Effect of a Telephone Health Coaching Intervention on Hypertension Control in Young Adults

Key Points Question Is a telephone coaching and blood pressure self-monitoring intervention effective in reducing blood pressure compared with usual care among young adults with uncontrolled hypertension? Findings In this randomized clinical trial of 316 participants, the intervention did not demonstrate a significant difference in systolic or diastolic blood pressures at 6 or 12 months between the intervention and control groups; however, both groups experienced blood pressure reduction. Compared with the control group, participants in the intervention group demonstrated significant behavior changes, including increased physical activity, reduction in dietary sodium intake, and increased frequency in home blood pressure monitoring. Meaning In this study, intervention participants did not experience a significant difference in blood pressure reduction when compared with control participants but did demonstrate behavior changes.


Background and Rationale
Uncontrolled hypertension in young adults is an enormous public health burden. 1,2 In the U.S., over 10 million 18-39 246 year-olds (1 in 5 men; 1 in 6 women) have hypertension, 3-6 increasing their risk of heart failure, stroke, and chronic 247 kidney disease. 5,[7][8][9][10] The medical costs of hypertension and its complications are $131 billion/year, 11,12 contributing 248 to 1,000 deaths per day. 3,5,11,13-15 Young adults with hypertension have a higher lifetime risk for cardiovascular 249 disease, especially with complicated hypertension (hypertension with diabetes or chronic kidney disease). 9,14-20 250 Hypertension control reduces morbidity, mortality, and future healthcare costs; 21-25 yet, only 35% of young adults 251 with hypertension in the U.S. have achieved blood pressure control (blood pressure <140/90 mmHg). 26-29 252 While hypertension self-management programs targeted towards adults ≥50 years old reduce blood pressure, 30-48 253 they primarily focus on medication titration. 49 In contrast, a trial of lifestyle modifications is commonly the initial 254 hypertension treatment step, rather than a medication, among young adults. 50 Medication initiation is also not 255 enough to achieve long-term blood pressure control in young adults. Even with medication adherence, systolic 256 blood pressure continues to increase from younger to older age. 51 Therefore, young adults need additional 257 hypertension self-management (home blood pressure monitoring and lifestyle modifications) to lower blood 258 pressures and reduce the amount of medication they may need over a lifetime. 52-55 259 The Institute of Medicine 56 highlighted the importance of self-management support to learn and effectively perform 260 self-management. 30,34,36,57,58 In multiple studies among older adults, hypertension self-management is superior to 261 office-based management. 30,34,36,57-59 However, in contrast to older adults, young adulthood is a time of frequent 262 healthcare and vocational transitions, new life responsibilities, and less interest in health-related goals (i.e., 263 prevention of heart attack and stroke). 60,61 Thus, the content and method of delivery of hypertension self-264 management must be individualized to young adults and address barriers specific to this population. 62 Stakeholders identified barriers to hypertension self-management and hypertension control among young adults,  298  justifying the need for this intervention, and proposed specific solutions to the identified barriers.  299 MyHEART is founded on the Self-Determination Theory (SDT), which is used to support chronic disease self-300 management and lifestyle modifications. 69-73 SDT has been used across races/ethnicities and with young adults. 74,75 301 To reduce the risk of negative sequelae from long-term hypertension, we need to not only initiate behaviors for 302 blood pressure control, but also foster maintenance of new behaviors. SDT acknowledges that young adults are 303 more likely to adopt and maintain health behaviors with: 1) autonomous (internal) motivation, instead of external 304 motivation (i.e., external pressure), 2) relatedness (i.e., supportive healthcare interactions), and 3) perceived self-305 competence (i.e., perceived self-efficacy; 76,77 confidence in starting and maintaining behaviors to reach a 306 goal  There is a small immediate risk that there may be minor discomfort or bruising at the site of 401 the upper arm automatic blood pressure cuff. To avoid this, patients will receive the appropriately sized cuff based 402 on their upper arm circumference. In addition, the 24-hour ambulatory monitor will be started prior to leaving the 403 research clinic to obtain at least two blood pressures to ensure comfort. Participants will also review information on 404 how to contact the research staff in case additional questions, concerns, or new discomfort arise. 405

Muscle/Joint Discomfort:
There is a small immediate risk that participants may experience new muscle and/or 406 joint discomfort after starting a new exercise program. However, they will be instructed to consult their provider 407 before starting a new exercise program. 408 Questionnaires: Multiple interviewer-administered and computer-administered questionnaires and surveys will be 409 completed at each visit. We expect this will pose very minimal risk of physical or psychological discomfort. 123 410 Breach of Confidentiality: The major potential social and psychological risk to participants is loss of confidentiality. 411 As our standard operating procedure, we have policies and procedures in place to protect the confidentiality and 412 security of subject data, see below in "Protection Against Risks". Young adults may be concerned about social 413 stigma associated with high blood pressure; therefore, immediate and/or long-range psychological risk is possible. 414 However, to minimize this risk as much as possible we will protect the confidentiality of participants with a unique 415 subject identifier number as outlined below in "Protection Against Risks". We anticipate no additional psychological 416 or legal consequence from study participation. Participants and their insurance plans will not be charged for any of 417 the visits, telephone contacts, or 24-hour ambulatory blood pressure monitoring. 418 be released to all subjects, as well as to their specific provider if they opt to give the provider's information on the 426 written consent form. Only clinically significant findings will be disclosed: research clinic blood pressure >/= 427 160/100 mmHg (during any research clinic visit), right/left arm blood pressure differential of >/= 20 mmHg (Visit 1), 428 and normal mean 24-hour ambulatory blood pressure (Visit 2). These clinical significant findings will be noted 429 immediately during the research clinic visit, and the research examiner will notify the subject verbally, complete 430 the incidental finding form, and provide a completed copy to the subject during the same visit. A copy of the 431 incidental finding form will be forwarded to the primary care provider (via fax) on the same day. 432 The protocol appendix has a table explaining recommended primary care follow-up based upon the research clinic 433 blood pressures (for all subjects). This is separate from the incidental finding process. Since young adults will be 434 arriving with elevated blood pressures, they should also continue to have routine clinical care per hypertension 435 guideline recommendations. This recommendation will be given by the research examiner on the same day as the 436 visit. 437 438 Version #: 05-04-2022 The same primary care follow-up (protocol appendix) will also be recommended based upon home blood pressure 439 readings (intervention arm only) by the health coach before the end of that call. However, instead of the participant 440 being "escorted" to the emergency department, they will be instructed to call 911. 441 Clinically significant findings could result in anxiety and psychological discomfort. Financial risks to clinically 442 significant findings could mean that subjects and their insurance would have to pay for follow-up procedures or 443 visits. False-positives are possible (i.e., a clinically concerning blood pressure measurement in our research 444 clinic), that is "white coat hypertension", not high blood pressure. 445 An additional risk is social stigma associated with high blood pressure and associated immediate and/or long-446 range psychological risks. 447 448

449
The alternative to study participation for all subjects is to continue to receive blood pressure care from their 450 healthcare providers, which would include blood pressure checks, blood pressure lifestyle counseling/education, 451 antihypertensive medication initiation and/or titration, and following their provider's treatment recommendations. 452 This may also include referrals to specialty care (example: dieticians). Participants may choose to not participate in 453 the study and at any time may discontinue their participation in the study. 454 Rationale for the necessity of exposing human participants to such risks: It is expected that this study will pose 455 minimal risks to participants and the intervention outlined in this proposal (24-hour, clinic, home blood pressure 456 monitoring, behavior change) are the same clinical interventions that can be prescribed during usual clinical care. 457 Why the value of the information to be gained outweighs the risks involved: Young adults with uncontrolled 458 hypertension are at increased risks for premature heart failure, stroke, and chronic kidney disease. Therefore, the 459 value of the information gained from this study far outweighs the risks involved. 460 461

462
As indicated above, we expect minimum risk to participants. The primary pre-defined serious adverse events 463 related to this study includes hypoglycemia among patients with diabetes mellitus starting a new exercise program. 464 Subjects with any form of diabetes will be instructed to talk with their diabetes care team about adjusting their 465 diabetes medication before starting a new exercise regimen and to discuss ways to treat hypoglycemia. 466 Additionally, these recommendations will be reinforced with a handout from our study team about risk of 467 hypoglycemia, signs, symptoms, and treatment of hypoglycemia and how to decrease their risk of hypoglycemia. 468 Patients with advanced chronic kidney disease (on dialysis or seeing a nephrologist) will be excluded to avoid 469 serious adverse events with the Dietary Approaches to Stop Hypertension (DASH) diet, which may cause 470 hyperkalemia. Once enrolled, study protocols will monitor and assess the presence of adverse events (AEs) and 471 serious adverse events (SAEs) at all follow-up contacts. 472 Should a serious adverse event or adverse event be identified, it will be immediately reported as outlined later in 473 this protocol. Should excessive risk to study participants be determined, the study will be stopped and all 474 participants notified in a manner appropriate to the nature of the risk. 475 Emails will be used for sending 1) research clinic visit appointment reminders for all subjects (day, time, location, 476 directions to UWHC or UWSMPH) and 2) handouts on blood pressure topics to reinforce the health coach phone 477 call (intervention arm only -if this method was selected by the subject over postal mail). Each email will contain the 478 minimum amount of information needed. Emails will be sent individually, with no cc or bcc. No group emails or lists 479 will be used for this study. Emails will not contain sensitive protected health information (PHI). Per the University of 480 Wisconsin HIPAA policy (www.hipaa.wisc.edu), the subject of the email will be "Documents for your UW Study". 481 Blood Pressure Cuffs: To minimize risks, patients will receive the appropriately sized cuff based on their upper arm 482 circumference. In addition, the 24-hour ambulatory monitor will be started prior to leaving the research clinic to 483 obtain at least two blood pressures to ensure comfort. Participants will also review information on how to contact the 484 research staff in case additional questions, concerns, or new discomfort arise. Lauver (lead researcher for this analysis) and a School of Nursing research student (a personnel change 494 IRB application will be submitted once determined). The original and transmitted digital audio copies will be 495 deleted/destroyed at the end of this study upon publication of the fidelity data. 496 • For Health Coach Calls Performed in Milwaukee, WI: The audio digital recordings will be kept in a locked 497 file cabinet in an Aurora Health Care research office. Encrypted audio files will be emailed from a password 498 protected research computer at Aurora Health Care to the study PI and study research coordinator, using 499 Aurora Health Care and UW-Madison/Department of Medicine emails. The audio files will then be saved on 500 the HIP network and maintained separately from other study documents in a password-protected database 501 on password-protected media. The audio files will then be electronically transmitted by the MyHEART 502 research staff to a UW Box file storage (approved by Richard Konopacki, UW SMPH; May 2017) accessible 503 to Dr. Diane Lauver (lead researcher for this analysis) and a School of Nursing research student (a 504 personnel change IRB application will be submitted once determined). 505 All original and transmitted digital audio copies will be deleted/destroyed at both research sites at the end of this 506 study upon publication of the fidelity data. 507 Breach of Confidentiality -Identifying information: Subject confidentiality will be protected with the coded patient IDs 508 whenever possible. Linking information will be maintained separately from other study documents in a password-509 protected database on password-protected media. 510 • Madison site: When handwritten or printed documents are required that include PHI or non-PHI with 511 identifiers, the paper copies will be secured in a locked file cabinet within a locked office within the HIP 512 Suite at 800 University Bay Drive (Suite 210) or within the UW Hospital and Clinics, Division of 513 Cardiovascular Medicine (H4/5). Access to the paper records will be restricted to the PI and project 514 personnel. As of May 2022, all paper records will be stored at the State of WI long term storage. 515 • Aurora site: When handwritten or printed documents are required that include PHI or non-PHI with 516 identifiers, the paper copies will be secured in a locked file cabinet within a locked office within a Aurora 517 Health Care research office, with oversight by the site PI. Access to the paper records will be restricted to 518 the PI, site PI, and project personnel. 519 Analysis Data: Direct identifiers are removed by HIP and Aurora Programmers prior to data delivery to minimize the 520 risk of loss of confidentiality. The data is labeled with a pseudo-identifier that is not derived from a patient identifying 521 number. Analysis data is stored on a secure server under the control of the Health Innovation Program and access 522 to study data is limited to persons who are approved to access it. Datasets for day-to-day analysis will be limited 523 datasets (no direct identifiers; include zip codes and dates only; labeled with a pseudoidentifier). Details of data 524 security protections are found in the "Privacy/confidentiality" section. Analysis data are never stored on paper. No 525 sensitive information will be included in the analysis dataset. Encrypted Aurora Health Care data sets with coded 526 patient IDs will be transferred to HIP and stored separately on the HIP network from data sets with linking 527 information. 528 As of May 2022, all data will be transferred from HIP and stored on the UW Department of Obstetrics and 529 Gynecology server. The transfer will proceed as follows: 530 HIP will copy and save files to a HIPAA compliant, FIPS140-2, encrypted disk. This disk has been approved by UW 531 Cybersecurity as an acceptable media source to store PHI. In fact, if this disk were to be lost or stolen, only the 532 business unit leadership would need to be notified (to replace the disk); UW Cybersecurity would not consider the 533 loss a reportable event. The hard drive meets the security and compliance standards needed to store PHI. The hard 534 drive will be stored in a locked cabinet in a locked office at HIP until MyHEART could bring it to Ob/Gyn. 535 Version #: 05-04-2022

536
No individual PHI will be released in presentation or publication. Only aggregate statistical output representing 537 groups of subjects will be released or removed from the secure HIP or UW Ob/Gyn department servers. 538 The Wisconsin Network for Health Research (WiNHR) of UW-Madison's Clinical and Translational Science Award 539 (CTSA) will oversee regulatory processes for this study, with the principal Investigator, site principal investigators, 540 and the ICTR Data Monitoring Committee (DMC). The WiNHR staff have developed plans for assuring data 541 accuracy and protocol compliance that will include biannual reviews with all research staff and WiNHR research 542 coordinators. All study data will be documented and monitored in ICTR's REDCap. Such plans will include data 543 verification and protocol compliance checks. The Principal Investigator will also be responsible for ensuring that the 544 data for the project are securely stored, that storage is in compliance with University and federal regulations, and 545 that no unauthorized persons have access (electronic or physical) to any participant-identifiable data. All HIPAA 546 regulations and guidelines will be followed, and all study staff must complete approved human subjects and HIPAA 547 training programs. 548 549

550
MyHEART's data safety monitoring plan requires that investigators (PI, site-PIs) notify the NIH, DMC, and the 551 University of Wisconsin IRB in a timely manner (consistent with IRB and NIH policies) of the occurrence of any SAE 552 or any AE which is severe, unexpected, and possibly related to the protocol. This study does not involve 553 pharmaceutical agents. Examples of SAE would be untoward medical or intervention occurrences that result in 554 death, are life-threatening, require hospitalization or prolonging of existing hospitalization, or create persistent or 555 significant disability/incapacity. Unanticipated AEs would include less serious problems that merit reporting because 556 they are severe, unexpected, and possibly related to study participation. Any SAE will be queried and reported even 557 if it appears that the serious adverse event is unrelated to intervention participation. The Principal Investigators will 558 also be responsible for the accurate documentation, investigation, and follow-up of all study-related adverse events. 559 Adverse event assessment, recording, reporting, and investigation will be accomplished through staff training, 560 structured/standardized assessments of untoward occurrences/events, and regular monitoring by site principal 561 investigators using REDCap. The Principal Investigators have ultimate responsibility for ensuring that SAEs are 562 detected and reported in a timely manner. Additionally, the IRB will receive an annual report of all SAEs and AEs 563 meeting the criteria listed above. 564 Important medical events are those that may not be immediately life threatening, but are clearly of major clinical 565 significance. They may jeopardize the subject, and may require intervention to prevent one of the other serious 566 outcomes noted above. For example, treatment of bronchospasm in an emergency department would typically be 567 considered serious. The primary pre-defined serious adverse events related to this study include hypoglycemia 568 among patients with diabetes mellitus starting a new exercise program. All adverse events that do not meet any of 569 the criteria for 'serious' should be regarded as non-serious adverse events. Throughout the study, any new clinically 570 significant findings/abnormalities that meet the definition of an adverse event will also be recorded and documented 571 as an adverse event. 572 573 Adverse Event Reporting Period: Adverse events must be reported once the subject undergoes any study 574 procedures, and adverse events must be reported during the entire active study period and for 30 days following the 575 last administration of study treatment. 576 Withdrawal of subjects: Any subject who experiences an adverse event or serious adverse event will be 577 immediately withdrawn from the study. All subjects have the option to withdraw from the study at any time. Subjects 578 will also be immediately withdrawn from the study if they report being pregnant, planning to become pregnancy, or 579 develop a medical condition (even if unrelated from this study) that prevents them from ongoing participation in the 580 study. 581 Post-study Adverse Event: All unresolved adverse events will be followed by the investigator until the events are 582 resolved, the subject is lost to follow-up, or the adverse event is otherwise explained. At the last scheduled visit, the 583 investigator will instruct each subject to report any subsequent event(s) that the subject, or the subject's personal 584 physician, believes might be related to participation in this study. The investigator should notify the study sponsor, 585 20 Version #: 05-04-2022 DMC, and IRB of any serious adverse event or death occurring up to 30 days after the subject has discontinued or 586 terminated study participation that may be related to this study. 587 Hospitalization, Prolonged Hospitalization, or Surgery: Any adverse event that results in hospitalization or 588 prolonged hospitalization will be documented and reported as a serious adverse event unless specifically instructed 589 otherwise in this protocol. Any condition responsible for surgery should be documented as an adverse event if the 590 condition meets the criteria for an adverse event. 591 Neither the condition, hospitalization, prolonged hospitalization, nor surgery are reported as an adverse event in the 592 following circumstance: Hospitalization or prolonged hospitalization for diagnostic or elective surgical procedures for 593 a preexisting condition. Surgery should not be reported as an outcome of an adverse event if the purpose of the 594 surgery was elective or diagnostic and the outcome was uneventful. 595 596 Referral for treatment, counseling, or other necessary follow-up. Participants who report excess alcohol use, 597 psychiatric illness (new or chronic), and/or willingness to quit smoking will be referred to their primary care provider 598 for necessary follow-up. Subjects will also receive written handouts about alcohol/tobacco cessation resources 599 (e.g., Wisconsin Tobacco Quit Line). Charges for treatment, counseling, and/or follow-up will be the sole 600 responsibility of the subject. 601 602

603
We do not expect any direct benefits to the study subjects randomized to the control group. We believe that those in 604 the MyHEART intervention group will demonstrate lower systolic and diastolic blood pressures, but this cannot be 605 guaranteed. If our results are positive, we are hopeful that our and other healthcare systems will use our results in 606 planning interventions to improve the hypertension treatment for young adults. The minimal risks to the subjects are 607 very reasonable in relation to the potential benefits to future young adults with hypertension if we find evidence that 608 the MyHEART intervention is effective. 609 610

611
No procedures, situations, or materials are expected to be hazardous. Except for the questionnaires, the remaining 612 study activities can be provided during routine clinical care. Introduction of the intervention will not increase the risk 613 of the procedures involved in standard of care. 614 Study staff interacting with enrolled participants will be blinded to the randomization to decrease risk of potential 615 biases. 616 21 Version #: 05-04-2022 MyHEART is a randomized, controlled clinical trial, across two large IRB-approved healthcare systems that will 621 examine the impact on several health outcomes of a self-monitoring intervention designed to decrease blood 622 pressure in young adults with uncontrolled hypertension. 623

Study Design and Endpoints
The study cohort will include 340 adults aged 18-39 years with documented hypertension. After screening for 624 eligibility, participants will be randomly assigned to either the MyHEART intervention or usual (routine) care. In 625 addition to their general medical care from the participants' own healthcare providers, those assigned to the 626 MyHEART intervention will receive a hypertension education packet, a home blood pressure monitor, and 12 phone 627 calls with a health coach to promote self-management of blood pressure. 628 The expected duration of subject participation, for all subjects, is 12 months.

631
The co-primary clinical outcome is a significant, clinically important change in systolic and diastolic blood pressure 632 at 6 and 12 months. 21,36 The 6-month outcome assesses the end of the 6-month MyHEART intervention. 43 The 12-633 month outcome (i.e., 6 months post-intervention) 58 assesses maintenance of blood pressure and sustainability of 634 behavior change after study completion. In contrast to the baseline assessment, follow-up questionnaires and 635 physiologic measurements will be conducted, obtained, and documented during the first visit of the 6-and 12-month 636 visits to decrease missing data. 637 638

639
• Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension 640 control will be defined using ambulatory blood pressures as the gold standard (<130/80 mmHg); otherwise a 641 clinic blood pressure of <140/90 mmHg will be used. 642 • Change in hypertension self-management behavior at 6 and 12 months compared to usual care The recruitment and screening protocol will be the same at both sites. The accrual goal is 340 participants total 665 (n=170 per arm) over 25 months of recruitment. Participants will be randomized to control or intervention arms at each 666 site. 667 668

669
The age range of the subjects is 18-39 years. The young adult age range is based upon the hypertension guidelines 670 for children and adolescents which applies to <18 year-olds. 125 The National Health and Nutrition Examination 671 Survey (NHANES) data (as reported by the American Heart Association 67 and the Center for Disease Control 3 ) 672 limits young adults to <40 years old. Young adults were selected for this research since they have the lowest 673 hypertension control rates compared to middle aged and older adults and lack effective hypertension interventions. 674 Version #: 05-04-2022 There are no enrollment restrictions based upon race or ethnic origins. We will target recruitment by minority status 675 to ensure that we achieve our expected enrollment numbers. Nationally, the prevalence of hypertension among 676 young adults is greater in young males and Blacks. We expect a higher recruitment of minority patients from an 677 IRB-approved urban site based on the racial/ethnic distribution of patients. Women who are or become pregnant will 678 be excluded to ensure we do not include patients with pregnancy-induced hypertension. 679 The information provided in the Targeted/Planned Enrollment Table represents the gender, ethnic, and racial make-680 up from a sample of potentially eligible subjects in the electronic health record: 681 UW Health: Sex: 62% male; Ethnicity: 5% Hispanic/Latino; the racial make-up is 82% white, 13% black, 2% 682 Asian, 0.3% American Indian or Alaska Native, and 3% "more than one race". 683 684

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 687 The inclusion criteria are designed to ensure that patients who have a single visit to a clinic but seek primary care 688 permanently elsewhere are not included in our study. 126 The patient has to be managed at the same healthcare 689 system prior to and during the study. 690 691

693
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 will be used to identify potentially eligible patients. 127 The electronic health record will also be used to identify 709 individuals with the ICD-10 diagnosis code R03.0 (elevated blood pressure reading, without diagnosis of 710 hypertension). The inclusion criteria will be entered by the data analysts at each healthcare system, which will 711 generate a list of potentially eligible patients. 50,60 712 The principal investigator and Milwaukee site investigator will work with programmers to determine who is 713 potentially eligible based on the EHR database. The project manager and student research coordinators will be 714 involved with mailing introductory packets, telephone screening, and inviting them for their first screening visits. 715 At the screening visit, research coordinators will lead eligibility assessment, informed consent, and enrollment. The 716 PI will oversee all aspects of this study. 717 718

719
See appendix for expected numbers of women and minorities to be recruited. 720 721 The site coordinators will mail an introductory research packet to patients who have been identified by each 722 electronic health record system as potentially eligible, based upon the WCHQ or ICD 10 diagnosis code R03.0 723 criteria described above. The packet will include an introductory letter, a flyer summarizing the MyHEART research 724 project, a magnet, bookmark and a pre-paid opt-out postcard. The packet will only be mailed once to the home 725 address listed within the electronic health record system. If a participant contacts us independently and requests a 726 packet, it will be mailed to the address that is provided by them. If an opt-out response is not received after 2 727 weeks, a research staff member will call patients to perform telephone screening to assess eligibility based on 728 inclusion and exclusion criteria; research staff at UW_Madison will be calling all Madison participants and research 729 staff at Aurora Health Care will be calling all Milwaukee participants (telephone scripts for each site are uploaded to 730 ARROW). The telephone screening for Aurora Health Care participants will also include a question to obtain verbal 731 authorization that the participants give verbal permission for Aurora Health Care research staff to send their 732 Version #: 05-04-2022 information to the University of Wisconsin-Madison research staff for data entry. At the completion of the telephone 733 screening, the patient will be subsequently invited for a face-to-face visit at the research clinic within their medically 734 homed region (Madison or Milwaukee). We will recruit a total of 340 participants over 25 months. We anticipate an 735 accrual rate of 12-13 eligible participants per month. We estimate having to screen approximately 930 potentially 736 eligible participants. 737 We will also try to recruit by collaborating with primary care providers to review weekly panels and posting 738 announcements within primary care clinics (upon approval from clinic managers and/or clinic directors). 128 Primary 739 care providers can also invite patients to the study. Healthcare providers will be able to directly ask patients about 740 participating in this study. The PI will ask for permission from the provider to review their clinic schedule to identify 741 potential subjects. The providers will be asked to tell potential subjects to contact the research team by telephone. 742 Providers will not be asked to collect potential subjects' contact information or provide it to study team members. 743 Other methods include newspaper, radio, TV, newsletters, and social media avenues and advertising to the general 744 public via flyers and community boards. We will publicize the research study on the

775
The PI will be responsible for ensuring that valid consent is obtained and documented for all subjects unless the 776 IRB waives the requirement for documentation of informed consent for all or part of the study. 777 The activities involved to review the EHR for potentially eligible subjects are considered "preparatory to research" 778 and will be conducted by administrators of the WCHQ database and programmers for each respective healthcare 779 system. If an opt-out card is not returned, then individuals will be contacted directly by the study team for a 780 recruitment telephone call. 781 During the recruitment screening phone call for Aurora Health Care participants, individuals will be asked to give 782 verbal permission for Aurora Health Care research staff to pass along their information to the University of 783 Wisconsin-Madison research staff for data entry (an "altered authorization"). 784 For individuals who express interest in participating during the telephone call and who potentially qualify, screening 785 visit 1 will be scheduled. Written informed consent will be obtained at the start of screening visit 1, which will include 786 authorization for additional screening/eligibility assessment (e.g., 24-hour ambulatory blood pressure monitoring) 787 and gathering data, including information from the patient's electronic health record and study procedures after 788 enrollment, if eligible. Signed informed consent will be obtained upon the participants arriving for Visit 1 (prior to 789 initiating data collection or physical contact for the visit). The consent process will consist of a detailed verbal 790 description of the study including its risks, potential benefits, and requirements. Potentially eligible participants will 791 be given an IRB-approved/stamped informed consent form with all required elements and factual correctness to 792 read, then ample time to read and reflect on participating. If the individual requests, they will be given additional 793 time to consider participation, including re-scheduling the screening visit. Before obtaining written consent, each 794 individual will be allowed to ask questions until a decision can be made by the individual. When ready, participants 795 will be required to sign the consent form. Study audits by the PI and WiNHR will include review of consent 796 documents for signatures and use of the IRB date-stamped form to ensure compliance. 797 798

799
Members of the research team including research coordinators and research assistants will be responsible for 800 obtaining consent. The written/signed consent (original copy) will be stored in a locked file cabinet, in a locked 801 office, on site at each research office. Electronically signed copies will be stored on the password protected 802 research network, locked to all non-study staff. 803 The process of informed consent will be structured to be conducive to rational and thoughtful decision making by 804 the subject -including time for discussion, questions, and the ability to reschedule if additional time for 805 consideration is needed. Legally authorized representatives will not be allowed to sign the consent; patients who 806 require legally authorized representatives are excluded from the study. 807 Auditors, Witnesses, and translators will not be part of the consent process. Information about study subjects will be kept confidential and managed according to the requirements of the Health 819 Insurance Portability and Accountability Act of 1996 (HIPAA). Version #: 05-04-2022 Signed HIPAA authorization will be obtained upon the participants arriving for Visit 1 (prior to initiating data 821 collection for the visit) after reviewing the Consent form. The same process (including extended time) will be given 822 to the individual to complete the HIPAA form. A copy will be given to the individual that signed the form, on the 823 same day the individual signs the form. 824 825

826
After study enrollment, in the event that a subject revokes authorization to collect or use PHI, the investigator, by 827 regulation, retains the ability to use all information collected prior to the revocation of subject authorization. 828 829

830
Subjects will not have to pay for study procedures (such as home blood pressure monitors, 24-hour monitoring). 831 Subjects who are randomized to receive a home blood pressure monitor will be able to keep the monitor after study 832 completion. The patient will not be billed by the healthcare system or their health insurance company for any costs 833 related to a study procedure. 834 Subjects will be responsible for any costs related to their blood pressure follow-up as directed by their healthcare 835 team, such as clinic visits and blood pressure medication, including all out-of-pocket costs. 836 837

838
Payments to participants will be provided as the study progresses; subjects do not have to complete the entire 839 study to receive a payment. 840 All intervention and usual care participants will receive a remuneration up to $170 for study completion. Each "face-841 to-face visit" will actually be two consecutive visits (screening/ If they arrive for Screening Visit 1 and are unable to complete the visit due to exclusion, they will receive $10 for 849 their screening participation. 850 An additional $20 cash gift card will be provided to all participants at Visit 4 (6-month visit) to offset study-related 851 cell phone/telephone charges. 852 853 The remuneration will acknowledge their time and study participation, not behavior change. Primary care providers 854 and clinics will not receive an honorarium. Additional payment will not be available to subjects for travel or other 855 costs (example: childcare) that are incurred. 856 857 This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written 860 notification, documenting the reason for study suspension or termination, will be provided by the suspending or 861

Early Withdrawal of Subjects
terminating party to all site investigators, the NIH/NHLBI, DSMB (i.e., ICTR DMC), and IRB. If the study is 862 prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the reason(s) for the 863 termination or suspension. 864 Version #: 05-04-2022 Circumstances that may warrant termination or suspension include, but are not limited to: 865 • Determination of unexpected, significant, or unacceptable risk to participants 866 • Demonstration of efficacy that would warrant stopping 867 • Insufficient compliance to protocol requirements by research study personnel 868 The study may resume once concerns about safety and protocol compliance are addressed and satisfy the IRB 869 and/or the NIH. All participant data that was collected prior to study termination will be analyzed and continue to be 870 handled/stored per this protocol. 871 872

873
Participants will be educated on the consent form that they are able to withdraw at any time without adverse effects 874 to receiving healthcare services. 875 Women that are currently pregnant or plan to become pregnant during enrollment screening will be excluded from 876 study participation. If a participant becomes pregnant during the study, she is excluded immediately from further 877 participation in all study activities. The presence/absence of birth control is not an inclusion or exclusion criteria. 878 Pregnancy testing is not part of the study protocol. Once enrolled in the study, individuals in either the usual care or 879 intervention group who become ineligible during the study (e.g., self-report of a new condition in the list of exclusion 880 criteria) will be informed that their participation has ended and will be provided the reason for ending their study 881 participation. 882 No medications will be administered by the study staff. Procedures are not needed to transition subjects of study 883 agents or alternate therapy if withdrawn from this study. 884 885

886
Withdrawn patients after enrollment will be analyzed as intention to treat. Missing data will be imputed using 887 multiple imputations along with sensitivity analyses for missingness according to the recommendations given in the 888 National Research Council report. 129 889 890

892
All concomitant antihypertensive medications prescribed by the patient's healthcare team are permitted during the 893 study. Ongoing antihypertensive medication changes by the patient's healthcare team (including medication  894 initiation, discontinuation, and/or dose changes) are allowed throughout the study. 895 All other medications, supplements, and lifestyle modifications that were part of the participant's treatment plan prior 896 to the study are included. 897 The participant may also be started on non-pharmacologic therapy (examples: physical activity, stress 898 management) by their medical team during this study. 899 900

901
Randomization assignments for both sites will be generated by the UW Biostatistics Clinical Trials Statistical Data 902 Analysis Center stratified by research site, in block sizes of 4 and 6 to ensure equal allocation. The Research 903 Electronic Data Capture (REDCap) clinical data management system will be used to verify eligibility and data 904 completeness prior to randomization. The UW Biostatistics team will develop a randomization list, which will be 905 provided to the MyHEART research staff in a binder. There will be two people responsible for the binder at all times 906 at HIP (PI and research manager) who will give the randomization assignment upon receiving a phone call from the 907 research assessor (from either site) conducting Visit 2. Until the staff receives a phone call, the binder will remain in 908 Version #: 05-04-2022 All study participants will have contact with research staff (e.g., research coordinators, research visit study 911 assessment staff). To reduce bias, MyHEART 6-and 12-month assessors will be blinded to treatment 912 assignments. 130 Assessors will be trained to treat patients in both study groups identically per protocol. 131

913
Ambulatory monitoring will be the gold standard for blood pressure measurements. 914 915

916
Usual care and intervention arm participants will receive routine hypertension clinical care per their primary care 917 provider. This includes the possibility of receiving untailored self-management resources (i.e., dietician referral) at 918 their provider's discretion, but this is not systematically tailored to young adults' needs. These patients would be 919 treated according to current hypertension guideline standards including, but not limited to, hypertension lifestyle 920 modification counseling: 1) reduced sodium intake, 2) weight loss, 3) reduced alcohol consumption, and 4) 921 increased physical activity. This may include verbal discussions and/or handouts. Medications would be initiated 922 and/or titrated per hypertension guidelines. 923 All patients would have clinic blood pressure checks and would be encouraged to have home blood pressure 924 monitoring. Additionally, providers may order 24-hour Ambulatory Blood Pressure Monitoring, per the U.S. 925 Preventive Services Task Force guidelines, to exclude white coat hypertension. Patients would also have additional 926 tests not limited to blood draws, EKGs, echocardiograms, etc. 927 We will assess the number of healthcare team contacts in the usual care arm by calculating the number of primary 928 care and specialty visits and dietician and exercise referrals after study enrollment (see IRB application with data 929 variable sheet). 50,60 Usual care arm participants will receive AHA's "What is High Blood Pressure" 131 handout 930 (copies of handouts are in the Appendix). 132 It is usual care for patients to receive hypertension educational material 931 when presenting for a hypertension visit. They will not receive home blood pressure monitors. Usual care 932 participants will have the same 6-and 12-month assessments as the intervention arm. 933 934

938
The same procedures will be followed at both research sites (Madison and Milwaukee). 939 940

Screening Visits: 941
Screening Visit 1: Screening Visit 1 occurs no more than 1 month after the telephone screening phone call. 942 Written informed consent and HIPAA authorization will be obtained at the start of Screening Visit 1, which will 943 include authorization for additional screening/eligibility assessment 133 (e.g., 24-hour ambulatory blood pressure 944 monitoring), gathering data, including information from the electronic health record, and all study procedures after 945 enrollment, if eligible. If a potentially eligible patient requests to reschedule to sign the consent and/or HIPAA 946 form, they may do so within 30 days of the screening phone call. Blood pressures will be measured. The patient is 947 not eligible if the between-arm blood pressure difference is ≥20 mmHg. If these findings are noted, the participant 948 will receive an incidental finding notification to discuss with their 949 primary care provider. All patients will be given their clinic blood 950 pressure in written format from Visit 1, regardless of eligibility. 951 Remaining eligible patients will receive an ambulatory blood 952 pressure (AMBP) monitor (example: SpaceLabs; final product to 953 be determined in the appendix) 134 for 24-hour blood pressure 954 Version #: 05-04-2022 monitoring. The selected AMBP device will be FDA approved or have a 510(k) clearance. 24-hour AMBP 955 monitoring is recommended to confirm a hypertension diagnosis (exclude white coat hypertension). 135 monitoring (see Figure 1) given its mobility and limited time commitment. 959 If a potentially eligible young adult already completed 24-hour ambulatory blood pressure monitoring through their 960 UW Health or Aurora Health Care Clinic within the past 3 months, they do not need to repeat 24-hour ambulatory 961 blood pressure monitoring for study eligibility. The ambulatory blood pressure monitoring report will be reviewed in 962 their electronic health record to evaluate for white coat hypertension (an exclusion criteria). If eligible, the 963 participant will be able to proceed with the Screening Visit 2/Baseline Assessment Visit. The individual's 964 honorarium for Visit 1 and Visit 2 will not be adjusted/decreased. 965 Screening Visit 2/Baseline Assessment Visit: After receiving a 24-hour AMBP monitor, participants will be 966 asked to return for Visit 2 on the next business day. Participants will have up to 30 days from Screening Visit 1 to 967 return for Visit 2 without having to restart with the telephone screening process. A research staff member (not the 968 individual acquiring consent or enrolling during this visit) will evaluate the mean 24-hour ambulatory blood 969 pressure. If there is white coat hypertension, the patient is ineligible, and will receive an incidental finding letter to 970 share with their primary care provider. Remaining eligible patients will be enrolled, randomized to MyHEART or 971 usual care, and complete the baseline assessment. 972 973

Baseline/Follow-Up Data Collection: 974
All research staff will be trained in all key elements of the protocol and use of the data management system. 975 976 Anthropometric Measurements 977 • Height will be determined at each assessment visit using a wall-mounted stadiometer, without shoes or 978 other outdoor footwear. Two measures of height will be taken and the average of the two will be used. We 979 will repeat the measurement of height at each assessment visit because growth may still be occurring in 980 young adults. Height will be measured to the nearest 0.1 cm. 981 • Weight will be determined at each assessment in light indoor clothes, removing all excess layers of 982 clothing, and without shoes at all visits. All scales will be calibrated using standard weights, annually by 983 the Bureau of Weights and Standards and quarterly by trained study personnel. Weight will be measured 984 to the nearest 0.1 kg. 985 • Body mass index (BMI). The weight and height measures will be used to calculate Body Mass Index 986 (weight in kilograms divided by height in meters squared; kg/m 2 ) 987 • Waist Circumference will be measured at baseline per established protocol/figures in the appendix. 988 989 Baseline Self-Reported Measures 990 All of the following measures will be recorded on paper by the participant, then electronically entered, with 991 confirmation of correct entry, by the research staff via REDCap on an encrypted research computer within the 992 research offices at UWHC and/or HIP. See appendix for final forms and questions. 993 • Alcohol Use: Alcohol consumption will be evaluated by alcohol beverage type and quantity as performed 994 in the CARDIA (Coronary Artery Risk Development in Young Adults) cohort study; answered by self-995 report. 140 996 • Financial Status: Participants will self-report their financial situation by selecting, for example, whether 997 they: a) had enough money after paying bills for extra things (e.g., dining out), b) enough to pay bills but 998 not to purchase extra things, c) enough money to pay bills by cutting back on things, or d) difficulty paying 999 bills no matter what was done. The first two answer choices are categorized as "adequate income" and 000 the last two choices as "inadequate income". 32 This financial assessment accounts for varying income, 001 which is more reflective of young adulthood. 002 • Annual Household Income: 141 income will be divided into six categories (for example: <$20,000, 003 $20,000-34,999, $35,000-49,999, $50,000-$99,999, ≥$100,000, prefer not to answer) and recorded by 004 Version #: 05-04-2022 self-report 005 • Self-Rated Health Status: Single-item assessments of self-rated health status have a strong association 006 with health outcomes 142-148 and provide a broad assessment of health. 149 Self-rated health will be 007 measured using the following question/responses similar to: "In general, would you say your health is 008 Excellent, Very Good, Good, Fair, or Poor?", which has been used in nationally representative 009 samples. 147-149 010 • Health literacy (i.e., the ability to obtain, process, and understand basic information to make appropriate 011 health decisions) 150-152 will be evaluated using a • Social Support will be evaluated using a brief multi-dimensional evaluation validated for patients' chronic 017 illnesses (example: The Medical Outcomes Study Social Support Survey). 149,160-162 018 • Global medication adherence will be assessed using the Morisky adherence scale. 163,164 019 020

Baseline Electronic Health Record and Other Database Data Collection 021
• Healthcare utilization will be evaluated using the John Hopkins Adjusted Clinical Group Case-Mix 022 System, which assesses morbidity burden based on patient age, gender, and patterns of 023 disease; 50,60,66,165 the number of clinic visits will be measured. 024 • Baseline antihypertensive medications and other medications: Number of antihypertensive 025 medication classes will account for varying hypertension treatment at baseline. Data will be acquired from 026 the electronic health record and participant self-report, and will include prescription and non-prescription 027 medications. 028 • Primary care provider characteristics (age, gender, specialty, time since completed medical school, % 029 of panel with hypertension, panel size) will be obtained when available from the electronic health record 030 and/or the American Medical Association Masterfile data. 50,60 031 032 Interviewer-Administered Data Collection (Baseline, 6 months, and 12 months) 033 • Physical Activity. We will assess physical activity using the Godin Exercise Questionnaire to evaluate 034 weekly leisure activity and total leisure activity. 035 • Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool -A web-based tool that 036 enables multiple, automatically coded, self-administered 24-hour recalls. This tool will be used to assess, 037 for example, sodium, fruit, and vegetable intake in relation to the DASH-sodium diet. 038 039 Blood Pressure Measurements 040 Blood pressures at each research site will be assessed with a Dinamap Monitor. Cuff size will be determined by 041 arm circumference. An appropriate sized 166 blood pressure cuff will be connected to an automated 042 sphygmomanometer (Dinamap). Each site will have the following cuff sizes available: small adult (for arm 043 circumference of 22-26 cm), regular adult (27-34 cm), and large adult (35-42 cm). A blood pressure measurement 044 will be obtained on the right upper arm, then the left upper arm, for the initial assessment. Right arm blood 045 pressures will be subsequently used for the initial and follow-up visits, unless the left arm systolic blood pressure 046 is ≥10 mmHg higher. The average of the second and third systolic and diastolic pressures, each taken 1 minute 047 apart, will define the baseline clinic blood pressure. 167 If a participant's upper arm is too large, a forearm blood 048 pressure will be obtained. All participants (intervention and control) will receive copies of their baseline, 6-month, 049 and 12-month research clinic blood pressures to share with their usual healthcare provider, and will receive 050 instructions on recommended primary care clinic follow-up. 43,168 051 [169][170][171] 24-hour blood pressure monitoring will take place at baseline, 6 052 months, and 12 months. Staff trained in the use of the 24-hour ambulatory blood pressure monitor will apply the 053 appropriate sized cuff to the subjects' non-dominant arms unless the systolic blood pressure difference as 054 Version #: 05-04-2022 measured during the clinic blood pressure assessment is >10 mmHg, in which case the arm with the highest 055 value obtained will be used. ABPM placement procedures and device recording setting will be per the AMBP 056 manufacturing company's instructions and hypertension guideline recommendations. Participants will be 057 instructed to keep their arm still during cuff inflation, and on the use of a diary to record the time of their activities, 058 sleep, symptoms, and medications. Participants will be given instructions on how and when to return the device to 059 study staff. Data from the returned device will be uploaded and time-matched with information from the 060 participants' diaries. Day-time and night-time will preferentially be defined using each participant's diary. All 061 acquired readings will be saved and used for analysis. If the participant is unable to complete ambulatory blood 062 pressure monitoring, they will not be excluded, but will alternatively have their blood pressure evaluated for study 063 eligibility using the automatic office blood pressure (AOBP) technique per the SPRINT protocol 172 (example: have 064 serial blood pressures acquired once every 5 minutes up to 5 times, using an automatic cuff without a research 065 staff member present [i.e., while sitting alone in the research clinic exam room]). 066

24-Hour Blood Pressure Monitoring:
Home Blood Pressure Monitoring: Intervention participants will be provided an Omron home blood pressure 067 monitor with an appropriate cuff size; details of the final model acquired for the study can be found in the 068 appendix. 173,174 The selected monitor will be based upon validation studies in young adults and also across BMI 069 categories. 175 Intervention arm participants will receive training and practice on proper cuff placement and monitor 070 use during their baseline enrollment visit. 36 They will be asked to take their blood pressure at least three days a 071 week, 2 measurements each time. 31,36 A normal home blood pressure (complicated and uncomplicated 072 hypertension) is <135/85 mmHg, 176 which accounts for changes in hypertension guidelines for patients with 073 diabetes and chronic kidney disease. 21,177 Participants will be able to read the recorded blood pressures to their 074 health coach during the scheduled health coach phone calls (see below). 178 Participants will be asked to bring 075 their home blood pressure monitor to the 6-and 12-month visits to review recorded blood pressures. Participants 076 will keep the blood pressure monitor after study completion. Malfunctioned monitors will be replaced during the 077 study. 078 079

080
Health Coach Training: Health coaches will receive training that builds on their prior education in motivational 081 interviewing 179 and hypertension management, using self-determination theory concepts. Training intensity is based 082 on prior studies 127 and resources from our pilot: interactive didactic lectures, videos, 180 and the MyHEART health 083 coach guide (see Appendix). Trainers will observe health coaches with role-playing, followed by problem solving 084 and debriefing. 181-183 Health coaches will already be certified as an exercise physiologist (American College of 085 Sports Medicine certification), registered dietician (Academy of Nutrition and Dietetics) with at least 3 years of 086 clinical experience including chronic disease management and adult education/counseling, or a registered nurse. 087 Health coaches will receive training on the MyHEART coaching guide that builds on their prior education in 088 motivational interviewing and hypertension management, using self-determination theory concepts. Training will 089 include interactive didactic lectures and videos and the MyHEART health coach guide. The trainer will also observe 090 health coaches with role playing followed by problem solving and debriefing. The references (scientific articles, etc.) 091 that will be given to the coach are optional reading materials for them to select based upon additional questions or 092 training needs about motivational interviewing, self-determination theory, and/or blood pressure lowering. The 093 individual needs of each coach will be identified during training and they will be directed to appropriate references. 094 All subject handouts developed for this study will be reviewed during training with discussion on when and how to 095 include the handouts to reinforce the telephone calls. Handouts will be distributed after each phone call either by 096 postal mail or email (based upon subject's preference). 097 Health Coach Fidelity: An audio recorder will be placed on the table during the health coach calls. The goal is to 098 record the coach's comments and adherence to the curriculum and protocol, and use of the self-determination 099 theory. The participant's first name will be heard on the audio recording as he/she communicates with the 100 participant. A recording device will NOT be attached to the phone or phone line. The secure storage and 101 transmission of these audio files is summarized in the "Protection Against Risks" section. 102

104
Health Coach Phone Calls: Intervention arm participants will receive a health coach phone call every 2 weeks for 105 6 months, for a total of 12 calls. The first call will be scheduled at the screening visit and subsequent calls will be set 106 Version #: 05-04-2022 up at the end of each prior call. If a participant is unavailable, the health coach will leave a message and reschedule 107 the call up to 3 times. Once a coach is ready to make calls for the MyHEART intervention: during each call, the 108 health coaches will review and discuss home blood pressures, if available, from home blood pressure monitoring, 109 and address barriers and concerns to home blood pressure monitoring. The MyHEART coaches will also 110 recommend clinic follow-up based on the 2-week average home blood pressures -see coach's guide, which 111 coincides with UW Health's blood pressure follow-up recommendation. During each telephone call, the coach will 112 guide the subject on selecting health behavior goals and completing the goal sheet (uploaded in this application). In 113 addition to home blood pressure monitoring, subjects will be able to choose which topics from the 8 additional 114 hypertension education modules they want to address during a call (options include: hypertension knowledge, low 115 sodium, DASH eating plan, weight loss/maintenance, smoking cessation, moderate alcohol consumption, blood 116 pressure medicine, social support and stress management). The coach may also offer topics to the participant 117 based upon barriers or concerns discussed during the call. A module is a "topic" to discuss which includes a 118 coach's education/counseling, associated handouts, and references (see module overview in table below). The 119 participant may focus on the same topics throughout the intervention based upon their personal needs or change 120 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' 139 current health behaviors and their desired behavior goals to promote internal motivation, 2) sharing reference points 140 for guideline-recommended behaviors to lower blood pressure, and 3) discussing short-term goals and developing 141 congruent action plans. Coaches will promote autonomy by individualizing the order and depth of educational 142 content based on the behavioral goals chosen by the subject. Subjects will be coached on practical skill building 143 (e.g., label reading) and coaches will encourage patients to set goals that are motivating but not overwhelming. The 144 "Coach's Guide" is to build on the coach's knowledge of blood pressure lowering behavioral techniques and how to 145 use the self-determination theory and motivational interviewing to guide the subject as they initiate and try to 146 maintain their new health behaviors. Abbreviated guides in the appendix highlight important "talking points" for the 147 coach to address during each call. Hypertension guidelines on exercise and dietary changes will be given to the 148 participant by the health coach, based upon the updated guidelines available at the time. Coach references will be 149 updated if new guidelines and scientific recommendations become available during this study. 150 All intervention participants will start with the home blood pressure monitoring module. The first follow-up phone call 151 will address hypertension knowledge and review home blood pressure monitoring. Home blood pressure monitoring 152 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 Version #: 05-04-2022 education will also be provided during all follow-up phone calls. The order of the remaining modules will be guided 153 by participant's choice and tailored to their goals. 170,171 Fewer modules than calls allows some topics to be repeated 154 as needed and per the participants' requests. Current tobacco users will be referred to the Wisconsin Tobacco Quit 155 Line (http://www.ctri.wisc.edu/quitline.html) when ready to attempt cessation and their primary care provider will be 156 notified of their intention to quit via the EHR. The participant will be encouraged to also discuss alcohol 157 reduction/cessation with their primary care provider if they report consuming >14 alcohol beverages/week. 122 The 158 MyHEART team created handouts to include specific topics requested by our young adult focus groups (see 159 Appendix). The MyHEART handouts were formatted with a Flesch-Kincaid readability of ≤6 th grade. 172 160 161

Follow up:
162 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 164

165
• Unscheduled visits are not included in this study. 166 • See the appendix for the study calendar with procedures and data collection 167 • Participants will be encouraged to continue routine blood pressure follow-up with their primary and routine 168 healthcare team. Otherwise, no additional concomitant therapies be advised or suggested. 169 170

171
The final study evaluation will be two visits (as above in the visit table) with the first visit occurring 12 months after 172 study enrollment. See appendix for the study calendar of study endpoints and evaluations. 35 Version #: 05-04-2022 During the 12-month visit, participants will be informed of their treatment assignments, final weight, clinic and 24-174 hour blood pressures, and body mass index. Additional data from the 12-month visit will not be analyzed in time to 175 be provided to the participant. 176 Additional follow-up for adverse or serious adverse events will continue for 30-days after the final 12-month visit 177 with one telephone follow-up by the research team. The participant will be responsible for scheduling any additional 178 clinic visits and medical care for adverse or serious adverse events. 179 180 6 Study Analysis Statistical Analysis Plan Overview: 197 Data will be analyzed by intent to treat. Missing data will be imputed using multiple imputations. 198 199 For Aim 1, the comparisons for the primary outcomes of systolic and diastolic blood pressure change from baseline 200 to 6 months will be done using analysis of covariance. The primary comparisons for the secondary outcome of 201 hypertension control at 6 months will be based on Fisher's exact tests. Sequential hypothesis testing will also be 202 performed. The 12-month analysis will focus on maintenance of behavior change, to assess whether significant 203 differences seen between baseline and 6 months are retained. We will also assess the differential effectiveness of 204 the intervention across subgroups by developing exploratory regression models. 205 For Aim 2, behavioral outcomes will be analyzed in a similar manner as with the clinical outcomes in Aim 1 206 depending on whether they are continuous or categorical. Analyses (t-tests or Wilcoxon tests and ANCOVA for 207 continuous variables; Fisher's exact test for the categorical variable) will be performed for differences from baseline 208 to 6 months between treatment groups. Linear or generalized linear mixed-effects regression models will be fit to 209 describe longitudinal behavioral measurements over time. 210 For Aim 3, analyses will examine hypothesized mediators of the MyHEART intervention (for example, autonomy 211 support, internal motivation, perceived competence, and patient activation). We will estimate mediation effects in 212 multilevel models [186][187][188][189][190] where mediation is assessed by fitting two models. Standard errors and 95% confidence 213 intervals for the mediation effect and percent-mediated estimates will be calculated. This analysis will be pivotal to 214 guide future replication and dissemination of MyHEART. 215 216

217
There is no interim analysis planned. However, we are prepared, if requested by the Data Safety and Monitoring 218 Committee at any point, to calculate interim statistical power for its review. Projections of interim power can be 219 made under several scenarios for future data, including assumptions that current trends continue or that the future 220 Version #: 05-04-2022 data reflect the relative effects used in the design of the trial. Safety reports will tally adverse events by intervention 221 assignment and postulated relationship to the trial interventions; event rates will be reported per person year of 222 follow-up. Should excessive risk to study participants be determined during the data safety monitoring review, the 223 study will be stopped and all participants notified in a manner appropriate to the nature of the risk as defined by the 224 IRB and DSMB. confidentiality will be protected with the coded patient IDs whenever possible. Linking information will be maintained 230 separately from other study documents in a password-protected database on password-protected media. Only the 231 principal investigator, HIP programmers, and the research coordinators responsible for mailing the study invitations 232 and remuneration will have access to directly identifiable subject data. Once these activities have ceased, 233 identifying information will be destroyed. Analysis datasets will be limited datasets and the research team will not 234 have access to identifiers other than those in a limited dataset (zip codes and dates), or any cross-walk information. 235 Identifiable Data: HIP and Aurora Health Care Programmers will identify potential participants using the criteria 236 described in this protocol. Each subject will be assigned a study-specific ID number, maintained separately from the 237 subject's medical record number (MRN). Only research team members listed in the IRB application shall have 238 access to the list. 239 Security levels for the UW Ob/Gyn and Health Innovation Program's data systems that include patient-identifiable 240 data are housed within a UW Health data center (and benefit from the same security configuration as other UW 241 Health servers housing fully identifiable clinical and administrative patient data) and include: 242 1. All new user account requests and access to any resource is reviewed and approved by the Health Innovation 243 Program Director or UW Ob/Gyn IT director. and/or those persons specified elsewhere to have privileges to view/use the data (e.g., data use 251 agreement or confidentiality agreement signatories Each individual patient record in the dataset is assigned a "pseudo ID" during dataset construction, which allows 286 HIP and Aurora Health Care Programmers to link patient records from multiple sources and/or across different file 287 types (e.g., demographics, laboratory results, medications). The pseudo ID also allows Programmers to cross-walk 288 the data back to the Electronic Health Record ("EHR"; example: UW Health Link) in the event data need to be 289 verified or additional elements extracted from the source. Information allowing data to be cross-walked with 290 identifiers will never be shared with the study team. 291 292 Following data aggregation, linking, and variable creation, the datasets used for day-to-day analysis will be securely 293 transferred to a second server with equivalent security. Data access is restricted to only IRB-approved personnel 294 conducting study analysis and with passwords for computer drive and project folder access. The limited datasets 295 are stored on a specified HIP server, housed in the Centennial Office Building managed by the UW SMPH IT, and is 296 connected via fiber optic cable to the HIP suite at 800 University Bay Drive. As of May 2022, all data will be 297 transferred from HIP and stored on the UW Department of Obstetrics and Gynecology server. No individual PHI will 298 be released for analysis, in presentation or publication. Only aggregate statistical output representing groups of 299 subjects will be released. The completed study data set will be securely transferred, using the latest Secure File 300 Transfer Protocol, to the Bioinformatics Computing Group (BCG) at the UW-Madison to the lead statistician. The 301 levels of security for the server are five-fold and include: 302 1) Physical Security: server is located in an enterprise level secure data center under control of UW School of 303 Medicine and Public Health (SMPH) ITS, which is a dedicated computer machine room requiring keycard and PIN 304 for access. The room is equipped with camera surveillance, a hot and cold isle chilling system and an automatic fire 305 detection and suppression system. SMPH ITS does not have access to the server. Ob-Gyn servers are supplied 306 power by redundant sources and are protected by both an uninterruptible power supply and a backup generator. 307 2) The data resides behind an SMPH managed hardware based firewall and a computer based software firewall 308 3) Access controls: Data directory access is limited to project PI and designees she approves (currently none at this 309 time) 310 4) Domain access restrictions: access to Ob-Gyn computing resources is restricted to individuals with an Ob-Gyn 311 logon 312 Once approved, each user will have their own account. To ensure that REDCap users have access only to data and 324 information that they are supposed to have access to within the application, the each user's privileges will be 325 assigned by the study's principal investigator. The Data Access Groups functionality will also be implemented to 326 allow site-specific research staff to only access records created at their respective site. 327 328

5) Authentication
Additional REDCap security features that will be used in this study include: 329 • authentication to validate the identity of end-users that log into the system 330 • auto-logout setting 331 • Limit number of failed login attempts before a user is locked out of the system 332 333 REDCap data entry, views, and modification will be audited for each user. A user's status will be immediately 334 suspended if an audit demonstrates that they are not complying with the protocol and the IRB and DSMB will be 335 notified per the IRB policy. 336 Disaster recovery plans include a back-up server at the UW Centennial Medical Building, independently managed 337 by the UW School of Medicine and Public Health, Department of Medicine. 338 We also have policies and procedures in place to protect the confidentiality and security of patient data, and our 339 data protection measures (for protected health information, or PHI) are consistent with the Federal Health Insurance 340 Portability and Protection Act's privacy and security rules (45 CFR §160.103; 45 CFR §160 and 164, Subparts A 341 and C, respectively). Only persons directly involved in the research will have access to identifiable research data. 342 All study data will be maintained in password-protected, secured computer files or in locked cabinets within locked 343 offices. 344 345

346
By signing the protocol, the Investigator agrees that the NIH/NHLBI or IRB representative may consult and/or copy 347 study documents in order to verify CRF data. By signing the consent form, the subject agrees to this process. If 348 study documents will be photocopied during the process of verifying CRF information, the subject will be identified 349 by unique code only and full names and similar identifying information (such as medical record number or social 350 security number) will be masked. 351 The Clinical Site Investigators will ensure that the identity of subjects will be protected. All study records will be 352 maintained in a secure fashion with access limited to essential study personnel only. All study documents submitted 353 to the Coordinating Center will have identifiers removed other than dates of birth and service and subjects will be 354 identified with a study-specific identification number only. 2), 6-month Visits (Visits 3 and 4), 12-month Visits (Visits 5 and 6), and during the health coach phone calls. 369 In addition, 24-ambulatory blood pressure monitoring will be performed at each site with data downloaded via 370 Spacelabs software and summary data transferred to REDCap. Data from these visits including participant 371 demographic information, vital signs, and other participant information will be uploaded into REDCap clinical 372 research management software. 373 374

375
The study case report form (CRF) is a data reporting instrument for the study. All data requested on the CRF must 376 be recorded. All missing data must be explained. 377 • All entries should be printed legibly in black ink. 378 • If any entry error has been made, to correct such an error, draw a single straight line through the incorrect 379 entry and enter the correct data above it. 380 • All such changes must be initialed and dated. 381 382 NOTE: 383 • If a space on the CRF is left blank because the procedure was not done or the question was not asked, 384 write "N/D". 385 • If the item is not applicable to the individual case, write "N/A". 386 • DO NOT ERASE OR WHITE OUT ERRORS. 387 • For clarification of illegible or uncertain entries, print the clarification above the item, then initial and date it. 388 389

390
The Madison site, under the direction of MyHEART's lead statistician, will serve as the data coordinating center and 391 the primary site to oversee timely and accurate data collection. 392 393

394
REDCap reports will be used to provide up-to-the-minute access to all entered data. This will allow verification of 395 completeness, timeliness, reliability, and accuracy of collection and coding of data. Quality reports will also be sent 396 to the MyHEART Steering Committee and will include comprehensive data on all quality control activities, including 397 protocol adherence and violation, training, retraining, certification, and site visit reporting. Corrective actions or changes that will be considered in response to an UP will include: 477 The following guidelines will be used to describe severity: 486 Mild -Events require minimal or no treatment and do not interfere with the participant's daily activities. 487 Moderate -Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate 488 events may cause some interference with functioning. 489 Severe -Events interrupt a participant's usual daily activity and may require systemic drug therapy or other 490 treatment. Severe events are usually potentially life threatening or incapacitating. 491 492

493
The principal investigator will be responsible for determining whether an AE is expected or unexpected. An AE will 494 be considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 495 previously described for the study agent. 496 497 Version #: 05-04-2022

498
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and interviews of 499 a study participant presenting for medical care, or upon review by a study monitor. All AEs including local and 500 systemic reactions not meeting the criteria for SAEs will be captured on the appropriate CRF. Information to be 501 collected includes event description, time of onset, clinician's assessment of severity, relationship to study product 502 (assessed only by those with the training and authority to make a diagnosis), and time of resolution/stabilization of 503 the event. All AEs occurring while on study must be documented appropriately regardless of relationship. All AEs 504 will be followed to adequate resolution. 505 Any medical condition that is present at the time that the participant is screened will be considered as baseline and 506 not reported as an AE. However, if the study participant's condition deteriorates at any time during the study, it will 507 be recorded as an AE. UPs will be recorded in the data collection system throughout the study. 508 Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each 509 level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration of 510 each episode. 511 The PI will record all reportable events with start dates occurring any time after informed consent is obtained until 512 30 days (for non-serious AEs and SAEs) after the last day of study participation. At each study visit, the investigator 513 will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information 514 until resolution or stabilization. Breaches of confidentiality and emotional upset will be reported to the PI who will 515 then review the incident with the study staff, information technology groups, and follow-up with the participant. The 516 PI is responsible for making the reports to the DSBM, IRB and NHLBI. 517 518 519 This study will follow the HS-IRB reporting and submission timeframes: 520 https://kb.wisc.edu/images/group78/18324/ReportingTimeframesJanuary2013.pdf 521 522

Reporting procedures
Reporting time frames are in the Appendix. 523 524 This document will take priority for timeframes. The PI is responsible for reporting to the IRB, DSMB, and NIH. 525 526

527
Adverse events must be reported once the participant undergoes any study procedures and adverse events must 528 be reported during the entire active study period and for 30 days following the last administration of study treatment. 529 The IRB, DSMB and NHLBI will be notifications about AEs. 530 531

532
The study clinician will complete a SAE Form within the following timelines: 533 All deaths and immediately life-threatening events, whether related or unrelated, will be recorded on the SAE Form 534 and submitted to the DCC/study sponsor within 24 hours of site awareness. See Section 1, Key Roles for contact 535 information. Other SAEs, regardless of relationship, will be submitted to the DCC/study sponsor within 72 hours of 536 site awareness. 537 538 All SAEs will be followed until satisfactory resolution or until the site investigator deems the event to be chronic or 539 the adherence to be stable. Other supporting documentation of the event may be requested by the DCC/study 540 sponsor and should be provided as soon as possible. 541 542 Version #: 05-04-2022

543
The site investigator will be responsible for creating and completing a UP report form. Incidents that meet the OHRP 544 criteria for UPs will be reported promptly per the HS IRB timeline (see Appendix). 545 546 • All UPs should be reported to appropriate institutional officials as required by the HS-IRB, the NHLBI, DSMB, 547 and OHRP upon receipt of the report of the problem from the investigator per the HS IRB policy: 548 https://kb.wisc.edu/images/group78/18324/ReportingTimeframesJanuary2013.pdf 549 550 The UP report will include the following information: 551 • Protocol identifying information: protocol title and number, PI's name, and the IRB project number;

552
• A detailed description of the event, incident, experience, or outcome;

553
• An explanation of the basis for determining that the event, incident, experience, or outcome represents an 554 UP; 555 • A description of any changes to the protocol or other corrective actions that have been taken or are proposed 556 in response to the UP. 557 558

559
Subjects will also be immediately withdrawn from the study if they report being pregnant or planning to become 560 pregnancy. Study data acquired up to the withdrawal date will be analyzed. No additional routine pregnancy 561 reporting is indicated for this study. 562 563

564
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written 565 notification, documenting the reason for study suspension or termination, will be provided by the suspending or 566 terminating party to all site investigators, the NIH/NHLBI, DSMB, and IRB. If the study is prematurely terminated or 567 suspended, the PI will promptly inform the IRB and will provide the reason(s) for the termination or suspension. 568 Circumstances that may warrant termination or suspension include, but are not limited to: 569 • Determination of unexpected, significant, or unacceptable risk to participants 570 • Demonstration of efficacy that would warrant stopping 571 • Insufficient compliance to protocol requirements 572 • Data that are not sufficiently complete and/or evaluable 573 • Determination of futility 574 575 Study may resume once concerns about safety, protocol compliance, data quality are addressed and satisfy the 576 sponsor, IRB, and/or DSMB. All participant data that was collected prior to study termination will be analyzed and 577 continue to be handled/stored per this protocol. 578 Subsequent review of serious, unexpected, and related AEs by the DSMB and/or IRB may also result in suspension 579 of the study. 580 581

582
Independent safety oversight will be provided by The UW ICTR Data Monitoring Committee (DMC). It is an 583 independent team supported in its mission of safety and compliance by experienced ICTR staff to provide 584 administrative assistance, experienced members representing a diversity of backgrounds (clinicians, 585 biostatisticians, bioethicist), skills, and knowledge, and the use of the Research Electronic Data Capture (REDCap) 586 tool, which provides data management functionality by allowing the development of eCRFs and surveys to support 587 data capture. In providing oversight for the conduct of this study, the ICTR DMC will meet annually (every 12 588 Version #: 05-04-2022 months) during the 5-year study with opportunities to meet face-to-face or via phone and web depending on each 589 individual's availability. The number of individuals will be determined by the UW ICTR. Additional meetings may be 590 scheduled as determined by the DMC or as requested by the PI. The DMC members will review protocol-specific 591 reports created by statisticians that serve a non-voting member role on the DMC using data pulled from REDCap. 592 These standard reports will include an overview of study objectives, a review of actual and projected accrual rates, 593 an evaluation of patient demographics for balance of randomization, and a summary of the number and seriousness 594 of adverse events. An interim analysis of study results may be performed and source documents may be reviewed 595 to allow the DMC to independently judge whether the overall integrity and conduct of the protocol remain acceptable 596 based on data provided and reported by the Principal Investigator. The DMC will make recommendations to the 597 Principal Investigator that could include actions of continuation, modification, suspension, or termination. 598 Data will be summarized and provided directly to the DSMB through the REDCap clinical trial software used for data 599 collection during the study. The DSMB will keep minutes of its meetings, and the PIs and all study staff will receive 600 verbal and written summaries of their reviews and recommendations. 601 602 See the DSMB charter in the Appendix 603 604

605
Although unlikely in this study, unblinding will be done in emergent medical circumstances. All efforts will be made 606 to maintain blinding except in the case of urgent medical necessity. If a subject needs to be unblinded, the study 607 site must document who broke the blind and the reason, and report the event to a member of the trial's executive 608 leadership team (principal investigator, site investigator, and senior biostatistician) within 24 hours, who will instruct 609 the data coordinating center to unblind. 610 9 Study Monitoring, Auditing, and Inspecting Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are protected, that 614 the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with 615 the currently approved protocol/amendment(s) and with applicable regulatory requirement(s). 616 • The PI and site PI will conduct monitoring, including on-site and centralized (via REDCap), initially weekly for 617 the early/initial enrollment procedures, and then monthly. The monitoring will be comprehensive (100% data 618 verification) via REDCap with random review of health coach calls. Monitoring reports will be available for the 619 DSMB. 620 • Each clinical site will also perform internal quality management of study conduct, data collection, 621 documentation, and completion as directed by ICTR/WINHR. An individualized quality management plan will 622 be developed to describe a site's quality management. 623 624 See appendix for the auditing tool. 625 626

627
A protocol deviation is any noncompliance with the clinical trial protocol or MOP requirements. The noncompliance 628 may be either on the part of the participant, the investigator, or the study site staff. As a result of deviations, 629 corrective actions are to be developed by the site and implemented promptly. 630 These will be reported per the HS IRB requirements (see appendix -reporting timeline). All deviations must be 631 addressed in study source documents, reported to the NIH Program Official, DSMB, and IRB. Protocol deviations 632 will be sent to the local IRB per their guidelines. The PI, site PI, and study staff are responsible for knowing and 633 adhering to the IRB requirements. 634 Version #: 05-04-2022 635

636
The Data Safety and Monitoring Plan (DSMP) for this research comprises research conducted at all sites for this 637 proposal. All investigators and site principal investigators must agree to comply with the procedures outlined in this 638 DSMP. This DSMP does not reduce any investigator's obligation to comply with the requirements of the Institutional 639 Review Board (IRB). 640 All research activities conform to the NIH definition of a clinical trial. The UW ICTR Data Monitoring Committee 641 (DMC) is an independent team supported in its mission of safety and compliance by experienced ICTR staff to 642 provide administrative assistance, experienced members representing a diversity of backgrounds (clinicians, 643 biostatisticians, bioethicist), skills, and knowledge, and the use of the Research Electronic Data Capture (REDCap) 644 tool, which provides data management functionality by allowing the development of eCRFs and surveys to support 645 data capture. In providing oversight for the conduct of this study, the ICTR DMC will meet annually (every 12 646 months) during the 5-year study with opportunities to meet face-to-face or via phone and web depending on each 647 individual's availability. The number of individuals will be determined by the UW ICTR. Additional meetings may be 648 scheduled as determined by the DMC or as requested by the PI. The DMC members will review protocol-specific 649 reports created by statisticians that serve a non-voting member role on the DMC using data pulled from REDCap. 650 These standard reports will include an overview of study objectives, a review of actual and projected accrual rates, 651 an evaluation of patient demographics for balance of randomization, and a summary of the number and seriousness 652 of adverse events. An interim analysis of study results may be performed and source documents may be reviewed 653 to allow the DMC to independently judge whether the overall integrity and conduct of the protocol remain acceptable 654 based on data provided and reported by the Principal Investigator. The DMC will make recommendations to the 655 Principal Investigator that could include actions of continuation, modification, suspension, or termination. 656 Data will be summarized and provided directly to the DSMB through the REDCap clinical trial software used for data 657 collection during the study. The DSMB will keep minutes of its meetings, and the PIs and all study staff will receive 658 verbal and written summaries of their reviews and recommendations. 659 660 See the DSMB charter in the Appendix section of the protocol. 661 662

663
The investigator will permit study-related monitoring, audits, and inspections by the IRB (or their representatives), 664 and/or the NIH of all study related documents (e.g., source documents, regulatory documents, data collection 665 instruments, study data etc.). The investigator will ensure the capability for inspections of applicable study-related 666 facilities (e.g., pharmacy, diagnostic laboratory, etc.). 667 668

669
The study team will assess and track subject compliance through previously published methods. 191 This will include: 670 -Intervention arm: Assessing the frequency that patients answer and complete health coach calls 671 -Intervention arm: Reviewing home blood pressure monitor directly during follow-up research visits and 672 assessing the presence/absence of home reading availability during health coach calls 673 -Usual care and intervention arms: Frequency upon returning for study visits, completing phone surveys 674 675 After at least 3 call attempts, each 1-week apart, and 1 mailed letter attempt, if the participant does not return for the 676 6-month research study visit they will be withdrawn from the study and analyzed as intention to treat. 677

678
This study is to be conducted according to NIH and Institutional research policies and procedures.