COVID
Conditions
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.
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.
Interventions
DEVICELifeSignals 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.
OTHERStandard of Care
This group will be treated based on standard of care at our institution.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Covid-19 positive patient * Does not require in-patient admission
Exclusion criteria
* Allergic to sensor patch * Has implanted pacemaker * Has excessive sweating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 14 days | Length of stay of subject if hospitalized |
| How Many Subjects Needed to Visit the Emergency Department | 14 days | compare the number of participants who visited Emergency Department between both arms |
| Number of Monitored Versus Non-Monitored In-patient Admission | 14 days | compare the number of in-patient admissions between the monitored and non-monitored patients |
| How Many Completed the Patient Satisfaction Survey | 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. |
| How Many Subjects End up Requiring Mechanical Ventilation and ECMO | 14 days | How often does a subject end up getting mechanical ventilation or ECMO |
| Serious Adverse Events | 14 days | events requiring extended hospital stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Of Care Patients without wearable monitoring technology undergoing routine standard of care at the hospital.
Standard of Care: This group will be treated based on standard of care at our institution. | 150 |
| 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
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. | 130 |
| Total | 280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 20 |
Baseline characteristics
| Characteristic | Standard Of Care | Monitored | Total |
|---|---|---|---|
| Age, Customized Average Age in Years | 65.50 years | 64 years | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 90 Participants | 89 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 41 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 150 participants | 130 participants | 280 participants |
| Sex: Female, Male Female | 82 Participants | 88 Participants | 170 Participants |
| Sex: Female, Male Male | 68 Participants | 42 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 150 | 1 / 130 |
| other Total, other adverse events | 8 / 150 | 9 / 130 |
| serious Total, serious adverse events | 2 / 150 | 1 / 130 |
Outcome results
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.
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Of Care | How Many Completed the Patient Satisfaction Survey | 84 Participants |
Primary
How Many Subjects End up Requiring Mechanical Ventilation and ECMO
How often does a subject end up getting mechanical ventilation or ECMO
Time frame: 14 days
Population: As only those monitored were surveyed, the following results only reflect one of the arms. There is no reason to conduct a satisfaction survey on individuals who received standard of care because they would not be aware of the monitoring option.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Of Care | How Many Subjects End up Requiring Mechanical Ventilation and ECMO | 0 Participants |
Primary
How Many Subjects Needed to Visit the Emergency Department
compare the number of participants who visited Emergency Department between both arms
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Of Care | How Many Subjects Needed to Visit the Emergency Department | 14 Participants |
| Monitored | How Many Subjects Needed to Visit the Emergency Department | 12 Participants |
Primary
Length of Stay
Length of stay of subject if hospitalized
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Of Care | Length of Stay | 7 days |
| Monitored | Length of Stay | 7 days |
Primary
Number of Monitored Versus Non-Monitored In-patient Admission
compare the number of in-patient admissions between the monitored and non-monitored patients
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Of Care | Number of Monitored Versus Non-Monitored In-patient Admission | 8 Participants |
| Monitored | Number of Monitored Versus Non-Monitored In-patient Admission | 9 Participants |
Primary
Serious Adverse Events
events requiring extended hospital stay
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Of Care | Serious Adverse Events | 2 Participants |
| Monitored | Serious Adverse Events | 1 Participants |