Study Results
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View full resultsBasic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2020-09-01
2021-12-10
Brief Summary
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Detailed Description
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Aim-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.
Aim 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.
Aim 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Of Care
Patients without wearable monitoring technology undergoing routine standard of care at the hospital.
Standard of Care
This group will be treated based on standard of care at our institution.
Monitored
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
LifeSignals 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.
Interventions
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LifeSignals 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.
Standard of Care
This group will be treated based on standard of care at our institution.
Eligibility Criteria
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Inclusion Criteria
* Does not require in-patient admission
Exclusion Criteria
* Has implanted pacemaker
* Has excessive sweating
18 Years
90 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jonathan Leff, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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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.
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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.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-11824
Identifier Type: -
Identifier Source: org_study_id
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