The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial
Phase: NA
Conditions: Hypertension, Blood Pressure, Lifestyle Risk Reduction
Sponsor: University of Wisconsin, Madison

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
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Version #: 05-04-2022 
 
THE MYHEART STUDY: A YOUNG ADULT HYPERTENSION SELF-
MANAGEMENT RANDOMIZED CONTROLLED TRIAL 
 
 
A randomized, multi-center study of MyHEART (My Hypertension Education And Reaching Target) on the change in systolic 
and diastolic blood pressure, hypertension control and hypertension self-management behavior compared to usual clinical 
care in young adults (18-39 years) with hypertension. 
 
 
Principal Investigator: Kara Hoppe 
 
 
NCT03158051 
 
This document is confidential. 
No part of it may be transmitted, reproduced, published, or used by other persons without prior written 
authorization from the Sponsor or Principal Investigator. 
 
 
 
 
 
 
PROTOCOL VERSION and AMENDMENTS 
 
Protocol 
Version 
Date 
Change Initiated 
(Initials) 
Brief description of protocol modification/actions requested, if any 
Template 
V6 
9/6/16 
TNK 
Input from IRB, OCT, MARCH, IND/IDE services, PIs 
V1 
3/23/17 
HJ, JL, VC (HIP); 
TNK (OCT) 
Version sent to the IRB with initial application 
V2 
4/4/17 
HJ, VC, JL (HIP) 
Responded to IRB’s pre-review comments 
V3 
4/19/17 
HJ, JL, VC (HIP) 
Responded to IRB committee’s modification requests 
V4 
5/16/2017 
HJ, JL, VC (HIP) 
Aurora Health Care added as a study site 
V5 
6/22/17 
JL, HJ (HIP) 
Responded to IRB’s pre-review comments 
V6 
12/4/17 
HJ 
Protocol change  
V7 
9/10/18 
HJ 
Protocol change 
V8 
11/22/19 
HJ 
Principal Investigator Change from Heather Johnson to Kara Hoppe 
V9 
04/28/22 
SB 
Change of storage of study documents 
 
 
 
 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
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STATEMENT OF COMPLIANCE 
The research will be conducted in accordance with the Code of Federal Regulations on the Protection of Human Subjects 
(45 CFR Part 46), and the NIH NHLBI Terms of Award. The Principal Investigator will assure that no deviation from, or 
changes to the protocol will take place without 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. 
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their obligations in meeting 
the above commitments.  
 
 
Principal Investigator: _Kara Hoppe, DO  
Print/Type Name  
 
 
 
 
 
Signed: ________________________ 
  
 
 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
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Version #: 05-04-2022 
Funding Sponsor: 
National Heart, Lung, and Blood Institute 
NHLBI Health Information Center 
P.O. Box 30105 
Bethesda, MD 20824-0105 
(301) 592-8573 
 
Study Product: 
Not applicable 
Protocol Number: 
UW-Madison HS IRB#: 2017-0372  
Aurora site approval UW-Madison HS IRB#: 2017-0372 -CP001 
 
IND/IDE Number: 
Not applicable 
Participating sites: 
UW Health; Madison, WI  
Aurora Health Care; Milwaukee, WI 
 
 
 
 
 
Figure. MyHEART R01 Organizational Chart as submitted to NIH/NHLBI 
 
Note: This protocol reflects the addition of the Aurora Health Care site and approval from Aurora Health Care and 
the Wisconsin IRB Consortium (WIC) to allow UW-Madison to serve as the IRB of record for this study. The 
appendix has also been updated to include Aurora site-specific recruitment and consent materials. 
 
 
 
 
MyHEART is a randomized, controlled trial with two IRB-approved participating healthcare systems. The Steering 
Committee is the primary decision-making body for the MyHEART trial. Membership to the Steering Committee includes 
the study principal investigator (PI) and site-PI, lead statistician from the UW Biostatistics and Medical Informatics, 
research coordinators from the Wisconsin Network for Health Research, and data programmers/analysts from the UW 
Health Innovation Program (HIP). The ICTR Data Safety and Monitoring Committee (ICTR DSMC; 
https://ictr.wisc.edu/DMC) will serve as an independent data and safety monitoring board. 
 
All versions of this protocol must be approved by the UW Health Sciences IRB. At the start of the MyHEART trial, study 
binders will be set up at each study site with the current protocol version (will include protocol number and date), and it 
will be available on a secure study intranet through HIP. If changes are necessary for the project, protocol modifications 
will be submitted to the UW Health Sciences IRB to change the protocol to fit the required changes. When the UW 
Health Sciences IRB approves amendments to the protocol, a copy of the approval will accompany the summary of 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
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changes approved and the new protocol version sent to the study sites. Electronic copies of the approval documents 
will be forwarded to each site with the other electronic documents and stored electronically and in paper form in an IRB 
folder at each study site. At each WiNHR coordinator conference call, reconciliation of all current approvals will be 
performed by all the investigators in their study binders and electronic files. 
 
List of Abbreviations 
 
 
AE 
Adverse event 
AMBP 
ambulatory blood pressure 
ASA24 
Automated Self-Administered 24-hour Dietary Assessment 
BCG 
Bioinformatics Computing Group 
BMI 
body mass index 
BP 
blood pressure 
CARDIA 
Coronary Artery Risk Development in Young Adults 
cm 
centimeters (used in measurements of height) 
CV 
cardiovascular 
DASH 
Dietary Approaches to Stop Hypertension diet 
DBP 
diastolic blood pressure 
DMC 
data monitoring committee 
DO 
doctor of osteopathic medicine 
DSMB 
Data Safety and Monitoring Board 
DSMP 
Data Safety and Monitoring Plan 
eCRF 
electronic case report forms 
EHR 
electronic health record 
FDA 
Food and Drug Administration 
HCCQ 
Health-Care Climate Questionnaire 
HEDIS 
Healthcare Effectiveness Data and Information Set 
HIP 
Health Innovation Program (at UW-Madison) 
HIPAA 
Health Insurance Portability and Accountability Act 
ICD-10 
International Classification of Disease, Tenth Edition 
ICTR 
Institute for Clinical and Translational Research (at UW-Madison) 
IRB 
Institutional Review Board 
J2EE 
Java 2 Platform, Enterprise Edition 
JDBC API 
Java Database Connectivity Application Program Interface 
 
 
JNC V 
The Fifth Report of the Joint National Committee on the Detection, Evaluation and Treatment of 
High Blood Pressure 
 
JNC VI 
The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and 
Treatment of High Blood Pressure 
JNC VII 
The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and 
Treatment of High Blood Pressure  
kcal/kg/hr 
kilo calories per kilogram per hour (used in the measurement of METs; one MET is defined as 
1 kcal/kg/hr and is roughly equivalent to the energy cost of sitting quietly) 
 
kg 
kilograms (used in measurements of weight) 
kg/m2 
kilograms per meters squared (used in measurements of body mass index) 
 
MD 
medical doctor 
MET 
Metabolic Equivalent 
mmHg 
millimeters of Mercury (used in measurements of blood pressure 

 
Protocol: MyHEART R01 Study Protocol 
 
 
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MyHEART My Hypertension Education and Reaching Target 
NHANES 
National Health and Nutrition Examination Survey 
NP 
nurse practitioner 
OSA 
obstructive sleep apnea 
PA 
physician assistant 
PCS 
Perceived Competence Scale 
PI 
principal investigator(s) 
REALM-R 
Rapid Estimate of Adult Literacy in Medicine-Revised 
REDCap 
Research Electronic Data Capture 
SAE 
serious adverse event 
SBP 
systolic blood pressure 
SDT 
self-determination theory 
SV 
Screening Visit 
TSRQ 
Treatment Self-Regulation Questionnaires 
USDA 
United States Department of Agriculture 
UW 
University of Wisconsin 
WCHQ 
Wisconsin Collaborative for Healthcare Quality 
WIC 
Wisconsin IRB Consortium 
WiNHR 
Wisconsin Network for Health Research 
 
 
 

 
Protocol: MyHEART R01 Study Protocol 
 
 
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Study Summary 
 
Title 
The MyHEART Study: A Young Adult Hypertension Self-Management 
Randomized Controlled Trial 
Short Title and Precis 
MyHEART R01 
Protocol Number 
UW-Madison HS IRB#: 2017-0372 
ClinicalTrials.gov 
number 
ClinicalTrials.gov Identifier: NCT03158051  
Phase 
not applicable 
Methodology 
Randomized controlled Trial 
Study Duration 
5 years 
Study Center(s) 
Two Healthcare Systems 
- UW Health (Madison, WI) 
- Aurora Health Care (Milwaukee, WI) 
Objectives 
Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor 
distribution and heath coaching) on clinical outcomes, the change in systolic 
and diastolic blood pressure (primary) and hypertension control (secondary) 
after 6 and 12 months, compared to usual clinical care. We hypothesize that 
MyHEART will significantly decrease systolic and diastolic blood pressures 
(clinic and 24-hour ambulatory) in young adults, compared to usual clinical 
care.  
Aim 2. To evaluate the effect of MyHEART on hypertension self-management 
behavior (behavioral outcomes) at 6 and 12 months, compared to usual 
clinical care. We hypothesize that MyHEART will increase the frequency of 
home blood pressure monitoring and lifestyle modifications (increased 
physical activity, decreased sodium intake). 
Aim 3. To examine whether MyHEART’s effects on self-management behavior 
are mediated through variables of perceived competence, autonomy, 
motivation, and activation (mediation outcomes). Based on our pilot study and 
theoretical framework, we hypothesize that MyHEART’s effects will be 
mediated through perceived competence, autonomy, internal motivation, and 
patient activation. 
Number of Subjects 
N=340 
Diagnosis  
uncontrolled hypertension  
Main Inclusion Criteria 
18-39 years with a diagnosis of “elevated blood-pressure reading, without 
diagnosis of hypertension” or a hypertension diagnosis, uncontrolled blood 
pressure (≥140/90 mmHg), and medically homed at one of the included clinical 
sites 
Main Exclusion Criteria 
Any of the following diagnoses: chronic kidney disease, congestive heart 
failure, sickle cell anemia, cystic fibrosis, stroke, myocardial infarction, 
coronary artery revascularization, or prior/planned organ transplant; inability to 
provide informed consent or read or communicate in English; residence at 
skilled nursing or correctional facility; prescription of warfarin, novel oral 
anticoagulant, planned chemotherapy, planned radiation therapy, plan to move 
out of area in next 6 months; pregnant or plan to become pregnant in next 
year; illegal drug use other than marijuana in past 30 days; syncope in past 12 
months 
Study Product, Dose, 
Route, Regimen 
Health coach face-to-face visits, with follow-up telephone calls, self-
management support, and primary care provider feedback 
FDA status of product 
not applicable 

 
Protocol: MyHEART R01 Study Protocol 
 
 
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Duration of 
administration 
6-month intervention; 6-month maintenance evaluation (12-month total follow-
up) 
Reference therapy 
Usual Clinical Care 
Statistical 
Methodology 
The primary comparisons for the co-primary outcomes of systolic and diastolic 
blood pressure change from baseline to 6 months will be done using analysis 
of covariance with MyHEART and baseline blood pressure as independent 
covariates. The primary comparisons for the secondary outcome of 
hypertension control will be based on Fisher’s exact tests. Mediation analysis 
will be performed for Aim 3. 
 
 
 

 
Protocol: MyHEART R01 Study Protocol 
 
 
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Schematic of Study Design 
 
 
 
 
Identify Eligible Patients with Hypertension Database and 
Electronic Health Record Review
Figure:  Eligibility, Enrollment, Randomization, Follow-up and Analysis
Telephone Screening 
Routine Care / 
Control Arm
(N=155)
Hypertension pamphlet  
MyHEART Intervention Arm
(N=155)
Hypertension pamphlet,  Home 
BP monitor distribution/training, 
Meet health coach face-to-face
Screening Visit 1: Written Consent, Eligibility Screening, 
24h-AMBP monitor placement
Mail Study Invitation with Opt-out postcard
telephone counseling (12 health 
coach calls total) + Home BP 
monitoring + education material 
distribution + electronic health 
record documentation
6-month visit
12-month visit
Identify Eligible Patients
Intervention
(Q2 weeks x  
6 months):
Follow-up/ 
Analysis
Screening Visit 2 and Baseline Assessment: 
Confirm 24h-AMBP, Enrollment, Obtain Baseline Variables
Analysis
Randomization (n=310)

 
Protocol: MyHEART R01 Study Protocol 
 
 
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Contents 
Study Summary ....................................................................................................................................................................... 6 
1 
Key Roles ....................................................................................................................................................................... 12 
2 
Background and Introduction ......................................................................................................................................... 12 
2.1 
Background and Rationale .................................................................................................................................... 13 
2.1.1 
Development of MyHEART ............................................................................................................................... 13 
2.2 
Hypothesis ............................................................................................................................................................. 14 
2.3 
Study Agent ........................................................................................................................................................... 14 
2.4 
Summary of Clinical Data ...................................................................................................................................... 15 
2.5 
Potential Risk and Benefits to Subjects ................................................................................................................ 16 
2.5.1 
Known Potential Risks ...................................................................................................................................... 16 
2.5.2 
Alternative to Study Participation ...................................................................................................................... 17 
2.5.3 
Protection Against Risks ................................................................................................................................... 17 
2.5.4 
Adverse Event Reporting .................................................................................................................................. 19 
2.5.5 
Potential Benefits to the Subjects ..................................................................................................................... 20 
2.5.6 
Risk Minimization .............................................................................................................................................. 20 
3 
Study Design and Endpoints.......................................................................................................................................... 21 
3.1 
General Design ..................................................................................................................................................... 21 
3.1.1 
Primary Study Endpoints ................................................................................................................................... 22 
3.1.2 
Secondary Study Endpoints .............................................................................................................................. 22 
3.1.3 
Primary Safety Endpoints .................................................................................................................................. 22 
4 
Study Subjects – Enrollment and Withdrawal ................................................................................................................ 22 
4.1 
Subject Population ................................................................................................................................................ 22 
4.2 
Inclusion Criteria .................................................................................................................................................... 23 
4.3 
Exclusion Criteria .................................................................................................................................................. 23 
4.4 
Subject Screening for Recruitment ....................................................................................................................... 24 
4.4.1 
Subject Identification ......................................................................................................................................... 24 
4.4.2 
Recruitment and Retention Strategies .............................................................................................................. 24 
4.5 
Vulnerable Populations ......................................................................................................................................... 25 
4.5.1  Subject Capacity ............................................................................................................................................... 25 
4.5.2  Subject/Representative Comprehension .......................................................................................................... 25 
4.6 
Informed Consent .................................................................................................................................................. 26 
4.6.1 
Process of Consent ........................................................................................................................................... 26 
4.6.2 
Consent Form .................................................................................................................................................... 26 
4.6.3 
HIPAA ................................................................................................................................................................ 26 
4.6.4 
Revoking Consent ............................................................................................................................................. 27 
4.6.5 
Costs to the Subject .......................................................................................................................................... 27 
4.6.6 
Payment for Participation .................................................................................................................................. 27 
4.7 
Early Withdrawal of Subjects ................................................................................................................................ 27 

 
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4.7.1 
Premature termination of study ......................................................................................................................... 27 
4.7.2 
When and How to Withdraw Subjects ............................................................................................................... 28 
4.7.3 
Data Collection and Follow-up for Withdrawn Subjects .................................................................................... 28 
5 
Study Procedures .......................................................................................................................................................... 28 
5.1 
Prior and Concomitant Therapy ............................................................................................................................ 28 
5.2 
Randomization and Blinding of Intervention ......................................................................................................... 28 
5.3 
Established Standard of Care ............................................................................................................................... 29 
5.4 
Study Visits ............................................................................................................................................................ 29 
5.4.1 
Screening/Baseline: .......................................................................................................................................... 29 
The same procedures will be followed at both research sites (Madison and Milwaukee). ............................................ 29 
5.4.2 
Intervention ........................................................................................................................................................ 32 
5.4.3 
Follow up: .......................................................................................................................................................... 34 
5.4.4 
Unscheduled: .................................................................................................................................................... 34 
5.4.5 
Final Study Visit ................................................................................................................................................. 34 
6 
Study Analysis ............................................................................................................................................................... 35 
6.1 
Sample Size Determination ................................................................................................................................... 35 
6.2 
Statistical Methods ................................................................................................................................................ 35 
6.3 
Planned Interim Analysis: ...................................................................................................................................... 35 
7 
Data Collection, Handling, and Record Keeping ........................................................................................................... 36 
7.1 
Data Confidentiality ............................................................................................................................................... 36 
7.1.1 
Confidentiality of Subject Records .................................................................................................................... 38 
7.2 
Data Capture ......................................................................................................................................................... 38 
7.2.1 
Source Documents ............................................................................................................................................ 38 
7.2.2 
Case Report Forms ........................................................................................................................................... 39 
7.3 
Data Management ................................................................................................................................................. 39 
7.4 
Data Monitoring ..................................................................................................................................................... 39 
7.5 
Records Retention ................................................................................................................................................. 39 
8 
Assessment of Safety .................................................................................................................................................... 39 
8.1 
Specifications of Safety Parameters ..................................................................................................................... 40 
8.1.1 
Definition of Adverse Events (AE) ..................................................................................................................... 40 
8.1.2 
Definition of Serious Adverse Events (SAE) ..................................................................................................... 40 
8.1.3 
Definition of Unanticipated Problems (UP) ....................................................................................................... 41 
8.2 
Classification of an Adverse Event ........................................................................................................................ 41 
8.2.1 
Severity of Event ............................................................................................................................................... 41 
8.2.2 
Expectedness .................................................................................................................................................... 41 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up ..................................................................... 41 
8.4 
Reporting procedures ............................................................................................................................................ 42 
8.4.1 
Adverse Event (AE) Reporting .......................................................................................................................... 42 
8.4.2 
Serious Adverse Event (SAE) Reporting .......................................................................................................... 42 

 
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8.4.3 
Unanticipated Problem (UP) Reporting ............................................................................................................. 42 
8.4.4 
Reporting of Pregnancy .................................................................................................................................... 43 
8.5 
Study Halting Rules ............................................................................................................................................... 43 
8.6 
Safety Oversight .................................................................................................................................................... 43 
8.7 
Unblinding Procedure ............................................................................................................................................ 44 
9 
Study Monitoring, Auditing, and Inspecting ................................................................................................................... 44 
9.1 
Medical Monitoring ................................................................................................................................................ 44 
9.1.1 
Study Monitoring Plan ....................................................................................................................................... 44 
9.2 
Protocol Deviations ............................................................................................................................................... 44 
9.2.1 
Internal Data and Safety Monitoring Board ....................................................................................................... 44 
9.3 
Auditing and Inspecting ......................................................................................................................................... 45 
9.4 
Subject Compliance Monitoring ............................................................................................................................ 45 
10 
Ethical Considerations .............................................................................................................................................. 45 
11 
Study Finances .......................................................................................................................................................... 46 
11.1 
Funding Source ..................................................................................................................................................... 46 
11.2 
Conflict of Interest ................................................................................................................................................. 46 
12 
Publication Plan ......................................................................................................................................................... 46 
13 
References ................................................................................................................................................................ 46 
 
 
 

 
Protocol: MyHEART R01 Study Protocol 
 
 
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1 Key Roles 
 
See Appendix for the Delegation of Authority log. 
 
Following is a list of all personnel in key roles: 
 
Kara Hoppe, DO, Principal Investigator; Site Principal Investigator – UW Health; Madison, WI 
University of Wisconsin-Madison,  
University of Wisconsin (UW) School of Medicine & Public Health, Dept. of Obstetrics & Gynecology 
McConnell Hall, 1010 Mound Street 
Madison, WI 53715 
Office: (608) 417-4224 
khoppe2@wisc.edu 
 
Lisa Sullivan-Vedder, MD, Site Principal Investigator – Aurora Health Care; Milwaukee, WI 
Aurora Health Care,  
Family Care Center 
1020 N. 12th Street 
Milwaukee, WI 53233 
Office: (414) 219-5970 
Lisa.Vedder@aurora.org  
 
UW Department of Biostatistics and Medical Informatics 
KyungMann Kim, PhD, Statistician  
256a Warf Office Building 
610 Walnut St 
Madison, WI 53726 
(608) 265-6380; (608) 263-1706 
Kyungmann.kim@wisc.edu  
 
UW Institute for Clinical and Translational Research (ICTR) Data Monitoring Committee (DMC)  
University of Wisconsin School of Medicine and Public Health  
2112 Health Sciences Learning Center 
750 Highland Avenue 
Madison, WI 53705 
(608) 263-3804 
 
Aurora Research Institute 
960 N 12th Street, Suite 4120 
Milwaukee, WI 53233 
(414) 219-4763 
 
Paula Einhorn, MD, MS 
NIH/ National Heart, Lung, and Blood Institute Project Officer 
Division of Cardiovascular Sciences 
6701 Rockledge Drive, Room 10222 
Bethesda, MD 20892 
(301) 435-0563 
einhorn@nhlbi.nih.gov  
 
2 Background and Introduction 
This document is a protocol for a human research study. This study is to be conducted according to NIH and Institutional 
research policies and procedures. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
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2.1 Background and Rationale  
Uncontrolled hypertension in young adults is an enormous public health burden.1,2 In the U.S., over 10 million 18-39 
year-olds (1 in 5 men; 1 in 6 women) have hypertension,3-6 increasing their risk of heart failure, stroke, and chronic 
kidney disease.5,7-10 The medical costs of hypertension and its complications are $131 billion/year,11,12 contributing to 
1,000 deaths per day.3,5,11,13-15 Young adults with hypertension have a higher lifetime risk for cardiovascular disease, 
especially with complicated hypertension (hypertension with diabetes or chronic kidney disease).9,14-20 Hypertension 
control reduces morbidity, mortality, and future healthcare costs;21-25 yet, only 35% of young adults with hypertension 
in the U.S. have achieved blood pressure control (blood pressure <140/90 mmHg).26-29 
While hypertension self-management programs targeted towards adults ≥50 years old reduce blood pressure,30-48 
they primarily focus on medication titration.49 In contrast, a trial of lifestyle modifications is commonly the initial 
hypertension treatment step, rather than a medication, among young adults.50 Medication initiation is also not enough 
to achieve long-term blood pressure control in young adults. Even with medication adherence, systolic blood pressure 
continues to increase from younger to older age.51 Therefore, young adults need additional hypertension self-
management (home blood pressure monitoring and lifestyle modifications) to lower blood pressures and reduce the 
amount of medication they may need over a lifetime.52-55  
The Institute of Medicine56 highlighted the importance of self-management support to learn and effectively perform 
self-management.30,34,36,57,58 In multiple studies among older adults, hypertension self-management is superior to 
office-based management.30,34,36,57-59 However, in contrast to older adults, young adulthood is a time of frequent 
healthcare and vocational transitions, new life responsibilities, and less interest in health-related goals (i.e., prevention 
of heart attack and stroke).60,61 Thus, the content and method of delivery of hypertension self-management must be 
individualized to young adults and address barriers specific to this population.62-64  
Our previous research highlighted the critical need to design hypertension programs targeted at young adults. An 
analysis of 48 months of data (Johnson HM, et al.), published in the Journal of Hypertension,60 evaluated diagnosis 
rates of 4,023 young adults with regular primary care visits and ongoing elevated blood pressures, but without a 
hypertension diagnosis. Among adults (≥18 years) only ~59% of young adults (18-39 year-olds) received an initial 
hypertension diagnosis as compared to over 70% of ≥40 year-olds (p<0.001). After adjustment for patient 
comorbidities, sociodemographic, and provider characteristics, young adults had a 33% lower rate of receiving a 
hypertension diagnosis compared to ≥60 year-olds (p=0.007). In a separate study, we demonstrated that young adults 
with isolated systolic hypertension had a 50% slower diagnosis rate than young adults with isolated diastolic or 
combined systolic/diastolic hypertension (p<0.001).65 Our publication in the Journal of General Internal Medicine50 
demonstrated similar disparities in hypertension treatment. Adjusted analysis demonstrated that young adults had a 
44% lower rate of medication initiation (HR 0.56; 0.47-0.67, p<0.001) than ≥60 year-olds. Thus, many more young 
adults continued on with uncontrolled blood pressure and no medication.  
We also published the first U.S. analysis describing electronic health record documentation of lifestyle education for 
young adults with incident (new) hypertension (Johnson HM, et al.).66 Among 500 randomly selected 18-39 year-olds, 
only 55% had documented lifestyle education within one year of developing hypertension. Critical provider and patient 
barriers included limited time to manage multiple co-morbidities and clinic visit non-adherence (no-shows, not 
scheduling follow-up visits), respectively. Therefore, out-of-clinic self-management support is needed to overcome 
these barriers. Of note, there were not significant race/ethnicity differences despite the higher prevalence of 
hypertension among Black young adults.67  
 
2.1.1 Development of MyHEART 
To address the unmet need in hypertensive care for young adults, we developed MyHEART (My Hypertension 
Education And Reaching Target), a multi-component, theoretically-based intervention designed to achieve self-
management among young adults with uncontrolled hypertension. MyHEART is a patient-centered program that uses 
evidence-based health behavior approaches to lower blood pressure. MyHEART differs from previous interventions 
by: 1) targeting barriers identified by young adults in our preliminary research, 2) tailoring the mode of delivery to 
preferences expressed by members of this age group, and 3) individualizing action plans to participants’ motivations 
and behavior goals. To design this intervention, we conducted focus groups of young adults with hypertension (45% 

 
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Black)61 and one-on-one interviews of providers68 in Madison (academic community), Milwaukee (urban), and 
Richland Center (rural), Wisconsin. Our diverse young adult respondents expressed a strong interest in blood 
pressure self-monitoring and increased communication with their healthcare team. They helped us recognize 
important hypertension education topics that were not addressed in current healthcare system handouts. 
Stakeholders identified barriers to hypertension self-management and hypertension control among young adults, 
justifying the need for this intervention, and proposed specific solutions to the identified barriers.  
MyHEART is founded on the Self-Determination Theory (SDT), which is used to support chronic disease self-
management and lifestyle modifications.69-73 SDT has been used across races/ethnicities and with young adults.74,75 
To reduce the risk of negative sequelae from long-term hypertension, we need to not only initiate behaviors for blood 
pressure control, but also foster maintenance of new behaviors. SDT acknowledges that young adults are more likely 
to adopt and maintain health behaviors with: 1) autonomous (internal) motivation, instead of external motivation (i.e., 
external pressure), 2) relatedness (i.e., supportive healthcare interactions), and 3) perceived self-competence (i.e., 
perceived self-efficacy;76,77 confidence in starting and maintaining behaviors to reach a goal).69,72,74,78-89 The 
information gained by applying a theoretical framework is crucial to designing interventions and understanding the 
translation of interventions to other chronic diseases and populations.90  
MyHEART incorporates important hypertension education components implemented by a health coach: 1) telephone-
based self-management counseling, 2) home blood pressure monitoring, and 3) young adult-focused hypertension 
education. These components are recommended by the Institute of Medicine91 and the American Heart Association;1 
in previous studies, the largest effect sizes were achieved by multi-component interventions that incorporated both 
behavioral and educational strategies.92,93 Health coaching provides informational and emotional support for chronic 
disease management.94-96 Telephone interventions increase contacts between patients and their healthcare team.97-
100 MyHEART uses telephone as the primary mode of communication between participants and coaches, because 
young adults indicated a preference for this mode of delivery. Contrary to our hypothesis, our focus group respondents 
disliked text messaging and social media for health coach communication or self-management reminders;61 young 
adults were concerned that peers would see the hypertension communications.  
MyHEART directly addresses NHLBI’s Strategic Priority 3.1.a to: “Develop and evaluate new approaches to 
implement proven preventive and lifestyle interventions.” MyHEART takes guideline-recommended hypertension self-
management tools and, in contrast to previous interventions, targets the delivery to young adults to increase the 
initiation and maintenance of behaviors to lower blood pressure. 
 
2.2 Hypothesis 
Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical 
outcomes, the change in systolic and diastolic blood pressure (primary) and hypertension control (secondary) after 6 
and 12 months, compared to usual clinical care. We hypothesize that MyHEART will significantly decrease systolic 
and diastolic blood pressures (clinic and 24-hour ambulatory) in young adults, compared to usual clinical care.  
Aim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral outcomes) at 6 
and 12 months, compared to usual clinical care. We hypothesize that MyHEART will increase the frequency of home 
blood pressure monitoring and lifestyle modifications (increased physical activity, decreased sodium intake). 
Aim 3. To examine whether MyHEART’s effects on self-management behavior are mediated through variables of 
perceived competence, autonomy, motivation, and activation (mediation outcomes). Based on our pilot study and 
theoretical framework, we hypothesize that MyHEART’s effects will be mediated through perceived competence, 
autonomy, internal motivation, and patient activation. 
 
2.3 Study Agent 
No investigational drugs, devices, or biologics will be used in this study.  
 

 
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2.4 Summary of Clinical Data 
Established Recommendations for Lifestyle Modifications101 
The Fifth Report of the Joint National Committee on the Detection, Evaluation and Treatment of High Blood Pressure 
(JNC V) and the Working Group Report on Primary Prevention of Hypertension recommended four lifestyle 
modifications to reduce blood pressure: 1) reduced sodium intake, 2) weight loss, 3) reduced alcohol consumption, 
and 4) increased physical activity.102 Based on the results of the Dietary Approaches to Stop Hypertension (DASH) 
clinical trial,13 the Sixth Report of the Joint National Committee also recommends a diet rich in fruits, vegetables, and 
low-fat dairy products, and reduced in saturated fat, total fat, and cholesterol.103 
 
Reduced Sodium Intake 
Inter-population and intra-population observational studies have documented a positive, direct relationship between 
sodium intake and blood pressure, and experimental studies confirm this relationship.104-107 Furthermore, from a 
population perspective, the benefits of a reduced sodium diet significantly outweigh possible risks. Since most adult 
Americans consume well over the maximum recommended daily intake of 2,300 mg of sodium, virtually all Americans 
are candidates for reducing sodium intake. Trials have demonstrated that behavior change interventions can reduce 
daily intake by approximately 690-1150 mg.108 Results tend to differ by race-ethnicity and to a lesser extent by gender, 
such that sodium reduction is less in African Americans than in European Americans and less in women than in men; 
the latter is largely explained by lower baseline intakes of sodium.109 Additional analyses of data indicate a dose 
response relationship between sodium reduction and the extent of blood pressure reduction and hypertension 
control.13 Trials have also documented that a reduced sodium intake, once achieved, tends to be well maintained.110  
 
Weight Loss 
A strong and persuasive body of evidence from both observational and experimental studies indicates that weight is 
positively (directly) associated with blood pressure and hypertension.111 The relationship is present in both genders 
and in most ethnic-racial groups. The importance of this relationship is reinforced by the high and increasing 
prevalence of obesity in the United States.112 Virtually every major trial that has examined the influence of weight loss 
on blood pressure has documented a substantial and significant relationship between change in weight and change 
in blood pressure. Reductions in blood pressure occur even before (and without) attainment of desirable body weight. 
In studies that aggregated results across weight loss trials, the average SBP/DBP reduction per kg of weight loss was 
1.6/1.1 mmHg.  
 
Regular Physical Activity 
Evidence from observational studies and experimental studies suggests that increased physical activity can lower 
blood pressure. Numerous studies have found a negative correlation between habitual physical activity and the 
development of hypertension. An inverse relationship between physical activity and blood pressure has been 
observed in both sexes, all age groups, and in both African American and European Americans.113,114 In addition to 
the observational evidence, more than 30 experimental studies have evaluated the impact of physical activity on blood 
pressure.115,116 Most of these studies used aerobic training protocols at vigorous intensities (i.e., 60% maximal oxygen 
uptake or 70% maximal heart rate or greater). Fewer trials have evaluated lower intensity of exercise for blood 
pressure effects. Moderate-intensity activity has been shown to decrease blood pressure to an extent similar to, if not 
greater than, higher-intensity exercise in normotensive and hypertensive individuals.117 The entirety of these studies 
indicates that regular, moderate to vigorous physical activity lowers blood pressure by 10/8 mmHg in hypertensives 
and 2/3 mmHg in normotensives. Policy-making bodies deem the evidence sufficient to advocate regular aerobic 
physical activity as a means to reduce blood pressure.21,103,117  
 
Limitation of Alcohol Intake 
The relationship between high alcohol intake (typically three or more drinks per day) and elevated blood pressure has 
been reported in a large number of observational studies.118,119 In the Prevention and Treatment of Hypertension 
Study (PATHS), a reduction in alcohol intake among moderate drinkers also reduced blood pressure to a small, albeit 

 
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nonsignificant, extent.120 A few trials have also demonstrated that reductions in alcohol intake among heavy drinkers 
can lower blood pressure in normotensive and hypertensive men.121,122  
 
Dietary Patterns and Blood Pressure 
Results from the Dietary Approaches to Stop Hypertension (DASH) clinical trial, in conjunction with previous studies 
of vegetarian diets, provide strong and persuasive evidence that modification of dietary patterns can have a profound 
influence on blood pressure.107  
 
2.5 Potential Risk and Benefits to Subjects 
2.5.1 Known Potential Risks 
Blood Pressure Cuffs: There is a small immediate risk that there may be minor discomfort or bruising at the site of 
the upper arm automatic blood pressure cuff. To avoid this, patients will receive the appropriately sized cuff based on 
their upper arm circumference. In addition, the 24-hour ambulatory monitor will be started prior to leaving the research 
clinic to obtain at least two blood pressures to ensure comfort. Participants will also review information on how to 
contact the research staff in case additional questions, concerns, or new discomfort arise. 
Muscle/Joint Discomfort: There is a small immediate risk that participants may experience new muscle and/or joint 
discomfort after starting a new exercise program. However, they will be instructed to consult their provider before 
starting a new exercise program. 
Questionnaires: Multiple interviewer-administered and computer-administered questionnaires and surveys will be 
completed at each visit. We expect this will pose very minimal risk of physical or psychological discomfort.123  
Breach of Confidentiality: The major potential social and psychological risk to participants is loss of confidentiality. 
As our standard operating procedure, we have policies and procedures in place to protect the confidentiality and 
security of subject data, see below in “Protection Against Risks”. Young adults may be concerned about social stigma 
associated with high blood pressure; therefore, immediate and/or long-range psychological risk is possible. However, 
to minimize this risk as much as possible we will protect the confidentiality of participants with a unique subject 
identifier number as outlined below in “Protection Against Risks”. We anticipate no additional psychological or legal 
consequence from study participation. Participants and their insurance plans will not be charged for any of the visits, 
telephone contacts, or 24-hour ambulatory blood pressure monitoring.  
Reproductive risk: No reproductive risks are expected from this trial. This study does not start, change, or alter 
medications in any way. Patients are excluded if pregnant and if planning to become pregnant.  
Hyperkalemia: The DASH diet may include a higher intake of potassium (due to a high content of daily fruits and 
vegetables).  
Hypoglycemia: During or immediately after exercise, there is a risk of hypoglycemia for subjects with diabetes 
mellitus.  
Clinically Significant Blood Pressure Findings: Clinically relevant results of blood pressure measurements will 
be released to all subjects, as well as to their specific provider if they opt to give the provider's information on the 
written consent form. Only clinically significant findings will be disclosed: research clinic blood pressure >/= 160/100 
mmHg (during any research clinic visit), right/left arm blood pressure differential of >/= 20 mmHg (Visit 1), and 
normal mean 24-hour ambulatory blood pressure (Visit 2). These clinical significant findings will be noted 
immediately during the research clinic visit, and the research examiner will notify the subject verbally, complete the 
incidental finding form, and provide a completed copy to the subject during the same visit. A copy of the incidental 
finding form will be forwarded to the primary care provider (via fax) on the same day. 
The protocol appendix has a table explaining recommended primary care follow-up based upon the research clinic 
blood pressures (for all subjects). This is separate from the incidental finding process. Since young adults will be 
arriving with elevated blood pressures, they should also continue to have routine clinical care per hypertension 
guideline recommendations. This recommendation will be given by the research examiner on the same day as the 
visit.  
 

 
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The same primary care follow-up (protocol appendix) will also be recommended based upon home blood pressure 
readings (intervention arm only) by the health coach before the end of that call. However, instead of the participant 
being "escorted" to the emergency department, they will be instructed to call 911. 
Clinically significant findings could result in anxiety and psychological discomfort. Financial risks to clinically 
significant findings could mean that subjects and their insurance would have to pay for follow-up procedures or 
visits. False-positives are possible (i.e., a clinically concerning blood pressure measurement in our research clinic), 
that is "white coat hypertension", not high blood pressure. 
An additional risk is social stigma associated with high blood pressure and associated immediate and/or long-range 
psychological risks. 
 
2.5.2 Alternative to Study Participation 
The alternative to study participation for all subjects is to continue to receive blood pressure care from their healthcare 
providers, which would include blood pressure checks, blood pressure lifestyle counseling/education, 
antihypertensive medication initiation and/or titration, and following their provider's treatment recommendations. This 
may also include referrals to specialty care (example: dieticians). Participants may choose to not participate in the 
study and at any time may discontinue their participation in the study. 
Rationale for the necessity of exposing human participants to such risks: It is expected that this study will pose 
minimal risks to participants and the intervention outlined in this proposal (24-hour, clinic, home blood pressure 
monitoring, behavior change) are the same clinical interventions that can be prescribed during usual clinical care.  
Why the value of the information to be gained outweighs the risks involved: Young adults with uncontrolled 
hypertension are at increased risks for premature heart failure, stroke, and chronic kidney disease. Therefore, the 
value of the information gained from this study far outweighs the risks involved. 
 
2.5.3 Protection Against Risks 
As indicated above, we expect minimum risk to participants. The primary pre-defined serious adverse events related 
to this study includes hypoglycemia among patients with diabetes mellitus starting a new exercise program. Subjects 
with any form of diabetes will be instructed to talk with their diabetes care team about adjusting their diabetes 
medication before starting a new exercise regimen and to discuss ways to treat hypoglycemia. Additionally, these 
recommendations will be reinforced with a handout from our study team about risk of hypoglycemia, signs, symptoms, 
and treatment of hypoglycemia and how to decrease their risk of hypoglycemia.  
Patients with advanced chronic kidney disease (on dialysis or seeing a nephrologist) will be excluded to avoid serious 
adverse events with the Dietary Approaches to Stop Hypertension (DASH) diet, which may cause hyperkalemia. Once 
enrolled, study protocols will monitor and assess the presence of adverse events (AEs) and serious adverse events 
(SAEs) at all follow-up contacts.  
Should a serious adverse event or adverse event be identified, it will be immediately reported as outlined later in this 
protocol. Should excessive risk to study participants be determined, the study will be stopped and all participants 
notified in a manner appropriate to the nature of the risk.  
Emails will be used for sending 1) research clinic visit appointment reminders for all subjects (day, time, location, 
directions to UWHC or UWSMPH) and 2) handouts on blood pressure topics to reinforce the health coach phone call 
(intervention arm only - if this method was selected by the subject over postal mail). Each email will contain the 
minimum amount of information needed. Emails will be sent individually, with no cc or bcc. No group emails or lists 
will be used for this study. Emails will not contain sensitive protected health information (PHI). Per the University of 
Wisconsin HIPAA policy (www.hipaa.wisc.edu), the subject of the email will be “Documents for your UW Study”.  
Blood Pressure Cuffs: To minimize risks, patients will receive the appropriately sized cuff based on their upper arm 
circumference. In addition, the 24-hour ambulatory monitor will be started prior to leaving the research clinic to obtain 
at least two blood pressures to ensure comfort. Participants will also review information on how to contact the research 
staff in case additional questions, concerns, or new discomfort arise.  
Muscle/joint discomfort: Participants will be instructed to consult their provider before starting a new exercise program.  

 
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Questionnaires/surveys: Participants will be informed that they can decline to answer any questions. 
Health coach fidelity audio recordings:  
• 
For Health Coach Calls Performed in Madison, WI: The audio digital recordings will be kept in a locked file 
cabinet in the PI’s office located in the Health Innovation Program (HIP) at 800 University Bay Drive Suite 
210, Madison, WI 53705. The audio files will be electronically transmitted by the MyHEART research staff to 
a UW Box file storage (approved by Richard Konopacki, UW SMPH; May 2017) accessible to Dr. Diane 
Lauver (lead researcher for this analysis) and a School of Nursing research student (a personnel change IRB 
application will be submitted once determined). The original and transmitted digital audio copies will be 
deleted/destroyed at the end of this study upon publication of the fidelity data.  
• 
For Health Coach Calls Performed in Milwaukee, WI: The audio digital recordings will be kept in a locked file 
cabinet in an Aurora Health Care research office. Encrypted audio files will be emailed from a password 
protected research computer at Aurora Health Care to the study PI and study research coordinator, using 
Aurora Health Care and UW-Madison/Department of Medicine emails. The audio files will then be saved on 
the HIP network and maintained separately from other study documents in a password-protected database 
on password-protected media. The audio files will then be electronically transmitted by the MyHEART 
research staff to a UW Box file storage (approved by Richard Konopacki, UW SMPH; May 2017) accessible 
to Dr. Diane Lauver (lead researcher for this analysis) and a School of Nursing research student (a personnel 
change IRB application will be submitted once determined).  
All original and transmitted digital audio copies will be deleted/destroyed at both research sites at the end of this study 
upon publication of the fidelity data.  
Breach of Confidentiality - Identifying information: Subject confidentiality will be protected with the coded patient IDs 
whenever possible. Linking information will be maintained separately from other study documents in a password-
protected database on password-protected media.  
• 
Madison site: When handwritten or printed documents are required that include PHI or non-PHI with 
identifiers, the paper copies will be secured in a locked file cabinet within a locked office within the HIP Suite 
at 800 University Bay Drive (Suite 210) or within the UW Hospital and Clinics, Division of Cardiovascular 
Medicine (H4/5). Access to the paper records will be restricted to the PI and project personnel. As of May 
2022, all paper records will be stored at the State of WI long term storage.  
• 
Aurora site: When handwritten or printed documents are required that include PHI or non-PHI with identifiers, 
the paper copies will be secured in a locked file cabinet within a locked office within a Aurora Health Care 
research office, with oversight by the site PI. Access to the paper records will be restricted to the PI, site PI, 
and project personnel.  
Analysis Data: Direct identifiers are removed by HIP and Aurora Programmers prior to data delivery to minimize the 
risk of loss of confidentiality. The data is labeled with a pseudo-identifier that is not derived from a patient identifying 
number. Analysis data is stored on a secure server under the control of the Health Innovation Program and access 
to study data is limited to persons who are approved to access it. Datasets for day-to-day analysis will be limited 
datasets (no direct identifiers; include zip codes and dates only; labeled with a pseudoidentifier). Details of data 
security protections are found in the "Privacy/confidentiality" section. Analysis data are never stored on paper. No 
sensitive information will be included in the analysis dataset. Encrypted Aurora Health Care data sets with coded 
patient IDs will be transferred to HIP and stored separately on the HIP network from data sets with linking information.  
As of May 2022, all data will be transferred from HIP and stored on the UW Department of Obstetrics and 
Gynecology server. The transfer will proceed as follows: 
HIP will copy and save files to a HIPAA compliant, FIPS140-2, encrypted disk. This disk has been approved by UW 
Cybersecurity as an acceptable media source to store PHI. In fact, if this disk were to be lost or stolen, only the 
business unit leadership would need to be notified (to replace the disk); UW Cybersecurity would not consider the 
loss a reportable event. The hard drive meets the security and compliance standards needed to store PHI. The hard 
drive will be stored in a locked cabinet in a locked office at HIP until MyHEART could bring it to Ob/Gyn. 
 

 
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No individual PHI will be released in presentation or publication. Only aggregate statistical output representing groups 
of subjects will be released or removed from the secure HIP or UW Ob/Gyn department servers. 
The Wisconsin Network for Health Research (WiNHR) of UW-Madison’s Clinical and Translational Science Award 
(CTSA) will oversee regulatory processes for this study, with the principal Investigator, site principal investigators, 
and the ICTR Data Monitoring Committee (DMC). The WiNHR staff have developed plans for assuring data accuracy 
and protocol compliance that will include biannual reviews with all research staff and WiNHR research coordinators. 
All study data will be documented and monitored in ICTR’s REDCap. Such plans will include data verification and 
protocol compliance checks. The Principal Investigator will also be responsible for ensuring that the data for the 
project are securely stored, that storage is in compliance with University and federal regulations, and that no 
unauthorized persons have access (electronic or physical) to any participant-identifiable data. All HIPAA regulations 
and guidelines will be followed, and all study staff must complete approved human subjects and HIPAA training 
programs. 
 
2.5.4 Adverse Event Reporting 
MyHEART’s data safety monitoring plan requires that investigators (PI, site-PIs) notify the NIH, DMC, and the 
University of Wisconsin IRB in a timely manner (consistent with IRB and NIH policies) of the occurrence of any SAE 
or any AE which is severe, unexpected, and possibly related to the protocol. This study does not involve 
pharmaceutical agents. Examples of SAE would be untoward medical or intervention occurrences that result in death, 
are life-threatening, require hospitalization or prolonging of existing hospitalization, or create persistent or significant 
disability/incapacity. Unanticipated AEs would include less serious problems that merit reporting because they are 
severe, unexpected, and possibly related to study participation. Any SAE will be queried and reported even if it 
appears that the serious adverse event is unrelated to intervention participation. The Principal Investigators will also 
be responsible for the accurate documentation, investigation, and follow-up of all study-related adverse events. 
Adverse event assessment, recording, reporting, and investigation will be accomplished through staff training, 
structured/standardized assessments of untoward occurrences/events, and regular monitoring by site principal 
investigators using REDCap. The Principal Investigators have ultimate responsibility for ensuring that SAEs are 
detected and reported in a timely manner. Additionally, the IRB will receive an annual report of all SAEs and AEs 
meeting the criteria listed above. 
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, treatment of bronchospasm in an emergency department would typically be 
considered serious. The primary pre-defined serious adverse events related to this study include hypoglycemia 
among patients with diabetes mellitus starting a new exercise program. All adverse events that do not meet any of 
the criteria for ‘serious’ should be regarded as non-serious adverse events. Throughout the study, any new clinically 
significant findings/abnormalities that meet the definition of an adverse event will also be recorded and documented 
as an adverse event. 
 
Adverse Event Reporting Period: Adverse events must be reported once the subject undergoes any study 
procedures, and adverse events must be reported during the entire active study period and for 30 days following the 
last administration of study treatment. 
Withdrawal of subjects: Any subject who experiences an adverse event or serious adverse event will be immediately 
withdrawn from the study. All subjects have the option to withdraw from the study at any time. Subjects will also be 
immediately withdrawn from the study if they report being pregnant, planning to become pregnancy, or develop a 
medical condition (even if unrelated from this study) that prevents them from ongoing participation in the study.  
Post-study Adverse Event: All unresolved adverse events will 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 will instruct each subject to report any subsequent event(s) that the subject, or the subject’s personal 
physician, believes might be related to participation in this study. The investigator should notify the study sponsor, 
DMC, and IRB of any serious adverse event or death occurring up to 30 days after the subject has discontinued or 
terminated study participation that may be related to this study. 

 
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Hospitalization, Prolonged Hospitalization, or Surgery: Any adverse event that results in hospitalization or 
prolonged hospitalization will be documented and reported as a serious adverse event unless specifically instructed 
otherwise in this protocol. Any condition responsible for surgery should be documented as an adverse event if the 
condition meets the criteria for an adverse event.  
Neither the condition, hospitalization, prolonged hospitalization, nor surgery are reported as an adverse event in the 
following circumstance: Hospitalization or prolonged hospitalization for diagnostic or elective surgical procedures for 
a preexisting condition. Surgery should not be reported as an outcome of an adverse event if the purpose of the 
surgery was elective or diagnostic and the outcome was uneventful. 
 
Referral for treatment, counseling, or other necessary follow-up. Participants who report excess alcohol use, 
psychiatric illness (new or chronic), and/or willingness to quit smoking will be referred to their primary care provider 
for necessary follow-up. Subjects will also receive written handouts about alcohol/tobacco cessation resources (e.g., 
Wisconsin Tobacco Quit Line). Charges for treatment, counseling, and/or follow-up will be the sole responsibility of 
the subject. 
 
2.5.5 Potential Benefits to the Subjects 
We do not expect any direct benefits to the study subjects randomized to the control group. We believe that those in 
the MyHEART intervention group will demonstrate lower systolic and diastolic blood pressures, but this cannot be 
guaranteed. If our results are positive, we are hopeful that our and other healthcare systems will use our results in 
planning interventions to improve the hypertension treatment for young adults. The minimal risks to the subjects are 
very reasonable in relation to the potential benefits to future young adults with hypertension if we find evidence that 
the MyHEART intervention is effective. 
 
2.5.6 Risk Minimization 
No procedures, situations, or materials are expected to be hazardous. Except for the questionnaires, the remaining 
study activities can be provided during routine clinical care. Introduction of the intervention will not increase the risk 
of the procedures involved in standard of care.  
Study staff interacting with enrolled participants will be blinded to the randomization to decrease risk of potential 
biases.  

 
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3 Study Design and Endpoints 
3.1 General Design  
 
 
MyHEART is a randomized, controlled clinical trial, across two large IRB-approved healthcare systems that will 
examine the impact on several health outcomes of a self-monitoring intervention designed to decrease blood pressure 
in young adults with uncontrolled hypertension. 
The study cohort will include 340 adults aged 18-39 years with documented hypertension. After screening for 
eligibility, participants will be randomly assigned to either the MyHEART intervention or usual (routine) care. In 
addition to their general medical care from the participants’ own healthcare providers, those assigned to the 
MyHEART intervention will receive a hypertension education packet, a home blood pressure monitor, and 12 phone 
calls with a health coach to promote self-management of blood pressure.  
The expected duration of subject participation, for all subjects, is 12 months.  
 
Identify Eligible Patients with Hypertension Database and 
Electronic Health Record Review
Figure:  Eligibility, Enrollment, Randomization, Follow-up and Analysis
Telephone Screening 
Routine Care / 
Control Arm
(N=155)
Hypertension pamphlet  
MyHEART Intervention Arm
(N=155)
Hypertension pamphlet,  Home 
BP monitor distribution/training, 
Meet health coach face-to-face
Screening Visit 1: Written Consent, Eligibility Screening, 
24h-AMBP monitor placement
Mail Study Invitation with Opt-out postcard
telephone counseling (12 health 
coach calls total) + Home BP 
monitoring + education material 
distribution + electronic health 
record documentation
6-month visit
12-month visit
Identify Eligible Patients
Intervention
(Q2 weeks x  
6 months):
Follow-up/ 
Analysis
Screening Visit 2 and Baseline Assessment: 
Confirm 24h-AMBP, Enrollment, Obtain Baseline Variables
Analysis
Randomization (n=310)

 
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3.1.1 Primary Study Endpoints 
The co-primary clinical outcome is a significant, clinically important change in systolic and diastolic blood pressure at 
6 and 12 months.21,36 The 6-month outcome assesses the end of the 6-month MyHEART intervention.43 The 12-
month outcome (i.e., 6 months post-intervention)58 assesses maintenance of blood pressure and sustainability of 
behavior change after study completion. In contrast to the baseline assessment, follow-up questionnaires and 
physiologic measurements will be conducted, obtained, and documented during the first visit of the 6- and 12-month 
visits to decrease missing data. 
 
3.1.2 Secondary Study Endpoints 
• 
Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension 
control will be defined using ambulatory blood pressures as the gold standard (<130/80 mmHg); otherwise a 
clinic blood pressure of <140/90 mmHg will be used. 
• 
Change in hypertension self-management behavior at 6 and 12 months compared to usual care  
o 
Dietary Changes (Automated Self-Administered 24-hour Dietary Assessment)  
o 
Change in physical activity (Godin Physical Activity Questionnaire) 
o 
Home Blood Pressure Monitoring Frequency124 
o 
Change in weight (kg) 
o 
Change in body mass index (BMI, kg/m2) 
• 
Change in perceived competence, autonomy, and motivation 
o 
Perceived Competence – Perceived Competence Scales (PCS) 
o 
Perceived autonomy/support form medical team - Health-Care Climate Questionnaire (HCCQ) 
o 
The Degree to which a person’s motivation for a behavior is autonomous or self-determined: Treatment 
Self-Regulation Questionnaires (TSRQ) 
o 
Health Coach Fidelity 
 
3.1.3 Primary Safety Endpoints 
• 
Number and type of adverse events  
• 
Number and type of serious adverse events  
• 
Subject Withdrawal rate and reason 
 
4 Study Subjects – Enrollment and Withdrawal 
 
See Appendix for accrual expectations by research site 
 
The recruitment and screening protocol will be the same at both sites. The accrual goal is 340 participants total (n=170 
per arm) over 25 months of recruitment. Participants will be randomized to control or intervention arms at each site.  
 
4.1 Subject Population  
The age range of the subjects is 18-39 years. The young adult age range is based upon the hypertension guidelines 
for children and adolescents which applies to <18 year-olds.125 The National Health and Nutrition Examination Survey 
(NHANES) data (as reported by the American Heart Association67 and the Center for Disease Control3) limits young 
adults to <40 years old. Young adults were selected for this research since they have the lowest hypertension control 
rates compared to middle aged and older adults and lack effective hypertension interventions. 

 
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There are no enrollment restrictions based upon race or ethnic origins. We will target recruitment by minority status 
to ensure that we achieve our expected enrollment numbers. Nationally, the prevalence of hypertension among young 
adults is greater in young males and Blacks. We expect a higher recruitment of minority patients from an IRB-
approved urban site based on the racial/ethnic distribution of patients. Women who are or become pregnant will be 
excluded to ensure we do not include patients with pregnancy-induced hypertension. 
The information provided in the Targeted/Planned Enrollment Table represents the gender, ethnic, and racial make-
up from a sample of potentially eligible subjects in the electronic health record:  
UW Health: Sex: 62% male; Ethnicity: 5% Hispanic/Latino; the racial make-up is 82% white, 13% black, 2% Asian, 
0.3% American Indian or Alaska Native, and 3% “more than one race”.  
 
4.2  Inclusion Criteria  
 
Inclusion Criteria  
1. 
Willing and capable of giving written informed consent  
2. 
Willing to comply with all study procedures and be available for the duration of the study  
3. 
Males and females ages 18-39 years old at the start of the study (inclusive) 
4. 
A single ICD-10 diagnosis code R03.0 (elevated blood pressure reading, without diagnosis of 
hypertension) in the last 24 months, OR, a minimum of two hypertension ICD-10 coded visits with a 
provider (MD, DO, PA, NP) on different dates in the last 24 months, with at least one code in the past 18 
months  
5. 
Medically homed at UW Health or Aurora Health Care  
 
The inclusion criteria are designed to ensure that patients who have a single visit to a clinic but seek primary care 
permanently elsewhere are not included in our study.126 The patient has to be managed at the same healthcare 
system prior to and during the study. 
 
4.3 Exclusion Criteria 
 
Exclusion Criteria  
1. History of medically determined Congestive Heart Failure 
2. Unable to provide informed consent (i.e., activated healthcare power of attorney) 
3. Unable or unwilling to travel to local clinic for research visits 
4. Currently residing in a skilled nursing facility  
5. Diagnosed with sickle cell anemia or cystic fibrosis 
6. Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years 
7. Syncope while exercising or doing strenuous activity within past 12 months 
8. Currently prescribed warfarin, novel oral anticoagulant, or insulin 
9. Planned organ transplant or prior transplant in the past 5 years 
10. Chemotherapy or radiation therapy within 6 the past months 
11. Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment 
12. Current participation or planning to participate in another clinical trial in the next 12 months 
13. Pregnant or planning to become pregnant in the next 12 months 
14. Planning to leave the geographic area in the next 6 months 
15. Health condition that will limit both increasing physical activity and changing diet 
16. Illegal drug use (other than marijuana) in the past 30 days 

 
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17. Unable to read or communicate in English 
18. Currently on dialysis or seeing a Nephrologist 
19. Unaware or denies history of high blood pressure or hypertension 
20. Between-arm blood pressure difference >20 mmHg 
21. White Coat Hypertension (24-hour ambulatory monitoring) 
22. Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site 
investigators 
23. Prisoners  
 
This list of medical conditions or conflicting medications was selected to exclude patients who might experience harm 
from participation. Patients with advanced chronic kidney disease (on dialysis or seeing a nephrologist) or congestive 
heart failure are excluded due to stringent dietary restrictions. Illegal drug use (except marijuana) in the past 30 days 
will result in ineligibility; illegal drug use will not be recorded. 
 
4.4 Subject Screening for Recruitment  
4.4.1 Subject Identification 
There will not be differences in recruitment methods between sites or by potential subject group (e.g., intervention 
versus a control group). 
Subject recruitment, screening, and enrollment between IRB approved sites will be coordinated by the Wisconsin 
Network for Health Research (WiNHR) of UW-Madison’s Clinical and Translational Science Award (CTSA). Each IRB 
approved site will identify potentially eligible patients using the Wisconsin Collaborative for Healthcare Quality 
hypertension registry data within respective electronic health record systems. Each IRB approved site will have an 
electronic health record with a Wisconsin Collaborative for Healthcare Quality (WCHQ) hypertension registry that will 
be used to identify potentially eligible patients.127 The electronic health record will also be used to identify individuals 
with the ICD-10 diagnosis code R03.0 (elevated blood pressure reading, without diagnosis of hypertension). The 
inclusion criteria will be entered by the data analysts at each healthcare system, which will generate a list of potentially 
eligible patients.50,60  
The principal investigator and Milwaukee site investigator will work with programmers to determine who is potentially 
eligible based on the EHR database. The project manager and student research coordinators will be involved with 
mailing introductory packets, telephone screening, and inviting them for their first screening visits.  
At the screening visit, research coordinators will lead eligibility assessment, informed consent, and enrollment. The 
PI will oversee all aspects of this study.  
 
4.4.2 Recruitment and Retention Strategies 
See appendix for expected numbers of women and minorities to be recruited. 
 
The site coordinators will mail an introductory research packet to patients who have been identified by each electronic 
health record system as potentially eligible, based upon the WCHQ or ICD 10 diagnosis code R03.0 criteria described 
above. The packet will include an introductory letter, a flyer summarizing the MyHEART research project, a magnet, 
bookmark and a pre-paid opt-out postcard. The packet will only be mailed once to the home address listed within the 
electronic health record system. If a participant contacts us independently and requests a packet, it will be mailed to 
the address that is provided by them. If an opt-out response is not received after 2 weeks, a research staff member 
will call patients to perform telephone screening to assess eligibility based on inclusion and exclusion criteria; research 
staff at UW_Madison will be calling all Madison participants and research staff at Aurora Health Care will be calling 
all Milwaukee participants (telephone scripts  for each site are uploaded to ARROW). The telephone screening for 
Aurora Health Care participants will also include a question to obtain verbal authorization that the participants give 
verbal permission for Aurora Health Care research staff to send their information to the University of Wisconsin-

 
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Madison research staff for data entry. At the completion of the telephone screening, the patient will be subsequently 
invited for a face-to-face visit at the research clinic within their medically homed region (Madison or Milwaukee). We 
will recruit a total of 340 participants over 25 months. We anticipate an accrual rate of 12-13 eligible participants per 
month. We estimate having to screen approximately 930 potentially eligible participants.  
We will also try to recruit by collaborating with primary care providers to review weekly panels and posting 
announcements within primary care clinics (upon approval from clinic managers and/or clinic directors).128 Primary 
care providers can also invite patients to the study. Healthcare providers will be able to directly ask patients about 
participating in this study. The PI will ask for permission from the provider to review their clinic schedule to identify 
potential subjects. The providers will be asked to tell potential subjects to contact the research team by telephone. 
Providers will not be asked to collect potential subjects' contact information or provide it to study team members. 
Other methods include newspaper, radio, TV, newsletters, and social media avenues and advertising to the general 
public via flyers and community boards. We will publicize the research study on the MyHEART website: 
myheartmychoice.org (a hypertension education website developed by the PI with funding from ICTR). The 
information on the website will be limited to what is usually contained in a ClinicalTrials.gov description [purpose, 
eligibility criteria, who to contact]. 
To enhance participant retention, we will contact patients with visit reminders via one email and one phone call.  
 
4.5 Vulnerable Populations 
 
TABLE: Vulnerable populations included and excluded from this study: 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g., infants, children, teenagers) 
 
X 
Wards of the State (e.g., foster children) 
 
X 
Pregnant women 
 
X 
Prisoners 
 
No vulnerable populations will be enrolled. Children <18 years of age are not eligible to participate in the trial. Although 
hypertension in children is a critical issue, children will not be included for three reasons: 1) the diagnosis and 
evaluation of high blood pressure in children and adolescents have different clinical guidelines than adults and are 
based on the 95th percentile for sex, age, and height,125 2) the home and ambulatory blood pressure monitors 
budgeted for this proposal will not be appropriately sized for children, and 3) the reading level of the educational 
material was not targeted to children. A separate proposal is needed to study this population. Pregnant women are 
excluded because the medication management of hypertension is different among pregnant women and there may 
be greater risk than benefit with starting a new exercise program or making dietary changes among some pregnant 
women. Prisoners will be excluded as per the Office for Human Research Protections (OHRP) guidelines; in addition, 
prisoners do not have flexibility in dietary and exercise options, as does the general population. 
 
4.5.1  Subject Capacity 
All subjects will have the capacity to give written informed consent.  
 
4.5.2  Subject/Representative Comprehension 
To ensure comprehension, after hearing and reading about the study, the subject will be asked to summarize the 
study and the requested activities for participation in the study. The investigator will then ask the subject if anything 
could be clarified before written/signed consent is obtained.  
Decisionally impaired adults are excluded from this study. 
 

 
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4.6 Informed Consent 
The PI will be responsible for ensuring that valid consent is obtained and documented for all subjects unless the 
IRB waives the requirement for documentation of informed consent for all or part of the study. 
The activities involved to review the EHR for potentially eligible subjects are considered “preparatory to research” and 
will be conducted by administrators of the WCHQ database and programmers for each respective healthcare system. 
If an opt-out card is not returned, then individuals will be contacted directly by the study team for a recruitment 
telephone call.  
During the recruitment screening phone call for Aurora Health Care participants, individuals will be asked to give 
verbal permission for Aurora Health Care research staff to pass along their information to the University of Wisconsin- 
Madison research staff for data entry (an “altered authorization”). 
For individuals who express interest in participating during the telephone call and who potentially qualify, screening 
visit 1 will be scheduled. Written informed consent will be obtained at the start of screening visit 1, which will include 
authorization for additional screening/eligibility assessment (e.g., 24-hour ambulatory blood pressure monitoring) and 
gathering data, including information from the patient’s electronic health record and study procedures after enrollment, 
if eligible. Signed informed consent will be obtained upon the participants arriving for Visit 1 (prior to initiating data 
collection or physical contact for the visit). The consent process will consist of a detailed verbal description of the 
study including its risks, potential benefits, and requirements. Potentially eligible participants will be given an IRB-
approved/stamped informed consent form with all required elements and factual correctness to read, then ample time 
to read and reflect on participating. If the individual requests, they will be given additional time to consider participation, 
including re-scheduling the screening visit. Before obtaining written consent, each individual will be allowed to ask 
questions until a decision can be made by the individual. When ready, participants will be required to sign the consent 
form. Study audits by the PI and WiNHR will include review of consent documents for signatures and use of the IRB 
date-stamped form to ensure compliance. 
 
4.6.1 Process of Consent 
Members of the research team including research coordinators and research assistants will be responsible for 
obtaining consent. The written/signed consent (original copy) will be stored in a locked file cabinet, in a locked office, 
on site at each research office. Electronically signed copies will be stored on the password protected research 
network, locked to all non-study staff.  
The process of informed consent will be structured to be conducive to rational and thoughtful decision making by the 
subject – including time for discussion, questions, and the ability to reschedule if additional time for consideration is 
needed. Legally authorized representatives will not be allowed to sign the consent; patients who require legally 
authorized representatives are excluded from the study.  
Auditors, Witnesses, and translators will not be part of the consent process. Non-English speakers are excluded from 
the study. Additionally, patients who are unable to read or write in English (i.e., illiterate) are excluded.  
 
4.6.2 Consent Form  
See Appendix for Consent Form  
 
A copy will be given to the individual that signed the form, on the same day the individual signs the form. 
 
4.6.3 HIPAA 
See Appendix for HIPAA Form  
 
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). 

 
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Signed HIPAA authorization will be obtained upon the participants arriving for Visit 1 (prior to initiating data collection 
for the visit) after reviewing the Consent form. The same process (including extended time) will be given to the 
individual to complete the HIPAA form. A copy will be given to the individual that signed the form, on the same day 
the individual signs the form.  
 
4.6.4 Revoking Consent 
After study enrollment, 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.  
 
4.6.5 Costs to the Subject 
Subjects will not have to pay for study procedures (such as home blood pressure monitors, 24-hour monitoring). 
Subjects who are randomized to receive a home blood pressure monitor will be able to keep the monitor after study 
completion. The patient will not be billed by the healthcare system or their health insurance company for any costs 
related to a study procedure.  
Subjects will be responsible for any costs related to their blood pressure follow-up as directed by their healthcare 
team, such as clinic visits and blood pressure medication, including all out-of-pocket costs.  
 
4.6.6 Payment for Participation 
Payments to participants will be provided as the study progresses; subjects do not have to complete the entire study 
to receive a payment.  
All intervention and usual care participants will receive a remuneration up to $170 for study completion. Each “face-
to-face visit” will actually be two consecutive visits (screening/baseline [visits 1, 2], 6 month [visits 3, 4], and 12 month 
[visits 5, 6]). They will receive a total of $50 for each completed face-to-face visit assessment. The payment difference 
is in relation to the participant’s time commitment for that visit.  
Screening Visit: Visit 1: $20  
Screening/Baseline Visit: Visit 2: $30 
6-month Visits: Visit 3: $30    Visit 4: $20 
12-month Visits: Visit 5: $30    Visit 6: $20 
If they arrive for Screening Visit 1 and are unable to complete the visit due to exclusion, they will receive $10 for their 
screening participation.  
An additional $20 cash gift card will be provided to all participants at Visit 4 (6-month visit) to offset study-related cell 
phone/telephone charges.  
 
The remuneration will acknowledge their time and study participation, not behavior change. Primary care providers 
and clinics will not receive an honorarium. Additional payment will not be available to subjects for travel or other costs 
(example: childcare) that are incurred.  
 
4.7 Early Withdrawal of Subjects 
4.7.1 Premature termination 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 all site investigators, the NIH/NHLBI, DSMB (i.e., ICTR DMC), and IRB. 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.  

 
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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 by research study personnel 
The study may resume once concerns about safety and protocol compliance are addressed and satisfy the IRB and/or 
the NIH. All participant data that was collected prior to study termination will be analyzed and continue to be 
handled/stored per this protocol.  
 
4.7.2 When and How to Withdraw Subjects 
Participants will be educated on the consent form that they are able to withdraw at any time without adverse effects 
to receiving healthcare services. 
Women that are currently pregnant or plan to become pregnant during enrollment screening will be excluded from 
study participation. If a participant becomes pregnant during the study, she is excluded immediately from further 
participation in all study activities. The presence/absence of birth control is not an inclusion or exclusion criteria. 
Pregnancy testing is not part of the study protocol. Once enrolled in the study, individuals in either the usual care or 
intervention group who become ineligible during the study (e.g., self-report of a new condition in the list of exclusion 
criteria) will be informed that their participation has ended and will be provided the reason for ending their study 
participation. 
No medications will be administered by the study staff. Procedures are not needed to transition subjects of study 
agents or alternate therapy if withdrawn from this study.  
 
4.7.3 Data Collection and Follow-up for Withdrawn Subjects 
Withdrawn patients after enrollment will be analyzed as intention to treat. Missing data will be imputed using multiple 
imputations along with sensitivity analyses for missingness according to the recommendations given in the National 
Research Council report.129 
 
  
5 Study Procedures 
5.1 Prior and Concomitant Therapy 
All concomitant antihypertensive medications prescribed by the patient’s healthcare team are permitted during the 
study. Ongoing antihypertensive medication changes by the patient’s healthcare team (including medication initiation, 
discontinuation, and/or dose changes) are allowed throughout the study.  
All other medications, supplements, and lifestyle modifications that were part of the participant’s treatment plan prior 
to the study are included.  
The participant may also be started on non-pharmacologic therapy (examples: physical activity, stress management) 
by their medical team during this study.  
 
5.2 Randomization and Blinding of Intervention 
Randomization assignments for both sites will be generated by the UW Biostatistics Clinical Trials Statistical Data 
Analysis Center stratified by research site, in block sizes of 4 and 6 to ensure equal allocation. The Research 
Electronic Data Capture (REDCap) clinical data management system will be used to verify eligibility and data 
completeness prior to randomization. The UW Biostatistics team will develop a randomization list, which will be 
provided to the MyHEART research staff in a binder. There will be two people responsible for the binder at all times 
at HIP (PI and research manager) who will give the randomization assignment upon receiving a phone call from the 

 
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research assessor (from either site) conducting Visit 2. Until the staff receives a phone call, the binder will remain in 
a locked file cabinet, separate from other research materials, within a locked office at 800 University Bay Drive (HIP).  
All study participants will have contact with research staff (e.g., research coordinators, research visit study 
assessment staff). To reduce bias, MyHEART 6- and 12-month assessors will be blinded to treatment assignments.130 
Assessors will be trained to treat patients in both study groups identically per protocol.131 Ambulatory monitoring will 
be the gold standard for blood pressure measurements.  
 
5.3 Established Standard of Care 
Usual care and intervention arm participants will receive routine hypertension clinical care per their primary care 
provider. This includes the possibility of receiving untailored self-management resources (i.e., dietician referral) at 
their provider’s discretion, but this is not systematically tailored to young adults’ needs. These patients would be 
treated according to current hypertension guideline standards including, but not limited to, hypertension lifestyle 
modification counseling: 1) reduced sodium intake, 2) weight loss, 3) reduced alcohol consumption, and 4) increased 
physical activity. This may include verbal discussions and/or handouts. Medications would be initiated and/or titrated 
per hypertension guidelines.  
All patients would have clinic blood pressure checks and would be encouraged to have home blood pressure 
monitoring. Additionally, providers may order 24-hour Ambulatory Blood Pressure Monitoring, per the U.S. Preventive 
Services Task Force guidelines, to exclude white coat hypertension. Patients would also have additional tests not 
limited to blood draws, EKGs, echocardiograms, etc. 
We will assess the number of healthcare team contacts in the usual care arm by calculating the number of primary 
care and specialty visits and dietician and exercise referrals after study enrollment (see IRB application with data 
variable sheet).50,60 Usual care arm participants will receive AHA’s “What is High Blood Pressure”131 handout (copies 
of handouts are in the Appendix).132 It is usual care for patients to receive hypertension educational material when 
presenting for a hypertension visit. They will not receive home blood pressure monitors. Usual care participants will 
have the same 6- and 12-month assessments as the intervention arm.  
 
5.4 Study Visits 
Study Calendar - see appendix 
 
5.4.1 Screening/Baseline: 
The same procedures will be followed at both research sites (Madison and Milwaukee). 
 
5.4.1.1 Screening Visits: 
Screening Visit 1: Screening Visit 1 occurs no more than 1 month after the telephone screening phone call. Written 
informed consent and HIPAA authorization will be obtained at the 
start of Screening Visit 1, which will include authorization for 
additional screening/eligibility assessment133 (e.g., 24-hour 
ambulatory blood pressure monitoring), gathering data, including 
information from the electronic health record, and all study 
procedures after enrollment, if eligible. If a potentially eligible 
patient requests to reschedule to sign the consent and/or HIPAA 
form, they may do so within 30 days of the screening phone call. 
Blood pressures will be measured. The patient is not eligible if the 
between-arm blood pressure difference is ≥20 mmHg. If these 
findings are noted, the participant will receive an incidental finding 
notification to discuss with their primary care provider. All patients 
Figure 1. 24-Hour Ambulatory BP Monitoring 

 
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will be given their clinic blood pressure in written format from Visit 1, regardless of eligibility. Remaining eligible 
patients will receive an ambulatory blood pressure (AMBP) monitor (example: SpaceLabs; final product to be 
determined in the appendix)134 for 24-hour blood pressure monitoring. The selected AMBP device will be FDA 
approved or have a 510(k) clearance. 24-hour AMBP monitoring is recommended to confirm a hypertension 
diagnosis (exclude white coat hypertension).135-138 The U.S. Preventive Services Task Force noted up to 65% of 
patients with high office blood pressures were not diagnosed with hypertension after AMBP monitoring.139 Previous 
young adult focus groups supported AMBP monitoring (see Figure 1) given its mobility and limited time commitment.  
If a potentially eligible young adult already completed 24-hour ambulatory blood pressure monitoring through their 
UW Health or Aurora Health Care Clinic within the past 3 months, they do not need to repeat 24-hour ambulatory 
blood pressure monitoring for study eligibility. The ambulatory blood pressure monitoring report will be reviewed in 
their electronic health record to evaluate for white coat hypertension (an exclusion criteria). If eligible, the participant 
will be able to proceed with the Screening Visit 2/Baseline Assessment Visit. The individual’s honorarium for Visit 
1 and Visit 2 will not be adjusted/decreased.   
Screening Visit 2/Baseline Assessment Visit: After receiving a 24-hour AMBP monitor, participants will be asked 
to return for Visit 2 on the next business day. Participants will have up to 30 days from Screening Visit 1 to return 
for Visit 2 without having to restart with the telephone screening process. A research staff member (not the individual 
acquiring consent or enrolling during this visit) will evaluate the mean 24-hour ambulatory blood pressure. If there 
is white coat hypertension, the patient is ineligible, and will receive an incidental finding letter to share with their 
primary care provider. Remaining eligible patients will be enrolled, randomized to MyHEART or usual care, and 
complete the baseline assessment. 
 
5.4.1.2 Baseline/Follow-Up Data Collection:  
All research staff will be trained in all key elements of the protocol and use of the data management system. 
  
Anthropometric Measurements 
• 
Height will be determined at each assessment visit using a wall-mounted stadiometer, without shoes or 
other outdoor footwear. Two measures of height will be taken and the average of the two will be used. We 
will repeat the measurement of height at each assessment visit because growth may still be occurring in 
young adults. Height will be measured to the nearest 0.1 cm. 
• 
Weight will be determined at each assessment in light indoor clothes, removing all excess layers of clothing, 
and without shoes at all visits. All scales will be calibrated using standard weights, annually by the Bureau 
of Weights and Standards and quarterly by trained study personnel. Weight will be measured to the nearest 
0.1 kg. 
• 
Body mass index (BMI). The weight and height measures will be used to calculate Body Mass Index 
(weight in kilograms divided by height in meters squared; kg/m2) 
• 
Waist Circumference will be measured at baseline per established protocol/figures in the appendix. 
 
Baseline Self-Reported Measures 
All of the following measures will be recorded on paper by the participant, then electronically entered, with 
confirmation of correct entry, by the research staff via REDCap on an encrypted research computer within the 
research offices at UWHC and/or HIP. See appendix for final forms and questions.  
• 
Alcohol Use: Alcohol consumption will be evaluated by alcohol beverage type and quantity as performed 
in the CARDIA (Coronary Artery Risk Development in Young Adults) cohort study; answered by self-
report.140 
• 
Financial Status: Participants will self-report their financial situation by selecting, for example, whether 
they: a) had enough money after paying bills for extra things (e.g., dining out), b) enough to pay bills but 
not to purchase extra things, c) enough money to pay bills by cutting back on things, or d) difficulty paying 
bills no matter what was done. The first two answer choices are categorized as “adequate income” and the 
last two choices as “inadequate income”.32 This financial assessment accounts for varying income, which 
is more reflective of young adulthood. 

 
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• 
Annual Household Income:141 income will be divided into six categories (for example: <$20,000, $20,000-
34,999, $35,000-49,999, $50,000-$99,999, ≥$100,000, prefer not to answer) and recorded by self-report 
• 
Self-Rated Health Status: Single-item assessments of self-rated health status have a strong association 
with health outcomes142-148 and provide a broad assessment of health.149 Self-rated health will be measured 
using the following question/responses similar to: "In general, would you say your health is Excellent, Very 
Good, Good, Fair, or Poor?", which has been used in nationally representative samples.147-149  
• 
Health literacy (i.e., the ability to obtain, process, and understand basic information to make appropriate 
health decisions)150-152 will be evaluated using a Rapid Estimate of Adult Literacy in Medicine 
instrument.33,153,154  
• 
Baseline comorbidities (examples: dyslipidemia,155 anxiety,156 depression,157 diabetes mellitus,158 chronic 
kidney disease159) will be assessed via self-report and the electronic health record using established ICD 
codes as per previous research.50,60,65,66,155-159  
• 
Social Support will be evaluated using a brief multi-dimensional evaluation validated for patients’ chronic 
illnesses (example: The Medical Outcomes Study Social Support Survey).149,160-162  
• 
Global medication adherence will be assessed using the Morisky adherence scale.163,164 
 
Baseline Electronic Health Record and Other Database Data Collection 
• 
Healthcare utilization will be evaluated using the John Hopkins Adjusted Clinical Group Case-Mix System, 
which assesses morbidity burden based on patient age, gender, and patterns of disease;50,60,66,165 the 
number of clinic visits will be measured. 
• 
Baseline antihypertensive medications and other medications: Number of antihypertensive medication 
classes will account for varying hypertension treatment at baseline. Data will be acquired from the electronic 
health record and participant self-report, and will include prescription and non-prescription medications.  
• 
Primary care provider characteristics (age, gender, specialty, time since completed medical school, % 
of panel with hypertension, panel size) will be obtained when available from the electronic health record 
and/or the American Medical Association Masterfile data.50,60 
 
Interviewer-Administered Data Collection (Baseline, 6 months, and 12 months) 
• 
Physical Activity. We will assess physical activity using the Godin Exercise Questionnaire to evaluate 
weekly leisure activity and total leisure activity. 
• 
Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool – A web-based tool that 
enables multiple, automatically coded, self-administered 24-hour recalls. This tool will be used to assess, 
for example, sodium, fruit, and vegetable intake in relation to the DASH-sodium diet.  
 
Blood Pressure Measurements 
Blood pressures at each research site will be assessed with a Dinamap Monitor. Cuff size will be determined by 
arm circumference. An appropriate sized166 blood pressure cuff will be connected to an automated 
sphygmomanometer (Dinamap). Each site will have the following cuff sizes available: small adult (for arm 
circumference of 22-26 cm), regular adult (27-34 cm), and large adult (35-42 cm). A blood pressure measurement 
will be obtained on the right upper arm, then the left upper arm, for the initial assessment. Right arm blood pressures 
will be subsequently used for the initial and follow-up visits, unless the left arm systolic blood pressure is ≥10 mmHg 
higher. The average of the second and third systolic and diastolic pressures, each taken 1 minute apart, will define 
the baseline clinic blood pressure.167 If a participant’s upper arm is too large, a forearm blood pressure will be 
obtained. All participants (intervention and control) will receive copies of their baseline, 6-month, and 12-month 
research clinic blood pressures to share with their usual healthcare provider, and will receive instructions on 
recommended primary care clinic follow-up.43,168  
24-Hour Blood Pressure Monitoring:169-171 24-hour blood pressure monitoring will take place at baseline, 6 
months, and 12 months. Staff trained in the use of the 24-hour ambulatory blood pressure monitor will apply the 
appropriate sized cuff to the subjects’ non-dominant arms unless the systolic blood pressure difference as measured 
during the clinic blood pressure assessment is >10 mmHg, in which case the arm with the highest value obtained 

 
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will be used. ABPM placement procedures and device recording setting will be per the AMBP manufacturing 
company’s instructions and hypertension guideline recommendations. Participants will be instructed to keep their 
arm still during cuff inflation, and on the use of a diary to record the time of their activities, sleep, symptoms, and 
medications. Participants will be given instructions on how and when to return the device to study staff. Data from 
the returned device will be uploaded and time-matched with information from the participants’ diaries. Day-time and 
night-time will preferentially be defined using each participant’s diary. All acquired readings will be saved and used 
for analysis. If the participant is unable to complete ambulatory blood pressure monitoring, they will not be excluded, 
but will alternatively have their blood pressure evaluated for study eligibility using the automatic office blood 
pressure (AOBP) technique per the SPRINT protocol172 (example: have serial blood pressures acquired once every 
5 minutes up to 5 times, using an automatic cuff without a research staff member present [i.e., while sitting alone in 
the research clinic exam room]). 
Home Blood Pressure Monitoring: Intervention participants will be provided an Omron home blood pressure 
monitor with an appropriate cuff size; details of the final model acquired for the study can be found in the 
appendix.173,174 The selected monitor will be based upon validation studies in young adults and also across BMI 
categories.175 Intervention arm participants will receive training and practice on proper cuff placement and monitor 
use during their baseline enrollment visit.36 They will be asked to take their blood pressure at least three days a 
week, 2 measurements each time.31,36 A normal home blood pressure (complicated and uncomplicated 
hypertension) is <135/85 mmHg,176 which accounts for changes in hypertension guidelines for patients with diabetes 
and chronic kidney disease.21,177 Participants will be able to read the recorded blood pressures to their health coach 
during the scheduled health coach phone calls (see below).178 Participants will be asked to bring their home blood 
pressure monitor to the 6- and 12-month visits to review recorded blood pressures. Participants will keep the blood 
pressure monitor after study completion. Malfunctioned monitors will be replaced during the study. 
 
5.4.2 Intervention 
Health Coach Training: Health coaches will receive training that builds on their prior education in motivational 
interviewing179 and hypertension management, using self-determination theory concepts. Training intensity is based 
on prior studies127 and resources from our pilot: interactive didactic lectures, videos,180 and the MyHEART health 
coach guide (see Appendix). Trainers will observe health coaches with role-playing, followed by problem solving and 
debriefing.181-183 Health coaches will already be certified as an exercise physiologist (American College of Sports 
Medicine certification), registered dietician (Academy of Nutrition and Dietetics) with at least 3 years of clinical 
experience including chronic disease management and adult education/counseling, or a registered nurse. Health 
fcoaches will receive training on the MyHEART coaching guide that builds on their prior education in motivational 
interviewing and hypertension management, using self-determination theory concepts. Training will include interactive 
didactic lectures and videos and the MyHEART health coach guide. The trainer will also observe health coaches with 
role playing followed by problem solving and debriefing. The references (scientific articles, etc.) that will be given to 
the coach are optional reading materials for them to select based upon additional questions or training needs about 
motivational interviewing, self-determination theory, and/or blood pressure lowering. The individual needs of each 
coach will be identified during training and they will be directed to appropriate references. All subject handouts 
developed for this study will be reviewed during training with discussion on when and how to include the handouts to 
reinforce the telephone calls. Handouts will be distributed after each phone call either by postal mail or email (based 
upon subject’s preference).  
Health Coach Fidelity: An audio recorder will be placed on the table during the health coach calls. The goal is to 
record the coach’s comments and adherence to the curriculum and protocol, and use of the self-determination 
theory. The participant’s first name will be heard on the audio recording as he/she communicates with the 
participant. A recording device will NOT be attached to the phone or phone line. The secure storage and 
transmission of these audio files is summarized in the “Protection Against Risks” section. 
 
 
Health Coach Phone Calls: Intervention arm participants will receive a health coach phone call every 2 weeks for 6 
months, for a total of 12 calls. The first call will be scheduled at the screening visit and subsequent calls will be set 
up at the end of each prior call. If a participant is unavailable, the health coach will leave a message and reschedule 
the call up to 3 times. Once a coach is ready to make calls for the MyHEART intervention: during each call, the health 

 
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coaches will review and discuss home blood pressures, if available, from home blood pressure monitoring, and 
address barriers and concerns to home blood pressure monitoring. The MyHEART coaches will also recommend 
clinic follow-up based on the 2-week average home blood pressures – see coach’s guide, which coincides with UW 
Health’s blood pressure follow-up recommendation. During each telephone call, the coach will guide the subject on 
selecting health behavior goals and completing the goal sheet (uploaded in this application). In addition to home blood 
pressure monitoring, subjects will be able to choose which topics from the 8 additional hypertension education 
modules they want to address during a call (options include: hypertension knowledge, low sodium, DASH eating plan, 
weight loss/maintenance, smoking cessation, moderate alcohol consumption, blood pressure medicine, social 
support and stress management). The coach may also offer topics to the participant based upon barriers or concerns 
discussed during the call. A module is a "topic" to discuss which includes a coach's education/counseling, associated 
handouts, and references (see module overview in table below). The participant may focus on the same topics 
throughout the intervention based upon their personal needs or change the topics with every call. Home blood 
pressure monitoring will be discussed during each call by the health coach.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The content of coach-participant interactions will focus on: 1) highlighting discrepancies between participants’ current 
health behaviors and their desired behavior goals to promote internal motivation, 2) sharing reference points for 
guideline-recommended behaviors to lower blood pressure, and 3) discussing short-term goals and developing 
congruent action plans. Coaches will promote autonomy by individualizing the order and depth of educational content 
based on the behavioral goals chosen by the subject. Subjects will be coached on practical skill building (e.g., label 
reading) and coaches will encourage patients to set goals that are motivating but not overwhelming. The "Coach's 
Guide" is to build on the coach's knowledge of blood pressure lowering behavioral techniques and how to use the 
self-determination theory and motivational interviewing to guide the subject as they initiate and try to maintain their 
new health behaviors. Abbreviated guides in the appendix highlight important "talking points" for the coach to address 
during each call. Hypertension guidelines on exercise and dietary changes will be given to the participant by the 
health coach, based upon the updated guidelines available at the time. Coach references will be updated if new 
guidelines and scientific recommendations become available during this study.  
All intervention participants will start with the home blood pressure monitoring module. The first follow-up phone call 
will address hypertension knowledge and review home blood pressure monitoring. Home blood pressure monitoring 
education will also be provided during all follow-up phone calls. The order of the remaining modules will be guided by 
participant’s choice and tailored to their goals.170,171 Fewer modules than calls allows some topics to be repeated as 
MyHEART Health Coach Educational Modules  
 
Module 
Topics 
Home Blood 
Pressure 
Monitoring 
How to measure blood pressure, include members in household to avoid isolation, what 
do the numbers mean 
Hypertension 
Knowledge 
Define blood pressure, goal blood pressure, long-term health consequences 
Low Sodium 
Reading labels, effects of sodium on blood pressure, culturally appropriate cooking 
alternatives, eating with peers, meal planning, shopping on a budget 
DASH Eating 
Plan 
DASH components, meal planning, grocery shopping on a budget, DASH with peers; 
Cultural and personal food preferences; Discuss cultural meaning of dietary practices 
Weight Loss/ 
Maintenance 
Relationship of weight with hypertension, dietary and activity options to lose weight, time 
management, social support to assist with weight loss, fitness apps 
Smoking 
Cessation* 
Negative effects of tobacco on heart health, social/peer influence 
Moderate 
Alcohol 
Consumption 
Negative effects on heart health; define quantity for types of alcohol 
Blood Pressure 
Medicine 
Why medications may be needed, side effects, adherence, possible lifelong commitment, 
remembering medication, cost 
Social Support 
Local resources for support, reducing clinic no-shows, peer/social support 
Stress 
Management 
Identifying ways to reduce stress, stress with life’s transitions and new challenges 
*Only for active tobacco users 

 
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needed and per the participants’ requests. Current tobacco users will be referred to the Wisconsin Tobacco Quit Line 
(http://www.ctri.wisc.edu/quitline.html) when ready to attempt cessation and their primary care provider will be notified 
of their intention to quit via the EHR. The participant will be encouraged to also discuss alcohol reduction/cessation 
with their primary care provider if they report consuming >14 alcohol beverages/week.122 The MyHEART team created 
handouts to include specific topics requested by our young adult focus groups (see Appendix). The MyHEART 
handouts were formatted with a Flesch-Kincaid readability of ≤6th grade.172  
 
5.4.3 Follow up:  
Table. Acceptable Window for Study Visits (including weekends) 
Visit 
Window 
Activities 
Baseline (Visit 1) 
No more than 30 days 
from telephone 
screening phone call 
Written, informed consent, clinic blood pressure, 24-hour 
AMBP placement, provide participant remuneration 
Baseline (Visit 2) 
No sooner than 24 
hours after Visit 1 and 
no more than 21 days 
after Visit 1 
Clinic blood pressure, 24-hour AMBP removal, if eligible, 
enrollment, randomization, baseline screening questions 
and assessment, provide participant remuneration  
6-month (Visit 3) 
No later than 30 days 
since the last health 
coach call (intervention 
arm) or the scheduler 
call (routine/usual care) 
Clinic blood pressure, 24-hour AMBP placement, 6-month 
follow-up assessment (ex: BMI), questionnaires, provide 
participant remuneration  
6-month (Visit 4) 
No sooner than 24 
hours from Visit 3 and 
no more than 21 days 
from Visit 3 
24-hour AMBP removal, provide participant remuneration 
12-month (Visit 5) 
No later than 30 days 
since scheduler call 
(both intervention and 
usual care arm) 
Clinic blood pressure, 24-hour AMBP placement, 6-month 
follow-up assessment (ex: BMI), questionnaires, provide 
participant remuneration  
12-month (Visit 6) 
No sooner than 24 
hours from Visit 5 and 
no more than 21 days 
from Visit 5 
24-hour AMBP removal, provide participant remuneration 
 
5.4.4 Unscheduled: 
• 
Unscheduled visits are not included in this study. 
• 
See the appendix for the study calendar with procedures and data collection  
• 
Participants will be encouraged to continue routine blood pressure follow-up with their primary and routine 
healthcare team. Otherwise, no additional concomitant therapies be advised or suggested. 
 
5.4.5 Final Study Visit 
The final study evaluation will be two visits (as above in the visit table) with the first visit occurring 12 months after 
study enrollment. See appendix for the study calendar of study endpoints and evaluations. 
During the 12-month visit, participants will be informed of their treatment assignments, final weight, clinic and 24-hour 
blood pressures, and body mass index. Additional data from the 12-month visit will not be analyzed in time to be 
provided to the participant. 

 
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Additional follow-up for adverse or serious adverse events will continue for 30-days after the final 12-month visit with 
one telephone follow-up by the research team. The participant will be responsible for scheduling any additional clinic 
visits and medical care for adverse or serious adverse events.  
 
6 Study Analysis 
6.1 Sample Size Determination 
For Aim 1, approximately 930 individuals will be screened to get to a total of 340 enrolled participants (170 participants 
per randomized arm). This is designed under the assumption that there will be a further 15% dropout rate at the 6-
month mark following randomization, to result in an effective sample size of 264.184 In Nidich et al.,185 the 3-month 
transcendental meditation program showed a mean difference of 6.3 and 4.0 in systolic and diastolic blood pressure 
change with a standard deviation of 13.6 and 9.7, respectively, as compared to a case of usual control among young 
adults at hypertension risk. With an effective sample size of 264, there is power of 0.94 and 0.87 for systolic and 
diastolic blood pressure, respectively, each at a two-tailed 0.025 test for an overall significance level of 0.05. For Aim 
2, the effective sample size of 264 subjects will provide 90% power to detect a difference in the population mean 
difference from baseline to 6 months between treatment groups of about 0.4 standard deviations of the differences 
(moderate effect size). Aim 3 is an exploratory aim.  
 
6.2 Statistical Methods 
See Appendix for the full Statistical Analysis Plan (SAP)  
 
Statistical Analysis Plan Overview:  
Data will be analyzed by intent to treat. Missing data will be imputed using multiple imputations. 
 
For Aim 1, the comparisons for the primary outcomes of systolic and diastolic blood pressure change from baseline 
to 6 months will be done using analysis of covariance. The primary comparisons for the secondary outcome of 
hypertension control at 6 months will be based on Fisher’s exact tests. Sequential hypothesis testing will also be 
performed. The 12-month analysis will focus on maintenance of behavior change, to assess whether significant 
differences seen between baseline and 6 months are retained. We will also assess the differential effectiveness of 
the intervention across subgroups by developing exploratory regression models. 
For Aim 2, behavioral outcomes will be analyzed in a similar manner as with the clinical outcomes in Aim 1 depending 
on whether they are continuous or categorical. Analyses (t-tests or Wilcoxon tests and ANCOVA for continuous 
variables; Fisher’s exact test for the categorical variable) will be performed for differences from baseline to 6 months 
between treatment groups. Linear or generalized linear mixed-effects regression models will be fit to describe 
longitudinal behavioral measurements over time. 
For Aim 3, analyses will examine hypothesized mediators of the MyHEART intervention (for example, autonomy 
support, internal motivation, perceived competence, and patient activation). We will estimate mediation effects in 
multilevel models186-190 where mediation is assessed by fitting two models. Standard errors and 95% confidence 
intervals for the mediation effect and percent-mediated estimates will be calculated. This analysis will be pivotal to 
guide future replication and dissemination of MyHEART. 
 
6.3 Planned Interim Analysis:  
There is no interim analysis planned. However, we are prepared, if requested by the Data Safety and Monitoring 
Committee at any point, to calculate interim statistical power for its review. Projections of interim power can be made 
under several scenarios for future data, including assumptions that current trends continue or that the future data 
reflect the relative effects used in the design of the trial. Safety reports will tally adverse events by intervention 
assignment and postulated relationship to the trial interventions; event rates will be reported per person year of follow-
up. Should excessive risk to study participants be determined during the data safety monitoring review, the study will 

 
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be stopped and all participants notified in a manner appropriate to the nature of the risk as defined by the IRB and 
DSMB. 
 
7 Data Collection, Handling, and Record Keeping 
7.1 Data Confidentiality 
Protecting Participant Confidentiality: Every effort will be made to protect participant confidentiality. Subject 
confidentiality will be protected with the coded patient IDs whenever possible. Linking information will be maintained 
separately from other study documents in a password-protected database on password-protected media. Only the 
principal investigator, HIP programmers, and the research coordinators responsible for mailing the study invitations 
and remuneration will have access to directly identifiable subject data. Once these activities have ceased, identifying 
information will be destroyed. Analysis datasets will be limited datasets and the research team will not have access 
to identifiers other than those in a limited dataset (zip codes and dates), or any cross-walk information.  
Identifiable Data: HIP and Aurora Health Care Programmers will identify potential participants using the criteria 
described in this protocol. Each subject will be assigned a study-specific ID number, maintained separately from the 
subject’s medical record number (MRN). Only research team members listed in the IRB application shall have access 
to the list.  
Security levels for the UW Ob/Gyn and Health Innovation Program’s data systems that include patient-identifiable 
data are housed within a UW Health data center (and benefit from the same security configuration as other UW Health 
servers housing fully identifiable clinical and administrative patient data) and include: 
1. All new user account requests and access to any resource is reviewed and approved by the Health Innovation 
Program Director or UW Ob/Gyn IT director. 
2. Resource administration is managed by the UW Ob/Gyn or Health Innovation Program’s (HIP’s) Compliance 
Officer and Information Technology personnel. UW Health user account creation is requested by HIP’s 
Compliance Officer and fulfilled by UW Health Information Technology personnel. 
a. A combination of Active Directory (AD) and New Technology File System (NTFS) folder permissions 
enforce authentication and file access policies. 
b. Folder access permissions are routinely reviewed and compared to the project's list of "Key Personnel" 
and/or those persons specified elsewhere to have privileges to view/use the data (e.g., data use 
agreement or confidentiality agreement signatories).  
3. These data systems are located behind UW Health’s firewall. 
4. These data systems are accessed via remote desktop connections originating from a subnet of Internet Protocol 
(IP) addresses reserved only for UW Ob/Gyn or Health Innovation Program computer workstations. 
5. These HIP data systems at UW Health are secured in a data center behind a series of two locked doors; access 
is restricted to key UW Health Information Technology personnel under the supervision of the UW Health server 
administrator. 
PC workstations used to access the server with identifiable data must be within HIP's subnet, which is preapproved 
by UW Health to access this server and have an additional layer of password protection. 
The Aurora Health Care Research Analytics team and the Aurora Health Care Information Technology personnel 
oversee the security, user access, and data systems that include patient-identifiable data and transfer of encrypted, 
limited data sets to the UW Ob/Gyn or Health Innovation Program. The research analytics team has received 
extensive training and numerous certifications on obtaining data from Aurora’s electronic health record. Each member 
of the research analytics team may serve as honest brokers and are skilled in de-identifying protected health 
information. 
 
For Aurora Health Care:  
1. Aurora Health Care Research Analytics, Aurora IRB/Compliance, and Aurora Information Technology teams 
review all new user account requests and access to any resource. 

 
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2. Aurora Health Care’s database servers are secured via firewall, hardened to remove nonessential access 
credentials, and strong password compliance. Hosted systems are constantly monitored for latencies and 
intrusion. 
3. There are differentiated user roles and privileges, password and user authentication security, electronic 
signatures, SSL encryption, and a comprehensive auditing record and monitoring of access and data changes 
to support the security of data transfer from Aurora Health Care to the Health Innovation Program. 
 
At the Aurora site, paper source documents will be kept in a clinical research office at Aurora Health Care (Milwaukee, 
WI) which is double locked and only accessible by key card and/or key. After REDCap entry, source documents will 
be stored in subject binders in a locked filing cabinet and maintained for the length of time approved by the IRB.  
 
Analysis Datasets: All research and analysis from the combined research sites will be conducted using a limited 
dataset (no direct identifiers; includes zip codes and dates only), provided by the Health Innovation Program.  
 
Each individual patient record in the dataset is assigned a "pseudo ID" during dataset construction, which allows HIP 
and Aurora Health Care Programmers to link patient records from multiple sources and/or across different file types 
(e.g., demographics, laboratory results, medications). The pseudo ID also allows Programmers to cross-walk the data 
back to the Electronic Health Record ("EHR"; example: UW Health Link) in the event data need to be verified or 
additional elements extracted from the source. Information allowing data to be cross-walked with identifiers will never 
be shared with the study team.  
 
Following data aggregation, linking, and variable creation, the datasets used for day-to-day analysis will be securely 
transferred to a second server with equivalent security. Data access is restricted to only IRB-approved personnel 
conducting study analysis and with passwords for computer drive and project folder access. The limited datasets 
are stored on a specified HIP server, housed in the Centennial Office Building managed by the UW SMPH IT, and is 
connected via fiber optic cable to the HIP suite at 800 University Bay Drive. As of May 2022, all data will be 
transferred from HIP and stored on the UW Department of Obstetrics and Gynecology server. No individual PHI will 
be released for analysis, in presentation or publication. Only aggregate statistical output representing groups of 
subjects will be released. The completed study data set will be securely transferred, using the latest Secure File 
Transfer Protocol, to the Bioinformatics Computing Group (BCG) at the UW-Madison to the lead statistician. The 
levels of security for the server are five-fold and include: 
1) Physical Security: server is located in an enterprise level secure data center under control of UW School of 
Medicine and Public Health (SMPH) ITS, which is a dedicated computer machine room requiring keycard and PIN 
for access. The room is equipped with camera surveillance, a hot and cold isle chilling system and an automatic fire 
detection and suppression system. SMPH ITS does not have access to the server. Ob-Gyn servers are supplied 
power by redundant sources and are protected by both an uninterruptible power supply and a backup generator. 
2) The data resides behind an SMPH managed hardware based firewall and a computer based software firewall 
3) Access controls: Data directory access is limited to project PI and designees she approves (currently none at this 
time) 
4) Domain access restrictions: access to Ob-Gyn computing resources is restricted to individuals with an Ob-Gyn 
logon 
5) Authentication: Password protection is used at the network level for all transactions that allow entry and editing of 
data, provide access to EPHI data, or administrative activities.  
 
Online Collaboration Tool: The Health Innovation Program developed a secure SharePoint-based Intranet. This 
web-based platform will be available to IRB-approved MyHEART investigators and staff to securely access this 
study’s materials (examples: up-to-date protocols, contact information, calendars). Access to the UW Ob/Gyn or HIP 
Intranet follows the same secure measures as defined above.  
Online Reporting Tool: This proposal will use the REDCap data management program. The REDCap application 
and data are hosted by the Bioinformatics Computing Group (BCG) at the UW-Madison on its server farm with 
redundant systems. To gain access to the REDCap system, study personnel will need to fill out a REDCap account 
request through ICTR using the following link: https://redcap.ictr.wisc.edu/surveys/?s=MPHF4FWP4D. 

 
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Once approved, each user will have their own account. To ensure that REDCap users have access only to data and 
information that they are supposed to have access to within the application, the each user’s privileges will be assigned 
by the study’s principal investigator. The Data Access Groups functionality will also be implemented to allow site-
specific research staff to only access records created at their respective site.  
 
Additional REDCap security features that will be used in this study include: 
• 
authentication to validate the identity of end-users that log into the system 
• 
auto-logout setting 
• 
Limit number of failed login attempts before a user is locked out of the system  
 
REDCap data entry, views, and modification will be audited for each user. A user’s status will be immediately 
suspended if an audit demonstrates that they are not complying with the protocol and the IRB and DSMB will be 
notified per the IRB policy.  
Disaster recovery plans include a back-up server at the UW Centennial Medical Building, independently managed by 
the UW School of Medicine and Public Health, Department of Medicine.  
We also have policies and procedures in place to protect the confidentiality and security of patient data, and our data 
protection measures (for protected health information, or PHI) are consistent with the Federal Health Insurance 
Portability and Protection Act’s privacy and security rules (45 CFR §160.103; 45 CFR §160 and 164, Subparts A and 
C, respectively). Only persons directly involved in the research will have access to identifiable research data. All study 
data will be maintained in password-protected, secured computer files or in locked cabinets within locked offices. 
 
7.1.1 Confidentiality of Subject Records 
By signing the protocol, the Investigator agrees that the NIH/NHLBI or IRB representative may consult and/or copy 
study documents in order to verify CRF data. By signing the consent form, the subject agrees to this process. If study 
documents will be photocopied during the process of verifying CRF information, the subject will be identified by unique 
code only and full names and similar identifying information (such as medical record number or social security 
number) will be masked. 
The Clinical Site Investigators will ensure that the identity of subjects will be protected. All study records will be 
maintained in a secure fashion with access limited to essential study personnel only. All study documents submitted 
to the Coordinating Center will have identifiers removed other than dates of birth and service and subjects will be 
identified with a study-specific identification number only. The Clinical Site Investigators will maintain, in a secure 
location, an enrollment log that includes subject identifying information and links subjects to their study-specific 
identification number.  
 
7.2 Data Capture  
7.2.1 Source Documents 
All source data will be kept and merged and/or entered into the electronic clinical trial software (REDCap). Source 
data is all information, original records of clinical findings, observations, or other activities in a clinical trial necessary 
for the reconstruction and evaluation of the trial. Source data are contained in source documents. Examples of these 
original documents and data records include: hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects’ diaries or evaluation checklists, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate and complete, subject files, and records kept at the 
pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial.  
Data will be collected at both study sites during the Screening Visit (Visit 1), Screening/Baseline assessment (Visit 
2), 6-month Visits (Visits 3 and 4), 12-month Visits (Visits 5 and 6), and during the health coach phone calls.  
In addition, 24-ambulatory blood pressure monitoring will be performed at each site with data downloaded via 
Spacelabs software and summary data transferred to REDCap. Data from these visits including participant 

 
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demographic information, vital signs, and other participant information will be uploaded into REDCap clinical research 
management software.  
 
7.2.2 Case Report Forms 
The study case report form (CRF) is a data reporting instrument for the study. All data requested on the CRF must 
be recorded. All missing data must be explained.  
• 
All entries should be printed legibly in black ink.  
• 
If any entry error has been made, to correct such an error, draw a single straight line through the incorrect 
entry and enter the correct data above it.  
• 
All such changes must be initialed and dated. 
 
NOTE: 
• 
If a space on the CRF is left blank because the procedure was not done or the question was not asked, write 
“N/D”.  
• 
If the item is not applicable to the individual case, write “N/A”.  
• 
DO NOT ERASE OR WHITE OUT ERRORS.  
• 
For clarification of illegible or uncertain entries, print the clarification above the item, then initial and date it. 
 
7.3 Data Management 
The Madison site, under the direction of MyHEART’s lead statistician, will serve as the data coordinating center and 
the primary site to oversee timely and accurate data collection.  
 
7.4 Data Monitoring  
REDCap reports will be used to provide up-to-the-minute access to all entered data. This will allow verification of 
completeness, timeliness, reliability, and accuracy of collection and coding of data. Quality reports will also be sent 
to the MyHEART Steering Committee and will include comprehensive data on all quality control activities, including 
protocol adherence and violation, training, retraining, certification, and site visit reporting. The Steering Committee, 
along with the UW Biostatistics and Medical Informatics’ lead MyHEART statistician, will develop and maintain 
standards to identify outlying values, and initiate and coordinate separate review of these observations for accuracy. 
Consistency checks and range checks have been built into the REDCap System. 
 
7.5 Records Retention 
For this non-FDA regulated study, all study data will be retained for at least 2 years after the last manuscript published 
under this clinical trials protocol number. If the analysis data will be retained beyond this window (example: for another 
study), a separate protocol and IRB approval will be obtained. The analysis data sets will only be shared with the 
Aurora Health Care research site as per the study structure outlined above. Any other outside institution will need to 
establish a data use agreement per UW Health’s, University of Wisconsin School of Medicine & Public Health, and 
any other applicable party’s protocol to acquire a copy of the de-identified dataset.  
 
8 Assessment of Safety 
Centralized safety oversight will be coordinated by the PI. The site PI will be notified of any adverse/serious adverse 
events for their specific site and will notify the PI, to ensure that all notifications (IRB, DSMB, etc.) occur according to 
protocol. 
 

 
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8.1 Specifications of Safety Parameters 
8.1.1 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 
 
8.1.2 Definition of Serious Adverse Events (SAE)  
Adverse events are classified as serious or non-serious. A serious adverse event is any AE that fulfills at least one of 
the following criteria:  
• 
is fatal 
• 
is life-threatening 
• 
requires or prolongs hospital stay 
• 
results in persistent or significant disability or incapacity 
• 
is a congenital anomaly or birth defect 
• 
is 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, treatment of bronchospasm in an emergency department would typically be 
considered serious. The primary pre-defined serious adverse events related to this study include hypoglycemia 
among patients with diabetes mellitus starting a new exercise program. All adverse events that do not meet any of 
the criteria for ‘serious’ should be regarded as non-serious adverse events. Throughout the study, any new clinically 
significant findings/abnormalities that meet the definition of an adverse event must also be recorded and documented 
as an adverse event. 
 
Post-Study Adverse Event: All unresolved adverse events will be followed by the investigator until the events are 
resolved, the participant is lost to follow-up, or the adverse event is otherwise explained. At the last scheduled visit, 
the research visit investigator will instruct each participant to report any subsequent event(s) that the participant, or 
the participant’s personal physician, believes might be related to participation in this study; the staff will contact the 
participant 30-days after study completion to inquire about any adverse events. The research visit investigator should 
notify the site-PI and the principal investigator (if different from the site-PI). The principal investigator will notify the 
study sponsor and IRB of any serious adverse event or death occurring up to 30 days after the participant has 
discontinued or terminated study participation that may be related to this study.  
Hospitalization, Prolonged Hospitalization, or Surgery: Any adverse event that results in hospitalization or 
prolonged hospitalization will be documented and reported as a serious adverse event unless specifically instructed 
otherwise in this protocol. Any condition responsible for surgery should be documented as an adverse event if the 
condition meets the criteria for an adverse event.  
Neither the condition, hospitalization, prolonged hospitalization, nor surgery are reported as an adverse event in the 
following circumstance: 
• 
Hospitalization or prolonged hospitalization for diagnostic or elective surgical procedures for a preexisting 
condition. Surgery should not be reported as an outcome of an adverse event if the purpose of the surgery was 
elective or diagnostic and the outcome was uneventful. 

 
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8.1.3 Definition of Unanticipated Problems (UP)  
OHRP considers unanticipated problems involving risks to participants or others to include, in general, any incident, 
experience, or outcome that meets all of the following criteria:  
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are described in 
the protocol-related documents, such as the IRB-approved research protocol and informed consent document; 
and (b) the characteristics of the participant population being studied;  
• 
Related or possibly related to participation in the research (“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); and  
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized.  
 
This study will use the OHRP definition of UP. 
 
Corrective actions or changes that will be considered in response to an UP will include:  
• 
Modification of inclusion or exclusion criteria to mitigate the newly identified risks  
• 
Implementation of additional safety monitoring procedures  
• 
Suspension of enrollment of new participants or halting of study procedures for enrolled participants  
• 
Modification of informed consent documents to include a description of newly recognized risks  
• 
Provision of additional information about newly recognized risks to previously enrolled participants. 
 
8.2 Classification of an Adverse Event 
8.2.1 Severity of Event 
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. 
 
8.2.2 Expectedness 
The principal investigator will be responsible for determining whether an AE is expected or unexpected. 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. 
 
8.3 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 CRF. 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 

 
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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 30 
days (for non-serious AEs and 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. Breaches of confidentiality and emotional upset will be reported to the PI who will then 
review the incident with the study staff, information technology groups, and follow-up with the participant. The PI is 
responsible for making the reports to the DSBM, IRB and NHLBI.  
 
8.4 Reporting procedures 
This study will follow the HS-IRB reporting and submission timeframes: 
https://kb.wisc.edu/images/group78/18324/ReportingTimeframesJanuary2013.pdf  
  
Reporting time frames are in the Appendix. 
 
This document will take priority for timeframes. The PI is responsible for reporting to the IRB, DSMB, and NIH.  
 
8.4.1 Adverse Event (AE) Reporting  
Adverse events must be reported once the participant undergoes any study procedures and adverse events must be 
reported during the entire active study period and for 30 days following the last administration of study treatment. The 
IRB, DSMB and NHLBI will be notifications about AEs.  
 
8.4.2 Serious Adverse Event (SAE) Reporting  
The study clinician will complete a SAE Form within the following timelines:  
All deaths and immediately life-threatening events, whether related or unrelated, will be recorded on the SAE Form 
and submitted to the DCC/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 DCC/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.  
 
8.4.3 Unanticipated Problem (UP) Reporting  
The site investigator will be responsible for creating and completing a UP report form. Incidents that meet the OHRP 
criteria for UPs will be reported promptly per the HS IRB timeline (see Appendix).  
 
• 
All UPs should be reported to appropriate institutional officials as required by the HS-IRB, the NHLBI, DSMB, 
and OHRP upon receipt of the report of the problem from the investigator per the HS IRB policy: 
https://kb.wisc.edu/images/group78/18324/ReportingTimeframesJanuary2013.pdf  
 

 
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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. 
 
8.4.4 Reporting of Pregnancy  
Subjects will also be immediately withdrawn from the study if they report being pregnant or planning to become 
pregnancy. Study data acquired up to the withdrawal date will be analyzed. No additional routine pregnancy reporting 
is indicated for this study. 
  
8.5 Study Halting Rules 
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 all site investigators, the NIH/NHLBI, DSMB, and IRB. 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 DSMB. All participant data that was collected prior to study termination will be analyzed and 
continue to be handled/stored per this protocol.  
Subsequent review of serious, unexpected, and related AEs by the DSMB and/or IRB may also result in suspension 
of the study.  
 
8.6 Safety Oversight 
Independent safety oversight will be provided by The UW ICTR Data Monitoring Committee (DMC). It is an 
independent team supported in its mission of safety and compliance by experienced ICTR staff to provide 
administrative assistance, experienced members representing a diversity of backgrounds (clinicians, biostatisticians, 
bioethicist), skills, and knowledge, and the use of the Research Electronic Data Capture (REDCap) tool, which 
provides data management functionality by allowing the development of eCRFs and surveys to support data capture. 
In providing oversight for the conduct of this study, the ICTR DMC will meet annually (every 12 months) during the 5-
year study with opportunities to meet face-to-face or via phone and web depending on each individual’s availability. 
The number of individuals will be determined by the UW ICTR. Additional meetings may be scheduled as determined 
by the DMC or as requested by the PI. The DMC members will review protocol-specific reports created by statisticians 
that serve a non-voting member role on the DMC using data pulled from REDCap. These standard reports will include 
an overview of study objectives, a review of actual and projected accrual rates, an evaluation of patient demographics 
for balance of randomization, and a summary of the number and seriousness of adverse events. An interim analysis 
of study results may be performed and source documents may be reviewed to allow the DMC to independently judge 
whether the overall integrity and conduct of the protocol remain acceptable based on data provided and reported by 
the Principal Investigator. The DMC will make recommendations to the Principal Investigator that could include actions 
of continuation, modification, suspension, or termination. 

 
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Data will be summarized and provided directly to the DSMB through the REDCap clinical trial software used for data 
collection during the study. The DSMB will keep minutes of its meetings, and the PIs and all study staff will receive 
verbal and written summaries of their reviews and recommendations.  
 
See the DSMB charter in the Appendix  
 
8.7 Unblinding Procedure 
Although unlikely in this study, unblinding will be done in emergent medical circumstances. All efforts will be made 
to maintain blinding except in the case of urgent medical necessity. If a subject needs to be unblinded, the study 
site must document who broke the blind and the reason, and report the event to a member of the trial’s executive 
leadership team (principal investigator, site investigator, and senior biostatistician) within 24 hours, who will instruct 
the data coordinating center to unblind.  
9 Study Monitoring, Auditing, and Inspecting 
9.1 Medical Monitoring 
9.1.1 Study Monitoring Plan 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are protected, that 
the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with 
the currently approved protocol/amendment(s) and with applicable regulatory requirement(s).  
• 
The PI and site PI will conduct monitoring, including on-site and centralized (via REDCap), initially weekly for 
the early/initial enrollment procedures, and then monthly. The monitoring will be comprehensive (100% data 
verification) via REDCap with random review of health coach calls. Monitoring reports will be available for the 
DSMB. 
• 
Each clinical site will also perform internal quality management of study conduct, data collection, 
documentation, and completion as directed by ICTR/WINHR. An individualized quality management plan will 
be developed to describe a site’s quality management. 
 
See appendix for the auditing tool.  
 
9.2 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol or 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 will be reported per the HS IRB requirements (see appendix – reporting timeline). All deviations must be 
addressed in study source documents, reported to the NIH Program Official, DSMB, and IRB. Protocol deviations 
will be sent to the local IRB per their guidelines. The PI, site PI, and study staff are responsible for knowing and 
adhering to the IRB requirements.  
 
9.2.1 Internal Data and Safety Monitoring Board 
The Data Safety and Monitoring Plan (DSMP) for this research comprises research conducted at all sites for this 
proposal. All investigators and site principal investigators must agree to comply with the procedures outlined in this 
DSMP. This DSMP does not reduce any investigator’s obligation to comply with the requirements of the Institutional 
Review Board (IRB). 
All research activities conform to the NIH definition of a clinical trial. The UW ICTR Data Monitoring Committee (DMC) 
is an independent team supported in its mission of safety and compliance by experienced ICTR staff to provide 

 
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administrative assistance, experienced members representing a diversity of backgrounds (clinicians, biostatisticians, 
bioethicist), skills, and knowledge, and the use of the Research Electronic Data Capture (REDCap) tool, which 
provides data management functionality by allowing the development of eCRFs and surveys to support data capture. 
In providing oversight for the conduct of this study, the ICTR DMC will meet annually (every 12 months) during the 5-
year study with opportunities to meet face-to-face or via phone and web depending on each individual’s availability. 
The number of individuals will be determined by the UW ICTR. Additional meetings may be scheduled as determined 
by the DMC or as requested by the PI. The DMC members will review protocol-specific reports created by statisticians 
that serve a non-voting member role on the DMC using data pulled from REDCap. These standard reports will include 
an overview of study objectives, a review of actual and projected accrual rates, an evaluation of patient demographics 
for balance of randomization, and a summary of the number and seriousness of adverse events. An interim analysis 
of study results may be performed and source documents may be reviewed to allow the DMC to independently judge 
whether the overall integrity and conduct of the protocol remain acceptable based on data provided and reported by 
the Principal Investigator. The DMC will make recommendations to the Principal Investigator that could include actions 
of continuation, modification, suspension, or termination. 
Data will be summarized and provided directly to the DSMB through the REDCap clinical trial software used for data 
collection during the study. The DSMB will keep minutes of its meetings, and the PIs and all study staff will receive 
verbal and written summaries of their reviews and recommendations.  
 
See the DSMB charter in the Appendix section of the protocol. 
 
9.3 Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the IRB (or their representatives), 
and/or the NIH 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.). 
 
9.4 Subject Compliance Monitoring 
The study team will assess and track subject compliance through previously published methods.191 This will include: 
- 
Intervention arm: Assessing the frequency that patients answer and complete health coach calls 
- 
Intervention arm: Reviewing home blood pressure monitor directly during follow-up research visits and 
assessing the presence/absence of home reading availability during health coach calls 
- 
Usual care and intervention arms: Frequency upon returning for study visits, completing phone surveys 
 
After at least 3 call attempts, each 1-week apart, and 1 mailed letter attempt, if the participant does not return for the 
6-month research study visit they will be withdrawn from the study and analyzed as intention to treat.  
10 Ethical Considerations 
This study is to be conducted according to NIH and Institutional research policies and procedures. 
This protocol and any amendments will be submitted to a properly constituted independent Institutional Review Board 
(IRB), in agreement with local legal prescriptions, for formal approval of the study conduct. The decision of the IRB 
concerning the conduct of the study will be made in writing to the investigator and a copy of this decision will be provided 
to the sponsor before commencement of this study. The investigator should provide a list of IRB members and their 
affiliate to the sponsor. 
All subjects for this study will be provided a consent form describing this study and providing sufficient information for 
subjects to make an informed decision about their participation in this study. See Appendix for a copy of the Subject 
Informed Consent Form. This consent form will be submitted with the protocol for review and approval by the IRB for 
the study. The formal consent of a subject, using the IRB-approved consent form, must be obtained before that subject 
undergoes any study procedure. The consent form must be signed by the subject and the investigator-designated 
research professional obtaining the consent.  

 
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11 Study Finances 
11.1 Funding Source 
This study is financed through a grant from the US National Institutes of Health. 
 
11.2 Conflict 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 a properly constituted Conflict of 
Interest Committee with a Committee-sanctioned conflict management plan that has been reviewed and approved by 
the study sponsor prior to participation in this study. All UW investigators will follow the UW conflict of interest policy. 
 
12 Publication Plan 
Neither the complete nor any part of the results of the study carried out under this protocol will be published or passed 
on to any third party without the consent of the principal investigator. The principal investigator holds the primary 
responsibility for publication of the results of the study. Study data and results will be published and shared as mandated 
by NIH and Federal data sharing regulations. We will share data generated from this study in the form of manuscripts 
submitted for peer-review and publication in appropriate journals. The timely release and sharing of data will coincide 
with dates on which manuscripts are accepted and subsequent page proofs are shared on PubMed/Medline as “Epub 
ahead of print” documents.  
 
13  References 
 
1. 
Go AS, Bauman MA, Coleman King SM, et al. An effective approach to high blood pressure control: a science 
advisory from the American Heart Association, the American College of Cardiology, and the Centers for Disease 
Control and Prevention. J Am Coll Cardiol. 2014;63(12):1230-1238. 
2. 
U.S. Department of Health and Human Services. Healthy People 2020: Heart Disease and Stroke - Increase the 
proportion 
of 
adults 
with 
hypertension 
whose 
blood 
pressure 
is 
under 
control. 
http://www.healthypeople.gov/node/4555/data_details. Accessed March 23, 2017. 
3. 
Centers 
for 
Disease 
Control 
and 
Prevention. 
High 
Blood 
Pressure 
Facts. 
http://www.cdc.gov/bloodpressure/facts.htm. Accessed March 23, 2017. 
4. 
Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-
2008. JAMA. 2010;303(20):2043-2050. 
5. 
Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the 
American Heart Association. Circulation. 2016;133(4):e38-e360. 
6. 
Nguyen QC, Tabor JW, Entzel PP, et al. Discordance in national estimates of hypertension among young adults. 
Epidemiology. 2011;22(4):532-541. 
7. 
Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional 
health literacy. Patient Educ Couns. 1999;38(1):33-42. 
8. 
Grubbs V, Lin F, Vittinghoff E, et al. Body mass index and early kidney function decline in young adults: a 
longitudinal analysis of the CARDIA (Coronary Artery Risk Development in Young Adults) study. Am J Kidney Dis. 
2014;63(4):590-597. 
9. 
Mitchell AB, Cole JW, McArdle PF, et al. Obesity increases risk of ischemic stroke in young adults. Stroke. 
2015;46(6):1690-1692. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
47 
Version #: 05-04-2022 
10. 
Schold JD, Goldfarb DA, Buccini LD, et al. Comorbidity burden and perioperative complications for living kidney 
donors in the United States. Clin J Am Soc Nephrol. 2013;8(10):1773-1782. 
11. 
Centers for Disease Control and Prevention. Vital signs: awareness and treatment of uncontrolled hypertension 
among adults--United States, 2003-2010. MMWR Morb Mortal Wkly Rep. 2012;61:703-709. 
12. 
Smith TW, Ruiz JM. Psychosocial influences on the development and course of coronary heart disease: current 
status and implications for research and practice. J Consult Clin Psychol. 2002;70(3):548-568. 
13. 
Appel LJ, Moore TJ, Obarzanek E, et al. A clinical trial of the effects of dietary patterns on blood pressure. DASH 
Collaborative Research Group. N Engl J Med. 1997;336(16):1117-1124. 
14. 
Jones DW, Peterson ED. Improving hypertension control rates: technology, people, or systems? JAMA. 
2008;299(24):2896-2898. 
15. 
Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet. 
2005;365(9455):217-223. 
16. 
Bautista LE. High Blood Pressure. In: Remington PL, Brownson RC, Wegner MV, eds. Chronic Disease, 
Epidemiology, and Control. 3rd ed. Washington, DC: American Public Health Association; 2010:335-362. 
17. 
Brosius FC, 3rd, Hostetter TH, Kelepouris E, et al. Detection of chronic kidney disease in patients with or at 
increased risk of cardiovascular disease: a science advisory from the American Heart Association Kidney and 
Cardiovascular Disease Council; the Councils on High Blood Pressure Research, Cardiovascular Disease in the 
Young, and Epidemiology and Prevention; and the Quality of Care and Outcomes Research Interdisciplinary 
Working Group: Developed in Collaboration With the National Kidney Foundation. Hypertension. 2006;48(4):751-
755. 
18. 
Kernan WN, Dearborn JL. Obesity increases stroke risk in young adults: opportunity for prevention. Stroke. 
2015;46(6):1435-1436. 
19. 
Lane C, Huws-Thomas M, Hood K, et al. Measuring adaptations of motivational interviewing: the development and 
validation of the behavior change counseling index (BECCI). Patient Educ Couns. 2005;56(2):166-173. 
20. 
Lloyd-Jones DM, Leip EP, Larson MG, et al. Prediction of lifetime risk for cardiovascular disease by risk factor 
burden at 50 years of age. Circulation. 2006;113(6):791-798. 
21. 
Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, 
Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19):2560-2572. 
22. 
Ford ES, Ajani UA, Croft JB, et al. Explaining the decrease in U.S. deaths from coronary disease, 1980-2000. N 
Engl J Med. 2007;356(23):2388-2398. 
23. 
Lloyd-Jones DM, Hong Y, Labarthe D, et al. Defining and setting national goals for cardiovascular health promotion 
and disease reduction: the American Heart Association's strategic Impact Goal through 2020 and beyond. 
Circulation. 2010;121(4):586-613. 
24. 
Paramore LC, Halpern MT, Lapuerta P, et al. Impact of poorly controlled hypertension on healthcare resource 
utilization and cost. Am J Manag Care. 2001;7(4):389-398. 
25. 
Yano Y, Stamler J, Garside DB, et al. Isolated Systolic Hypertension in Young and Middle-Aged Adults and 31-Year 
Risk for Cardiovascular Mortality: The Chicago Heart Association Detection Project in Industry Study. J Am Coll 
Cardiol. 2015;65(4):327-335. 
26. 
Holland N, Segraves D, Nnadi VO, et al. Identifying barriers to hypertension care: implications for quality 
improvement initiatives. Dis Manag. 2008;11(2):71-77. 
27. 
James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure 
in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 
2014;311(5):507-520. 
28. 
Ma J, Urizar GG, Jr., Alehegn T, Stafford RS. Diet and physical activity counseling during ambulatory care visits in 
the United States. Prev Med. 2004;39(4):815-822. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
48 
Version #: 05-04-2022 
29. 
Weber MA, Schiffrin EL, White WB, et al. Clinical practice guidelines for the management of hypertension in the 
community: a statement by the American Society of Hypertension and the International Society of Hypertension. J 
Clin Hypertens (Greenwich). 2014;16(1):14-26. 
30. 
Artinian NT, Flack JM, Nordstrom CK, et al. Effects of nurse-managed telemonitoring on blood pressure at 12-
month follow-up among urban African Americans. Nurs Res. 2007;56(5):312-322. 
31. 
Bosworth HB, Olsen MK, Grubber JM, et al. Two self-management interventions to improve hypertension control: 
a randomized trial. Ann Intern Med. 2009;151(10):687-695. 
32. 
Bosworth HB, Olsen MK, Grubber JM, Powers BJ, Oddone EZ. Racial differences in two self-management 
hypertension interventions. Am J Med. 2011;124(5):468 e461-468. 
33. 
Bosworth HB, Olsen MK, Neary A, et al. Take Control of Your Blood Pressure (TCYB) study: a multifactorial tailored 
behavioral and educational intervention for achieving blood pressure control. Patient Educ Couns. 2008;70(3):338-
347. 
34. 
Bosworth HB, Powers BJ, Olsen MK, et al. Home blood pressure management and improved blood pressure 
control: results from a randomized controlled trial. Arch Intern Med. 2011;171(13):1173-1180. 
35. 
Friedberg JP, Rodriguez MA, Watsula ME, et al. Effectiveness of a tailored behavioral intervention to improve 
hypertension control: primary outcomes of a randomized controlled trial. Hypertension. 2015;65(2):440-446. 
36. 
Green BB, Cook AJ, Ralston JD, et al. Effectiveness of home blood pressure monitoring, Web communication, and 
pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008;299(24):2857-2867. 
37. 
Jackson GL, Oddone EZ, Olsen MK, et al. Racial differences in the effect of a telephone-delivered hypertension 
disease management program. J Gen Intern Med. 2012;27(12):1682-1689. 
38. 
Kim KB, Han HR, Huh B, et al. The effect of a community-based self-help multimodal behavioral intervention in 
Korean American seniors with high blood pressure. Am J Hypertens. 2014;27(9):1199-1208. 
39. 
Margolius D, Bodenheimer T, Bennett H, et al. Health coaching to improve hypertension treatment in a low-income, 
minority population. Ann Fam Med. 2012;10(3):199-205. 
40. 
Mehos BM, Saseen JJ, MacLaughlin EJ. Effect of pharmacist intervention and initiation of home blood pressure 
monitoring in patients with uncontrolled hypertension. Pharmacotherapy. 2000;20(11):1384-1389. 
41. 
Ralston JD, Cook AJ, Anderson ML, et al. Home blood pressure monitoring, secure electronic messaging and 
medication intensification for improving hypertension control: a mediation analysis. Appl Clin Inform. 2014;5(1):232-
248. 
42. 
Rudd P, Miller NH, Kaufman J, et al. Nurse management for hypertension. A systems approach. Am J Hypertens. 
2004;17(10):921-927. 
43. 
Appel LJ, Champagne CM, Harsha DW, et al. Effects of comprehensive lifestyle modification on blood pressure 
control: main results of the PREMIER clinical trial. JAMA. 2003;289(16):2083-2093. 
44. 
Boulware LE, Daumit GL, Frick KD, et al. An evidence-based review of patient-centered behavioral interventions 
for hypertension. Am J Prev Med. 2001;21(3):221-232. 
45. 
Glynn LG, Murphy AW, Smith SM, Schroeder K, Fahey T. Interventions used to improve control of blood pressure 
in patients with hypertension. Cochrane Database Syst Rev. 2010(3):CD005182. 
46. 
Ogedegbe G, Tobin JN, Fernandez S, et al. Counseling African Americans to Control Hypertension (CAATCH) trial: 
a multi-level intervention to improve blood pressure control in hypertensive blacks. Circ Cardiovasc Qual Outcomes. 
2009;2(3):249-256. 
47. 
Senesael E, Borgermans L, Van De Vijver E, Devroey D. Effectiveness of a quality improvement intervention 
targeting cardiovascular risk factors: are patients responsive to information and encouragement by mail or post? 
Vasc Health Risk Manag. 2013;9:13-20. 
48. 
Watson AJ, Singh K, Myint UK, et al. Evaluating a web-based self-management program for employees with 
hypertension and prehypertension: a randomized clinical trial. Am Heart J. 2012;164(4):625-631. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
49 
Version #: 05-04-2022 
49. 
Magid DJ, Ho PM, Olson KL, et al. A multimodal blood pressure control intervention in 3 healthcare systems. Am J 
Manag Care. 2011;17(4):e96-103. 
50. 
Johnson HM, Thorpe CT, Bartels CM, et al. Antihypertensive medication initiation among young adults with regular 
primary care use. J Gen Intern Med. 2014;29(5):723-731. 
51. 
Pinto E. Blood pressure and ageing. Postgrad Med J. 2007;83(976):109-114. 
52. 
Allen NB, Siddique J, Wilkins JT, et al. Blood pressure trajectories in early adulthood and subclinical atherosclerosis 
in middle age. JAMA. 2014;311(5):490-497. 
53. 
Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity 
interventions: a meta-regression. Health Psychol. 2009;28(6):690-701. 
54. 
Sher T, Braun L, Domas A, et al. The partners for life program: a couples approach to cardiac risk reduction. Fam 
Process. 2014;53(1):131-149. 
55. 
Voils CI, Gierisch JM, Yancy WS, Jr., et al. Differentiating behavior initiation and maintenance: theoretical 
framework and proof of concept. Health Educ Behav. 2014;41(3):325-336. 
56. 
Agency for Healthcare Research and Quality (AHRQ). Patient Self-Management Support Programs: An Evaluation. 
Rockville, MD: Agency for Healthcare Research and Quality (AHRQ):48. 08-0011. 
57. 
Magid DJ, Olson KL, Billups SJ, et al. A pharmacist-led, American Heart Association Heart360 Web-enabled home 
blood pressure monitoring program. Circ Cardiovasc Qual Outcomes. 2013;6(2):157-163. 
58. 
Margolis KL, Asche SE, Bergdall AR, et al. Effect of home blood pressure telemonitoring and pharmacist 
management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013;310(1):46-56. 
59. 
Magid DJ, Farmer SA. Hypertension self-management: a home run for patients and payers. Circ Cardiovasc Qual 
Outcomes. 2014;7(2):205-206. 
60. 
Johnson HM, Thorpe CT, Bartels CM, et al. Undiagnosed hypertension among young adults with regular primary 
care use. J Hypertens. 2014;32(1):65-74. 
61. 
Johnson HM, Warner RC, LaMantia JN, Bowers BJ. "I have to live like I'm old." Young adults' perspectives on 
managing hypertension: a multi-center qualitative study. BMC Fam Pract. 2016;17(1):31. 
62. 
O'Brien K, Venn BJ, Perry T, et al. Reasons for wanting to lose weight: different strokes for different folks. Eat 
Behav. 2007;8(1):132-135. 
63. 
Underbakke G, McBride PE. Office systems for heart disease prevention. Prim Care. 2005;32(4):883-900. 
64. 
Wolpert HA, Anderson BJ. Young adults with diabetes: need for a new treatment paradigm. Diabetes Care. 
2001;24(9):1513-1514. 
65. 
Johnson HM, Bartels CM, Thorpe CT, et al. Differential Diagnosis and Treatment Rates Between Systolic and 
Diastolic Hypertension in Young Adults: A Multidisciplinary Observational Study. J Clin Hypertens (Greenwich). 
2015;17(11):885-894. 
66. 
Johnson HM, Olson AG, LaMantia JN, et al. Documented lifestyle education among young adults with incident 
hypertension. J Gen Intern Med. 2014;30(5):556-564. 
67. 
Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics—2015 update: a report from the 
American Heart Association. Circulation. 2015;131(4):e29-e322. 
68. 
Johnson HM, Warner RC, Bartels CM, LaMantia JN. "They're younger... it's harder." Primary providers' perspectives 
on hypertension management in young adults: a multicenter qualitative study. BMC Res Notes. 2017;10(1):9. 
69. 
Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. 
JAMA. 2002;288(19):2469-2475. 
70. 
Jolly K, Duda JL, Daley A, et al. Evaluation of a standard provision versus an autonomy promotive exercise referral 
programme: rationale and study design. BMC Public Health. 2009;9:176. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
50 
Version #: 05-04-2022 
71. 
Kinnafick FE, Thogersen-Ntoumani C, Duda JL. Physical activity adoption to adherence, lapse, and dropout: a self-
determination theory perspective. Qual Health Res. 2014;24(5):706-718. 
72. 
Markland D, Ryan RM, Tobin VJ, Rollnick S. Motivational interviewing and self-determination theory. J Soc Clin 
Psychol. 2005;24(6):811-831. 
73. 
Scales R, Miller JH. Motivational techniques for improving compliance with an exercise program: skills for primary 
care clinicians. Curr Sports Med Rep. 2003;2(3):166-172. 
74. 
Carroll JK, Fiscella K, Epstein RM, Sanders MR, Williams GC. A 5A's communication intervention to promote 
physical activity in underserved populations. BMC Health Serv Res. 2012;12:374. 
75. 
Zoellner J, Thomson JL, Landry AS, et al. Improvements in blood pressure among undiagnosed hypertensive 
participants in a community-based lifestyle intervention, Mississippi, 2010. Prev Chronic Dis. 2014;11:E53. 
76. 
Kupst MJ, Butt Z, Stoney CM, et al. Assessment of stress and self-efficacy for the NIH Toolbox for Neurological 
and Behavioral Function. Anxiety Stress Coping. 2015:1-14. 
77. 
Molton IR, Jensen MP, Nielson W, Cardenas D, Ehde DM. A preliminary evaluation of the motivational model of 
pain self-management in persons with spinal cord injury-related pain. J Pain. 2008;9(7):606-612. 
78. 
Deci EL, Eghrari H, Patrick BC, Leone DR. Facilitating internalization: the self-determination theory perspective. J 
Pers. 1994;62(1):119-142. 
79. 
Deci EL, Ryan RM. Intrinsic Motivation and Self-Determination in Human Behavior. New York, NY: Plenum Press; 
1985. 
80. 
Deci EL, Ryan RM. Human Autonomy: The Basis for True Self-Esteem. In: Kernis MH, ed. Efficacy, Agendy, and 
Self-Esteem. New York, NY: Plenum Press; 1995:31-49. 
81. 
Deci EL, Ryan RM. The "what" and "why" of goal pursuits: human needs and the self-determination of behavior. 
Psychol Inq. 2000;11(4):227-268. 
82. 
Deci EL, Ryan RM. Self-determination theory: a macrotherapy of human motivation, development, and health. Can 
Psychol. 2008;49(3):182-185. 
83. 
Li K, Iannotti RJ, Haynie DL, Perlus JG, Simons-Morton BG. Motivation and planning as mediators of the relation 
between social support and physical activity among U.S. adolescents: a nationally representative study. Int J Behav 
Nutr Phys Act. 2014;11(1):42. 
84. 
Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 
2003;26(1):1-7. 
85. 
Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic 
disease. Eff Clin Pract. 2001;4(6):256-262. 
86. 
Roth G. Perceived parental conditional regard and autonomy support as predictors of young adults' self- versus 
other-oriented prosocial tendencies. J Pers. 2008;76(3):513-534. 
87. 
Ryan RM, Frederick CM, Lepes D, Rubio N, Sheldon KM. Intrinsic motivation and exercise adherence. Int J Sport 
Psychol. 1997;28:335-354. 
88. 
Silva MN, Markland D, Minderico CS, et al. A randomized controlled trial to evaluate self-determination theory for 
exercise adherence and weight control: rationale and intervention description. BMC Public Health. 2008;8:234. 
89. 
Williams GC, Deci EL, Ryan RM. Building Health-Care Partnerships by Supporting Autonomy: Promoting 
Maintained Behavior Chage and Positive Health Outcomes. In: Suchman AL, Botelho RJ, Hinton-Walker P, eds. 
Partnerships in Healthcare: Transforming Relational Process. Rochester, NY: University of Rochester Press; 
1998:67-87. 
90. 
Bosworth HB, Oddone EZ, Weinberger M. Patient Treatment Adherence: Concepts, Interventions, and 
Measurement. Mahwah, NJ: Lawrence Erlbaum Associates, Inc.; 2006. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
51 
Version #: 05-04-2022 
91. 
Institute of Medicine (US) Committee on Public Health Priorities to Reduce and Control Hypertension. A Population-
Based Policy and Systems Change Approach to Prevent and Control Hypertension. Washington, D.C.: National 
Academies Press (US); 2010. 
92. 
Ho PM, Rumsfeld JS. Beyond inpatient and outpatient care: alternative model for hypertension management. BMC 
Public Health. 2006;6:257. 
93. 
Walsh JM, McDonald KM, Shojania KG, et al. Quality improvement strategies for hypertension management: a 
systematic review. Med Care. 2006;44(7):646-657. 
94. 
The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002;25(12):2165-
2171. 
95. 
Bokhour BG, Cohn ES, Cortes DE, et al. The role of patients' explanatory models and daily-lived experience in 
hypertension self-management. J Gen Intern Med. 2012;27(12):1626-1634. 
96. 
Willard-Grace R, DeVore D, Chen EH, et al. The effectiveness of medical assistant health coaching for low-income 
patients with uncontrolled diabetes, hypertension, and hyperlipidemia: protocol for a randomized controlled trial and 
baseline characteristics of the study population. BMC Fam Pract. 2013;14:27. 
97. 
Bosworth HB, Olsen MK, Gentry P, et al. Nurse administered telephone intervention for blood pressure control: a 
patient-tailored multifactorial intervention. Patient Educ Couns. 2005;57(1):5-14. 
98. 
Lovejoy TI, Heckman TG, Suhr JA, et al. Telephone-administered motivational interviewing reduces risky sexual 
behavior in HIV-positive late middle-age and older adults: a pilot randomized controlled trial. AIDS Behav. 
2011;15(8):1623-1634. 
99. 
Madlensky L, Natarajan L, Flatt SW, et al. Timing of dietary change in response to a telephone counseling 
intervention: evidence from the WHEL study. Health Psychol. 2008;27(5):539-547. 
100. 
Miller SM, Hui SK, Wen KY, et al. Tailored telephone counseling to improve adherence to follow-up regimens after 
an abnormal pap smear among minority, underserved women. Patient Educ Couns. 2013;93(3):488-495. 
101. 
Funk KL, Elmer PJ, Stevens VJ, et al. PREMIER--a trial of lifestyle interventions for blood pressure control: 
intervention design and rationale. Health Promot Pract. 2008;9(3):271-280. 
102. 
Frohlich ED. Detection, evaluation, and treatment of hypertension: JNC-5 (Joint National Committee on Detection, 
Evaluation, and Treatment of High Blood Pressure). Heart Dis Stroke. 1993;2(6):459-460. 
103. 
The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High 
Blood Pressure. In: National Heart L, and Blood Institute, ed. Bethesda, MD: National Institutes of Health; 1997:70. 
104. 
Intersalt: an international study of electrolyte excretion and blood pressure. Results for 24 hour urinary sodium and 
potassium excretion. Intersalt Cooperative Research Group. BMJ. 1988;297(6644):319-328. 
105. 
Cutler JA, Follmann D, Allender PS. Randomized trials of sodium reduction: an overview. Am J Clin Nutr. 1997;65(2 
Suppl):643S-651S. 
106. 
Elliott P, Stamler J, Nichols R, et al. Intersalt revisited: further analyses of 24 hour sodium excretion and blood 
pressure within and across populations. Intersalt Cooperative Research Group. BMJ. 1996;312(7041):1249-1253. 
107. 
Appel LJ, Brands MW, Daniels SR, et al. Dietary approaches to prevent and treat hypertension: a scientific 
statement from the American Heart Association. Hypertension. 2006;47(2):296-308. 
108. 
Appel LJ. Lifestyle modification as a means to prevent and treat high blood pressure. J Am Soc Nephrol. 2003;14(7 
Suppl 2):S99-S102. 
109. 
Svetkey LP, Harsha DW, Vollmer WM, et al. Premier: a clinical trial of comprehensive lifestyle modification for blood 
pressure control: rationale, design and baseline characteristics. Ann Epidemiol. 2003;13(6):462-471. 
110. 
Liese AD, Nichols M, Sun X, D'Agostino RB, Jr., Haffner SM. Adherence to the DASH Diet is inversely associated 
with incidence of type 2 diabetes: the insulin resistance atherosclerosis study. Diabetes Care. 2009;32(8):1434-
1436. 
111. 
Stamler J. Epidemiologic findings on body mass and blood pressure in adults. Ann Epidemiol. 1991;1(4):347-362. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
52 
Version #: 05-04-2022 
112. 
Flegal KM, Carroll MD, Kuczmarski RJ, Johnson CL. Overweight and obesity in the United States: prevalence and 
trends, 1960-1994. Int J Obes Relat Metab Disord. 1998;22(1):39-47. 
113. 
Ainsworth BE, Keenan NL, Strogatz DS, Garrett JM, James SA. Physical activity and hypertension in black adults: 
the Pitt County Study. Am J Public Health. 1991;81(11):1477-1479. 
114. 
Reaven PD, Barrett-Connor E, Edelstein S. Relation between leisure-time physical activity and blood pressure in 
older women. Circulation. 1991;83(2):559-565. 
115. 
Kelley G, McClellan P. Antihypertensive effects of aerobic exercise. A brief meta-analytic review of randomized 
controlled trials. Am J Hypertens. 1994;7(2):115-119. 
116. 
Kelley GA, Kelley KA, Tran ZV. Aerobic exercise and resting blood pressure: a meta-analytic review of randomized, 
controlled trials. Prev Cardiol. 2001;4(2):73-80. 
117. 
Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular 
risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 
J Am Coll Cardiol. 2014;63(25 Pt B):2960-2984. 
118. 
Halanych JH, Safford MM, Kertesz SG, et al. Alcohol consumption in young adults and incident hypertension: 20-
year follow-up from the Coronary Artery Risk Development in Young Adults Study. Am J Epidemiol. 
2010;171(5):532-539. 
119. 
MacMahon S. Alcohol consumption and hypertension. Hypertension. 1987;9(2):111-121. 
120. 
Cushman WC. Alcohol consumption and hypertension. J Clin Hypertens (Greenwich). 2001;3(3):166-170. 
121. 
Puddey IB, Beilin LJ, Vandongen R, Rouse IL, Rogers P. Evidence for a direct effect of alcohol consumption on 
blood pressure in normotensive men. A randomized controlled trial. Hypertension. 1985;7(5):707-713. 
122. 
Puddey IB, Beilin LJ, Vandongen R. Regular alcohol use raises blood pressure in treated hypertensive subjects. A 
randomised controlled trial. Lancet. 1987;1(8534):647-651. 
123. 
Viera AJ, Lingley K, Hinderliter AL. Tolerability of the Oscar 2 ambulatory blood pressure monitor among research 
participants: a cross-sectional repeated measures study. BMC Med Res Methodol. 2011;11:59. 
124. 
Baral-Grant S, Haque MS, Nouwen A, Greenfield SM, McManus RJ. Self-Monitoring of Blood Pressure in 
Hypertension: A UK Primary Care Survey. Int J Hypertens. 2012;2012:582068. 
125. 
U.S. Department of Health and Human Services. The Fourth Report on the Diagnosis, Evaluation, and Treatment 
of High Blood Pressure in Children and Adolescents. Bethesda, MD: National Institutes of Health - National Heart, 
Lung, and Blood Institute; 2005:1-60. 
126. 
Sheehy AM, Flood GE, Tuan WJ, et al. Analysis of guidelines for screening diabetes mellitus in an ambulatory 
population. Mayo Clin Proc. 2010;85(1):27-35. 
127. 
Blonstein AC, Yank V, Stafford RS, et al. Translating an evidence-based lifestyle intervention program into primary 
care: lessons learned. Health Promot Pract. 2013;14(4):491-497. 
128. 
Rocha-Goldberg Mdel P, Corsino L, Batch B, et al. Hypertension Improvement Project (HIP) Latino: results of a 
pilot study of lifestyle intervention for lowering blood pressure in Latino adults. Ethn Health. 2010;15(3):269-282. 
129. 
Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York, NY: John Wiley & Sons; 1987. 
130. 
Friedberg JP, Lipsitz SR, Natarajan S. Challenges and recommendations for blinding in behavioral interventions 
illustrated using a case study of a behavioral intervention to lower blood pressure. Patient Educ Couns. 
2010;78(1):5-11. 
131. 
Margolis KL, Kerby TJ, Asche SE, et al. Design and rationale for Home Blood Pressure Telemonitoring and Case 
Management to Control Hypertension (HyperLink): a cluster randomized trial. Contemp Clin Trials. 2012;33(4):794-
803. 
132. 
Department of Health and Human Services. Interventions to Improve Hypertension Control Rates in African 
Americans. http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-04-007.html. Accessed March 23, 2017. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
53 
Version #: 05-04-2022 
133. 
Fielding RA, Rejeski WJ, Blair S, et al. The Lifestyle Interventions and Independence for Elders Study: design and 
methods. J Gerontol A Biol Sci Med Sci. 2011;66(11):1226-1237. 
134. 
Spacelabs 
Healthcare. 
OnTrak, 
the 
NEW 
Evolution 
of 
ABPM 
from 
Spacelabs 
Healthcare. 
http://www.spacelabshealthcare.com/diagnostic-cardiology/abp-monitoring/abp-monitors/ontrak#.VUuCLE10zct. 
Accessed March 23, 2017. 
135. 
Green BB, Kaplan RC, Psaty BM. How do minor changes in the definition of blood pressure control affect the 
reported success of hypertension treatment? Am J Manag Care. 2003;9(3):219-224. 
136. 
Little P, Barnett J, Barnsley L, et al. Comparison of agreement between different measures of blood pressure in 
primary care and daytime ambulatory blood pressure. BMJ. 2002;325(7358):254. 
137. 
Pickering TG. 24 Hour Ambulatory Blood Pressure Monitoring: Is it Necessary to Establish a Diagnosis Before 
Instituting Treatment of Hypertension? J Clin Hypertens (Greenwich). 1999;1(1):33-40. 
138. 
Piper MA, Evans CV, Burda BU, et al. Diagnostic and predictive accuracy of blood pressure screening methods 
with consideration of rescreening intervals: a systematic review for the U.S. preventive services task force. Ann 
Intern Med. 2015;162(3):192-204. 
139. 
U.S. Preventive Services Task Force. Final Recommendation Statement: High Blood Pressure in Adults: Screening. 
http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/high-blood-
pressure-in-adults-screening. Accessed March 23, 2017. 
140. 
Gaffo AL, Roseman JM, Jacobs DR, Jr., et al. Serum urate and its relationship with alcoholic beverage intake in 
men and women: findings from the Coronary Artery Risk Development in Young Adults (CARDIA) cohort. Ann 
Rheum Dis. 2010;69(11):1965-1970. 
141. 
Fitzpatrick AL, Rapp SR, Luchsinger J, et al. Sociodemographic Correlates of Cognition in the Multi-Ethnic Study 
of Atherosclerosis (MESA). Am J Geriatr Psychiatry. 2015;23(7):684-697. 
142. 
Idler EL, Benyamini Y. Self-rated health and mortality: a review of twenty-seven community studies. J Health Soc 
Behav. 1997;38(1):21-37. 
143. 
Idler EL, Angel RJ. Self-rated health and mortality in the NHANES-I Epidemiologic Follow-up Study. Am J Public 
Health. 1990;80(4):446-452. 
144. 
Idler EL, Kasl S. Health perceptions and survival: do global evaluations of health status really predict mortality? J 
Gerontol. 1991;46(2):S55-65. 
145. 
Ho SC. Health and social predictors of mortality in an elderly Chinese cohort. Am J Epidemiol. 1991;133(9):907-
921. 
146. 
Idler EL, Russell LB, Davis D. Survival, functional limitations, and self-rated health in the NHANES I Epidemiologic 
Follow-up Study, 1992. First National Health and Nutrition Examination Survey. Am J Epidemiol. 2000;152(9):874-
883. 
147. 
DeSalvo KB, Jones TM, Peabody J, et al. Health care expenditure prediction with a single item, self-rated health 
measure. Med Care. 2009;47(4):440-447. 
148. 
DeSalvo KB, Fan VS, McDonell MB, Fihn SD. Predicting mortality and healthcare utilization with a single question. 
Health Serv Res. 2005;40(4):1234-1246. 
149. 
McDowell I. Measuring Health: A Guide to Rating Scales and Questionnaires. 3rd ed. New York, NY: Oxford 
University Press; 2006. 
150. 
Nielsen-Bohlman L, Panzer AM, Kindig DA. Health Literacy: A Prescription to End Confusion. Washington, DC: The 
National Academies Press; 2004. 
151. 
Kripalani S, Henderson LE, Chiu EY, et al. Predictors of medication self-management skill in a low-literacy 
population. J Gen Intern Med. 2006;21(8):852-856. 
152. 
DeWalt DA, Pignone MP. Reading is fundamental: the relationship between literacy and health. Arch Intern Med. 
2005;165(17):1943-1944. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
54 
Version #: 05-04-2022 
153. 
Bass PF, 3rd, Wilson JF, Griffith CH. A shortened instrument for literacy screening. J Gen Intern Med. 
2003;18(12):1036-1038. 
154. 
Bass SB, Wolak C, Rovito GM, Gordon TF, Ward L. Use of REALM-R vs. S-TOFHLA in an urban African American 
clinic population to assess health literacy: Practical implications. American Public Health Association 138th Annual 
Meeting & Expo: Social Justice. Denver, CO; 2010. 
155. 
Borzecki AM, Wong AT, Hickey EC, Ash AS, Berlowitz DR. Identifying hypertension-related comorbidities from 
administrative data: what's the optimal approach? Am J Med Qual. 2004;19(5):201-206. 
156. 
Marciniak MD, Lage MJ, Dunayevich E, et al. The cost of treating anxiety: the medical and demographic correlates 
that impact total medical costs. Depress Anxiety. 2005;21(4):178-184. 
157. 
Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 
1998;36(1):8-27. 
158. 
Hebert PL, Geiss LS, Tierney EF, et al. Identifying persons with diabetes using Medicare claims data. Am J Med 
Qual. 1999;14(6):270-277. 
159. 
Foley RN, Murray AM, Li S, et al. Chronic kidney disease and the risk for cardiovascular disease, renal replacement, 
and death in the United States Medicare population, 1998 to 1999. J Am Soc Nephrol. 2005;16(2):489-495. 
160. 
Shelbourne CD. Social Functioning: Social Activity Limitations Measure. In: Stewart AL, Ware JE, Jr., eds. 
Measuring Functioning and Well-Being: The Medical Outcomes Study Approach. Durham, NC: Duke University 
Press; 1992:173-181. 
161. 
Shelbourne CD, Stewart AL, Wells KB. Role Functioning Measures. In: Stewart AL, Ware JE, Jr., eds. Measuring 
Functioning and Well-Being: The Medical Outcomes Study Approach. Durham, NC: Duke University Press; 
1992:205-219. 
162. 
Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-714. 
163. 
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication 
adherence. Med Care. 1986;24(1):67-74. 
164. 
Bosworth HB, Powers B, Grubber JM, et al. Racial differences in blood pressure control: potential explanatory 
factors. J Gen Intern Med. 2008;23(5):692-698. 
165. 
Starfield B, Weiner J, Mumford L, Steinwachs D. Ambulatory care groups: a categorization of diagnoses for research 
and management. Health Serv Res. 1991;26(1):53-74. 
166. 
Pickering TG, Hall JE, Appel LJ, et al. Recommendations for blood pressure measurement in humans and 
experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the 
Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood 
Pressure Research. Circulation. 2005;111(5):697-716. 
167. 
Unger E, Diez-Roux AV, Lloyd-Jones DM, et al. Association of neighborhood characteristics with cardiovascular 
health in the multi-ethnic study of atherosclerosis. Circ Cardiovasc Qual Outcomes. 2014;7(4):524-531. 
168. 
Victor RG, Ravenell JE, Freeman A, et al. Effectiveness of a barber-based intervention for improving hypertension 
control in black men: the BARBER-1 study: a cluster randomized trial. Arch Intern Med. 2011;171(4):342-350. 
169. 
Grossman E. Ambulatory blood pressure monitoring in the diagnosis and management of hypertension. Diabetes 
Care. 2013;36 Suppl 2:S307-311. 
170. 
Fravel MA, Ernst ME, Weber CA, et al. Influence of patient characteristics on success of ambulatory blood pressure 
monitoring. Pharmacotherapy. 2008;28(11):1341-1347. 
171. 
Vollmer WM, Appel LJ, Svetkey LP, et al. Comparing office-based and ambulatory blood pressure monitoring in 
clinical trials. J Hum Hypertens. 2005;19(1):77-82. 
172. 
Bakris GL. The Implications of Blood Pressure Measurement Methods on Treatment Targets for Blood Pressure. 
Circulation. 2016;134(13):904-905. 

 
Protocol: MyHEART R01 Study Protocol 
 
 
PI: K. Hoppe 
 
55 
Version #: 05-04-2022 
173. 
Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron 705IT (HEM-759-E) oscillometric blood 
pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit. 
2006;11(1):27-32. 
174. 
O'Brien E, Waeber B, Parati G, Staessen J, Myers MG. Blood pressure measuring devices: recommendations of 
the European Society of Hypertension. BMJ. 2001;322(7285):531-536. 
175. 
Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices for the self-measurement of blood pressure 
according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron 
BP760N (HEM-7320-Z). Vasc Health Risk Manag. 2015;11:49-53. 
176. 
Bosworth HB, Olsen MK, McCant F, et al. Hypertension Intervention Nurse Telemedicine Study (HINTS): testing a 
multifactorial tailored behavioral/educational and a medication management intervention for blood pressure control. 
Am Heart J. 2007;153(6):918-924. 
177. 
American Diabetes Association. Standards of medical care in diabetes--2015. Diabetes Care. 2015;38 (Suppl 
1):S1-S93. 
178. 
Anthony CA, Polgreen LA, Chounramany J, et al. Outpatient blood pressure monitoring using bi-directional text 
messaging. J Am Soc Hypertens. 2015;9(5):375-381. 
179. 
Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol. 2009;64(6):527-537. 
180. 
Madson MB, Loignon AC, Lane C. Training in motivational interviewing: a systematic review. J Subst Abuse Treat. 
2009;36(1):101-109. 
181. 
Bellg AJ, Borrelli B, Resnick B, et al. Enhancing treatment fidelity in health behavior change studies: best practices 
and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004;23(5):443-451. 
182. 
Carroll JK, Fiscella K, Epstein RM, et al. Physical activity counseling intervention at a federally qualified health 
center: improves autonomy-supportiveness, but not patients' perceived competence. Patient Educ Couns. 
2013;92(3):432-436. 
183. 
Spillane V, Byrne MC, Byrne M, et al. Monitoring treatment fidelity in a randomized controlled trial of a complex 
intervention. J Adv Nurs. 2007;60(3):343-352. 
184. 
Wing RR, Tate DF, Espeland MA, et al. Innovative Self-Regulation Strategies to Reduce Weight Gain in Young 
Adults: The Study of Novel Approaches to Weight Gain Prevention (SNAP) Randomized Clinical Trial. JAMA Intern 
Med. 2016;176(6):755-762. 
185. 
Nidich SI, Rainforth MV, Haaga DA, et al. A randomized controlled trial on effects of the Transcendental Meditation 
program on blood pressure, psychological distress, and coping in young adults. Am J Hypertens. 2009;22(12):1326-
1331. 
186. 
Bauer DJ, Preacher KJ, Gil KM. Conceptualizing and testing random indirect effects and moderated mediation in 
multilevel models: new procedures and recommendations. Psychol Methods. 2006;11(2):142-163. 
187. 
Kenny DA, Korchmaros JD, Bolger N. Lower level mediation in multilevel models. Psychol Methods. 2003;8(2):115-
128. 
188. 
Krull JL, MacKinnon DP. Multilevel mediation modeling in group-based intervention studies. Eval Rev. 
1999;23(4):418-444. 
189. 
Krull JL, MacKinnon DP. Multilevel Modeling of Individual and Group Level Mediated Effects. Multivariate Behav 
Res. 2001;36(2):249-277. 
190. 
Preacher KJ, Zyphur MJ, Zhang Z. A general multilevel SEM framework for assessing multilevel mediation. Psychol 
Methods. 2010;15(3):209-233. 
191. 
Spiker B. Methods of assessing and improving patient compliance in clinical trials. IRB: Ethics & Human Research. 
1992;14(3):1-6. 
 
  

 
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Attachments/Appendix (see separate table of contents for complete contents) 
• Study Procedures Flowchart/Table 
• Delegation log 
• Study Calendar 
• DMC/DSMB charter and composition 
• Health coach curriculum, call logs, instructions 
• AMBP instructions