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

N/ACompletedNCT02391987

Mayo Clinic112 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

112

Conditions

Heart Failure

Interventions

Tele-monitoring and health coachingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Mayo Clinic

Jacksonville, Florida, United States

Memorial Regional Medical Center

Mechanicsville, Virginia, United States

St. Francis Medical Center

Midlothian, Virginia, United States

St. Mary's Hospital

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Hospital Readmission

Occurrence of all-cause hospital readmissions or death within 60 days

Time frame: 60 days

Secondary Outcomes

Number of Readmissions or Visits

Number of hospital readmissions or emergency room visits (visits without admissions)

Time frame: 60 days

Mortality

All-cause mortality

Time frame: 60 days

Data from ClinicalTrials.gov

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