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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-monitoring and health coaching
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic
  • Memorial Regional Medical Center
  • St. Francis Medical Center
  • St. Mary's Hospital
  • Mayo Clinic Health Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Tele-Monitoring

Standard Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Hospital Readmission
Occurrence of all-cause hospital readmissions or death within 60 days

Secondary Outcome Measures

Number of Readmissions or Visits
Number of hospital readmissions or emergency room visits (visits without admissions)
Mortality
All-cause mortality

Full Information

First Posted
March 12, 2015
Last Updated
January 16, 2020
Sponsor
Mayo Clinic
Collaborators
Preventice
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1. Study Identification

Unique Protocol Identification Number
NCT02391987
Brief Title
Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Preventice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-Monitoring
Arm Type
Active Comparator
Arm Description
Tele-monitoring and health coaching in addition to standard health care
Arm Title
Standard Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Tele-monitoring and health coaching
Intervention 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.
Primary Outcome Measure Information:
Title
Hospital Readmission
Description
Occurrence of all-cause hospital readmissions or death within 60 days
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Number of Readmissions or Visits
Description
Number of hospital readmissions or emergency room visits (visits without admissions)
Time Frame
60 days
Title
Mortality
Description
All-cause mortality
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Bruce, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Memorial Regional Medical Center
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
St. Francis Medical Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
St. Mary's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Mayo Clinic Health Systems
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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