Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure
Tele-HC
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
1 other identifier
interventional
112
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started May 2015
Typical duration for not_applicable heart-failure
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
January 29, 2020
CompletedJanuary 29, 2020
January 1, 2020
3.8 years
March 12, 2015
January 16, 2020
January 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital Readmission
Occurrence of all-cause hospital readmissions or death within 60 days
60 days
Secondary Outcomes (2)
Number of Readmissions or Visits
60 days
Mortality
60 days
Study Arms (2)
Tele-Monitoring
ACTIVE COMPARATORTele-monitoring and health coaching in addition to standard health care
Standard Care
NO INTERVENTIONStandard 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.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Preventicecollaborator
Study Sites (5)
Mayo Clinic
Jacksonville, Florida, 32224, United States
Memorial Regional Medical Center
Mechanicsville, Virginia, 23116, United States
St. Francis Medical Center
Midlothian, Virginia, 23114, United States
St. Mary's Hospital
Richmond, Virginia, 23226, United States
Mayo Clinic Health Systems
La Crosse, Wisconsin, 54601, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles J. Bruce
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Bruce, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, College of Medicine
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 18, 2015
Study Start
May 1, 2015
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
January 29, 2020
Results First Posted
January 29, 2020
Record last verified: 2020-01