CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
Non-Invasive Continuous Remote Patient Monitoring +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04738279
NCT04738279Phase 3Completed

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

Endeavor Health·interventional·Posted Feb 4, 2021·Updated Oct 3, 2023

In Brief

A Phase 3 clinical trial evaluating Non-Invasive Continuous Remote Patient Monitoring and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring for Heart Failure. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 4, 2021
Enrollment StartDec 14, 2020
Primary CompletionOct 30, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.4 years ago

Interventions

Non-Invasive Continuous Remote Patient Monitoringdevice

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 Monitoringother

Survey and qualitative interviewing of participants