NCT05900362

Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Saint Luke's Health System · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-12-31
• Completion: 2026-04-30
• First posted: 2023-06-12
• Last updated: 2024-06-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study