Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-30 @ 12:08 AM
Study NCT ID:
NCT05826561
Status:
TERMINATED
Last Update Posted:
2025-07-08
First Post:
2023-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing a Childhood Asthma Risk Passive Digital Marker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'NIH funding was terminated due to new agency priorities.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived PDM acceptance', 'timeFrame': '8 to 12 months', 'description': 'Perceived PDM acceptance will be measured using a Behavioral Intention scale (BIS).'}, {'measure': 'Perceived PDM usability', 'timeFrame': '8 to 12 months', 'description': 'Perceived Usability will be measured using a modified Simplified System Usability Scale (SUS).'}, {'measure': 'Study feasibility', 'timeFrame': '8 to 12 months', 'description': 'Percent of successful study enrollment of eligible clinicians (\\>80%)'}], 'secondaryOutcomes': [{'measure': 'Prognostic accuracy', 'timeFrame': '3 to 12 months', 'description': '% correct clinician predictions at pre and post test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Asthma', 'Early Detection', 'Screening', 'Passive Digital Marker', 'Risk Factors'], 'conditions': ['Pediatric Asthma']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Practicing pediatricians within the IU Health Network\n\nExclusion Criteria:\n\n• Non-practicing pediatricians within the IU Health Network'}, 'identificationModule': {'nctId': 'NCT05826561', 'briefTitle': 'Developing a Childhood Asthma Risk Passive Digital Marker', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Developing a Childhood Asthma Risk Passive Digital Marker', 'orgStudyIdInfo': {'id': '15873'}, 'secondaryIdInfos': [{'id': 'K01HL166436', 'link': 'https://reporter.nih.gov/quickSearch/K01HL166436', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Clinicians - post test only', '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."}, {'type': 'EXPERIMENTAL', 'label': 'PDM Intervention Clinicians - post test only', '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.", 'interventionNames': ['Other: Childhood Asthma Passive Digital Marker']}, {'type': 'NO_INTERVENTION', 'label': 'Control Clinicians - pre and post test', '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."}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PDM Intervention Clinicians - pre and post test', '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.", 'interventionNames': ['Other: Childhood Asthma Passive Digital Marker']}], 'interventions': [{'name': 'Childhood Asthma Passive Digital Marker', 'type': 'OTHER', 'otherNames': ['Passive Screening Test (PDM)'], '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.', 'armGroupLabels': ['PDM Intervention Clinicians - post test only', 'PDM Intervention Clinicians - pre and post test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Arthur H. Owora, MPH, PhD', 'investigatorAffiliation': 'Indiana University'}}}}