Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

NCT ID: NCT05900362

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-04-30

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

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

Group Type: EXPERIMENTAL

VitalCare Platform

Intervention Type: DEVICE

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

Interventions

VitalCare Platform

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Luke's Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint Luke's Hospital of Kansas City

Kansas City, Kansas, United States

Saint Luke's South Hospital

Overland Park, Kansas, United States

Saint Luke's North Hospital

Kansas City, Missouri, United States

Saint Luke's East Hospital

Lee's Summit, Missouri, United States

Countries

United States

Central Contacts

Sanjaya Gupta, MD

Role: CONTACT

sgupta@saint-lukes.org

8169311883

Valerie Rader, MD

Role: CONTACT

vrader@saint-lukes.org

8169311883

Facility Contacts

Sanjaya Gupta, MD

Role: primary

sgupta@saint-lukes.org

Role: backup

sgupta@saint-lukes.org

Sanjaya Gupta, MD

Role: primary

sgupta@saint-lukes.org

816-931-1883

Sanjaya Gupta, MD

Role: primary

sgupta@saint-lukes.org

816-931-1883

Sanjaya Gupta

Role: primary

sgupta@saint-lukes.org

816-931-1883

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id