Trial Outcomes & Findings for Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure (NCT NCT02391987)

NCT ID: NCT02391987

Last Updated: 2020-01-29

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 112 participants
• Primary outcome timeframe: 60 days
• Results posted on: 2020-01-29

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	54	58
Overall Study COMPLETED	54	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tele-Monitoring n=54 Participants 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.	Standard Care n=58 Participants 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.	Total n=112 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 14 • n=5 Participants	68 years STANDARD_DEVIATION 13 • n=7 Participants	69 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	28 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized White	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants	58 participants n=7 Participants	112 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

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

Outcome measures

Measure	Tele-Monitoring n=54 Participants 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.	Standard Care n=58 Participants 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.
Hospital Readmission	14 Participants	16 Participants

SECONDARY outcome

Timeframe: 60 days

Number of hospital readmissions or emergency room visits (visits without admissions)

Outcome measures

Measure	Tele-Monitoring n=54 Participants 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.	Standard Care n=58 Participants 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.
Number of Readmissions or Visits	19 visits	20 visits

SECONDARY outcome

Timeframe: 60 days

All-cause mortality

Outcome measures

Measure	Tele-Monitoring n=54 Participants 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.	Standard Care n=58 Participants 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.
Mortality	1 Participants	4 Participants

Adverse Events

Tele-Monitoring

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Standard Care

Serious events: 2 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Measure	Tele-Monitoring n=54 participants at risk 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.	Standard Care n=58 participants at risk 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.
Cardiac disorders Transient Ischemic Attack	0.00% 0/54 • Adverse Events were collected up to 60 days post discharge for all subjects	1.7% 1/58 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects
Gastrointestinal disorders Gastrointestinal Bleed	0.00% 0/54 • Adverse Events were collected up to 60 days post discharge for all subjects	1.7% 1/58 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects
Nervous system disorders Tiny Lacunar Infarct (Cerebral Vascular Accident)	0.00% 0/54 • Adverse Events were collected up to 60 days post discharge for all subjects	1.7% 1/58 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects
Cardiac disorders Ventricular tachycardia	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects
Cardiac disorders Hypotension and Cardiogenic shock	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects
Renal and urinary disorders Acute Kidney Injury	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects
Gastrointestinal disorders Shock Liver	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects
Respiratory, thoracic and mediastinal disorders Acute hypoxic respiratory failure	0.00% 0/54 • Adverse Events were collected up to 60 days post discharge for all subjects	1.7% 1/58 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects
Cardiac disorders Right Heart Failure Exacerbation	0.00% 0/54 • Adverse Events were collected up to 60 days post discharge for all subjects	1.7% 1/58 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects
Vascular disorders Fluid overload	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects

Other adverse events

Measure	Tele-Monitoring n=54 participants at risk 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.	Standard Care n=58 participants at risk 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.
Skin and subcutaneous tissue disorders Wound at acrylic strip site	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects
Skin and subcutaneous tissue disorders Reaction at acrylic strip site	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects
Skin and subcutaneous tissue disorders Reaction at strip site	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects
Skin and subcutaneous tissue disorders Blisters in area having contact with strip	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects
Skin and subcutaneous tissue disorders Blisters at acrylic/silicon strip site	1.9% 1/54 • Number of events 1 • Adverse Events were collected up to 60 days post discharge for all subjects	0.00% 0/58 • Adverse Events were collected up to 60 days post discharge for all subjects

Additional Information

Charles J. Bruce

Mayo Clinic

Phone: 904-953-7227

Email: bruce.charles@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place