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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 112
- Locations
- 5
- Primary Endpoint
- Hospital Readmission
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tele-Monitoring
Tele-monitoring and health coaching in addition to standard health care
Intervention: Tele-monitoring and health coaching (Device)
Standard 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 Outcomes
Hospital Readmission
Time Frame: 60 days
Occurrence of all-cause hospital readmissions or death within 60 days
Secondary Outcomes
- Number of Readmissions or Visits(60 days)
- Mortality(60 days)
Investigators
Charles J. Bruce
Professor of Medicine, College of Medicine
Mayo Clinic