The CASCADE HF Soft Launch and Calibration Phase I and II

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738279
• Other study ID #: EH20-288 Cascade Soft Launch
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 14, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: October 2023
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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

Other:
• Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
Survey and qualitative interviewing of participants

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem Evanston Hospital	Evanston	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Carnegie Mellon University, Northwestern University, physIQ, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attrition Rate	Drop out from study	30 days from patient discharge date
Primary	Enrollment Rate	Enrollment rate for entire patient cohort	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.	30 days from patient discharge date
Secondary	30-day Readmission	30-day readmission to hospital	30 days from patient discharge date