Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICENon-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
Survey and qualitative interviewing of participants
Sponsors
physIQ, Inc.
Carnegie Mellon University
Northwestern University
Endeavor Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is an inpatient at NorthShore University HealthSystem * Patient is on the heart failure consult list * Patient has a history of heart failure * Patient received at least one dose of IV diuretics at index hospitalization * Patient is discharging with NorthShore Home Health services * Symptoms corresponding to New York Heart Association function class II-IV * Patient has heart failure with reduced left ventricular ejection fraction (LVEF)\<40%, or HF with mid-ranged ejection fraction (LVEF 40-50%), or HF with preserved ejection fraction (LVEF≥50%) * Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model * Patient is at least 18 years of age * Patient is fluent in English * Patient agrees to protocol-required procedures
Exclusion criteria
* Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to maintain patch, phone * Patient has allergy to hydrocolloid adhesives * Patient has present skin damage preventing them from wearing a study device * Patient has renal dysfunction requiring dialysis * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attrition Rate | 30 days from patient discharge date | Drop out from study |
| Enrollment Rate | Through study completion, an average of 30 days for each patient | Enrollment rate for entire patient cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Diuretic Escalation | 30 days from patient discharge date | Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient. |
| 30-day Readmission | 30 days from patient discharge date | 30-day readmission to hospital |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted at Evanston Hospital during December 2020 to October 2021
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 15 |
| Total | 20 |
Baseline characteristics
| Characteristic | Phase I: Soft Launch (120 Days) | Phase II: Calibration (210 Days) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 10 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 14 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 4 Participants | 12 Participants | 16 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 11 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 15 |
| other Total, other adverse events | 0 / 5 | 0 / 15 |
| serious Total, serious adverse events | 0 / 5 | 0 / 15 |
Outcome results
Primary
Attrition Rate
Drop out from study
Time frame: 30 days from patient discharge date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I: Soft Launch (120 Days) | Attrition Rate | 1 Participants |
| Phase II: Calibration (210 Days) | Attrition Rate | 2 Participants |
Primary
Enrollment Rate
Enrollment rate for entire patient cohort
Time frame: Through study completion, an average of 30 days for each patient
Population: Overall number of participants analyzed reflects the number of participants who were screened for phase I and phase II, respectively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I: Soft Launch (120 Days) | Enrollment Rate | 5 Participants |
| Phase II: Calibration (210 Days) | Enrollment Rate | 15 Participants |
Secondary
30-day Readmission
30-day readmission to hospital
Time frame: 30 days from patient discharge date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I: Soft Launch (120 Days) | 30-day Readmission | 2 Participants |
| Phase II: Calibration (210 Days) | 30-day Readmission | 2 Participants |
Secondary
Number of Participants With Diuretic Escalation
Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient.
Time frame: 30 days from patient discharge date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I: Soft Launch (120 Days) | Number of Participants With Diuretic Escalation | 2 Participants |
| Phase II: Calibration (210 Days) | Number of Participants With Diuretic Escalation | 9 Participants |