Back to resultsThe CASCADE HF Soft Launch and Calibration Phase I and II
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Non-Invasive Continuous Remote Patient Monitoring
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
Sponsored by
About this trial
This is an interventional other trial for Heart Failure
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
Sites / Locations
- NorthShore University HealthSystem Evanston Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phase I: Soft Launch (120 days)
Phase II: Calibration (210 days)
Arm Description
The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Outcomes
Primary Outcome Measures
Attrition Rate
Drop out from study
Enrollment Rate
Enrollment rate for entire patient cohort
Secondary Outcome Measures
Number of Participants With Diuretic Escalation
Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient.
30-day Readmission
30-day readmission to hospital
Full Information
NCT ID
NCT04738279
First Posted
January 27, 2021
Last Updated
October 1, 2023
Sponsor
NorthShore University HealthSystem
Collaborators
physIQ, Inc., Carnegie Mellon University, Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT04738279
Brief Title
The CASCADE HF Soft Launch and Calibration Phase I and II
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
physIQ, Inc., Carnegie Mellon University, Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase I: Soft Launch (120 days)
Arm Type
Experimental
Arm Description
The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Arm Title
Phase II: Calibration (210 days)
Arm Type
Experimental
Arm Description
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Intervention Type
Device
Intervention Name(s)
Non-Invasive Continuous Remote Patient Monitoring
Intervention Description
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
Other
Intervention Name(s)
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
Intervention Description
Survey and qualitative interviewing of participants
Primary Outcome Measure Information:
Title
Attrition Rate
Description
Drop out from study
Time Frame
30 days from patient discharge date
Title
Enrollment Rate
Description
Enrollment rate for entire patient cohort
Time Frame
Through study completion, an average of 30 days for each patient
Secondary Outcome Measure Information:
Title
Number of Participants With Diuretic Escalation
Description
Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient.
Time Frame
30 days from patient discharge date
Title
30-day Readmission
Description
30-day readmission to hospital
Time Frame
30 days from patient discharge date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirav S Shah, MD, MPH
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The CASCADE HF Soft Launch and Calibration Phase I and II
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