Phase 3
N=20
The CASCADE HF Soft Launch and Calibration Phase I and II
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04738279 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Attrition Rate — 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Non-Invasive Continuous Remote Patient Monitoring (Device); Affective Analysis of Participant Response to Continuous Remote Patient Monitoring (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endeavor Health
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attrition Rate |
1; 2 | — |
| PRIMARY Enrollment Rate |
5; 15 | — |
| SECONDARY Number of Participants With Diuretic Escalation |
2; 9 | — |
| SECONDARY 30-day Readmission |
2; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04738279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.