NCT04425720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 19, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

June 2, 2020

Results QC Date

November 4, 2021

Last Update Submit

January 20, 2022

Conditions

COVID

Outcome Measures

Primary Outcomes (6)

  • Number of Monitored Versus Non-Monitored In-patient Admission

    compare the number of in-patient admissions between the monitored and non-monitored patients

    14 days

  • How Many Subjects Needed to Visit the Emergency Department

    compare the number of participants who visited Emergency Department between both arms

    14 days

  • Length of Stay

    Length of stay of subject if hospitalized

    14 days

  • How Many Completed the Patient Satisfaction Survey

    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.

    14 days

  • How Many Subjects End up Requiring Mechanical Ventilation and ECMO

    How often does a subject end up getting mechanical ventilation or ECMO

    14 days

  • Serious Adverse Events

    events requiring extended hospital stay

    14 days

Study Arms (2)

Standard Of Care

ACTIVE COMPARATOR

Patients without wearable monitoring technology undergoing routine standard of care at the hospital.

Other: Standard of Care

Monitored

EXPERIMENTAL

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*

Interventions

LifeSignals Biosensor 1AX*DEVICE

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.

Monitored
Standard of CareOTHER

This group will be treated based on standard of care at our institution.

Standard Of Care

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (24)

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  • 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: 32044814BACKGROUND

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    PMID: 32091533BACKGROUND

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    PMID: 32247898BACKGROUND

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    PMID: 32200400BACKGROUND

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    PMID: 22038879BACKGROUND

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    PMID: 22699035BACKGROUND

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    PMID: 23185988BACKGROUND

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    PMID: 15158632BACKGROUND

  • 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: 32197108BACKGROUND

  • 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: 32114094BACKGROUND

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    PMID: 33334565BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Dr. Jonathan Leff
Organization
Montefiore Medical Center
jleff@montefiore.org
7189204316

Study Officials

  • Jonathan Leff, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 11, 2020

Study Start

September 1, 2020

Primary Completion

February 10, 2021

Study Completion

December 10, 2021

Last Updated

January 24, 2022

Results First Posted

November 19, 2021

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)