NCT04738279

The CASCADE HF Soft Launch and Calibration Phase I and II

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
OTHER	Affective Analysis of Participant Response to Continuous Remote Patient Monitoring	Survey and qualitative interviewing of participants

Timeline

• Start date: 2020-12-14
• Primary completion: 2021-10-30
• Completion: 2021-10-30
• First posted: 2021-02-04
• Last updated: 2023-10-03
• Results posted: 2023-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study