Heart Failure
Conditions
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.
Interventions
DEVICETele-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.
Sponsors
Preventice
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmission | 60 days | Occurrence of all-cause hospital readmissions or death within 60 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Readmissions or Visits | 60 days | Number of hospital readmissions or emergency room visits (visits without admissions) |
| Mortality | 60 days | All-cause mortality |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tele-Monitoring Tele-monitoring and health coaching in addition to standard health care
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. | 54 |
| 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. | 58 |
| Total | 112 |
Baseline characteristics
| Characteristic | Standard Care | Total | Tele-Monitoring |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 13 | 69 years STANDARD_DEVIATION 13 | 70 years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants | 27 Participants | 13 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 78 Participants | 38 Participants |
| Region of Enrollment United States | 58 participants | 112 participants | 54 participants |
| Sex: Female, Male Female | 30 Participants | 63 Participants | 33 Participants |
| Sex: Female, Male Male | 28 Participants | 49 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 54 | 4 / 58 |
| other Total, other adverse events | 5 / 54 | 0 / 58 |
| serious Total, serious adverse events | 2 / 54 | 2 / 58 |
Outcome results
Primary
Hospital Readmission
Occurrence of all-cause hospital readmissions or death within 60 days
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-Monitoring | Hospital Readmission | 14 Participants |
| Standard Care | Hospital Readmission | 16 Participants |
p-value: 0.73Cochran-Mantel-Haenszel
Secondary
Mortality
All-cause mortality
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-Monitoring | Mortality | 1 Participants |
| Standard Care | Mortality | 4 Participants |
p-value: 0.37Fisher Exact
Secondary
Number of Readmissions or Visits
Number of hospital readmissions or emergency room visits (visits without admissions)
Time frame: 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tele-Monitoring | Number of Readmissions or Visits | 19 visits |
| Standard Care | Number of Readmissions or Visits | 20 visits |
p-value: 0.98Cochran-Mantel-Haenszel