Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04425720
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2020-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Remote Monitoring for COVID-19 Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jleff@montefiore.org', 'phone': '7189204316', 'title': 'Dr. Jonathan Leff', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 17 days after admission', 'description': 'As this is a novel pandemic, there are limited resources available for accurate identification of patients at high risk for respiratory failure and other adverse events. Subjects who were repeatedly admitted into the hospital will count as an adverse event. Death will count as a serious adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Of Care', 'description': 'Patients without wearable monitoring technology undergoing routine standard of care at the hospital.\n\nStandard of Care: This group will be treated based on standard of care at our institution.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 8, 'seriousNumAtRisk': 150, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 9, 'seriousNumAtRisk': 130, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Repeated Admission', 'notes': 'Subjects who were repeatedly admitted into the hospital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Monitored Versus Non-Monitored In-patient Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Of Care', 'description': 'Patients without wearable monitoring technology undergoing routine standard of care at the hospital.\n\nStandard of Care: This group will be treated based on standard of care at our institution.'}, {'id': 'OG001', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'compare the number of in-patient admissions between the monitored and non-monitored patients', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'How Many Subjects Needed to Visit the Emergency Department', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Of Care', 'description': 'Patients without wearable monitoring technology undergoing routine standard of care at the hospital.\n\nStandard of Care: This group will be treated based on standard of care at our institution.'}, {'id': 'OG001', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'compare the number of participants who visited Emergency Department between both arms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Of Care', 'description': 'Patients without wearable monitoring technology undergoing routine standard of care at the hospital.\n\nStandard of Care: This group will be treated based on standard of care at our institution.'}, {'id': 'OG001', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '14'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'Length of stay of subject if hospitalized', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'How Many Completed the Patient Satisfaction Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Survey given to patients who were monitored to ask about satisfaction with the program. A research associate calls enrolled subjects to determine their opinions having participated in the program.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'How Many Subjects End up Requiring Mechanical Ventilation and ECMO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'How often does a subject end up getting mechanical ventilation or ECMO', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As only those monitored were surveyed, the following results only reflect one of the arms. There is no reason to conduct a satisfaction survey on individuals who received standard of care because they would not be aware of the monitoring option.'}, {'type': 'PRIMARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Of Care', 'description': 'Patients without wearable monitoring technology undergoing routine standard of care at the hospital.\n\nStandard of Care: This group will be treated based on standard of care at our institution.'}, {'id': 'OG001', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'events requiring extended hospital stay', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Of Care', 'description': 'Patients without wearable monitoring technology undergoing routine standard of care at the hospital.\n\nStandard of Care: This group will be treated based on standard of care at our institution.'}, {'id': 'FG001', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Of Care', 'description': 'Patients without wearable monitoring technology undergoing routine standard of care at the hospital.\n\nStandard of Care: This group will be treated based on standard of care at our institution.'}, {'id': 'BG001', 'title': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary\n\nLifeSignals Biosensor 1AX\\*: Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Average Age in Years', 'categories': [{'measurements': [{'value': '65.50', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '73'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '58', 'upperLimit': '74'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '74'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-08', 'size': 234980, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-04T13:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2020-06-02', 'resultsFirstSubmitDate': '2021-11-04', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-18', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Monitored Versus Non-Monitored In-patient Admission', 'timeFrame': '14 days', 'description': 'compare the number of in-patient admissions between the monitored and non-monitored patients'}, {'measure': 'How Many Subjects Needed to Visit the Emergency Department', 'timeFrame': '14 days', 'description': 'compare the number of participants who visited Emergency Department between both arms'}, {'measure': 'Length of Stay', 'timeFrame': '14 days', 'description': 'Length of stay of subject if hospitalized'}, {'measure': 'How Many Completed the Patient Satisfaction Survey', 'timeFrame': '14 days', 'description': 'Survey given to patients who were monitored to ask about satisfaction with the program. A research associate calls enrolled subjects to determine their opinions having participated in the program.'}, {'measure': 'How Many Subjects End up Requiring Mechanical Ventilation and ECMO', 'timeFrame': '14 days', 'description': 'How often does a subject end up getting mechanical ventilation or ECMO'}, {'measure': 'Serious Adverse Events', 'timeFrame': '14 days', 'description': 'events requiring extended hospital stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['COVID']}, 'referencesModule': {'references': [{'pmid': '32112977', 'type': 'BACKGROUND', 'citation': "Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26."}, {'pmid': '32145768', 'type': 'BACKGROUND', 'citation': 'Wilder-Smith A, Chiew CJ, Lee VJ. Can we contain the COVID-19 outbreak with the same measures as for SARS? Lancet Infect Dis. 2020 May;20(5):e102-e107. doi: 10.1016/S1473-3099(20)30129-8. Epub 2020 Mar 5.'}, {'pmid': '31986264', 'type': 'BACKGROUND', 'citation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.'}, {'pmid': '32031570', 'type': 'BACKGROUND', 'citation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.'}, {'pmid': '32044814', 'type': 'BACKGROUND', 'citation': 'Liu K, Fang YY, Deng Y, Liu W, Wang MF, Ma JP, Xiao W, Wang YN, Zhong MH, Li CH, Li GC, Liu HG. Clinical characteristics of novel coronavirus cases in tertiary hospitals in Hubei Province. Chin Med J (Engl). 2020 May 5;133(9):1025-1031. doi: 10.1097/CM9.0000000000000744.'}, {'pmid': '32091533', 'type': 'BACKGROUND', 'citation': 'Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.'}, {'pmid': '32247898', 'type': 'BACKGROUND', 'citation': 'Grech V. Unknown unknowns - COVID-19 and potential global mortality. Early Hum Dev. 2020 May;144:105026. doi: 10.1016/j.earlhumdev.2020.105026. Epub 2020 Mar 31.', 'retractions': [{'pmid': '34120096', 'source': 'Early Hum Dev. 2021 Aug;159:105377'}]}, {'pmid': '32200400', 'type': 'BACKGROUND', 'citation': 'Goh KJ, Choong MC, Cheong EH, Kalimuddin S, Duu Wen S, Phua GC, Chan KS, Haja Mohideen S. Rapid Progression to Acute Respiratory Distress Syndrome: Review of Current Understanding of Critical Illness from Coronavirus Disease 2019 (COVID-19) Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118.'}, {'pmid': '22038879', 'type': 'BACKGROUND', 'citation': 'Liu V, Kipnis P, Rizk NW, Escobar GJ. Adverse outcomes associated with delayed intensive care unit transfers in an integrated healthcare system. J Hosp Med. 2012 Mar;7(3):224-30. doi: 10.1002/jhm.964. Epub 2011 Oct 28.'}, {'pmid': '22699035', 'type': 'BACKGROUND', 'citation': 'Mardini L, Lipes J, Jayaraman D. Adverse outcomes associated with delayed intensive care consultation in medical and surgical inpatients. J Crit Care. 2012 Dec;27(6):688-93. doi: 10.1016/j.jcrc.2012.04.011. Epub 2012 Jun 12.'}, {'pmid': '23185988', 'type': 'BACKGROUND', 'citation': 'Mokart D, Lambert J, Schnell D, Fouche L, Rabbat A, Kouatchet A, Lemiale V, Vincent F, Lengline E, Bruneel F, Pene F, Chevret S, Azoulay E. Delayed intensive care unit admission is associated with increased mortality in patients with cancer with acute respiratory failure. Leuk Lymphoma. 2013 Aug;54(8):1724-9. doi: 10.3109/10428194.2012.753446. Epub 2012 Dec 26.'}, {'pmid': '15158632', 'type': 'BACKGROUND', 'citation': 'Cheng PK, Wong DA, Tong LK, Ip SM, Lo AC, Lau CS, Yeung EY, Lim WW. Viral shedding patterns of coronavirus in patients with probable severe acute respiratory syndrome. Lancet. 2004 May 22;363(9422):1699-700. doi: 10.1016/S0140-6736(04)16255-7.'}, {'pmid': '32197108', 'type': 'BACKGROUND', 'citation': 'Weiss P, Murdoch DR. Clinical course and mortality risk of severe COVID-19. Lancet. 2020 Mar 28;395(10229):1014-1015. doi: 10.1016/S0140-6736(20)30633-4. Epub 2020 Mar 17. No abstract available.'}, {'pmid': '32114094', 'type': 'BACKGROUND', 'citation': 'Tian S, Hu W, Niu L, Liu H, Xu H, Xiao SY. Pulmonary Pathology of Early-Phase 2019 Novel Coronavirus (COVID-19) Pneumonia in Two Patients With Lung Cancer. J Thorac Oncol. 2020 May;15(5):700-704. doi: 10.1016/j.jtho.2020.02.010. Epub 2020 Feb 28.'}, {'pmid': '32109013', 'type': 'BACKGROUND', 'citation': 'Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.'}, {'pmid': '32219362', 'type': 'BACKGROUND', 'citation': "Bonow RO, Fonarow GC, O'Gara PT, Yancy CW. Association of Coronavirus Disease 2019 (COVID-19) With Myocardial Injury and Mortality. JAMA Cardiol. 2020 Jul 1;5(7):751-753. doi: 10.1001/jamacardio.2020.1105. No abstract available."}, {'pmid': '32171076', 'type': 'BACKGROUND', 'citation': 'Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.'}, {'pmid': '27532679', 'type': 'BACKGROUND', 'citation': 'Hu SB, Wong DJ, Correa A, Li N, Deng JC. Prediction of Clinical Deterioration in Hospitalized Adult Patients with Hematologic Malignancies Using a Neural Network Model. PLoS One. 2016 Aug 17;11(8):e0161401. doi: 10.1371/journal.pone.0161401. eCollection 2016.'}, {'pmid': '32293639', 'type': 'BACKGROUND', 'citation': 'Yancy CW. COVID-19 and African Americans. JAMA. 2020 May 19;323(19):1891-1892. doi: 10.1001/jama.2020.6548. No abstract available.'}, {'pmid': '29205294', 'type': 'BACKGROUND', 'citation': 'Izmailova ES, Wagner JA, Perakslis ED. Wearable Devices in Clinical Trials: Hype and Hypothesis. Clin Pharmacol Ther. 2018 Jul;104(1):42-52. doi: 10.1002/cpt.966. Epub 2018 Apr 2.'}, {'pmid': '30695675', 'type': 'BACKGROUND', 'citation': 'Menta AK, Subbiah IM, Subbiah V. Bringing wearable devices into oncology practice: fitting smart technology in the clinic. Discov Med. 2018 Dec;26(145):261-270.'}, {'pmid': '30633301', 'type': 'BACKGROUND', 'citation': 'Ip JE. Wearable Devices for Cardiac Rhythm Diagnosis and Management. JAMA. 2019 Jan 29;321(4):337-338. doi: 10.1001/jama.2018.20437. No abstract available.'}, {'pmid': '30963188', 'type': 'BACKGROUND', 'citation': 'Shan R, Sarkar S, Martin SS. Digital health technology and mobile devices for the management of diabetes mellitus: state of the art. Diabetologia. 2019 Jun;62(6):877-887. doi: 10.1007/s00125-019-4864-7. Epub 2019 Apr 8.'}, {'pmid': '33334565', 'type': 'BACKGROUND', 'citation': 'Radin JM, Wineinger NE, Topol EJ, Steinhubl SR. Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. Lancet Digit Health. 2020 Feb;2(2):e85-e93. doi: 10.1016/S2589-7500(19)30222-5. Epub 2020 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.', 'detailedDescription': 'Aim-I To develop and test a clinical care pathway that can be utilized in similar epidemic conditions in the future. To study this aim, the investigators will be using the COVID-19 medical surge as a condition to evaluate the framework of delivering care through remote patient monitoring. The success of this care delivery model will be evaluated on ease of model implementation, patient satisfaction, clinical outcomes, and the utilization of shared decision making.\n\nAim-II To evaluate remote patient monitoring for appropriate resource utilization in epidemic and pandemic conditions. To evaluate this aim, the investigators plan to compare the emergency department (ED) visits and in-patient admission of patients with and without wearable remote patient monitoring devices. Additionally, the investigators will compare the number of patients that required critical interventions (mechanical ventilation and ECMO) during the hospital stay.\n\nAim III To evaluate the utilization of wearable technology for upfront predictions of patients that would require in-patient admissions. To evaluate this aim, patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary. The comparison group will be patients undergoing routine standard of care at the hospital. ED visits, in-patient hospital admissions, and patient satisfaction will be the outcome measures compared between the two groups.\n\nAim IV To evaluate the association between early identification of critical, abnormal vital signs and the prevention of serious adverse events. To evaluate this aim, patients in the monitored group and non-monitored group will be compared for ED visits, in-patient admissions, length of hospital stay, and serious adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Covid-19 positive patient\n* Does not require in-patient admission\n\nExclusion Criteria:\n\n* Allergic to sensor patch\n* Has implanted pacemaker\n* Has excessive sweating'}, 'identificationModule': {'nctId': 'NCT04425720', 'acronym': 'RPM', 'briefTitle': 'Use of Remote Monitoring for COVID-19 Patient', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient', 'orgStudyIdInfo': {'id': '2020-11824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Of Care', 'description': 'Patients without wearable monitoring technology undergoing routine standard of care at the hospital.', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Monitored', 'description': 'Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary', 'interventionNames': ['Device: LifeSignals Biosensor 1AX*']}], 'interventions': [{'name': 'LifeSignals Biosensor 1AX*', 'type': 'DEVICE', 'description': 'Shared-clinical decisions will be made based on the monitored data and patient diary. Two devices will be used to monitor data, LifeSignals Biosensor 1AX\\* and a pulse oximeter.', 'armGroupLabels': ['Monitored']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'This group will be treated based on standard of care at our institution.', 'armGroupLabels': ['Standard Of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Jonathan Leff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}