Physical Activity Assessment, Promotion and Monitoring in a Preventive Cardiology Clinic: A Pilot Study
Phase: PHASE1
Conditions: Cardiovascular Diseases
Sponsor: NYU Langone Health

 
 
 
        
      
s20-00388 Date: 05252022 
 
 
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Interventional Template Version: 11 January 2019 
 
PHYSICAL ACTIVITY ASSESSMENT, PROMOTION AND MONITORING IN A PREVENTIVE 
CARDIOLOGY CLINIC: A PILOT STUDY 
 
 
Principal Investigator: 
 
Margaret M. McCarthy, PhD, RN, FNP-BC 
Rory Meyers College of Nursing 
433 First Avenue 
New York NY 10001 
mmm529@nyu.edu 
212-992-5796 
Additional Investigators: 
[PI at additional sites, etc. 
as applicable] 
 
Co-I Stuart Katz, MD 
NYU Langone Health Cardiology 
530 1st Avenue, New York, NY 10016 
Stuart.katz@nyulangone.org 
646-501-0119 
NYULMC Study Number: 
s20-00388 
Funding Sponsor 
National Institute for Nursing Research K23 Career 
Development Award 
National Institute of Nursing Research National Institutes of 
Health 
31 Center Drive, Room 5B03 
Bethesda, MD 20892-2178 
301-496-0207  
ClinicalTrials.gov 
Number                 
NCT04656132 
 
Initial version: April 21, 2020 
Amended: 
[May 25, 2022] 
 
Tool Revision History: 
 
Version Number 
Version Date 
Summary of Revisions Made 
1.0 
April 21 2020 
Final version 
2.0 
February 5 
2021 
1. Modification to data collection methods  
2. adding Spanish language surveys and consents 
3.0 
January 18, 
2022 
3. Revision to replacement of subjects section 
4.0 
May 25 2022 
4. Adding the nurse practitioner from the Center for 
Prevention of CVD (study site) to the interviews  
 
 

Study number: s20-00388 
 
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Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as 
applicable, any other applicable US government research regulations, and institutional research 
policies and procedures. The International Conference on Harmonisation (“ICH”) Guideline for 
Good Clinical Practice (“GCP”) (sometimes referred to as “ICH-GCP” or “E6”) will be applied 
only to the extent that it is compatible with FDA and DHHS regulations. The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place without 
prior agreement from the sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All 
personnel involved in the conduct of this study have completed Human Subjects Protection 
Training. 
 
 

Study number: s20-00388 
 
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Table of Contents 
 
S20-00388....................................................................................................................................................... I 
STATEMENT OF COMPLIANCE .................................................................................................................. II 
LIST OF ABBREVIATIONS ......................................................................................................................... V 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1 
KEY ROLES .......................................................................................................................................... 4 
Co-I Allison Vorderstrase, APRN DNSc MSN RN ................................................................................ 4 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....................... 4 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE AND RATIONALE ....................................... 4 
2.2 
POTENTIAL RISKS & BENEFITS ........................................................................................................ 5 
2.2.1 
Known Potential Risks ............................................................................................................. 5 
2.2.2 
Known Potential Benefits ......................................................................................................... 6 
3 
OBJECTIVES AND PURPOSE ............................................................................................................ 6 
3.1 
PRIMARY OBJECTIVE ....................................................................................................................... 6 
3.2 
SECONDARY OBJECTIVES (IF APPLICABLE) ....................................................................................... 6 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................... 6 
4.1 
DESCRIPTION OF STUDY DESIGN ..................................................................................................... 6 
4.2 
STUDY ENDPOINTS ......................................................................................................................... 7 
4.2.1 
Primary Study Endpoints.......................................................................................................... 7 
4.2.2 
Secondary Study Endpoints ..................................................................................................... 7 
5 
STUDY ENROLLMENT AND WITHDRAWAL ..................................................................................... 7 
5.1 
INCLUSION CRITERIA ....................................................................................................................... 7 
5.2 
EXCLUSION CRITERIA ...................................................................................................................... 8 
5.3 
VULNERABLE SUBJECTS .................................................................................................................. 8 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION ............................................................................ 8 
5.5 
PARTICIPATION ............................................................................................................................... 8 
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES .................................................................................. 8 
5.7 
PARTICIPANT WITHDRAWAL OR TERMINATION .................................................................................. 9 
5.7.1 
Reasons for Withdrawal or Termination .................................................................................. 9 
5.7.2 
Handling of Participant Withdrawals or Termination ................................................................ 9 
5.8 
PREMATURE TERMINATION OR SUSPENSION OF STUDY .................................................................... 9 
5.9 
STUDY BEHAVIORAL OR SOCIAL INTERVENTION(S)............................................................................ 9 
5.9.1 
Administration of Intervention .................................................................................................. 9 
5.9.2 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity .................... 10 
5.9.3 
Assessment of Subject Compliance with Study Intervention................................................. 10 
6 
STUDY PROCEDURES AND SCHEDULE ........................................................................................ 10 
6.1 
STUDY PROCEDURES/EVALUATIONS .............................................................................................. 10 
6.1.1 
Study Specific Procedures ..................................................................................................... 10 
6.1.2 
Standard of Care Study Procedures ...................................................................................... 12 
6.1.3 
Screening ............................................................................................................................... 13 
6.1.4 
Enrollment/Baseline ............................................................................................................... 13 
6.1.5 
Final Study Visit ..................................................................................................................... 13 
6.1.6 
Withdrawal/Early Termination Visit ........................................................................................ 13 
7 
ASSESSMENT OF SAFETY .............................................................................................................. 13 
7.1 
SPECIFICATION OF SAFETY PARAMETERS ...................................................................................... 13 

Study number: s20-00388 
 
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7.1.1 
Definition of Adverse Events (AE).......................................................................................... 13 
7.1.2 
Definition of Serious Adverse Events (SAE) .......................................................................... 14 
7.1.3 
Definition of Unanticipated Problems (UP) ............................................................................ 14 
7.2 
CLASSIFICATION OF AN ADVERSE EVENT........................................................................................ 14 
7.2.1 
Severity of Event .................................................................................................................... 14 
7.2.2 
Expectedness ......................................................................................................................... 15 
7.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP .................................... 15 
7.4 
REPORTING PROCEDURES – NOTIFYING THE IRB ........................................................................... 15 
7.4.1 
Adverse Event Reporting ....................................................................................................... 16 
7.4.2 
Serious Adverse Event Reporting .......................................................................................... 16 
7.4.3 
Unanticipated Problem Reporting .......................................................................................... 16 
7.5 
REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR ....................................................... 16 
7.6 
STUDY HALTING RULES................................................................................................................. 17 
7.7 
SAFETY OVERSIGHT ...................................................................................................................... 17 
8 
CLINICAL MONITORING ................................................................................................................... 17 
9 
STATISTICAL CONSIDERATIONS ................................................................................................... 18 
9.1 
STATISTICAL AND ANALYTICAL PLANS (SAP) .................................................................................. 18 
9.2 
ANALYSIS DATASETS..................................................................................................................... 19 
9.2.1 
General Approach .................................................................................................................. 19 
9.2.2 
Adherence and Retention Analyses....................................................................................... 19 
9.3 
SAMPLE SIZE ................................................................................................................................ 19 
10 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 20 
11 
QUALITY ASSURANCE AND QUALITY CONTROL ........................................................................ 20 
12 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 20 
12.1 
ETHICAL STANDARD ...................................................................................................................... 20 
12.2 
INFORMED CONSENT PROCESS ..................................................................................................... 21 
12.2.1 
Consent/Assent and Other Informational Documents Provided to Participants ............... 21 
12.2.2 
Consent Procedures and Documentation ......................................................................... 21 
12.3 
POSTING OF CLINICAL TRIAL CONSENT FORM ................................................................................ 21 
12.4 
PARTICIPANT AND DATA CONFIDENTIALITY ..................................................................................... 21 
13 
DATA HANDLING AND RECORD KEEPING ................................................................................... 22 
13.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 22 
13.2 
STUDY RECORDS RETENTION........................................................................................................ 23 
13.3 
PROTOCOL DEVIATIONS ................................................................................................................ 23 
13.4 
PUBLICATION AND DATA SHARING POLICY ..................................................................................... 24 
14 
STUDY FINANCES ............................................................................................................................. 24 
14.1 
FUNDING SOURCE ........................................................................................................................ 24 
14.2 
COSTS TO THE PARTICIPANT ......................................................................................................... 24 
14.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................. 24 
15 
STUDY ADMINISTRATION ................................................................................................................ 25 
15.1 
STUDY LEADERSHIP ...................................................................................................................... 25 
16 
CONFLICT OF INTEREST POLICY ................................................................................................... 25 
17 
REFERENCES .................................................................................................................................... 26 
18 
SCHEDULE OF EVENTS ................................................................................................................... 30 
 
 
 
 
 

Study number: s20-00388 
 
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List of Abbreviations 
 
PA:   physical activity. 
PAVS: physical activity vital sign 
EHR: electronic health record

Study number:  
 
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Protocol Summary 
Title 
Physical activity assessment, promotion and monitoring in a 
preventive cardiology clinic: a pilot study.  
Short Title 
PAVS in Cardiology 
Brief Summary 
This is a pilot study implemented physical activity assessment, 
promotion and monitoring in patients. Patients will be assessed by the 
physical activity vital sign (PAVS) during check-in for their 
appointment. During their visit with the cardiologist, a clinical decision 
support tool will alert the cardiologist to patients achieving low (<50% 
of recommended) physical activity. The cardiologist may refer the 
patient to cardiac rehabilitation if appropriate and/or counsel them to 
increase their physical activity levels. The patients may opt to enroll in 
the monitoring phase of the study. They will be given a Fitbit 
pedometer and their Fitbit account can sync to their MyChart account. 
After that sync, the patients step counts will be available for their 
cardiologists to review as needed.  
Phase 
Clinical study Phase 1 
Objectives 
There are two objectives for this study.  
Objective 1: Test the preliminary clinical efficacy of a PA promotion 
intervention on patients’ cardiovascular risk profile (PA, 
cardiorespiratory fitness, BMI, waist circumference, blood pressure, 
lipids and Framingham Heart Study Risk Score).  
Objective 2: Evaluate the implementation feasibility of the PA 
promotion intervention. The Practical, Robust Implementation and 
Sustainability Model (PRISM) will be used to guide the 
implementation, and evaluate the intervention’s reach, efficacy, 
adoption, implementation and maintenance for both HCPs and 
patients, in addition to qualitative feedback on acceptability.  
Methodology 
This study is a pilot feasibility study implementing physical activity 
assessment, promotion and monitoring in a cardiology clinical setting.  
Endpoint 
The primary endpoints include: physical activity levels (step-counts), 
cardiorespiratory fitness, BMI, waist circumference, blood pressure, 
lipids and Framingham Heart Study Risk Score 
For our secondary endpoints we will conduct a process evaluation we 
will evaluate the intervention’s reach, efficacy, adoption, 
implementation and maintenance using The Practical, Robust 
Implementation and Sustainability Model (PRISM).  
Study Duration 
A study duration of three years will include development of the clinical 
decision support tool, training clinic staff on intervention, recruitment, 
and data collection and analysis.  
Participant Duration 
Each participant will be in the study for 3 months. Baseline data 
collection is at Time 1; followed wearing the Fitbit for 3 months; and 
follow-up data collection at Time 2 (3 months).  

Study number: s20-00388 
 
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Population 
We will recruit 59 males and females age > 18 being seen in the NYU 
Langone Center for Prevention of Cardiovascular Disease (4F). 
Participants have cardiovascular disease or cardiovascular disease 
risk factors.  
Study Site 
 NYU Langone Center for Prevention of Cardiovascular Disease (4F) 
Number of 
participants 
59 participants in one site 
Description of Study 
Agent/Procedure 
The intervention consists of physical activity assessment promotion 
and remote home step-count monitoring in a clinical cardiology center.  
Reference Therapy 
This is a one-group study. There is no comparison group.  
Key Procedures 
Key procedures include assessment of physical activity; counseling by 
the cardiologist if physical activity levels are <50% of recommended; 
remote home monitoring via Fitbit sync to MyChart.  
Statistical Analysis 
Paired t-tests will be used to assess changes in average PA from 
week 2 to three-month follow-up using PAVS and Fitbit Zip data. 
Paired t-tests will be used to assess changes in readiness to change 
number, the 6MWT, BMI, waist circumference, systolic and diastolic 
BP, lipids, and Framingham Heart Study Risk Score. To assess 
meaningful improvement in CRF, we will report the percent of 
participants who achieve a clinically important difference of 25 meters 
in the 6MWT. Bivariate analyses will compare all CVD risk factors, as 
well as other potential confounders (e.g. age, sex, race/ethnicity, 
depressive symptoms, comorbidities), between those who achieve PA 
recommendations and those who do not.   
Preliminary effect sizes of change in PA (step counts) will be 
generated following the Physical Activity Change Detection (PACD) 
approach. Aim 2 is to conduct a process evaluation of the intervention. 
Implementation data will be evaluated using the PRISM framework.  
 

Study number: s20-00388 
 
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Flow diagram Single Group 
 
 
 
 
Total N=59 (single group): Obtain informed consent. Screen potential subjects by 
inclusion and exclusion criteria.   
Time 1. Perform baseline assessments: physical activity vital sign, 
cardiorespiratory fitness (6-minute walk test), body mass index, waist 
circumference, blood pressure, lipids, Framingham Heart Study Risk Score, 
depressive symptoms (PROMIS), and quality of life (SF-36).  
3 Months of Remote Home Monitoring of Physical Activity with Fitbit Step-counts 
syncing to MyChart in Epic.   
Prior to enrollment: Present protocol to CTSI Patient Advisory Council for Research 
to solicit feedback on how to appeal to participants and improve engagement. 
Review protocol with participating cardiologists and medical assistants. Informatics 
team to develop clinical decision support tool in Epic.  
 Implement the collection of Physical Activity Vital Sign for all patients at appointment 
check-in via check-in kiosk. If patients report < 50% of recommended physical activity 
alert to provider to refer to cardiac rehabilitation or counsel patients on improving 
physical activity levels. Cardiologists will describe remote monitoring phase of study 
and refer to PI or RA if interested. The PI or RA will describe the 3 months of patient 
remote home monitoring of physical activity using a Fitbit.  
Time 2. (3-months) Perform Follow-up assessments: physical activity vital sign, 
cardiorespiratory fitness (6-minute walk test), body mass index, waist 
circumference, blood pressure, lipids, Framingham Heart Study Risk Score, 
depressive symptoms (PROMIS), and quality of life (SF-36). 

Study number: s20-00388 
 
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1 
Key Roles 
PI: Margaret McCarthy, PhD, RN, FNP-BC,  
Assistant Professor  
NYU Rory Meyers College of Nursing.  
433 First Ave 
NY, NY, 10010  
212-992-5796 
mmm529@nyu.edu 
 
Mentor for K23 Mentored Patient-Oriented Research Career Development Award 
 
Co-I Stuart Katz, MD 
NYU Langone Health 
530 1st Avenue, Skirball 9N 
New York, NY 10016 
 
 
NIH Point of Contact: NINR Program Director: Amanda Price, PhD 
National Institute of Nursing Research National Institutes of Health 
31 Center Drive, Room 5B03 
Bethesda, MD 20892-2178 
301-496-0207 
Amanda.Price2@nih.gov 
 
2 
Introduction, Background Information and Scientific Rationale 
 
2.1 
Background Information and Relevant Literature and Rationale 
Physical inactivity is the fourth leading cause of death worldwide.1 Despite the numerous 
benefits of routine physical activity (PA) (e.g., lower risk for heart disease, stroke, type 2 
diabetes, and depression), only half of U.S. adults achieve the recommended levels of PA: 2 a 
minimum of 150 minutes/week of moderate-to-vigorous PA.3  Meeting PA guidelines could result 
in significant improvements in body fat, body mass index (BMI), blood glucose, and 
cardiorespiratory fitness.4 Improving these risk factors would lower the risk of cardiovascular 
disease (CVD) and stroke, the two leading causes of death in the U.S.5  
The American Heart Association (AHA) and American College of Cardiology have 
recommended that healthcare providers (HCPs) counsel patients on adopting PA guidelines. 6 
While PA counseling trends are improving, little has been done in terms of routinely assessing 
PA in a standardized way.7 The first step in promoting PA is to assess patients’ current habits.8 
A 2018 AHA scientific statement on assessing and promoting PA in healthcare settings 
suggested use of the electronic health record (EHR) for self-report and activity trackers (e.g. 
Fitbit) for monitoring. 9 
The purpose of this feasibility study based on the Chronic Care Model10 is to address the low 
levels of PA in adults by testing a PA promotion intervention based on an EHR clinical decision 
support tool. This tool will facilitate HCPs in assessing and promoting patients’ PA, and in turn 
patients will be involved in negotiating ways of increasing PA, which may improve their CVD risk 
profile.  Clinical decision support tools have been used to screen for CVD risk and can play an 
important role in improving patient outcomes, particularly when the patient is involved.11 In 

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response to the major health problem of physical inactivity, the 3-question physical activity vital 
sign (PAVS) was developed to assess PA duration and intensity.12,13 
According to the AHA physical inactivity is a major modifiable risk factor for CVD.14 Despite the 
strong evidence regarding the hazards of physical inactivity half of U.S. adults do not achieve the 
recommended levels of PA.2 Moving individuals out of the lowest category of cardiorespiratory 
fitness results in the greatest reductions in all-cause mortality.39 and can be achieved with 
increased PA.4 HCPs are in a position to influence this process by routinely counseling patients 
on this important CVD risk factor.  
The U.S. 2018 PA Guidelines for Americans recommends 150 minutes/week of moderate 
intensity PA or 75 minutes/week of vigorous intensity PA, or an equivalent combination of both, 
with vigorous activity weighted twice that of moderate.3 Improving rates of HCP counseling on 
PA is one of the objectives of Healthy People 2020.15 The U.S. Preventive Services Task Force 
recommends referring adults with CVD risk factors seen in primary care to behavioral 
counseling interventions to promote PA for CVD prevention.16 HCPs can be instrumental 
sources of health guidance for their patients, but they do not routinely counsel patients on 
PA.15,17 PA counseling (face-to-face or by phone) offered on multiple occasions in primary care 
settings resulted in improved PA levels at 12 months in previously sedentary adults.18 Primary 
care behavioral counseling for CVD prevention was also associated with a 35-minute/week 
(95% CI: 22-47) improvement in PA levels.19 While the use of brief one-time counseling has not 
been shown to be enough to effect long-term change, routine office-based screening and advice 
coupled with ongoing support has been effective in improving PA.17 The AHA recommends the 
use of goal setting, self-monitoring, follow-up, and feedback when promoting PA.20 In adults with 
CVD, wearing an activity tracker coupled with PA advice resulted in greater improvements in 
cardiorespiratory fitness (CRF) as compared to those not wearing an activity tracker.21 This 
proposal will address the gap in routine PA counseling with an intervention that standardizes the 
assessment, promotion and monitoring of PA in the clinical setting through utilization of the 
EHR.  
The PAVS is a valid clinical tool to assess PA22 which can be the basis for PA promotion and 
counseling. Several large healthcare systems have implemented the PAVS for assessment of 
PA.7 Data from almost 20 hospitals indicate the PAVS has strong face and discriminant validity 
(between groups of patients with differing activity levels).23 However, despite strong 
endorsement from the AHA,6 many HCPs continue to describe barriers to PA counseling, 
including lack of time, required counseling skills, reimbursement and routine screening of PA.24 
This proposed intervention, embedded in the EHR, expands upon the current use of the PAVS 
and may help to overcome the existing barriers to addressing PA. In a systematic review of 
behavior change techniques used in eHealth PA interventions in adults with CVD, providing 
information on health consequences, goal-setting and self-monitoring were the three most 
common behavior change techniques used.25 Our intervention will educate the patient on PA 
recommendations, help them set goals, and employ a self-monitoring tool that has the added 
benefit of PA data syncing to the EHR.  
2.2 Potential Risks & Benefits 
2.2.1 Known Potential Risks 
Potential risks associated with this research are fatigue from data collection, inconvenience 
caused by the need to schedule visits, and loss of confidentiality. There are also inherent risks 
to participating in physical activity. This will be minimized with the appropriate clinical judgement 
of the physician in the physical activity promotion process. There is a slight risk of loss of 
confidentiality in the data collection from the electronic health record, but this will be minimized 

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by the collection of de-identified data only. There are some risks during the fingerstick blood 
collection of lipids and glucose.  With respect to fingerstick blood collection in general (requiring 
a small sample size of 40μL of blood), some participants may experience temporary discomfort. 
Some may bruise. Extremely rare risks associated with a fingerstick are bleeding, feeling 
lightheaded, hematoma, or infection. This risk will be minimized by following established 
hospital protocols for fingerstick blood collection.  
2.2.2 Known Potential Benefits 
 
There may not be direct benefit to patient subjects of this study. However, subjects may 
increase their physical activity levels enough to reduce their cardiovascular risk by reductions in 
weight, blood pressure or hemoglobin A1c or improvements in lipids. Subjects may gain of 
sense of contribution to the process of improving physical activity assessment and promotion.  
3 
Objectives and Purpose 
The purpose of this feasibility study is to implement a physical activity intervention in a 
preventive cardiology clinic to assist HCPs in assessing, promoting and monitoring their 
patients’ PA.  
3.1 
Primary Objective 
Aim 1: Test the preliminary clinical efficacy of a PA promotion intervention on patients’ 
cardiovascular risk profile (PA, cardiorespiratory fitness, BMI, waist circumference, blood 
pressure, lipids and Framingham Heart Study Risk Score).  
3.2 
Secondary Objectives (if applicable) 
Aim 2: Evaluate the implementation feasibility of the PA promotion intervention. The Practical, 
Robust Implementation and Sustainability Model (PRISM)26 will be used to guide the 
implementation, and evaluate the intervention’s reach, efficacy, adoption, implementation and 
maintenance for both HCPs and patients, in addition to qualitative feedback on acceptability.  
4 
Study Design and Endpoints 
4.1 
Description of Study Design 
This is a one-group, pre-post, single-center phase 1 clinical trial feasibility study based on the 
Chronic Care Model.10 This study has two phases.  
Phase 1: The PI will train the medical assistants on the collection of the PAVS (in case the 
patient had not entered the kiosk data). The PI will meet the CTSI Patient Advisory Council for 
feedback on how to appeal to participants and improve engagement. The PI will review the plan 
and the American College of Sports Medicine exercise screening guidelines with the 
cardiologists and elicit final questions or feedback.27 
Phase 2: Each patient in the Center is seen by the medical assistant for the assessment of their 
vital signs and confirmation of the PAVS completion in the check-in kiosk. During the patient’s 
visit with the cardiologist, an EHR decision support tool will be presented as an alert to the 
cardiologist for patients who are not achieving at least 50% of recommended PA levels. This 
threshold was chosen for two reasons. A higher threshold (e.g. < 90%) would create many more 
alerts for the cardiologist and possibly lead to ‘alert fatigue’. Second, our focus will be on the 
least active patients. The cardiologist will choose and acknowledge the PA promotion 
recommendations they discussed with the patient: #1) patients with a diagnosis appropriate for 
cardiac rehabilitation28 will be given a suggested verbal and/or electronic referral to cardiac 

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rehabilitation services; and/or #2) patients who are not eligible for a cardiac rehabilitation 
referral (or do not want to attend) will be given a verbal recommendation to start engaging in 
PA, or increase intensity and/or duration of PA with an agreed upon goal for the next 3 months. 
Patients who should not increase PA due to certain medical diagnoses (e.g. aortic stenosis, 
unstable angina) will be excluded. The cardiologist will inform these patients about the remote 
PA monitoring.  
Upon contact, the PI will describe the study, and if patients agree to participate, obtain consent, 
enroll the participant and collect baseline data. The PI will give participant a Fitbit Zip, set up an 
account with a study ID and ask them to wear the Fitbit Zip during all waking hours. NYU 
Langone has implemented integration of Fitbit Zip data into the EHR which requires the patient 
to sync their Fitbit account to the patient portal (MyChart) once and step counts will then sync to 
EHR and can populate the cardiologists’ note. 
 
4.2 
Study Endpoints 
4.2.1 Primary Study Endpoints 
For this feasibility study, we will implement the intervention (PA assessment using the PAVS; 
counseling by the cardiologists; and PA monitoring of patients wearing a Fitbit) for 12 months. 
Patient subjects who enroll in the PA monitoring will wear the Fitbit for 3 months.  
Primary endpoints include: patients’ cardiovascular risk profile (PA, cardiorespiratory fitness, 
BMI, waist circumference, blood pressure, lipids and Framingham Heart Study Risk Score).  
4.2.2 Secondary Study Endpoints 
We will evaluate the implementation feasibility of the PA promotion intervention. The Practical, 
Robust Implementation and Sustainability Model (PRISM)26 will be used to guide the 
implementation, and evaluate the intervention’s reach, efficacy, adoption, implementation and 
maintenance for both HCPs and patients, in addition to qualitative feedback on acceptability.  
5 
Study Enrollment and Withdrawal 
Cardiologists from Preventive Cardiology that have agreed to participate in this pilot study will 
have the study described and will sign an informed consent. Patient participants are those 
patients being treated in Preventive Cardiology. Their cardiologist can inform them of the study 
and given them the PI’s contact information or introduce them to the PI or RA if they are present 
in the clinic. All patients who achieve < 50% of recommended PA and do not meet any of the 
exclusion criteria will have the study described to them. The PI or RA will confirm inclusion and 
exclusion criteria.  
5.1 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
Adult patients in the Center who are age 18 and above will be assessed with the PAVS as part 
of routine care. To enroll in the home monitoring of PA:  
1. Patients must achieve < 50% of PA recommendations according to PAVS screening 
questions 
2. Have a cellular phone with data plan or a computer to sync Fitbit data 
3. Speak English or Spanish  
4. Be willing to wear a Fitbit Zip for 3 months 

Study number: s20-00388 
 
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5.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. Adults with a physical disability or medical diagnosis limiting their ability to exercise (e.g. 
wheelchair bound, aortic stenosis, unstable angina) 
2. Planned surgery within three months 
3. Those with decisional incapacity therefore unable to comply with study requirements (i.e. 
related to cognitive deficits or psychiatric diagnosis) 
4. Pregnant or breastfeeding women.  
 
5.3 
Vulnerable Subjects 
No vulnerable subjects are included in this study.  
 
5.4 
Strategies for Recruitment and Retention 
Appropriate patients will be invited to participate by the cardiologist during the visit. They will be 
given a study information flyer and contact information of the PI, who will screen for 
inclusion/exclusion criteria. The informatics team at NYU Langone may also provide a list of 
patients on a monthly basis who achieve < 50% of recommended PA. This will facilitate 
recruitment in the event of virtual visits when the patient fills out the PAVS via MyChart.  
The PI will contact the individual cardiologist by email to inform them of the intent to recruit their 
patient into the remote monitoring study. If the cardiologist has any objections, they can inform 
the PI. The ‘Friendly’ Letter to the Provider is attached. If met, the PI will enroll them in the 
study. If the PI is not immediately present in the Center, the interested patient will be given the 
PI contact information. The PI will also access the expertise of the NYU School of Medicine 
CTSI Recruitment and Retention Unit as needed for both recruitment and retention. Description 
of the study and consent for participation will take place in one of the offices in the Preventive 
Cardiology Center. The PI may also describe the study over the phone to patients who call after 
being referred by their cardiologist.  
Retention strategy: While subjects are wearing the Fitbit they will be contacted the first week to 
check in and see if they have any questions. They will be contacted as needed over the 3 
months if the PI or RA notice they are not wearing the Fitbit daily to troubleshoot ideas to 
improve their Fitbit wear time.  
Our target sample size is 59 subjects. Our target is to enroll 2-3 subjects per week. When the PI 
or RA is not present in the clinic, a study flyer will be left with the cardiologists and staff.  
5.5 
 Participation 
Baseline data collection will take place on the day of consent. Each subject will be asked to 
wear a Fitbit pedometer for 3 months. Follow-up data collection will take place as close to the 3-
month date as possible.  
5.6 
Total Number of Participants and Sites  
This is a single site study conducted at the Preventive Cardiology Center (4F). All 59 subjects 
will be enrolled at this site.  
Recruitment will end when approximately 59 subjects are enrolled. It is expected that 
approximately 59 participants will be enrolled in order to produce 47 evaluable subjects. We 
have anticipated approximately 20% attrition.  
 

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5.7 
Participant Withdrawal or Termination 
5.7.1 Reasons for Withdrawal or Termination 
 
Participants are free to withdraw from participation in the study at any time upon request. An 
investigator may terminate participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurs such that continued participation in the study would not be in the best 
interest of the participant 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 
5.7.2 Handling of Participant Withdrawals or Termination 
Subjects that withdraw from the study will continue to receive usual care from their cardiologist. 
Every effort will be made to capture the reason for subject withdrawal and to ascertain if any 
adverse events or serious adverse events occurred, which would be immediately reported to the 
IRB and study sponsor. Subjects who fail to comply with baseline data collection activities after 
signing the consent, despite several efforts to contact the subject with no response from the 
subject, will be replaced.  
 
5.8 
Premature Termination or Suspension of Study 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to the IRB and funding 
agency. If the study is prematurely terminated or suspended, the PI will promptly inform the IRB 
and will provide the reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, data quality are 
addressed and satisfy the sponsor, IRB and/or FDA. 
 
5.9 
Study Behavioral or Social Intervention(s) 
This study is testing a behavioral intervention that includes assessment (using PAVS), 
promotion (by the cardiologists) and monitoring of PA (by Fitbit) for patients seen in Preventive 
Cardiology Center.  
 
5.9.1 Administration of Intervention 
This intervention will be incorporated into clinical care in the Preventive Cardiology Center. The 
patient will answer the 3-question PAVS: 1) “On average, how many days per week do you 

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engage in PA or exercise?”; 2) “On average, how many total minutes of PA or exercise do you 
perform on those days?”; and 3) “Describe the intensity of your PA or exercise (light=casual 
walk, moderate=brisk walk, or vigorous=jogging)” in the EHR when they check in for their 
appointment. During their clinical visit with their cardiologist, if they achieve < 50% of 
recommended PA on average, the cardiologist will make a referral to cardiac rehabilitation (if 
appropriate) or make a PA recommendation to increase intensity or duration of PA. The patient 
can choose to participate in the remote monitoring using the Fitbit activity monitor. The Fitbit 
data will sync to their MyChart account in the EHR. 
 
5.9.2 Procedures for Training Interventionalists and Monitoring Intervention Fidelity 
The PI will conduct intervention fidelity checks on a monthly basis. The PI will be given a 
monthly report generated from the Epic analyst team which will include data on completion of 
the PAVS questions and the cardiologists’ referral system for PA. If use of the PAVS or referral 
system is < 80% for the month, the PI will meet with the medical assistant or cardiologist to 
discuss strategies to improve use. If the patient subject does not wear the Fitbit for at least 5 
days per week, they will be contacted by the PI or RA to discuss strategies to improve 
adherence.  
 
5.9.3 Assessment of Subject Compliance with Study Intervention 
If the patient subject has less than 5 days of valid Fitbit wear (less than 10 hours/day) for the 
week, the PI or RA will call the patient subject and discuss strategies to improve adherence.  
We will use utilize the resources of the NYU Recruitment and Retention Unit as needed. We will 
follow up with the patient subjects with the method they prefer (phone, email, text) for Fitbit data 
collection and to schedule the follow-up data collection at 3 months.   
6 
Study Procedures and Schedule 
Baseline visit: After their visit with their cardiologist, interested patient subjects will have the 
study described and consent and enrollment in the study if desired. Baseline data collection will 
take place. For the next 3 months the patient subject is asked to wear the Fitbit and sync to their 
app on their phone. At 3 months patient subjects will return to the clinic for follow-up 
assessment.  
A sample of 10 patient subjects will be asked to provide feedback about the study at this follow-
up visit. A semi structured interview guide will be used to obtain feedback about the intervention 
from their perspective. Upon study completion, qualitative interviews using a semi-structured 
interview guide with the three cardiologists and the one nurse practitioner in the Center who 
works with one of the cardiologists will explore the acceptability, clinical utility and usability of 
the implementation.  
6.1 
Study Procedures/Evaluations 
6.1.1 Study Specific Procedures 
 
Phase 1. The PI will train the medical assistants on the collection of the PAVS (in case the 
patient had not entered the kiosk data). The PI will meet the CTSI Patient Advisory Council for 
feedback on how to appeal to participants and improve engagement. The PI will review the plan 
and the American College of Sports Medicine exercise screening guidelines with the 
cardiologists and elicit final questions or feedback.29 

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Phase 2.  Each patient in the Center is seen by the medical assistant for the assessment of 
their vital signs and confirmation of the PAVS completion in the check-in kiosk. During the 
patient’s visit with the cardiologist, an EHR decision support tool will be presented as an alert to 
the cardiologist for patients who are not achieving at least 50% of recommended PA levels. This 
threshold was chosen for two reasons. A higher threshold (e.g. < 90%) would create many more 
alerts for the cardiologist and possibly lead to ‘alert fatigue’. Second, our focus will be on the 
least active patients. The cardiologist will choose and acknowledge the PA promotion 
recommendations they discussed with the patient: #1) patients with a diagnosis appropriate for 
cardiac rehabilitation30 will be given a suggested verbal referral to cardiac rehabilitation 
services; and/or #2) patients who are not eligible for a cardiac rehabilitation referral (or do not 
want to attend) will be given a verbal recommendation to start engaging in PA, or increase 
intensity and/or duration of PA with an agreed upon goal for the next 3 months. Patients who 
should not increase PA due to certain medical diagnoses (e.g. aortic stenosis, unstable angina) 
will be excluded. The cardiologist will inform these patients about the remote PA monitoring.  
Upon contact, the PI will describe the study, and if patients agree to participate, obtain consent, 
enroll the participant and collect baseline data. The PI will give participant a Fitbit Zip, set up an 
account with a study ID and ask them to wear the Fitbit Zip during all waking hours. NYU 
Langone has implemented integration of Fitbit Zip data into the EHR which requires the patient 
to sync their Fitbit account to the patient portal (MyChart) once and step counts will then sync to 
EHR and can populate the cardiologists’ note. Participants will be given the first compensation 
for their time ($50 gift card) at completion of this baseline visit. One week after enrollment, a 
follow-up call will be made to the participants to answer questions. The PI will review the PA 
data weekly to ensure that participants are correctly wearing the Fitbit Zip and data are being 
downloaded and synced.  The PI will make follow-up reminders as needed. Data will be 
downloaded from each participant’s record at the end of three months. At three months, the PI 
will meet with the participant to collect follow-up data and provide the second incentive of $50. 
Qualitative interviews to assess the acceptability of the intervention (including previous use of 
smart devices) will be collected in a purposive sample (n=10) of participants with varying levels 
of PA and varying degrees of adherence to the Fitbit Zip. The participant may keep the Fitbit.  
In the event virtual recruitment and data collection is needed due to Covid-19 restrictions, or to 
minimize the amount of in-person time involved for the consent, the PI will discuss the study by 
telephone with the interested patient. If they meet inclusion criteria they will be sent via email an 
electronic link to the consent on REDCap (REDCap consent link attached). The PI will discuss 
the study and review the consent with the interested patient by telephone page by page. If the 
patient is interested in participation, they can electronically sign their consent.  
Measures:  
Baseline visit after consent and enrollment in the study. Data collection will include: 
Physical Activity Vital Sign (PAVS): 3 questions as described above when patients check in for 
their clinical appointment. 
Stages of Change will be assessed with a Readiness to Change Ruler.31 A straight line is drawn 
on paper representing the process of change (from 1= ‘not ready to change’ to 10=‘already 
changing’). 
Cardiorespiratory fitness (CRF) will be measured by the six-minute walk test, a valid and reliable 
measure for use in field testing of CRF.32 The 6MWT will be conducted in a quiet hallway using 
a 30-meter track with standard instructions.33 
BMI will be calculated by height and weight measured at the time of the Center visit on a 
balance beam scale.  
Waist Circumference will be measured to the nearest inch using standard technique.34 Blood 
pressure (BP) will be measured in right arm (unless contraindicated) after sitting for 5 minutes 
and repeated after a 5-minute interval. Both will be recorded and the average used in analyses.  
 

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Total cholesterol, HDL, and triglycerides will be measured by CLIA-waived Alere Cholestech 
LDX® Analyzer which is certified by the Center for Disease Control’s Lipid Standardization 
Program and Cholesterol Reference Method Laboratory Method Network. This will be measured 
by a single fingerstick using standard aseptic technique.  
The Framingham Heart Study Risk Score (10-year risk) will be calculated using the appropriate 
risk model based on participants’ age, gender, diabetes status and prior coronary heart 
disease.35 Two covariates that have an inverse association with PA, depressive symptoms and 
general health-related quality of life,36,37 will be assessed.  
Depressive symptoms will be measured by the PROMIS Depression Short Form 6a, 
a reliable (α =.92) 6-item survey with strong convergent validity (α =.72-.84) which assesses 
negative views of self, social cognition, decreased positive affect and engagement38  and is also 
available in Spanish.39 It will be scored with REDCap auto-score.  
General health-related quality of life will be measured by the common data element 36-Item 
Short Form Health Survey (SF-36) v-1, a reliable measure (α =.90) of physical and mental 
health with strong criterion validity, which is also available in Spanish.77-80 PROMIS surveys will 
be scored using the REDCap auto score for accuracy. 
Clinical data will be collected from the EHR including potential confounding variables: age, sex, 
race/ethnicity, primary diagnosis, smoking status, and comorbidities (summarized as continuous 
data by the Charlson Comorbidity Index).40  
Sociodemographics, collected using common data elements survey41 and clinical data from the 
EHR will be collected at baseline. Fitbit steps will be collected daily for 3 months.  
All other data will be collected baseline and at 3 months. 
In the event all data collection must be remote or the subject prefers remote data collection, the 
PI will use baseline data from the electronic health record. The six-minute walk test can be 
administered remotely via an app on the subject’s mobile phone with the distance walked 
emailed to the PI. BMI and blood pressure taken on the day of their recent clinical visit will be 
used for baseline data. A measuring tape will be mailed to the participant with instructions on 
measurement of waist circumference using standard technique. The PI or RA can schedule a 
videoconference to review the technique of measuring waist circumference. The most recent 
total cholesterol, HDL, and triglycerides results from the EHR will be used. All other baseline 
data collection will remain as planned. 
If at 3-months remote data collection continues for a subject, the six-minute walk test will be 
done remotely with the mobile app. BMI and blood pressure will be used from the most recent 
office visit, as close to the 3-month follow-up date as possible. The patient will measure waist 
circumference as directed using standard technique and reviewed via video conference. The 
next available lab data for total cholesterol, HDL and triglycerides will be used. All other 3-month 
data collection will remain as planned. 
If at 3-months in-person data collection is possible, the PI will resume in-person data collection 
as planned and meet the subject at the preventive cardiology center for data collection.  
The PRISM26 will be used to collect process evaluation data throughout the implementation. 
This will include data on the reach (proportion that participate in intervention), efficacy (success 
rate if implemented as designed), adoption (proportion that adopt intervention), implementation 
(extent to which intervention is implemented as intended) and maintenance (extent to which 
program is sustained over time) of the PA promotion intervention 
 
6.1.2 Standard of Care Study Procedures 
Patient subjects will continue to see their cardiologists for routine clinical care according to their 
diagnosis.  
 

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6.1.3 Screening  
Screening: the RA or PI or evaluate each potential patient subject to determine eligibility before 
the study is described.  
6.1.4 Enrollment/Baseline 
Enrollment/Baseline Visit (Visit 1, Day 0) 
• 
Obtain informed consent of potential participant verified by signature on study informed 
consent form or on the REDCap electronic consent form. 
• 
Verify inclusion/exclusion criteria. 
• 
Obtain demographic and clinical information 
• 
Collect baseline data (surveys, fingerstick lipids, six-minute walk test, waist 
circumference, body mass index) 
 
6.1.5 Final Study Visit 
 
Final Study Visit (Visit 2; 3 months after baseline visit +/- 2 weeks)  
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Collect follow-up data (surveys, fingerstick lipids, six-minute walk test, waist 
circumference, body mass index) 
6.1.6 Withdrawal/Early Termination Visit 
If the patient subject terminates the study early and is willing to participate, the PI will collect 
follow-up data if the patient subject has completed at least 2.5 months of follow-up.   
7 
Assessment of Safety 
7.1 
Specification of Safety Parameters  
Patient subjects will be counseled on PA by their cardiologist. If they experience any adverse 
events (for example transient or new chest discomfort) they will be instructed to call their 
cardiologists immediately. If they experience a severe adverse event (chest discomfort that 
does not go away or last longer than usual), they will be instructed to activate the emergency 
response system. The cardiologists will counsel the patients on PA and to monitor for any 
adverse events during PA.  
7.1.1 Definition of Adverse Events (AE) 
 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in 
severity during the course of the study.  Intercurrent illnesses or injuries should be regarded as 
adverse events.  Abnormal results of diagnostic procedures are considered to be adverse 
events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
 

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7.1.2 Definition of Serious Adverse Events (SAE) 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE 
that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 
• an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly 
of major clinical significance. They may jeopardize the subject, and may require intervention to 
prevent one of the other serious outcomes noted above. For example, drug overdose or abuse, 
a seizure that did not result in in-patient hospitalization, or intensive treatment of bronchospasm 
in an emergency department would typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-
serious adverse events.  
 
7.1.3 Definition of Unanticipated Problems (UP) 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency (i.e. not described in study-related 
documents such as the IRB-approved protocol or consent form, the investigators 
brochure, etc) 
• Related or possibly related to participation in the research (i.e. possibly related means 
there is a reasonable possibility that the incident experience, or outcome may have been 
caused by the procedures involved in the research) 
• Suggests that the research places subjects or others at greater risk of harm (including 
physical, psychological, economic, or social harm). 
 
7.2 
Classification of an Adverse Event 
7.2.1 Severity of Event 
 
For AEs not included in the protocol defined grading system, the following guidelines will be 
used to describe severity. 
 
• Mild – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities. 
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating. 
 

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7.2.2 Expectedness 
 
PI Margaret McCarthy, in consultation with the DSMB will be responsible for determining 
whether an AE is expected or unexpected. The patient-subject’s cardiologist will also be 
consulted. An AE will be considered unexpected if the nature, severity, or frequency of the event 
is not consistent with the risk information previously described for the study agent. 
7.3 
Time Period and Frequency for Event Assessment and Follow-Up 
 
The occurrence of an AE or SAE may come to the attention of study personnel during study 
visits and interviews of a study participant presenting for medical care, or upon review by a 
study monitor. All AEs including local and systemic reactions not meeting the criteria for SAEs 
will be captured on the appropriate RF. Information to be collected includes event description, 
time of onset, clinician’s assessment of severity, relationship to study product (assessed only by 
those with the training and authority to make a diagnosis), and time of resolution/stabilization of 
the event. All AEs occurring while on study must be documented appropriately regardless of 
relationship. All AEs will be followed to adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE. UPs will be recorded in 
the data collection system throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
 
The PI will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation. At each study visit, the investigator will inquire about the occurrence of 
AE/SAEs since the last visit. Events will be followed for outcome information until resolution or 
stabilization.  
 
All unresolved 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 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 investigator should notify the study 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 investigator should become aware of the development of cancer or of a congenital anomaly 
in a subsequently conceived offspring of a subject that has participated in this study.  
7.4 
Reporting Procedures – Notifying the IRB  
Adverse Events. We do not anticipate any life-threatening adverse events for this proposed 
research project. In the event an adverse event or serious adverse event occurs, this will be 
reported immediately to the Data Safety Monitoring Board, the NYU IRB and to the sponsoring 
agency. A thorough investigation will be initiated, including review of the protocol to insure no 
undue exposure to risk occurred.  

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7.4.1 Adverse Event Reporting 
Protocol for Adverse Events. If a patient participant experiences an adverse event during 
physical activity (e.g. experiencing a fall or musculoskeletal injury), they will be instructed to 
contact their physician immediately. If the event is an emergency that requires immediate 
medical attention (e.g. chest, jaw or arm pain, severe shortness of breath, rapid heart rate) they 
will be instructed to activate the emergency response system (e.g. call 911). The PI will monitor 
all reports of adverse events or serious adverse events related to this intervention. In the event 
an adverse or serious adverse event occurs, this will be reported immediately to the Data Safety 
Monitoring Board, the NYU IRB and to the sponsoring agency. A thorough investigation will be 
initiated, including review of the protocol to insure no undue exposure to risk occurred.  
7.4.2 Serious Adverse Event Reporting 
The protocol for serious adverse events will follow the same protocol for adverse events. If the 
event is an emergency that requires immediate medical attention (e.g. chest, jaw or arm pain, 
severe shortness of breath, rapid heart rate) they will be instructed to activate the emergency 
response system (e.g. call 911). The PI will monitor all reports of adverse events or serious 
adverse events related to this intervention. In the event an adverse or serious adverse event 
occurs, this will be reported immediately to the Data Safety Monitoring Board, the NYU IRB and 
to the sponsoring agency. A thorough investigation will be initiated, including review of the 
protocol to insure no undue exposure to risk occurred.  
7.4.3 Unanticipated Problem Reporting 
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of 
an UP report form. It is the site investigator’s responsibility to report UPs to their IRB and to the 
DCC/study sponsor. The UP report will include the following information: 
 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• A detailed description of the event, incident, experience, or outcome; 
• An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP; 
• A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline: 
 
• UPs that are SAEs will be reported to the IRB and to the DSMB/study sponsor within 1 
day of the investigator becoming aware of the event. 
• Any other UP will be reported to the IRB and to the DSMB study sponsor within 2 days of 
the investigator becoming aware of the problem. 
• All UPs should be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), the supporting agency head (or designee), and 
OHRP within<insert timeline in accordance with policy> of the IR’s receipt of the report of 
the problem from the investigator. 
 
7.5 
Reporting Procedures – Notifying the Study Sponsor 
 
The study clinician will complete a SAE Form within the following timelines: 

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• All deaths and immediately life-threatening events, whether related or unrelated, will be 
recorded on the SAE Form and submitted to the DSMB/study sponsor within 24 hours of 
site awareness. See Section 1, Key Roles for contact information. 
• Other SAEs regardless of relationship will be submitted to the DSMB/study sponsor 
within 72 hours of site awareness. 
 
All SAEs will be followed until satisfactory resolution or until the site investigator deems the 
event to be chronic or the adherence to be stable. Other supporting documentation of the event 
may be requested by the DCC/study sponsor and should be provided as soon as possible.  
 
As a follow-up to the initial report, within the following 48 hours of awareness of the event, the 
investigator shall provide further information, as applicable, on the unanticipated event or the 
unanticipated problem in the form of a written narrative.  This should include a copy of the 
completed Unanticipated Problem form, and any other diagnostic information that will assist the 
understanding of the event.  Significant new information on ongoing unanticipated adverse 
effects shall be provided promptly to the study sponsor. 
 
7.6 
Study Halting Rules 
 
Review of serious, unexpected, and related AEs by the DSMB, IRB, the sponsor(s), or the FDA 
or relevant local regulatory authorities may result in suspension of the study.  
 
Examples of findings that might trigger a safety review are the number of SAEs overall, the 
number of occurrences of a particular type of SAE, severe AEs/reactions, or increased 
frequency of events. 
 
7.7 
Safety Oversight 
 
It is the responsibility of the Principal Investigator to oversee the safety of the study at his/her 
site.  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. Medical monitoring will include a regular assessment of the number 
and type of serious adverse events. 
 
Safety oversight will be under the direction of a DSMB composed of individuals with the 
appropriate expertise, including PA, cardiovascular disease, and statistics. The DSMB will meet 
at least semiannually to assess safety and efficacy data of the study. The DSMB will operate 
under the rules of an approved charter that will be written and reviewed at the organizational 
meeting of the DSMB. At this time, each data element that the DSMB needs to assess will be 
clearly defined. The DSMB will provide its input to NIH.  
8 
Clinical Monitoring 
The PI will conduct continuous site monitoring at the study site. Any adverse or serious adverse 
events or unexpected problems will be reported to the DSMB and IRB as noted.  
If a subject has an elevated score indicating moderate or severe depressive symptoms on the 
PROMIS Depression Short Form (raw score > 16) there will be a protocol in place to contact the 

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subject to facilitate a medical referral for potential treatment. No additional clinical monitoring 
plan is needed.  
 
9 
Statistical Considerations 
9.1 
Statistical and Analytical Plans (SAP) 
Aim 1. Analysis will be performed using SAS 9.4. Surveys will be administered using the 
Research Electronic Data Capture (REDCap) system,42 a secure web-based tool licensed and 
supported by NYU. Standard descriptive statistics will be used to describe baseline 
sociodemographic and clinical characteristics. Mean scores and standard deviations as well as 
Cronbach’s α will be calculated on questionnaires to confirm reliability of study instruments in 
our sample. Week 2 of the Fitbit Zip PA data will be used as baseline to assure the participant is 
accustomed to the device and to minimize the effect of reactivity, which can last approximately 
one week.43 To calculate total minutes/week of PA from PAVS, the following standard 
calculation will be used:44 light activity will be multiplied by 0 (light activity is not included in PA 
recommendations but is collected to acknowledge all attempts at PA and encourage increased 
intensity); moderate activity is multiplied by 1; vigorous activity is multiplied by 2 (one minute of 
vigorous activity being equal to two minutes of moderate activity). Paired t-tests will be used to 
assess changes in average PA from week 2 to three-month follow-up using PAVS and Fitbit Zip 
data. Using Fitabase software which allows for high resolution data, we will compare minutes of 
PA in three levels of intensity (light, moderate, and vigorous) as well as minutes spent in 
sedentary behavior. We will report the percentage of weeks each participant achieves the 
recommended levels of PA during the monitoring period and will assess weekly PA trends. We 
will compare improvements in PA by levels of protocol adoption by the HCP (e.g. 100% vs. 50% 
adoption). At 3 months we will compare mean minutes of moderate-to-vigorous PA between 
those who report achieving recommended levels of PA by the PAVS to those who do not.  
Paired t-tests will be used to assess changes in readiness to change number, the 6MWT, BMI, 
waist circumference, systolic and diastolic BP, lipids, and Framingham Heart Study Risk Score. 
To assess meaningful improvement in CRF, we will report the percent of participants who 
achieve a clinically important difference of 25 meters in the 6MWT.45 Bivariate analyses will 
compare all CVD risk factors, as well as other potential confounders (e.g. age, sex, 
race/ethnicity, depressive symptoms, quality of life, comorbidities), between those who achieve 
PA recommendations and those who do not.   
Preliminary effect sizes of change in PA (step counts) will be generated following the Physical 
Activity Change Detection (PACD) approach.46,47    PACD is a framework for mining longitudinal 
PA data to detect and describe change over time. This method provides guidelines for defining 
time periods, detecting outliers, data smoothing, quantifying and describing change in PA 
patterns. Following data collection, longitudinal trends in PA will be examined descriptively and 
graphically to determine the optimal parameters for these analyses (e.g. window size- weekly or 
monthly; comparison type- baseline reference or rolling reference). An example of a possible 
structure is weeklong activity windows, and a static baseline reference. This would entail 
comparing average weekly step counts for each individual to their baseline (week 2) step 
counts. Significance of observed changes will be assessed, and effect sizes will be calculated to 
quantify the magnitude of change (e.g., Cohen’s d). Plots of change over time will include error 
bars to reflect the precision of estimates. Benjamini-Hochberg method48 will be used to control 
family-wise error rate for multiple comparisons. Lastly, exploratory linear regression analysis will 
be conducted to determine if change in average weekly PA is influenced by covariates. Change 
in physical activity between week 2 and 3 months will be the outcome variable, and the model 
will include up to 5 covariates, including week 2 physical activity to account for baseline levels of 

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activity. Up to 4 additional covariates will be selected from those identified in bivariate analyses 
of factors related to achieving physical activity goals. 
 
Aim 2 is to conduct a process evaluation of the intervention. Implementation data will be 
evaluated using the PRISM framework.  All data collected monthly as outlined below will be 
analyzed over time to assess trends. We will collect data from the EHR on the HCP practice 
patterns that may inform our outcomes (e.g. # patients/week). Qualitative interview data will be 
analyzed using content analysis, an inductive analytic method. Cardiologist, nurse practitioner, 
and patient interviews will be transcribed verbatim and coded by the PI using Atlas.ti, a software 
package developed for qualitative data analysis. Preliminary analysis will include a line-by-line 
review that yields clusters of data that will be labeled into brief headings. Codes derived from 
this data will be linked to interview questions (focused on acceptability and clinical utility) and 
result in coding categories which will be summarized across cases. Emerging themes both 
within and across coding categories will be identified. Methodological rigor will be maintained 
through an audit trail, periodic peer debriefing and member checking that will support the 
credibility of the study.49  
 
9.2 
Analysis Datasets 
This pilot study will provide preliminary effects sizes on all patient subjects and process 
evaluation data.  
 
9.2.1 General Approach 
This pilot study is a one-group pre-post pilot feasibility study design.  
 
9.2.2 Adherence and Retention Analyses 
Adherence to the protocol will be monitored on a monthly basis for both the cardiologists use of 
PA referral and counseling and patient subject use of Fitbit over 3 months and follow-up data 
collection. Completion/adherence data will be collected for all study endpoints.  
 
9.2.2.1 Safety Review 
The DSMB will review the occurrence of adverse and serious adverse events.  This study may 
be temporarily suspended or prematurely terminated if there is sufficient reasonable cause as 
determined by the DSMB.  
9.3 
Sample Size 
The purpose of this pilot study is to test our study protocol and obtain preliminary clinical 
efficacy data on patient outcomes. With a type 1 error of 5% and 80% power, a sample of 59 
participants will allow us to detect a minimal clinically important difference (seen in adults with 
CVD) in the six-minute walk test of 25 meters.45 (effect size =0.33) There is a potential for 20% 
attrition based on the PIs previous work. With a type 1 error of 5% and 80% power, this sample 
of 47 participants will allow us to detect an effect size of 0.41 (28 meters for the six-minute walk 
test, an increase of 9,710 in weekly step count, and an increase of 10% of the sample achieving 
recommended levels of PA) and will have 80% power to detect a small effect (R2 of .09 to .11) 
associated with a predictor assuming up to 4 covariates which have a combined R2 of .4 to .2 

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with change in average weekly PA. Given our timeline and weekly volume of patients we believe 
it is feasible to enroll a sample of 59 participants.  
 
10 Source Documents and Access to Source Data/Documents 
 
 
Access to study records will be limited to IRB-approved members of the study team. The 
investigator will permit study-related monitoring, audits, and inspections by the IRB, the 
sponsor, and University compliance and quality assurance groups of all study related 
documents (e.g. source documents, regulatory documents, data collection instruments, study 
data etc.).  The investigator will ensure the capability for inspections of applicable study-related 
facilities (e.g. pharmacy, diagnostic laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable University compliance and quality assurance 
offices. 
 
11 Quality Assurance and Quality Control 
 
QC procedures will be implemented beginning with the data entry system and data QC checks 
that will be run on the database will be generated.  
Following written SOPs, the PI will verify that the clinical trial is conducted and data are 
generated, documented (recorded), and reported in compliance with the protocol and GCP.  
 
 
12 Ethics/Protection of Human Subjects 
12.1 Ethical Standard 
 
 
The investigator will ensure that this study is conducted in full conformity with Regulations for 
the Protection of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 
CFR Part 56, and/or the ICH E6. 
 
 Institutional Review Board 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form must be obtained before any participant is enrolled. Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form will be IRB approved; a determination will be made regarding 
whether previously consented participants need to be re-consented. 
 

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12.2 Informed Consent Process 
12.2.1 Consent/Assent and Other Informational Documents Provided to Participants 
 
Consent forms describing in detail the study procedures, and risks are given to the participant 
and written or electronic REDCap documentation of informed consent is required prior to 
starting intervention. The following consent materials are submitted with this protocol (consent 
for cardiologist subjects; consent for patient subjects). 
 
12.2.2 Consent Procedures and Documentation 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the study and continues throughout the individual’s study participation. Extensive discussion of 
risks and possible benefits of participation will be provided to the participants and their families. 
Consent forms will be IRB-approved and the participant will be asked to read and review the 
document. The investigator will explain the research study to the participant and answer any 
questions that may arise. All participants will receive a verbal explanation in terms suited to their 
comprehension of the purposes, procedures, and potential risks of the study and of their rights 
as research participants. Participants will have the opportunity to carefully review the written 
consent form and ask questions prior to signing. The participants should have the opportunity to 
discuss the study with their surrogates or think about it prior to agreeing to participate. The 
participant will sign the informed consent document prior to any procedures being done 
specifically for the study. The participants may withdraw consent at any time throughout the 
course of the trial. A copy of the signed informed consent document will be given to the 
participants for their records. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they 
decline to participate in this study. 
 
A copy of the signed informed consent document will be stored in the subject’s research record 
or in REDCap. The consent process, including the name of the individual obtaining consent, will 
be thoroughly documented in the subject’s research record. Any alteration to the standard 
consent process (e.g. use of a translator, consent from a legally authorized representative, 
consent document presented orally, etc.) and the justification for such alteration will likewise be 
documented.  
 
12.3 Posting of Clinical Trial Consent Form 
 
The informed consent form will be posted on the Federal website after the clinical trial is closed 
to recruitment, and no later than 60 days after the last study visit by any subject, as 
required by the protocol.  
 
12.4 Participant and Data 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 

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• 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, attempts 
should be made to obtain permission to collect at least vital status (i.e. that the subject is alive) 
at the end of their scheduled study period. 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and 
the sponsor(s) and their agents. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the IRB 
product may inspect all documents and records required to be maintained by the investigator, 
including but not limited to, medical records (office, clinic, or hospital) and pharmacy records for 
the participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal 
use during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at NYU Langone Medical Center. This will not include 
the participant’s contact or identifying information. Rather, individual participants and their 
research data will be identified by a unique study identification number. The study data entry 
and study management systems used by clinical sites and by NYU Langone Medical Center 
research staff will be secured and password protected. At the end of the study, all study 
databases will be de-identified and archived at the NYU Langone Medical Center. 
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be 
obtained from the NIH. This certificate protects identifiable research information from forced 
disclosure. It allows the investigator and others who have access to research records to refuse 
to disclose identifying information on research participation in any civil, criminal, administrative, 
legislative, or other proceeding, whether at the federal, state, or local level. By protecting 
researchers and institutions from being compelled to disclose information that would identify 
research participants, Certificates of Confidentiality help achieve the research objectives and 
promote participation in studies by helping assure confidentiality and privacy to participants. 
 
13 Data Handling and Record Keeping 
13.1 Data Collection and Management Responsibilities 
 

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Data collection is the responsibility of the PI and the RA under the supervision of the PI. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data. Black ink is required to ensure clarity of reproduced copies. When making 
changes or corrections, cross out the original entry with a single line, and initial and date the 
change. DO NOT ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE 
ORIGINAL. 
 
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) 
and clinical laboratory data will be entered into REDCap data system, a 21 CFR Part 11-
compliant data capture system provided by NYU Langone Health. The data system includes 
password protection and internal quality checks, such as automatic range checks, to identify 
data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly 
from the source documents. 
 
13.2 Study Records Retention 
Study documents will be retained for the longer of 3 years after close-out, 5 years after final 
reporting/publication, or 2 years after the last approval of a marketing application is approved for 
the drug for the indication for which it is being investigated or 2 years after the investigation is 
discontinued and FDA is notified if no application is to be filed or if the application has not been 
approved for such indication. No records will be destroyed without the written consent of the 
sponsor, if applicable. It is the responsibility of the sponsor to inform the investigator when these 
documents no longer need to be retained. 
 
13.3 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of 
Procedures (MOP) requirements. The noncompliance may be either on the part of the 
participant, the investigator, or the study site staff. As a result of deviations, corrective actions 
are to be developed by the site and implemented promptly. 
 
These practices are consistent with ICH E6: 
• 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 5.1 Quality Assurance and Quality Control, section 5.1.1 
• 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
It is the responsibility of the site PI/study staff to use continuous vigilance to identify and report 
deviations within <specify number> working days of identification of the protocol deviation, or 
within <specify number> working days of the scheduled protocol-required activity. 
 
All protocol deviations must be addressed in study source documents, reported to National 
Institute of Nursing Research Program Official.  
 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff 
is responsible for knowing and adhering to their IRB requirements. Further details about the 
handling of protocol deviations will be included in the MOP. 

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13.4 Publication and Data Sharing Policy 
 
This study will comply with the NIH Public Access Policy, which ensures that the public has 
access to the published results of NIH funded research. It requires scientists to submit final 
peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed 
Central upon acceptance for publication. 
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted 
a clinical trials registration policy as a condition for publication. The ICMJE defines a clinical trial 
as any research project that prospectively assigns human subjects to intervention or concurrent 
comparison or control groups to study the cause-and-effect relationship between a medical 
intervention and a health outcome. Medical interventions include drugs, surgical procedures, 
devices, behavioral treatments, process-of-care changes, and the like. Health outcomes include 
any biomedical or health-related measures obtained in patients or participants, including 
pharmacokinetic measures and adverse events. The ICMJE policy, and the Section 801 of the 
Food and Drug Administration Amendments Act of 2007, requires that all clinical trials be 
registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the 
National Library of Medicine. Other biomedical journals are considering adopting similar 
policies. For interventional clinical trials performed under NIH IC grants and cooperative 
agreements, it is the grantee’s responsibility to register the trial in an acceptable registry, so the 
research results may be considered for publication in ICMJE member journals. The ICMJE does 
not review specific studies to determine whether registration is necessary; instead, the 
committee recommends that researchers who have questions about the need to register err on 
the side of registration or consult the editorial office of the journal in which they wish to publish. 
 
 
14 Study Finances 
14.1 Funding Source 
This study is financed through a grant from the US National Institute of Health, National Institute 
of Nursing Research.  
 
14.2 Costs to the Participant 
There will be no cost to participation in this study.  
 
14.3 Participant Reimbursements or Payments 
At the initial enrollment visit the patient subject will be compensated with a $50 gift card for their 
time and effort in completing the baseline data collection (approximately one hour) and agreeing 
to wear the Fitbit for 3 months. At the follow-up visit they will be compensated for their time and 
effort in completing follow-up data collection (approximately one hour) with a second $50 gift 
card. They will be able to keep the Fitbit activity tracker. The cardiologists will not receive any 
compensation for their participation in the study.  
 

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15 Study Administration 
The following subsections should describe the governance of the study and its committee 
structure. Alternately, this section may describe the role of the study team, its composition (e.g., 
those listed in Section 1, Key Roles) and describe how study decisions and progress are 
communicated and reported. Some example text is provided below. 
15.1 Study Leadership 
The PI will govern the conduct of the study. The PI will be advised during the study 
implementation on a monthly basis (or more frequently if needed) by her co-I’s and K23 mentors 
Dr. Allison Vorderstrasse and Dr. Stuart Katz.  
 
16 Conflict of Interest Policy 
 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who have 
a role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed 
and managed. Furthermore, persons who have a perceived conflict of interest will be required to 
have such conflicts managed in a way that is appropriate to their participation in the trial. The 
study leadership in conjunction with the <specify NIH IC> has established policies and 
procedures for all study group members to disclose all conflicts of interest and will establish a 
mechanism for the management of all reported dualities of interest.  
 
Any investigator 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 the NYU Langone Conflict of Interest Management Unit (CIMU) with a Committee-
sanctioned conflict management plan that has been reviewed and approved by the study 
sponsor prior to participation in this study. All NYULMC investigators will follow the applicable 
conflict of interest policies. 
 
 
 

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17 References 
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13.  Ball TJ, Joy EA, Gren LH, Cunningham R, Shaw JM. Predictive Validity of an Adult 
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25.  Duff OM, Walsh DM, Furlong BA, O’Connor NE, Moran KA, Woods CB. Behavior Change 
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CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as 
authorized in writing by the study sponsor 
Interventional Template Version: 11 January 2019 
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Study number:  
 
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CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as authorized in 
writing by the study sponsor 
Interventional Template Version: 11 JAN 2019 
 
18 Schedule of Events 
 
Activity 
Baseline Visit 
At Enrollment 
 
Follow-up 
Visit after 
3 months 
Study team procedures 
  
  
Consent 
X 
 
Clinical Data from EHR  
X 
 
Survey completion, PAVS, six-
minute walk test, lipid fingerstick 
collection, height, weight, waist 
circumference and blood pressure 
measured 
X 
X 
Patient subject given Fitbit and 
instructions on wearing an activity 
tracker 
X 
 
Interviews with patient subjects 
and cardiologists/nurse 
practitioner on the feasibility and 
acceptability of the intervention  
 
X