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OpenTrials
Completed

NCT Number: NCT04738279

The CASCADE HF Soft Launch and Calibration Phase I and II

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NorthShore University HealthSystem Evanston Hospital

Evanston, Illinois, 60201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Other

Survey and qualitative interviewing of participants

Primary outcomes

  1. Attrition Rate

    Time frame: 30 days from patient discharge date

    Drop out from study

  2. Enrollment Rate

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

    Enrollment rate for entire patient cohort

Secondary outcomes

  1. Number of Participants With Diuretic Escalation

    Time frame: 30 days from patient discharge date

    Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient.

  2. 30-day Readmission

    Time frame: 30 days from patient discharge date

    30-day readmission to hospital

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Carnegie Mellon University
  • Northwestern University
  • physIQ, Inc.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2021
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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