NCT05900362

Brief Summary

Previous research has investigated the use of remote patient monitoring in various clinical contexts, however there has not been a clinical trial examining use of the VitalCare platform for ambulatory management of heart failure. This trial will serve as a pilot study examining the feasibility of use of the VitalCare platform for ambulatory heart failure management and examine the effect of remote patient monitoring on patient engagement. To the investigators' knowledge, this will be the first study examining the effect of remote patient monitoring with the VitalCare platform on heart failure clinical outcomes, such as hospitalization for heart failure exacerbations and emergency room visits for heart failure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2021

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1.4 years

First QC Date

March 28, 2021

Last Update Submit

June 5, 2024

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Compliance with monitoring protocol

    Actual rate of completed patient data transmissions is greater than or equal to 60% of the expected rate of patient data transmissions (BP, HR, Weight, EKG)

    6 month

Secondary Outcomes (2)

  • Patient engagement as measured by Patient Activation Measure

    6 months

  • Heart failure hospitalizations, emergency room visits for Heart Failure as compared to prior to trial enrollment

    6 month

Study Arms (1)

Interventional

EXPERIMENTAL

All patients receive the VitalCare platform with a tablet computer, an Eko Duo device, a weight scale, a blood pressure cuff, a pulse oximeter

Device: VitalCare Platform

Interventions

VitalCare PlatformDEVICE

All participants will receive an VitalCare platform with tablet, Eko Duo with capability to record heart/lung sounds, blood pressure cuff, pulse oximetry and digital scale

Interventional

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical diagnosis of heart failure
  • New York Heart Association Class II or III congestive HF symptoms
  • Admission to hospital within 12 months for symptomatic heart failure.
  • Own a smartphone or tablet or comfortable with using one
  • English as primary language
  • Able to provide informed consent

You may not qualify if:

  • Left Ventricular Ejection Fraction \< 35%
  • Implanted cardiac device (permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), chronic resynchronization therapy (CRT), implantable loop recorder (ILR))
  • CardioMEMS
  • Left ventricular assist device (LVAD)
  • NYHA Class I or IV congestive HF symptoms
  • Listed for cardiac transplant
  • Pregnant at time enrollment
  • End-stage renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Saint Luke's Hospital of Kansas City

Kansas City, Kansas, 64111, United States

Location

Saint Luke's South Hospital

Overland Park, Kansas, 66213, United States

Location

Saint Luke's North Hospital

Kansas City, Missouri, 64154, United States

Location

Saint Luke's East Hospital

Lee's Summit, Missouri, 64086, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Sanjaya Gupta, MD

CONTACT

8169311883sgupta@saint-lukes.org

Valerie Rader, MD

CONTACT

8169311883vrader@saint-lukes.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2021

First Posted

June 12, 2023

Study Start

August 1, 2024

Primary Completion

December 31, 2025

Study Completion

April 30, 2026

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Mid 2021
Access Criteria
Contact PI

Locations

US(4)