Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure

Not Applicable

Completed

Brief Summary: This study evaluates the effectiveness of remote tele-monitoring and health coaching in helping to reduce hospitalizations in heart failure patients. Half of participants will receive tele-monitoring and health coaching, while the other half will receive standard health care provided by their chosen provider.

Detailed Description: Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.

Health Coaching involves a team of health care professionals including a registered nurse (RN). The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management.

Recruitment & Eligibility

Inclusion Criteria

Hospitalized with primary or secondary diagnosis of Acute Decompensated Heart Failure (one or more of these symptoms: shortness of breath, orthopnea or edema AND one or more of these signs: rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)
Adult patients >18 years old

Exclusion Criteria

Overall life expectancy < 1 year
Known skin allergy to adhesives (hydrocolloid, silicone, acrylic)
Active systemic infection
Pregnant or lactating
End stage renal disease on dialysis
Subject or caregiver is not visually and tactile capable of smartphone and home device usage
Inadequate cell phone coverage (including international patients or international travel during study period)
Subject or legal guardian is not willing and able to provide appropriate informed consent

Arm && Interventions

Group	Intervention	Description
Tele-Monitoring	Tele-monitoring and health coaching	Tele-monitoring and health coaching in addition to standard health care

Primary Outcome Measures

Name	Time	Method
Hospital Readmission	60 days	Occurrence of all-cause hospital readmissions or death within 60 days

Secondary Outcome Measures

Name	Time	Method
Number of Readmissions or Visits	60 days	Number of hospital readmissions or emergency room visits (visits without admissions)
Mortality	60 days	All-cause mortality

Locations (5): St. Mary's Hospital
🇺🇸
Richmond, Virginia, United States
St. Francis Medical Center
🇺🇸
Midlothian, Virginia, United States
Mayo Clinic
🇺🇸
Jacksonville, Florida, United States
Memorial Regional Medical Center
🇺🇸
Mechanicsville, Virginia, United States
Mayo Clinic Health Systems
🇺🇸
La Crosse, Wisconsin, United States