N/A
N=54
The Cascade Feasibility Pilot (HF) Phase 3
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04993287 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Enrollment Rate — 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-invasive continuous remote monitoring with structured escalation pathway (Other); Affective Analysis of Participant Response to Continuous Remote Patient Monitoring (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endeavor Health
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate |
39 | — |
| PRIMARY Adherence Rate |
27 | — |
| SECONDARY Documented Diuretic Escalation |
17 | — |
| SECONDARY 30-day Readmission Rate |
6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04993287). 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.