La Crosse, Wisconsin 54601


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02391987


Primary Contact:

Principal Investigator
Charles Bruce, MD
Mayo Clinic

Monica L Olson
Phone: 507-285-2649
Email: Olson.Monica2@mayo.edu


Backup Contact:

Email: Paulson.Kelly@mayo.edu
Kelly Paulson, PhD
Phone: 507-266-3415


Location Contact:

La Crosse, Wisconsin 54601
United States

Carolyn Flock
Phone: 608-392-7187
Email: Flock.Carolyn@mayo.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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