Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-04 @ 4:44 AM
Study NCT ID:
NCT06547268
Status:
TERMINATED
Last Update Posted:
2025-10-31
First Post:
2024-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advancing the Science of Pediatric Interstage Home Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Changes to sensor to test', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-08-07', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiologic measurements', 'timeFrame': 'up to 14 days per patient of data collection', 'description': 'Physiologic data waveform morphology'}], 'secondaryOutcomes': [{'measure': 'Systems Usability Score', 'timeFrame': 'up to 14 days per patient of data collection', 'description': 'Score from 0 (min) to 100 (max) of usability with higher is better (100=perfect).'}, {'measure': 'Utilization', 'timeFrame': 'up to 14 days per patient of data collection', 'description': 'Emergency departnment use'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Heart Defects, Congenital', 'Digital Health'], 'conditions': ['Heart Defects, Congenital']}, 'referencesModule': {'references': [{'pmid': '35102417', 'type': 'BACKGROUND', 'citation': 'Foster C, Schinasi D, Kan K, Macy M, Wheeler D, Curfman A. Remote Monitoring of Patient- and Family-Generated Health Data in Pediatrics. Pediatrics. 2022 Feb 1;149(2):e2021054137. doi: 10.1542/peds.2021-054137.'}, {'pmid': '33079264', 'type': 'BACKGROUND', 'citation': 'Foster CC, Steltzer M, Snyder A, Alden C, Helner K, Schinasi DA, Bohling K, Allen K. Integrated Multimodality Telemedicine to Enhance In-Home Care of Infants During the Interstage Period. Pediatr Cardiol. 2021 Feb;42(2):349-360. doi: 10.1007/s00246-020-02489-7. Epub 2020 Oct 20.'}, {'pmid': '32777961', 'type': 'BACKGROUND', 'citation': 'Rudd NA, Ghanayem NS, Hill GD, Lambert LM, Mussatto KA, Nieves JA, Robinson S, Shirali G, Steltzer MM, Uzark K, Pike NA; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Clinical Cardiology; and Council on Lifestyle and Cardiometabolic Health. Interstage Home Monitoring for Infants With Single Ventricle Heart Disease: Education and Management: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2020 Aug 18;9(16):e014548. doi: 10.1161/JAHA.119.014548. Epub 2020 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at home.', 'detailedDescription': "The goal of this study is to examine how well continuous sensor-based monitoring performs at detecting physiologic data in infants with single ventricle physiology at home compared to existing approaches, in manner that is feasible and acceptable to patients' families. Performance features of interest include how the data compares to family measurements, whether it correlates with parents' observable symptoms, and how this approach may be integrated into home life and health system workflows. The investigators will also explore whether the collected data can be used to develop predictive analytics for acute deterioration and/or advanced chronic cardiopulmonary management compared to what is currently being done in remote patient monitoring."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children receiving remote patient monitoring in tele-interstage home monitoring program.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Receiving active remote patient monitoring (RPM) in Lurie's Tele-Interstage Home Monitoring Program.\n* Age 0-2 years of age at enrollment.\n* In the opinion of the investigator, parent or legally authorized guardian, and participant, the participant and (when relevant) family can follow study procedures.\n\nExclusion Criteria:\n\n* Is going to discontinue RPM before their enrollment would end (i.e., within 14 days).\n* Skin breakdown or severe rash at the site of sensor placement.\n* Patient without a parental guardian to consent.\n* The patient is in active hospice or similar end-of-life care.\n* The patient will be living in a long-term institution or transitional facility."}, 'identificationModule': {'nctId': 'NCT06547268', 'acronym': 'Heart@Home', 'briefTitle': 'Advancing the Science of Pediatric Interstage Home Monitoring', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Heart@Home: Advancing the Science of Pediatric Interstage Home Monitoring', 'orgStudyIdInfo': {'id': '2023-6397'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Home monitoring program patients', 'description': 'Patients enrolled in the study are those patients who are already enrolled in (or are being discharged with) home monitoring in an existing program', 'interventionNames': ['Device: Wireless sensor and platform']}], 'interventions': [{'name': 'Wireless sensor and platform', 'type': 'DEVICE', 'otherNames': ['Arc'], 'description': 'Skin-mounted sensor that pairs with tablet platform', 'armGroupLabels': ['Home monitoring program patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Carolyn C Foster, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ann and Robert H. Lurie Children's Hospital of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data requests will be reviewed by PI if the occur.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'collaborators': [{'name': 'Sibel Health Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Carolyn Foster', 'investigatorAffiliation': 'Northwestern University'}}}}