Clinical trial NCT02391987: Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Preventice
First posted: 2015-03-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Hospital Readmission
timeFrame: 60 days
Secondary outcomes:
measure: Number of Readmissions or Visits
timeFrame: 60 days
measure: Mortality
timeFrame: 60 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Mechanicsville
country: United States
facility: Memorial Regional Medical Center
state: Virginia
city: Midlothian
country: United States
facility: St. Francis Medical Center
state: Virginia
city: Richmond
country: United States
facility: St. Mary's Hospital
state: Virginia
city: La Crosse
country: United States
facility: Mayo Clinic Health Systems
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Charles Bruce, MD
role: PRINCIPAL_INVESTIGATOR
References: