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| Name | Class |
|---|---|
| Preventice | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-Monitoring | Active Comparator | Tele-monitoring and health coaching in addition to standard health care |
|
| Standard Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-monitoring and health coaching | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Readmission | Occurrence of all-cause hospital readmissions or death within 60 days | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Readmissions or Visits | Number of hospital readmissions or emergency room visits (visits without admissions) | 60 days |
| Mortality | All-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Bruce, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States | ||
| Memorial Regional Medical Center |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Readmission | Occurrence of all-cause hospital readmissions or death within 60 days | Posted | Count of Participants | Participants | 60 days |
|
Adverse Events were collected up to 60 days post discharge for all subjects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischemic Attack | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound at acrylic strip site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles J. Bruce | Mayo Clinic | 904-953-7227 | bruce.charles@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2018 | Jan 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 60 days |
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Number of Readmissions or Visits | Number of hospital readmissions or emergency room visits (visits without admissions) | Posted | Number | visits | 60 days |
|
|
|
|
| Secondary | Mortality | All-cause mortality | Posted | Count of Participants | Participants | 60 days |
|
|
|
|
| 1 |
| 54 |
| 2 |
| 54 |
| 5 |
| 54 |
| EG001 | 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. | 4 | 58 | 2 | 58 | 0 | 58 |
| Gastrointestinal Bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Tiny Lacunar Infarct (Cerebral Vascular Accident) | Nervous system disorders | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypotension and Cardiogenic shock | Cardiac disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Shock Liver | Gastrointestinal disorders | Systematic Assessment |
|
| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Right Heart Failure Exacerbation | Cardiac disorders | Systematic Assessment |
|
| Fluid overload | Vascular disorders | Systematic Assessment |
|
| Reaction at acrylic strip site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Reaction at strip site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blisters in area having contact with strip | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blisters at acrylic/silicon strip site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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