Status:
COMPLETED
The CASCADE HF Soft Launch and Calibration Phase I and II
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
physIQ, Inc.
Carnegie Mellon University
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 telemoni...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04738279
Start Date
December 14 2020
End Date
October 30 2021
Last Update
October 3 2023
Active Locations (1)
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1
NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois, United States, 60201