Use of Remote Monitoring for COVID-19 Patient

COVID Clinical Trial

— RPM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425720
• Other study ID #: 2020-11824
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 10, 2021

Study information

• Verified date: January 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Covid-19 positive patient

• Does not require in-patient admission

Exclusion Criteria:

• Allergic to sensor patch

• Has implanted pacemaker

• Has excessive sweating

Related Conditions & MeSH terms

• COVID

Intervention

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.

Other:
• Standard of Care
This group will be treated based on standard of care at our institution.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	How Many Subjects Needed to Visit the Emergency Department	compare the number of participants who visited Emergency Department between both arms	14 days
Primary	Length of Stay	Length of stay of subject if hospitalized	14 days
Primary	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
Primary	How Many Subjects End up Requiring Mechanical Ventilation and ECMO	How often does a subject end up getting mechanical ventilation or ECMO	14 days
Primary	Serious Adverse Events	events requiring extended hospital stay	14 days