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Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure (FAST-RPM-HF)

Primary Purpose

Congestive Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VitalCare Platform
Sponsored by
Saint Luke's Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Saint Luke's Hospital of Kansas City
  • Saint Luke's South Hospital
  • Saint Luke's North Hospital
  • Saint Luke's East Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Patient engagement as measured by Patient Activation Measure
Patient engagement as measured by the Patient Activation Measure will increase by 1 or more points from baseline to 6 months. The PAM score ranges from 1 to 100 corresponding to 1 of 4 levels of patient engagement. Higher numbers correlate with greater patient engagement.
Heart failure hospitalizations, emergency room visits for Heart Failure as compared to prior to trial enrollment
Patients who undergo remote patient monitoring via the VitalCare platform will have a lower rate of hospitalization for heart failure and lower rate of emergency room presentation for heart failure symptoms as compared to previous rate of heart failure hospitalization and emergency room presentations for heart failure symptoms for the 6 months prior to trial enrollment

Full Information

First Posted
March 28, 2021
Last Updated
June 12, 2023
Sponsor
Saint Luke's Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05900362
Brief Title
Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure
Acronym
FAST-RPM-HF
Official Title
Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Luke's Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The next step in determining the role of remote patient monitoring in the management of patients with heart failure is to better understand which patients are most likely to benefit from a more intensive outpatient management or simply conservative management. The subject population is patients with mild HFrEF or HFpEF who are prone to readmission. This patient population does not have implanted devices to supply objective data to evaluate patient's volume status and therefore can be challenging to manage on an outpatient basis. By providing regular data on weight, blood pressure, pulse oximetry, electrocardiogram and heart/lung sounds that is reviewed on a monthly basis, this may allow a clinician greater insight into their patient's clinical status and allow for a more accurate and timely intervention to prevent clinical deterioration. Furthermore, this should enhance patient engagement with their own health as well as with their healthcare provider. This study would significantly add to the current knowledge of management of heart failure in an ambulatory patient population without implanted devices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
All patients receive the VitalCare platform with a tablet computer, an Eko Duo device, a weight scale, a blood pressure cuff, a pulse oximeter
Intervention Type
Device
Intervention Name(s)
VitalCare Platform
Intervention Description
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
Primary Outcome Measure Information:
Title
Compliance with monitoring protocol
Description
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)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Patient engagement as measured by Patient Activation Measure
Description
Patient engagement as measured by the Patient Activation Measure will increase by 1 or more points from baseline to 6 months. The PAM score ranges from 1 to 100 corresponding to 1 of 4 levels of patient engagement. Higher numbers correlate with greater patient engagement.
Time Frame
6 months
Title
Heart failure hospitalizations, emergency room visits for Heart Failure as compared to prior to trial enrollment
Description
Patients who undergo remote patient monitoring via the VitalCare platform will have a lower rate of hospitalization for heart failure and lower rate of emergency room presentation for heart failure symptoms as compared to previous rate of heart failure hospitalization and emergency room presentations for heart failure symptoms for the 6 months prior to trial enrollment
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjaya Gupta, MD
Phone
8169311883
Email
sgupta@saint-lukes.org
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Rader, MD
Phone
8169311883
Email
vrader@saint-lukes.org
Facility Information:
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64111
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta, MD
Email
sgupta@saint-lukes.org
Ext
Gupta
Email
sgupta@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta, MD
Facility Name
Saint Luke's South Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta, MD
Phone
816-931-1883
Email
sgupta@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta, MD
Facility Name
Saint Luke's North Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta, MD
Phone
816-931-1883
Email
sgupta@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta, MD
Facility Name
Saint Luke's East Hospital
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta
Phone
816-931-1883
Email
sgupta@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Mid 2021
IPD Sharing Access Criteria
Contact PI

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Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

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