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

Mayo Clinic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Tele-monitoring and health coaching

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02391987

15-001448

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Tele-Monitoring

Active Comparator group

Description:

Tele-monitoring and health coaching in addition to standard health care

Treatment:

Device: Tele-monitoring and health coaching

Standard Care

No Intervention group

Description:

Standard care is defined as Heart Failure (HF) care based on current American College of Cardiology (ACC) and American Heart Association (AHA) HF guidelines implemented and orchestrated by a cardiologist and support staff at the participating institution.