The CASCADE HF Soft Launch and Calibration Phase I and II

NCT04738279 | Completed Phase 2 Results FDA Device

• 1 other identifier: EH20-288 Cascade Soft Launch
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Attrition Rate

  Drop out from study

  30 days from patient discharge date

• Enrollment Rate

  Enrollment rate for entire patient cohort

  Through study completion, an average of 30 days for each patient

Secondary Outcomes (2)

• Number of Participants With Diuretic Escalation

  30 days from patient discharge date

• 30-day Readmission

  30 days from patient discharge date

Study Arms (2)

Phase I: Soft Launch (120 days)

EXPERIMENTAL

The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.

Device: Non-Invasive Continuous Remote Patient Monitoring; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Phase II: Calibration (210 days)

EXPERIMENTAL

After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes

Device: Non-Invasive Continuous Remote Patient Monitoring; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Interventions

Non-Invasive Continuous Remote Patient Monitoring DEVICE

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

Phase I: Soft Launch (120 days); Phase II: Calibration (210 days)

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring OTHER

Survey and qualitative interviewing of participants

Phase I: Soft Launch (120 days); Phase II: Calibration (210 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead
• physIQ, Inc.: collaborator
• Carnegie Mellon University: collaborator
• Northwestern University: collaborator

Study Sites (1)

NorthShore University HealthSystem Evanston Hospital

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Nirav Shah, MD, MPH
• Organization: NorthShore University HealthSystem

nshah2@northshore.org

(847) 570-1236

Study Officials

• Nirav S Shah, MD, MPH

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Quality Innovation and Clinical Practice Analytics, Program Director of Outcomes Research for Quality and Transformation

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 4, 2021
• Study Start: December 14, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: October 3, 2023
• Results First Posted: February 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)