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Completed

NCT Number: NCT04425720

Use of Remote Monitoring for COVID-19 Patient

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.

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Key information

Conditions

COVID

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Standard of care

Other

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

Primary outcomes

  1. Number of 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. How Many Subjects Needed to Visit the Emergency Department

    Time frame: 14 days

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

  3. Length of Stay

    Time frame: 14 days

    Length of stay of subject if hospitalized

  4. How Many Completed the Patient Satisfaction Survey

    Time frame: 14 days

    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.

  5. How Many Subjects End up Requiring 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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Acronym: RPM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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