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Use of Remote Monitoring for COVID-19 Patient (RPM)

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ClinicalTrials.gov Identifier: NCT04425720
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Leff, Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID Device: LifeSignals Biosensor 1AX* Other: Standard of Care Not Applicable

Detailed Description:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Active Comparator: Standard Of Care
Patients without wearable monitoring technology undergoing routine standard of care at the hospital.
Other: Standard of Care
This group will be treated based on standard of care at our institution.

Experimental: 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
Device: 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.




Primary Outcome Measures :
  1. Monitored versus Non-Monitored in-patient admission [ Time Frame: 14 days ]
    compare the number of in-patient admissions between the monitored and non-monitored patients

  2. Emergency Department Visits [ Time Frame: 14 days ]
    compare the number of Emergency Department visits

  3. Length of stay [ Time Frame: 14 days ]
    Length of stay of subject if hospitalized

  4. patient satisfaction [ Time Frame: 14 days ]
    Survey given to patient to ask about satisfaction

  5. the incidence of mechanical ventilation and ECMO [ Time Frame: 14 days ]
    How often does a subject end up getting mechanical ventilation or ECMO

  6. serious adverse events [ Time Frame: 14 days ]
    events requiring extended hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Covid-19 positive patient
  • Does not require in-patient admission

Exclusion Criteria:

  • Allergic to sensor patch
  • Has implanted pacemaker
  • Has excessive sweating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04425720


Contacts
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Contact: Jonathan Leff, MD 7189204316 jleff@montefiore.org
Contact: Singh Nair, PhD 7189205932 sinair@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Singh Nair    718-920-5932    sinair@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Jonathan Leff, MD Montefiore Medical Center
Publications:

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Responsible Party: Jonathan Leff, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04425720    
Other Study ID Numbers: 2020-11824
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes