The Cascade Feasibility Pilot (HF) Phase 3

NCT04993287 | Completed Results FDA Device

• 1 other identifier: EH20-288 Cascade HF
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The study 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, and heart failure specialists, and has the potential to transform heart failure management in the post-discharge period, where patients are the most vulnerable for readmission. This feasibility study will contribute to the understanding of post-discharge heart failure continuous remote patient monitoring, promote patient self-care, and has the potential of improving patient outcomes.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Enrollment Rate

  Enrollment rate for entire patient cohort

  Through study completion, an average 1 year

• Adherence Rate

  Patient adherence to electronic patient reported outcomes

  Through study completion, an average of one year

Secondary Outcomes (2)

• Documented Diuretic Escalation

  30 days from patient discharge date

• 30-day Readmission Rate

  30 days from patient discharge date

Study Arms (1)

Pilot

EXPERIMENTAL

39 eligible HF patients

Other: Non-invasive continuous remote monitoring with structured escalation pathway; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Interventions

Non-invasive continuous remote monitoring with structured escalation pathway OTHER

Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and HF care team

Pilot

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring OTHER

Surveys and interviews with enrolled participants

Pilot

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is an inpatient at Evanston Hospital
• Patient is followed by the heart failure service team after discharge
• Patient has a history of heart failure
• Patient received at least one dose of IV diuretic at index hospitalization
• Symptoms corresponding to NYHA 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 investigator's opinion, limit the patient's ability to maintain patch device and phone
• Patient has visual impairments
• Patient has an allergy to hydrocolloid adhesives
• Patient has present skin damage preventing them from wearing a study device
• Patient has renal dysfunction requiring dialysis
• Patient has CardioMEMS
• Pregnancy
• Patient receiving hospice care

Sponsors & Collaborators

• Endeavor Health: lead

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: Dr. Nirav Shah
• Organization: NorthShore University HealthSystem

nshah2@northshore.org

847-657-5959

Study Officials

• Nirav S Shah

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• 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: July 16, 2021
• First Posted: August 6, 2021
• Study Start: June 17, 2021
• Primary Completion: March 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)