Clinical trial NCT05900362: Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure
Official title: Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congestive Heart Failure
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Compliance with monitoring protocol
timeFrame: 6 month
Secondary outcomes:
measure: Patient engagement as measured by Patient Activation Measure
timeFrame: 6 months
measure: Heart failure hospitalizations, emergency room visits for Heart Failure as compared to prior to trial enrollment
timeFrame: 6 month
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Kansas
city: Overland Park
country: United States
facility: Saint Luke's South Hospital
state: Kansas
city: Kansas City
country: United States
facility: Saint Luke's North Hospital
state: Missouri
city: Lee's Summit
country: United States
facility: Saint Luke's East Hospital
state: Missouri
Study officials:
References: