Assessing the Efficacy of Digital Health Technology in the Management of Congestive Heart Failure: An Evaluation of Three Novel Digital Health Products
Phase: NA
Conditions: Congestive Heart Failure
Sponsor: Yale University

Page 1 of 31 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
Protocol Title: Assessing the Efficacy of Digital Health Technology in the Management of Congestive Heart Failure:  
An Evaluation of Three Novel Digital Health Products 
 
NCT:  NCT04394754 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 2 of 31 
 
                    
                                    
HRP-503B – BIOMEDICAL RESEARCH PROTOCOL  
(2017-1) 
 
 
 
 
Protocol Title: Assessing the Efficacy of Digital Health Technology in the Management of Congestive Heart Failure:  
An Evaluation of Three Novel Digital Health Products 
 
 
Principal Investigator(s): F. Perry Wilson, MD MSCE, Tariq Ahmad MD MPH, Nihar Desai MD MPH 
Co-Investigators: TBD 
 
Version Date: February 16th, 2021  
 
 
Clinicaltrials.gov Registration #: NCT04394754 
 
 
 
INSTRUCTIONS
This template is intended to help investigators prepare a protocol that includes all of the necessary information 
needed by the IRB to determine whether a study meets approval criteria. Read the following instructions 
before proceeding: 
 
1. Use this protocol template for a PI initiated study that includes direct interactions with research 
subjects. Additional templates for other types of research protocols are available in the system Library. 
 
2. If a section or question does not apply to your research study, type “Not Applicable” underneath. 
 
3. Once completed, upload your protocol in the “Basic Information” screen in IRES IRB system.  
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 3 of 31 
 
 
SECTION I: RESEARCH PLAN 
 
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.  
The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual 
care in the management of congestive heart failure, as assessed by a primary outcome of improvement in 
quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider 
satisfaction, clinical efficiency, and patient outcomes.   
 
2. Probable Duration of Project:  
We anticipate the duration of the study to be 12 months.  Three months will be spent developing all study-
related materials including protocols, consents and recruitment materials, and completing training of site 
coordinators and providers.  Eight months will be spent recruiting patients and performing follow up visits.  
The last month will be spent performing data analysis activities. 
 
3. Background: Describe the background information that led to the plan for this project. Provide references to 
support the expectation of obtaining useful scientific data. 
 
Heart failure is the most common cause of mortality and morbidity in the United States and in Western 
Europe.1 It is a complex and chronic illness, and patient etiology and prognosis varies considerably. However, 
to date, guidance about how to best treat patients has relied on large clinical international trials that do not 
represent contemporary patients and only include snapshots of the syndrome—at the few times when the 
patients interact with the health care system.2 Patient participation in clinical research in the US is also 
extremely low, approximated at 3% in cancer and far lower for chronic disease states such as heart failure.3 
Furthermore, as with many chronic diseases, there is lack of patient engagement in care.  
 
Insights from behavioral economics have the potential to improve patient engagement in self-management 
and clinical research as well as increase uptake of guideline recommended medical therapies in heart failure.4 
Whereas several medical studies have examined the application of behavioral economic principles in helping 
patients lose weight, quit smoking, and adhere to medications, there are limited data on applying these 
concepts to the management of chronic diseases, such as heart failure.5 Therefore, there is an unmet need to 
test the hypothesis as to whether behavioral interventions can improve self-care and engagement with the 
health care system in heart failure, thus leading to better clinical outcomes.  
 
Digital health technologies also have the potential to streamline and optimize clinical management of heart 
failure.6 The types of digital health interventions range from apps (applications) to devices that might provide 
patients and providers with information about their cardiovascular health. As was seen with the Apple Heart 
Study and others, these technologies can be integrated with health care systems and allow for true patient 
engagement in management of their disease.7 To date, no prior study has comprehensively examined the 
ability of digital health products that collect a variety of key physiological measures to improve self-
management of heart failure, nor have subsequent downstream impacts on clinical outcomes been assessed.  
 
To this end, the proposed study seeks to measure the efficacy of three digital health technologies to improve 
the management of care and quality of life of patients with congestive heart failure (CHF).  Patients who are 
enrolled in a general heart failure clinic within the Yale health system specializing in the treatment of heart 
failure will be eligible for the study and approached for consent.  Subjects will be randomized into either a 
control (usual care) group, or to one of three intervention arms assessing three digital health technologies 

Page 4 of 31 
 
(described below).  These technologies are either devices that measure and relay to the provider key 
physiological parameters in patients with CHF or are data-driven communication applications that provide 
either live or automated personalized coaching.  All technologies can be used on a daily basis by patients at 
home and are meant to both increase patient engagement in the management of their disease as well as 
provide physicians with additional information that can be used in the clinical decision-making process.  
Patients will be followed for 6 months.  Our primary outcome will assess changes in quality of life, while 
secondary outcomes will measure various parameters of clinical efficiency, patient and provider satisfaction, 
and patient outcomes (i.e. mortality, hospital visits, etc). 
 
4. Research Plan:  
 
Study Overview:  
 
This study will be an unblinded, 4-arm parallel group, randomized controlled trial designed to determine the 
efficacy of three digital health products versus usual care in improving quality of life metrics in patients with 
congestive heart failure (CHF).  This will be a joint project between Yale’s Program of Applied Translational 
Research, Boehringer Ingelheim (BI), and Medullan Inc.  While this protocol has been developed together 
with BI and Medullan, and these third parties will contribute to data collection and storage, all decisions 
regarding data analysis, presentation and publication reside with the Yale investigators. 
 
Patients with CHF who are enrolled at one of several outpatient clinics with the Yale New Haven Health 
system specializing in the treatment of heart failure will be eligible for this study.  These clinics are located 
across the state of Connecticut, in New London, Norwich, North Haven, New Haven, Greenwich, Trumbull and 
Bridgeport, allowing us to capture a broad and diverse patient population.   
 
Rollout of the study will be conducted in 2 distinct phases.  Initial rollout will occur in three clinics (in New 
Haven, North Haven, and Trumbull) so that we can perform any necessary quality assurance and 
troubleshooting prior to a larger rollout.  This will be followed by expansion to three additional clinic sites in 
New London, Bridgeport, and Greenwich.  At day 45 of our study, we will perform an interim enrollment 
assessment to determine enrollment rates and trajectories, and we will expand to the final clinics as needed 
to achieve our sample size target within our anticipated timeframe. 
 
The overall structure of the study is as follows: 
 
 
 
 

Page 5 of 31 
 
 
Yale and Medullan will provide central oversight and responsibility of all aspects of the study.  Further, each 
site will have a trained physician and trained registered nurse who will oversee the study at their specific 
location.  Four on-site coordinators will be specially trained and responsible for patient screening, 
recruitment, education, survey administration and data collection at each of the nine clinic sites.  A Yale-
based study coordinator will oversee the study at large, ensuring quality control between all sites, performing 
virtual patient screening and recruitment, administering training to site coordinators, and providing 
assistance across all sites as needed via regular site visits and phone calls.  We describe the roles of the on-
site and central study coordinators in more detail below.   
 
On-site coordinators and providers will be trained and educated prior to study commencement by members 
of both Yale and Medullan teams via a virtual training session.  Training will include an overview of the study, 
use of the various technologies, screening and recruitment protocols, e-consent processes, and training for 
Case Report Form completion and data collection in RedCap. 
 
Subject Eligibility and Recruitment 
 
Eligible patients will be prospectively identified via electronic medical chart review for enrollment into our 
study.  We will have two avenues for subject screening and recruitment, using both a central study 
coordinator and four on-site study coordinators.   
 
1. On-site study coordinators will perform prospective identification of eligible patients via daily 
review of a patient dashboard we will create. Patients will be screened based on the inclusion and 
exclusion criteria outlined below and eligible patients will then be approached by a site study 
coordinator for consent at one of their regular clinic visits.    
2. The central study coordinator will perform off-site eligibility screening of patients across all sites.  
Responsibilities of the central coordinator may include: 1) Notifying on-site coordinators of upcoming 

Page 6 of 31 
 
clinic visits of eligible or already enrolled patients 2) Contacting potentially eligible patients to give 
them information about the study prior to their clinic visit and discussion with an on-site coordinator 
3) Contact eligible patients that were missed by on-site coordinators for virtual recruitment and 
consent 4) Make clinic visits for in -person patient recruitment and consent should onsite 
coordinators be unable to do so. 
 
When an eligible patient is identified during a clinic visit, they will be approached by a study coordinator who 
will thoroughly explain the study, provide informational pamphlets, answer any questions, and ensure patient 
understanding of the study, each device, and their expectations.  All study coordinators will have study tablets 
on which they can access our study website containing an entirely electronic patient enrollment platform, 
including baseline assessments and consent forms.  Interested patients will be given this tablet and asked to 
review the information and study details and be given ample opportunity to ask any questions they may have.  
When ready, patients will be asked to read through and sign an e-consent document.  Finally, they will be 
directed to create an account and profilee on our study website.    
 
Eligible patients who have been missed during an in-clinic visit will be contacted by one of the study 
coordinators by phone.  This may be via a phone call or, if unable to reach the patient, via text messaging 
and/or via e-email through a MyChart message.  The following text messaging script will be sent to an eligible 
patient: 
 
 
 

Page 7 of 31 
 
The following MyChart message will be sent: 
If you attend one of Yale’s Congestive Heart Failure Clinics and are between the ages of 18 and 79, you may be 
eligible to participate in a free and confidential research study investigating the use of digital health 
technologies in the care of patients with heart failure. If you enroll, you will potentially receive free access to 
new digital health tools at no cost to you, and you will be compensated up to $180 for your time and 
participation. To learn more or to see if you are eligible to participate, click on “I am interested” or call the Yale 
Heart Failure Digital Health Study line at 203-350-6124. You can also visit our website at 
yale.digitalhealthstudy.org for more information. 
No action by you is required. You may ignore this message or click “not interested.” Thank you very much for 
considering being a part of research at Yale. 
To learn about future research opportunities, you may also create a volunteer profile through the Research Tab 
in MyChart. 
To opt-out of all future research communications, please call the Yale Clinical Trials Office at 1-877-978-8343 
and select #3. 
 
During an enrollment phone call, the coordinator will discuss the study and instruct the patient through the 
enrollment process outlined above.  The patient will access our study website through a link that will be sent 
to them via email, text messaging, or other electronic means acceptable to the potential enrollee.  
 
Once a patient has electronically consented and created a study profile, an email will be sent with next steps, 
and will also contain an electronic copy of the signed consent form.  They will be directed to complete the 
KCCQ questionnaire and a medication adherence survey for baseline data collection towards our primary and 
secondary outcomes, as well as a health literacy assessment and a technology literacy assessment to track 
any improvements over the course of the study. 
 
While patients are typically followed for approximately three months in several of these heart failure specialty  
clinics, this is not always the case.  Even when patients have continued visits past the three month point, 
patients may still not have optimized care.  We will reach out to any eligible patient within one month of a 
visit to the clinic, regardless of the length of time they have been attending clinic visits.  Should we not enroll 
a patient during this initial call, we will continue to attempt to enroll either until a patient declines consent or 
until they are no longer within a month of a clinic visit. 
 
Subject Randomization and Intervention 
 
At this point, all consented patients will be enrolled and randomized, via a stratified permuted block 
randomization scheme, to one of the 4 study arms.  An independent statistician will create randomization lists 
stratified by clinic.   
 
Our study flow is as follows: 
 
 
 

Page 8 of 31 
 
 
 
 
Three of the four study arms will be intervention groups where patients will be randomized to receive one of 
three digital health devices or experiences designed to enhance patient care, reduce symptoms and improve 
disease management, provide health coaching, and/or detect abnormalities in patients living with CHF, and 
overall improve the quality of life for this patient population.   
 
Patients in each of these three groups will be encouraged to interact with their device on a daily basis. It is 
important to note that no formal protocol is being mandated for any of the devices (for example, patients will 
not be obligated to step on the BodyPort scale everyday as part of a specified protocol).  They will be given 
information about the product, what information it provides, and how it can be helpful for them, and then 
will simply be encouraged to use it regularly, but may use it as often or as little as they like.   
 
 Any clinical data that is collected directly by the device, or any clinical information put into the device directly 
by the patient (e.g. a daily weight) will be accessible to the patient’s physician via device-specific clinician 
dashboards available to the health care team.  Importantly, we do not outline any standardized protocols for 
physicians to follow regarding use of this data.  We will make it clear to all participating physicians that data 
collected from any device is purely informational and a supplement to regular clinical care.  The collected 
data should not be used on its own to make any clinical decisions.  Data must be used by providers in the 
context of all other clinical information available using their own clinical judgement.  Further, the use of these 
devices should not disrupt usual clinic care in any way.  Subjects will continue to see their provider as they 
would outside of the context of this study and will receive their usual care. 
 
While physicians will have access to all clinical data collected via the devices, we have outlined a limited 
number of device-specific “triggers”, such that when a key datapoint reaches a particular pre-specified 
threshold, the physician will be notified and asked to follow a standardized protocol in which the healthcare 
team calls the patient to check in and asks a series of standardized questions to assess the patient’s condition 
and document the responses.  We will not provide any pre-specified or standardized protocols beyond these 
“check-ins” and leave further care decisions up to the discretion and clinical judgement of the patient’s 

Page 9 of 31 
 
healthcare team.  Any decisions made by the provider should be based on all clinical information available in 
addition to any data provided by a device.  These triggers were selected based on the type of information 
collected by the device and the importance of these data points in the assessment of a CHF patient’s status 
(as determined by our heart failure experts). 
 
The three devices are described below, including the type of data collected and how it is stored, and which 
clinical data points will be used as triggers to notify the health care team.   
 
Device Based Interventions:  
 
- 
BodyPort:  A novel data-driven smart scale that provides advanced cardiac monitoring and risk 
assessment data that feed directly to an analytics platform visible to providers.  The scale also provides 
limited patient instruction and educational materials. 
 
Patients will be encouraged to step on the scale on a regular basis.  They may also use an optional 
BodyPort Patient Portal to track view their measurements, track their symptoms, and complete 
educational modules.  The following data will be collected by BodyPort for use in our study and stored by 
Medullan in a HIPAA-compliant manner.  All clinical data will be available to physicians in the provider 
dashboard provided by BodyPort.  We have included both the physician and patient user manuals in this 
application.  We have also included a document outlining both the patient and provider dashboards that 
includes what elements each can see and actions each can take within the portal. 
 
# 
Source data 
Data type 
How 
Collected 
Intended use 
Collection 
Frequency 
Data storage (specify where 
the data is stored and the 
compliance with HIPPA, ISO 
and or Hitrust)
Is it Protected 
Health 
Information 
(PHI)?
Additional Comments 
1 
Body weight 
Biomarker data 
Own 
Device 
Assess weight of patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) & 
Azure Blob Storage (HIPPA, 
HITRUST & ISO27001 ) 
No 
2 
Heart rate 
Biomarker data 
Own 
Device 
Assess cardiovascular status of 
patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
3 
Heart rate variability 
Biomarker data 
Own 
Device 
Assess cardiovascular status of 
patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
4 
Impedance (8kHz) 
Biomarker data 
Own 
Device 
Assess fluid status of patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
5 
Impedance (64kHz) 
Biomarker data 
Own 
Device 
Assess fluid status of patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
6 
Fluid Index 
Biomarker data 
Own 
Device 
Assess fluid status of patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
7 
Ballistocardiograph 
Biomarker data 
Own 
Device 
Raw data to extract additional 
biomarkers 
Daily 
Stored in Azure Blob Storage 
(HIPPA, HITRUST & ISO27001 
) 
No 
8 
Impedance 
plethysmograph 
Biomarker data 
Own 
Device 
Raw data to extract additional 
biomarkers 
Daily 
Stored in Azure Blob Storage 
(HIPPA, HITRUST & ISO27001 
) 
No 
9 
Electrocardiograph 
Biomarker data 
Own 
Device 
Raw data to extract additional 
biomarkers 
Daily 
Stored in Azure Blob Storage 
(HIPPA, HITRUST & ISO27001 
) 
No 
10
Center of pressure 
Biomarker data 
Own 
Device 
Assess balance/sway of patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
11
Risk score 
Biomarker data 
Own 
Device 
Assess overall status of a 
patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
12
Systolic time intervals 
Biomarker data 
Own 
Device 
Assess cardiovascular status of 
patient 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
13
Date/Time 
Biomarker data 
Own 
Device 
Assess Date and time of a 
measurement 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) & 
Azure Blob Storage (HIPPA, 
HITRUST & ISO27001 ) 
No 
14
Measurement ID 
Biomarker data 
Own 
Device 
Uniquely identify 
measurements 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) & 
Azure Blob Storage (HIPPA, 
HITRUST & ISO27001 ) 
No 
If PII is shared with Bodyport 
15
Temperature 
Environmental data 
Own 
Device 
Assess environmental 
conditions during measurement 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 

Page 10 of 31 
 
16
Humidity 
Environmental data 
Own 
Device 
Assess environmental 
conditions during measurement 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
17
Battery voltage 
Device data 
Own 
Device 
Assess device status (battery 
status) 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
18
Signal strength 
Device data 
Own 
Device 
Assess device status (cellular 
signal strength/coverage) 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
19
Device Status 
Device data 
Own 
Device 
Assess device status and error 
conditions 
Daily 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
20
Height 
Demographic data 
Own 
Device 
Demographic information used 
to calculate certain biometric 
parameters 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
21
Gender 
Demographic data 
Own 
Device 
Demographic information used 
to calculate certain biometric 
parameters 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
22
Date of Birth (YYYY 
required, MM/DD 
optional) 
Demographic data 
Own 
Device 
Demographic information used 
to calculate certain biometric 
parameters 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
if full DOB is provided this 
becomes PII 
23
Patient ID 
Contact information 
Own 
Device 
A unique ID used by the clinical 
site and Bodyport to identify a 
patient 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
If PII is shared with Bodyport 
24
Bodyport ID 
Contact information 
Own 
Device 
A unique ID used by Bodyport 
used to identify a patient 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
If PII is shared with Bodyport 
25
Device ID 
Device Information 
Own 
Device 
A unique ID assigned by 
Bodyport to a device 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
If PII is shared with Bodyport 
26
Name (optional) 
Contact information 
Own 
Device 
(optional) user identifier on 
device display and contact 
name for care services 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
Yes 
If PII is shared with Bodyport 
27
Phone Number 
(optional) 
Contact information 
Own 
Device 
(optional depending on care 
services provided) Phone 
number for patient follow up 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
Yes 
If PII is shared with Bodyport 
28
Address (optional) 
Shipping information
Own 
Device 
(optional depending on 
enrollment pathway) Address of 
where to send device 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
Yes 
If PII is shared with Bodyport 
29
Communication History 
(optional) 
Communications 
(patient/care team) 
Own 
Device 
(optional depending on care 
services provided) To manage 
care delivery 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
If PII is shared with Bodyport 
30
Medical History 
(optional) 
Health data of 
patient 
Own 
Device 
(optional depending on care 
services provided) To manage 
care delivery 
Adhoc 
Stored in Aptible (HIPPA, 
HITRUST & ISO27001 ) 
No 
If PII is shared with Bodyport 
 
 
#
API description
API Type (SOAP (Simple Object Access Protocol), 
RPC (Remote Procedure Call), and REST 
(Representational State Transfer)
Data currently exchanged via this 
API
Is it PHI? 
(yes/no)
Additional Comments
1
/groups/{group_id} 
Returns group information for a 
specific account
REST 
JSON - Group Name, Group ID, 
Bodyport ID 
No 
Used Internally & 
Externally 
2
/users/{user_id} 
Returns information about patients 
assigned to a group
REST 
JSON - Height, Date of Birth, Gender, 
Patient ID, Name, Bodyport ID 
Yes (if PII is 
shared with 
Bodyport) 
Used Internally & 
Externally 
3
/measures/{measurement_id} 
Returns measurements belonging to 
a patient or a group
REST 
No
Yes (if PII is 
shared with 
Bodyport) 
Used Internally 
& Externally 
4
/devices/{device_id} 
Returns devices assigned to patients 
in a group
REST 
JSON - Temperature, Humidity, Battery 
Voltage, Signal Strength 
No 
Used Internally & 
Externally 
5
/device 
Used internally to support 
measurement uploads
REST 
Multi-part Binary File + JSON 
No 
Bodyport Internal Use 
Only 
6
/dashboard 
Returns data for populating Clinical 
Dashboard
REST 
JSON 
Yes (if PII is 
shared with 
Bodyport) 
Bodyport Internal Use 
Only 
7
/user_dashboard 
Returns data for populating Patient 
Dashboard 
REST 
JSON 
Yes (if PII is 
shared with 
Bodyport) 
Bodyport Internal Use 
Only 
 
Data to be used as triggers to notify providers when values reach specific thresholds may include the 
following, and are subject to change based on provider burden, utility, and frequency of alerts: weight, 
fluid index, heart rate, heart rate variability, impedance, electrocardiogram values, and systolic time 
intervals. 
 
 
Coaching Based Interventions: 
 

Page 11 of 31 
 
- 
Noom: A live, data-driven coaching application personalized to individuals for diet and weight 
management.  Patients will be encouraged to use this application on a daily basis to track their activity 
and steps, their caloric intake, daily weights, blood pressure measurements, glucose measurements, and 
medication logs (i.e. patients can track when/if they take their daily medications).  Educational modules 
and coaching support are also available through the application.  While Noom does not have an 
information manual, they do have online support, FAQs, and instructions for individual portions of the 
application on their website: https://web.noom.com/support/.  There are also several video tutorials that 
can be found here and will be given to the patient: 
- 
Food Logging: 
- 
iOS and Android : https://bit.ly/2D7Xanh 
- 
Syncing Fitbit: 
- 
iOS : https://bit.ly/2FtgRYn 
- 
Android : https://bit.ly/2tfoomu 
- 
Group Posts, Threads And Direct Messages (DM): 
- 
iOS : https://bit.ly/2UOMoIK 
- 
Android : https://bit.ly/2GxFSSH 
- 
Meal Reminders: 
- 
iOS : https://bit.ly/2VTmaGu 
- 
Android : https://bit.ly/2SCEowR 
- 
Syncing Apple Watch: 
- 
iOS : https://bit.ly/2UpINB5 
- 
Saving A Custom Dish: 
- 
iOS : https://bit.ly/2H891pC 
- 
 
- 
Patients will be given a thorough orientation to the application and these materials during enrollment. 
 
The following data will be collected by Noom for use in our study and stored by Medullan in a HIPAA-
compliant manner.  
 
 
# 
Source 
data 
Data type 
How Collected 
Intended use 
Collection 
Frequency 
Data storage (specify 
where the data is stored 
and the compliance with 
HIPPA, ISO and or Hitrust) 
Is it 
Protected 
Health 
Information 
(PHI)?
Additional Comments 
1 
Weight 
Physical data 
Both 
Tracking/monitoring of weight, Calculation of 
caloric needs  
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No  
The patient (Noom user) can 
choose the data source - manual 
entry or connected device 
2 
Height 
Physical data 
Own Device 
Calculation of caloric needs 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No  
3 
Gender 
Physical data 
Own Device 
Calculation of caloric needs 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No  
4 
Age 
Physical data 
Own Device 
Calculation of caloric needs 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No  
5 
Username 
Personal data Own Device 
Identification for coach and peers 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No  
6 
Steps 
Activity data 
Both 
Tracking of activity 
Daily 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No  
The patient (Noom user) can 
choose the data source - manual 
entry or connected device 
7 
Email 
address  
Personal data Own Device 
Account creation 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
Yes 
8 
Exercise  
Activity data 
Both 
Tracking of activity 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
No 
The patient (Noom user) can 
choose the data source - manual 
entry or connected device 

Page 12 of 31 
 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
9 
Food/Meal  
Activity data 
Own Device 
Tracking of food & caloric intake 
Daily 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No 
10 
Blood 
pressure 
(systolic) 
Biometric data 
Both 
Tracking/monitoring of blood pressure 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No 
The patient (Noom user) can 
choose the data source - manual 
entry or connected device 
11 
Blood 
pressure 
(diastolic) 
Biometric data 
Both 
Tracking/monitoring of blood pressure 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No 
The patient (Noom user) can 
choose the data source - manual 
entry or connected device 
12 
Blood 
glucose 
Biometric data 
Both 
Tracking/monitoring of blood glucose  
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No 
The patient (Noom user) can 
choose the data source - manual 
entry or connected device 
13 
User 
message 
Personal data 
Own Device 
Communication with coach or peer group 
Adhoc 
Data is stored in the AWS 
cloud database. Noom is 
HIPAA compliant. AWS is 
SOC 1,2, &3 certified.  
No 
 
# 
API 
description 
API Type (SOAP (Simple 
Object Access Protocol), 
RPC (Remote Procedure 
Call), and REST 
(Representational State 
Transfer) 
 
Data currently exchanged via this API 
Collection 
Frequency 
Data storage (specify where the data 
is stored and the compliance with 
HIPPA, ISO and or Hitrust) 
Is it Protected 
Health Information 
(PHI)? 
 
1 
Validic Device 
API 
REST 
3rd-Party 
Connected 
Device 
Noom can receive the following data from 
connected devices via Validic API: weight, steps, 
exercise, blood pressure, blood glucose.  
Adhoc 
Data is accessed through HIPAA-
compliant REST API. Data is stored in 
the AWS cloud database. Noom is 
HIPAA compliant. AWS is SOC 1,2, &3 
certified.  
No 
 
Data to be used as triggers to notify providers when values reach specific thresholds may include the 
following and are subject to change based on provider burden, utility, and frequency of alerts:  daily 
weights, number of daily steps, blood pressure, sodium intake, and self-reported medication adherence. 
 
- 
Conversa: An automated conversational platform and coaching application designed to motivate patients 
to take more active and engaged roles in their healthcare using AI technology to create “clinically 
intelligent” conversations.  Patients can interact with the application by participating in brief 
(approximately 5 minute) “conversations” about their health and current symptoms, with prompts to 
keep engaged in their disease management.  Each conversation ends with an educational tutorial about 
some aspect of their condition.  The device itself does not measure any new clinical data, but records 
clinical data based on patient input during these conversations.  Conversa does not have a user manual, 
as conversations and instructions are customized based on the engagement of the patient.  We have 
attached with this protocol an example of a user brochure used for similar programs with the application. 
 
The following data will be collected by Conversa for use in our study and stored by Medullan in a HIPAA-
compliant manner.  Data to be used as triggers based on patient conversations in the application may 
include the following, and are subject to change based on provider burden, utility, and frequency of 
alerts: patient complaints of increased swelling, increased weakness and fatigue, and/or increased 
shortness of breath. 
 
#
Source data 
Data type 
How Collected 
Intended use 
Collection 
Frequency 
Data storage (specify where the data is stored 
and the compliance with HIPPA, ISO and or 
Hitrust) 
Is it Protected Health 
Information (PHI)? 
1
Biometrics 
readings 
Medical and fitness 
device data 
3rd-Party 
Connected 
Device 
Experience personalization
Adhoc 
HIPAA compliant 
No 
2
EHR / Clinical 
Patient clinical history 
Experience personalization
Adhoc 
HIPAA compliant 
Yes 
3
EHR / 
Medications 
Patient medications 
history 
Experience personalization
Adhoc 
HIPAA compliant 
Yes 
4
EHR / 
Preferences 
Patient communication 
preferences 
Experience personalization 
/ communication 
Adhoc 
HIPAA compliant 
Yes 

Page 13 of 31 
 
5
EHR / Care 
team 
Patient care team 
(provider relationship) 
Experience personalization
Adhoc 
HIPAA compliant 
Yes 
 
#
API 
description 
API Type (SOAP (Simple Object Access 
Protocol), RPC (Remote Procedure Call), 
and REST (Representational State 
Transfer) 
Data currently 
exchanged via this API 
Collection 
Frequency 
Data storage (specify where the data is stored and the 
compliance with HIPPA, ISO and or Hitrust) 
Is it Protected 
Health 
Information 
(PHI)?
1
Patient 
REST 
Patient entity per FHIR 
http://hl7.org/fhir/STU3/patient.html 
Yes 
2
Conversation 
REST 
Transactional service for 
conversation support 
No 
3
Encounter 
REST 
Encounter entity per FHIR 
http://hl7.org/fhir/STU3/encounter.html 
No 
4
Questionnaire 
Response 
REST 
QuestionnaireResponse per 
FHIR 
http://hl7.org/fhir/STU3/questionnaireresponse.html 
No 
 
 
 
Patients will be thoroughly trained and oriented to their designated digital health product during their clinical 
visit by a study coordinator using on-site demo products (or over the phone if not consented in the clinic), 
and they will receive their product via mail.  Each vendor will be responsible for the delivery, tracking, and 
distribution of their specific product.   
 
Patients will be asked to actively engage with their product throughout the course of the study. If necessary, 
based on an eligibility questionnaire which assesses smart phone and data plan availability, patients will also 
be given a smart phone device that can be used with the product, such that no eligible patient is excluded on 
the basis of lack of access to a smart phone or internet connection.   
 
Patients randomized to the control arm of the study will receive usual care only.  Patients in the control group 
will attend their normal clinic visits throughout the first three months of the study as they normally would, 
however, they will not receive any of the four digital health technologies above and their healthcare team will 
receive no additional information from any of these products.   
 
Patient Follow-Up and Data Collection 
 
All subjects will be enrolled in the study for a period of 6 months.  The first three months will involve active 
clinic management, and subjects will be seen every 2-3 weeks as clinically indicated for an in-person visit as 
they normally would outside the research paradigm.  Between visits, data regarding device usage, withdrawal 
rates, and device-generated health data described above will be passively collected from patients in the 
intervention arms of the trial and stored on a secure HIPAA-compliant database created by Medullan.  During 
clinic visits, patients will also have the opportunity to meet with a study coordinator, who will administer 
surveys assessing device usability and user satisfaction (for those patients in the intervention groups only), as 
well as the KCCQ, health literacy and technology questionnaires, and medication adherence surveys (for all 
patients in the study, regardless of randomization status) to assess changes from baseline. 
 
Once patients have “graduated” from the clinic, they will be followed for the final three months of the study 
via monthly phone calls from the study team.  During this time, passive data collection from devices will 
continue. At 6 months, subjects will be asked to complete the final surveys appropriate to their 
randomization group either electronically or via telephone with one of our study coordinators.  
 
Overview and Timeline of the Patient Experience 
 
Day 0 

Page 14 of 31 
 
- 
Patients who have passed initial screening will be approached by site study coordinators at a clinic visit 
(or via phone call/text messaging) regarding their interest in study participation. 
- 
Study coordinators will describe, in detail, the study protocol with all interested patients, and patients will 
be asked to provide e-consent via a hippa-compliant, secure website set up for the purpose of the study, 
after all questions have been adequately answered. 
- 
Consented patients will be asked to fill out a series of surveys and questionnaires used to collect baseline 
data for the study, including: 
o Both a health and technology literacy survey, to gauge baseline status that will be tracked 
throughout the course of the study 
o A KCCQ questionnaire to assess baseline quality of life metrics that will be tracked throughout the 
course of the study as a measure of primary outcome 
o A medication adherence survey to assess and baseline medication adherence that will be tracked 
throughout the course of the study 
- 
Patients will be randomized to one of four study arms.  Those in one of the three intervention arms will 
receive the appropriate digital health product.  A study coordinator will educate the patient on the 
product, demonstrating all available features and ensuring the patient understands how to use the 
product and its value.  The digital health product will be mailed to the patient’s home and the patient will 
be encouraged (but not required) to engage with it on a daily basis. 
 
Days 1-89 
- 
Ongoing data collection regarding usage statistics of all digital health products will occur. 
- 
Patients (regardless of randomization status to intervention or usual care groups) will be seen once every 
2-3 weeks at in-person clinic visits as they normally would outside of this study.  Physicians will have an 
opportunity to engage with patients about that data collected from their digital health product and make 
any changes or recommendations to their plan of care. 
 
Day 90 
- 
Patients will have their final in-person clinic visit.  At this time, patients will meet with an on-site or virtual 
(via phone calls) study coordinator and be asked to complete a variety of study-related questionnaires 
and surveys electronically, including: 
o A health and technology literacy survey, to track progress over the course of the study 
o A KCCQ questionnaire to track any changes over the course of the study as a measure of the 
primary outcome 
o A medication adherence survey to track changes from baseline 
o A product satisfaction survey (intervention groups only), to determine a Net Promoter Score 
(NPS) that measures satisfaction with the digital health product 
o A usability survey (intervention groups only), which assesses user friendliness, frequency of use, 
product satisfaction, and perceived impact of the product. 
- 
Patients will graduate from the clinic, but will be asked to continue using their products until study close-
out. 
 
Days 90-179 
- 
Ongoing data collection regarding usage statistics of all digital health products will continue. 
- 
Patients will receive monthly calls from the clinic, regardless of randomization status, to track progress, 
assess engagement with products, and answer any questions. 
 
Day 180 

Page 15 of 31 
 
- 
Patients will be asked to complete a final electronic visit with study coordinators for study close-out. They 
will also be mailed a return-labeled envelope to return the digital health product.  During this visit, 
patients will work with study coordinators and be asked to fill out final assessments electronically, 
including: 
o A health and technology literacy survey, to track progress over the course of the study 
o A KCCQ questionnaire to track any changes over the course of the study as a measure of the 
primary outcome 
o A medication adherence survey to track changes from baseline 
o A product satisfaction survey (intervention groups only), to determine a Net Promoter Score 
(NPS) that measures satisfaction with the digital health product 
o A usability survey (intervention groups only), which assesses user friendliness, frequency of use, 
product satisfaction, and perceived impact of the product. 
- 
Study coordinators will collect any final data needed and answer any remaining questions, and patients 
will complete their participation in the study. 
 
 
The study timeline for an enrolled patient is as follows: 
 
 
Clinician Data Collection 
 
An important aspect of our study is to determine whether the digital health products enhance clinical 
efficiency and reduces physician burden.  At the end of the study, we will ask participating clinicians to 
complete an anonymous survey that assesses physician satisfaction with the products, ease of use, effect on 
workload and efficiency, and contribution to clinical-decision making. 
 
Outcomes 
 
Our primary outcome is the rate of improved quality of life of enrolled patients after 90 days as measured by 
the Kansas City Cardiomyopathy Questionnaire (KCCQ), which will be given to patients prior to enrollment, at 
the 90 day mark, and after study completion (day 180).  The KCCQ is a standardized 23- question instrument 
that combines aspects of physical functions, symptoms (frequency, severity, and recent changes), social 
function, self-efficacy, and quality of life into a single summary score on a scale of 0 to 100, giving a sensitive 
and specific measure of quality of life for heart failure patients. 
 

Page 16 of 31 
 
The following pre-specified secondary outcomes will be measured to determine the effect of the various 
technologies on patient outcomes, quality of patient care, clinical efficiency, and both patient and provider 
satisfaction with the products. 
 
 
 
 
 
 
We will also perform prespecified secondary analyses to determine the above primary and secondary 
outcomes at day 180, to determine if outcomes improve once clinic visits end. 
Outcome
Measure
Data Storage
Hospital Admissions
Epic, Ping
RedCap (Yale)
Guideline directed medical therapy
Rates of prescribing and dosing of beta 
blockers, ACEi/ARBs, spironolactone (via 
Surescripts)
RedCap (Yale)
ED visits
Hospital records
RedCap (Yale)
Mortality
Hospital records
RedCap (Yale)
Clinic no show rates
Medical records
RedCap (Yale)
AKI/AKD Development
Medical records
RedCap (Yale)
Satisfaction with device/technology
NPS score via post-study survey
HIPAA-compliant dashboard (Medullan)
Frequency of use (overall and feature level)
Post-study survey
HIPAA-compliant dashboard (Medullan)
Content rating
Post-study survey
HIPAA-compliant dashboard (Medullan)
Perceived impact
Post-study survey
HIPAA-compliant dashboard (Medullan)
Outcome
Measure
Data Storage
Amount of intravisit contact
Telephone logs in medical record
Number of clinic visits
Medical records
Time devoted to patient care
Number of chart openings per patient
Provider assessment of global disease severity
Post-study survey
Satisfaction
Effect on workload and efficiency
Post-study survey
Outcome
Measure
Data Storage
Number of enrolled patients
Number of incomplete enrollments
Number of complete and incomplete aseessments
Time to complete initial assessments
Number of complete and incomplete product set-ups
Number of products that completed initial data sync
Subject drop-off 
rates
Percent of patients with last screen assessed in session
Number of active (>1 login per week) patients per 
week
Average number of logins per week
Number of patients without logins per week
Statistic for each session (time of day, day of week, 
number of page views, origin of login (direct, email))
Average number of interactions
Average number of daily check-ins
Number of patients not using product per week
Time of day of product usage
Completeness of data provided per question in session
User engagement
Dwell time per feature
Completion of 
subject 
enrollment
Completion rate 
of baseline 
assessments
Usage Analytics of Digital Health Products
Continuous data collection via product 
databases
HIPAA-compliant dashboard (Medullan)
RedCap (Yale)
Completion of 
digital health 
product set-up
Device usage 
(Descriptive 
statistics)
Clinical Efficiency
Patient Outcomes
Adverse Events
Clinician Outcomes
Usability

Page 17 of 31 
 
 
An additional secondary analysis will assess the heterogeneity of the effect of each product across clinics. 
 
5. Genetic Testing    
N/A ☒ 
 
6. Subject Population: Provide a detailed description of the types of human subjects who will be recruited into 
this study. 
This study will enroll adult patients attending one of the nine clinics located within YNHHS specializing in the 
treatment of heart failure, for management of congestive heart failure.  See inclusion and exclusion criteria 
below. 
 
7. Subject classification: Check off all classifications of subjects that will be specifically recruited for enrollment in 
the research project. Will subjects who may require additional safeguards or other considerations be enrolled 
in the study? If so, identify the population of subjects requiring special safeguards and provide a justification 
for their involvement. 
 
☐Children 
 
 
☐ Healthy  
 
 
☐Fetal material, placenta, or dead fetus 
☐Non-English Speaking  
☐ Prisoners 
 
 
☐Economically disadvantaged persons 
☐Decisionally Impaired  
☐ Employees 
 
 
☐Pregnant women and/or fetuses 
☐Yale Students  
 
☐ Females of childbearing potential 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential subjects? 
Yes ☐  No ☒  
 
8. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or exclusion? 
Inclusion Criteria: 
1. Adults ≥ 18 years and < 80 years of age 
2. Enrolled in a  YNHHS clinic specializing in heart failure treatment 
3. Diagnosed with congestive heart failure (CHF) (preserved ejection fraction 
(HFpEF) or reduced ejection fraction (HFrEF)) with or without diabetes 
4. Within one month of a clinic visit 
 
Exclusion Criteria: 
1. Class IV heart failure 
2. Stage 4 or end stage renal disease (eGFR < 30) 
3. Recipient of a heart transplant or ventricular assist device 
4. Under hospice care 
5. Dementia 
6. Incarceration 
7. Pregnancy 
8. Currently homeless or residing in an unstable living situation (i.e., transitional 
housing, rehab facility, etc.) 
9. Inability to consent 
10. Currently enrolled in a study investigating a digital health product or technology 
11. Life expectancy of less than 6 months as determined by the clinical judgement of 
the patient’s primary physician 
12. Weight greater than 400 pounds 

Page 18 of 31 
 
13. Unable to stand up straight for thirty seconds without assistance, such as from a 
cane or walker 
14. Non -english speaking 
 
Note regarding pacemakers, and other implantable electronic devices: 
While Bodyport has statements in their user manuals that their products are not to be used in patients with 
pacemakers and other electronic implanted devices, we have received statement from the vendor that the device 
is safe to use in this patient population. 
 
Bodyport has stated that “With respect to the Bodyport product, there are no known safety issues related to the 
use of the device with patients with pacemakers or ICDs.  However, we have not specifically tested the device in 
this population, and cannot make claims about its performance in these patients.”  We have included in the 
application an informational sheet on the theory of operation behind the Bodyport scale, which outlines the 
possible affect that a pacemaker or other device may have on the ability of the scale to perform accurate ECG 
readings, which is the reason that the warning statement regarding use in this patient population was included in 
the manual. 
 
The BodyPort scale has been previously used in studies that do not exclude patients with pacemakers.  Given that 
there are no safety concerns regarding the use of this device, we plan to enroll patients with pacemakers and 
other implantable devices, as excluding this population would be highly restrictive to the study. 
 
9. How will eligibility be determined, and by whom?  
Eligibility will be assessed by on site and central study coordinators who will prospectively review our patient 
dashboard and further consult the electronic medical record for inclusion and exclusion criteria of patients 
currently enrolled in the clinics.  Criteria will be further confirmed during the patient’s in clinic visit or via a 
telephone call with a study coordinator prior to consent.  Digital and technology literacy is not considered an 
eligibility requirement, as one main goal of the study is to assess whether these digital health products would 
be efficacious and applicable for this patient demographic.  Once a patient has consented to participate in the 
study and has been enrolled, he/she will be asked to take a digital literacy survey as a means for baseline 
assessment and to track improvement of this metric over the course of the study.  
 
10. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts, or 
inconveniences associated with subjects participating in the research.  
General study risks: 
- 
Loss of confidentiality:  We will be collecting patient information and data, which is subject to loss of 
confidentiality in any clinical trial. 
- 
Physician burden: Physicians will be receiving additional information about their patients via the study 
devices, which may increase workload via additional time spent on patient care, reviewing medical record 
data, and/or ordering additional tests and reviewing subsequent results.   
- 
Overtreatment:  It is possible that patients in the intervention group may be at risk for more aggressive 
therapies or treatments and increased medical costs as a consequence of closer monitoring. 
 
Bodyport-specific risks and restrictions: 
- 
The Bodyport scale cannot be exposed to extreme temperatures or submerged in liquid. 
- 
The scale should not be used if the glass surface is cracked or chipped, as this could result in personal 
injury. 
- 
The scale should not be used of the surface is wet, as this could cause a slippery surface that could result 
in personal injury. 

Page 19 of 31 
 
 
 
 
11. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized. 
- 
Risk of loss of confidentiality: Data collected both from patient visits/assessments/surveys and abstracted 
from the medical record will be de-identified and stored on RedCap and on a secure HIPAA-compliant 
central server within the Program of Applied Translational Research. The server is only accessible from 
within the Yale intranet (or via VPN remotely) and additionally requires separate logon username and 
password.  No PHI will be included in analysis or publication.  All analyses will proceed on this server 
alone.  
 
We will maintain a linking file in a separate location that will allow for future linking of de-identified data 
to protected health information (PHI) for the purpose of potential future studies.  Studies that require the 
use of PHI (for example, linking patient info to national outcomes databases) will require approval of both 
the manuscript and executive committees and a separate IRB approval.  
 
We plan to share non-aggregate de-identified data with Medullan under with the appropriate data 
sharing agreements.  We will provide periodic transfer of this data via encrypted secure file transfer. 
 
- 
Risk of physician burden:  We have strived to create a study in which physician burden is minimized.  
Additional clinic visits outside of usual care are minimized, and physicians are expected to manage patient 
care at their own discretion.  The study devices were designed to increase clinical efficiency rather than 
hamper it, and one of our secondary outcomes is to assess provider satisfaction with the products and 
usability so that we can better understand how these technologies have helped or hindered their 
provision of care. Additionally, this risk will be mitigated in part as there will be a technical support hotline 
(independent of physician involvement) maintained by Medullan, inc to address technical issues with the 
device or software interventions.  Support staff working for Medullan are trained to escalate issues that 
prove to be medical to the supervising physician. 
 
- 
Risk of overtreatment:  The technologies in this study are designed to relay additional information to 
providers that can be used in conjunction with all other medical information available to them to aid in 
the clinical decision-making process.  Any additional tests or treatments should be prescribed using their 
own clinical judgement based on all available information sources regarding the patient’s condition.  We 
will appropriately educate providers about the nature of the study devices and the information that each 
provides so that physicians can understand how to best incorporate this information into their decision-
making. 
 
- 
Device-specific risks for Bodyport:  We will discuss the above risks with the patient before and during the 
consent process to ensure the patient understand the risks and proper use of the device.  The patient will 
be shown product manuals and informational materials for the scale and will be given the opportunity to 
answer any questions.  Once enrolled into the study and assigned to a treatment group, patients will be 
given manuals and instructions for the device they receive, and will receive a thorough orientation to the 
product by a study coordinator who will emphasize any risks involved. 
 
12. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan (DSMP) based on 
the investigator’s risk assessment stated below. (Note: the HIC will make the final determination of the risk to 
subjects.) 

Page 20 of 31 
 
 
a.  
What is the investigator’s assessment of the overall risk level for subjects participating in this 
study? This protocol presents minimal risk to all subjects. 
b. 
If children are involved, what is the investigator’s assessment of the overall risk level for the 
children participating in this study? N/A 
c. 
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are   
available here http://your.yale.edu/policies-procedures/forms/420-fr-01-data-and-safety-
monitoring-plans-templates for 
i. Minimal risk 
ii. Greater than minimal 
 
Assessing the Efficacy of Digital Health Technology in the Management of Congestive Heart 
Failure: An Evaluation of Four Novel Digital Health Products 
420 FR.1 
PI: F. Perry Wilson, MD MSCE 
 
The principal investigator is responsible for monitoring the data, assuring protocol compliance, 
and conducting the safety reviews bi-monthly.  During the review process the principal 
investigator will evaluate whether the study should continue unchanged, require 
modification/amendment, or close to enrollment. 
 
The principal investigator or the Institutional Review Board (IRB) have the authority to stop or 
suspend the study or require modifications.   We will conduct an internal interim analysis at 50% 
recruitment to assess for efficacy, as described below. 
 
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks to 
Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely event 
that such events occur, Reportable Events (which are events that are serious or life-threatening 
and unanticipated (or anticipated but occurring with a greater frequency than expected) and 
possibly, probably, or definitely related) or Unanticipated Problems Involving Risks to Subjects or 
Others that may require a temporary or permanent interruption of study activities will be reported 
immediately (if possible), followed by a written report within 5 calendar days of the Principal 
Investigator becoming aware of the event to the IRB (using the appropriate forms from the 
website) and any appropriate funding and regulatory agencies. The investigator will apprise fellow 
investigators and study personnel of all UPIRSOs and adverse events that occur during the conduct 
of this research project through regular study meetings and/or via email as they are reviewed by 
the principal investigator.  The protocol’s research monitors, including study sponsors, funding and 
regulatory agencies, and regulatory and decision-making bodies will be informed of all adverse 
events within 5 days of the event becoming known to the principal investigator. 
 
 
d. For multi-site studies for which the Yale PI serves as the lead investigator: N/A 
 
13. Statistical Considerations: Describe the statistical analyses that support the study design.  
 
Baseline comparisons across the study arms will be conducted with chi-square tests for categorical variables, 
applying the Maentel-Haenszel correction for stratification by clinic site. Continuous variables will be 
compared using the Van-Elteren test for continuous, non-parametric variables and stratified t-tests for 
normally distributed variables. 

Page 21 of 31 
 
 
The study was designed to provide adequate power to detect a clinically significant change in the primary 
outcome measure, the score on the Kansas City Cardiomyopathy Questionnaire.8 
 
The 23-item questionnaire has been validated in multiple heart failure populations, and quantified the 
physical limitations, symptoms, self-efficacy, social interference, and quality of life associated with living with 
heart failure. The KCCQ composite score can theoretically range from 0 – 100 (with 100 being the best 
possible score) and a change of 10 points has been determined to be the minimum clinically important 
difference. Within a given patient, the score is quite stable in the absence of clinical changes, with a within-
patient standard of deviation of 11.8 for patients with no change in clinical status.9 
 
In order to detect the minimum clinically important difference of a 10-point improvement in the KCCQ, we 
would need to enroll 40 patients in each arm of the trial across all centers to provide 90% power at an alpha 
threshold of 0.017. This gives a total of enrollment of 160. Given uncertainties around the intraclass 
correlation coefficient (assumed to be 0.10 here and reflecting the overall efficacy of each individual clinic) 
we will inflate the target sample size to 200, or 50 per arm of the trial. The lower alpha threshold represents a 
bonferonni correction that provides statistical power to test multiple comparisons – each of the 3 digital 
health interventions against the control intervention. We will attempt to balance recruitment across the 
centers with a per-center target of 5 individuals per trial arm. 
 
An interim analysis will be completed at 50% enrollment.  We will stop the trial for efficacy for a p value 
threshold of < 0.0006. Given the interim analysis, the threshold p-value for statistical significance at the end 
of the trial will be 0.016. 
 
The primary analysis will be a mixed effects model comparing change in KCCQ over time in the intervention 
group versus the control, without accounting for a center-by-treatment interaction. In secondary analyses, we 
will model that interaction to determine if certain interventions are uniquely effective in certain centers. 
 
Secondary and exploratory analyses will examine the outcomes listed above using the same procedure 
applied to baseline variables for outcomes assessed at one time point, and using mixed-effects models for 
continuous outcomes assessed at multiple timepoints.  
 
 
    
SECTION II: RESEARCH INVOLVING DRUGS, BIOLOGICS, RADIOTRACERS, PLACEBOS AND DEVICES 
 
 
If this section (or one of its parts, A or B) is not applicable, check off N/A and delete the rest of the section. 
 
A.  RADIOTRACERS 
☒N/A 
 
B.  DRUGS/BIOLOGICS    ☒N/A 
 
B.  DEVICES 
 ☐N/A 
 
1. 
Are there any investigational devices used or investigational procedures performed at Yale-New Haven 
Hospital (YNHH) (e.g., in the YNHH Operating Room or YNHH Heart and Vascular Center)?  ☐Yes   ☒No    
 

Page 22 of 31 
 
 If Yes, please be aware of the following requirements: 
 
A YNHH New Product/Trial Request Form must be completed via EPIC: Pull down the Tools tab in the EPIC Banner, 
Click on Lawson, Click on “Add new” under the New Technology Request Summary and fill out the forms 
requested including the “Initial Request Form,” “Clinical Evidence Summary”, and attach any other pertinent 
documents. Then select “save and submit” to submit your request;   AND 
 
Your request must be reviewed and approved in writing by the appropriate YNHH committee before 
patients/subjects may be scheduled to receive the investigational device or investigational procedure. 
 
2. Background Information: Provide a description of previous human use, known risks, and any other factors 
that might influence risks. If this is the first time this device is being used in humans, include relevant data on 
animal models.  
 
Digital health devices or experiences: 
 
 
BodyPort:  A novel data-driven smart scale that provides advanced cardiac monitoring and risk assessment 
data that feed directly to an analytics platform visible to providers.  The scale also provides limited patient 
instruction and educational materials. 
 
BodyPort has not yet received clearance by the FDA and is not exempt from IDE regulations in this study, 
however, we assess this use representing a non-significant risk (NSR) investigational device (in an NSR study).  
We have included in our application both the instruction manuals for BodyPort as well as a review of previous 
clinical studies and their results. 
 
Noom: A live, data-driven coaching application personalized to individuals for diet and weight management.  
Noom is not an approved application and is not exempt from IDE regulations, however, we assess its use 
representing a non-significant risk (NSR) investigational device (in an NSR study).   
 
Conversa: An automated conversational platform and coaching application designed to motivate patients to 
take more active and engaged roles in their healthcare using AI technology to create “clinically intelligent” 
conversations.  Conversa is not an approved platform and is not exempt from IDE regulations, however, we 
assess its use representing a non-significant risk (NSR) investigational device (in an NSR study).   
 
 
3. Source:  
a) Identify the source of the device to be used. Device vendors 
b) Is the device provided free of charge to subjects? ☒Yes   ☐No     
 
 
4. Investigational device accountability:  State how the PI, or named designee, ensures that an investigational 
device is used only in accordance with the research protocol approved by the HIC, and maintains control of 
the investigational device as follows: 
 
a) Maintains appropriate records, including receipt of shipment, inventory at the site, dispensation or use 
by each participant, and final disposition and/or the return of the investigational device (or other 

Page 23 of 31 
 
disposal if applicable): Vendors will be responsible for shipment and tracking of their respective devices, 
including maintaining inventory and appropriate records of each product, and for the distribution to 
subjects.  Vendors will also be responsible for collecting the devices back from patients at study close-
out. 
 
b) Documents pertinent information assigned to the investigational device (e.g., date, quantity, batch or 
serial number, expiration date if applicable, and unique code number): Vendors will be responsible for 
documenting all relevant device information for their respective product. 
c) Stores the investigational device according to the manufacturer's recommendations with respect to 
temperature, humidity, lighting, and other environmental considerations: Vendors will be responsible for 
the proper storage of their product.  Study coordinators will also be trained on the proper storage 
environment for each device. 
  
d) Ensures that the device is stored in a secure area with limited access in accordance with applicable 
regulatory requirements: Both vendors and study coordinators at each clinic will be responsible for the 
storage and access to study devices.  
e)  Distributes the investigational device to subjects enrolled in the IRB-approved protocol: Vendors will 
be responsible for the distribution of each study device to subjects.  Study coordinators will be 
responsible for the training of subjects on the use of the device via in-clinic demos or in depth 
instructions during over the phone enrollment. 
 
SECTION III: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
1. Targeted Enrollment: Give the number of subjects: 200 
a. Targeted for enrollment at Yale for this protocol: 200 
b. If this is a multi-site study, give the total number of subjects targeted across all sites: 200 
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used. 
☒ Flyers 
☒ Internet/web postings 
☐ Radio 
☒ Posters 
☐ Mass email solicitation 
☒ Telephone 
☐ Letter 
☒ Departmental/Center website 
☐ Television 
☒ Medical record review*  
☐ Departmental/Center research boards 
☐ Newspaper 
☐ Departmental/Center newsletters 
☐ Web-based clinical trial registries 
☒ Clinicaltrails.gov  
☐ YCCI Recruitment database 
☐ Social Media (Twitter/Facebook):  
☒ Other: Informational screen 
advertisement in clinic waiting areas 
 
* Requests for medical records should be made through JDAT as described at 
http://medicine.yale.edu/ycci/oncore/availableservices/datarequests/datarequests.aspx 
 
3.  Recruitment Procedures:  
a. Describe how potential subjects will be identified.  
Subjects will be identified by on-site and central study coordinators through prospective daily review of 
the study dashboard and review of the electronic medical record for inclusion and exclusion criteria. 
b. Describe how potential subjects are contacted.  

Page 24 of 31 
 
Potential subjects will be approached for e- consent by on- site study coordinators during any normal 
clinic visit..  Patients will have the opportunity to complete eligibility assessments and the consent form 
on a study tablet provided by a coordinator.  Eligible patients who were not seen by an on-site 
coordinator will be contacted by a study coordinator via phone call and/or text messaging and/or 
MyChart messaging (as described above) for enrollment and consent.  In this case, a link will be emailed 
to the patient allowing for access to the required eligibility assessments and consent form. 
c. Who is recruiting potential subjects?  
 
   Specially-trained on-site and central study coordinators. 
 
 
4. Assessment of Current Health Provider Relationship for HIPAA Consideration: 
Does the Investigator or any member of the research team have a direct existing clinical relationship with any 
potential subject?  
☐Yes, all subjects 
☒Yes, some of the subjects 
☐No 
 
If yes, describe the nature of this relationship.  
Doctors Soucier, Ahmad, and Desai are cardiologists who may encounter potential study participants in the 
course of their clinical care. 
 
5. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization for either the 
entire study, or for recruitment purposes only.  Note: if you are collecting PHI as part of a phone or email 
screen, you must request a HIPAA waiver for recruitment purposes.)  
Choose one:  
☐ For entire study  
☒ For recruitment/screening purposes only  
☐ For inclusion of non-English speaking subject if short form is being used and there is no translated HIPAA 
research authorization form available on the University’s HIPAA website at hipaa.yale.edu. 
 
i. Describe why it would be impracticable to obtain the subject’s authorization for use/disclosure of this 
data:  
Each clinic sees, on average, 80 patients per day.  As screening would be required before patients are 
initially seen in the clinic, consenting each patient would be time consuming, impractical, and 
unnecessary for the majority of patients who will not enroll into the study.  Eligibility assessments 
present no more than minimal risk, with the primary risk being loss of confidentiality, however, 
extensive safeguards are in place to prevent such loss and any data collected on patients who are not 
enrolled into the study will be immediately deleted. 
 
ii. If requesting a waiver of signed authorization, describe why it would be impracticable to obtain the 
subject’s signed authorization for use/disclosure of this data: Write here 
 
The investigator assures that the protected health information for which a Waiver of Authorization has been 
requested will not be reused or disclosed to any person or entity other than those listed in this application, except 
as required by law, for authorized oversight of this research study, or as specifically approved for use in another 
study by an IRB. 
 

Page 25 of 31 
 
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale HIPAA-Covered 
entity must be accounted for in the “accounting for disclosures log”, by subject name, purpose, date, recipients, 
and a description of information provided.  Logs are to be forwarded to the Deputy HIPAA Privacy Officer. 
 
6. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will be obtained, 
including parental permission or surrogate permission and the steps taken to ensure subjects’ independent 
decision-making.  
An eligible patient will be approached for consent during his or her normal clinic visit by a trained on-site 
study coordinator.  Patients will be given informational materials and ample time to review the information 
and have any questions or concerns addressed before making their decision.  Should a study coordinator not 
be present for consenting at the time of the patient’s clinic visit, the patient will be called at a later time by a 
coordinator for the purposes of consent.  If agreeable, a link will be sent via email to the patient and the 
coordinator will be available to walk the patient through eligibility assessment and consent via phone. 
7. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the personnel obtaining 
consent will assess the potential subject’s ability and capacity to consent to the research being proposed.  
The study coordinator will decide whether the subject has expressed an accurate understanding of the study, 
its risk, and its benefits. 
8. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for research involving 
non-English speaking subjects. If enrollment of these subjects is anticipated, translated copies of all consent 
materials must be submitted for approval prior to use.  
N/A 
 
As a limited alternative to the above requirement, will you use the short form* for consenting process if you 
unexpectedly encounter a non-English speaking individual interested in study participation and the translation of 
the long form is not possible prior to intended enrollment?  YES ☐  NO ☒ 
 
Note* If more than 2 study participants are enrolled using a short form translated into the same language, then 
the full consent form should be translated into that language for use the next time a subject speaking that 
language is to be enrolled. 
 
Several translated short form templates are available on the HRPP website (yale.edu/hrpp) and translated HIPAA 
Research Authorization Forms are available on the HIPAA website (hipaa.yale.edu). If the translation of the short 
form is not available on our website, then the translated short form needs to be submitted to the IRB office for 
approval via modification prior to enrolling the subject.   Please review the guidance and presentation on use of 
the short form available on the HRPP website. 
 
If using a short form without a translated HIPAA Research Authorization Form, please request a HIPAA waiver in 
the section above.  
 
9. 
Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, or a full waiver 
of consent, depending on the study. If you will request either a waiver of consent, or a waiver of signed consent 
for this study, complete the appropriate section below.   
 
☐Not Requesting any consent waivers  
 
☐Requesting a waiver of signed consent: 

Page 26 of 31 
 
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only) 
☐ Entire Study (Note that an information sheet may be required.) 
 
 
  
  ☒ Requesting a waiver of consent: 
☒ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only) 
☐ Entire Study   
 
 
 
 
 
 
 
 
 
 
SECTION IV: PROTECTION OF RESEARCH SUBJECTS 
 
    Confidentiality & Security of Data: 
1. What protected health information (medical information along with the HIPAA identifiers) about subjects will 
be collected and used for the research?   Name, SSN, zip code, DOB, medical record number, laboratory values, 
provider notes, medical procedures, medical history, medication lists, imaging/radiology results, hospital 
admission dates/discharges/records. 
 
2. How will the research data be collected, recorded and stored?  
All data collected from study coordinators from the EHR and through clinic visits and assessments/surveys will 
be will be entered and stored in Red Cap, Yale’s HIPAA-compliant and secure data collection platform.  The 
primary dataset will contain no PHI.  We will maintain a separate “linking file” that contains all PHI and will be 
stored on a separate secure HIPAA-compliant central server within the Program of Applied Translational 
For a waiver of signed consent, address the following:
 Would the signed consent form be the only record linking the subject and the research?  YES ☐  NO ☐  
 Does a breach of confidentiality constitute the principal risk to subjects? YES ☐  NO ☐ 
  
 OR 
 Does the research pose greater than minimal risk? YES ☐    NO☐  
 Does the research include any activities that would require signed consent in a non-research context? YES ☐   
NO ☐ 
For a full waiver of consent, please address all of the following:
 
Does the research pose greater than minimal risk to subjects?   
☐ Yes If you answered yes, stop. A waiver cannot be granted.   
☒ No 
 
Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☒ 
 
Why would the research be impracticable to conduct without the waiver? It would be impracticable to 
conduct the research without the waiver as each patient would need to be engaged to determine 
eligibility with most being ineligible.   
 
Where appropriate, how will pertinent information be returned to, or shared with subjects at a later date? 
Via fully informed consent.   

Page 27 of 31 
 
Research to limit the risk of accidental disclosure. The server is only accessible from within the Yale intranet (or 
via VPN remotely) and additionally requires separate logon username and password.  No PHI will be included 
in analysis or publication.  All analyses will proceed on this server alone.  The linking file is being maintained for 
potential future linking to national databases of death and dialysis. 
 
Medullan will collect data from the devices regarding frequency of use, user engagement and any health-
related data and store on the secure HIPAA-compliant storage databases described in the methods above. 
 
Information regarding the collection of the Participant data by the Vendor from the Participant and the storage 
of this collected data in the Vendor's solution is outlined below: 
 
 Bodyport: The following information is stored on the Bodyport scale: Bodyport device ID, Bodyport user ID, 
display name, year of birth, gender, and height.  This profile information is retrieved and reset each time the 
device is power cycled (i.e. the batteries are inserted).  Bodyport also stores measurement data on the scale so 
that uploads to the server can be re-attempted in the event of an upload failure.  Up to 30 measurements are 
stored at any time.  Once a data point is uploaded, it is flagged for deletion, with the oldest measurements 
deleted first.  Once the scale is returned by the participant, it is scanned and the pairing between the device ID 
and user ID is deleted, resetting it to its factory state.  Once a device is unpaired from a user or reassigned a 
new user ID, all existing measurements and profile information is erased from the device.  Anonymized 
measurement data will be maintained by Bodyport on the server in perpetuity. 
 
 
Noom:  Data will be available within the application on their mobile device.  Once participation is over, the 
account with all associated data will be deleted. 
 
Conversa: All data is stored on the platform for 7 years, unless a specific request to redact the data is received 
by the participant. 
 
3. How will the digital data be stored? ☐CD  ☐DVD  ☐Flash Drive  ☐Portable Hard  Drive   ☒Secured Server  
☐Laptop Computer  ☐Desktop Computer  ☐Other 
 
4. What methods and procedures will be used to safeguard the confidentiality and security of the identifiable 
study data and the storage media indicated above during and after the subject’s participation in the study?  
 
All data will be stored on an encrypted, HIPAA-Compliant server with 2-factor authentication. Data will not be 
stored on personal computing devices of any kind. The server will only be accessible from within the Yale 
firewall or via VPN. No portable devices will be used to store study data at any time. 
 
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical reason a 
device cannot be encrypted please submit an exception request to the Information Security, Policy and Compliance 
Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu 
 
5. What will be done with the data when the research is completed? Are there plans to destroy the identifiable 
data? If yes, describe how, by whom and when identifiers will be destroyed. If no, describe how the data and/or 
identifiers will be secured.  
PHI will be deleted by study personnel within one year of closing of the study. 
 
6. If appropriate, has a Certificate of Confidentiality been obtained? N/A 

Page 28 of 31 
 
 
SECTION V: POTENTIAL BENEFITS 
 
 
Potential Benefits: Identify any benefits that may be reasonably expected to result from the research, either to 
the subject(s) or to society at large. (Payment of subjects is not considered a benefit in this context of the risk 
benefit assessment.)  
Subjects in the intervention arms of this study may benefit from the use of their device through the receipt of 
more optimal and individualized care. This benefit may be derived as a consequence of additional health 
coaching, access to more educational materials, closer physician monitoring, and more thorough disease 
management.  
 
The results of this study will be used to refine how these technologies can provide better disease management of 
CHF.  If successful, further refinement, testing, and broad adoption of these tools may overall lead to enhanced 
clinical efficiency and better quality of care for patients living with CHF, which may result in lower rates of CHF 
complications and a lower societal burden on the healthcare system. 
 
 
         SECTION VI: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
 
1. Alternatives: What other alternatives are available to the study subjects outside of the research?  
Usual care 
2. Payments for Participation (Economic Considerations): Describe any payments that will be made to subjects, 
the amount and schedule of payments, and the conditions for receiving this compensation. 
Participants will be compensated for their completion of assessments and surveys at study enrollment, the 90 
day time point, and at study close out.  Patients will be given up to a total of one hour to complete all study 
related surveys and will be compensated $60 for this time, for a total of $180 paid to the patient by study 
completion.  This payment will take the form of a $60 prepaid Bank of America card sent to the patient after 
completion of each set of surveys (baseline, 90 day and 180 day). 
Costs for Participation (Economic Considerations): Clearly describe the subject’s costs associated with 
participation in the research, and the interventions or procedures of the study that will be provided at no cost 
to subjects.  
N/A  
3. In Case of Injury: This section is required for any research involving more than minimal risk, and for minimal 
risk research that presents the potential for physical harm (e.g., research involving blood draws). 
N/A 
a. Will medical treatment be available if research-related injury occurs? Write here 
 
b. Where and from whom may treatment be obtained? Write here 
c. Are there any limits to the treatment being provided? Write here 
d. Who will pay for this treatment? Write here 
e. How will the medical treatment be accessed by subjects? Write here 
 
 
 
 
 
 

Page 29 of 31 
 
 
 
 
 
 
 
 
 
 
 

Page 30 of 31 
 
IMPORTANT REMINDERS 
 
Will this study have a billable service?  Yes ☐  
 No☒ 
 
A billable service is defined as any service rendered to a study subject that, if he/she was not on a study, would 
normally generate a bill from either Yale-New Haven Hospital or Yale Medical Group to the patient or the patient’s 
insurer. The service may or may not be performed by the research staff on your study, but may be provided by 
professionals within either Yale-New Haven Hospital or Yale Medical Group (examples include x-rays, MRIs, CT 
scans, specimens sent to central labs, or specimens sent to pathology). Notes: 1. There is no distinction made 
whether the service is paid for by the subject or their insurance (Standard of Care) or by the study’s funding 
mechanism (Research Sponsored). 2. This generally includes new services or orders placed in EPIC for research 
subjects.  
 
If answered, “yes”, this study will need to be set up in OnCore, Yale’s clinical research management system, for 
Epic to appropriately route research related charges. Please contact oncore.support@yale.edu 
 
Are there any procedures involved in this protocol that will be performed at YNHH or one of its affiliated entities?  
Yes ☐  No ☒  
 
If Yes, please answer questions a through c and note instructions below.   
a. Does your YNHH privilege delineation currently include the specific procedure that you will perform? Yes ☐  No 
☐ 
b. Will you be using any new equipment or equipment that you have not used in the past for this procedure? Yes 
☐  No ☐ 
c. Will a novel approach using existing equipment be applied? Yes ☐  No ☐ 
  
If you answered “no” to question 4a, or "yes" to question 4b or c, please contact the YNHH Department of 
Physician Services (688-2615) for prior approval before commencing with your research protocol. 
 
IMPORTANT REMINDER ABOUT RESEARCH AT YNHH  
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at the HRU, the 
Principal Investigator and any co-investigators who are physicians or mid-level practitioners (includes PAs, APRNs, 
psychologists and speech pathologists) who may have direct patient contact with patients on YNHH premises 
must have medical staff appointment and appropriate clinical privileges at YNHH. If you are uncertain whether 
the study personnel meet the criteria, please telephone the Physician Services Department at 203-688-2615. By 
submitting this protocol as a PI, you attest that you and any co-investigator who may have patient contact has a 
medical staff appointment and appropriate clinical privileges at YNHH. 
 
 
 
 
 
 
 
 
 

Page 31 of 31 
 
References: 
 
 
 
 
1. 
Braunwald E. Heart Failure. JACC: Heart Failure. 2013;1(1):1-20. 
2. 
Packer M. Unbelievable Folly of Clinical Trials in Heart Failure: The Inconvenient Truth About 
How Investigators and Guidelines Weigh Evidence. Circ Heart Fail. 2016;9(4):e002837. 
3. 
Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-
based disparities. JAMA. 2004;291(22):2720-2726. 
4. 
Chang LL, DeVore AD, Granger BB, Eapen ZJ, Ariely D, Hernandez AF. Leveraging 
Behavioral Economics to Improve Heart Failure Care and Outcomes. Circulation. 
2017;136(8):765-772. 
5. 
McConnell MV, Turakhia MP, Harrington RA, King AC, Ashley EA. Mobile Health Advances 
in Physical Activity, Fitness, and Atrial Fibrillation: Moving Hearts. J Am Coll Cardiol. 
2018;71(23):2691-2701. 
6. 
Sharma A, Harrington RA, McClellan MB, et al. Using Digital Health Technology to Better 
Generate Evidence and Deliver Evidence-Based Care. J Am Coll Cardiol. 2018;71(23):2680-
2690. 
7. 
Perez MV, Mahaffey KW, Hedlin H, et al. Large-Scale Assessment of a Smartwatch to Identify 
Atrial Fibrillation. N Engl J Med. 2019;381(20):1909-1917. 
8. 
Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas 
City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll 
Cardiol. 2000;35(5):1245-1255. 
9. 
The Kansas City Cardiomyopathy Questionnaire (KCCQ). 2004.