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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:May 2015
End Date:March 2019
Contact:Monica L Olson
Email:Olson.Monica2@mayo.edu
Phone:507-285-2649

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A Randomized Study of the Effectiveness of an Integrated Tele-monitoring and Patient-centric Health Coaching Strategy (Tele-HC) in Adult Patients Recently Hospitalized With Acute Decompensated Heart Failure (ADHF) Compared to Standard Care

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.

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
We found this trial at
5
sites
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
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La Crosse, Wisconsin 54601
Phone: 608-392-7187
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Mechanicsville, Virginia 23116
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Midlothian, Virginia 23114
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Richmond, Virginia 23226
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