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| Name | Class |
|---|---|
| physIQ, Inc. | INDUSTRY |
| Carnegie Mellon University | OTHER |
| Northwestern University | OTHER |
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Invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring. Our proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, specialists, and surgeons, and has the potential to transform care management in the post-discharge period, where patients are the most vulnerable for readmission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Soft Launch (120 days) | Experimental | The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol. |
|
| Phase II: Calibration (210 days) | Experimental | After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive Continuous Remote Patient Monitoring | Device | Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition Rate | Drop out from study | 30 days from patient discharge date |
| Enrollment Rate | Enrollment rate for entire patient cohort | Through study completion, an average of 30 days for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Diuretic Escalation | Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient. | 30 days from patient discharge date |
| 30-day Readmission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nirav S Shah, MD, MPH | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem Evanston Hospital | Evanston | Illinois | 60201 | United States |
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Recruitment was conducted at Evanston Hospital during December 2020 to October 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: Soft Launch (120 Days) | The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol. Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants |
| FG001 | Phase II: Calibration (210 Days) | After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: Soft Launch (120 Days) | The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol. Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attrition Rate | Drop out from study | Posted | Count of Participants | Participants | 30 days from patient discharge date |
|
We collected adverse event data over the 30-day participation period for each participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I: Soft Launch (120 Days) | The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol. Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nirav Shah, MD, MPH | NorthShore University HealthSystem | (847) 570-1236 | nshah2@northshore.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2022 | Dec 14, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Affective Analysis of Participant Response to Continuous Remote Patient Monitoring | Other | Survey and qualitative interviewing of participants |
|
30-day readmission to hospital
| 30 days from patient discharge date |
| BG001 | Phase II: Calibration (210 Days) | After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
|
| Primary | Enrollment Rate | Enrollment rate for entire patient cohort | Overall number of participants analyzed reflects the number of participants who were screened for phase I and phase II, respectively. | Posted | Count of Participants | Participants | Through study completion, an average of 30 days for each patient |
|
|
|
| Secondary | Number of Participants With Diuretic Escalation | Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient. | Posted | Count of Participants | Participants | 30 days from patient discharge date |
|
|
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| Secondary | 30-day Readmission | 30-day readmission to hospital | Posted | Count of Participants | Participants | 30 days from patient discharge date |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Phase II: Calibration (210 Days) | After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants | 0 | 15 | 0 | 15 | 0 | 15 |
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