Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-10 @ 4:49 PM
Study NCT ID:
NCT03207802
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2017-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remotely Monitoring Patients With Chronic Conditions in Their Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Data correlation', 'timeFrame': '2-6 months', 'description': 'Correlation between data collection and potential heart failure event'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['CHF']}, 'descriptionModule': {'briefSummary': "Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health.", 'detailedDescription': "Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health. Data from the CoVa Monitoring System will be compared against electronic health records to determine if the data captured will provide insight into a patient's overall health. Additionally, user compliance will be monitored"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving home health care with one or more chronic diseases including CHF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Disease including CHF\n* Currently receiving home health care\n* Recent discharge for a CHF event\n\nExclusion Criteria:\n\n* Skin reaction to electrodes\n* Inability to take measurements due to low BMI'}, 'identificationModule': {'nctId': 'NCT03207802', 'briefTitle': 'Remotely Monitoring Patients With Chronic Conditions in Their Home', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'Necklace-Shaped Sensor for Non-Invasive Measurement of Vital Signs, Thoracic Impedance, ECG, Skin Temperature and Motion', 'orgStudyIdInfo': {'id': 'PERM-IRB-001-OCS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 3', 'description': 'This cohort is living at home with a chronic condition.', 'interventionNames': ['Device: Discontinuation of using device']}], 'interventions': [{'name': 'Discontinuation of using device', 'type': 'DEVICE', 'description': 'Subject will be instructed to discontinuation of use of device', 'armGroupLabels': ['Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71854', 'city': 'Texarkana', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Elite Home Health', 'geoPoint': {'lat': 33.44179, 'lon': -94.03769}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}