Improving Hypertension Using a Smartphone-Enabled Personal Control Program: The Smart Hypertension Control Study
Phase: NA
Conditions: Hypertension
Sponsor: Northwestern University

PROTOCOL TITLE: Improving Hypertension Using a Smartphone-Enabled Personal Control 
Program: The SMART Hypertension Control Study 
 
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PROTOCOL TITLE: 
Improving Hypertension Using a Smartphone-Enabled Personal Control Program: The Smart 
Hypertension Control Study 
 
PRINCIPAL INVESTIGATOR: 
Stephen D. Persell, MD, MPH 
Associate Professor of Medicine, Division of General Internal Medicine & Geriatrics 
Director, Center for Primary Care Innovation 
Telephone Number: (312) 503-6464 
Email Address: spersell@nm.org 
 
CO-INVESTIGATORS: 
 
Kunal N. Karmali, MD, MS 
 
Instructor of Medicine, Division of Cardiology 
 
Kunal-Karmali@northwestern.edu 
 
 
 
Jody D. Ciolino, PhD 
Assistant Professor 
Biostatistics Collaboration Center 
Department of Preventive Medicine 
jody.ciolino@northwestern.edu 
 
 
 
VERSION DATE: 
 
25 January 2019 
 
 
 
 

PROTOCOL TITLE: Improving Hypertension Using a Smartphone-Enabled Personal Control 
Program: The SMART Hypertension Control Study 
 
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1.0  Purpose of the Study:  
Purpose 
Investigators at Northwestern University will partner with Omron Healthcare Co., Ltd. (hereinafter 
referred to as “Omron”) to conduct a randomized controlled trial of a hypertension personal control 
program (HPCP), known as Lark HTN Pro with a home blood pressure monitoring device (HBMD) 
compared to a HBMD alone. The overarching goal of this study is to investigate the effects of the 
HPCP on blood pressure control, blood pressure self-management, and healthy lifestyle behaviors 
among adults with hypertension. 
 
Specific Aims and Hypotheses 
Our primary aims and hypotheses (H) are to:  
 Aim 1: To determine the effects of the HPCP+HBMD compared with HBMD alone on blood 
pressure control in adults with hypertension.  
o H1: HPCP+HBMD will lower systolic blood pressure at 6 months compared with HBMD alone. 
o H2: HPCP+HBMD will improve hypertension control rates at 6 months compared with HBMD 
alone. 
o H3: HPCP+HBMD will lower diastolic blood pressure at 6 months compared with HBMD alone. 
 
 Aim 2: To determine the effects of the HPCP+HBMD compared with HBMD alone on 
antihypertensive medication use in adults with hypertension.  
o H4: HPCP+HBMD will increase number of antihypertensive medication classes used at 6 
months compared with HBMD alone. 
o H5: HPCP+HBMD will increase medication adherence at 6 months compared with HBMD 
alone. 
 
 Aim 3: To determine the effects of the HPCP+HBMD compared to HBMD alone on hypertension 
self-management among adults with hypertension.  
o H6: HPCP+HBMD will increase the proportion of months where a home blood pressure 
reading is obtained compared with HBMD alone in adults with hypertension  
o H7: HPCP+HBMD will increase the number of home blood pressure readings per month 
compared with HBMD alone in adults with hypertension. 
o H8: HPCP+HBMD will increase self-efficacy to monitor and control blood pressure at 6 months 
compared with HBMD alone.  
 
 Aim 4: To determine the effects of the HPCP+HBMD compared to HBMD alone on healthy 
lifestyle behaviors among adults with hypertension.  
o H9: HPCP+HBMD will lower weight at 6 months compared with HBMD alone.  
o H10: HPCP+HBMD will improve diet quality score compared with HBMD alone. 
o H11: HPCP+HBMD will increase physical activity compared with HBMD alone.  
o H12: HPCP+HBMD will increase sleep duration compared with HBMD alone.  
 
 
2.0  Background / Literature Review / Rationale for the study: 
Hypertension, defined by elevated blood pressure, is a major contributor to death and disability from 
heart and vascular diseases.1 Currently, an estimated 86 million adults or 1 in every adults in the US 
have hypertension, and rates are projected to increase.1 Clinical trials have consistently shown that 
antihypertensive medications can reduce important health outcomes like stroke by 30-40%, heart 
attacks by 20-25%, and heart failure by as much as 50%.2 Therefore, reduction of raised blood 
pressure with healthy lifestyle modifications (diet, exercise, weight loss, alcohol moderation) and 
antihypertensive medications are a cornerstone of cardiovascular disease prevention strategies.3-6 
 

PROTOCOL TITLE: Improving Hypertension Using a Smartphone-Enabled Personal Control 
Program: The SMART Hypertension Control Study 
 
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Despite the impressive efficacy of antihypertensive medications in clinical trials, hypertension 
treatment and control rates remain suboptimal in the United States. According to data from the 
National Health and Nutrition Examination Survey (NHANES) 2009-2010, high blood pressure control 
rates among all individuals was 47% and among treated hypertensives was 64%.7  
 
Strategies to promote self-monitoring of hypertension have been shown to reduce blood pressure and 
improve hypertension control rates.8-10 However, many self-monitoring interventions require significant 
resources for face-to-face counseling and patient activation, which can be costly over time.  
 
Mobile health technologies such as smartphone apps provide a unique opportunity to augment self-
monitoring interventions with health behavior coaching to promote behavior change for risk 
reduction.11-13 However, there is limited high quality evidence to guide the optimal implementation of 
this intervention.11 We seek to address this evidence gap with the proposed study. 
 
3.0  Inclusion and exclusion criteria: 
Screening for eligibility:  
We will use structured language queries of electronic health record data from the Northwestern 
Medicine Enterprise Data Warehouse (NMEDW) to identify potentially-eligible participants with 
elevated blood pressure and exclude patients with clinical exclusion criteria from Northwestern 
Medical Group outpatient practices. We will provide primary care clinicians with lists of potential 
candidates and allow them two weeks to indicate which patients should not be contacted. We will then 
attempt to recruit from this remaining population. Potentially-eligible participants will be contacted by 
telephone by the research team for initial screening. Volunteers who remain candidates for 
participation as a result of the phone screening questions will be asked to schedule an on-site visit. 
During the on-site visit individuals will be asked to provide written informed consent and have blood 
pressure measured in a standardized fashion (described in section #4) to see if this inclusion criteria 
is met. 
 
Inclusion and exclusion criteria:  
We will use these criteria to determine who will be included or excluded in the final study sample. 
 
Inclusion criteria: 
 
Adults aged 18 years to <85 years at the time of screening 
 
Standardized mean blood pressure measurement ≥135 to <180 mmHg systolic or ≥85 to <110 
mmHg diastolic 
 
Have and use an iOS device(s) (iPhone generation 5s or newer) 
 
Able to provide written informed consent prior to participation in the study 
 
Receive their primary care from a Northwestern Medicine clinic site  
Exclusion criteria: 
 
Current user of the HCPC (Lark HTN Pro) 
 
Standardized mean blood pressure measurement ≥180 mmHg systolic or ≥110 mmHg 
diastolic 
 
Persistent atrial fibrillation as indicated in the electronic health record (EHR) 
 
Pregnant or planning to become pregnant during the study period 
 
Severe kidney disease, defined as estimated glomerular filtration rate <30 per 1.73 m2 or 
currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis) 
 
Hearing impaired and unable to respond to phone calls 
 
Lack of fluency in English 
 
History of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, 
coronary artery bypass grafting) in the past 3 months 
 
Diagnosis of dementia as indicated in the electronic health record 
 
Diagnosis of psychosis  as indicated in the electronic health record 

PROTOCOL TITLE: Improving Hypertension Using a Smartphone-Enabled Personal Control 
Program: The SMART Hypertension Control Study 
 
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 
Terminal cancer diagnosis or NYHA III or IV heart failure 
 
Deemed unsuitable for study by primary care provider 
 
Individuals requiring BP monitor cuff size larger than 17 incles or 42cm 
 
We will not recruit, enroll, or study special populations: adults who are unable to consent, individuals 
who are not yet adults (minors), pregnant women, or prisoners or other detained individuals.  
 
4.0  Procedures Involved: 
1. Describe the setting of the study, including all locations where research procedures will be 
performed. 
 
This study will take place in Northwestern Medicine Group outpatient clinic settings. Northwestern 
Medical Group (NMG) is a multi-specialty group practice, with more than 1,200 physicians and other 
healthcare professionals, and is an integral component of Northwestern Medicine. NMG physicians 
work within Northwestern Memorial Hospital, Northwestern Lake Forest Hospital, Northwestern 
University Feinberg School of Medicine, and in more than 25 outpatient care locations spread across 
Chicago and the northern suburbs, offering primary, specialty and immediate care within and 
surrounding the communities where people live and work. Before contacting individual physicians 
within a practice, we will obtain permission from the clinical practice director to do so and will seek 
opportunities to introduce the study to the practice’s clinicians at practice meetings and through email.  
We will initially recruit from the Galter 18 General Internal Medicine practice and subsequently extend 
recruitment to additional NMG practices as needed to achieve recruitment goals. 
 
2. Describe the study design including the rationale. 
 
We will conduct a non-blinded randomized controlled trial among hypertensive adults in NMG 
outpatient clinics. We will randomize participants in a 1:1 fashion to the intervention group (HPCP + 
HBMD) or the comparator group (HBMD alone). We will recruit adults with elevated blood pressure as 
assessed by in-person standardized examination at baseline. We will measure change in blood 
pressure by in-person examination at 6 months. All in-person study procedures will be performed at 
NMG outpatient clinic sites or at Northwestern Univerisity locations. We will recruit between 350 to 
400 participants in order to have 300 participants with analyzable data at the time of study completion. 
If changes are deemed necessary, a revision to the study protocol will be submitted to the IRB for 
review and approval prior to implementing these changes. Based on higher than predicted retention at 
6 months, in discussion with our funder we will stop recruitment activities once 333 participants are 
enrolled. 
 
3. Provide a description of all research procedures and activities.  
 
Randomization 
We will perform randomization with the use of a centralized computer-generated assignment 
sequence uploaded a priori to Northwestern University’s REDCap (Research Electronic Data Capture) 
application. Randomization will be stratified by: age (<65 or ≥65 years of age) and baseline systolic 
blood pressure (<145 or ≥145 mmHg) to optimize the likelihood of obtaining similar populations in 
each treatment group. 
 
Study assignments 
Control group: Control group participants will be provided with a home blood pressure monitoring 
device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor)  and 
will be instructed in its use at the baseline study visit. Participants will also receive an information 
sheet describing home blood pressure monitoring that gives advice for how to respond to different 
home readings (see attached form). At the baseline visit, participants will be instructed to install an 
Omron application to their smart phone device (to monitor use of the HBMD). Participants will 

PROTOCOL TITLE: Improving Hypertension Using a Smartphone-Enabled Personal Control 
Program: The SMART Hypertension Control Study 
 
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continue to receive all routine care, including anti-hypertensive medications as prescribed by their 
regular clinicians.  
 
Intervention Group: The intervention group will receive all the interventions provided to the control 
group.Participants randomized into the intervention group will not be asked to download the Omron 
application to their smart phone device. In addition, intervention group participants will be sent a 
hyperlink to install the hypertension personal control program (HPCP) (“Lark HTN Pro”), which is a 
smartphone application. The intervention group will have the HPCP installed on their iOS device 
during their initial office visit (screening/baseline) and will successfully take a reading from their 
HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic 
reminders for the user to measure blood pressure, measure weight, and take their medication(s). The 
HPCP provides real-time feedback based on user input, such as out-of-range measurements and has 
additional features designed to encourage behavior change in areas such as dietary intake, physical 
activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through 
the app. 
 
Endpoints 
 
Primary:  
o Systolic blood pressure (mmHg) at 6 months (adjusted for baseline systolic blood 
pressure) 
 
Secondary:  
Blood Pressure 
o Diastolic blood pressure (mmHg) at 6 months (adjusted for baseline diastolic blood 
pressure) 
o Proportion with controlled blood pressure at 6 months (defined as BP <140/<90 mmHg) 
Medication use 
o Medication adherence, measured as 4-day recall of antihypertensive medications 
o Number of antihypertensive agents used at 6 months 
o Number of antihypertensive medication changes (increases or substitution) at 6 
months 
o Number of health system contacts (telephone, office, or mychart encounters) at 6 
months – derived from electronic health record (EHR) 
Self-management 
o Frequency of home blood pressure measurements per month – derived from HBMD 
device 
o Proportion of months where a home blood pressure reading is obtained – derived from 
HBMD device 
o Self-efficacy to monitor and control high blood pressure. 
Lifestyle behaviors 
o Weight at 6 months (lbs) 
o Diet quality score (as assessed by Dietary Approaches to Stop Hypertension 
questionnaire, DASH-Q)14  
o Self-reported physical activity 
o Self-reported sleep duration 
 
4. Include when they are performed, and any procedures being used to monitor participants 
for safety or minimize risks. 
 
Before initial visit 
All potential participants will go through a telephone screening. The following information will be 
obtained during the telephone screening:  
 
Age 

PROTOCOL TITLE: Improving Hypertension Using a Smartphone-Enabled Personal Control 
Program: The SMART Hypertension Control Study 
 
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 
Confirmation of hypertension diagnosis, use of antihypertensive medications, or being told by 
a healthcare professional of elevated blood pressure 
 
Smoking status 
 
Presence of any exclusion criteria 
If participants express study interest and qualify based on the telephone screening, they will attend a 
screening visit at a study clinic site.  
 
Screening/Baseline study visit 
Participants will be given  a hard copy  of both privacy  and use documents for both Omron 
and Lark mobile applications to be reviewed before they will receive informed consent.  
After providing informed written consent, the following information will be obtained during the 
screening/baseline study visit.  
 
Height and weight 
 
Measurement of blood pressure using standardized procedures.15 Research assistants will 
perform standardized measurements of blood pressures and pulse using an automated device 
(Omron HEM-907XL Pro Blood Pressure Monitor). Participants will be asked to be seated 
quietly with their feet and back supported for 5 minutes before blood pressure is obtained. 
Patient positioning, arm selection, cuff size selection and other techniques will follow the 
procedures for blood pressure measurement outlined in guidelines from the American Heart 
Association.15 Three recordings will be performed and the mean of the 2nd and 3rd readings will 
be used to indicate the blood pressure. For participants meeting eligibility, this mean blood 
pressure value will also serve as the baseline systolic and diastolic blood pressures. 
 
If participants meet eligibility criteria for the study, we will also obtain:  
 
Detailed review of chronic daily antihypertensive medication and other cardiovascular 
(including cholesterol lowering medications) the patient is taking at the start of the trial. 
Adherence to antihypertensive medications will be measured for each prescription medication 
using a 4-day assessment of pills taken/pills prescribed based upon patient self-report. 
Missing any doses will be considered non-adherent for that medication. 
 
Questionnaire data to measure:  
o General self-efficacy16 as well as self-efficacy to monitor and control high blood 
pressure 
o Diet quality as assessed by the DASH-Q14 
o Physical activity 
o Sleep duration 
 
After screening, all participants will be provided with an Omron Bluetooth-enabled HBMD (Omron BP 
761N) and taught how to use it for home blood pressure monitoring. Participants randomized to the 
HPCP group, will install the HPCP application to their iOS device. Study staff will instruct participants 
how to collect and transmit data from the HBMD to their phone and assist participants in their initial 
conversation with the HPCP coach, including an initial conversation about blood pressure reading 
from their HBMD. Participants in the HPCP group will be prompted to enter the Lark HTN Pro 
application frequently (as much as every day) via notification on their iOS device.  
 
Participants’ physicians will continue to manage blood pressure for both groups according to standard 
of care.  
 
6-month study visit 
Study participants will be required to return for a 6-month study visit (within 2 weeks before to 8 weeks 
after). During the 6-month visit, subjects will have their height/weight and blood pressure measured 
again. Participants will also repeat questionnaires related to their current cardiovascular medications. 
They will also complete questionnaires measuring: medication adherence, self-efficacy, diet, physical 

PROTOCOL TITLE: Improving Hypertension Using a Smartphone-Enabled Personal Control 
Program: The SMART Hypertension Control Study 
 
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activity, and sleep duration. An exit survey will also be provided to participants at the end of the 6-
month follow up visit to obtain feedback on Lark and Omron apps usability.  
 
EDW data extraction from Epic electronic health record 
Study participants will be asked to consent to the automated collection of data from their Northwestern 
Medicine electronic health record. We will collect EHR data using the Northwestern EDW to measure 
during the study period: the frequency of office visits, telephone and patient portal (email contacts), 
and antihypertensive medications prescribed, changed, or discontinued. 
 
Procedures to monitor participants for safety or minimize risks 
Individuals involved in any aspect of this study will be subject to minimal risk through their 
participation. This study collects personal health information and information that identifies study 
participants. While we work to keep this information confidential, there is a risk of loss of 
confidentiality. There is a risk that personal identifying information could be released. 
 
Participants will be informed in all cases about their rights as research participants. They may 
withdraw at any time during the study without penalty or loss of any healthcare benefit or service to 
which they are entitled. Participants will be assigned a unique identification number; the research 
database will be password protected and accessible only to the research team and the Institutional 
Review Board. Information linking participants’ names and contact information with their unique 
identifier will be kept in a separate password protected file on a password and firewall protected FSM 
network server as well as 3 encrypted study laptops.  The laptops are whole disk encrypted utilizing 
Symantec Endpoint Encryption. Whole Disk Encryption (WDE) provides protection for computers by 
preventing data loss with strong access control and powerful disk encryption. It is important that 
Northwestern University personnel storing sensitive information such as Protected Health Information 
(PHI), Personally Identifiable Information (PII) or research data, protect their machines and data with 
whole disk encryption software.  We believe that in using these methods we will be compliant with the 
“Standards for Privacy of Individual Identifiable Health Information” under the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.  Information obtained during the 
delivery of clinical care at the Northwestern Medicine clinic sites (such as documentation of clinical 
encounters with the nurse) may be recorded in patients’ medical records and will be subject to the 
confidentiality protections for medical records under HIPAA. 
 
5. Describe the study timelines including: the duration of an individual participant’s 
participation in the study and the overall anticipated duration of the project.  
The duration of an individual participant’s participation in this study is approximately 6 months. 
Overall, we anticipate that this project will last from May 1, 2017 to January 1, 2019.  
 
6. Describe the actual source records or measures that will be used to collect data about 
participants. (All surveys, interview scripts, and data collection forms will be attached 
elsewhere in the application. Do not add other documents to the protocol.)  Describe what data 
will be collected and how it will be collected at all measurement/data collection time-points. 
 
Source records used to collect data about participants 
We will administer a baseline survey at enrollment consisting of demographics, past medical 
information, medications and other questions as detailed in the survey instruments (attached).  
 
During the course of study, blood pressure and pulse will be measured by the HBMD and transmitted 
together with measurement time to the patient’s iPhone via Bluetooth Low Energy (BLE) 
communication. An iPhone application will then send the transmitted data to an Omron server.  Data 
collected from the Lark HTN Pro app will be stored on a Lark server. Lark will make available a 
research file with the participants’ unique identifier consisting of all data collected by the Lark app: 
physical activity times and duration, foods logged, sleep duration, and patient-entered messages (see 
attached list).   

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At the 6 month visit, we will assess medication lists and administer structured questionnaires 
to measure medication adherence, self-efficacy, diet score, and physical activity. For 
participants randomized to the intervention group, we will also administer survey questions to 
assess the usability of the HPCP application. 
 
7. If doing online research, include the URL where the data collection will occur. 
Not applicable. 
 
8. If your research is conducted outside of Northwestern University, please identify any site-
specific regulations or customs affecting your project, including any local scientific and 
ethical review structure. 
Not applicable. This research will not be conducted outside of Northwestern University 
 
9. Describe any approvals that will be obtained prior to commencing the research. (e.g., 
school, external site. funding agency.) 
Not applicable. This research will be commenced after obtaining IRB approval from Northwestern 
University.  
 
10. If the research involves individuals who are vulnerable or susceptible to coercion or undue 
influence1, describe additional safeguards included to protect their rights and welfare.  
Not applicable. This research will not involve individuals who are vulnerable or susceptible to coercion 
or undue influence.  
 
5.0 Multiple sites:  
Not applicable. This is not a multi-site study. 
 
6.0  Incomplete Disclosure or Deception: 
Not applicable. This study will not use incomplete disclosure or deception.  
 
7.0  Recruitment: 
1. Describe when, where, and how potential participants will be recruited. 
2. Describe the types of strategies and materials that will be used to recruit participants.  
Note:  Do not attach recruitment documents to the protocol but for additional guidance on 
the recruitment process and documents see: http://irb.northwestern.edu/process/new-
study/requirements/recruitment-materials-guidelines.  
Participant recruitment 
We will apply structured language query to data within the NMEDW to screen for participants who are 
likely to meet study eligibility criteria. In phase 1 of our recruitment, we will identify patients in the 
NMEDW whose most recent in-office blood pressures are ≥145 mmHg systolic or ≥ 95 mmHg 
diastolic. If we are not meeting recruitment targets, we will expand NMEDW screening criteria to 
identify patients with in-office blood pressure ≥ 140 mmHg systolic or ≥ 90 mmHg diastolic.  
 
Once potentially-eligible patients are identified, research assistants will send primary care physicians 
a secure message within the EHR notifying them of their patients who may be eligible for this study. 
                                                          
1 Coercion occurs when an overt or implicit threat of harm is intentionally presented to obtain compliance. Undue 
influence, by contrast, often occurs through an offer of an excessive or inappropriate reward or other overture in order to 
obtain compliance (http://www.hhs.gov/ohrp/policy/faq/informed-consent/what-does-coercion-or-undue-influence-
mean.html). For example, the threat of the loss of reputation, good standing in class or of a bad grade if a student does 
not participate in a study would be an example of coercion. The offer of excessive money or special treatment or rewards 
for participation could be an example of undue influence. 

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Program: The SMART Hypertension Control Study 
 
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Physicians will be asked to review the list and identify patients who they feel we should not contact. If 
a physician does not respond within 10 business days, we will recruit their eligible patients. Once 
physician approval has been received, eligible patients will be sent a recruitment opt-out letter that 
describes the study, instructs patients that they are eligible for this study, and informs them that a 
study staff member will be contacting them via email or telephone to discuss the study. The letter will 
include a phone number and e-mail address to call and leave a voicemail/message if they choose not 
to be contacted further about the study. We have attached the opt-out letter within eIRB+ application. 
Potential participants will not receive more than one letter per year about the trial. In order to avoid an 
individual receiving multiple letters, the list will be reviewed for duplicate names first by a computer 
analyst and re-examined by study staff. Individuals may request to not receive future recruitment 
letters. Five days later, a research assistant will begin telephone recruitment. We will contact patients 
by telephone to ask if they are interested in hearing more about the study. Up to 3 telephone contacts 
will be made within a one-week time frame. If a voicemail greeting is identified as the patient, a brief 
message will be left asking patient to return call. We will also give clinicians at participating practices 
study contact information so they may refer patients with uncontrolled hypertension directly to the 
study.  
 
During the telephone recruitment, patients interested in possibly participating in study will be asked a 
series of questions to screen for eligibility (attached in eIRB). Patients who screen positive for study 
participation will be asked to schedule a study visit. 
 
8.0  Consent Process (see also the Process of Obtaining Consent guidance on the web 
site. 
 
Consent location 
Consent will occur at NMG outpatient clinic or Northwestern University sites on the day of the 
screening/baseline study visit. 
 
Ongoing consent process 
Not applicable to this study. There will be no reconsenting over time.  
 
Details of consent process 
I. 
Role of investigators. The investigator is responsible for ensuring that the participant 
understands the potential risks and benefits of participating in the study, including answering 
any questions the participant may have throughout the study and sharing in a timely manner 
any new information that may be relevant to the participant’s willingness to continue his or her 
participation in the trial. 
The investigator is ultimately responsible for ensuring that informed consent is given by each 
participant before the study is started. This includes obtaining the appropriate signatures and 
dates on the informed consent form prior to the performance of any protocol procedures.   
II. 
Amount of time devoted to the consent discussion. We will devote approximately 5 
minutes to the consent discussion and use standardized language per an informed consent 
document to structure the consent discussion.  
III. 
Steps to minimize the possibility of coercion or undue influence. Trial recruitment will be 
performed by Northwestern study staff using structured recruitment scripts (attached). 
Research staff will receive training that includes didactic review of these materials and role 
play practice. Participants will also be informed that they withdraw from the study at any time. 
IV. 
Steps to ensure participants’ understanding. The informed consent process will be used to 
explain the potential risks and benefits of study participation to the participant in simple terms 
before he or she is entered into the study, and to document that satisfaction and 
understanding of the potential risks and benefits of participating in the study. The research 
assistant will make sure the participant understands what procedures and clinical data will be 
collected. 

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We will not include: 
 
Non-English speaking participants 
 
Participants who are not yet adults (infants, children teenagers) 
 
Cognitively impaired adults 
 
Adults unable to provide consent.  
 
9.0  Process to Document Consent:  
The research assistant will review the informed consent document with the participant and answer 
any questions. Participants will provide written informed consent. We have attached consent script 
within eIRB+ application. 
 
10.0  Risks to Participants: 
 
1. List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related the 
participants’ participation in the research. Describe the probability, magnitude, duration, and 
reversibility of the risks.  
2. Consider physical, psychological, social, legal, and economic risks as well as community or 
group harms. 
 
Participant risks in this study are minimal. Any potential risks that might exist fall into four categories: 
(a) risks associated with the Intervention. The main intervention risk is that patients may try to access 
the mobile phone or participate in assessments while driving. Risks associated with cell phone use 
and driving will be managed by informing the participants that they are not permitted to use the 
phones while driving; (b) risks associated with research assessments, consisting of questions about 
hypertension management; (c) risks associated with potential loss of confidentiality; and (d) risks of 
worsening mental or emotional state. 
 
Participants will be told that they are not permitted to use the phones while driving. If study staff 
become aware of mobile phone use while driving, they will do what is necessary to eliminate the risk 
(e.g. let the person know they should not use the phone while driving). Data for all participants will be 
kept strictly confidential except as mandated by law. All research files are kept on secure, password 
protected departmental and medical school servers. All data collected via the Lark HPCP and the 
Omron applications will be transmitted using a secure file transfer protocol (FTP) All electronic data 
will be stored on secure servers behind firewalls. Any paper documentation will be kept in locked file 
cabinets or a locked file room. All data presentation will be of aggregate-level data; participants are 
never individually named.  
 
Any risks associated with antihypertensive medications are beyond the scope of this study because 
we are examining hypertension self-management, not medications. Participants will be prescribed 
antihypertensive medications by their physician as part of their conventional medical care. 
Participants can add, change or discontinue their medications at any time as they would do if they 
were not in the study. Study staff will encourage regular contact with their physicians to facilitate 
optimal treatment decision-making. 
 
3. If applicable, describe risks to others who are not participants. 
There are no risks to others who are not participants. 
 
4. Withdrawal of Participants 
There are no specific criteria for removal of a patient from the study or termination of the trial. A 
patient will be removed if continued participation is determined to constitute a danger to the patient’s 
health or well-being by the PI based on input from the evaluators. Clinical evaluators are required to 

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Program: The SMART Hypertension Control Study 
 
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inform the PI and study coordinator if they suspect deterioration or adverse effects in the patient. The 
PI and study coordinators will perform all necessary evaluations. If the PI determines the patient must 
be removed from the study immediately, the patient will be removed and all appropriate referrals will 
be made. The IRB will be informed. 
 
Participants may discontinue their antihypertensive medication at any time and still continue in the 
study by completing assessments. Participants may withdraw from the study at any time. 
 
11.0  Potential Benefits to Participants:  
1. Describe the potential benefits that individual participants may experience from taking part 
in the research.  Describe also the probability, magnitude, and duration of the potential 
benefits. 
Participants may directly benefit from their participation. Use of the HPCP application (Lark HTN Pro) 
during the study may improve blood pressure level, hypertension control, adherence to 
antihypertensive medications, build better medication-taking behavior, and improve lifestyle behaviors 
(i.e. diet, physical activity, sleep duration, and weight maintenance), all of which are associated with 
improved health outcomes. The control group will receive a HBMD (commercially available without a 
prescription) that may assist them in the self-management of their hypertension.  
 
2. Indicate if there is no direct benefit to participants. Do not include benefits to society 
or others. 
Not applicable. 
 
 
12.0  Financial Compensation: 
1. Describe any financial compensation that will be provided to participants. Include how much 
money or what gifts will be provided and for what activities.  
Participants attending a screening visit who are not eligible or who choose not to participate will 
receive $10.  Participants who are enrolled in the study will be given $25 and a commercially-available 
HBMD manufactured by Omron.  Participants who complete the follow up visit will receive $50. 
 
2. Include whether compensation will be prorated if there are multiple research activities or if a 
participant withdraws from the study before finishing.  
See above 
 
3. Describe any costs that participants may be responsible for because of participation in the 
research. 
Participants will not be provided with iPhones or phone service. Participants who lose their iPhone or 
phone service during the course of the study will not be excluded. Participants will be compensated 
for public transit, taxi (up to $25) or be provided with a parking voucher for study visits. 
 
13.0  Provisions to Protect the Privacy Interests of Participants: 
1. Describe the steps that will be taken to protect participants’ privacy interests throughout the 
research activities. 
 
Participants will be assigned a unique identification number; the research database will be password 
protected and accessible only to the research team and the Institutional Review Board. Information 
linking patients with their unique identifier will be kept on a password and firewall protected FSM 
network server. Once the study is complete, the linking file containing identifiers will be permanently 
deleted. Northwestern will retain a completely de-identified data file for analysis. These methods are 
compliant with the “Standards for Privacy of Individual Identifiable Health Information” under the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. 

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Data collected from participants using the Lark app or the Omron app will be collected by these 
companies using the same approaches and securities they employ for regular consumers (see 
attached privacy documents, available at these websites: https://omronhealthcare.com/privacy/ AND 
http://lark.com/hipaa-privacy-policy/). Data collected by these apps will be stored at Lark or Omron, 
respectively, along with personal identifiers that are used by the participant to register for the app. 
However, when this data is used for research purposes or transmitted between research partners 
(namely between Northwestern, Omron, and/or Lark) these files will not contain personal identifiers 
other than an anonymous study code. Northwestern investigators will provide these codes to 
participants at the time of enrollment and have them enter these codes into the applications. 
Northwestern study staff will use these study codes to merge data collected from the Lark and Omron 
applications with data collected at Northwestern. Merged data will only be stored with the participant’s 
unique Subject ID (different from the study code used in the app) and not with any other personal 
identifiers. Omron and Lark agree to make no attempt to re-identify individuals from these research 
data sets. 
 
2. Indicate who on the research team and how the research team is permitted to access any 
sources of information about the participants. 
 
At Northwestern, only authorized research staff who are included on the IRB approved protocol will 
have access to participant data. Data collected by Northwestern will be shared with Omron the 
sponsor only with study ID identifiers.  
 
14.0  Confidentiality and Data Management: 
1. Describe how data (and if applicable, biological specimens) will be handled study-wide 
including: 
a. What information will be included as data (or associated with the specimens)? “Data” 
includes all information collected in the conduct of the research, such as but not limited 
to: consents, surveys, interview notes, audio or video recordings, photographs, notes of 
observations, field notes, etc. 
b. Where and how will data (or specimens) be stored?  How will data be transported from the 
point of collection to where they will be stored? Note: electronic storage of data in both 
domestic and international research must be secured using adequate protections.  
c. How long will the data or specimens be stored? (Note: IRB policy is 7 years after the 
completion of the study. However, there are circumstance when other time frames may 
apply.) 
d. Who will have access to the stored data or specimens? 
e. Who is responsible for receipt or transmission of the data or specimens? 
Data handling study-wide 
Information furnished to the investigator shall be maintained in confidence, and such information will 
be divulged to the institutional review board, ethics committee (IRB/EC) or similar committee; affiliated 
institution and employees, under appropriate understanding of confidentiality with such committee, 
affiliated institution and employees.  Data generated by this study will be considered confidential by 
the investigator, except to the extent that it is included in a publication as provided in the Publications 
section of this protocol. 
 
The Research data collected by Northwestern shall be anonymized and files sent back to our 
associates (Omron, and Lark) will not include identifying data other than. Specifically, anonymized 
data include only a unique Subject ID as identifier of an individual subject. Study staff and doctors will 
connect the identity of the individual patient with the Subject ID through maintenance of a Subject ID 
Log. The Subject ID Log and other documents containing identifying information are required to be 
kept in locked storage. 
 

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The associates (or associates representative), IRB/EC, or regulatory authority representatives may 
consult and/or copy trial documents in order to verify source document/case report form data.  In this 
way, these individuals will have access to a patient’s identifying information.  By signing the consent 
form, patients agree to this process.  If trial documents will be photocopied during the process of 
verifying source document/case report form information, the patient will be identified by the unique 
Subject ID only; full names will be masked prior to transmission to the associates. 
 
2. Describe the steps that will be taken secure the data (e.g., training, authorization of access, 
password protection, encryption, physical controls, certificates of confidentiality, and 
separation of identifiers and data) during storage, use, and transmission. 
 Training: All personnel involved in study will complete human subjects protections training and 
register within eIRB+, and be added to authorized personnel list. Dr. Karmali and or Dr. Persell will 
regularly evaluate the workflows and procedures of project coordinators and IT personnel 
interacting with participants and their data.  
 Authorization of access: All Northwestern staff on the study will be on the authorized personnel 
list. We will work with the ‘minimum necessary’ framework to grant access to secure study folders 
on secure division drives based on an individual’s need to see data. Analysts and investigators 
working on data analysis will have a restricted access folder. Project coordinators will only have 
access to what they need to do their job and will not interact with patient data unless as required 
by their role.  
 Password protection and Encryption: All study files with identified data will be kept password 
protected. This includes recruitment tracking files, survey files, and chart abstraction data. The 
laptops study staff use will be encrypted and will require log-in and password.  
 Separation of Identifiers: All subjects will be assigned a unique identification number (Subject ID). 
Information linking participants’ names and contact information with their unique identifier will be 
kept in a separate password protected file on FSM servers. Similarly, we will generate study codes 
to provide to participants that are distinct from the Subject ID that we will have participants enter 
into Omron and Lark apps. These codes will allow Omron and Lark to securely send us files that 
do not contain other personal identifiers. 
  These methods are compliant with the “Standards for Privacy of Individual Identifiable Health 
Information” under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
Privacy Rule. 
 Once study enrollment and data analysis are complete, the file linking patients with their unique 
identifier will be permanently deleted. 
 
3. Describe any procedures that will be used for quality control of collected data. If conducting 
online research, specify if you will be using any attention check measures. If yes, you need to 
indicate what you will be doing and what happens if a participant fails the attention checks. 
Quality control of collected data 
The HBMD provided by Omron  (Omron BP761N) is an FDA approved model. The integrity of 
collected blood pressure data is secured with automated data transfer from device to server. The 
study will be conducted and data will be generated, documented, and reported in compliance with the 
protocol, accepted standards of Good Clinical Practice, and all applicable local regulations. Dr. Persell 
and or Dr. Karmali will work with data programmer and other study staff members to ensure validity of 
collected data. 
 
4. Describe the data analysis plan, including any statistical procedures is applicable. 
Data analysis plan, including any statistical procedures 
We will perform analysis to address each primary and secondary aim using SAS v9.4 (SAS Institute, 
Carey, NC). We will use a 5% level to signify statistical significance and calculate 95% confidence 
intervals. All analyses will assume intention-to-treat principles.  
 

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The proposed study is a simple randomized controlled trial where the unit of randomization is the 
participant. Anticipating a follow-up rate of 85% at 6 months, we aim to recruit 350 participants in total 
who will be allocated in a 1:1 fashion to the HPCP+HBMD group or the HBMD alone group. This will 
provide at least 300 total participants who will contribute to the primary data analysis at follow-up. If 
time and resources permit, we may expand recruitment efforts to 400 participants in total in case 
follow-up rates are lower (i.e. 75%). 
  
Statistical analyses 
Before conducting formal analyses, we will perform descriptive statistics to compare the two treatment 
groups to ensure adequate balance of potential confounders. These characteristics include: socio-
demographic characteristics, comorbidities, baseline blood pressure values, and number of 
antihypertensive medications used.  
 
For the primary analysis plan, we will compare the differences in systolic blood pressure at 6 months 
of follow-up between the two treatment groups using a linear regression model, adjusting for baseline 
age (years), sex (male or female), and baseline systolic blood pressure (mmHg).  We will perform 
similar analyses for the secondary outcomes of continuous variables (diastolic blood pressure, weight, 
diet score, and physical activity), adjusting for age, sex, and baseline variable. We will assess model 
assumptions and explore residual diagnostics. As appropriate, transformations of variables and/or 
nonparametrics may be employed.  
 
For the binary outcome of blood pressure control (systolic blood pressure <140 mmHg and diastolic 
blood pressure <90 mmHg), we will use a logistic regression model adjusting for age, sex, and 
baseline systolic blood pressure level. For the secondary outcomes that are not measured at 
baseline, we will adjust only for age and sex in regression models. 
 
We will also compare the effects of treatment group in stratified analyses by weight (BMI >=25 and 
BMI <25) and SBP >=150 or <150.  
 
Power Calculation 
Without much prior knowledge regarding the overall variance in outcome that may be accounted for 
by the planned covariates, we can conservatively estimate power based on the independent two-
sample t-test. With the planned analytic sample size of 300 (150 per arm), we have 80% power to 
detect a small to moderate (0.3 standard deviations) effect size across the two arms at the 5% level of 
significance. Thus, if the observed standard deviation is 15mmHg, we have adequate power to detect 
a 5mmHg difference in mean six-month SBP across the two arms. Since we have pre-specified 
adjustment for baseline SBP, sex, and age, we anticipate increased precision in analysis of primary 
outcome, allowing for more than 80% power to detect the same effect size via our planned primary 
outcome analyses. If we estimate between 0% - 25% of the variation (R-squared) to be explained by 
the planned covariates, the analytic approach will allow for 80% power to detect a 5mmHg mean 
difference in six-month SBP across the two arms if the standard deviation is no larger than 17mmHg 
(i.e., a slightly smaller [0.29] effect size). 
 
 
15.0  Data Monitoring Plan to Ensure the Safety of Participants: 
 
1. Describe the plan to periodically evaluate the information collected regarding risks or harms 
to determine whether participants remain safe. For example, if you are collecting depression 
or suicidality data, what is your plan for monitoring severity? Note: the plan might include 
establishing a data monitoring committee and a plan for reporting their findings to the IRB and 
the sponsor. It also could include referral to an appropriate resource. Include the following: 
a. What information / data are reviewed, including safety data, untoward events, and efficacy 
data. 

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b. How the safety information will be collected (e.g., with case report forms, at study visits, 
by telephone calls with participants). 
c. The frequency of data collection, including when safety data collection starts. 
d. Who will review the data. 
e. The frequency or periodicity of review of cumulative data. 
f. The statistical tests for analyzing the safety data to determine whether harm is occurring. 
g. Describe any conditions where the research team may intervene and what the plan is for 
intervening. (For example, if a participant identifies harm to self or others.) 
h. Describe any conditions that might trigger an immediate suspension of the research. 
This is a minimal risk study because participants are only subject to an app that promotes the 
standard of care for individuals with hypertension and the use of a commercially available home blood 
pressure monitor (currently available without a prescription for self-monitoring of blood pressure).  We 
will convene a data and safety monitoring committee for this study consisting of 4 clinical researchers 
(of which one is a statistician) for data and safety monitoring. Meetings will be organized every 6 
months. At these meetings, the study protocol, procedures, and any issues of concern related to 
research integrity will be discussed. Email correspondence, or teleconference meetings may be 
arranged for issues that require immediate attention.  
 
We will set thresholds for blood pressure readings taken as part of the study visit that require a clinical 
response. All study participants will receive a notification of their average blood pressure taken on the 
study visit day.  Lower threshold: If the average systolic blood pressure is < 80 mmHg or the average 
diastolic blood pressure is <50 mmHg, study staff will alert the patient to speak with their clinician that 
day. Upper threshold: If the average systolic blood pressure is >180 mmHg or the average diastolic 
blood pressure is >110 mmHg, study staff will alert the patient to speak with their clinician that day.  
 
 
16.0  Data and if applicable, Specimen Banking:  
Not applicable for this study. 
 
17.0  Qualifications to Conduct Research and Resources Available: 
1. For international research or research with vulnerable populations, describe the 
qualifications (e.g., training, experience, oversight) of you and your staff as required to 
conduct the research. When applicable describe the knowledge of the local study sites, 
culture, and society. Provide enough information so the IRB knows that you have qualified 
staff for the proposed research. 
Note: If you specify a person by name, a change to that person will require prior approval by 
the IRB. If you specify people by role (e.g., coordinator, research assistant, co-investigator, or 
pharmacist), a change to that person will not require prior approval by the IRB, provided that 
person meets the qualifications described above to fulfill their roles. 
 
Not applicable. Not conducting international research or research with vulnerable populations.  
 
2. Describe other resources available to conduct the research: For example, as appropriate: 
a. 
Describe your facilities or other physical resources needed for the conduct of the 
research.  
This study will take place in General Internal Medicine (GIM) outpatient clinics - The GIM clinic of 
Northwestern Medical Group has 40 doctors who practice full or part time in the clinic. The clinic has 
39 exam rooms and approximately 250 to 300 patient visits per day. All physicians use an electronic 
medical record (Epic; Epic Systems Corporation; Verona, Wisconsin) for all clinical encounters (in-
person and telephone). The GIM clinic has three private rooms in the clinic dedicated for research. 
The Division also has a Clinical Research Center with 4 examination rooms in the same building as 

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the clinic.  Additional private rooms that may be used are located in the General Internal Medicine and 
Geriatrics academic offices on the 10th floor of 750 N Lake Shore Drive. 
 
b. Describe the availability of social, emotional or psychological resources that participants 
might need as a result of an anticipated consequences of the human research. 
Because this is a minimal risk study, we do not expect that participation will result in significant 
changes in the needs for social, emotional or psychological resources. Physician investigators (who 
are practicing physicians at Northwestern) will be available by phone or pager to help participants and 
research staff plan appropriate responses to unanticipated social or emotional problems that might 
occur and to help participants access appropriate care if needed. 
 
 
c. Describe your process to ensure that all persons assisting with the research are 
adequately informed about the protocol, the research procedures, and their duties and 
functions. 
Research staff will have adequate time devoted to this study in order to conduct recruitment activities 
and answer any questions that participants have about using the HPCP application. A project 
coordinator and data analyst are familiar with this protocol and have estimated the time needed to 
successfully meet objectives. Within the division of General Internal Medicine & Geriatrics, our study 
team work together frequently on studies similar to this protocol. We have adequate computer (both 
hardware and statistical software) resources and server storage capacity. The study team will meet 
quarterly to ensure all authorized personnel are informed about protocol. Drs. Persell and Karmali will 
be working closely with study staff to ensure the study protocol is followed and all duties are being 
appropriately carried out. 
 
 
 
 

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