The CASCADE HF Soft Launch and Calibration Phase I and II

NCT ID: NCT04738279

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2021-10-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Phase I: Soft Launch (120 days)

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

Group Type: EXPERIMENTAL

Non-Invasive Continuous Remote Patient Monitoring

Intervention Type: 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

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Intervention Type: OTHER

Survey and qualitative interviewing of participants

Phase II: Calibration (210 days)

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

Group Type: EXPERIMENTAL

Non-Invasive Continuous Remote Patient Monitoring

Intervention Type: 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

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Intervention Type: OTHER

Survey and qualitative interviewing of participants

Interventions

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

Intervention Type: DEVICE

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Survey and qualitative interviewing of participants

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

physIQ, Inc.

INDUSTRY

Sponsor Role: collaborator

Carnegie Mellon University

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Nirav Shah

Medical Director of Quality Innovation and Clinical Practice Analytics, Program Director of Outcomes Research for Quality and Transformation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nirav S Shah, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

NorthShore University HealthSystem Evanston Hospital

Evanston, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

EH20-288 Cascade Soft Launch

Identifier Type: -

Identifier Source: org_study_id