Heart Failure Clinical Trial

The CASCADE HF Soft Launch and Calibration Phase I and II

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT04738279

Recruitment Status:

Completed

Sponsor:

NorthShore University HealthSystem

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There is 1 Location for this study

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NorthShore University HealthSystem Evanston Hospital
Evanston Illinois, 60201, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT04738279

Recruitment Status:

Completed

Sponsor:


NorthShore University HealthSystem

How clear is this clinincal trial information?

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