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
Phase: NA
Conditions: Heart Failure
Sponsor: Mayo Clinic

 
 
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 
 
NCT# NCT02391987 
 
Date 4/3/2018 

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Mayo Clinic Cardiovascular Research Center 
 
CONFIDENTIAL 
 
 
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 
 
 
Study Chair 
 
 
 
 
 
Charles J. Bruce, M.D. 
Mayo Clinic 
200 First Street, SW 
Rochester, MN 55905 
 
 
Co-Principal Investigators 
 
 
 
 
 
 
Study Statistician: 
  
 
 
 
 
Funding Sponsor: 
National Institutes of Health (NIH)  
Protocol Number:  
 
Tele-HC 
 
 
 
 
Document History 
(Effective Date) 
Activation date 
Version 2.0 
Version 3.0 
Version 4.0 
Version 5.0 
Version 6.0 
Version 7.0 
29 May 2015 
09 Jul 2015 
17 Feb 2016 
13 Apr 2016 
25 Jan 2017 
10 Nov 2017 
03 Apr 2018 
 
 
Cardiovascular Research Center 

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Protocol Resources 
 
Questions: 
Contact Name: 
Protocol document, consent form, Medidata Rave® 
access 
Monica Olson 
Mayo Clinic 
Phone: (507) 255-2649 
E-mail: Olson.Monica2@mayo.edu 
Monitoring clinical sites, adverse event review and 
reporting 
 
 
High-touch liaison 
 
 
 
 
 

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Table of Contents 
1.0 
BACKGROUND ................................................................................................................................... 8 
1.1 
HEART FAILURE READMISSIONS ................................................................................................................. 8 
1.2 
TELE-MONITORING ...................................................................................................................................... 8 
1.3 
HEALTH COACHING ..................................................................................................................................... 8 
1.4 
SELF-CARE .................................................................................................................................................. 8 
2.0 
INVESTIGATIONAL DEVICES .......................................................................................................... 9 
2.1 
BODYGUARDIAN® ...................................................................................................................................... 9 
2.2 
HIGH TOUCH SERVICE ............................................................................................................................... 11 
2.3 
PRELIMINARY DATA .................................................................................................................................. 11 
2.4 
STUDY RATIONALE AND RISK/BENEFITS ................................................................................................... 15 
2.4.1 
Study Rationale ........................................................................................................................ 15 
2.4.2 
BodyGuardian® Risks .............................................................................................................. 15 
2.4.3 
Wireless Blood Pressure Machine Risks ..................................................................................... 16 
2.4.4 
Expected Clinical Events .......................................................................................................... 16 
2.4.5 
Potential Benefits ..................................................................................................................... 16 
3.0 
STUDY OBJECTIVES ........................................................................................................................ 17 
3.1 
PRIMARY OBJECTIVE ................................................................................................................................. 17 
3.2 
SECONDARY OBJECTIVES: ......................................................................................................................... 17 
4.0 
STUDY DESIGN ................................................................................................................................. 17 
4.1 
GENERAL DESIGN...................................................................................................................................... 17 
4.2 
RANDOMIZATION ...................................................................................................................................... 17 
4.3 
STUDY PROCEDURES ................................................................................................................................. 17 
4.4 
INTERVENTION PROTOCOL (TELE-HC) ...................................................................................................... 19 
4.5 
STUDY SCHEMA ........................................................................................................................................ 21 
4.6 
OUTCOME MEASURES ............................................................................................................................... 21 
4.6.1 
Primary Study Endpoint ........................................................................................................... 21 
4.6.2 
Secondary Study Endpoints ....................................................................................................... 21 
4.6.3 
Exploratory Outcomes .............................................................................................................. 22 
4.6.4 
Primary Safety Endpoints ......................................................................................................... 22 
4.7 
QUESTIONNAIRE TOOLS ............................................................................................................................ 22 
4.7.1 
Assessment of Depression and Adherence Tool ........................................................................... 22 
4.7.2 
Self-Care and Life Quality Evaluation ....................................................................................... 22 
4.7.3 
Health Literacy Evaluation ....................................................................................................... 23 
5.0 
SUBJECT SELECTION, ENROLLMENT AND WITHDRAWAL ..................................................... 23 
5.1 
INCLUSION CRITERIA ................................................................................................................................. 23 
5.2 
EXCLUSION CRITERIA ............................................................................................................................... 23 
5.3 
SUBJECT RECRUITMENT, ENROLLMENT, AND SCREENING ......................................................................... 24 
6.0 
STUDY PROCEDURES ...................................................................................................................... 25 
6.1 
STUDY SCHEDULE ..................................................................................................................................... 25 
6.2 
PATIENT CONFIDENTIALITY ...................................................................................................................... 26 
7.0 
STATISTICAL PLAN ......................................................................................................................... 26 
7.1 
SAMPLE SIZE DETERMINATION ................................................................................................................. 26 
7.2 
STATISTICAL METHODS............................................................................................................................. 27 
7.2.1 
Descriptive Statistics ................................................................................................................ 27 
7.2.2 
Handling of Missing Data ......................................................................................................... 27 
7.2.3 
Multiplicity .............................................................................................................................. 28 
7.2.4 
Primary Outcomes ................................................................................................................... 28 

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7.2.5 
Secondary and Exploratory Outcomes ....................................................................................... 28 
7.2.6 
Interim Analysis ....................................................................................................................... 29 
7.2.7 
Subject Population(s) for Analysis ............................................................................................. 30 
8.0 
PARTICIPANT SAFETY, ADVERSE EVENTS, AND CLINICAL ENDPOINTS .............................. 30 
8.1 
INSTITUTIONAL REVIEW BOARDS .............................................................................................................. 30 
8.2 
DEFINITIONS .............................................................................................................................................. 31 
8.2.1 
Unanticipated Adverse Device Effect (UADE) ............................................................................ 31 
8.2.2 
Study-Related Adverse Effect (Event) ......................................................................................... 31 
8.2.3 
General Physical Examination Findings .................................................................................... 31 
8.2.4 
Hospitalization, Prolonged Hospitalization, or Surgery ............................................................... 31 
8.2.5 
Post-study Adverse Event .......................................................................................................... 32 
8.2.6 
Preexisting Condition ............................................................................................................... 32 
8.2.7 
Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO) .................................... 32 
8.3 
CLINICAL ENDPOINTS/ADVERSE EVENT REPORTING PERIOD .................................................................... 33 
8.4 
RECORDING OF CLINICAL ENDPOINTS ....................................................................................................... 33 
8.5 
RECORDING OF ADVERSE EVENTS............................................................................................................. 33 
8.6 
PREVENTICE REPORTING OF UNANTICIPATED ADVERSE DEVICE EFFECTS AND UNANTICIPATED 
PROBLEMS ............................................................................................................................................................... 34 
8.7 
PREVENTICE REPORTING, NOTIFYING THE FDA ........................................................................................ 35 
8.8 
REPORTING PROCESS ................................................................................................................................. 35 
8.9 
DEVIATIONS FROM THE INVESTIGATIONAL PLAN ....................................................................................... 36 
8.10 
MEDICAL MONITORING ............................................................................................................................. 36 
9.0 
DATA HANDLING AND RECORD KEEPING .................................................................................. 36 
9.1 
CONFIDENTIALITY ..................................................................................................................................... 36 
9.2 
SOURCE DOCUMENTS ................................................................................................................................ 37 
9.3 
CASE REPORT FORMS ................................................................................................................................ 37 
9.4 
DATA MANAGEMENT ................................................................................................................................ 37 
9.5 
DATA SECURITY AND CONFIDENTIALITY .................................................................................................. 38 
9.6 
DATA QUALITY ASSURANCE ..................................................................................................................... 38 
9.7 
RECORDS RETENTION ................................................................................................................................ 38 
10.0 
STUDY MONITORING, AUDITING, AND INSPECTING ............................................................ 39 
10.1 
STUDY MONITORING PLAN ....................................................................................................................... 39 
10.2 
AUDITING AND INSPECTING ....................................................................................................................... 39 
11.0 
ETHICAL CONSIDERATIONS ..................................................................................................... 40 
12.0 
STUDY FINANCES ........................................................................................................................ 40 
12.1 
FUNDING SOURCE ..................................................................................................................................... 40 
12.2 
CONFLICT OF INTEREST ............................................................................................................................. 40 
13.0 
PUBLICATION PLAN ................................................................................................................... 40 
14.0 
REFERENCES ............................................................................................................................... 41 
15.0 
APPENDIX ..................................................................................................................................... 44 
15.1 
BLOOD PRESSURE MONITOR AND CUFF MANUAL ..................................................................................... 44 
15.2 
BODYGUARDIAN® MANUAL .................................................................................................................... 44 
15.3 
CASE REPORT FORMS ................................................................................................................................ 44 
15.4 
DATA AND SAFETY MONITORING PLAN .................................................................................................... 44 
15.5 
DRUG DICTIONARY ................................................................................................................................... 44 
15.6 
HEALTH LITERACY MEASURE ................................................................................................................... 44 
15.7 
MEDICAL OUTCOMES GENERAL ADHERENCE MEASURE (PHQ9) ............................................................. 44 
15.8 
MINNESOTA LIVING WITH HEART FAILURE QUESTIONNAIRE (MLHFQ) .................................................. 44 
15.9 
NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION .............................................. 44 

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15.10 
SELF-CARE OF HEART FAILURE INDEX (SCHFI) ....................................................................................... 44 
15.11 
SKIN IRRITATION TREATMENT .................................................................................................................. 44 
15.12 
FOLLOW-UP SCRIPT ................................................................................................................................... 44 
15.13 
WEIGHT SCALES MANUAL ........................................................................................................................ 44 
15.14 
ICD INTERFERENCE LETTER AND ABSTRACT – HAYES ............................................................................. 44 
 
 
 
 

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LIST OF ABBREVIATIONS 
ACC 
American College of Cardiology 
ADE 
Adverse Device Effect 
ADHF 
Acute Decompensated Heart Failure 
AE 
Adverse Event/Adverse Experience 
AF 
Atrial Fibrillation 
AHA 
American Heart Association 
APRN 
Advanced Practice Registered Nurse 
BEACH 
Billing Encounter Archive for Clinic and Hospital 
BG 
BodyGuardian® 
BP 
Blood Pressure 
CFR 
Code of Federal Regulations 
CHF 
Congestive Heart Failure 
CRF 
Case Report Form 
FDA 
Food and Drug Administration 
ECG 
Electrocardiogram 
ER 
Emergency Room 
EF 
Ejection Fraction 
GCP 
Good Clinical Practice 
HF 
Heart Failure 
HIPAA 
Health Insurance Portability and Accountability Act 
HR 
Heart Rate 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
MLHFQ 
Minnesota Living with Heart Failure Questionnaire 
NYHA 
New York Heart Association  
OCHEUD 
Olmsted County Healthcare Utilization Database 
PHI 
Protected Health Information 
PI 
Principal Investigator 
RR 
Respiratory Rate 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SCHFI 
Self-Care of Heart Failure Index 
SOP 
Standard Operating Procedure 
TM 
Tele-monitoring 
UADE 
Unanticipated Adverse Device Effect 
UI 
User Interface 
 
 
 
 
 

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Study Summary 
 
Title 
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 
Running Title 
Tele-HC 
Phase 
III 
Methodology 
Randomized 
Overall Study 
Duration 
2 years 
Subject Participation 
Duration 
1.5 years 
Objectives 
To test an integrated tele-monitoring and patient-centric health coaching 
system to reduce hospital readmissions in HF patients. 
Number of Subjects 
304 
Diagnosis and Main 
Inclusion Criteria 
Diagnosis:  Acute Decompensated Heart Failure (ADHF)  
Main inclusion criteria:  Hospitalized for treatment of ADHF 
Study Device 
BodyGuardian® Remote Monitoring System  
Duration of 
Exposure 
60 days 
Reference therapy 
Standard clinical care 
Statistical 
Methodology 
The primary analysis will be a Cochran-Mantel-Haenszel Chi-square 
test to compare the 60-day readmission rates between the two 
interventions while controlling for enrolling hospital (site). 
 
 
 
  
 
 
 

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1.0 
Background 
1.1 Heart Failure Readmissions 
Heart failure (HF) poses a significant public health burden as it affects approximately 6 
million Americans, with 670,000 new cases/year and a projected annual cost of 56 billion 
Medicare dollars by 2020.1,2,3,4  Chronic HF is characterized by suboptimal self-care 
behaviors, frequent hospitalizations, and a national 23% readmission rate at 30 days.5,6,7,8 
The drivers of readmission are multifactorial and often attributed to fragmented 
transitions from the hospital to the home or skilled facility due to a lack of 
communication and care coordination.10-12  Behavioral factors including poor self-care 
combined with scarcity of economic resources, insufficient social support, and lifestyle 
choices also contribute to rehospitalization.10,13-15  
1.2 Tele-monitoring 
Tele-monitoring (TM), the use of remote monitoring technology, has been an integral 
part of transitional care for adult patients with HF for the past 2 decades.16,17 However, 
TM interventions to prevent readmissions in HF have shown inconsistent results in 
effectiveness for prevention of HF-related and all-cause re-hospitalization which likely 
reflects the complexity of managing patients with HF and the challenges in readmission 
prevention. 17   
1.3 Health Coaching 
Health coaching, rooted in motivational interviewing and education, is an integrative 
process of partnering with patients to change behavior .18 The goal of health coaching is 
to facilitate patient self-management strategies for the purposes of preventing disease 
exacerbation and hospitalization.18 Although health coaching has been widely used in 
chronic disease management and cardiovascular risk reduction, little has been published 
regarding this strategy for the HF population.19-22  The use of technology to monitor 
patient clinical status at home in concert with a health-coach has been demonstrated to be  
a viable model to engage patients in self-care behaviors, close the patient-provider 
communication gap, foster patient autonomy, and enhance the patient experience.23   
1.4 Self-care 
The Self-Care of Heart Failure Model provides a framework for examining self-care 
behaviors in the context of a continuum of self-care maintenance and management.15 
Self-care maintenance includes fundamental behaviors to maintain physiological stability 
such as symptom monitoring and treatment adherence.15  Self-care management reflects 

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an engagement in deliberate decision-making processes in response to symptoms.15 Self- 
care maintenance incorporates symptom recognition and evaluation followed by 
treatment implementation and appraisal of response.15 Self-care confidence both mediates 
and moderates the relationship between self-care behaviors and outcomes, secures the 
individual's progression, and is strengthened as the individual moves through the stages.24 
A comprehensive transitional care model is needed that links providers, patients with 
chronic diseases, and health coaches to help navigate the health care system following an 
acute hospitalization.  Acquired data will be reviewed to support clinical decision 
making.  A model has been developed that significantly reduces re-hospitalization and 
improves patient self-care behaviors in managing their chronic disease, thus positively 
affecting the “triple aim”. 
The purpose of this study is to evaluate the impact of an integrated tele-monitoring and 
patient-centric health coaching (Tele-HC) strategy in adult patients recently hospitalized 
with ADHF compared to standard care on clinical outcomes using a randomized control 
design. The study will evaluate clinical outcomes by looking at all-cause 60 day 
readmission rates for ADHF.  
2.0 
Investigational Devices 
2.1 
BodyGuardian® 
The end-to-end remote monitoring system is a mobile, multi-tiered healthcare platform 
which links personal health sensors (front-end) to secure mobile communication devices 
to enable transmission of discrete and summarized physiologic and symptom information 
to providers (back-end).  The front-end includes an adhesive body sensor 
(BodyGuardian®) which acquires/quantifies HR, ECG, RR, and activity and has been 
FDA-cleared (510k) and CE Marked for detection of non-lethal cardiac arrhythmias.  The 
BodyGuardian® control unit (including sensor) is a patch-style device which can be worn 
either horizontally or vertically on the chest and is comprised of the rechargeable control 
unit and a disposable adhesive strip (SnapStrip™).  The SnapStrip™ has four conductive 
pads covered by pre-applied hydroelectric gel which can be worn while showering.  The 
system is able to wirelessly communicate with a commercially available BP monitor and 
cuff (see BP Monitor and Cuff Manual) and scale (see Weight Scale Manuals). 
The BodyGuardian® control unit has a 32-bit ARM processor with 1 Gigabit of on-board 
memory.  The device uses a Lithium-ION rechargeable battery.  The BodyGuardian® 
control unit runs approximately 24 hours between recharges.  The sensors collect and 
correlate three areas of on-body physiologic measures: 1) ECG, HR, RR variability, and 
HR reliability that can be used to assess skin contact quality of the electrodes; 2) 

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respiration derived from bio-impedance measurements; and 3) body-position along with a 
summarized measure of activity derived from a 3-axis accelerometer.  The system also 
acquires off-body measures via Bluetooth connectivity including weight and BP. 
Physiologic information is securely transmitted to a remote data storage center (the 
Cloud) using mobile phone technology as the communication hub.  The system can also 
function as an event recorder where the mobile phone automatically solicits symptoms (if 
directed by the physician) from the user-triggered events and by programs which analyze 
the acquired physiologic data. The secure central data center (the Cloud) stores 
information and a proprietary mid-tier logic layer supports development of automated 
alerts, messages, and other personalized health applications.   
The Preventice Care Platform is the proprietary web and mobile software which enables 
the BodyGuardian® system access to data stored in the Cloud and includes server 
support, web-based user-interfaces (UIs), and access for mobile applications for 
clinicians.  Server hardware physically resides in a secure SSAE-16 compliant data 
center.  The server is built upon grid technologies that allow a dynamic increase or 
decrease in processing, storage, and network capacity based on workload.  Personal 
health information and clinical measurements are stored separately.   
The BodyGuardian® Connect mobile application runs on an Android smartphone which 
provides data transmission as well as user interfaces (UIs) for control and monitoring.  
Data are immediately sent to the Preventice Care Platform if network connectivity is 
available; otherwise data are stored on the handset until the network is available.  The 
handset has the capacity to store several gigabytes of data locally when network 
connectivity is not available.  Data are automatically forwarded to the Cloud where 
clinicians can review the information.   
Remotely acquired data will be transmitted to the Mayo Heart Rhythm and Physiologic 
Monitoring Laboratory.  This is a clinical area staffed 24/7 by Mayo Clinic monitoring 
technicians at 
 Hospital) who have been fully trained to use the 
BodyGuardian® system and are currently using this system clinically for remote 
monitoring of patients for non-lethal cardiac arrhythmia.  Data will also be transmitted to 
a cloud-based management platform that is alert and protocol driven to assist the care 
team in patient management (see section below).  Rhythm monitoring, classification and 
alerting will be the responsibility of the Mayo Clinic Remote Monitoring Center in 
  Alerts will be communicated via phone or the secure web-based portal 
during the hours of 7am-7pm EST, seven days a week; outside this time range alerts will 
be communicated via phone.  

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2.2 
High Touch Service 
The high touch service includes utilization of a cloud-based management platform built 
on an open source EMR architecture. Physiological data (ECG, HR, activity, respiration, 
posture, BP, and weight) will be uploaded directly to a cloud-based management 
platform.  The cloud-based management platform patient data dashboard will identify, 
triage, and escalate actionable information for the study team to review via a secure web 
portal.  Patient-generated biometric data will be continuously analyzed and displayed on 
an hourly basis.  Patient-reported symptom information will also be captured.  The 
dashboard uses color-coded (red, yellow, green) to quickly communicate exception data.  
Live data will be evaluated by the care team 7 days per week from 7am – 7 pm EST with 
additional monitoring and evaluation of the transmitted data on an as needed basis for 
calls generated outside of the 12-hour monitoring window. 
An RN will be designated as the primary coach on the high touch team focused on 
disease management including symptom recognition, adherence to treatment strategies, 
care coordination, medication matters, and problem solving.  Medication matters include 
initial medication reconciliation and the organization of resources to obtain medications 
for patients who have socioeconomic challenges.  An RN will also be responsible for 
managing socio-economic challenges, and providing a nutrition and wellness assessment 
and goal setting.   
The high touch team establishes a patient-centric relationship using techniques of 
motivational interviewing coupled with a transactional model of communication. Health 
literacy will be assessed using a validated tool to help personalize coaching interactions.  
Coaching topics will include the patient’s understanding of their disease, establishing 
goals of health, treatment strategies, medication adherence, and therapy expectations.  As 
the high touch team identifies knowledge deficits, they customize the education and 
employ the teach-back methodology to address the gaps.   
2.3 
Preliminary Data 
Studies have been completed to evaluate the BodyGuardian® (BG) system in healthy 
elderly subjects and to test the usability from a subject’s perspective and from a 
clinician’s perspective.   
In one study, twenty subjects were enrolled; 19 subjects completed the study and 1 
withdrew because he could not manage to use the device.  The 18 subjects were 
monitored for 22 days on average (in 21.7 days monitoring exceeded 80% of the day).  
Six subjects stopped wearing the BG monitor after less than 30 days due to: skin irritation 
(1); difficulty using/placing the monitor (4); or reluctance to use it due to aches and pains 
unrelated to the monitoring system (1).  An evaluation was done on the ECG signal, 

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arrhythmia classification algorithm, respiration signal, accelerometer data, and the 
reliability of wireless connection with the BP cuff and scale. Heart rate data was obtained 
99.2% of the time (91.4% reliable); respiration data was obtained 53.9% of the time.  
Weight and blood pressure were captured 75.7% and 74.0% of the time, respectively.   
Since many HF patients have pacemakers and implantable cardiac defibrillators (ICDs), 
the system was evaluated for electromagnetic interference (EMI) with these devices.  The 
BodyGuardian® module and adhesive electrode strip was applied to the skin directly 
over the implanted device in 100 subjects. In 208 successful acquisitions and 
transmissions of electrocardiograms, no EMI was detected (see Appendix 15.14 ICD 
Interference Letter and Abstract – Hayes). 
The system has also been studied in 29 outpatients with atrial fibrillation (AF) who had 
undergone cardioversion or radiofrequency ablation to assess arrhythmia recurrence 
within thirty days.  This study allowed for the testing of the usability of the body worn 
sensor, effectiveness of data transmission in a variety of ambulatory settings, and the 
ability to develop and refine the back-end monitoring infrastructure.  The BG was worn 
for an average of 25 days and 58.6% of subjects had AF recurrence during monitoring; on 
average AF recurred 11 days and 9 hours after the procedure.  We made the novel 
observation that physical activity is significantly increased in the 15 minutes prior to AF 
recurrence, suggesting that avoidance of vigorous exertion in the first month post rhythm 
intervention may be warranted.  The BG system is now being routinely used clinically at 
Mayo Clinic for remote detection and monitoring of atrial fibrillation.   
In-depth qualitative interviews have been completed, transcribed, and analyzed for 56 
participants.  These semi-structured individual interviews occurred at baseline, at end of 
study, and after any documented incident (R01 phase 2 trial only), totaling 111 completed 
interviews.  The qualitative interview guide was revised in response to new findings and 
modifications of the BG system (e.g., technology updates) and instructions for use.  
Predominant themes (subject’s opinions and concerns repeated by many) included skin 
discomfort from the adhesive strip, concern about not knowing if the unit was 
transmitting data properly, early confusion with the process of applying and using the 
system (learning curve which improves over time), misconceptions about the type and 
timing of feedback on monitoring data, and frustration with the process of charging two 
devices.  Subsequent refinements, responsive to participant feedback (e.g., the 
education/instructional approach, phone display/feedback that data transmitted) positively 
impacted later interview data.  Within the qualitative interviews, participants were asked 
to rate perceived burden of wearing the device, confidence to put it on properly each day, 
and confidence to wear it every day on a scale from 0 (not at all) to 10 (very much).  End 
of study (n = 37) means (SD) were: burden = 3.14 (2.44); confidence to wear properly = 
9.14 (1.93); confidence to wear every day = 9.30 (1.53).  The majority of participants 

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would recommend the system to other patients.  This data was evaluated to better 
understand acceptance of the monitoring system and usability so that refinement could be 
done before commencing with a randomized trial. 
The BodyGuardian system incorporated into a high-touch model of care has also been 
recently studied. Findings from this descriptive, cross-sectional observational study of 30 
older adult patients with demographics referenced in Table 1 who were hospitalized with 
HF between 06/01/2013 and 11/30/2013 show a 30-day all-cause readmission rate of 6% 
with no patients being re-hospitalized for HF.  As seen in Table 2, patient self-care scores 
improved with all three categories reaching statistical significance (p < .0001).   
A larger cohort experience of 142 patients from a single suburban hospital, including 
both HF and AMI patients treated with the tele-monitoring and patient-centric health 
coach (Tele-HC) intervention, show a 30-day all-cause readmission rate of 4.2% and a 
30-day cardiac readmission rate of 2.8%. 
 

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Preliminary data from these studies demonstrate the feasibility and potential benefits of 
an integrated TM and health coach intervention for older patients hospitalized with HF.  
Interventions with personalized coaching on diet, lifestyle, pharmacotherapy, and other 
strategies engage patients as partners in their self-care, leverage technology, reduce 
hospital readmissions, and improve self-care outcomes. 
2.4 
Study Rationale and Risk/Benefits 
2.4.1 Study Rationale 
A comprehensive transitional care model is needed that links providers, patients with 
chronic diseases, and health coaches to help navigate the health care matrix following 
an acute hospitalization.  The purpose of this study is to evaluate the impact of an 
integrated tele-monitoring and patient-centric health coaching (Tele-HC) strategy on 
hospital readmissions in adult patients recently hospitalized with acute 
decompensated heart failure (ADHF).   
2.4.2 BodyGuardian® Risks 
The BodyGuardian® is a Class II FDA cleared device for ambulatory monitoring of 
non-lethal arrhythmias. As a Class II ECG device, it has been classified as a Non-
Significant Risk device that is not implantable, does not sustain human life, does not 
actively treat or cure disease, and does not pose a serious risk to the health and safety 
of the patient. In the context of this trial as described below, the BodyGuardian® 
Device and the Patient Care Platform will acquire physiologic data and provide 
individualized physician-prescribed automated alerts based on physician-prescribed 
thresholds. These alerts will then be reviewed by the appropriate medical staff as 
defined in the care protocols and within the scope of practice of the medical staff. 
This design uses the BodyGuardian® to acquire data and present to the medical staff 
data they have asked to review based on individual prescriptions for each patient. 
This design of a Class II device presenting relevant information to medical staff to 
review and confirm within their scope of practice is consistent with a Non-Significant 
Risk Device Study. 
The BodyGuardian® is being used in this study consistent with its indications for use 
to remotely monitor ambulatory, non-lethal arrhythmias. The risk of direct harm to a 
subject using the BodyGuardian® as an external sensor is minimal. As part of the 510 
K submission, the FDA reviewed a comprehensive hazard analysis and risk 
mitigation strategy. The most common potential adverse event is skin irritation or 
reaction to the adhesive on the SnapStrip™. This will be monitored for all subjects. 

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Skin irritation:  Skin irritation may result from the SnapStrip™ adhesive. For ease in 
removal, subjects will be instructed to use a warm, damp cloth to soften the edges of 
the SnapStrip™ before slowly peeling back and rolling the adhesive away from the 
chest. Subjects should not rip or tear off the SnapStrip™ quickly and the SnapStrip™ 
should not be attached to broken, damaged, or irritated skin. 
Delay in identifying or responding to an abnormal clinical finding.  Subjects will be 
reminded that if they are having worrisome symptoms they should not rely on the BG 
platform, but rather contact their primary healthcare provider or if necessary, visit the 
emergency room (ER). 
False reassurance:  False reassurance that monitoring is occurring when data is not 
being transmitted due to poor connectivity is a possibility.  Subjects will be educated 
that there may be periods where monitoring is not occurring, but that they will be 
informed by the technicians if no data is received after a 24 hour period. 
User errors:  User errors may result in missed events and/or data resulting in missed 
diagnosis.  
Confidentiality:  As with all research and any time information is transmitted over the 
internet, there is a chance that confidentiality could be compromised.  However, 
precautions have been taken to minimize this risk. 
2.4.3 Wireless Blood Pressure Machine Risks  
Measurements may be distorted if the device is used close to televisions, microwave 
ovens, cellular telephones, X-ray, or other devices with strong electrical fields. 
2.4.4 Expected Clinical Events 
Expected clinic events include those related to heart failure.  Examples include: 
• ER visits 
• Hospitalizations 
• Death 
2.4.5 Potential Benefits 
Earlier detection of heart failure decompensation or clinically significant arrhythmias 
may lead to earlier intervention and potentially reduce re-hospitalization.  

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3.0 
Study Objectives 
3.1 
Primary Objective 
To demonstrate that Tele-HC in adult patients recently hospitalized with ADHF 
compared to standard care reduces all cause readmissions rates at 60 days. 
3.2 
Secondary objectives: 
• Quantify the time to the first readmission or death 
• Quantify the number of hospital readmissions or ER visits  
• Quantify all-cause mortality 
4.0 
Study Design 
4.1 
General Design 
This is a randomized controlled study evaluating consecutive adult patients hospitalized 
with primary or secondary diagnosis of ADHF. Patients will be randomized to receive 
either standard care or to the intervention group (Tele-HC model) to assess the impact of 
the intervention on 60 day all-cause readmission rates. 
4.2 
Randomization 
Participants will be allocated to their respective treatment groups in a 4:1 ratio 
(intervention to standard of care), stratified by institution, sex, and NYHA functional 
classification.  This unequal allocation ratio will lead to more patients receiving active 
intervention while maintaining a random component so that study staff and patients are 
unable to predict treatment assignment before randomization. 
4.3 
Study Procedures 
Standard Care Arm   
Standard care is defined as HF care based on current ACC/AHA HF guidelines 
implemented and orchestrated by a cardiologist and support staff at the participating 
institution.   

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Intervention Arm 
The Intervention arm (Tele-HC) will include standard care in addition to remote 
physiologic monitoring with a wearable monitor (BodyGuardian®, Preventice) coupled 
with tailored health coaching.  Details of the remote monitoring platform and health-
coaching infrastructure are described below. 
ECG monitoring, HR, activity, and posture will be collected via on-body sensors while 
BP and weight data will be collected by off-body sensors linked to BodyGuardian®.  
Information will be obtained via Bluetooth enabled devices and transmitted to a cloud-
based management platform that is alert and protocol driven to assist the care team in 
patient management.  Rhythm monitoring, classification and alerting will be the 
responsibility of the Mayo Clinic monitoring center in Rochester, MN.  Alerts will be 
communicated to the high touch care team via phone or the secure web-based portal 
during the hours of 7am-7pm EST, seven days a week. Outside of this time, alerts will be 
communicated via phone.  
The remaining physiological data (HR, activity, posture, BP, and weight) will be 
uploaded directly to the cloud-based management platform. The cloud-based 
management platform patient data dashboard will identify, triage, and escalate actionable 
information for the study team to review via a secure web portal.  Patient-generated 
biometric data will be continuously analyzed and displayed on an hourly basis.  Patient-
reported symptom information will also be captured.  The dashboard uses color-coded 
(red, yellow, green) to quickly communicate exception data.  Live data will be evaluated 
by the care team 7 days per week from 7am – 7 pm EST with additional monitoring and 
evaluation of the transmitted data on an as needed basis for calls generated outside of the 
12-hour monitoring window.   
An RN will be designated as the primary coach on the high touch study team focused on 
disease management including symptom recognition, adherence to treatment strategies, 
care coordination, medication matters, and problem solving.  Medication matters include 
initial medication reconciliation and the organization of resources to obtain medications 
for patients who have socioeconomic challenges.  A RN will also be responsible for 
managing socio-economic challenges, and providing a nutrition and wellness assessment 
and goal setting.  The high touch study team establishes a patient-centric relationship 
using techniques of motivational interviewing coupled with a transactional model of 
communication.24, 25 Health literacy will be assessed using a validated tool to help 
personalize coaching interactions.  Coaching topics will include the patient’s 
understanding of their disease, establishing goals of health, treatment strategies, 
medication adherence, and therapy expectations.  As the high touch study team identifies 
knowledge deficits, they customize the education and employ the teach-back 

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methodology to address the gaps.  The high touch study team will engage the patient in 
collaborative care planning and goal setting to ensure interventions are congruent with 
the patient’s readiness for change, needs, values, culture, desires, and health goals.  
Patient engagement and self-care management will be measured with the Self-Care of 
Heart Failure Index in a pre-test/post-test fashion at the time of enrollment and at 60 days 
post-enrollment. 
The research coordinator will screen patients hospitalized with ADHF.  Those who meet 
all inclusion and exclusion criteria will be randomized with unequal allocation, 4:1 Tele-
HC intervention to standard care and enrolled in the study.  Demographic and clinical 
data will be collected.  
All patients will be assessed at 30 days and 60 days for the occurrence of re-
hospitalization and all-cause mortality. De-identified hospital records will be collected so 
that the study monitor can review to verify cause of re-hospitalization. 
4.4 
Intervention Protocol (Tele-HC) 
Intake – high touch study liaison (pre hospital discharge) 
• Program introduction 
• Review medical history 
• Introduce team members 
On boarding- study team members or staff contracted by clinical site 
• Patient visit prior to hospital discharge, medication reconciliation, sodium intake 
reconciliation, BodyGuardian® application  
Stabilization phase – high touch study team member (day 1-14 post discharge) 
• Baseline physiological data 
• Daily review of patient generated data  
• Medication adherence 
• Low sodium adherence 
• Reinforce self-care behaviors 
• Daily touches at a minimum 

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Optimization phase – high touch study team member (day 15-60 post discharge) 
• Daily review of patient generated data 
• Reinforce self-care behaviors 
• Screen for depression and sleep apnea 
• Optimize disease management (in collaboration with primary cardiologist) 
• Targeted touches 
Measured variables (to be obtained from both groups)  
• 6 minute walk test (pre-discharge, 60 day)  
• ECG (onboarding) 
• SCHFI Self-care index and MLHFQ Heart Failure questionnaire  (onboarding, 60 
day) 
• NYHA functional class (pre-discharge, 60 day) 
• 60 day readmission 
• Unscheduled clinic, hospital and/or ER visits 
• Echocardiogram derived EF within 6 months prior to randomization 
• Pre-discharge metabolic profile, creatinine, Hb, K, Na, GFR   
Data collection obtained from clinically indicated investigations include the 6 minute 
walk, ECG, EF, chest x-ray, and blood test.  

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4.5 
Study Schema 
 
Randomization
Standard Care Arm
Tele-HC Arm
Day 0
Date of hospital discharge
Primary Outcome:  Re-hospitalization or death
Screening/Eligibility
Informed Consent
30 & 60 day follow-up
 
4.6 
Outcome Measures 
4.6.1 Primary Study Endpoint 
Occurrence of all-cause hospital readmissions or death within 60 days of 
randomization  
4.6.2 Secondary Study Endpoints 
• Time to readmission or death 
• Number of hospital readmissions or ER visits (visits without admissions) 

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• All-cause mortality 
4.6.3 Exploratory Outcomes 
• Change in self-care score at baseline and at end of study in both groups 
• NYHA functional class at baseline and at end of study in both groups 
• 6 minute walk results at baseline and at end of study in both groups 
• Quality of life scores (Minnesota Living with HF) at baseline and at end of study 
in both groups 
• Correlation of data obtained from the BodyGuardian® remote monitoring 
platform with clinical outcomes 
4.6.4 Primary Safety Endpoints 
• All cases of skin irritation requiring prescription treatment and/or withdrawal 
from the study will be documented  
• All Serious Adverse Device Events (SADE) and Unexpected Adverse Device 
Events (UADE) will be documented and reported according to IRB and federal 
guidelines. 
4.7 
Questionnaire Tools 
4.7.1 Assessment of Depression and Adherence Tool 
In order to assess adherence in future users, each subject will be asked to complete a 
baseline depression assessment survey (PHQ-9) and a demographic survey.  If a 
PHQ-9 score indicates a more than minimal severity, standard of care treatment for 
depression will be followed.  
4.7.2 Self-Care and Life Quality Evaluation 
Each subject will be asked to complete two separate questionnaires at baseline prior 
to use of the remote monitoring system and again at completion of the study.  The 
first questionnaire is the Self-Care of Heart Failure Index (SCHFI), and the second is 
the Minnesota Living with Heart Failure Questionnaire (MLHFQ), which are 
validated tools for quantifying self-care and quality of life.   

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The SCHFI is comprised of three subscales:  self-care maintenance (choice of 
behaviors used to maintain physiologic stability), self-care management (response to 
symptoms when they occur) and self-care confidence.  The maintenance, 
management, and confidence subscales are comprised of 5, 6, and 4 Likert questions, 
respectively.  A higher score on the SCHFI indicates improved self-care.   
The MLHFQ consists of 21 questions that use a 6-point Likert scale.  The physical 
dimension score for the MLHFQ is the summation of 8 questions (e.g., Did your heart 
failure make you sit or lie down to rest during the day?), while the emotional 
dimension score is the summation of 5 other questions (e.g., Did your heart failure 
make you worry?).  A lower score on the MLHFQ indicates higher quality of life. 
4.7.3 Health Literacy Evaluation 
One question regarding health literacy will be included in the questionnaire 
assessment.  See Appendix 15.6. 
5.0 
Subject Selection, Enrollment and Withdrawal 
This protocol will accrue 304 subjects hospitalized with a primary or secondary diagnosis 
of ADHF.  These subjects will then be enrolled and randomized to receive either standard 
care or to the intervention group (Tele-HC model) to assess the impact of the intervention 
on 60 day all cause readmission rates. 
Definition of ADHF:  One or more of these symptoms:  shortness of breath, orthopnea or 
edema AND may have one or more of these signs:  rales, peripheral edema, ascites, or 
pulmonary vascular congestion on chest radiography 
5.1 
Inclusion Criteria 
• Hospitalized with primary or secondary diagnosis of ADHF (one or more of these 
symptoms:  shortness of breath, orthopnea or edema AND may have one or more of 
these signs:  rales, peripheral edema, ascites, or pulmonary vascular congestion on 
chest radiography) 
• Adult patients >18 years old 
5.2 
Exclusion Criteria 
• Overall life expectancy < 2 months 
• Known skin allergy to adhesives (hydrocolloid, silicone, acrylic) 

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• Active systemic infection 
• End stage renal disease (ESRD) 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 
5.3 
Subject Recruitment, Enrollment, and Screening 
Eligible subjects will be enrolled and randomized prior to hospital discharge to either 
remote monitoring or standard care.  After randomization, participants will be remotely 
monitored for 60 days.  Standard care will be per published guidelines (ACC/AHA HF 
guidelines).  At these evaluations, routine and clinically-indicated investigations will 
include history and assessment of NYHA class, ECG, and blood work, as deemed 
appropriate by the clinician.  Data from any clinical visits & assessments will be 
collected.  Medication compliance will be assessed and adjustments in management made 
in accordance with individual subject needs as per the judgment of care providers. Rate 
of ER visits, hospital admissions, episodes of contact with health care providers, and 
mortality data will be collected by research assistants working with the clinical electronic 
medical record (EMR) and entered into Medidata Rave® for subsequent analysis. If the 
subject’s primary provider requests information while the subject is on the study, 
identifiable information will be released to them for clinical care. Specifically, 
information regarding their ECG, weight, and overall health related to their heart failure.  
Study Completion 
A subject will be considered to have completed the study if he or she completed all 
assessments and procedures during the baseline and follow-up period of 60 days for 
primary endpoint events.  All randomized patients will have a follow-up assessment at 30 
and 60 days to determine survival status and hospitalization data.  If the subject dies 
during this period, the study coordinator and/or PI should make every effort to obtain 
details of the subject’s death from the relevant hospital or subject’s physicians and/or 
relatives.  If confirmation of death is not available through these mechanisms, the study 
coordinator and/or PI will attempt to confirm the subject’s death through a death index 
search. 
Study Withdrawal 

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If the subject dies after being randomized but prior to hospital dismissal, the subject will 
be withdrawn from the study. 
If the subject is lost to follow up, every effort will be made to contact the subject and 
determine the reason that will then be documented, including the measures taken to 
follow-up.  If subject withdraws or drops out of the study, the reason for withdrawal from 
the study is to be documented on the case report form (CRF) and in the source document.  
The study coordinator or investigator must attempt to document re-hospitalization data 
unless the subject expressly refuses to provide this information.   
Treatment discontinuation 
Subjects who terminate the use of the BodyGuardian® device will continue to be 
followed.  Interruption of the BodyGuardian® device will not be considered treatment 
discontinuation.   
6.0 
Study Procedures   
6.1 
Study Schedule 
 
 
Follow-up Visits 
Data Collection 
Screening through 2 
working days post 
hospital dismissal 
 
30 Days     
(-2/+7 days) 
60 Days  (+/-
14 days) 
Informed Consent/Assessment of 
Eligibility 
X 
 
 
 
Randomization 
X 
 
 
 
Demographics/Medical History 
X 
 
 
 
Medications 
X 
 
X 
X 
ECG (within 2 weeks)  
X 
 
 
 
6 minute walk (to be taken from 
medical record if done) 
X 
 
 
X 
Blood work (Creatinine, Hb, 
potassium, sodium, GFR) 
X 
 
 
 
 
 
 
 
 
Ejection fraction (within 6 months) 
X 
 
 
 
Home visit (BodyGuardian® 
implementation, medicine 
X1 
 
 
 

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reconciliation, nutrition review) 2 
Self-Care of Heart Failure Index 
(SCHFI) 2 
X2 
 
 
X2 
Minnesota Living with Heart Failure 
Questionnaire (MLHFQ)  
X2 
 
 
X2 
New York Heart Class 
X 
 
 
X 
Health Literacy Measure 
X 
 
 
 
Medical Outcomes General 
Adherence Measure (PHQ9) 
X 
 
 
 
Subject training 
X 
 
 
 
Follow-up outcomes/study endpoint 
events 
 
 
X 
X 
1Intervention Arm only 
2 The purpose of these measures is to summarize participant characteristics that may relate to 
later adherence behaviors (e.g., wearing the monitor and measuring body weight as 
instructed).  The participant data will also be used to provide further context to qualitative 
interview data.  
6.2 
Patient Confidentiality 
The identity of the patients participating in this study will be protected by the use of a 
subject number on all study materials, including specimen requisitions, laboratory 
reports, case report forms, etc. 
7.0 
Statistical Plan 
7.1 
Sample Size Determination 
The sample size for this study is estimated to be 152 participants / group (304 total) based 
on the primary outcome of 60-day all cause readmission.  The calculation and 
assumptions made are detailed below:  
Assumptions: 
• Standard of care 60 readmission rate: 25%. This estimate is based on the Bon Secours 
Richmond Health System data for December 2013 - November 2014. 
• A 50% reduction in the readmission rate would be a clinically relevant difference 

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• Type 1 error rate: alpha=0.05 (two-sided) 
• No interim analysis 
• No site effect so that the data across sites could be pooled for purposes of sample size 
determination 
A chi-square test of proportions at the alpha=0.05 level of significance will have 80% to 
detect the 12.5 percentage point difference (i.e., 25% vs. 12.5%) in 60 day readmission 
rates provided 152 participants per group are enrolled. The sample size calculations are 
estimated using the bsamsize function from the Hmisc package using R version 3.1.1. 
7.2 
Statistical Methods 
7.2.1 Descriptive Statistics 
Univariate descriptive statistics and frequency distributions will be calculated, as 
appropriate for all variables.  Baseline values for demographic, clinical, and outcome 
variables (primary and secondary) will be tabulated for the treatment groups.  These 
analyses will help identify potential confounding variables to be used as covariates in 
sensitivity analyses.  Distributions across subgroups used in randomization will be 
compared to assess whether the randomization was successful in equalizing distributions 
of these prognostic variables across treatment groups.  Putative prognostic variables that 
will be investigated through these descriptive analyses include variables such as age, 
subject inclusion group (inclusion criteria group), and proximity to the treatment 
provider.  
Handling of Missing Data 
Analyses will be conducted under intention to treat principles.  All randomized subjects 
will be analyzed.  The primary outcome (all-cause readmission within 60 days of 
randomization) is expected to be available for all participants through continuity of care 
documentation, patient/family contacts and medical record searches. Death prior to 60 
days will be counted as an event (See Section 7.2.3 below). If there is loss to follow-up in 
the groups, the cumulative probability of readmission will be estimated using the Kaplan-
Meier method as a sensitivity analysis to the primary analysis. 
For the remaining outcome variables, all-available-data (for longitudinal measurements) 
and worst-case imputation will be considered alongside of multiple imputation to test the 
robustness of study findings to missing data. 

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7.2.2 Multiplicity 
To avoid spurious results due to Type I error inflation, the primary endpoint of interest 
has been defined a priori.  Secondary outcomes will not be adjusted for multiple 
comparisons.  There are no planned interim analyses. 
7.2.3 Primary Outcomes 
Hypothesis: The 60-day readmission rate will be decreased with the addition of remote 
monitoring. 
To test this hypothesis, a Cochran-Mantel-Haenszel chi-square test of proportions will be 
used.  The stratification factor in this test will be the enrolling clinical site.  The primary 
outcome is all cause readmission, so no adjudication is required for the primary objective.  
If a participant dies within 60 days of initial hospital discharge prior to any readmission, 
the participant will be considered as readmitted for the purpose of the primary outcome. 
Intention to treat analysis will be used for the primary analysis.  If there is loss to follow-
up in the groups, the cumulative probability of readmission will be estimated using the 
Kaplan-Meier method as a sensitivity analysis to the primary analysis.  Differences in the 
hazard rates will be tested using the stratified log-rank test.  An additional sensitivity 
analysis will be conducted using the “per protocol” analysis set (see below), which 
consists of all subjects that completed the study and were adherent to monitoring. 
7.2.4 Secondary and Exploratory Outcomes 
General considerations: The secondary and exploratory endpoints require a variety of 
standard analytical methods along with sophisticated analytical strategies.  
For the secondary endpoint of HF-related readmission, the same analytical approach 
described for the primary outcome measure will be used.  The time to (first) hospital 
readmission will be modeled using a Kaplan-Meier survival and tested using a stratified 
log-rank test. 
For all-cause mortality, the difference in the hazard for death will be tested using a 
stratified a log-rank test on the intention-to-treat sample.  
For the exploratory outcomes involving serial measurements originating from the device, 
longitudinal summary statistics will also be used to condense the longitudinal data stream 
into meaningful summary measures (e.g., daily mean BP, incremental AUCs) prior to 
analysis. Longitudinal changes in weight and other continuous measures such as HR and 

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blood pressures will be modeled using mixed effects models that incorporate random 
slope and intercept effects. 
When the patient is actively monitoring with a BodyGuardian® Control Unit, an activity 
measure is gathered every 60 seconds.  This measure is gathered regardless of the signal 
quality of the ECG signal or bioimpedance signal quality.  When monitoring for 24 
hours, a subject should have 1440 samples per day.  Adherence for a specific day is 
measured as the number of activity samples gathered divided by 1440 (expressed as a 
percentage).  Adherence for a given monitoring period will be the number of days where 
the daily adherence is greater than 80% divided by the total number of days (expressed as 
a percentage of days monitored). 
Figure 6 Secondary & Exploratory Outcomes Illustration 
 
7.2.5 Interim Analysis 
There is no planned interim analysis for efficacy.   

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7.2.6 Subject Population(s) for Analysis 
Intention-to-Treat Analysis Set 
The primary analysis will be conducted according to modified “Intention-to-Treat” (ITT) 
principles; that is, each subject will be analyzed according to the randomized treatment 
arm, whether or not that treatment was actually received and provided they are 
discharged from the hospital.  The ITT method includes analysis of all subjects according 
to the treatment arm to which they were originally randomized irrespective of protocol 
violations, crossover, and events arising post randomization.  Because randomization 
carries the expectation of creating treatment arms balanced with respect to known and 
unknown prognostic factors, removing randomized subjects from the analysis, even for 
the best of intentions, runs the risk of introducing differential selection biases into the 
treatment comparisons.  Participants not discharged alive or which are transferred to 
another care facility that prohibits the randomized assignment from being implemented, 
will be excluded from the ITT analysis set. 
Per-protocol Analysis Set 
The per-protocol analysis set will be of participants followed according to the schedule 
outlined.  For the primary analysis, which is based on 60 days, the per-protocol adherence 
is only during the first 60 days.  The results of this potentially non-representative 
subset(s) will be compared to the results obtained using the ITT Analysis Set as a 
sensitivity analysis.  Should the results disagree qualitatively, the ITT results will be 
considered the less-biased results; however, a careful examination of putative causes for 
the differences will be fully investigated to inform the design of subsequent research 
studies.  
8.0 
Participant Safety, Adverse Events, and Clinical Endpoints 
All study-related adverse events occurring during the study, including those not meeting 
the criteria of an Unanticipated Adverse Device Effect (UADE) will be recorded on the 
appropriate case report form.  Records of these events will be maintained and reports 
submitted to the FDA and IRB according to the regulatory requirements.  Expected 
clinical adverse events and non-significant (not serious) clinical adverse events will not 
be reported.  Expected clinical adverse events and anticipated adverse device effects are 
those listed in Section 2.4. 
8.1 
Institutional Review Boards 
Before initiating this study, the protocol, informed consent forms, recruitment materials, 
and other relevant information will be reviewed and approved by each participating site’s 

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institutional review boards (IRB).  Any amendments to the protocol must be approved by 
each institution’s IRB before they are implemented.   
8.2 
Definitions 
8.2.1 Unanticipated Adverse Device Effect (UADE) 
A UADE is any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or IDE application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects. 
8.2.2 Study-Related Adverse Effect (Event) 
Any untoward medical occurrence in a subject involved in a clinical study of an 
investigational device that has a causal relationship with the device or, if applicable, other 
study related treatment(s). 
8.2.3 General Physical Examination Findings 
At screening, any clinically significant abnormality should be recorded as a preexisting 
condition.  At the end of the study, any new clinically significant findings/abnormalities 
that meet the definition of a study-related adverse event must also be recorded and 
documented as an adverse event. 
8.2.4 Hospitalization, Prolonged Hospitalization, or Surgery 
Any adverse event that results in hospitalization or prolonged hospitalization should be 
documented and reported as an unanticipated adverse device effect unless specifically 
instructed otherwise in this protocol.  Any condition responsible for surgery should be 
documented as an adverse event if the condition meets the criteria for a study-related 
adverse event. 
Neither the condition, hospitalization, prolonged hospitalization, nor surgery are reported 
as an adverse event in the following circumstances:  
• Hospitalization or prolonged hospitalization for diagnostic or elective surgical 
procedures for a preexisting condition.  Surgery should not be reported as an outcome 
of an adverse event if the purpose of the surgery was elective or diagnostic and the 
outcome was uneventful. 

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• Hospitalization or prolonged hospitalization required to allow efficacy measurement 
for the study. 
• Hospitalization or prolonged hospitalization for therapy of the target disease of the 
study, unless it is a worsening or increase in frequency of hospital admissions as 
judged by the site PI. 
8.2.5 Post-study Adverse Event 
All unresolved study-related adverse events should be followed by the investigator until 
the events are resolved, the subject is lost to follow-up, or the adverse event is otherwise 
explained.  At the last scheduled visit, the local investigator should instruct each subject 
to report any subsequent event(s) that the subject, or the subject’s personal physician, 
believes might reasonably be related to participation in this study.  The local investigator 
should notify the study regulatory sponsor of any death or adverse event occurring at any 
time after a subject has discontinued or terminated study participation that may 
reasonably be related to this study.  The sponsor should also be notified if the local 
investigator should become aware of the development of problems, cancer, or of a 
congenital anomaly in a subsequently conceived offspring of a subject that has 
participated in this study. 
8.2.6 Preexisting Condition 
A preexisting condition is one that is present at the start of the study.  A preexisting 
condition should be recorded as an adverse event if the frequency, intensity, or the 
character of the condition worsens during the study period and the adverse event is 
considered to be study related. 
8.2.7 Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO) 
Any unanticipated problem or adverse event that meets all of the following three criteria: 
• 
Serious: Serious problems or events that results in significant harm, (which may be 
physical, psychological, financial, social, economic, or legal) or increased risk for the 
subject or others (including individuals who are not research subjects). These include: 
(1) death; (2) life threatening adverse experience; (3) hospitalization - inpatient, new, 
or prolonged; (4) disability/incapacity - persistent or significant; (5) birth 
defect/anomaly; (6) breach of confidentiality and (7) other problems, events, or new 
information (i.e. publications, DSMB reports, interim findings, product labeling 
change) that in the opinion of the local investigator may adversely affect the rights, 
safety, or welfare of the subjects or others, or substantially compromise the research 
data, AND 

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• 
Unanticipated: (i.e. unexpected) problems or events are those that are not already 
described as potential risks in the protocol, consent document, not listed in the 
Investigator’s Brochure, or not part of an underlying disease. A problem or event is 
"unanticipated" when it was unforeseeable at the time of its occurrence. A problem or 
event is "unanticipated" when it occurs at an increased frequency or at an increased 
severity than expected, AND 
• 
Related: A problem or event is "related" if it is possibly related to the research 
procedures. 
8.3 
Clinical Endpoints/Adverse Event Reporting Period 
For this study, the study treatment follow-up period is defined as 60 days following the 
administration of study treatment.  The study period during which clinical endpoints and 
adverse events must be reported is defined as the period from the initiation of any study 
procedures to the end of the study treatment follow-up.  
8.4 
Recording of Clinical Endpoints 
Information on all clinical endpoints will be recorded in the source documentation and in 
the applicable CRF.   
When a hospital readmission occurs, the site coordinator will record the information in 
the source documentation and in the applicable CRF and will forward all relevant de-
identified medical information to the Project Coordinator for review. 
8.5 
Recording of Adverse Events 
At each contact with the subject, the investigator must seek information on study-related 
adverse events by specific questioning and, as appropriate, by examination.  Study 
subjects will be routinely questioned about study-related adverse effects at study visits.  
Information on all study-related adverse events should be recorded immediately in the 
source document, and also in the appropriate adverse event section of the case report 
form (CRF).  All clearly related signs, symptoms, and abnormal diagnostic, laboratory, or 
procedure results should recorded in the source document. 
All study-related adverse events occurring during the study period must be recorded.  All 
observed or volunteered adverse effects (serious or non-serious) and abnormal test 
findings, regardless of the treatment group if applicable or suspected causal relationship 
to the investigational device or if applicable other study treatment or diagnostic 
product(s) will be recorded in the subjects’ case history.  For all adverse effects sufficient 
information will be pursued and or obtained as to permit: an adequate determination of 
the outcome; an assessment of the casual relationship between the adverse effect and the 

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investigational device; or if applicable other study treatment or diagnostic product.  The 
clinical course of each study-related event should be followed until resolution, 
stabilization, or until it has been ultimately determined that the study treatment or 
participation is not the probable cause.  Serious adverse events that are still ongoing at the 
end of the study period must be followed up to determine the final outcome.  Any serious 
adverse event that occurs after the study period and is considered to be at least possibly 
related to the study treatment or study participation should be recorded and reported 
immediately. 
The Adverse Event CRF shall include the following information:  
• Subject Study Number/Identifier 
• Device information (BG kit and serial number) 
• Date of event onset 
• Date investigator became aware of event 
• Description of the event 
• Description of treatment the subject received as a result of the event 
• Indication if study treatment was discontinued or if investigational device was 
removed 
• Subject’s current status or if the event was resolved 
• Date of resolution 
• Investigator assessment of the event and justification for determination 
• Investigator assessment of causality and relationship to device and study treatment 
8.6 
Preventice Reporting of Unanticipated Adverse Device Effects and Unanticipated 
Problems 
When a study-related adverse event has been identified, the study team will take 
appropriate action necessary to protect the study participant and then complete the Study 
Adverse Event CRF.  Preventice will evaluate the event and determine the necessary 
follow-up and reporting required as it relates to device related events. Those that mayo 
necessitate reporting but are not device related will be addressed by Mayo Clinic. 

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Preventice will promptly review documented Unanticipated Adverse Device Effects and 
as necessary shall report the results of such evaluation to the FDA within 10 working 
days of initial notice of the effect.  Thereafter, Preventice will submit such additional 
reports concerning the effect as requested. 
8.7 
Preventice Reporting, Notifying the FDA 
Preventice will report to the FDA all unanticipated adverse device effects according to 
the required reporting timelines, formats and regulations. 
Preventice will submit a completed FDA Form 3500A to the FDA’s Center for Devices 
and Radiological Health for any observed or reported adverse effect that is determined to 
be an unanticipated adverse device effect.  A copy of this completed form will be 
provided to the DSMB and all participating sub-investigators. 
The completed FDA Form 3500A will be submitted to the FDA as soon as possible and, 
in no event, later than 10 working days after Preventice first receives notice of the 
adverse effect. 
If the results of Preventice’s follow-up evaluation shows that an adverse effect that was 
initially determined to not constitute an unanticipated adverse device effect does, in fact, 
meet the requirements for reporting; Preventice will submit a completed FDA Form 
3500A as soon as possible, but in no event later than 10 working days, after the 
determination was made. 
For each submitted FDA Form 3500A, Preventice will identify all previously submitted 
reports that that addressed a similar adverse effect experience and will provide an 
analysis of the significance of newly reported adverse effect in light of any previous, 
similar report(s). 
Subsequent to the initial submission of a completed FDA Form 3500A, Preventice will 
submit additional information concerning the reported adverse effect as requested by the 
FDA. 
8.8 
Reporting Process 
Unanticipated Adverse Device Effect reports will be submitted on FDA Form 3500A.  
The contact information for submitting reports is: 
Food and Drug Administration 
Center for Devices and Radiological Health 
Document Mail Center - WO66-G609 

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10903 New Hampshire Avenue 
Silver Spring, Maryland 20993-0002 
8.9 
Deviations from the investigational plan 
Mayo Clinic shall notify each participating sites’ IRB (see 21 CFR 56.108(a) (3) and (4)) 
of any deviation from the investigational plan to protect the life or physical well-being of 
a subject in an emergency. Such notice shall be given as soon as possible, but in no event 
later than 5 working days after the emergency occurred. Except in such an emergency, 
prior approval by Mayo Clinic is required for changes in or deviations from a plan, and if 
these changes or deviations may affect the scientific soundness of the plan or the rights, 
safety, or welfare of human subjects, FDA and IRB notification in accordance with 21 
CFR 812.35(a) also is required. 
8.10 
Medical Monitoring 
It is the responsibility of Mayo Clinic to oversee the safety of the study.  This safety 
monitoring will include careful assessment and appropriate reporting of adverse events as 
noted above, as well as the construction and implementation of a site data and safety-
monitoring plan (see Section 10, Study Monitoring, Auditing, and Inspecting).  Medical 
monitoring will include a regular assessment of the number and type of serious adverse 
events. 
9.0 
Data Handling and Record Keeping 
9.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  Those regulations require a signed subject authorization informing the subject 
of the following: 
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their PHI. 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of 
subject authorization.  For subjects that have revoked authorization to collect or use PHI, 

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attempts should be made to obtain permission to collect at least vital status (long-term 
survival status that the subject is alive) at the end of their scheduled study period. 
9.2 
Source Documents 
Source data comprise all information, original records of clinical findings, observations, 
or other activities in a clinical trial necessary for the reconstruction and evaluation of the 
trial.  Source data are contained in source documents.  Examples of these original 
documents, and data records include: hospital records, clinical and office charts, 
laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy 
dispensing records, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate and complete, microfiches, photographic 
negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the 
pharmacy, at the laboratories, and at medico-technical departments involved in the 
clinical trial.  When applicable, information recorded on the CRF shall match the Source 
Data recorded on the Source Documents. 
Any data where an electronic system will be used as the sole instrument for the recording 
and analysis of clinical and laboratory data related to the safety and/or efficacy of the 
investigational device will be compliant with FDA 21 CRF Part 11 and Guidance for 
Industry Electronic Source Data in Clinical Investigations, September 2013. 
9.3 
Case Report Forms 
Electronic case report forms (eCRFs) will be created within Medidata Rave® to structure 
data entry for the study for each of the proposed outcomes and subject characteristics 
assessed in the study.   
9.4 
Data Management 
The Medidata Rave® system supported institutionally by the Mayo Clinic 
 
will be used for data processing. This online system has 
built-in training, security, and audit features that allow for 21 CFR Part 11 compliance.  
Data consistency checks will be programmed into the system to minimize the number of 
data entry errors.  Furthermore, any changes to the data, once saved, is audited for both 
person and time of the change.  The system includes an integrated randomization module, 
Balance, which will be used to determine the model of care for each participant.  
Additional data as it pertains to latency and interactions with the BodyGuardian® device 
will be obtained by electronic retrieval through Preventice.  

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9.5 
Data Security and Confidentiality 
Database and web servers will be secured by a firewall and through controlled physical 
access.  The Medidata Rave system has security features to ensure that study personnel 
accessing the database have the proper authority to perform the functions he or she 
requests of the system.  Unix group-access control will provide access security for the 
secondary SAS data sets used by the Mayo statistician.  Workstation login is secured by 
extensive user-password facilities under Unix and Windows. 
9.6 
Data Quality Assurance 
Quality control will be ensured through oversight by Preventice, who will review the 
electronic data for participants on a regular basis for completeness and consistency.  
Quality and completeness of data entry will be reviewed as soon as possible after data 
entry, within 5 business days of data entry for the first 5 participants randomized at each 
site, and within 15 days of data entry thereafter.  Preventice will generate data quality 
reports monthly for review by the study team.  Data queries generated by identification of 
incomplete or inconsistent data will be raised directly within the electronic eCRF and 
should be resolved by the study coordinator or PI in a timely manner.  Corrections or 
changes in the data management system are tracked with the retention of the original data 
and the corrected data with the date of data entry and submitting personnel.  Sites with 
persistent delays or difficulties in data capture will be provided additional study-based 
training.   
9.7 
Records Retention 
The sponsor-investigator will maintain records and essential documents related to the 
conduct of the study.  These will include subject case histories and regulatory documents. 
The sponsor-investigator will retain the specified records and reports for: 
• 
An investigator or sponsor shall maintain the records required by this subpart 
during the investigation and for a period of 2 years after the latter of the following 
two dates: The date on which the investigation is terminated or completed, or the 
date that the records are no longer required for purposes of supporting a 
premarket approval application or a notice of completion of a product 
development protocol. CFR 812.140 

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10.0 Study Monitoring, Auditing, and Inspecting 
10.1 
Study Monitoring Plan 
The investigator will allocate adequate time for monitoring activities.  The Investigator 
will also ensure that the monitor or other compliance or quality assurance reviewer is 
given access to all study-related documents and study related facilities (e.g. pharmacy, 
diagnostic laboratory, etc.), and has adequate space to conduct the monitoring visit. 
This clinical study will be monitored for appropriate study conduct and data integrity 
including review of CRFs and parity checks with the source documentation including 
operator worksheets retained with CRF documentation and hospital charts.  Periodic site 
visits shall be conducted.  CRFs will be monitored by the study monitor(s) prior to 
submission to Mayo Clinic. Monitoring will include comparison of CRFs to source 
documentation for accuracy and appropriateness, study device accountability, review 
for/of adverse events, prompt evaluation of unanticipated adverse device effects, and site 
compliance. 
Should discrepancies be identified between the comparison of source documentation and 
the data contained within the CRF, the most accurate information shall be recorded on a 
Data Clarification Form (DCF)/or query.  Following conclusion of the study, site specific 
Study Closure Visits will be conducted.  Site Study Closure Visits will occur no more 
than 3 months following study conclusion. 
The clinical site will be monitored routinely for fulfillment of Investigator duties and 
responsibilities, the clinical study as it is conducted in accordance to GCP, EN ISO 14155 
and timeliness/completeness of CRF submission to Sponsor.  Any evident pattern of non-
compliance (i.e. non-reporting of AE or protocol deviations, device accountability 
inconsistencies, etc.) may initiate remedial actions.  If corrective actions are not 
subsequently undertaken, the clinical site may be withdrawn. 
10.2 
Auditing and Inspecting 
The sponsor-investigator will permit study-related monitoring, audits, and inspections by 
the IRB, the monitor, and government regulatory agencies of all study related documents 
(e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The sponsor-investigator will ensure the capability for inspections of applicable 
study-related facilities (e.g., pharmacy, diagnostic laboratory, etc.). 
Participation as a sponsor-investigator in this study implies acceptance of potential 
inspection by government regulatory authorities and applicable compliance offices. 

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11.0 Ethical Considerations 
This study is to be conducted according to United States government regulations and 
institutional research policies and procedures. 
This protocol and any amendments will be submitted to a properly constituted local 
Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal 
approval of the study.  The decision of the IRB concerning the conduct of the study will 
be made in writing to the sponsor-investigator before commencement of this study. 
All subjects for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study.  This consent form will be submitted with the protocol for 
review and approval by the IRB for the study.  The formal consent of a subject, using the 
Approved IRB consent form, must be obtained before that subject undergoes any study 
procedure.  The consent form must be signed and dated by the subject or the subject’s 
legally authorized representative, and the individual obtaining the informed consent. 
12.0 Study Finances 
12.1 
Funding Source 
This study is financed through a grant from the National Institute of Health (NIH). 
12.2 
Conflict of Interest 
Any study team member who has a conflict of interest with this study (patent ownership, 
royalties, or financial gain greater than the minimum allowable by their institution, etc.) 
must have the conflict reviewed by a properly constituted Conflict of Interest Committee 
with a Committee-sanctioned conflict management plan that has been reviewed and 
approved by the study sponsor-investigator prior to participation in this study.  The 
investigational device manufacturer shall also require a Financial Disclosure form to be 
completed by the Principal Investigator and all co-investigators.  
13.0 Publication Plan 
The Principal Investigator may publish the results of work performed under this research 
protocol.  However, copies of any abstracts, papers, or manuscripts shall be provided to 
the investigational device manufacturer for review at least thirty (30) days prior to 
submittal for publication or presentation.  When reasonably requested by the 
investigational device manufacturer, the Investigator and Institution will delay 

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publication up to sixty (60) days to allow manufacturer to protect its rights in patentable 
or copyrightable material. 
This study shall be registered in ClinicalTrials.gov (https://register.clinicaltrials.gov/) 
prior to subject recruitment and enrollment, as well as posting of results to 
ClinicalTrials.gov within 12 months of final data collection for the primary outcome.   
14.0  References 
1. 
Jessup M, Abraham WT, Casey DE, et al. ACCF/AHA guidelines for the 
diagnosis and management of heart failure in adults: A report of the American 
College of Cardiology Foundation/American Heart Association task force on 
practice guidelines developed in collaboration with the International Society for 
Heart and Lung Transplantation.  J Am Coll Cardiol.2009; 53(15):1343–1382. 
 
2. 
Lloyd-Jones D, Brown TM, Carnethon M, et al. Heart disease and stroke 
statistics—2010 Update.Circ.  2010; 121(7):e46 –e215.doi:10.1161/circulation 
aha.109.192667. 
 
3. 
Roger VL, Lloyd-Jones DM, and Adams R J, et al. Executive summary: Heart 
disease and stroke statistics--2011 update: A report from the American Heart 
Association.Circ.  2011; 123:459–463.  doi:10.1161/cir.0b013e31820c7a50. 
 
4. 
Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the future of 
cardiovascular disease in the United States.  Circ. 2011; 123(8):933–944.  
doi:10.1161/CIR.0b013e31820a55f5. 
 
5. 
Brandon AF, Schuessler JB, Ellison KJ.  The effects of an advanced practice 
nurse led telephone intervention on outcomes of patients with heart failure.  Appl 
Nurs Res. 2009; 22(4):e1–e7.  doi:10.1016/j.apnr.2009.02.003.  
 
6. 
Rogers JG, Bostic RR, Tong KB.  Cost-effectiveness analysis of continuous flow 
left ventricular assist devices as destination therapy.  Circ. Heart 
Fail.2012;5(1):10-16.  doi:10.1161/circheartfailure.111.962951.  
 
7. 
Rose EA, Moskowitz AJ, Packer M, Sollano J, et al.  The REMATCH Trial: 
Rationale, design, and endpoints.  Ann Thorac Surg. 1999; 67(3):723–30. 
 
8. 
Gheorghiade M, Vaduganathan M, Fonarow G.  Rehospitalization for heart 
failure: Problems and perspectives.  J Am Coll Cardiol.2013; 61(4):391–403. 
 
9. 
Roger VL, Go AS, Lloyd-Jones DM, et al. Heart Disease and Stroke Statistics—
2012 Update A Report From the American Heart Association. Circulation. 
2012;125(1):e2-e220. doi:10.1161/CIR.0b013e31823ac046. 
 

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10. 
Bennett S, Huster G, Baker S, et al. Characterization of the precipitants of 
hospitalization for heart failure decompensation.  J Crit Care.1998; 7(3):168–74. 
 
11. 
Forster AJ, Murff HJ, Peterson JF, et al.  The incidence and severity of adverse 
events affecting patients after discharge from the hospital.  Ann Intern Med. 2003; 
138(3):161-167. 
 
12. 
Naylor MD, Brooten D, Jones R, et al.  (1994). Comprehensive discharge 
planning for the hospitalized elderly.  Ann Intern Med. 1994; 120(12):999 –1006.  
doi:  10.1059/0003-4819-120-12-199406150-00005. 
 
13. 
Jessup M, Abraham WT, Casey DE, et al. ACCF/AHA guidelines for the 
diagnosis and management of heart failure in adults: A report of the American 
College of Cardiology Foundation/American Heart Association task force on 
practice guidelines developed in collaboration with the International Society for 
Heart and Lung Transplantation.  J Am Coll Cardiol.  2009; 53(15):1343–1382. 
 
14. 
Krumholz H, Parent E, Tu N, et al. Readmission after hospitalization for 
congestive heart failure among Medicare beneficiaries.  Arch Intern Med. 1997; 
157(1):99–104. 
 
15. 
Riegel B, Carlson B, Moser D, et al.  Psychometric testing of the self-care of heart 
failure index.  J Card Fail.  2004; 10(4): 350–60. 
 
16. 
Kulshreshtha A, Kvedar JC, Goyal A, et al. Use of remote monitoring to improve 
outcomes in patients with heart failure: A pilot trial.  Int J Telemed App. 2010; 
2010(3).  doi:10.1155/2010/870959. 
 
17. 
Roger V L.  The changing landscape of heart failure hospitalizations.  J Am Col 
Cardiol.  2013; 61(12):1268–1270. 
 
18. 
Huffman M. Health coaching: a new and exciting technique to enhance patient 
self-management and improve outcomes.  Home Healthc Nurse, 2007; 25(4): 
271–4. 
 
19. 
Edelman D, Oddone E, Lieboitz R, et al. A multidimensional integrative medicine 
intervention to improve cardiovascular risk.  J Gen Int Med. 2006; 21(7):728-734. 
doi:10.1111/j.152-1497.2006.00495x. 
 
20. 
Ivey S, Tseng W, Kurtovicj E, et al. Evaluating a culturally and linguistically 
competent health coach intervention for Chinese-American patients with diabetes.  
Diab Spect, 2012;25(2):93-102.  doi:10.2337/diabspect.25.2.93. 
 
21. 
Vale M, Jetliner M, Best J, et al. Coaching patients with coronary heart disease to 
achieve their target cholesterol: A method to bridge the gap between evidence-

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based medicine and the “real world-“ randomized controlled trial.  J Clinic 
Epidem, 2002; 55(3): 245-252. doi.10.1016/S0895-4356 (01)00460-7. 
 
22. 
Vale M, Jelinke M, Best J, et al. Coaching patients on achieving cardiovascular 
health (COACH): A multicenter randomized trials in patients with coronary heart 
disease. 
 
Arch 
Int 
Med, 
(2003); 
163(22): 
 
2775-2783.  
doi:10.1001/archinte.163.22.2775. 
 
23. 
Gellis ZD, Kenaley B, McGinty J, et al. Outcomes of a telehealth intervention for 
homebound older adults with heart or chronic respiratory failure: A randomized 
controlled trial.  Gerontologist.  2012;52(4):541–552.  doi:10.1093/geront/gnr134. 
 
24. 
Riegel B, Lee C, Dickson V, Carlson B.  An update on the self-care of heart 
failure 
index. 
 
J 
Cardiovasc 
Nurs.2009; 
24(6):485–97.  
doi:http://dx.doi.org/10.1097/JCN.0b013e3181b4baa0. 
 
25. 
Van Walraven C, Dhalla IA, Bell C, et al.  Derivation and validation of an index 
to predict early death or unplanned readmission after discharge from hospital to 
the 
community. 
 
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2010;182(6):551–557.  
doi:10.1503/cmaj.091117. 
 

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15.0 APPENDIX 
15.1 
Blood Pressure Monitor and Cuff Manual 
15.2 
BodyGuardian® Manual 
15.3 
Case Report Forms  
15.4 
Data and Safety Monitoring Plan 
15.5 
Drug Dictionary 
15.6 
Health Literacy Measure 
15.7 
Medical Outcomes General Adherence Measure (PHQ9) 
15.8 
Minnesota Living with Heart Failure Questionnaire (MLHFQ) 
15.9 
New York Heart Association (NYHA) Functional Classification 
15.10 Self-Care of Heart Failure Index (SCHFI) 
15.11 Skin Irritation Treatment 
15.12 Follow-up Script 
15.13 Weight Scales Manual 
15.14 ICD Interference Letter and Abstract – Hayes