Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-04-02 @ 5:43 PM
Study NCT ID:
NCT03480204
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2018-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000071064', 'term': 'Alert Fatigue, Health Personnel'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-15', 'studyFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2018-03-21', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Connectivity', 'timeFrame': '48 hours', 'description': 'Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server'}, {'measure': 'Continuity', 'timeFrame': '48 hours', 'description': 'Loss of cardiac waveform signal from patch compared with traditional telemetry monitor.'}], 'secondaryOutcomes': [{'measure': 'Agreement for cardiac arrhythmia detection (post hoc, offline)', 'timeFrame': '48 hours', 'description': 'Analysis of cardiac arrhythmia detections on patch compared with traditional telemetry for agreement, concordance and discordance.'}, {'measure': 'Body temperature (post hoc, offline)', 'timeFrame': '48 hours', 'description': 'Body temperature recorded by patch compared with nursing documentation in a post hoc analysis. Data from patch will not be assessed for patient care in real time.'}, {'measure': 'Cardiac waveform (post hoc, offline)', 'timeFrame': '48 hours', 'description': 'Pre-specified analysis of cardiac waveform characteristics in association with pre-specified clinical events such as deployment of emergency response team.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemetry, Patch Monitor, Alarm Fatigue'], 'conditions': ['Cardiac Arrhythmia']}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.', 'detailedDescription': 'This study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-ICU hospitalized patients on a selected nursing ward at the Cleveland Clinic Heart and Vascular Institute. All patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. The patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-ICU hospitalized patients on the J8-3 nursing ward at the Cleveland Clinic Heart and Vascular Institute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 years old and able to provide informed consent\n* Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order\n\nExclusion Criteria:\n\n* Cardiac implantable device (pacemaker or ICD)\n* Contact precautions or isolation\n* Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)'}, 'identificationModule': {'nctId': 'NCT03480204', 'briefTitle': 'Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY', 'orgStudyIdInfo': {'id': '17-1656'}}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Daniel J Cantillon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Isansys Lifecare LTD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dan Cantillon', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}