Clinical trial NCT04738279: The CASCADE HF Soft Launch and Calibration Phase I and II
Official title: A Study to Determine the Efficacy of Continuous Ambulatory Wearable Technology and a Cascading Alert System in Reducing 30d Readmission in High Risk Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: physIQ, Inc.
name: Carnegie Mellon University
name: Northwestern University
First posted: 2021-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Attrition Rate
timeFrame: 30 days from patient discharge date
measure: Enrollment Rate
timeFrame: Through study completion, an average of 30 days for each patient
Secondary outcomes:
measure: Number of Participants With Diuretic Escalation
timeFrame: 30 days from patient discharge date
measure: 30-day Readmission
timeFrame: 30 days from patient discharge date
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem Evanston Hospital
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Nirav S Shah, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: