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

Heart Failure Clinical Trial

— Tele-HC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391987
• Other study ID #: 15-001448
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2019

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Tele-monitoring and health coaching
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic Health Systems	La Crosse	Wisconsin
United States	Memorial Regional Medical Center	Mechanicsville	Virginia
United States	St. Francis Medical Center	Midlothian	Virginia
United States	St. Mary's Hospital	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Preventice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Readmission	Occurrence of all-cause hospital readmissions or death within 60 days	60 days
Secondary	Number of Readmissions or Visits	Number of hospital readmissions or emergency room visits (visits without admissions)	60 days
Secondary	Mortality	All-cause mortality	60 days

External Links

•   Mayo Clinic Clinical Trials