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
|Condition or disease||Intervention/treatment||Phase|
|COVID||Device: LifeSignals Biosensor 1AX* Other: Standard of Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
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.
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.
- 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
- Emergency Department Visits [ Time Frame: 14 days ]compare the number of Emergency Department visits
- Length of stay [ Time Frame: 14 days ]Length of stay of subject if hospitalized
- patient satisfaction [ Time Frame: 14 days ]Survey given to patient to ask about satisfaction
- the incidence of mechanical ventilation and ECMO [ Time Frame: 14 days ]How often does a subject end up getting mechanical ventilation or ECMO
- serious adverse events [ Time Frame: 14 days ]events requiring extended hospital stay
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
|Contact: Jonathan Leff, MDemail@example.com|
|Contact: Singh Nair, PhDfirstname.lastname@example.org|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Singh Nair 718-920-5932 email@example.com|
|Principal Investigator:||Jonathan Leff, MD||Montefiore Medical Center|