Percent of successful study enrollment of eligible clinicians (>80%)
    Time Frame
    8 to 12 months
    Secondary Outcome Measure Information:
    Title
    Prognostic accuracy
    Description
    % correct clinician predictions at pre and post test
    Time Frame
    3 to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Practicing pediatricians within the IU Health Network Exclusion Criteria: • Non-practicing pediatricians within the IU Health Network

    12. IPD Sharing Statement

    Learn more about this trial

    Developing a Childhood Asthma Risk Passive Digital Marker

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