Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure - Better BP Study
Phase: NA
Conditions: Blood Pressure
Sponsor: University of Alabama at Birmingham

Evaluating novel approaches for estimating awake and sleep 
blood pressure: The Better BP Study 
 
Study Protocol & Statistical Analysis Plan 
 
NCT04307004 
 
April 05, 2023 
 
Emily B. Levitan, Professor and Vice Chair, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 

Better BP Study: Manual of Operations 
 
 
 
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BETTER BP STUDY 
Table of Contents 
 
 
 
 
 
 
 
             Page  
 
Administrative Information ............................................................................................... 4 
Introduction ..................................................................................................................... 5 
Background and Rationale ....................................................................................... 5 
Objectives ................................................................................................................. 7 
Inclusion and Exclusion Criteria ................................................................................ 8 
Sites of Recruitment ................................................................................................. 8 
Target sample size ................................................................................................... 8 
Study Flow ...................................................................................................................... 9 
Recruitment Procedures ................................................................................................ 10 
Summary ....................................................................................................................... 14 
Overview of Better BP Study Visits ............................................................................... 16 
MOP items .................................................................................................................... 17 
REDCAP Mobile App .................................................................................................... 19 
Measurements .............................................................................................................. 34 
Neck Circumference Measurement ........................................................................ 34 
Arm Circumference Measurement (non-dominant arm) .......................................... 34 
Waist Circumference Measurement ........................................................................ 36 
Questionnaire administration ......................................................................................... 37 
Clinic BP Measurements ............................................................................................... 43 
Blood Pressure Safety Protocol .............................................................................. 45 
WatchBP Office AFIB Initializing Procedures ......................................................... 46 
ABPM Procedures ......................................................................................................... 54 
O3 Ambulatory Device Initializing Procedures ........................................................ 58 
HBPM Procedures......................................................................................................... 65 

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WatchBP Home N Initializing Procedures ............................................................... 68 
Fitting the Actiwatch ...................................................................................................... 73 
Configure/Initialize the Actiwatch ............................................................................ 74 
Instruction for Returning the ABPM/HBPM Device and Actiwatch ................................ 80 
ABPM, HBPM, and Actiwatch Data Download Procedures ........................................... 81 
Troubleshooting Devices ............................................................................................... 95 
Storing and Sending Results ......................................................................................... 96 
Device Storage and Cleaning Cuffs .............................................................................. 97 
Blood and Urine Specimen Collection ........................................................................... 98 
Blood samples summary ........................................................................................ 98 
Overview of specimen processing and aliquots ...................................................... 99 
Processing Procedures and Timing ...................................................................... 100 
Shipping Specimen to CALM Lab ......................................................................... 101 
Echocardiograms ........................................................................................................ 102 
Adult Transthoracic Echocardiogram Protocol ...................................................... 103 
Echocardiogram Checklist .................................................................................... 106 
Shipping Echocardiograms ................................................................................... 110 
Payment Structure (Reimbursing Participants) ........................................................... 111 
Parking and Transportation Reimbursement ............................................................... 113 
Better BP Supplement ................................................................................................. 114 
Questionnaire Administration ................................................................................ 115 
Examples of Questionnaire Administration ........................................................... 115 
Checking Statistics in REDCap ................................................................................... 117 
Calculating Better BP Results ..................................................................................... 120 
Appendices ................................................................................................................. 123 
HIPAA Authorization Form .................................................................................... 124 
Screening Form .................................................................................................... 127 
Draft Email ............................................................................................................ 132 
Consent Form (Study Participant) ......................................................................... 135 
Consent Form (Mock Participant) ......................................................................... 145 

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Better BP Study Visit 1 Checklist .......................................................................... 156 
Study Visit 1 Data Collection Form ....................................................................... 157 
Better BP Study Visit 2 Checklist .......................................................................... 161 
Study Visit 2 Data Collection Form ....................................................................... 162 
Better BP Study Visit 3 Checklist .......................................................................... 167 
Study Visit 3 Data Collection Form ....................................................................... 168 
Better BP Study Visit 4 Checklist .......................................................................... 172 
Study Visit 4 Data Collection Form ....................................................................... 173 
Sociodemographic and Medical History Questionnaire ........................................ 175 
Pittsburg Sleep Quality Index ............................................................................... 177 
Post-ambulatory Blood Pressure Monitoring Questionnaire ................................. 182 
Post-sleep Blood Pressure Monitoring Questionnaire .......................................... 185 
Comparability questionnaire ................................................................................. 187 
State Anxiety Questionnaire ................................................................................. 189 
Trait Anxiety Questionnaire .................................................................................. 190 
Expectations of Outcomes Questionnaire ............................................................. 191 
ABPM Device Log ................................................................................................. 192 
HBPM Device Log ................................................................................................ 193 
ABPM Reminder Card .......................................................................................... 194 
HBPM Reminder Card .......................................................................................... 195 
Physician Fax Numbers ........................................................................................ 196 
Ambulatory Blood Pressure Monitor - Participant Instructions .............................. 199 
Home Blood Pressure Device - Participant Instructions ....................................... 203 
Wrist Activity Monitor - Participant Instructions ..................................................... 206 
Results Packet ...................................................................................................... 208 
 
 
 

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Administrative Information 
 
Title: Evaluating novel approaches for estimating awake and sleep blood pressure (The Better 
BP Study) 
Primary Sponsor:  NIH/NHLBI 
Contact for Inquiries:  
Paul Muntner, PhD 
Professor of Epidemiology 
Associate Dean for Research  
School of Public Health 
University of Alabama at Birmingham 
(205) 975-8077 
pmuntner@uab.edu 
 
Protocol Version: IRB-300001727 
Roles and Responsibilities:  
Paul Muntner, PhD, pmuntner@uab.edu 
Principal Investigator 
 
Suzanne Oparil, MD,soparil@uabmc.edu 
Co-investigator  
 
Julia Medina, BS, juliamedina@uabmc.edu 
Clinical research coordinator 
 
Kellen Lenz, BS, kellenz1@uab.edu 
Clinical research coordinator 
 
Erin Contratto, MD, edoud@uabmc.edu 
Primary Care Liaison 
 
Deonna Rasberry-Elmore, MS, eternal2@uab.edu 
Program Manager  
 
 
 

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Introduction 
 
Background and Rationale  
 
Compared with other risk factors, elevated BP is associated with more CVD events and BP is 
associated with more CVD events and disability-adjusted life years lost in the US and 
worldwide. To identify patients with hypertension and monitor their BP while taking 
antihypertensive medication, most US guidelines and scientific statements recommend BP be 
measured in the clinic setting by a trained healthcare professional. This recommendation is 
supported by extensive data, demonstrating that elevated BP, measured using this approach, is 
associated with increased risk for CVD and renal disease events. In clinical practice and 
research studies conducted in the US, BP is almost universally measured in the clinic with an 
observer present (attended clinic BP). 
 
Several studies have found that compared with attended clinic BP, BP measured outside of the 
clinic is a better predictor of a person’s CVD risk. The US Preventive Services Task Force 
(USPSTF) and the UK National Institute for Health and Care Excellence recommend that 
elevated BP measured in the clinic be confirmed by out-of-clinic BP measurements prior to 
diagnosing hypertension. ABPM is the reference standard for out-of-clinic BP assessment and 
making the diagnosis of hypertension. ABPM monitors are compact, worn on a belt or in a 
pouch, and connected to a BP cuff on the upper arm by a tube. The monitors are programmed 
to obtain readings using the oscillometric method, every 15 to 30 minutes, typically for 24 hours, 
throughout the day and night. 
 
In some people, there is a transient BP increase that occurs in the clinic setting (i.e., white coat 
effect). For others, BP is lower in the clinic when compared to measurements obtained outside 
of the clinic environment (i.e., masked effect). White coat hypertension is defined as 
hypertension based on clinic-ma≥ 140 mm Hg the clinic setting (awake BP < 135/85 mm Hg). In 
most ABPM studies, white coat hypertension has not been associated with increased CVD risk. 
In contrast, masked hypertension, defined as not having hypertension based on BP measured 
in the clinic setting (< 140/90 mm Hg) but hypertension based on out-of-clinic measurements 
(awake BP ≥ 155 mm Hg) is associated with a markedly increased CVD risk. Among adults with 
SBP/DBP ≥ 140 mm Hg white coat hypertension. Additionally, between 15% and 30% of adults 
with SBP/DBP < 140/90 mm Hg, defined using attended BP measured in the clinic, have 
masked hypertension. 
 
There is a diurnal pattern of BP, which normally falls to its lowest level during sleep. Nocturnal 
hypertension, defined by having high mean sleep BP (SBP/DBP ≥ 120/70 mm Hg) with an 
increased risk for CVD events, independent of BP measured in the clinic and awake BP on 
ABPM. Assessing sleep BP may be particularly important for African Americans, a population 
with high CVD risk and approximately two times higher prevalence of nocturnal hypertension 
compared with whites. In the Jackson Heart Study (JHS), a cohort comprised exclusively of 
African Americans, 60% of participants had nocturnal hypertension and the multivariable-
adjusted hazard ratio for CVD events was 1.84 (95% CI: 1.00, 3.38) comparing participants with 
and without nocturnal hypertension. Also, a high percentage of African Americans with nocturnal 
hypertension do not have hypertension based on clinic BP or awake BP on ABPM. 
 

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Until recently, ABPM has been the only method that could assess sleep BP. The misdiagnosis 
of hypertension when BP is measured by an observer in the clinic versus by ABPM is well 
recognized by guidelines, scientific statements, and position papers. However, there are several 
challenges that have prevented the wide-spread use of ABPM in clinical practice. Recently, we 
conducted a nominal groups study, a qualitative research approach, with 40 physicians in 
Alabama and New York to identify barriers to performing ABPM. Reported barriers included 
need for staff training, time constraints in patient preparation, and lack of infrastructure and 
inaccessibility of equipment and specialists to whom providers could refer their patients for the 
ABPM procedure. Also, ABPM devices cost over $2,000 each, insurance companies do not 
commonly reimburse for indications other than white coat hypertension, and when reimbursed, 
the compensation is low. 
 
Low patient tolerability for ABPM has been reported in previous studies. For example, in one 
study, side effects associated with ABPM ranged from 7% for bruising to 70% for the device 
awakening the participant during sleep. Given the real world limitations of ABPM, novel 
approaches are needed for measuring awake and sleep BP. An emerging method that has been 
proposed for estimating awake BP is to measure BP in the clinic using a fully automated 
oscillometric device (AOBP) without an observer being present (unattended clinic BP 
measurement). There are currently two validated oscillometric devices available in the US 
(Omron HEM-907XL and Microlife’s Watch BP office) that can be programmed to measure BP 
automatically without an observer being present. Using these devices, the technician or 
healthcare provider leaves the room after a person has a BP cuff placed on their arm and they 
are positioned for measurements. After a minute rest, the device inflates the cuff and BP is 
measured. AOBP devices can obtain several BP measurements at preset (e.g., one minute) 
intervals. The maker of BPTru, a third device, went out of business in 2017. 
 
Canadian studies suggest that patients with hypertension have lower unattended BP compared 
with attended BP. Therefore, the use of unattended clinic BP may result in a lower prevalence of 
white coat hypertension. In a pooled analysis of 8558 adults, the mean clinic BP was 10/7 mm 
Hg lower with unattended AOBP versus BP recorded by a provider in clinical practice by 
auscultation and a mercury sphygmometer. In the only randomized study of AOBP published to 
date, the difference between BP when measured observed and unobserved was small (< 5 mm 
Hg). In 2017, the Hypertension Canada guideline recommended unattended BP (i.e., AOBP) as 
the preferred method of clinic BP measurement.10 However, this recommendation was based 
on a Grade D level of evidence (i.e. quality of evidence is very low, based on expert opinion, no 
direct research evidence, and studies had very severe limitations). US guidelines do not 
currently recommend AOBP for use in clinic practice. Recently, in a post-hoc analysis of 
SPRINT data, there was no difference in clinic BP between sites that measured it unattended 
versus attended (manuscript under review at Hypertension, personal communication, S. Oparil). 
At each visit, SPRINT participants did not have both unattended and attended BP 
measurements; there was no randomization; information about the conduct of unattended or 
attended BP measurements was obtained retrospectively after study end; and no comparison to 
ABPM was made. There is currently equipoise as to whether unattended clinic BP provides an 
accurate estimate of awake BP on ABPM. 
 
Two issues have been raised as barriers to implementing AOBP in clinical practice: the time it 
takes to perform this procedure and the need for dedicated space. Although AOBP takes longer 
than unstandardized clinic BP measurement (clinic BP taken without following guideline-
recommended approaches), AOBP takes a shorter amount of time than clinic BP 
measurements taken following American Heart Association (AHA) recommendations. Further, 

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unstandardized clinic BP measurements are very common in clinical practice, generate poor 
estimates of BP, and interventions targeted at observers to obtain standardized clinic BP have 
been largely unsuccessful. Having a dedicated room to perform unattended BP has been 
reported as a barrier to AOBP. However, if clinic space is not available, unattended AOBP can 
be successfully performed while a patient is in a waiting room. 
 
Recently, home BP monitors (HBPM) have been adapted to measure asleep BP. As described 
below, there are compelling preliminary data supporting this approach. Until recently, sleep BP 
could only be assessed by ABPM. HBPM devices have been developed that measure BP 
automatically during sleep. These devices have been previously validated for accuracy. Before 
going to sleep, a person attaches a BP cuff to their arm and turns on the HBPM device, which is 
programmed to take BP measurements while the person is asleep. In a prior study conducted in 
Japan, an HBPM device (Omron HEM-5001) was programmed to obtain BP measurements at 
2am, 3am and 4am. Given that only three readings are obtained during the sleep period and 
that a prior study demonstrated the feasibility for measuring sleep BP, there is great potential for 
using these HBPM devices for accurately measuring sleep BP with less burden than ABPM. 
Table 3 shows the major limitations of published studies using HBPM to assess sleep BP. In the 
current study, we will test whether HBPM is an accurate and better tolerated approach for 
measuring sleep BP than ABPM. 
 
 
Objectives  
 
Primary Aim 1: To examine whether measuring unattended clinic BP with an automated device 
will provide a more accurate estimate of awake BP on ABPM than measuring attended clinic BP 
with an automated device. Hypothesis 1a: The absolute difference with awake BP will be 
smaller for unattended vs. attended clinic BP. Hypothesis 1b: The agreement between 
hypertension status using BP measured in the clinic and on ABPM while awake will be higher 
when clinic BP is measured unattended vs. attended. Also, the prevalence of both white coat 
and masked hypertension will be lower when measuring unattended clinic BP. 
 
Primary Aim 2: To examine whether a new HBPM device provides an accurate approach for 
measuring sleep BP. Hypothesis 2a: Sleep BP on HBPM will provide an accurate estimate of 
sleep BP on ABPM. Hypothesis 2b: HBPM will be better tolerated (e.g., less awakening during 
sleep, pain, bruising) than ABPM. 
 
Primary Aim 3: To compare the associations of unattended versus attending clinic BP, 
unattended clinic BP versus awake BP on ABPM, and sleep BP on HBPM versus ABPM with 
two markers of end-organ damage, left ventricular mass index (LVMI) and urinary albumin-to-
creatinine ratio (ACR). Hypothesis 3a: The association with end-organ damage will be stronger 
for unattended vs. attended clinic BP. Hypothesis 3b: The association with end-organ damage 
will be similar for unattended clinic BP and awake BP. Hypothesis 3c: The association with end-
organ damage will be similar for sleep BP by HBPM and ABPM. 
 
 
 
 
 

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Inclusion and Exclusion Criteria  
 
Inclusion Criteria:  
• Age 19 years or older  
• Mean screening systolic blood pressure of 110 to less than 160 mm Hg or mean 
screening diastolic blood pressure of 70 to less than 100 mm Hg  
 
Exclusion Criteria:  
• Taking antihypertensive medications  
• Known to be pregnant  
• History of sleep apnea  
• History of cardiovascular disease, atrial fibrillation, and/or ventricular tachycardia  
• High risk for sleep apnea, scoring 5 or greater on the STOP-BANG questionnaire  
• Participants who work overnight shifts (11PM-7AM)  
• Inability to wear the ABPM and/or HBPM devices and BP cuffs  
• Completed ABPM in the past year 
• No permanent residence  
 
 
Sites of Recruitment: Columbia University Medical Center and University of Alabama at 
Birmingham 
 
 
Target sample size: 315 participants with complete data. 
 
 
 
 
 
 

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• Return device and complete satisfaction survey 
• Complete fasting blood draw and spot urine collection  
• Signed consent for future studies 
• Complete echocardiogram (or schedule within the next two weeks)       
Study Flow  
 
 
 
 
 
Telephone screening  
Randomization 1 
• Signed consent 
• Blood pressure screening  
• Height and weight measurements  
• Complete all questionnaires  
3 unattended BP measurements followed 
by 3 attended BP measurements  
Clinic Visit 1 
3 attended BP measurements followed by 
3 unattended BP measurements 
3 unattended BP measurements followed 
by 3 attended BP measurements 
Randomization 2 
Receive ambulatory blood pressure 
monitor 
Receive home blood pressure monitor 
Clinic Visit 2 
Clinic Visit 3 
Clinic Visit 4 
24 – 48 hours later  
24 – 48 hours later  
24 – 48 hours later  
3 attended BP measurements followed by 
3 unattended BP measurements  
Receive ambulatory blood pressure 
monitor 
Receive home blood pressure monitor 
• Return device (ABPM or HBPM). 
• Complete device satisfaction 

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Recruitment Procedures  
 
Potential participants will be recruited using flyers and contact cards placed around UAB 
campus and UAB primary care clinics. 
 
 
There are three methods in which the participant may be contacted/contact us. 
 
1. If the participant returns the contact card, contact the participant using their 
preferred method (e.g. - phone call or email).  
a. If the participant prefers to be contacted via phone, please call them 
during their preferred day and time as indicated on the contact card.  
b. If the participant prefers to be contacted via email, please refer to the draft 
email to schedule a screening visit to discuss the study and determine 
their eligibility (Appendix 1).  
 
2. If the potential participant calls in to ask about the study, invite them to a 
screening visit to determine their eligibility (Appendix 1). 
 
3. If the potential participant emails the study (bpstudy@uab.edu), use the draft 
email (Appendix 1) to schedule a screening visit to discuss the study and 
determine their eligibility. 
 
 
Once you have confirmed the potential participant is eligible for the study, confirm that 
the participant will be able to attend all four study visits over a short period of time 
(within 1-2 weeks). Schedule their first study visit and provide them with a participant 
packet which will include the following:  
1. Consent Form – Ask them to read through this carefully but do not 
sign prior to their first visit. 
2. W9 Form – Inform them that they will need to fill this out for 
compensation  
3. Parking decal for the UAB Hypertension Research Clinic  
4. Directions and a parking map for the UAB Hypertension Research 
Clinic 
 
Remind the participants of the following before their first study visit: 
1. Please wear a loose fitting shirt or button down shirt with an undershirt so that we 
can properly place your blood pressure cuff on their bare skin. 
 

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2. Refrain from smoking, exercise, eating food, or drinking any caffeinated 
beverage (including soda and tea) 30 minutes prior to your first clinic visit. 
 
 
 
 

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Participant Scheduling  
 
Following telephone screening, participants who are preliminarily eligible for inclusion in 
the study should be scheduled within the next 2 weeks for their screening visit with the 
study coordinator at the UAB Hypertension Clinic. 
 
To access the schedule and schedule a participant, please do the following:  
1. Log-in to REDCap using your log-in credentials. 
2. In the left-hand column, please select ‘Calendar’.  
3. Select the ‘Month’ tab at the top of the calendar.  
4. Click on ‘+New’ on a day that has less than 4 participants scheduled.  
5. Confirm with the participant that they are available on that day.  
6. Ask the participant a time they would like to come in for their screening visit and 
enter the time in the ‘Time:’ box. 
7. In the ‘Notes’ section, please enter the participant’s first and last name. 
8. Using the drop-down menu next to ‘Record ID’, please select the participant’s 
record id number. 
9. After you have entered all information, please click ‘Add Calendar Event’. 
 
After scheduling the participant, please email or call the study coordinator to inform her 
of the new participant added to the schedule. 
 

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If the participant needs to re-schedule, please make the necessary change to the 
REDCap calendar by clicking on their calendar event and entering their new date and 
time. Please make sure you save both the new date and new time. Inform the study 
coordinator of the change to the calendar. 
 
 
 

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Summary 
 
During the screening process, participants will complete an initial telephone screening to 
determine their preliminary eligibility. If eligible, they will be asked to complete a blood pressure 
screening in the clinic to determine if they are eligible to continue in the study.  
 
There is a consent addendum that was prepared for the Better BP study.  Participants will be 
consented immediately prior to initiation of this study.  
 
Below are the steps to follow for participants who are eligible and consent for the Better BP 
study. 
 
1. Participants will be randomized to have their clinic blood pressure measured unattended 
or attended first using a Microlife WatchBP Office AFIB device.  Blood pressure will be 
measured three times in the non-dominant arm following a standard protocol. They will 
then have their blood pressure measured three times again using the opposite method 
(i.e. if attended first, then unattended second). 
 
2. The following questionnaires will be administered to participants: 
a. Sociodemographic/Medical History 
b. Pittsburgh Sleep Quality Index (PSQI) 
 
Whenever possible, these questionnaires will be self-administered.  Research 
coordinators can administer these questions orally for participants who would otherwise 
have difficulty completing questionnaires on their own. 
3. Measure height, weight, and waist and neck circumference. Neck circumference is 
needed for the STOP-BANG sleep apnea scale. 
4. Participants will then return to the clinic for the next visit in 24 to 48 hours and have their 
clinic blood pressure measured three times unattended and attended in the reverse 
order of visit 1 using the Microlife WatchBP Office AFIB device. 
5. Participants will be randomized to receive either the ABPM or HBPM device at visit 2.  
6. They will be fitted for the device (WatchBP O3 ABPM or WatchBP Home N) that they 
were randomized to receive first. 
7. The staff member will explain how the participant should act when a BP measurement is 
taken. 
8. One measurement will be taken – check to make sure the cuff inflates and deflates and 
that a valid reading is obtained.  Watch to make sure that the participant positions their 
arm as instructed.  If an error reading is obtained, check that the cuff is properly placed 
and neither too tight nor too loose, and retake the BP measurement.  If three 
consecutive error readings are obtained, try a different device. 
9. Participants will be given instructions for placing (Home N) or replacing (O3 ABPM) the 
device if it has to be removed. 
10. Participants will be given a phone number to call if they have any questions during the 
monitoring period.  
11. Participants will be given the appropriate (ABPM or HBPM) device log to fill out.  This 
form captures the time a participant goes to sleep and awakens. Additionally, this form 
can be used to document any time when a participant removes the device and puts it 
back on. 

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12. The Actiwatch device will be fitted. 
13. The next day, participants will return the device and device log, complete either the post-
ABPM or post-HBPM questionnaire based on what device was worn, and be fitted for 
the opposite device (either O3 ABPM or Home N).  
14. At the last visit, participants will return the device and device log and complete either the 
post-ABPM or post-HBPM questionnaire based on what device was worn. 
15. Participant will complete the comparability questionnaire. 
16. Participants will complete a non-fasting blood draw and spot urine.  
17. Participants will complete an echocardiogram. If the echo lab does not have availability 
for that day, schedule their echocardiogram within the next two weeks. 
 
Participants will return to the clinic the next day to return their ABPM/HBPM devices and 
actigraphy (Actiwatch) devices and the participant device log.  
  
 
Upon returning the devices, the technician will: 
1. Review the device log with the participant, verifying times the participant went to sleep, 
woke up, and took device(s) off. If the participant does not return the device log (or it is 
blank), be sure to fill it out at the return visit. 
2. Download the data from the ABPM, HBPM, and actigraphy devices.  
3. Confirm that at least 35 of planned ABPM readings are valid or all three HBPM readings 
are valid.  If this is not the case, the participant will be offered the opportunity to 
complete a second ABPM or HBPM (along with actigraphy and filling out the participant 
device log).  
 
For participants who have a complete ABPM (or for those who have the device picked up at 
their house), the participant device log will be checked for completeness, scanned and saved 
electronically.  Next, we will administer the post-ABPM study visit form. 
 
Upon completion of the physical exam and echocardiogram, we will then process their 
reimbursement. The participants will receive reimbursement through the mail. 
 
When clinic staff will handle the return of the ABPM/HBPM:   
For participants for whom the device is picked up at their house or who mail in the device, the 
forms/device will be delivered to the clinic staff. The staff member will check to confirm that at 
least 35 valid ABPM readings or 3 valid HBPM readings were obtained and that the post-ABPM 
questionnaire has been completed. If ≥ 35 valid ABPM readings are obtained, they will be 
processed as described in the manual of procedures.  
 
 
 
 

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Overview of Better BP Study Visits 
 
The Better BP study involves five visits. Ideally, all five visits will occur within 24-48 hours of 
each other.  For some participants the next visit will not occur within this timeframe; however, 
the next visit should be scheduled as soon as possible.   
 
The screening visit will take approximately 10 minutes to conduct including signing of the 
consent form and blood pressure screening. If eligible, the participant will continue on with their 
first study visit. 
 
The first study visit will take approximately 45 minutes to conduct including the initial five-minute 
rest prior to obtaining clinic blood.  This visit includes confirming eligibility, obtaining three clinic 
blood pressure measurements both attended and unattended (randomized order), and 
completing two questionnaires (Sociodemographic/Medical History and Pittsburgh Sleep Quality 
Index). The visits for this study will be conducted in a separate room or, at minimum, in an area 
properly screened from all other activity and participants in the UAB Hypertension Research 
Clinic.   
 
The second study visit will include an additional three clinic blood pressure measurements, both 
attended and unattended, in the reverse order of visit 1 and fitting the participant for the ABPM  
or HBPM device (randomized) and Actiwatch.  
 
The third study visit will include the participant returning their device (ABPM or HBPM) and 
device log, confirmation that an adequate number of blood pressure readings were obtained, 
and completion of a post-ABPM or post-HBPM questionnaire (based on the device worn 
previously). The participant will then be fitted for the opposite device (either ABPM or HBPM) 
and receive a device log. 
 
The fourth study visit will include the participant returning their device (ABPM or HBPM) and 
device log, confirmation that an adequate number of blood pressure readings were obtained, 
and completion of a post-ABPM or post-HBPM questionnaire (based on the device worn 
previously). They will also complete the comparability questionnaire. The participant will have a 
brief physical exam which includes a non-fasting blood draw and spot urine collection. Finally, 
the participant will complete an echocardiogram. Upon completion of the echocardiogram, 
participants will receive reimbursement through the mail.  
 
 
 

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MOP items 
 
Initial visit 
Information from this visit will be recorded on the Better BP study Visit 1 Data Collection Form. 
1. Consent participant and measure screening blood pressure to confirm participant 
eligibility. 
2. Measure height, weight, and waist and neck circumference. 
3. Take non-dominant arm circumference measurement.   
4. Identify randomization assignment for unattended and attended clinic BP 
measurement. 
5. Clinic BP measurements (unattended and attended, in randomized order). 
6. Questionnaire administration: 
a. Sociodemographic/Medical History 
b. Pittsburg Sleep Quality Index (PSQI) 
 
Visit 2  
Information from this visit will be recorded on the Better BP study Visit 2 Data Collection Form. 
1. Clinic BP measurements (reverse order of study visit 1).  
2. Identify randomization assignment for ABPM and HBPM. 
3. ABPM or HBPM fitting and guidance (based on randomization).  
4. Actiwatch fitting and guidance. 
 
Visit 3 
Information from this visit will be recorded on the Better BP study Visit 3 Data Collection Form. 
1. Download ABPM or HBPM and Actiwatch data and check completeness. 
2. Review device log with participant for completeness and accuracy. 
3. Complete post-ABPM or post-HBPM questionnaire (based on device worn). 
4. ABPM or HBPM fitting and guidance (opposite device of visit 2).  
 
Visit 4  
Information from this visit will be recorded on the Better BP study Visit 4 Data Collection Form. 
1. Download ABPM or HBPM and Actiwatch data and check completeness. 
2. Review device log with participant for completeness and accuracy. 
3. Complete post-ABPM or post-HBPM questionnaire (based on device worn). 
4. Complete comparability questionnaire.  
5. Brief physical exam (non-fasting blood draw and spot urine collection). 
6. Echocardiogram 
7. Processing of reimbursement  

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Preparation for Visit 1 (Day of Appointment – before the participant arrives to the UAB 
Hypertension Research Clinic) 
• 
Just prior to the scheduled appointment, the research coordinator (RC) should do the 
following:  
• 
Confirm the participant is eligible: 
o  Is their screening SBP between 110-159 mm Hg or DBP between 70-99 mm Hg 
and SBP < 160 mm Hg and DBP < 100 mm Hg? 
o Not currently taking antihypertensive medication? 
o No history of myocardial infarction, stroke, or arrhythmias? 
o Not currently pregnant? 
o Do they have an arm available for placement of a BP cuff? 
o Arm circumference <=52 cm?   
o Can rest their arm every 30 minutes for 24 hours to allow for a BP 
measurement?  
o Has not had an ABPM in the past year? 
o Does not work at night (or is completing ABPM on a non-work day with a one day 
wait following working the night shift)?   
o Is willing to return to the clinic after both the ABPM and HBPM periods to return 
the devices?  
o STOP-BANG score less than 4? 
o Do you have a permanent residence? 
 
• 
Enable REDCap Mobile with the questionnaires (Sociodemographic/Medical History and 
PSQI). 
• 
Initialize the WatchBP Office AFIB device. 
• 
Have the WatchBP Office AFIB device set up for the correct measurement intervals [5-
minute initial rest period and 1-minute interval between readings]. 
 
 
For participants who consent for the Better BP study at the beginning of study visit 1, 
please ask the participant if he/she needs to use the restroom prior to their 
height/weight/waist/neck measurements. 
 
Use the Study Visit 1 Data Collection Form to record information from the first study 
visit.  
 
 
 

Better BP Study: Manual of Operations 
 
 
 
19
COVID-19 Screening Procedures 
 
Prior to the participant entering the building or exam room for each in-person study visit, the 
research coordinator should complete the following:  
1. Symptom Tracker (remotely within 24 hours prior to the in-person visit AND when they 
arrive at their in-person visit) 
 
2. Temperature Check (when they arrive at the in-person visit) 
 
If the participant screens positive (i.e. any of the symptoms on the symptom tracker or have 
a fever > 100.4o), please refer them for testing at their primary care physician. If they do not 
have a primary care physician, please use the link below to register them for COVID-19 testing 
at an approved UAB site. 
 
UAB COVID-19 Testing Registration E-form:  
https://irap-apps.ad.uab.edu/covidtestrequest/ 
 
If the primary care physician oversees COVID-19 testing for the research participant, written 
documentation of a negative test result will need to be provided by the participant or 
physician to the research study team within 4 days of testing in order to proceed with research 
activities. 
 
Upon completion of the e-form, a nurse from the COVID testing team will contact the research 
study team to register the research participant for COVID-19 testing. The COVID testing team 
nurse will also provide detailed instructions on the UAB testing location in addition to what to 
expect when they confirm the COVID-19 testing appointment. The results of the test will be 
communicated by the testing team nurse to the research subject and the research team within 
24-48 hours. 
 
COVID-19 testing will be billed to the participant’s health insurance (without a deductible 
applied) OR will be covered through alternative means (such as through the CARES act funding 
or otherwise). The participant will not be billed directly. 
 

Better BP Study: Manual of Operations 
 
 
 
20
If a participant screens positive during their study visits (i.e. after the completion of 
study visit 1), they have up to 3 days to complete their next study visit. 
 If they are unable to complete their next study visit within 3 days, they will be 
allowed to restart the study from Study Visit 1 and receive full compensation again for their 
completion of the study.  
NOTE: If they restart the study, please create a new study ID number for them (i.e. 11XX-
1) in the REDCap database. Do not delete any data from the REDCap database.  
 
 

Better BP Study: Manual of Operations 
 
 
 
21
Blood Pressure Screening Procedures 
 
Two BP measurements will be performed using the non-dominant arm, attended (i.e. – 
technician in the room for the resting and measurement period) following the protocol 
listed below.  
 
1. Screening BP measurements 
a. Explain to the participant the following: 
i. You will have them turn off their phone and place the phone out of 
their view but not out of the room 
ii. Have them sit in a firm chair with a flat back 
iii. Have them place their feet flat on the floor 
iv. They should not speak until both blood pressure readings are 
obtained 
v. After 5 minutes of rest, you will start the blood pressure 
measurement device 
vi. They will have their blood pressure measured two times at a one 
minute interval 
vii. They should relax but not move and there should be no talking until 
the two blood pressure measurements are taken 
a. Connect the BP device to the cuff 
b. Position patient for their BP measurement 
c. Start the device after a 5 minute rest period and stay in the room doing 
other activities without talking to the participant 
 
 
 
 

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22
Following the measurements, please use the average of both measurements to 
determine the participant’s eligibility for the study.  
 
ELIGIBLE: Systolic BP ≥ 110 mm Hg or Diastolic BP ≥ 70 mm Hg 
AND  
Systolic BP < 160 mm Hg and Diastolic BP < 100 mm Hg 
_____________________________________________________________________ 
INELIGIBLE: Systolic BP < 110 mm Hg and Diastolic BP < 70 mm Hg 
OR 
Systolic BP ≥ 160 mm Hg or Diastolic BP ≥ 100 mm Hg 
 
 
 
If the participant is ineligible based on their average blood pressure readings, please 
inform them that they will be allowed to re-screen in 1 month if they would like to.  
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
23
REDCAP Mobile App 
 
1. Open the REDCap Mobile App on the Ipad.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
24
2. Select your username and enter your pin number (e.g. – last six digits of UAB 
phone number). 
 
 
3. Select ‘My Projects’. 
 
 
 
 
 
 
 
 

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25
4. Select ‘Better BP Study’.
5. Select ‘Collect Data’.
8
5

Better BP Study: Manual of Operations
26
6a
6b
6. Select either of the following: 
a. Participant record id number 
b. If you do not see the participant’s record id number, then select ‘Create 
New Record’ and enter the participant’s record id number.

Better BP Study: Manual of Operations 
 
 
 
27
7. Select the study visit and begin entering data on the forms.  
 
 
 
8. Once you have collected all the data, select ‘Send Data to Server’  ‘Begin Send of 
All Data’  ‘Sync Modified Records’. NOTE: If the participant already has data in 
the server, select ‘Upload Anyway’.  
9. When the sync is complete, select ‘Options’ and ‘Return to Project’ to return to the 
Home Screen.  

Better BP Study: Manual of Operations 
 
 
 
28
 
 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
29
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
30
E-Consent Process 
 
If the participant indicates that they would like to complete their paperwork via electronically, 
please schedule them for a Zoom conference call to go over the consent form virtually.  
You may send them the PDF version of the consent form to review prior to their Zoom call.  
Do not send the REDCap consent form until you are on the Zoom conference call with 
the participant, as you must observe them completing the form. 
Prior to sending the REDCap consent form, please sign the portion labeled ‘Signature of 
Person Obtaining Consent’. You will not be able to go back and sign the consent form after 
the participant completes the form. 
The process for sending the REDCap consent form to the participant is below. 
 
1. Go to the participant’s REDCap chart.  
 
2. Select ‘Consent Form’.  
 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
31
3. Go to the bottom of the consent form and select ‘Sign’ in the field labeled ‘Signature 
of Person Obtaining Consent’. 
 
 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
32
4. Once you sign, please return to the top of the consent form and select ‘Survey 
Options’. 
 
5. Select ‘Compose Survey Invitation’. 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
33
 
6. Enter the participant’s email address that they provide during the Zoom call. 
 
7. In the subject box, enter ‘Better BP Consent Form’.  
 
 
 
8. Do not edit anything in the message box. Press ‘Send Invitation’. 
 
9. Confirm with the participant that they have received the consent form, go through it 
with them, and instruct them where to sign. 
 
 

Better BP Study: Manual of Operations 
 
 
 
34
Measurements 
 
Neck Circumference Measurement 
Participants will be asked to stand with their head held erect and eyes facing forward. They will 
be asked to breathe normally. If the participant has long hair, please ask them to pull it up and 
away from their neck.  
 
 
 
A flexible tape measure (AdvoCare) will be used to measure neck circumference at the level of 
the cricothyroid membrane (thyroid cartilage or Adam’s apple). 
 
Neck circumference should be recorded to the nearest 0.1 centimeter. 
 
 
Arm Circumference Measurement (non-dominant arm) 
  
The participant should remove his/her upper garment, or clear the upper arm area so that an 
unencumbered measurement may be made.  The technician should: 
• Have the participant stand, with the non-dominant arm hanging and bending the 
elbow so that the forearm is horizontal (parallel) to the floor. 
• Measure their arm length from the acromion (bony protuberance at the shoulder) 
to the olecranon (tip of the elbow), using the AdvoCare anthropometric tape. 
• Mark the midpoint on the dorsal surface of the arm. 
• Have the participant relax their arm alongside of the body. 
• Draw the tape snugly around the arm at the midpoint mark.  Note: Tape should 
be horizontal and should not indent the skin. 
• Noting the arm circumference indicated by the tape to the nearest tenth of a 
centimeter, use the criteria above for determining cuff size.  Note:  If > 52 cm, 
the participant will be excluded from the study. 

Better BP Study: Manual of Operations 
 
 
 
35
 
 
 
1. Select the appropriate cuff for WatchBP Office AFIB device (see Table below). 
2. Fit participant with the following sized cuff: 
 
 
Cuff Size 
WatchBP Office AFIB 
Small adult 
17-21.9 cm 
Medium adult 
22-32 cm 
Large adult 
32.1-42 cm 
Extra-large 
42.1-52 cm 
 
3. The research coordinator will select the appropriate cuff size, based on arm 
circumference (see Table above).  
 
 
 

Better BP Study: Manual of Operations 
 
 
 
36
Waist Circumference Measurement  
 
• 
Have the participant stand erect with the abdomen relaxed, arms at the sides and 
feet together.   
• 
Draw the tape snugly around the midpoint between the lower rib margin and the 
iliac crest (or 2 inches below the belly button).  Note:  Tape should be horizontal 
and should not indent the skin. Note: Tape should be horizontal and should 
not indent the skin. 
 

Better BP Study: Manual of Operations 
 
 
 
37
Questionnaire administration 
 
Whenever possible, these questionnaires will be self-administered. Participants have 
the option to complete these surveys in-person or electronically. Research coordinators 
can administer these questions orally for participants who would otherwise have 
difficulty completing questionnaires on their own. 
 
a. Sociodemographic/Medical History 
b. PSQI 
c. Post-ABPM questionnaire (following ABPM period) 
d. Post-HBPM questionnaire (following HBPM period) 
e. Comparability questionnaire (following both ABPM and HBPM 
period) 
 
 

Better BP Study: Manual of Operations 
 
 
 
38
Electronic questionnaire set-up  
 
1. Before you get started, go to the ‘Project Set-Up’ tab and make sure ‘Use surveys 
in this project?’ is enabled. 
 
 
 
2. Go to the ‘Designer’ tab and click ‘Enable’ for all of the forms that you would like 
to be able to send participants as a survey. A green checkmark will appear once it 
is enabled. 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
39
 
3. To change the survey settings (i.e. appearance, wording, and other 
functionalities), please select ‘Survey settings’.  
 
 
 
4. To apply your changes to all surveys, select ‘Copy design to other surveys’. 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
40
Electronic questionnaire administration  
 
1. Go to the participant’s record and select the survey form you would like to 
send. 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
41
2. Select ‘Survey Options’ then ‘Compose Survey Invitation’. 
 
 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
42
3. Enter the participant’s email address provided on the screening form. 
 
4. In the subject box, enter ‘Better BP’ + title of the survey. 
 
5. Do not edit anything in the message box. Press ‘Send Invitation’.  
*Note – if you need to test the email, press ‘Send test email’.  
 
 

Better BP Study: Manual of Operations 
 
 
 
43
Clinic BP Measurements  
 
Three BP measurements will be performed in the non-dominant arm, both attended (i.e. 
– technician in the room for the resting and measurement period) and unattended (i.e. – 
technician starts the device and leaves the room during the measurement period), 
based on the participant’s randomization order following the protocol listed below.  
2. Unattended BP measurements  
a. Explain to participant the steps involved in obtaining unattended BP 
measurements: 
i. You will have them turn off their phone and place the phone out of 
their view but not out of the room 
ii. Have them sit in a firm chair with a flat back 
iii. Have them place their feet flat on the floor 
iv. They should not speak until all three blood pressure readings are 
obtained 
v. You will start the blood pressure measurement device 
vi. You will leave the room for 10 minutes 
vii. After 5 minutes, they will have their blood pressure measured 
viii. They will have their blood pressure measured two more times at 
one minute intervals 
ix. They should relax but not move or talk until you return to the room 
b. Connect the BP device to the cuff 
c. Position patient for their BP measurement 
d. Start the device for a 5 minute waiting period 
e. Leave the room for 10 minutes 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
44
3.  Attended BP measurements 
d. Explain to participant the steps involved in obtaining unattended BP 
measurements: 
i. You will have them turn off their phone and place the phone out of 
their view but not out of the room 
ii. Have them sit in a firm chair with a flat back 
iii. Have them place their feet flat on the floor 
iv. They should not speak until all three blood pressure readings are 
obtained 
v. You will start the blood pressure measurement device 
vi. After 5 minutes, they will have their blood pressure measured 
vii. They will have their blood pressure measured two more times at 
one minute intervals 
viii. They should relax but not move and there should be no talking until 
the three blood pressure measurements are taken 
e. Connect the BP device to the cuff 
f. Position patient for their BP measurement 
g. Start the device for a 5 minute waiting period and stay in the room doing 
other activities without talking to the participant 
 
If the participant asks about his/her clinic blood pressure, the technician should tell the 
participant that the readings will be given to him/her in a report approximately 7 days 
following their final study visit if they have provided consent to receive their results.  
 
A standard automated blood pressure measurement monitor (Microlife WatchBP Office 
AFIB) and a specific protocol for the measurement of blood pressure will be utilized. 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
45
Blood Pressure Safety Protocol 
 
 

Better BP Study: Manual of Operations 
 
 
 
46
WatchBP Office AFIB Initializing Procedures 
 
1. Plug the adapter in the wall and plug into the back of the device. 
2. On the top of the clinic device is the on/off switch. Turn the clinic device on by switching the 
on/off button.  
 
 
 

B ett er B P St u d y: M a n u al of O p er ati o n s
4 7
3
3.
Pr e s s t h e cir c ul ar o n/ off b utt o n o n t h e l o w er ri g ht of t h e d e vi c e t o p o w er u p t h e d e vi c e.
4.
M a k e s ur e t h e sli d er o n t h e fr o nt of t h e d e vi c e b et w e e n t h e ‘ M’ a n d o n/ off b utt o n i s all t h e 
w a y t o t h e l eft o n ‘ R o uti n e’.
5.
Pr e s s a n d h ol d t h e o n/ off b utt o n f or 3 s e c o n d s u ntil t h e d e vi c e li g ht s u p bl u e, ‘ S e c’ a p p e ar s,
a n d a fl a s hi n g n u m b er a p p e ar s. T hi s will all o w y o u t o s et t h e i nt er v al b et w e e n r e a di n g s a n d 
t h e r e st p eri o d.
6.
N e xt, t h e r e sti n g p eri o d ti m e will b e gi n t o fl a s h. Pr e s s t h e ‘ M’ b utt o n u ntil t h e ‘ 3 0 0’ a p p e ar s 
o n t h e d e vi c e. T hi s will s et t h e r e sti n g p eri o d t o 5 -mi n ut e s. Pr e s s t h e o n/ off b utt o n t o 
c o nfir m t h e r e sti n g p eri o d.
7.
Pr e s s t h e ‘ M’ b utt o n u ntil t h e ‘ 6 0’ a p p e ar s o n t h e d e vi c e. T hi s will s et t h e i nt er v al b et w e e n 
m e a s ur e m e nt s t o 1 -mi n ut e. Pr e s s t h e o n/ off b utt o n t o c o nfir m t hi s i nt er v al ( s e e 3 i n t h e 
Fi g ur e b el o w) .
5
6

B ett er B P St u d y: M a n u al of O p er ati o n s   
 
 
 
4 8  
7  a n d 8 
8 
 
 
8.  T o s wit c h t h e ar m t h at i s b ei n g m e a s ur e d ( L eft or Ri g ht; w hi c h e v er i s t h e p arti ci p a nt’ s n o n -
d o mi n a nt ar m), pr e s s a n d h ol d t h e M  b utt o n f or 3 s e c o n d s.  
9.  T o hi d e t h e bl o o d pr e s s ur e r e a di n g s, pr e s s a n d h ol d t h e M  b utt o n f or 7 s e c o n d s.  
1 0.  C o n n e ct t h e cli ni c  d e vi c e t o t h e c o m p ut er u si n g t h e U S B t o mi cr o - U S B c o m p ut er c a bl e . 
1 1.  L a u n c h W at c h B P A n al y z er Offi c e  s oft w ar e.  

B ett er B P St u d y: M a n u al of O p er ati o n s   
 
 
 
4 9  
 
 
1 2.  S el e ct ‘ W at c h B P Offi c e A FI B’ ( s e e b el o w) . 
 
 

Better BP Study: Manual of Operations 
 
 
 
50
13. Create a new patient entry by selecting ‘New’.  
 

Better BP Study: Manual of Operations
51
14. Enter the participant’s information in window. The Participant ID number will be entered 
three times in the following text fields: ID number, Last Name and First Name. Do not enter 
participant name and Date of Birth and Gender. 
Enter ‘NA’ for Physician ID, Name, and Surname.
a.
Participant ID number (required – enter participant ID)
b.
Last name (required – enter participant ID)
c.
First name (required – enter participant ID)
d.
Date of Birth (Leave as pre-filled value 1/1/1900)
e.
Gender (Leave as ‘Male’)
14a
14b
14c

Better BP Study: Manual of Operations
52
15.Select ‘Save’ once you enter their information.
16. Select the participant id number you created (see screen grab below). 
17. Select ‘Routine’ measurements.
18. Select the arm (Left/Right) the participant will have their clinic blood pressure measured. 
This should be their non-dominant arm unless there is some reason it is not possible to 
use their non-dominant arm. This should be notated on the Study Visit 1 Form.
19. Under ‘Select the number of measurement(s):’ select ‘3 measurements: take 3 consecutive 
measurements’. 
20. Select ‘Hide Record (Device display in both Screen and Routine mode)’. This ensures that 
participant will not be able to see their blood pressure readings.
17
16
18
19
20
21 and 22

Better BP Study: Manual of Operations 
 
 
 
53
 
21. If taking attended clinic blood pressure, press ‘Measure’ and remain in the room, but do not 
talk or interact with the participant. Make sure the 5-minute rest period has begun by looking 
at the countdown on the device. 
22. If taking unattended clinic blood pressure, press ‘Measure’ and look at the device to make 
sure the 5-minute has begun by looking at the countdown on the device. Once countdown 
has started, remind the participant to rest, not talk or move until three blood pressure 
measurements are taken, then exit the room and return in 10-minutes. 
 
 

Better BP Study: Manual of Operations 
 
 
 
54
ABPM Procedures  
 
Use the Better BP Study Visit 2 and Study Visit 3 Data Collection Forms to record information 
from the second and third study visit.  
 
Testing the ABPM Device and Fitting Participant with Equipment 
1. 
The appropriate cuff size should be ready (see arm circumference measurement on Study 
Visit Form 1 to verify correct size).  Place the cuff on the participant’s non-dominant arm.  If the 
non-dominant arm cannot be used, use the participant’s dominant arm (this will require 
using a bladder positioned for the other arm). The cuff must be placed against the skin (not over 
any clothing). Locate the brachial artery by palpation and mark the skin with a small dot, using a 
black pen. (The brachial artery is usually found just medial and superior to the cubital fossa, 
posterior to the biceps muscle and slightly toward the body.) For brachial artery palpation, 
fingertips or thumb may be used. Refer to the Participant Instructions.  
2. 
The research coordinator will explain to the participant that the cuff will feel tight during the 
first measurement. The participant will be instructed that the ABPM will inflate the cuff to a 
pressure between 170 and 180 mmHg, but this will only occur on the first reading.  Each 
subsequent reading will go only 20 mmHg higher than the previous systolic reading. The 
research coordinator will instruct the participant that a tone will go off during the daytime to alert 
them that a reading is about to occur.   
3. 
During recordings, the participant is instructed to: (1) remain as still as possible, (2) keep 
his/her arm relaxed at his/her side or at heart level as if in a sling or resting on a table or 
armrest, and (3) refrain from talking The research coordinator should demonstrate the 
appropriate arm positioning to the study participant. 
4. 
Next, a blood pressure reading should be taken using the ABPM device to confirm it is 
working properly. The research coordinator will press the On/Off button and place the device in 

Better BP Study: Manual of Operations 
 
 
 
55
‘Ambulatory’ mode. The purpose of taking an initial reading is to make sure the cuff inflates and 
deflates as expected. Once one successful reading is acquired, proceed to the next step. If the 
cuff does not inflate and then deflate, then check that batteries are properly inserted and if so, 
initialize a new ABPM device for use.  Also, if three readings are attempted and all result in 
errors, then a new ABPM device will be initialized for use.  If either of the above occurs, the 
research coordinator will email Paul Muntner (pmuntner@uab.edu) to inform them of a non-
functioning device.  
5. 
Final fitting of the ABPM device:  the non-latex red tubing should go around the back of the 
participant’s neck and come down the dominant side of his/her body. Usually, it is placed 
underneath the participant’s clothing, coming out at the waist or between two button holes of the 
shirt. The pouch with the ABPM device can be 1) placed in a jacket pocket, 2) hooked onto a 
belt (using the loop on the back of the pouch), or 3) worn with a shoulder strap connected by 2 
black plastic tabs to the inside edges of the pouch. 
6. 
The research coordinator will explain how the ABPM device works to the participant, noting 
that every 30 minutes the ABPM device will automatically make a BP measurement.   
7. 
The research coordinator will show the participant the phone number for the research team. 
This is located inside the Participant Instructions that will be provided to them.  Therefore, the 
participant can call with any questions or concerns about any of the equipment.  Also, the 
research coordinator will show the participant the number to call for the research coordinator 
during regular business hours.  For after hours’ calls, participants will be provided with a cell 
phone number for one of the study staff members familiar with the study.   
8. 
The participant will be informed that if an ABPM measurement fails, usually because of 
motion (including driving), talking, or because the arm is not relaxed, the device will attempt 
another measurement 2 minutes later.  If this repeat attempt fails, no further attempts will be 
made until the next scheduled reading 30 minutes later.   

Better BP Study: Manual of Operations 
 
 
 
56
9. 
The participant will then be told that in the very unlikely event the cuff does not deflate after 
a reading, the On/Off circular button on the ABPM device should be pressed (shown in picture 
above).  The cuff should automatically deflate. If the cuff still does not deflate, the participant 
should turn off the device.  To do so, they will hold the On/Off circular button for three seconds. 
Once the cuff has deflated, the participant can push the On/Off circular button to turn the device 
back on.  Then, they can resume wearing the device as before (i.e., they can place the device 
back in the pouch) and their blood pressure should be measured every 30 minutes. 
10. At this time, the research coordinator should tell the participant that the ABPM device will 
continue to obtain recordings during sleep. The participant is told that the device is programmed 
so that during the daytime, the ABPM device will emit a tone immediately before each BP 
measurement to signal that the cuff is about to be inflated; however, during the participant’s 
usual sleep hours, this tone is turned off.   
11. The research coordinator will then ask the participant to avoid getting the ABPM 
device wet, but mention that there is no personal danger to the participant if the ABPM 
device does get wet.  The research coordinator will ask the participant to keep the 
equipment dry at all times. We prefer that participants not shower, swim, or go to the 
gym during the 24 hours they are wearing the ABPM device.  However, if this is 
absolutely not possible, then the equipment should be removed before showering, 
swimming or engaging in vigorous activity.  Each time the participant removes 
equipment he/she should log the time the equipment was removed as well as the time it 
was put back on (see ABPM Device Log; Appendix 2). 
12. The research coordinator will show the participant how to remove and put back on the 
ABPM device.  
13. To remove ABPM device, the research coordinator instructs the participant to pull the 

Better BP Study: Manual of Operations 
 
 
 
57
Velcro flap away from his/her body and slide the cuff down off his/her arm.  
14. The participant is told to gently pull the white tubing over his/her head and away from 
his/her body.   
15. To put the ABPM device back on, the participant is instructed to place the cuff on his/her 
non-dominant arm, lead the white tubing behind his/her neck and let it rest by his/her opposite 
side.  The arrow on the bottom of the cuff should be pointing down and situated over the 
brachial artery, about 1 inch above the bend in the elbow.  If the participant does not know 
where the brachial artery is located, the research coordinator will offer to mark it with a pen (if 
this has not already been done) so that the participant can be assured the cuff is situated 
properly. 
16. The researcher will ask the participant to demonstrate to them how to properly remove and 
replace the device before moving forward. 
17. Next, the research coordinator will show the participant how to remove and replace the 
Actiwatch device (see Participant Instructions).  
 
 
 
 
 
 
 
 
 

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58
O3 Ambulatory Device Initializing Procedures 
 
1. On the front of the ABPM device (lower right) is the on/off (circular) button. Turn the ABPM 
device on by pressing the on/off button.  
 
 
 
2. Connect the ABPM device to the computer using the USB to micro-USB computer cable. 
3. Launch WatchBP Analyzer O3 software.  
4. To ensure that the data from a previous participant has been cleared, select ‘Clear Memory’. 

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5.
Select ‘Ambulatory settings’ to set the participant id number, day period, night period, 
intervals between readings, highest inflation pressure, alert noise, and hiding BP data.
a.
Participant id number – corresponds to record id number in REDCap
b.
Day period – participant reported awake time to sleep time
c.
Night period – participant reported sleep time to awake time
d.
Intervals – 30 minutes during day period and night period 
e.
Highest inflation pressure – enabled at 180 mmHg
f.
Select ‘Hide BP data’
g.
Silent Mode – Make sure that this is checked for each participant
6.
Once everything is entered, select ‘Program’.
4
5

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60
5a
5b
5c
5e
5d
5f
5f
5g
6

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61
Buffer: 
We will buffer both the sleep and awakening times by at least 30 minutes so that the tone will 
not awaken participants.  Remember the sleep/awake time settings on the O3 ABPM device can 
only be set to the hour.  Take the participant’s anticipated wake-up time, add 30 minutes, and 
round up to the next hour; take the participant’s anticipated sleep time, subtract 30 minutes, and 
round down to the next hour. Here are three examples of how sleep and awake times will be set 
during the initialization process: 
- 
A participant who reports going to bed at 11pm and waking up at 6am will 
have their sleep time set to 10pm to 7am.   
- 
A participant who reports going to bed at 11:30pm and waking up at 6:30am 
will have their sleep time set to 11pm to 7am.   
- 
A participant who reports going to bed at 11:15pm and waking up at 6:15am 
will have their sleep time set to 10pm to 7am.   
 
 
 
 
 
 
 
 

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7.
A program warning will pop-up (screen grab below), select ‘Yes’.
8.
A message will appear that programming was successful, press ‘Okay’.
7

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63
9 
9. Disconnect the device from the computer and make sure the slider on the right side of the 
device is on ‘Ambulatory’ mode. 
10. Once you see ‘Ambulatory’ appear on the screen and a countdown at the bottom right of the 
device appears, the ABPM device is ready to be used by the participant. 
  
 
 
 

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HBPM Procedures  
 
Use the Better BP Study Visit 2 and Study Visit 3 Data Collection Forms to record information 
from the second and third study visit.  
 
Testing the HBPM Device and Fitting Participant with Equipment 
1. 
The appropriate cuff size should be ready (see arm circumference measurement on Study 
Visit Form 1 to verify correct size).   
2. 
Demonstrate to the participant how to place the cuff on their non-dominant arm.  If the 
non-dominant arm cannot be used, use the participant’s dominant arm (this will require 
using a bladder positioned for the other arm). The cuff must be placed against the skin (not over 
any clothing). Locate the brachial artery by palpation and mark the skin with a small dot, using a 
black pen. (The brachial artery is usually found just medial and superior to the cubital fossa, 
posterior to the biceps muscle and slightly toward the body.) For brachial artery palpation, 
fingertips or thumb may be used. 
3. 
The research coordinator will explain to the participant that the cuff will feel tight during the 
first measurement. The participant will be instructed that the HBPM will inflate the cuff to a 
pressure between 170 and 180 mmHg, but this will only occur on the first reading.  Each 
subsequent reading will go only 20 mmHg higher than the previous systolic reading.  
4. 
The research coordinator will inform the participant that to begin their recordings they 
should press and hold the On/Off button for 3 seconds to begin the initial reading. 
5. 
Next, a reading should be taken to confirm the device is working properly. The research 
coordinator will press the On/Off button and place the device in ‘Casual’ mode. The first reading 
will be based on the device’s internal algorithm. The purpose is to make sure the cuff inflates 
and deflates as expected. Once one successful reading is acquired, proceed to the next step. If 
the cuff does not inflate and then deflate, then check that batteries are properly inserted and if 

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so, initialize a new HBPM device for use.  Also, if three readings are attempted and all result in 
errors, then a new HBPM device will be initialized for use.  If either of the above occurs, the 
research coordinator will email Paul Muntner (pmuntner@uab.edu) to inform him of a non-
functional device.  
6. 
The research coordinator will explain how the HBPM device works to the participant. Note 
that the HBPM device will automatically take a blood pressure reading at 2, 3, and 4 hours after 
the initial reading.   
7. 
At this time, the research coordinator tells the participant that the HBPM device will 
continue to obtain recordings during sleep.  
8. 
The research coordinator will show the participant the phone number for the research team 
is located inside the Participant Instructions that will be provided to them.  Therefore, the 
participant can call with any questions or concerns about any of the equipment.  Also, the 
research coordinator will show the participant the number to call for the research coordinator 
during regular business hours.  For after hours’ calls, participants will be provided with a cell 
phone number for one of the study staff members familiar with the study.   
9. 
The research coordinator will ask the participant to keep the equipment dry at all times. The 
participant should log the time they went to bed and the time they wake up in the morning. If the 
participant removes equipment during the night, he/she should log the time the equipment was 
removed as well as the time it was put back on (see HBPM Device Log; Appendix 2). 
10. The research coordinator will show the participant how to put the HBPM device on, the 
participant is instructed to place the cuff on his/her non-dominant arm, lead the white tubing 
behind his/her neck and let it rest by his/her opposite side.  The arrow on the bottom of the cuff 
should be pointing down and situated over the brachial artery, about 1 inch above the bend in 
the elbow.  If the participant does not know where the brachial artery is located, the research 
coordinator will offer to mark it with a pen (if this has not already been done) so that the 

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participant can be assured the cuff is situated properly. The research coordinator will inform the 
participant that they should place the device on their nightstand by the bed or under their pillow. 
11. The researcher will ask the participant to demonstrate to them how to properly place the 
device before moving forward. 
12. Next, the research coordinator will show the participant how to remove and replace the 
Actiwatch device.  
 
 

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WatchBP Home N Initializing Procedures 
 
1. Connect the clinic device to the computer using the USB to micro-USB computer cable. 
 
 
 

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2. Launch WatchBP Analyzer Home N software.  
 
 
 
 
 
 

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3. Select the “Set Patient ID” button on the main screen. 
 

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4.
Enter the participant record id number.
5.
Select ‘Program’.
6.
A message will appear that says ‘Send ID successful’, press ‘Okay’.
7.
Disconnect the device from the computer.
8.
Make sure the device is in ‘Nocturnal’ mode by sliding the slider on the right side of the 
device to ‘Nocturnal’.
4
5

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Fitting the Actiwatch 
 
1. 
Next, the research coordinator will explain to the participant how the Actiwatch works. 
The participant will be told the Actiwatch should be worn on the wrist of the non-
dominant arm, the same arm as the BP cuff, and that it will provide a measure of his/her 
overall sleep.  
2. 
The research coordinator will place the Actiwatch on the wrist of the participant’s non-
dominant arm, and then ask the participant to avoid getting the Actiwatch wet. We 
would prefer that the light sensor on the device be on the outside of the wrist. 
3. 
After reviewing this information, the research coordinator will ask the participant if they 
have any questions regarding the Actiwatch.  
4. 
Next, the research coordinator will review the Participant Instructions (see Appendix 3) 
with the participant and remind him/her that if anything should happen with the equipment in the 
next 24 hours, he/she should contact the research team immediately using one of the phone 
numbers provided.   
5. 
The research coordinator will thank the participant and confirm how the participant will bring 
back the ABPM/HBPM and Actiwatch devices along with the Device Log (Appendix 2) (see 
procedures for returning the equipment and Device Log below). Be sure to instruct the 
participant where he/she should record their sleep and wake times on the Device Log 
(Appendix 1), and any times the equipment was removed.  
6. 
Finally, the participant should be given the Participant Instructions (see Appendix 3). 
The participant should be informed of how to contact the research coordinators if he/she has a 
question/concern. The location of this information in the Participant Instructions should be 
shown to the participants.  
 

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Configure/Initialize the Actiwatch
1.
Make sure before using an Actiwatch device that it is fully charged. When the watch is 
on the charger, a solid green light indicates the watch is fully charged.  A blinking light 
indicates that the watch is not fully charged.  Before starting the process below, place 
the Actiwatch to be used in the charging station.  Open the Philips Actiware 6.02 
software (NOTE: the same computer must be used to initialize the ABPM and 
Actiwatch; ideally the data would also be downloaded to the same computer). Then 
select “Communications” on the menu bar at the top of the window, and select 
“Actiwatch Console”, which will bring up the “Actiwatch Communications Console”. 
2.
Select the “Actiwatch 2 device” and then select the “Configure” button at the bottom of 
2

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the screen.
2
2

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3.
Select “New Subject” button (see screen grab 3A below). Under the “Identity” field, type the 
participant ID (see screen grab 3B below). Do not enter the date of birth or gender. Leave as 
the default settings. Then under the “Last Name” field, enter the participant ID again (see 
screen grab 3B below). Then select the “OK” button. 
3A

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4. Then the “Configure Actiwatch” window will be shown on the screen. Select the 
“Next” button.  
3B
3B
3B
4

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5. Make sure that the “Epoch Length” is 15 seconds and the “Logging Mode” is “Activity and 
Photopic Light”. Make sure that the “Maximum Recording Time” is at least 3 days.  Select 
the “Next” button. 
 
 

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6. Select the check box for “Start collecting data as soon as possible”. The “Data Collection 
Duration” should be set at 7 days. Select “Configure” button. Then select “Continue” button. 
When done, hit “OK”.  
 
 
 
 

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Instruction for Returning the ABPM/HBPM Device and Actiwatch 
 
To return the ABPM/HBPM and actigraphy (Actiwatch) devices and the participant device log, 
participants must return to the clinic the day after performing the ABPM or HBPM (REQUIRED).  
 
 
 

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ABPM, HBPM, and Actiwatch Data Download Procedures  
 
ABPM 
1. On the front of the ABPM device (lower right) is the on/off (round) button. Make sure the 
monitor is on (if needed - press the on/off button). 
 
2. Connect the ABPM device to the computer using the USB to micro-USB computer cable. 
3. Launch Microlife O3 Analyzer software. 
 
 

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4.
Enter the participant’s ID number. The patient id number should match the id number you 
entered prior to their ABPM period, but it should not match their record id number in 
REDCap. Do not enter the participant’s first and last name, date of birth, age, or sex 
[do not included any protected health information (PHI)]: 
a.
Participant’s first name; use participant’s id number 
b.
Participant’s last name; use participant’s id number 
c.
Participant’s date of birth; select 1/1/1950
d.
Participant’s age; this field should auto-populate an age based on DOB 
e.
Participant’s sex; select ‘M’ for male for all participants 
f.
Physician Name; enter ‘NA’
4A
4B
4C
4D
4E
5
4F

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5. Select ‘Report Settings’. 
6. Make sure the blood pressure thresholds for day and night systolic and diastolic blood 
pressure are correct. 
a. Day SYS – 130 mmHg 
b. Day DIA – 80 mmHg 
c. Night SYS – 110 mmHg 
d. Night DIA – 65 mmHg 
7. 
Set the participant’s reported ‘Awake time’ and ‘Asleep time’ based on their device log. 
8. 
Select ‘ABPM Report’. 
9. 
De-select ‘Hiding error message’. 

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10. Select ‘OK’.
11. Select ‘Download BP data’.
12. Select ‘Save Excel report’.
13. Open the Excel report to verify that the data is present and accurate.
14. Go back to the WatchBP Analyzer O3.
15. Enter the participant’s information.
a.
Participant’s first name; 
b.
Participant’s last name;  
c.
Participant’s date of birth; 
6A
6B
6C
6D
7
7
8
9
10

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d.
Participant’s age; this field should auto-populate an age based on DOB 
e.
Participant’s sex; 
f.
Physician Name – if it is not provided or the participant did not consent to sharing 
their results with their provider; enter ‘NA”
16. Select ‘Report settings’ again. Select ‘Hiding error message’ then ‘Okay’. Select ‘Save PDF 
report’.
17. The PDF report will automatically open once it is downloaded and a comment box will 
appear. Make sure that you remove the following from the comment box before selecting
‘OK’.
11
12
13

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a. White coat hypertension; remove from the comment box if it appears 
b. Masked hypertension; remove from the comment box if it appears 
18. Once finished, remove the ABPM device from the computer by disconnecting it from the 
USB to micro-USB computer cable connector. Turn off the ABPM device and remove the 
batteries. 
 
If at least 35 readings are obtained, ask the participant to complete the “POST ABPM 
QUESTIONNAIRE”. 
Ask the participant to complete questions regarding the quality of sleep over the 24-hour 
monitoring period and the comfort of the ABPM device. 
 
If at least 35 readings are NOT obtained, ask the participant to repeat the ABPM 
monitoring period for one night. 
If they say yes, clear the memory and re-initialize the device with the participant’s id number 
and adding the text (‘-2’) at the end (i.e. - 1101-2). Replace the device on the participant and 
review the instructions again. Give the participant a new ABPM device log to complete. 
If they say no, ask the participant to complete questions regarding the quality of sleep over the 
24-hour monitoring period and the comfort of the ABPM device using the “POST ABPM 
QUESTIONNAIRE”. 
 
 
 
 

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HBPM 
1. 
On the front of the HBPM device (lower right) is the on/off (round) button. Make sure the 
monitor is on (if needed - press the on/off button). 
 
2. Connect the HBPM device to the computer using the USB to micro-USB computer cable. 
3. Launch Microlife Home N Analyzer software. 
 
 

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4.
Make sure the Patient ID matches the participant’s record id number in REDCap. Enter the 
following: 
a.
Participant’s first name; enter participant id number
b.
Participant’s last name; ; enter participant id number
4A
4B
6
5

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5. Select ‘Download’. 
6. Select ‘Save to excel’. 
Once you have confirmed the Excel document has the data in it by opening the file, remove 
the HBPM device from the computer by disconnecting it from the USB to micro-USB 
computer cable connector. Turn off the HBPM device and remove the batteries. 
 
If at least 2 readings are obtained, have the participant complete the “POST HBPM 
QUESTIONNAIRE” 
Have the participant complete questions regarding the quality of sleep over the overnight 
monitoring period and the comfort of the HBPM device. 
 
If at least 2 readings are NOT obtained, ask the participant to repeat the HBPM period 
overnight. 
If they say yes, give the device back to the participant and provide them with instructions again 
on how to place the device and begin the readings. Also, provide them with a new HBPM device 
log.  
If they say no, have the participant complete questions regarding the quality of sleep over the 
overnight monitoring period and the comfort of the HBPM device using the “POST HBPM 
QUESTIONNAIRE”. 
 
 

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Actiwatch* 
The Actiwatch database is updated with each new participant’s downloaded data. Before 
starting the study (before the first participant), the database should be saved onto a network 
drive that is backed up daily. This is done by selecting File  Database  New. Then the 
Database should be saved into the appropriate location.  
1. Place Actiwatch device onto the charger.  
2. Launch Philips Actiware 6 software.  
3. In the Actiwatch software window, click “Communications” on the Menu Bar at the top of the 
window and then select “Actiwatch Communications Console”.  
 
 

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4. Select the “Actiwatch 2” device (the participant’s ID number should be located under the 
“Actiwatch 2”). Click the “Retrieve” button at the bottom of the window.  
  
 
 

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5. Make sure that the “Launch Actogram” check box is selected. Then select the “Save Data” 
button. 
  
 

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6. Make sure the radio button for “Put Actiwatch to sleep for later use” is selected and then 
click “Next”. Then select “Put Actiwatch to Sleep” (if this message comes up).  
 
 

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7. Next, click the “OK” button on the “Actogram window” (if this appears).  
8. Review the Actogram window to make sure that data has been collected. Then close 
“Actogram” window (see screen grab below).  
*If low battery warning comes up during any steps, click “OK”.  
 
 

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Troubleshooting Devices  
 
If the Office AFIB device is not working properly, please check the following:  
• 
If the opening screen does not read ‘Connected’ in the bottom left corner, please turn the 
device off and back on until it is connected. 
• 
If still not connected, check to make sure the proper USB connection cable is being used 
(labeled ‘Office AFIB’). 
• 
If the cuff does not inflate, please make sure that the blood pressure cuff is connected to 
the correct side of the device (i.e., if ‘Left’ is selected, then the device cuff should be 
connected to the left side of the device). 
 
If the O3 ABPM device is not working properly, please check the following:  
• 
If the opening screen does not provide information on the battery life then the device is 
not properly connected. Check to make sure the proper USB connection cable is being 
used (labeled ‘WatchBP O3’). 
• 
If the data is not downloading, disconnect the device from the laptop and reconnect. If 
there is still trouble connecting, use another USB connection cable. 
• 
If the cuff is not inflating, please check the connector on the tube (see picture below). If 
still not inflating correctly, use another blood pressure cuff. 
 
If the Home N device is not working properly, please check the following:  
• 
If the opening screen does not provide information on the battery life then the device is 
not properly connected. Check to make sure the proper USB connection cable is being 
used (labeled ‘WatchBP Home N’). 
• 
If the data is not downloading, disconnect the device from the laptop and reconnect. If 
there is still trouble connecting, use another USB connection cable. 
• 
If the cuff is not inflating, please check the connector on the tube (see picture below). If 
still not inflating correctly, use another blood pressure cuff. 
 
If none of these troubleshooting methods work, please call Dr. Muntner at (205)-975-8077. 
 
 
 
 
 

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Storing and Sending Results  
 
Once you have downloaded the participant’s data from the ABPM and HBPM devices, verify 
that the reports contain the data and is named using the participant’s study id number. 
 
ABPM Excel reports should be stored in the following folder on the shared CVD drive: 
 
‘O:\BetterBP\ABPM Excel Reports’ 
 
ABPM PDF reports should be stored in the following folder on the shared CVD drive: 
 
‘O:\BetterBP\ABPM PDF Reports’ 
 
HBPM Excel reports should be stored in the following folder on the shared CVD drive: 
 
‘O:\BetterBP\ HBPM Excel Reports’ 
 
 
For ABPM PDF reports that will be sent to participants and their providers, you must use Adobe 
Pro to redact the participant’s ID number (i.e., place a black box over the id number). All PDF 
reports that are redacted and ready to be sent must be stored in the following folder: 
 
‘O:\BetterBP\ABPM PDF Reports\To be sent to participants (redacted)’ 
 
We will mail all results to the participant following the conclusion of their study visits. For 
participants who indicated they would like their results sent to their provider, please refer to the 
list of physician fax numbers in the Appendix. 
 

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Device Storage and Cleaning Cuffs  
 
Clinic  
On the top of the clinic device, there is a battery indicator light. If the indicator light blinks 
‘Orange’, the battery is at half power. ‘Red’ indicates that the battery is low. Please plug in the 
device and charge until the indicator light turns ‘Green’.  
Once the device is fully charged, please unplug the device and store in the storage room 
(CHB19 Rm 116). 
After each participant, please wipe the blood pressure cuff and tubing with a mild antiseptic 
wipe. Allow it to dry and then store in the storage room (CHB19 Rm 116). 
 
 
Once the participant has returned their device and their data has been downloaded, 
please do the following: 
 
ABPM 
Remove the batteries from the device, wipe the cuff and tubing with a mild antiseptic wipe, and 
store in the proper place. Place the used batteries in the box labeled ‘Used Batteries’. Store the 
device in the storage room (CHB19 Rm 116). 
 
HBPM 
Remove the batteries from the device, wipe the cuff and tubing with a mild antiseptic wipe, and 
store in the proper place. Place the used batteries in the box labeled ‘Used Batteries’. Store the 
device in the storage room (CHB19 Rm 116). 
 
Actiwatch 
Wipe the device with an alcohol wipe and place it on the docking station to charge. Once the 
indicator light on the front of the docking station remains firmly ‘Green’, remove the device and 
store the device in the storage room (CHB19 Rm 116). 
 

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Blood and Urine Specimen Collection 
 
The following table includes the volume and processing procedures of specimen to be collected 
and sent to Columbia. Note: The volume for collection includes enough for both 
processing and storage for future use. Please only send the volume for processing to 
Columbia’s CALM Lab. 
Supplies Needed 
1. (Velcro) Tourniquets  
2. Vacutainer Safety-Lok Blood Collection 21 G  
3. Vacutainer Safety-Lok Blood Collection 23 G  
4. Vacutainer Needle Holder 
5. Gauze pads 2x2 
6. Band-Aids 
7. Non-latex Gloves (Small and medium) 
8. Hypoallergenic Tape 
9. Alcohol swabs 
 
 
 
Blood samples summary  
 
Blood draw 
order 
Tube type 
Test type 
1 
5 mL Gold top tube 
Creatinine Complete Lipid 
Panel Glucose 
2 
2 mL EDTA lavender top tube 
HbA1c 
3* 
4 mL EDTA lavender top tube 
Genetic Testing 
4* 
5 mL Gold top tube 
TBD testing 
5* 
5 mL EDTA lavender top tube 
TBD testing 
6* 
Citrate blue top tube 
TBD testing 
*Only if the participant consented to future testing. 
 
 

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Overview of specimen processing and aliquots 
 
Order 
Specimen 
type 
Volume 
Collection 
Test 
Procedures after collection 
NA 
Urine 
3 mL 
Urine 
collection 
container w/o 
preservatives 
Urine 
albumin 
and urine 
creatinine 
Transfer 3ml of urine to a 5ml 
cryovial for storage in freezer (-20 
to -80 C) until shipment 
 
Store remaining sample for future 
use 
1 
Blood 
5 mL 
Gold top 
tube  
Creatinine 
Complete 
Lipid 
Panel 
Glucose 
1. Centrifuge sample at least 30 
minutes after collection but no 
more than 2 hours 
2. Aliquot serum into (1) 1ml 
cryovial 
3. Store cryovial in freezer (-20 to -
80 C) until shipment 
2 
Blood 
2 mL 
EDTA 
lavender top  
tube 
HbA1c 
No processing needed by UAB 
staff, store tube in freezer (-15 to -
25C) until shipment  
3* 
Blood 
4 mL 
EDTA 
lavender top  
tube 
Genetic 
testing 
No processing needed by UAB 
staff, store tube in freezer (-15 to -
25C) for future use 
4* 
Blood 
5 mL 
Gold top 
tube 
TBD 
testing 
1 mL aliquots x 2 for storage 
5* 
Blood 
5 mL 
EDTA 
lavender top  
tube 
TBD 
testing 
1 mL aliquots x 3 for storage 
6* 
Blood 
4.5 mL 
Citrate blue 
top tube 
TBD 
testing 
1 mL aliquots x 2 for storage 
*Only if the participant consented to future testing. 
 
 
 
 

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Processing Procedures and Timing 
 
One 5 mL Gold Top Tube (for Creatinine Complete Lipid Panel Glucose, 
immediate) 
- 
Allow the sample to sit for at least 30 minutes prior to centrifuging.  
- 
Centrifuge using 2300 g for 10 minutes at room temperature.  
- 
1 mL of serum needed for processing at CALM Lab 
 
One 2 mL EDTA lavender top tube (for Hemoglobin A1c, immediate) 
- 
Do not centrifuge this sample. Store in tube. 
- 
2 mL of whole blood needed for processing at CALM Lab.  
 
One 4 mL EDTA lavender top tube (for Genetic testing) 
- 
Do not centrifuge this sample. Store in tube. 
- 
4 mL of whole blood needed for processing at CALM Lab. 
 
One 5 mL Gold top tube (for TBD testing) 
- 
Allow the sample to sit for at least 30 minutes prior to centrifuging.  
- 
Centrifuge using 2300 g for 10 minutes at room temperature.  
- 
Store two (2) 1 mL aliquots for future use. 
 
One 5 mL EDTA lavender top tube (for TBD testing) 
- 
Allow the sample to sit for at least 30 minutes prior to centrifuging.  
- 
Centrifuge using 2300 g for 10 minutes at room temperature.  
- 
Store three (3) 1 mL aliquots for future use. 
 
One 4.5 mL Citrate blue top tube (for TBD testing) 
- 
Allow the sample to sit for at least 30 minutes prior to centrifuging.  
- 
Centrifuge using 2300 g for 10 minutes at room temperature.  
- 
Store two (2) 1 mL aliquots for future use. 
 
Storage of specimen 
Once processed and aliquoted, please label each sample using the pre-printed labels 
with the participant id number, study name, and sample type.  
Place the samples in the -20C freezer in CHB19 Rm 101-G. 

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Shipping Specimen to CALM Lab 
 
SPECIMEN TO SHIP TO CALM LAB 
ASSAYS PERFORMED ON 
SINGLE SPECIMEN 
SHIPPING PROCEDURES 
At least 3ml of urine housed in 5ml cryovial 
Urine albumin                   
Urine creatinine 
1. Place cryovial or tube in specimen tube 
mailer and wrap mailer with a rubber band 
 
At least 1ml of serum in a 2ml cryovial 
Serum creatinine 
Complete lipid panel  
Glucose 
2. Place mailer in a biohazard bag        
                                                                            
3. Place bag inside a FedEx shipping cooler 
that is filled with dry ice                       
                                                                            
4. Adhere dry ice and biohazard labels to 
outside of FedEx package 
2ml of whole blood in a 2ml EDTA lavender top tube HbA1C 
  
**shipping procedures are the same for all specimens: overnight shipping every 1st Monday of the month (if holiday, please 
ship next business day) 
**make sure all vials, tubes and boxes are labeled properly with IDs, study name (Better BP Study), and test to be done 
**keep tracking numbers with UAB staff to ensure delivery at CALM lab 
**send all requisition forms to CALM lab for detailed processing instructions 
**confirm someone from Dr. Shimbo’s group will be able to receive the specimen 
 
Samples should be shipped to:     Daichi Shimbo, MD 
Columbia University Medical Center 
622 West 168th Street 
PH 9-310 
NEW YORK, NY 100323720 

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Echocardiograms  
 
Cardiac measurements will be obtained according to the 2015 recommendations* of the American 
Society of Echocardiography (ASE) and European Association of Cardiovascular Imaging (EACVI). 
Left ventricular (LV) measurements for LV end-diastolic dimension (LVEDd), septal wall thickness 
(SWTd), and posterior wall thickness (PWTd) will be obtained.  
 
LVM (grams) will be determined using the ASE formula. LVMI will be calculated as LVM divided by 
body surface area (g/m2) and secondarily by dividing by height2.7 (g/m2.7).  
 
The following are additional measures to be conducted: 
• 
Shortening (FS, %)  
• 
LV systolic function defined by LV ejection fraction (LVEF, %) = 100 x (LVEDV-LVESV) / 
LVEDV using modified Simpson’s rule.  
 
The following are measures that may be obtained at a future date. Imaging will be conducted now to 
capture these items, but measurements will not be performed.  
• 
LV diastolic function: E/A ratio, E’ (cm/s), A’ (cm/s), E/E’ ratio, isovolumetric relaxation time 
(ms), deceleration time (ms) 
• 
Other parameters:  Left atrial volume (mL), right ventricular fractional area change, tricuspid 
annular plane systolic excursion (TAPSE) and tricuspid annulus s’, and global longitudinal 
strain (GLS) 
• 
Hemodynamics: stroke volume (SV, mL) = VTI x cross-sectional areaLVOT; heart rate (HR); 
cardiac output (L/min) = SV x HR 
 
 
*J Am Soc Echocardiogr 2015;28:1-39.  
 
 

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Adult Transthoracic Echocardiogram Protocol 
 
Note: Heart Rate should be continuously documented on screen during image acquisition.  
Heart rate is needed to calculate different formulae. All spectral Doppler should be displayed 
at a sweep speed of 100 mm/sec. 
 
Also, the disk (CD or DVD) should be labeled with a participant ID#. 
 
A.  Parasternal Long Axis: 
 
1. 
Show at increased depth to show extra-
cardiac structures. 
2.  
Decrease depth and then show at least 3 
beats in parasternal long axis view for LV 
wall motion. LV chamber and wall thickness 
measurements will be performed using 2D-
guided linear measurements (see Figure 1). 
3. 
Zoom on aortic valve. Show aortic valve and 
LVOT (for diameter measurements). 
 
4.  
Perform Color Doppler of aortic valve. 
 
 
B.  Parasternal Short Axis: 
1. 
Will not obtain images. 
 
 
 
 
 
 
 
 

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C. Apical Views: 
1. 
Start 2D with the apical four-chamber view at 
increased depth to show extra-cardiac structures. 
 
2.  
Decrease depth and show the LV in apical four-
chamber view for at least 3 beats.  This view will be 
used for LVEF assessment (using modified Simpson’s 
rule).  
 
Then optimally show the left atrium for assessment of 
left atrial volume (see Figure 2). Put Color Doppler on 
the mitral valve to show a complete jet of regurgitation 
if any is present.  
 
Interrogate the mitral valve with PW Doppler with the 
sample volume at the tips of the mitral leaflets (show E 
and A waves).  Show for at least 3 beats. If mitral stenosis is present, switch 
to CW Doppler, and show enough of E and A waves for assessment of 
mean gradient and pressure half-time.  
 
Perform DTI of mitral annulus (lateral and medial) and show e’ and a’.  
Show for at least 3 beats for each annulus.  
 
Show RV for size and function in apical four-chamber view for at least 3 
beats.  Switch to M-mode for assessment of tricuspid annular plane systolic 
excursion (TAPSE). Show for at least 3 beats. Finally, switch to DTI of 
tricuspid annulus. Show for at least 3 beats 
 
Angle and show the apical five-chamber view for at least 3 beats. 
Then interrogate across AV and LVOT with CW Doppler. If increased 
gradient is present, slide the sample volume using PW from the LV apex, 
down the LVOT, and to the AV to pinpoint the area of increased gradient. 
Once area of increased gradient is identified, switch to CW Doppler and 
show the peak resting gradient for at least 3 beats.  
 
 
Fi
2

Better BP Study: Manual of Operations 
 
 
 
105
Perform PW Doppler of the LVOT for the assessment of LVOT VTI for at least 3 
beats. 
 
3. Also, in the apical five-chamber view, 
using CW Doppler, place the sample volume 
at the junction of the LVOT and the anterior 
mitral leaflet to capture both LVOT mitral 
valve inflow profiles (see Figure 3). 
 
4.  Rotate to apical two-chamber view: 
show the LV at least 3 beats for LVEF 
assessment. Then optimally show the left 
atrium for assessment of left atrial volume 
(see Figure 2). Put Color Doppler on the 
mitral valve to show a complete jet of 
regurgitation if any is present. 
 
5. Rotate to apical three-chamber view: show the LV at least 3 beats. Put Color 
Doppler on the mitral valve to show a complete jet of regurgitation if any is present. 
 
 
 
 
Fi
3

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106
Echocardiogram Checklist 
Record all images at least 3 beats. For more details, refer to the protocol. 
Parasternal long axial view 
 
  Show at increased depth for extra cardiac structure 
□ 
  Show at decreased depth for 2D measurements 
□ 
  Zoom on AV and LVOT 
□ 
  Color Doppler of AV 
□ 
Apical 4-ch view 
 
Show at Increased depth for extra cardiac structure 
□ 
  Show at decreased depth for LVEF assessment 
□ 
  Show LA optimally for LA volume assessment 
□ 
  Color Doppler of MV 
□ 
  PW Doppler for E and A wave assessment 
□ 
  CW Doppler if mitral stenosis is present 
□ Absent           □ CW  
  DTI of mitral annulus (both lateral and medial) 
□ Lateral annulus 
□ Medial annulus 
  Show RV optimally for RV volume assessment 
□ 
M-mode for TAPSE 
□ 
DTI of tricuspid annulus 
□ 
Apical 5-ch view 
 
  Show plain 5-ch image 
□ 

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107
  CW Doppler across AV and LVOT 
□ 
  PW and CW Doppler if increased gradient is present 
□ Not increased   □ PW  □ CW 
PW Doppler for LVOT VTI 
□ 
  CW Doppler for IVRT 
□ 
Apical 2-ch view 
 
  Show plain 2-ch image for LVEF assessment 
□ 
  Show LA optimally for LA volume assessment 
□ 
  Color Doppler of MV (for MR) 
□ 
Apical 3-ch view 
 
  Show plain 3-ch image  
□ 
Color Doppler of MV (for MR) 
□ 
AV, aortic valve; CW continuous wave; DTI, Doppler tissue imaging; IVRT, isovolumetric 
relaxation time; LA, left atrium; LV, left ventricle; LVOT, left ventricular outflow tract; MV, 
mitral valve; PW, pulse wave; RV, right ventricle; TAPSE, tricuspid annular plane systolic 
excursion; VTI, velocity time integral.  
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
108
Protocol for Handling Echocardiograms  
 
1. Participants will return to the Hypertension Clinic on the day of their echocardiogram 
appointment. 
2. The study coordinator will provide the participant with a sealed envelope which contains the 
following:  
a. Two pre-made labels for the DVDs with the participant ID number and date  
b. A hand-written reminder card with the participant name and ID number  
c. An instruction sheet for the sonographer on how to enter the participant information 
into the PACS system before downloading the scan onto the DVD  
3. The participant will take the envelope with them to the Echo Lab and give it to the 
sonographer. If the study coordinator is not with a participant, he/she should offer to escort 
the participant to the echo lab. 
4. The study coordinator will go pick up the DVDs from the Echo Lab receptionist desk before 
the end of the day. If he/she is not available, he/she will contact the alternate(s) to pick up the 
DVD. 
5. The person who picks up the DVD will enter into the REDCap database that the 
echocardiograms have been retrieved from the Echo Lab. 
6. The study coordinator will check the echo scans every Monday to confirm there is no PHI and 
that the participant information (i.e. –participant ID number) is accurate  
a. Each reviewed DVD will be labeled with a colored sticky dot and initialed by the 
reviewer so that we can confirm that they have been reviewed and by whom. 
b. The reviewer will also enter that the DVD has been reviewed into REDCap on the 
‘Echocardiogram’ form. 
7. All DVDs that have been reviewed will be shipped to CUMC every Monday with the exception 
of holidays. If Monday is a holiday, the DVDs will be shipped on Tuesdays. 

Better BP Study: Manual of Operations 
 
 
 
109
How to View Echocardiograms on a Desktop  
 
1. Once the DVD has been placed in the CD drive, Click on the DVD drive in File Explorer. 
 
2. Once the drive is open there will be several options, click on the PMSDVIEW option
  
3. This will allow the viewer to be opened and you can see all images that are on that disk. 
 
 
• 
If these options are not available, please contact Christian Carter 
(christiancarter@uabmc.edu) 

Better BP Study: Manual of Operations 
 
 
 
110
Shipping Echocardiograms  
 
All echocardiogram CDs should be shipped by study staff to the following address using 
FedEx overnight shipping every Monday of the month (if holiday, please ship on the 
following business day):  
 
Daichi Shimbo, MD 
Columbia University Medical Center 
622 West 168th Street 
PH 9-310 
NEW YORK, NY 100323720 
 
 
During the COVID-19 epidemic, please mail all echocardiogram CDs to the following address:  
 
Daichi Shimbo 
310 West 114th Street 
Apt. 6 
New York, NY 10026 
Phone: 646-462-1083 
 
 
Please do not delete the participant echocardiograms from the echo machine until they have 
been received and analyzed at Columbia University. 
 
 

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111
Payment Structure (Reimbursing Participants) 
 
There will be two potential approaches for reimbursement: 
 
1. Please see the following compensation schedule:  
 
Study visit 1 - $15 
Study visit 2 - $15 
Study visit 3 - $45 
Study visit 4 - $75 
If you are having difficulty scheduling a participant for their next study visit within two weeks, 
call the participant to encourage them to continue the study.  
If they say ‘yes’, please schedule the participant for their next visit within a week. 
If they say ‘no’, ask them if they would like you to call back in two weeks to confirm that 
they would no longer like to be in the study. 
If they say ‘yes’, schedule a day and time that would be best for you to call back. 
If they say ‘no’, let them know that they will receive compensation on a ClinCard in 
the next 7-10 business days for the study visits they completed.  
 
2. Upon completion of each study visit, inform the participant that they will receive 
compensation for their visit on a ClinCard. They will receive a ClinCard from the study 
coordinator at Visit 1. All participants will need to have completed all payment forms 
prior to the conclusion of their study visits. 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
112
Paying Participants  
 
Please use the Clincard Site Coordinator reference guide to access the Clincard system: 
 
Link to reference guide:  
https://www.uab.edu/medicine/ctao/images/ClinCard_Reference_Guide_for_Site_Coordinat
ors_with_Graphics.pdf  
 
Our study number: 379600000-2020672-300001727 
 
To order additional Clincards, please contact Deonna Rasberry-Elmore 
(eternal2@uab.edu). 
 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
113
Parking and Transportation Reimbursement 
 
A parking decal will be provided to participants for the UAB Hypertension Clinic prior to their 
first visit in their participant packet. Inform participants that an additional $5 for parking at the 
4th or 6th Avenue parking deck will be included in their compensation for those who would 
prefer to drive to UAB West Pavilion to complete their echocardiograms. 
 
 

Better BP Study: Manual of Operations 
 
 
 
114
OnCore Management  
 
Prior to entering information into OnCore, you will need the following information:  
1. Participant Medical Record Number (MRN)  
o You may request the MRN number using the EMMI Request Form that is 
completed by the study coordinator during study visit 1. 
o To download EMMI Request Forms, go to the link listed and scroll down and 
select ‘Additional Forms’ and it will navigate to a SharePoint page. Select the 
“EMMI Form” and download and print.  
o https://www.uab.edu/ccts/research-commons/oncore/resources 
 
2. Participant Race/Ethnicity 
o This may be found in REDCap. 
 
3. Participant Schedule of Visits  
o This may be found in REDCap. 
 
 
Once you have the above mentioned information, you may follow the instructions for 
‘Subject Administration’ pages 4 – 19. You may find the instructions at the bottom of the 
page at this web address:  
https://www.uab.edu/ccts/research-commons/oncore/training 
 
Once you register the participant, click on ‘Calendar’ and click each visit and enter their visit 
date and select ‘Occurred’.  
 
For Visit 4, make sure to scroll down and enter the date of the echocardiogram next to 
‘Echocardiogram’. If the echocardiogram did not occur, select the checkbox for ‘Missed’. 

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Better BP Supplement 
 
Questionnaire Administration  
 
1. State Anxiety Index (Prior to unattended and attended blood pressure 
measurements at visits 1 and 2 [based on randomization order]; during night of 
ABPM and HBPM) 
2. Trait Anxiety Index (At visit 4 – optional to administer electronically) 
3. Expectations of Outcomes (At visit 4 - optional to administer electronically) 
 
Examples of Questionnaire Administration 
 
If participant is randomized to UnattendedAttended and ABPM  HBPM, please administer the 
questionnaires in the following order:  
Unattended = give the participant the questionnaire and leave the room for 5 minutes 
Attended = give the participant the questionnaire and remain in the room while they complete it 
 
 
 
 
 
Visit 1 
Visit 2 
Visit 3  
Visit 4 
After office BP 
randomization, the state 
anxiety inventory will be 
administered unattended 
in concordance with the 
first clinic BP 
measurement. 
After office BP 
randomization, the state 
anxiety inventory will be 
administered attended in 
concordance with the first 
clinic BP measurement. 
 
After participants 
complete the device 
satisfaction 
questionnaire, the 
trait anxiety 
questionnaire and 
expectations of 
outcomes survey will 
be completed. 
 
After ABPM or home 
randomization, the state 
anxiety inventory will be 
completed at bedtime 
on the night of ABPM 
After ABPM or home 
randomization, the state 
anxiety inventory will be 
completed at bedtime 
on the night of HBPM 
 

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116
If participant is randomized to AttendedUnattended and HBPM  ABPM, please administer 
the questionnaires in the following order:  
Unattended = give the participant the questionnaire and leave the room for 5 minutes 
Attended = give the participant the questionnaire and remain in the room while they complete it 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Visit 1 
Visit 2 
Visit 3  
Visit 4 
After office BP 
randomization, the 
state anxiety 
inventory will be 
administered attended 
in concordance with the 
first clinic BP 
measurement. 
After office BP 
randomization, the 
state anxiety 
inventory will be 
administered 
unattended in 
concordance with the 
first clinic BP 
measurement. 
 
After participants 
complete the device 
satisfaction 
questionnaire, the 
trait anxiety 
questionnaire and 
expectations of 
outcomes survey will 
be completed. 
 
After ABPM or home 
randomization, the 
state anxiety 
inventory will be 
completed at bedtime 
on the night of HBPM 
After ABPM or home 
randomization, the 
state anxiety 
inventory will be 
completed at bedtime 
on the night of ABPM 
 

Better BP Study: Manual of Operations 
 
 
 
117
Checking Statistics in REDCap 
 
1. On the REDCap database home screen, in the applications panel to the left-
hand side, select ‘Data Exports, Reports, and Stats’. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. Click on ‘Selected Instruments – Make custom selections’. 
 

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118
3. Select ‘Sociodemographic and Medical History’ and click ‘Stats & Charts’. 
 
 
 
 

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119
4. You should now see statistics and plots for every question in this survey. If 
you would like to export the data, please select ‘Export Data’ in the top right 
hand corner.  
 
 
 
 
 
 
 
 
 

Better BP Study: Manual of Operations 
 
 
 
120
Calculating Better BP Results  
 
Codebook Location (For REDCap data):  
O:\BetterBP\Data Dictionary 
 
File Locations:  
libname data 'O:\BetterBP\Database Back-Up\November 2019'; 
libname echo 'O:\BetterBP\Echo Data'; 
libname labs 'O:\BetterBP\Lab Data'; 
 
 
Items to be calculated: 
1. Left ventricular mass index  
2. Left ventricular ejection fraction 
3. Average attended systolic blood pressure  
4. Average attended diastolic blood pressure  
5. Average attended heart rate 
6. Average unattended systolic blood pressure  
7. Average unattended diastolic blood pressure  
8. Average unattended heart rate  
9. Estimated glomerular filtration rate 
10. Microalbumin-to-creatinine ratio 
 
NOTES:  
• For the lab data, please use the ‘month_year_clean’ SAS datasets for analyses. 
• I have noted the correct variables to use for the echo equations on the next page. 
• Provided sample code for EGFR 
 
 

Better BP Study: Manual of Operations 
 
 
 
121
Echo Equations 
 
Left ventricular mass index (g/m2) = Left ventricular mass (g)/ Body surface area (m2) 
  
Left ventricular mass (g) = 0.8 x 1.04 x [(A+B+C)3-C3] + 0.6 
  A = Average of SWTd#1, SWTd#2, and SWTd#3 [Variable: ivsd1…ivsd3] 
  B = Average of PWTd#1, PWTd#2, and PWTd#3 [Variable: pwtd1…pwtd3] 
  C = Average of LVEDd#1, LVEDd#2, and LVEDd#3 [Variable: lvidd1…lvidd3] 
 
 Body surface are (m2) = 0.007184 x [height (cm)]0.725 x [weight (kg)]0.425 
   
Left ventricular ejection fraction (%) ＝100 x (D-E)/D  
 
  D= Average of LVEDV#1, LVEDV#2, and LVEDV#3 [Variable: lvedv1…lvedv3] 
   E= Average of LVESV#1, LVESV#2, and LVESV#3 [Variable: lvesv1…lvesv3] 
 
 

Better BP Study: Manual of Operations 
 
 
 
122
Paul’s Example Code for Calculating EGFR (CKD-Epi Equation) 
 
**** Calculate estimated glomerular filtration rate; 
if black=1 and male=0 and lbxscr<=0.7 then eGFR =166*((lbxscr/0.7)**(-
0.329))*(0.993**(ridageyr));  
if black=1 and male=0 and lbxscr>0.7 then eGFR =166*((lbxscr/0.7)**(-
1.209))*(0.993**(ridageyr));  
if black=1 and male=1 and lbxscr<=0.9 then eGFR =163*((lbxscr/0.9)**(-
0.411))*(0.993**(ridageyr));  
if black=1 and male=1 and lbxscr>0.9 then eGFR =163*((lbxscr/0.9)**(-
1.209))*(0.993**(ridageyr));  
if black=0 and male=0 and lbxscr<=0.7 then eGFR =144*((lbxscr/0.7)**(-
0.329))*(0.993**(ridageyr));  
if black=0 and male=0 and lbxscr>0.7 then eGFR =144*((lbxscr/0.7)**(-
1.209))*(0.993**(ridageyr));  
if black=0 and male=1 and lbxscr<=0.9 then eGFR =141*((lbxscr/0.9)**(-
0.411))*(0.993**(ridageyr));  
if black=0 and male=1 and lbxscr>0.9 then eGFR=141*((lbxscr/0.9)**(-
1.209))*(0.993**(ridageyr)); 
 
 

Better BP Study: Manual of Operations 
 
 
 
123
 
 
 
 
 
 
 
 
 
 
Appendices

 
 
124
HIPAA Authorization Form 
 
University of Alabama at Birmingham 
Authorization to Use and Disclose Information for Research Purposes 
 
Participant Name:   
 
 
_________ 
UAB IRB Protocol Number:  IRB-300001727 
Research Protocol:  Evaluating Novel Approaches for 
Estimating Awake and Sleep Blood Pressure -  Better BP 
Study 
Principal Investigator:  Paul Muntner, PhD 
Sponsor:  NIH/NHLBI 
 
Federal regulations give you certain rights related to your health information. These include the right to 
know who will be able to get the information and why they may be able to get it. The study doctor must 
get your authorization (permission) to use or give out any health information that might identify you. 
 
What protected health information may be used and/or given to others? 
All medical information, including but not limited to information and/or records of any diagnosis or 
treatment of disease or condition, which may include sexually transmitted diseases (e.g., HIV, etc.) or 
communicable diseases, drug/alcohol dependency, etc.; all personal identifiers, including but not limited 
to your name, social security number, medical record number, date of birth, dates of service, etc.; any 
past, present, and future history, examinations, laboratory results, imaging studies and reports and 
treatments of any kind, including but not limited to drug/alcohol treatment, psychiatric/psychological 
treatment; financial/billing information, including but not limited to copies of your medical bills; any 
other information related to or collected for use in the research study, regardless of whether the 
information was collected for research or non-research (e.g., treatment) purposes; records about any 
study drug you received or about study devices used; and consent forms from past studies that might be 
in your medical record. 
 
Who may use and give out information about you? 
Information about your health may be used and given to others by the study doctor and staff. They 
might see the research information during and after the study. 
 
Who might get this information? 

 
 
125
All Individuals/entities listed in the informed consent document(s), including but not limited to, the 
physicians, nurses and staff and others performing services related to the research (whether at UAB or 
elsewhere). Your information may also be given to the sponsor of this research. “Sponsor” includes any 
persons or companies that are working for or with the sponsor, or are owned by the sponsor, or are 
providing support to the sponsor (e.g., contract research organization). 
 
Information about you and your health which might identify you may be given to: 
• 
the Office for Human Research Protections (OHRP) 
• 
the U.S. Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
Governmental agencies in other countries 
• 
Governmental agencies to whom certain diseases (reportable diseases) must be reported 
• 
the University of Alabama at Birmingham - the physicians, nurses and staff working on the research 
study (whether at UAB or elsewhere); other operating units of UAB, UAB Hospital, UAB Highlands 
Hospital, University of Alabama Health Services Foundation, Children’s of Alabama, Eye Foundation 
Hospital, and the Jefferson County Department of Health, as necessary for their operations; the UAB 
IRB and its staff 
• 
the billing offices of UAB and UAB Health Systems affiliates and/or Children’s of Alabama and its billing 
agents 
 
 
 
Why will this information be used and/or given to others? 
Information about you and your health that might identify you may be given to others to carry out the 
research study. The sponsor will analyze and evaluate the results of the study. In addition, people from 
the sponsor and its consultants will be visiting the research site. They will follow how the study is done, 
and they will be reviewing your information for this purpose. 
 
What if I decide not to give permission to use and give out my health information? 
By signing this authorization form, you are giving permission to use and give out the health information 
listed above for the purposes described above. If you refuse to give permission, you will not be able to 
be in this research. 
 
May I review or copy the information obtained from me or created about me? 

 
 
126
You have the right to review and copy your health information. However, if you decide to be in this 
study and sign this permission form, you will not be allowed to look at or copy your information until 
after the research is completed. 
 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. The use of your personal health information will 
continue until you cancel your permission. 
 
You may withdraw or take away your permission to use and disclose your health information at any 
time. You do this by sending written notice to the study doctor. If you withdraw your permission, you 
will not be able to continue being in this study. 
 
When you withdraw your permission, no new health information which might identify you will be 
gathered after that date. Information that has already been gathered may still be used and given to 
others. This would be done if it were necessary for the research to be reliable. 
 
Is my health information protected after it has been given to others? 
If you give permission to give your identifiable health information to a person or business, the 
information may no longer be protected. There is a risk that your information will be released to others, 
including others outside of UAB, without your permission. 
 
 
Signature of participant:  
 
 
 
 
 
 
 
Date:   
 
 
or participant's legally authorized representative:  
 
 
 
 
Date:   
 
 
Printed Name of participant’s representative:   
 
 
 
 
 
Relationship to the participant:   
 
 
 
 
 
 
 
 
 

 
 
127
Telephone Screening Form                                                                                                                    
 
Confirm that you are speaking with the potential participant that has contacted us or 
who has filled out a contact card. 
 
Introduction: We’re enrolling 660 adults to take part in a research study about how to 
measure blood pressure.  If you enroll, you will be asked to visit the UAB Hypertension 
Research Clinic four times for this study.  We will try to schedule these visits on 
consecutive days but there may be a need to schedule these visits a few days apart.  
During the course of the study, you will have your blood pressure measured twelve 
times over your first two visits in the Hypertension Clinic, you will wear an automated 
blood pressure monitor that measures your blood pressure every 30 minutes for 24 
hours, and you will wear a new blood pressure monitor that you put on before going to 
bed and it measures your blood pressure three times at night while you are asleep. 
Afterwards, you will answer some questions about your experience while wearing each 
of the monitors. At your last visit, we will ask you to provide a blood and urine sample 
and complete an echocardiogram. Does this sound like something you might be 
interested in doing?  If no—thank them for their time.  If yes, see text for screen. 
 
Screen: Now I’d like to ask you a few questions to make sure you’re eligible to 
participate.  Go to question 1. 
1. Are you willing to complete four or more study visits over the course of 2 weeks 
at UAB? 
If yes, go to question 2. If no, see text for not eligible.  
 
2. Do you have reliable transportation to and from UAB Hypertension Research 
Clinic located on 19th Street? 
If yes, go to question 3. If no, see text for not eligible.  
 
3. How old are you?   
If ≥ 19 years, go to question 4.  If < 19 years, see text for not eligible. 

 
 
128
 
4. What is your sex?* 
 
If female and age < 60 years, go to question 3. Otherwise, go to question 5.  
*The protocol specifies recruitment of 330 women and 330 men.  Once the recruitment 
cap in each group is met, we will no longer accept participants in that group. 
 
5. Are you currently pregnant? 
 
If no, go to question 6. If yes, see text for not eligible.  
 
6. Which of the following race/ethnicities would you consider yourself?  
Non-Hispanic white 
Non-Hispanic black 
Non-Hispanic Asian 
Hispanic 
Other 
 
7. Are you currently taking medication for high blood pressure or hypertension? 
 
If no, go to question 8.  If yes, see text for not eligible. 
 
8. Have you ever been told by a physician that you have sleep apnea? 
 
If yes, see text for not eligible. If no, administer STOP-BANG questionnaire.   
 
 
 
 

 
 
129
STOP 
 
 
Do you SNORE loudly (louder than 
talking or loud enough to be heard 
through closed doors)? 
Yes  
No 
Do you often feel TIRED, fatigued, or 
sleepy during daytime? 
Yes  
No 
Has anyone OBSERVED you stop 
breathing during your sleep? 
Yes  
No 
Do you have or are you being treated 
for high blood PRESSURE? 
Yes  
No 
BANG 
 
 
BMI more than 35kg/m2? 
Yes  
No 
AGE over 50 years old? 
Yes  
No 
NECK circumference > 16 inches 
(40cm)? 
Yes  
No 
GENDER: Male? 
Yes  
No 
Total Score  
 
 
High risk of OSA: Yes 5 - 8 
Intermediate risk of OSA: Yes 3 - 4 
Low risk of OSA: Yes 0 - 2 
 
*If STOP-BANG score (minus neck circumference and BMI) is greater than 3, then see 
text for ineligible. 
*If STOP-BANG score (minus neck circumference and BMI) 3 or less, then see text for 
eligible. 
 
 
9. Have you ever been told by a physician that you have heart disease? 
 
If no, go to question 9.  If yes, see text for not eligible. 
 
10. Have you ever been told by a physician that you have had a heart attack? 
 
If no, go to question 10.  If yes, see text for not eligible. 

 
 
130
 
11. Have you ever been told by a physician that you have had a stroke? 
 
If no, go to question 11.  If yes, see text for not eligible. 
 
12. Have you ever been told by a physician that you have congestive heart failure? 
 
If no, go to question 12.  If yes, see text for not eligible. 
 
13. Have you ever been told by a physician that you have an arrhythmia (e.g. atrial 
fibrillation and/or ventricular tachycardia)? 
 
If no, go to question 13.  If yes, see text for not eligible. 
 
14. Have you ever had heart surgery? 
 
If no, go to question 14.   
If yes, please ask them for the reason for the surgery.  
If for revascularization or coronary artery bypass surgery, see text for ineligible.  
If for other reasons (e.g. congenital heart defect), please go to question 14. 
 
15. Have you completed ABPM over 24 hours in the past year? 
 
If no, go to question 15. If yes, see text for not eligible. 
 
16. Do you work overnight shift (e.g. – 11pm to 7am)? 
          If no, go to question 17. If yes, see text for not eligible. 
 
17. Do you have a permanent address? 
 If yes, see text for not eligible. 
 

 
 
131
Not eligible: Sorry, it looks like you are not eligible to participate at this time.  Thank 
you for taking the time to learn more about our study.  I hope you have a nice day. 
 
Eligible: Great! It looks like you are eligible to participate in the study.  If I can collect 
your name and contact information, I will send you a consent form with more details.   
 
 
Full Name __________________________________ 
 
 
Email Address _________________________________ 
 
 
Mailing Address _________________________________ 
 
 
Phone Number __________________________________ 
 
Thank you. Due to the current ongoing pandemic, we now have the option for you to 
complete your study documents electronically. Would you prefer to complete your study 
documents in-person or electronically? 
            Electronically     
           In-Person          
 
If participant would like to complete forms electronically: We would like to give you 
time to read over the consent form and answer any questions you may have over a 
conference call.  Can we schedule you for a conference call this week?  
 
If participant would like to complete forms in-person: We would like to give you time to 
read over the consent form but we can find a convenient time for you to start the study. 
Can we schedule your first visit now?  
 
Just to make you aware, prior to each of your in-person visits, we will ask you to 
complete COVID-19 screening questions and a temperature check. We also ask that 
you wear a mask to each of your visits. We will call and email you the day before your 
first visit as a reminder. Thank you for taking the time to learn about our study. I hope 
you have a nice day.   

 
 
132
Blood Pressure Screening Form  
 
ID:  _________ 
 
 
 
 
 
 
 
Date: ___/___/___ 
 
Participant First Name: ___________________________ 
Participant Last Name: ___________________________ 
 
 
 
 
 
 
 
 
First blood pressure reading: __________/__________/_________ 
 
 
 
 
      
     SBP        
   DBP              HR 
 
 
 
 
 
 
 
     
 
Second blood pressure reading: 
__________/__________/_________ 
 
 
 
 
      
      
       SBP              DBP              HR 
 
 
 
 
     
 
 
 
Average blood pressure reading: 
__________/__________/_________ 
 
 
 
 
      
     
        SBP           DBP              HR 
 
 

 
 
133
COVID-19 Screening Form  
 
VISIT ____   
 
 
 
 
 
 
 
 
ID ______ 
 
Symptom Tracker: 
 
I need to ask about any symptoms you may have related to COVID-19. 
Do you have any of the following? 
 
 A current diagnosis of COVID-19? [ ] Yes [ ] No 
If yes, have you had a negative test result since? [ ] Yes [ ] No 
 A new cough [ ] Yes [ ] No 
 Shortness of breath or difficulty breathing [ ] Yes [ ] No 
 Chills [ ] Yes [ ] No 
 Muscle pain [ ] Yes [ ] No 
 Sore throat [ ] Yes [ ] No 
 New loss of taste or smell [ ] Yes [ ] No 
 
 
Temperature: ________ 
 
 

 
 
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Draft Telephone Screening Email 
 
Hello (insert potential participant name), 
 
    Thank you for your interest in the Better BP study. We are currently enrolling 660 adults to 
take part in this research study about how to measure blood pressure. To confirm your eligibility 
for this study, please respond to this email with a day and time that would work best for us to 
schedule your telephone screening. The screening call should take approximately 10 minutes. 
 
   Thank you again for your interest in the Better BP study. 
 
Sincerely,  
 
(Insert your name)

 
 
135
Consent Form (Study Participant) 
 
Title of Research: 
Evaluating Novel Approaches for Estimating Awake and Sleep 
Blood Pressure –Better BP study. 
UAB IRB Protocol #: 
IRB-300001727 
Principal Investigator: 
Paul Muntner, PhD 
Sponsor: 
National Heart, Lung, and Blood Institute (NHLBI) 
 
General Information 
You are being asked to take part in a research study. This research 
study is voluntary, meaning you do not have to take part in it. The 
procedures, risks, and benefits are fully described in the consent 
form. 
Purpose 
The purpose of the study is to test whether blood pressure measured 
in a clinic setting without medical staff present is comparable to 
blood pressure levels measured during the daytime outside of the 
clinic.  Also, we will test whether blood pressure can be accurately 
measured while you’re asleep using a new home blood pressure 
monitoring device.   
Duration & Visits 
You will be in this study for approximately 1 to 2 weeks. You will 
come to the UAB Hypertension Research Clinic for four study visits. 
Overview of 
Procedures 
Prior to the start of this study, you will have your blood pressure 
measured two times in the clinic to confirm your eligibility. 
 
During this study, you will have your blood pressure measured in the 
clinic a total of twelve times during the first two study visits. You 
will wear a device called an ambulatory blood pressure monitor that 
measures your blood pressure every 30 minutes for 24 hours and 
wear a home blood pressure monitor for one night while you sleep.  
 
Also, you will complete questionnaires regarding your 
demographics, medical history, your sleeping habits and your 
experience wearing both the ambulatory blood pressure monitor and 
home blood pressure monitor. 
 
You will conclude the study with a brief physical exam, which 
includes blood and urine collection and an echocardiogram (a 
procedure that involves getting a picture of your heart image with a 
wand that is rubbed on your skin). 
Risks 
The most common risk is minimal discomfort and/or skin irritation 
from the inflation of the blood pressure cuff every 30 minutes for 24 
hours.  You may also experience difficulty sleeping while having 
your blood pressure measured. 
Benefits 
We will provide you with your blood pressure measurements and the 
results from the echocardiogram. Also, the principal investigator 
hopes that the information from this study will be able to provide 
knowledge that will improve the measurement of blood pressure for 
patients in the future.  
 

 
 
136
Purpose of the Research Study 
For many people, blood pressure levels differ when measured in a doctor’s office versus during 
normal daily activities. Ambulatory blood pressure monitoring, also called ABPM, involves 
wearing a blood pressure cuff attached to a device that is programmed to measure your blood 
pressure every 30 minutes for a 24-hour period.  ABPM can help better estimate a person’s true 
average blood pressure.  Although ABPM is recommended for diagnosing high blood pressure 
and it also measures blood pressure while people sleep, it is not available in many clinics and 
some people find the procedure to be uncomfortable. The purpose of this research study is to test 
whether blood pressure measured in a clinic setting without medical staff present is comparable 
to blood pressure levels measured during the daytime measured using an ABPM device.  Also, 
we will test whether asleep blood pressure can be accurately measured using a home blood 
pressure monitoring device.  These findings may help identify new approaches for diagnosing 
high blood pressure without the need for ABPM. We will enroll a total of 660 participants at the 
University of Alabama at Birmingham (UAB) and Columbia University in New York. UAB will 
enroll 330 adults who recently had a doctor’s visit and are not currently taking a blood pressure 
lowering medication to take part in this study. Each participant will complete four study visits. 
 
Study Participation & Procedures 
We are asking you to take part in a research study. If you enroll, you will be asked to visit the 
UAB Hypertension Research Clinic, located at 933 19th Street South, four times for this study. 
Ideally, the study visits will occur on four consecutive days.  However, the timing of the visits 
will be determined by your availability and that of the study staff.  During the course of the 
study, you will: 
 
• During the screening process, you will have your blood pressure measured two 
times in the clinic by study staff to confirm your eligibility. 
• Have your blood pressure measured in the clinic, six times at each of the first two 
study visits for a total of twelve blood pressure measurements). 
• Sign a medical release form for us to review your medical records from the past 
three months and record your blood pressure levels as measured when you visit 
your doctor’s office. 
• Complete questionnaires about your demographics, medical history, and your 
sleeping habits. 
• Have 4 tablespoons of blood drawn and provide a sample of your urine. 
• Wear a Food and Drug Administration-approved ABPM device (Microlife 
WatchBP O3) for 24 hours. 
• Wear a Food and Drug Administration-approved home blood pressure monitor 
(Microlife WatchBP Home N) while you sleep for one night. 
• Wear an activity monitor (Actiwatch) for two 24-hour periods. The Actiwatch 
activity monitor is like a watch worn on your wrist and it measures your activity 
levels and can be used to identify when you are asleep. 
• Answer some questions about your experience while wearing the ABPM and 
home blood pressure monitoring 
• Have an echocardiogram performed. An echocardiogram is a procedure where a 
wand is rubbed along your ribcage, under your shirt, to obtain an image of your 
heart. 

 
 
137
 
First UAB Hypertension Center visit 
At the beginning of this visit, we will ask you to sign this form agreeing to participate in the 
study. Prior to beginning any study procedures, a staff member will measure your blood pressure 
two times separated by a I-minute interval following a 5-minute rest period using an automated 
blood pressured device. These measurements will be used to confirm that you are eligible to 
participate in this study. To be eligible, your systolic blood pressure will need to be greater than 
or equal to 110 mm Hg and your diastolic blood pressure will need to be greater than or equal to 
70 mm Hg. Your systolic blood pressure will need to be less than 160 mm Hg and your diastolic 
blood pressure will need to be less than 100 mm Hg. Additionally, we will ask you questions 
about your sleep and measure your neck circumference. If you are eligible to participate, we will 
continue your first visit by measuring your arm circumference and medical staff will take your 
blood pressure three times using a machine, similar to how it is done in your doctor ' s office. We 
will also measure your blood pressure three times using the same machine after it is programmed 
to measure your blood pressure without staff being present. You will be randomly picked (like 
the flip of a coin) by a computer to have your blood pressure measured by staff first, followed by 
the automated measurements or to have your blood pressure measured by the automated device 
first and then by a staff member. Next, you will complete a brief physical exam, which includes 
height, weight and waist circumference measurements. Finally, you will be asked to complete 
questionnaires at the conclusion of this visit. These questionnaires will ask you questions about 
your medical history, stress you may experience, and your sleeping habits. This visit will last 
about 45 minutes to one hour. 
 
Second visit at the UAB Hypertension Center 
Your second visit will ideally occur the day after the first visit. At this visit, we will measure 
your blood pressure three times using a machine, similar to how it is done in your doctor’s office 
and three times using the same machine without another person in the room. The ordering of 
these blood pressure measurements will be the opposite of your first visit. For example, if your 
blood pressure is measured at the first visit without a staff member present three times and then 
with the staff member present then at the second visit your blood pressure will first be measured 
three times with the staff member present and then three times without the staff member present.  
Next, you will be asked to wear one of two different types of blood pressure monitors (a 
Microlife WatchBP O3 ABPM device or a Microlife WatchBP Home N blood pressure device). 
Which device you will be asked to wear after the second visit will be randomly picked by a 
computer.  You will wear either the Microlife WatchBP O3 ABPM device for 24 hours and then 
the Microlife WatchBP Home N sleep blood pressure device for one night or the Microlife 
WatchBP Home N sleep blood pressure device for one night and then the Microlife WatchBP O3 
ABPM device for 24 hours. You will also be asked to wear an Actiwatch activity monitor for the 
same duration as the device you are assigned. This visit will last about 45 minutes to one hour. 
 
24-hour blood pressure recording 
Your blood pressure over 24 hours will be measured by a Microlife WatchBP O3 ABPM device. 
This device has an arm cuff, similar to the one your doctor uses to measure your blood pressure 
during an examination. The cuff is attached to a small monitor about two or three times larger 
than a cell phone. You will wear this part of the ABPM device on your waist. A study staff 
member who is trained to measure blood pressure will instruct you on how to use the ABPM 
device, and how to remove it if necessary. The ABPM device will take your blood pressure 
automatically every 30 minutes while you are awake and while you are asleep.  
 

 
 
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Asleep home blood pressure recording 
For the asleep home blood pressure recording, you will be given a Microlife WatchBP Home N 
home blood pressure monitoring device and cuff and instructed on how to put on the cuff and use 
the monitor properly.  This device has an arm cuff similar to what your doctor uses to measure 
your blood pressure during an examination. This will be attached to a device, which is two or 
three times larger than a cell phone. You will be asked to put on the cuff and start the device 
before going to bed and keep it on until you wake up in the morning.  The device will measure 
your blood pressure when you put it on and then three times while you sleep (at 2, 3, and 4 hours 
after you have gone to sleep). 
 
Third visit at the UAB Hypertension Center 
Your third visit will ideally occur the day after the second visit and involves returning the 
electronic device you were given during the second visit (either the Microlife WatchBP O3 
ABPM device or the Microlife WatchBP Home N sleep blood pressure device) and answering a 
questionnaire about your experiences with the device. You will then be provided with the blood 
pressure device you haven’t worn yet (either the Microlife WatchBP O3 ABPM device or the 
Microlife WatchBP Home N sleep blood pressure device) for the next stage of the protocol. You 
will again wear an Actiwatch on your wrist for another 24 hours. A staff member from the clinic 
will instruct you how to use this device.  This visit will last about 30 minutes.  
 
Fourth visit at the UAB Hypertension Center  
Your fourth visit will ideally occur the day after the third visit and involves returning the devices 
you were given during the third visit and answering a written questionnaire about your 
experiences with the device you wore (either the Microlife WatchBP O3 ABPM device or the 
Microlife WatchBP Home N sleep blood pressure device). Next, a staff member will collect a 
sample of your blood and urine. You will then have an echocardiogram done (or scheduled 
within the next two weeks). Upon completion of the echocardiogram, you will have successfully 
completed the study. An echocardiogram is a procedure where a wand is rubbed along your 
ribcage, under your shirt, to obtain an image of your heart.  The wand has some gel on it that 
may be cold.  This visit should last 45 minutes to one and a half hours depending on whether the 
echocardiogram is done at this visit or scheduled to occur at a later visit.  
 
Your de-identified private information and de-identified biospecimens (private information and 
biospecimens with all identifiers removed) may be used for future research studies or distributed 
to another researcher for future research studies without additional informed consent. This is 
only when there are no identifiers associated with the data or biospecimens. 
 
Risks and Discomforts 
The following risks/discomforts may occur as a result of your participation in this study: There 
may be minimal pain or discomfort during the inflation of the blood pressure device arm cuffs (as 
might occur when your doctor takes your blood pressure). This discomfort is temporary and minor. 
Both the Microlife WatchBP O3 and the Microlife WatchBP Home N blood pressure monitoring 
devices take measurements while you sleep. This may produce some disturbance of your sleep. 
You may also experience bruising or skin irritation from wearing the blood pressure devices.  
 
Questionnaires will include potentially sensitive information concerning possible sources of stress. 
It is possible that you could feel temporarily upset, tired, or anxious when reporting this 

 
 
139
information. If you need to talk with someone, we can consult the principal investigator, a 
counselor, social worker, or chaplain. 
 
There may be some slight discomfort when taking a blood sample and you may experience 
bruising, soreness, and pain at the site of the needle stick. A trained technician will draw your 
blood and every effort will be made to minimize any discomfort. The risk of infection is minimal, 
and only sterile materials will be used. 
 
There may also be risks that are unknown at this time. You will be given more information if other 
risks are found. 
 
Benefits 
Every research participant has the opportunity to receive a report with their 24-hour blood 
pressure recording, lab results, and an echocardiogram. Blood pressure measured on ABPM has 
been shown to provide information above and beyond the usual measurements taken in the 
doctor’s office. An echocardiogram provides information on how well your heart pumps your 
blood to the rest of your body.  This can be used to detect if your heart is not pumping blood as 
well as it should.  These results will be shared with you and your doctor if you would like. Please 
initial your choice below to indicate whether you would like us to send you a report describing 
your study results: 
 
_____ No, do not mail my blood pressure readings, lab results or echocardiogram 
results to me. 
_____ Yes, I would like a copy of my blood pressure readings, lab results or 
echocardiogram results mailed to me. 
 
_____ No, do not mail my blood pressure readings, lab results or echocardiogram 
results to my doctor. 
_____ Yes, I would like a copy of my blood pressure readings, lab results or 
echocardiogram results mailed to my doctor. 
 
In addition to providing you and your doctor with these results, we hope that this study will 
provide knowledge to improve cardiovascular outcomes for patients in the future.  
 
 
Alternatives 
Your alternative is to not participate in this study. 
 
 
 
Confidentiality and Authorization to Use and Disclose Information for Research Purposes 
 
Federal regulations give you certain rights related to your health information. These include the 
right to know who will be able to get the information and why they may be able to get it. The 
investigator must get your authorization (permission) to use or give out any health information 
that might identify you. 

 
 
140
 
What protected health information may be used and/or given to others? 
All medical information, including but not limited to information and/or records of any diagnosis 
or treatment of disease or condition, which may include sexually transmitted diseases (e.g., HIV, 
etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal identifiers, including 
but not limited to your name, social security number, medical record number, date of birth, dates 
of service, etc.; any past, present, and future history, examinations, laboratory results, imaging 
studies and reports and treatments of any kind, including but not limited to drug/alcohol 
treatment, psychiatric/psychological treatment; financial/billing information, including but not 
limited to copies of your medical bills; any other information related to or collected for use in the 
research study, regardless of whether the information was collected for research or non-research 
(e.g., treatment) purposes; records about any study drug you received or about study devices 
used; and consent forms from past studies that might be in your medical record. 
 
Who may use and give out information about you? 
Information about your health may be used and given to others by the study investigator and 
research staff at UAB and Columbia University. They might see the research information during 
and after the study. 
 
Who might get this information? 
All individuals/entities listed in the informed consent document(s), including but not limited to, 
the physicians, nurses and staff and others performing services related to the research (whether at 
UAB or elsewhere). Your information may also be given to the sponsor of this research. 
“Sponsor” includes any persons or companies that are working for or with the sponsor, or are 
owned by the sponsor, or are providing support to the sponsor (e.g., contract research 
organization). 
 
Information about you and your health which might identify you may be given to: 
• the Office for Human Research Protections (OHRP) 
• the U.S. Food and Drug Administration (FDA) 
• Department of Health and Human Services (DHHS) agencies 
• Governmental agencies in other countries 
• Governmental agencies to whom certain diseases (reportable diseases) must be reported 
• the University of Alabama at Birmingham - the physicians, nurses and staff working on the 
research study (whether at UAB or elsewhere); other operating units of UAB, UAB Hospital, 
UAB Highlands Hospital, University of Alabama Health Services Foundation, Children’s of 
Alabama, Eye Foundation Hospital, and the Jefferson County Department of Health, as 
necessary for their operations; the UAB IRB and its staff 
• the billing offices of UAB and UAB Health Systems affiliates and/or Children’s of Alabama 
and its billing agents 
• Columbia University – physicians and staff working on the research study 
 
 
Why will this information be used and/or given to others? 
Information about you and your health that might identify you may be given to others to carry 
out the research study. The sponsor will analyze and evaluate the results of the study.  
 
What if I decide not to give permission to use and give out my health information? 

 
 
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By signing this consent form, you are giving permission to use and give out the health 
information listed above for the purposes described above. If you refuse to give permission, you 
will not be able to participate in this research. 
 
May I review or copy the information obtained from me or created about me? 
You have the right to review and copy your health information. However, if you decide to be in 
this study and sign this permission form, you will not be allowed to look at or copy your 
information until after the research is completed. 
 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. The use of your personal health information 
will continue until you cancel your permission. 
 
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the principal investigator. If you withdraw 
your permission, you will not be able to continue being in this study. 
 
When you withdraw your permission, no new health information which might identify you will 
be gathered after that date. Information that has already been gathered may still be used and 
given to others. This would be done if it were necessary for the research to be reliable. 
 
Is my health information protected after it has been given to others? 
If you give permission to give your identifiable health information to a person or business, the 
information may no longer be protected. There is a risk that your information will be released to 
others. Including others outside of UAB, without your permission. 
 
Voluntary Participation and Withdrawal 
 
Taking part in this study is your choice. There will be no penalty if you decide not to be in the 
study. If you decide not to be in the study, you will not lose any benefits you are otherwise owed. 
You are free to withdraw from this research at any time. Your choice to leave the study will not 
affect your relationship with UAB. You may be removed from the study without your consent if 
the sponsor ends the study, if the principal investigator decides it is not in the best interest of 
your health, or if you are not following the study rules. 
 
If you are a UAB student or employee, taking part in this research is not a part of your UAB 
class work or duties. You can refuse to enroll, or withdraw after enrolling at any time before the 
study is over, with no effect on your class standing, grades, or job at UAB. You will not be 
offered or receive any special consideration if you take part in this research. 
 
Cost of Participation 
There will be no cost to you for taking part in this study. All devices and exams related to this 
study will be provided to you at no cost during the study period. 
 
Payment for Participation 

 
 
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There will be no compensation for screening to determine if you are eligible to participate in the 
study. If you are eligible and participate in the study, you will be paid the following amount for 
each study visit you complete: $15 for study visit 1, $15 for study visit 2, $45 for study visit 3, 
and $75 for study visit 4. You will also receive an additional $5 for parking at the 6th Avenue 
parking deck to receive their echocardiograms at Kirklin Clinic. You may be paid a total of $155 
for completing all four study visits, including successfully completing the questionnaires, blood 
and urine collection, blood pressure recordings and echocardiogram. All three measurements 
must be successfully taken by the Microlife WatchBP Home N sleep blood pressure device and 
at least 80% (39 or more) of the measurements must be successfully taken by the Microlife 
WatchBP O3 ABPM device, with at least 10 measurements taken during the day and 5 
measurements taken at night. If fewer than 3 of the Microlife WatchBP Home N sleep blood 
pressure device measurements or fewer than 80% (38 or fewer) of the Microlife WatchBP O3 
ABPM device measurements are successful and you have completed the study visits, you may 
choose to wear the device(s) for which you had incomplete measurements again to complete the 
study and receive the full $150 compensation. You will be compensated 2-3 weeks following the 
last visit you complete. Ask the study staff about the method of payment that will be used for this 
study (e.g., check, cash, gift card, direct deposit). 
 
Payment for Research-Related Injuries 
UAB and the NHLBI will not provide for any payment if you are harmed as a result of taking 
part in this study. If such harm occurs, treatment will be provided. However, this treatment will 
not be provided free of charge. 
 
New Findings 
You will be told by the study investigator or the study staff if new information becomes available 
that might affect your choice to stay in the study. 
 
Optional Research 
This section of the consent form is about optional research that may be done with people who are 
taking part in this study.  You may take part in this optional research if you want to.  You can be 
a part of this study even if you decline to take part in any of the optional research. 
 
Future Research Use of Private Information and/or Biospecimens  
 
We would like your permission to keep your private information (data containing personal 
information) and biospecimens (blood and urine specimen) collected in this study for future 
research. The future research may be similar to this study or may be completely different. 
Your private information and biospecimens will be stored indefinitely or until used. 
 
Your private information and biospecimens will be labeled with a code that only the study 
investigators can link back to you. Results of any future research will not be given to you or 
your doctor.  
 
You can take part in this study even if you decide not to let us keep your private information 
and biospecimens for future research. 
 

 
 
143
If you give us permission now to keep your private information and biospecimens, you can 
change your mind later and ask us to destroy it. However, once we have analyzed your 
private information and biospecimens, we may not be able to take it out of our future 
research. 
 
We may share your private information and biospecimens, so that others can use it in their 
research. Their research may be similar to this study or may be completely different. Once 
we have shared your private information and biospecimens with other researchers, we will 
not be able to get it back. 
 
Future research use of your private information and biospecimens will be conducted in 
compliance with applicable regulatory requirements. 
 
You will not find out the results of future research on your private information and 
biospecimens. Allowing us to do future research on your private information and 
biospecimens will not benefit you directly. 
 
The private information and biospecimens used for future research may be used for 
commercial profit. There are no plans to provide financial compensation to you should this 
occur. 
 
Initial your choices below: 
 
Research related to cardiovascular disease and/or hypertension  
 
___ I agree to allow my private information and biospecimens to be kept and used for future 
research related to cardiovascular disease and/or hypertension. 
 
___ I do not agree to allow my private information and biospecimens to be kept and used for 
future research related to cardiovascular disease and/or hypertension. 
 
Research not related to cardiovascular disease and/or hypertension  
 
___ I agree to allow my private information and biospecimens to be kept and used for future 
research not related to cardiovascular disease and/or hypertension. 
 
___ I do not agree to allow my private information and biospecimens to be kept and used for 
future research not related to cardiovascular disease and/or hypertension. 
 
Research related to genetic testing   
 
In the future, the DNA from your blood sample may be used to measure inherited factors that 
might relate to cardiovascular disease or hypertension. Results of these tests will not be 
reported to you without your permission and unless they have a clinical meaning. If we 
happen to find a gene problem that is linked to a medically treatable genetic disease, we will 
contact you if have given us permission to do so. Results from these tests will not be 
released, placed in your medical record, or shared in any way with your relatives, personal 
physicians, insurance companies, or any other third party unless you authorize the Better BP 
study staff, in writing, to do so. 

 
 
144
 
___ I agree to allow my private information and biospecimens to be kept and used for future 
research related to genetic testing. 
 
___ I do not agree to allow my private information and biospecimens to be kept and used for 
future research related to genetic testing. 
 
Results related to genetic testing   
 
___ Yes, I would like to be notified if a potentially treatable genetic condition is identified 
during future research related to genetic testing. 
 
___ No, I would not like to be notified if a potentially treatable genetic condition is identified 
during future research related to genetic testing 
 
 
Questions 
If you have any questions, concerns, or complaints about the research or a research-related injury 
including available treatments, please contact the study principal investigator. You may contact 
Dr. Paul Muntner at (205) 975-8077. 
 
If you have questions about your rights as a research participant, or concerns or complaints about 
the research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free 
at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through 
Friday. 
 
Legal Rights 
You are not waiving any of your legal rights by signing this consent form. 
 
Signatures 
Your signature below indicates that you have read (or been read) the information provided above 
and agree to participate in this study. You will receive a copy of this signed consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Participant 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator or Person Obtaining Consent  
 
 
 
Date 
 
 

 
 
145
Consent Form (Mock Participant) 
 
Title of Research: 
Evaluating Novel Approaches for Estimating Awake and Sleep 
Blood Pressure –Better BP study. 
 
UAB IRB Protocol #: 
IRB-300001727 
 
Principal Investigator: 
Paul Muntner, PhD 
 
Sponsor: 
National Heart, Lung, and Blood Institute (NHLBI) 
 
General Information 
You are being asked to take part in a research study. This research 
study is voluntary, meaning you do not have to take part in it. The 
procedures, risks, and benefits are fully described in the consent 
form. 
Purpose 
The purpose of the study is to test whether blood pressure measured 
in a clinic setting without medical staff present is comparable to 
blood pressure levels measured during the daytime outside of the 
clinic.  Also, we will test whether blood pressure can be accurately 
measured while you’re asleep using a new home blood pressure 
monitoring device. The purpose of the mock participants is to test 
protocol procedures before we recruit and enroll study participants. 
Duration & Visits 
You will be in this study for approximately 1 to 2 weeks. You will 
come to the UAB Hypertension Research Clinic for four study visits. 
Overview of 
Procedures 
During this study, you will have your blood pressure measured in the 
clinic a total of twelve times during the first two study visits. You 
will wear a device called an ambulatory blood pressure monitor that 
measures your blood pressure every 30 minutes for 24 hours and 
wear a home blood pressure monitor for one night while you sleep.  
 
Also, you will complete questionnaires regarding your 
demographics, medical history, your sleeping habits and your 
experience wearing both the ambulatory blood pressure monitor and 
home blood pressure monitor. 
 
You will conclude the study with a brief physical exam, which 
includes blood and urine collection and an echocardiogram (a 
procedure that involves getting a picture of your heart image with a 
wand that is rubbed on your skin). Your data will not be used in the 
study data analysis. 
Risks 
The most common risk is minimal discomfort and/or skin irritation 
from the inflation of the blood pressure cuff every 30 minutes for 24 
hours.  You may also experience difficulty sleeping while having 
your blood pressure measured. 
Benefits 
We will provide you with your blood pressure measurements and the 
results from the echocardiogram. Also, the principal investigator 
hopes that the information from this study will be able to provide 

 
 
146
knowledge that will improve the measurement of blood pressure for 
patients in the future.  
 
 
 

 
 
147
Purpose of the Research Study 
For many people, blood pressure levels differ when measured in a doctor’s office versus during 
normal daily activities. Ambulatory blood pressure monitoring, also called ABPM, involves 
wearing a blood pressure cuff attached to a device that is programmed to measure your blood 
pressure every 30 minutes for a 24-hour period.  ABPM can help better estimate a person’s true 
average blood pressure.  Although ABPM is recommended for diagnosing high blood pressure 
and it also measures blood pressure while people sleep, it is not available in many clinics and 
some people find the procedure to be uncomfortable. The purpose of this research study is to test 
whether blood pressure measured in a clinic setting without medical staff present is comparable 
to blood pressure levels measured during the daytime measured using an ABPM device.  Also, 
we will test whether asleep blood pressure can be accurately measured using a home blood 
pressure monitoring device.  These findings may help identify new approaches for diagnosing 
high blood pressure without the need for ABPM. We will enroll a total of 10 mock study 
participants at the University of Alabama at Birmingham (UAB) and Columbia University in 
New York. UAB will enroll 5 adults who are not currently taking a blood pressure lowering 
medication to take part in this study. Each participant will complete four study visits. The 
purpose of the mock participants is to test protocol procedures. 
 
Study Participation & Procedures 
We are asking you to take part in a research pilot study. If you enroll, you will be asked to visit 
the UAB Hypertension Research Clinic, located at 933 19th Street South, four times for this 
study. Ideally, the study visits will occur on four consecutive days.  However, the timing of the 
visits will be determined by your availability and that of the study staff.  During the course of the 
study, you will: 
 
• Have your blood pressure measured in the clinic, six times at each of the first two 
study visits for a total of twelve blood pressure measurements). 
• Complete questionnaires about your demographics, medical history, and your 
sleeping habits. 
• Have 4 tablespoons of blood drawn and provide a sample of your urine. 
• Wear a Food and Drug Administration-approved ABPM device (Microlife 
WatchBP O3) for 24 hours. 
• Wear a Food and Drug Administration-approved home blood pressure monitor 
(Microlife WatchBP Home N) while you sleep for one night. 
• Wear an activity monitor (Actiwatch) for two 24-hour periods. The Actiwatch 
activity monitor is like a watch worn on your wrist and it measures your activity 
levels and can be used to identify when you are asleep. 
• Answer some questions about your experience while wearing the ABPM and 
home blood pressure monitoring 
• Have an echocardiogram performed. An echocardiogram is a procedure where a 
wand is rubbed along your ribcage, under your shirt, to obtain an image of your 
heart. 
 
First UAB Hypertension Center visit 
At this visit, we will ask you to sign this form agreeing to participate in the study and a form that 
will allow us to retrieve your medical records from the past three months.  Additionally, we will 
ask you questions about your sleep and measure your neck circumference. Next, we will measure 

 
 
148
your arm circumference and medical staff will take your blood pressure three times using a 
machine, similar to how it is done in your doctor’s office.  We will also measure your blood 
pressure three times using the same machine after it is programmed to measure your blood 
pressure without staff being present.  You will be randomly picked (like the flip of a coin) by a 
computer to have your blood pressure measured by staff first, followed by the automated 
measurements or to have your blood pressure measured by the automated device first and then 
by a staff member.  Next, you will complete a brief physical exam, which includes height, weight 
and waist circumference measurements. Finally, you will be asked to complete questionnaires at 
the conclusion of this visit.  These questionnaires will ask you questions about your medical 
history, stress you may experience, and your sleeping habits. This visit will last about 45 minutes 
to one hour. 
 
Second visit at the UAB Hypertension Center 
Your second visit will ideally occur the day after the first visit. At this visit, we will measure 
your blood pressure three times using a machine, similar to how it is done in your doctor’s office 
and three times using the same machine without another person in the room. The ordering of 
these blood pressure measurements will be the opposite of your first visit. For example, if your 
blood pressure is measured at the first visit without a staff member present three times and then 
with the staff member present then at the second visit your blood pressure will first be measured 
three times with the staff member present and then three times without the staff member present.  
Next, you will be asked to wear one of two different types of blood pressure monitors (a 
Microlife WatchBP O3 ABPM device or a Microlife WatchBP Home N blood pressure device). 
Which device you will be asked to wear after the second visit will be randomly picked by a 
computer.  You will wear either the Microlife WatchBP O3 ABPM device for 24 hours and then 
the Microlife WatchBP Home N sleep blood pressure device for one night or the Microlife 
WatchBP Home N sleep blood pressure device for one night and then the Microlife WatchBP O3 
ABPM device for 24 hours. You will also be asked to wear an Actiwatch activity monitor for the 
same duration as the device you are assigned. This visit will last about 45 minutes to one hour. 
 
24-hour blood pressure recording 
Your blood pressure over 24 hours will be measured by a Microlife WatchBP O3 ABPM device. 
This device has an arm cuff, similar to the one your doctor uses to measure your blood pressure 
during an examination. The cuff is attached to a small monitor about two or three times larger 
than a cell phone. You will wear this part of the ABPM device on your waist. A study staff 
member who is trained to measure blood pressure will instruct you on how to use the ABPM 
device, and how to remove it if necessary. The ABPM device will take your blood pressure 
automatically every 30 minutes while you are awake and while you are asleep.  
 
Asleep home blood pressure recording 
For the asleep home blood pressure recording, you will be given a Microlife WatchBP Home N 
home blood pressure monitoring device and cuff and instructed on how to put on the cuff and use 
the monitor properly.  This device has an arm cuff similar to what your doctor uses to measure 
your blood pressure during an examination. This will be attached to a device, which is two or 
three times larger than a cell phone. You will be asked to put on the cuff and start the device 
before going to bed and keep it on until you wake up in the morning.  The device will measure 
your blood pressure when you put it on and then three times while you sleep (at 2, 3, and 4 hours 
after you have gone to sleep). 
 
Third visit at the UAB Hypertension Center 

 
 
149
Your third visit will ideally occur the day after the second visit and involves returning the 
electronic device you were given during the second visit (either the Microlife WatchBP O3 
ABPM device or the Microlife WatchBP Home N sleep blood pressure device) and answering a 
questionnaire about your experiences with the device. You will then be provided with the blood 
pressure device you haven’t worn yet (either the Microlife WatchBP O3 ABPM device or the 
Microlife WatchBP Home N sleep blood pressure device) for the next stage of the protocol. You 
will again wear an Actiwatch on your wrist for another 24 hours. A staff member from the clinic 
will instruct you how to use this device.  This visit will last about 30 minutes.  
 
Fourth visit at the UAB Hypertension Center  
Your fourth visit will ideally occur the day after the third visit and involves returning the devices 
you were given during the third visit and answering a written questionnaire about your 
experiences with the device you wore (either the Microlife WatchBP O3 ABPM device or the 
Microlife WatchBP Home N sleep blood pressure device). Next, a staff member will collect a 
sample of your blood and urine. You will then have an echocardiogram done (or scheduled 
within the next two weeks). Upon completion of the echocardiogram, you will have successfully 
completed the study. An echocardiogram is a procedure where a wand is rubbed along your 
ribcage, under your shirt, to obtain an image of your heart.  The wand has some gel on it that 
may be cold.  This visit should last 45 minutes to one and a half hours depending on whether the 
echocardiogram is done at this visit or scheduled to occur at a later visit.  
 
 
Risks and Discomforts 
The following risks/discomforts may occur as a result of your participation in this study: There 
may be minimal pain or discomfort during the inflation of the blood pressure device arm cuffs (as 
might occur when your doctor takes your blood pressure). This discomfort is temporary and minor. 
Both the Microlife WatchBP O3 and the Microlife WatchBP Home N blood pressure monitoring 
devices take measurements while you sleep. This may produce some disturbance of your sleep. 
You may also experience bruising or skin irritation from wearing the blood pressure devices.  
 
Questionnaires will include potentially sensitive information concerning possible sources of stress. 
It is possible that you could feel temporarily upset, tired, or anxious when reporting this 
information. If you need to talk with someone, we can consult the principal investigator, a 
counselor, social worker, or chaplain. 
 
There may be some slight discomfort when taking a blood sample and you may experience 
bruising, soreness, and pain at the site of the needle stick. A trained technician will draw your 
blood and every effort will be made to minimize any discomfort. The risk of infection is minimal, 
and only sterile materials will be used. 
 
There may also be risks that are unknown at this time. You will be given more information if other 
risks are found. 
 
Benefits 
Every research participant has the opportunity to receive a report with their 24-hour blood 
pressure recording, lab results, and an echocardiogram. Blood pressure measured on ABPM has 

 
 
150
been shown to provide information above and beyond the usual measurements taken in the 
doctor’s office. An echocardiogram provides information on how well your heart pumps your 
blood to the rest of your body.  This can be used to detect if your heart is not pumping blood as 
well as it should.  These results will be shared with you and your doctor if you would like. Please 
initial your choice below to indicate whether you would like us to send you a report describing 
your study results: 
 
_____ No, do not mail my blood pressure readings, lab results or echocardiogram 
results to me. 
_____ Yes, I would like a copy of my blood pressure readings, lab results or 
echocardiogram results mailed to me. 
 
_____ No, do not mail my blood pressure readings, lab results or echocardiogram 
results to my doctor. 
_____ Yes, I would like a copy of my blood pressure readings, lab results or 
echocardiogram results mailed to my doctor. 
 
In addition to providing you and your doctor with these results, we hope that this study will 
provide knowledge to improve cardiovascular outcomes for patients in the future.  
 
Alternatives 
Your alternative is to not participate in this study. 
 
 
Confidentiality and Authorization to Use and Disclose Information for Research Purposes 
 
Federal regulations give you certain rights related to your health information. These include the 
right to know who will be able to get the information and why they may be able to get it. The 
investigator must get your authorization (permission) to use or give out any health information 
that might identify you. 
 
What protected health information may be used and/or given to others? 
All medical information, including but not limited to information and/or records of any diagnosis 
or treatment of disease or condition, which may include sexually transmitted diseases (e.g., HIV, 
etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal identifiers, including 
but not limited to your name, social security number, medical record number, date of birth, dates 
of service, etc.; any past, present, and future history, examinations, laboratory results, imaging 
studies and reports and treatments of any kind, including but not limited to drug/alcohol 
treatment, psychiatric/psychological treatment; financial/billing information, including but not 
limited to copies of your medical bills; any other information related to or collected for use in the 
research study, regardless of whether the information was collected for research or non-research 
(e.g., treatment) purposes; records about any study drug you received or about study devices 
used; and consent forms from past studies that might be in your medical record. 
 
Who may use and give out information about you? 
Information about your health may be used and given to others by the study investigator and 
research staff at UAB and Columbia University. They might see the research information during 
and after the study. 

 
 
151
 
Who might get this information? 
All individuals/entities listed in the informed consent document(s), including but not limited to, 
the physicians, nurses and staff and others performing services related to the research (whether at 
UAB or elsewhere). Your information may also be given to the sponsor of this research. 
“Sponsor” includes any persons or companies that are working for or with the sponsor, or are 
owned by the sponsor, or are providing support to the sponsor (e.g., contract research 
organization). 
 
Information about you and your health which might identify you may be given to: 
• the Office for Human Research Protections (OHRP) 
• the U.S. Food and Drug Administration (FDA) 
• Department of Health and Human Services (DHHS) agencies 
• Governmental agencies in other countries 
• Governmental agencies to whom certain diseases (reportable diseases) must be reported 
• the University of Alabama at Birmingham - the physicians, nurses and staff working on the 
research study (whether at UAB or elsewhere); other operating units of UAB, UAB Hospital, 
UAB Highlands Hospital, University of Alabama Health Services Foundation, Children’s of 
Alabama, Eye Foundation Hospital, and the Jefferson County Department of Health, as 
necessary for their operations; the UAB IRB and its staff 
• the billing offices of UAB and UAB Health Systems affiliates and/or Children’s of Alabama 
and its billing agents 
• Columbia University – physicians and staff working on the research study 
 
Why will this information be used and/or given to others? 
Information about you and your health that might identify you may be given to others to carry 
out the research study. The sponsor will analyze and evaluate the results of the study.  
 
What if I decide not to give permission to use and give out my health information? 
By signing this consent form, you are giving permission to use and give out the health 
information listed above for the purposes described above. If you refuse to give permission, you 
will not be able to participate in this research. 
 
May I review or copy the information obtained from me or created about me? 
You have the right to review and copy your health information. However, if you decide to be in 
this study and sign this permission form, you will not be allowed to look at or copy your 
information until after the research is completed. 
 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. The use of your personal health information 
will continue until you cancel your permission. 
 
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the principal investigator. If you withdraw 
your permission, you will not be able to continue being in this study. 
 

 
 
152
When you withdraw your permission, no new health information which might identify you will 
be gathered after that date. Information that has already been gathered may still be used and 
given to others. This would be done if it were necessary for the research to be reliable. 
 
Is my health information protected after it has been given to others? 
If you give permission to give your identifiable health information to a person or business, the 
information may no longer be protected. There is a risk that your information will be released to 
others. Including others outside of UAB, without your permission. 
 
Voluntary Participation and Withdrawal 
Taking part in this study is your choice. There will be no penalty if you decide not to be in the 
study. If you decide not to be in the study, you will not lose any benefits you are otherwise owed. 
You are free to withdraw from this research at any time. Your choice to leave the study will not 
affect your relationship with UAB. You may be removed from the study without your consent if 
the sponsor ends the study, if the principal investigator decides it is not in the best interest of 
your health, or if you are not following the study rules. 
 
If you are a UAB student or employee, taking part in this research is not a part of your UAB 
class work or duties. You can refuse to enroll, or withdraw after enrolling at any time before the 
study is over, with no effect on your class standing, grades, or job at UAB. You will not be 
offered or receive any special consideration if you take part in this research. 
 
Cost of Participation 
There will be no cost to you for taking part in this study. All devices and exams related to this 
study will be provided to you at no cost during the study period. 
 
Payment for Participation 
You will not be compensated for your participation in this study. 
 
Payment for Research-Related Injuries 
UAB and the NHLBI will not provide for any payment if you are harmed as a result of taking 
part in this study. If such harm occurs, treatment will be provided. However, this treatment will 
not be provided free of charge. 
 
 
New Findings 
You will be told by the study investigator or the study staff if new information becomes available 
that might affect your choice to stay in the study. 
 
Optional Research 
 
Your data will not be stored for future use in optional research.  
 
Questions 

 
 
153
If you have any questions, concerns, or complaints about the research or a research-related injury 
including available treatments, please contact the study principal investigator. You may contact 
Dr. Paul Muntner at (205) 975-8077. 
 
If you have questions about your rights as a research participant, or concerns or complaints about 
the research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free 
at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through 
Friday. 
 
Legal Rights 
You are not waiving any of your legal rights by signing this consent form. 
 
Signatures 
Your signature below indicates that you have read (or been read) the information provided above 
and agree to participate in this study. You will receive a copy of this signed consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Participant 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator or Person Obtaining Consent  
 
 
 
Date 
 
 
 

 
 
154
 
 

 
 
155
Better BP Screening Visit Checklist 
 
[  ] COVID-19 Screening 
[  ] Yes        [  ] No  
[  ] Symptom Tracker 
[  ] Temperature Check 
 
 
Consent sign and dated 
[   ] Yes      [ ] No 
BP cuff verified  
Left arm   
 
Right arm   
 
[  ] Yes         [ ] No 
 
 
Two Blood Pressure Measurements [  ] Yes    [  ] No  
Continue to visit 1 [  ] Yes [  ] No 
Screen fail [  ] Yes 
To be re-screen in one month [  ] Yes [  ] No  
Date   
 
 
 
Inform participants that qualify for the study that the morning of the clinic visit, 
participant should avoid coffee (and other caffeine containing food of beverages) 
smoking, exercise or eating for at least 30 minutes prior to office BP measurements. 
 
 
Completed by  
 
Date   
 

 
 
156
Better BP Study Visit 1 Checklist 
 
[  ] COVID-19 Screening               
 [  ] Yes   [  ] No 
[  ] Symptom Tracker  
[  ] Temperature Check 
 
[  ] Consent sign and dated  
 
[  ] Yes   [   ] No  
[  ] BP cuff verified                  
[  ] Yes   [  ] No  
[  ] Vital signs done               
 
[  ] Yes   [  ] No 
[  ] Height and Weight 
[  ] Waist and Neck circumference 
[  ] Questionnaires done       
 
[  ] Yes   [  ] No 
[  ] Social demographic (circle one:  email     or    in-person) 
[  ] Pittsburg Sleep Quality Index (circle one:  email     or    in-person) 
[  ] State Anxiety Index (Based on randomization order) 
[  ] Unattended  
 [  ] Attended  
[  ] Randomization 1 
[  ] Unattended then attended 
[  ] Attended then unattended 
Inform participant that the morning of the clinic visit, participant should 
avoid coffee (and other caffeine containing food or beverages) smoking, 
exercise or eating for at least 30 minutes prior to office BP 
measurements. 
 
Completed by   
 
Date   

 
 
157
Better BP Study 
Study Visit 1 Data Collection Form 
 
 
ID:  ___________ 
 
 
 
 
Date of Visit: __________________ 
Name of tech performing visit: _________________ 
Time of Visit: __________________ 
 
BEFORE PARTICIPANT ARRIVES 
1. Complete symptom tracker and temperature check 
2. Print consent form and all questionnaires (if not completed electronically) 
3. Verify cuffs of various sizes are available:       
 
AFTER PARTICIPANT ARRIVES 
4. Ask the participant if he/she needs to use the restroom prior to beginning  
5. Consent participant, if not previously completed electronically 
6. Measure height, weight, waist and neck circumference 
a. Height (cm) ___________ 
b. Weight (lbs) ___________ 
c. Waist circumference (cm) ____________ 
d. Neck circumference (cm) ____________ 
 
7. Allow participants to complete the following questionnaires: Sociodemographic, Perceived 
Stress, and Pittsburgh Sleep Quality Index (PSQI) [if not completed electronically]  
 
8. Measure arm circumference 
a. Is participant right or left handed (i.e., dominant arm; circle one): 
Left 
Right 
b. Arm circumference of dominant arm:   
______.__ cm  
c. Arm circumference of non-dominant arm: 
______.__ cm  
d. Is the clinic device being worn on the (non-dominant)? 
Yes  
No 
i. Reason if not worn on non-dominant __________________ 
e. Put “” next to cuff sizes that will be used 
 
 

 
 
158
 
 
 
 
 
 
 
 
9. Identify randomization assignment.   
 
Record randomization order: 
 
 
 
 
 
Unattended then attended 
 
 
 
 
Attended then unattended 
 
10. If the participant is randomized to unattended BP,  
a. Explain to participant the steps involved in obtaining unattended BP measurements: 
i. You will position them and they should not move or talk 
ii. You will start the blood pressure measurement device 
iii. You will leave the room for 10 minutes 
iv. After 5 minutes, they will have their blood pressure measured 
v. They will have their blood pressure measured two more times at one minute 
intervals 
vi. They should relax but not move until you return to the room 
b. Connect the BP device to the cuff 
c. Position patient for their BP measurement 
d. Start the device for a 5 minute waiting period 
e. Leave the room for 10 minutes 
 
8. If the participant is randomized to attended BP measurements 
h. Explain to participant the steps involved in obtaining unattended BP 
measurements: 
i. You will position them and they should not move or talk 
ii. You will start the blood pressure measurement device 
 
Clinic (Microlife Office AFIB) 
Cuff Size 
Arm 
circumference 
Dominant arm 
Non-dominant arm 
Small adult 
17-21.9 cm 
 
 
Med adult 
22-32 cm 
 
 
Large adult 
32.1-42 cm 
 
 
Extra-large 
42.1-52 cm 
 
 

 
 
159
iii. After 5 minutes, they will have their blood pressure measured 
iv. They will have their blood pressure measured two more times at one minute 
intervals 
v. They should relax but not move and there should be no talking until the three 
blood pressure measurements are taken 
i. 
Connect the BP device to the cuff 
j. 
Position patient for their BP measurement 
k. Start the device for a 5 minute waiting period 
 
 
 
 
11. Record measurements of clinic blood pressure assessments in the order determined by 
randomization using the WatchBP Office AFIB device.  
 
   Attended 
 
A)  _____/_____/_____ B)  _____/_____/_____ 
C)  _____/_____/_____ 
                  SBP      DBP         HR 
          SBP      DBP         HR  
            SBP      DBP         HR 
 
 
 
     Unattended  
 
 
A)  _____/_____/_____ 
B)  _____/_____/_____ 
C)  _____/_____/_____ 
           SBP      DBP         HR 
            SBP      DBP         HR  
            SBP      DBP         HR 
 
 
 
 
RESULTS WILL NOT BE PROVIDED TO PARTICIPANTS UNTIL THEY COMPLETE THE STUDY 
 
 
 
12. Schedule the participant for their next visit (visit 2). The participant should be strongly 
encouraged to schedule their visit for the same time the following day. 
13. Answer any questions that the participant may have.  
 
 
 

 
 
160
NOTES:  ____________________________________________________________________ 
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
_______________________________________________________ 
 
 

 
 
161
Better BP Study Visit 2 Checklist 
 
[  ] COVID-19 Screening               
 [  ] Yes   [  ] No 
[  ] Symptom Tracker  
[  ] Temperature Check 
 
[  ] Confirm that participant has avoid caffeinated products, food, 
smoking, and exercise for at least 30 minutes prior to this visit. 
[  ] State Anxiety Index (Opposite of Visit 1) 
[  ] Unattended 
 
 [  ] Attended  
[  ] Clinic BP measurements: (order will be opposite of Visit 1) 
[  ] Attended then Unattended 
 
[  ] Unattended then Attended 
 
[  ] Randomization 2  
[  ] ABPM device  
[  ] HBPM device 
 
[  ] Actiwatch activity monitor device 
 
(Actiwatch device will be remove at visit 4) 
 
[  ] Provide participant with the assigned Device Log form 
 
[  ] Provide participant with State Anxiety Index for home 
(To be completed during night of monitoring) 
 
 
 
 
Completed By   
 
Date   

 
 
162
Better BP Study 
Study Visit 2 Data Collection Form 
 
 
ID:  ___________ 
 
 
 
 
Date of Visit: __________________ 
Name of tech performing visit: _________________ 
Time of Visit: __________________ 
 
BEFORE PARTICIPANT ARRIVES 
1. Verify cuff size worn at Visit 1:      ☐ 
 
AFTER PARTICIPANT ARRIVES 
2. Greet the participant and explain what will be done during their visit: 
a. They will have their blood pressure measured six more times. 
b. They will begin their 24-hour blood pressure monitoring period or asleep blood 
pressure monitoring 
c. They will begin wearing an activity monitor on their wrist. 
 
3. Ask the participant if he/she needs to use the restroom prior to beginning their 
measurements. 
 
4. Identify the order for blood pressure measurement for the second visit (opposite order of 
visit 1).  
 
If BP is being measured unattended: 
a. Explain to participant the steps involved in obtaining unattended BP measurements: 
i. You will position them and they should not move or talk 
ii. You will start the blood pressure measurement device 
iii. You will leave the room for 10 minutes 
iv. After 5 minutes, they will have their blood pressure measured 
v. They will have their blood pressure measured two more times at one minute 
intervals 
vi. They should relax but not move until you return to the room 
b. Connect the BP device to the cuff 

 
 
163
c. Position patient for their BP measurement 
d. Start the device for a 5 minute waiting period 
e. Leave the room for 10 minutes 
 
If BP is being measured attended: 
l. 
Explain to participant the steps involved in obtaining unattended BP 
measurements: 
i. You will position them and they should not move or talk 
ii. You will start the blood pressure measurement device 
iii. After 5 minutes, they will have their blood pressure measured 
iv. They will have their blood pressure measured two more times at one minute 
intervals 
v. They should relax but not move and there should be no talking until the three 
blood pressure measurements are taken 
m. Connect the BP device to the cuff 
n. Position patient for their BP measurement 
o. Start the device for a 5 minute waiting period 
 
 
5. Record measurements of clinic blood pressure assessments in the using the WatchBP 
Office AFIB device.  
 
   Attended 
 
A)  _____/_____/_____ B)  _____/_____/_____ 
C)  _____/_____/_____ 
  
  SBP      DBP         HR 
           SBP      DBP         HR  
            SBP      DBP         HR 
 
 
 
     Unattended  
 
A)  _____/_____/_____ 
B)  _____/_____/_____ 
C)  _____/_____/_____ 
SBP      DBP         HR 
            SBP      DBP         HR  
            SBP      DBP         HR 
 
 
6. Identify randomization assignment – ambulatory blood pressure monitoring or home sleep 
blood pressure monitoring. 
Ambulatory Blood Pressure Monitoring  
Home Blood Pressure Monitoring  
 
 
 

 
 
164
IF PARTICIPANT IS ASSIGNED THE ABPM DEVICE FIRST  
7. Ask participant what time he/she anticipates going to sleep tonight and waking up tomorrow 
a. Anticipated time going to sleep:   
__________________ 
b. Anticipated time waking up:   
__________________ 
8. Initialize ABPM device.  Serial number:  ________________ 
9. Use the participant’s non-dominant arm for the WatchBP O3 ABPM. 
a. Arm where ABPM device will be worn (non-dominant)? 
   
Left 
Right 
i. Reason if not worn on non-dominant __________________ 
b. Put “” next to cuff sizes that will be used 
 
 
 
 
 
 
 
 
10. Place cuff on arm 
a. Find brachial artery (perhaps make small mark) 
b. Arrow on cuff over brachial artery, non-latex tubing coming out of cuff top 
c. Bottom of cuff 1” above bend/crease in elbow (if possible) 
d. Equal tension top and bottom of cuff (1 finger easily, 2 fingers snug, top and bottom) 
e. Wrap grey non-latex tubing around back of neck 
11. Connect tubing to ABPM device (make sure it will not pull out)  
12. Place the O3 device in ‘Ambulatory’ mode. 
13. Explain to participant about importance of remaining still during readings and keeping arm a) 
relaxed at side or in a “sling-like” position if standing, b) resting on table, arm rest, bed, etc. if 
sitting/reclining 
14. Take one test reading; repeat until obtain a valid reading (max 5 tries) 
a. If cannot get a valid reading, check for cuff too loose, kink in tubing, tubing not 
securely connected to ABPM device; if need be, change cuff and/or ABPM device 
(be sure to record new serial #) 
b. After getting a good reading, wait 30 secs, then start another reading & immediately 
cancel it 
15. Decide if participant will use shoulder strap (preferred), Microlife belt, own belt, or jacket 
pocket. Instrument ABPM cover appropriately, insert ABPM in cover, and make sure 
participant is comfortable with this method of wearing device. 
16. Review ABPM device log with participant (and remind them to bring it tomorrow or their next 
study visit) 
 
ABPM (Microlife WatchBP O3) 
Cuff Size 
Arm circumference 
Non-dominant arm 
Small adult 
17-21.9 cm 
 
Med adult 
22-32 cm 
 
Large adult 
32.1-42 cm 
 
Extra-large 
42.1-52 cm 
 

 
 
165
17. If the participant intends to remove the device to shower/changes clothes, require the 
participant to practice placing the device correctly with you present. 
18. Review with participant: 
a. Importance of remaining still when BP readings are being taken 
b. Importance of keeping arm relaxed/supported 
c. If there is a failed reading, device will attempt three (3) retries ~1 minute apart. 
d. If participant is consistently getting 2 failed readings, should call the study cellphone 
e. ABPM cannot get wet 
f. 
If they intend to remove the device at any point, please do so between readings 
g. Payment depends on getting 80% successful readings 
 
IF PARTICIPANT IS ASSIGNED THE HBPM DEVICE FIRST  
19. Ask participant what time he/she anticipates going to sleep tonight and waking up tomorrow 
a. Anticipated time going to sleep:   
__________________ 
b. Anticipated time waking up tomorrow:   __________________ 
20. Initialize HBPM device.  Serial number:  ________________ 
21. Use the participant’s non-dominant arm for the WatchBP Home N. 
a. Arm where HBPM device will be worn (non-dominant)? 
 Left 
Right 
i. Reason if not worn on non-dominant __________________ 
b. Put “” next to cuff sizes that will be used 
 
 
 
 
 
 
22. Demonstrate to the participant how to place the cuff on their arm 
a. Find brachial artery (perhaps make small mark) 
b. Arrow on cuff over brachial artery, non-latex tubing coming out of cuff top 
c. Bottom of cuff 1” above bend/crease in elbow (if possible) 
d. Equal tension top and bottom of cuff (1 finger easily, 2 fingers snug, top and bottom) 
e. Wrap grey non-latex tubing around back of neck 
f. 
Connect tubing to HBPM device (make sure it will not pull out) 
 
23. Require the participant practice placing the cuff on their arm with you present.  
24. Explain to participant the importance of placing the device correctly and initializing the 
device when they get in bed by holding the on/off button for 3 seconds to start the initial 
reading and the following readings will occur 2, 3, and 4 hours after they have gone to bed. 
25. Take one test reading in ‘Usual’ mode; repeat until obtain a valid reading (max 3 tries) 
 
HBPM (Microlife WatchBP Home N) 
Cuff Size 
Arm circumference 
Non-dominant arm 
Small adult 
17-21.9 cm 
 
Med adult 
22-32 cm 
 
Large adult 
32.1-42 cm 
 
Extra-large 
42.1-52 cm 
 

 
 
166
a. If cannot get a valid reading, check for cuff too loose, kink in tubing, tubing not 
securely connected to HBPM device; if need be, change cuff and/or HBPM device 
(be sure to record new serial #) 
26. Place the device in ‘Nocturnal’ mode. 
27. Place the device in a carrier bag for the participant.  
28. Review with participant: 
a. Importance of initializing the device before going to bed by holding the on/off button 
for 3 seconds 
b. If there is a failed reading, device will attempt three (3) ~1 minute apart. 
c. If participant is consistently getting 2 failed readings while initializing the device, they 
should call the study cellphone 
d. Payment depends on getting three successful readings while asleep 
 
29. Schedule participant for their return visit (24 hours later). 
30. Answer any questions that the participant may have.  
 
 
NOTES:  ____________________________________________________________________ 
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
_______________________________________________________ 

 
 
167
Better BP Study Visit 3 Checklist 
 
[  ] COVID-19 Screening               
 [  ] Yes   [  ] No 
[  ] Symptom Tracker  
[  ] Temperature Check 
 
[  ] Device return 
 
[  ] Check the device for complete readings 
 
[  ] HBPM three sleep BP readings [  ] Yes [  ] No 
 
[  ] ABPM ~35 measurements [  ] Yes [  ] No 
If No, ask participant to wear the device again to collect all 
necessary readings or measurements. 
 
If yes, complete the Post Questionnaire (circle one:  email   or    in-person) 
 
[  ] Post ABPM Questionnaire 
 
[  ] Post HBPM Questionnaire 
 
[  ] Participant will wear the opposite monitor of Visit 2 
 
      [  ] ABPM device  
[  ] HBPM device 
 
(Actiwatch device will be remove at visit 4) 
 
[  ] Provide participant with the assigned Device Log Form 
 
[  ] Provide participant with State Anxiety Index for home 
(To be completed during night of monitoring) 
 
 
Completed by   
     Date   
____________ 

 
 
168
Better BP Study 
Study Visit 3 Data Collection Form 
 
 
ID:  ___________ 
 
 
 
 
Date of Visit: __________________ 
Name of tech performing visit: _________________ 
Time of Visit: __________________ 
BEFORE PARTICIPANT ARRIVES 
4. Verify cuffs of various sizes are available for the WatchBP O3 and WatchBP Home N:      
 
AFTER PARTICIPANT ARRIVES 
 
IF PARTICIPANT COMPLETED THE HBPM DEVICE FIRST  
1. Check a complete recording (i.e. – two sleep BP readings) was obtained. 
a. Yes       No 
2. If yes, complete the post-HBPM questionnaire.  
3. If no, ask the participant to repeat the HBPM. Discuss with participant the challenges they 
encountered with obtaining a complete HBPM. 
4. Ask participant what time he/she anticipates going to sleep tonight and waking up tomorrow 
a. Anticipated time going to sleep:   
__________________ 
b. Anticipated time waking up tomorrow:   __________________ 
5. Initialize ABPM device.  Serial number:  ________________ 
6. Is the participant’s non-dominant arm being used for the WatchBP O3 ABPM? 
Yes  
No 
7. Reason for not using the non-dominant arm: _____________________________________ 
a. Put “” next to cuff sizes that will be used 
 
 
 
 
 
 
8. Place cuff on arm 
a. Find brachial artery (perhaps make small mark) 
b. Arrow on cuff over brachial artery, non-latex tubing coming out of cuff top 
c. Bottom of cuff 1” above bend/crease in elbow (if possible) 
d. Equal tension top and bottom of cuff (1 finger easily, 2 fingers snug, top and bottom) 
e. Wrap grey non-latex tubing around back of neck 
 
 
ABPM (Microlife WatchBP O3) 
Cuff Size 
Arm circumference 
Dominant arm 
Non-dominant arm 
Small adult 
17-21.9 cm 
 
 
Med adult 
22-32 cm 
 
 
Large adult 
32.1-42 cm 
 
 
Extra-large 
42.1-52 cm 
 
 

 
 
169
9. Connect tubing to ABPM device (make sure it will not pull out)  
10. Place the O3 device in ‘Ambulatory’ mode. 
11. Explain to participant about importance of remaining still during readings and keeping arm a) 
relaxed at side or in a “sling-like” position if standing, b) resting on table, arm rest, bed, etc. if 
sitting/reclining 
12. Take one test reading; repeat until obtain a valid reading (max 5 tries) 
a. If cannot get a valid reading, check for cuff too loose, kink in tubing, tubing not securely 
connected to ABPM device; if need be, change cuff and/or ABPM device (be sure to record 
new serial #) 
b. After getting a good reading, wait 30 secs, then start another reading & immediately cancel 
it 
13. Decide if participant will use shoulder strap (preferred), Microlife belt, own belt, or jacket pocket. 
Instrument ABPM cover appropriately, insert ABPM in cover, and make sure participant is 
comfortable with this method of wearing device. 
14. Review ABPM device log with participant (and remind them to bring it tomorrow or their next study 
visit) 
15. If the participant intends to remove the device to shower/changes clothes, require the participant to 
practice placing the device correctly with you present. 
16. Review with participant: 
a. Importance of remaining still when BP readings are being taken 
b. Importance of keeping arm relaxed/supported 
c. If there is a failed reading, device will attempt three (3) retries ~1 minute apart  
d. If participant is consistently getting 2 failed readings, should call study cellphone 
e. ABPM cannot get wet 
f. 
If they intend to remove the device at any point, please do so between readings 
g. Payment depends on getting 80% successful readings 
 
 
 

 
 
170
IF PARTICIPANT COMPLETED THE ABPM DEVICE FIRST  
17. Check a complete recording (i.e. ~35 BP measurements) was obtained. 
a. Yes       No 
18. If yes, complete the post-ABPM questionnaire.  
19. If no, ask the participant to repeat the ABPM. Discuss with participant the challenges they 
encountered with obtaining a complete ABPM. 
20. Ask participant what time he/she anticipates going to sleep tonight and waking up tomorrow 
a. Anticipated time going to sleep:   
__________________ 
b. Anticipated time waking up tomorrow:   __________________ 
21. Initialize HBPM device.  Serial number:  ________________ 
22. Is the participant’s non-dominant arm being used for the WatchBP Home N?  Yes  
No 
23. Reason for not using the non-dominant arm: __________________________________ 
a. Put “” next to cuff sizes that will be used 
 
 
 
 
 
  
24. Demonstrate to the participant how to place the cuff on their arm 
a. Find brachial artery (perhaps make small mark) 
b. Arrow on cuff over brachial artery, non-latex tubing coming out of cuff top 
c. Bottom of cuff 1” above bend/crease in elbow (if possible) 
d. Equal tension top and bottom of cuff (1 finger easily, 2 fingers snug, top and bottom) 
e. Wrap grey non-latex tubing around back of neck 
f. 
Connect tubing to HBPM device (make sure it will not pull out) 
 
25. Allow the participant to practice placing the cuff on their arm with you present.  
26. Explain to participant the importance of placing the device correctly and initializing the device when 
they get in bed by holding the on/off button for 3 seconds to start the initial reading and the following 
readings will occur 2, 3, and 4 hours after they have gone to bed. 
27. Take one test reading in ‘Usual’ mode; repeat until obtain a valid reading (max 3 tries) 
a. If cannot get a valid reading, check for cuff too loose, kink in tubing, tubing not securely 
connected to HBPM device; if need be, change cuff and/or HBPM device (be sure to record 
new serial #) 
28. Place the device in ‘Nocturnal’ mode. 
29. Place the device in a carrier bag for the participant.  
30. Review with participant: 
a. Importance of initializing the device before going to bed by holding the on/off button for 3 
seconds 
b. If there is a failed reading, device will attempt three (3) retries ~1 minute apart  
 
 
HBPM (Microlife WatchBP Home N)  
Cuff Size 
Arm 
circumference  
Dominant arm 
Non-dominant arm  
Small adult 
17-21.9 cm 
 
  
Med adult 
22-32 cm 
 
   
Large adult 
32.1-42 cm 
 
     
Extra-large 
42.1-52 cm 
 
  

 
 
171
c. If participant is consistently getting 2 failed readings while initializing the device, they should 
call the study cellphone 
d. Payment depends on getting three successful readings while asleep 
 
 
 
31. Answer any questions that the participant may have.  
 
 
NOTES:  ____________________________________________________________________ 
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
_________________________ 

 
 
172
Better BP Study Visit 4 Checklist 
 
[  ] COVID-19 Screening               
 [  ] Yes   [  ] No 
[  ] Symptom Tracker  
[  ] Temperature Check 
 
 [  ] Device return 
 
[  ] Check the device for complete readings 
 
[  ] HBPM two sleep BP readings [  ] Yes [  ] No 
 
[  ] ABPM ~35 measurements [  ] Yes [  ] No 
 
[  ] Actiwatch to be remove at this visit 
 
If No, ask participant to wear the device again to collect all necessary 
readings or measurements. 
 
If yes, complete the following questionnaires  
(circle one:  email       or   
in-person) 
 
[  ] Post ABPM Questionnaire         [  ] Trait Anxiety Index  
 
[  ] Post HBPM Questionnaire         [  ] Expectations of Outcomes  
 
[  ] Comparability Questionnaire 
 
[  ] Collect non-fasting blood work 
 
[  ] Biospecimens                             [  ] Urine sample 
 
[  ] Genetic sample 
 
[  ] Echocardiogram 
 
Completed by   
        Date                  

 
 
173
Better BP Study 
Study Visit 4 Data Collection Form 
 
 
ID:  ___________ 
 
 
 
 
Date of Visit: __________________ 
Name of tech performing visit: _________________ 
Time of Visit: __________________ 
 
AFTER PARTICIPANT ARRIVES 
32. Participant will return the device and device log for you to check for completion. 
33. Check a complete recording (i.e. – two sleep BP readings or ~35 ABPM readings) was obtained. 
a. Yes       No 
34. If yes, complete the post-HBPM or post-ABPM questionnaire.  
35. If no, ask the participant to repeat the HBPM or ABPM. Discuss with participant the challenges they 
encountered with obtaining a complete HBPM or ABPM. 
36. Participant will complete the post-HBPM questionnaire or post-ABPM questionnaire.  
37. Complete a non-fasting blood draw  
38. Collect a spot urine collection.  
39. Take the participant to complete their echocardiogram or schedule them for an echocardiogram within 
the next 2 weeks. 
40. Please confirm the participant’s mailing address.  
41. Remind the participant that they will:  
a. Be compensated for all 4 study visits within 2-3 weeks following their echocardiogram 
b. Receive their 24-hour ABPM report, labs and echocardiogram results in the mail 
c. We may contact them in the future for additional studies if they have consented to be 
contacted 
 
42. Answer any questions that the participant may have.  
 
 

 
 
174
 
NOTES:  ____________________________________________________________________ 
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
_______________ 
 
 

 
 
175
Sociodemographic and Medical History Questionnaire 
 
1. What is your age? ____ 
 
2. What is your date of birth? _______\_______\_______ 
 
3. Are you Hispanic? 
 
a. Yes  
b. No  
c. Decline to respond  
 
4. What is your race? 
a. White 
b. Black 
c. American Indian/Alaska Native 
d. Asian  
e. Native Hawaiian or Other Pacific Islander  
f. More than one race  
g. Decline to respond 
 
5. What is your sex?  
a. Male 
b. Female 
 
6. What is your highest level of education completed? 
a. Less than high school 
b. High school diploma or equivalency 
c. Some college 
d. Bachelor’s degree  
e. Graduate degree  
 
7. What is your combined annual household income? 
a. < $25,000 
b. $25,000 to $49,999 
c. $50,000 to $74,999 
d. $75,000 or greater 

 
 
176
8. What is your marital status?  
a. Single 
b. Married 
c. Separated 
d. Divorced 
e. Widowed 
 
9. Are you living alone?  
a. Yes 
b. No 
 
10. Have you ever been told by a doctor or a health professional that you have any of the 
following?  Check those to which the answer is yes (leave other blank). 
 High blood pressure or hypertension (excluding during pregnancy) 
 High cholesterol 
 Diabetes 
 Asthma or hay fever 
 
11. Have you smoked 100 cigarettes in your lifetime? 
a. Yes  
b. No  
 
12. If you answered ‘Yes’ to Q11, do you smoke cigarettes now, even occasionally?  
a. Yes  
b. No  
 
13. How many times per week do you engage in intense physical activity, enough to 
work up a sweat?   ______  
 
14. Do you presently drink alcoholic beverages, including beer, wine, and other 
drinks made with hard liquor, even occasionally? 
a. Yes  
b. No  
 
If yes, how many alcoholic beverages do you drink during an average week?  

 
 
177
Pittsburg Sleep Quality Index 
Instructions: The following questions relate to your usual sleep habits during the past month 
only. Your answers should indicate the most accurate reply for the majority of days and nights in 
the past month. Please answer all questions. 
 
 
1. During the past month, what time have you usually gone to bed at night? ________________ 
2. During the past month, how long (in minutes) has it usually taken you to fall asleep each 
night? __________ 
3. During the past month, what time have you usually gotten up in the morning? ____________ 
4. During the past month, how many hours of actual sleep did you get at night? (This may be 
different than the number of hours you spent in bed.) ___________________ 
5. During the past month, how often 
have you had trouble sleeping 
because you… 
Not during 
the past 
month 
Less than once a 
week 
Once or 
twice a 
week 
Three or 
more times a 
week 
a. Cannot get to sleep within 30 
minutes 
 
 
 
 
b. Wake up in the middle of the night 
or early morning 
 
 
 
 
c. Have to get up to use the bathroom 
 
 
 
 
d. Cannot breathe comfortably 
 
 
 
 
e. Cough or snore loudly 
 
 
 
 
f. Feel too cold 
 
 
 
 
g. Feel too hot 
 
 
 
 
h. Have bad dreams 
 
 
 
 
i. Have pain 
 
 
 
 
j. Other reason(s), please describe: 
 
 
 
 
 
 
 
6. During the past month, how often 
have you taken medicine to help you 
sleep (prescribed or “over the 
counter”)? 
 
 
 
 
7. During the past month, how often 
have you had trouble staying awake 
while driving, eating meals, or 
engaging in social activity? 
 
 
 
 
 
No problem 
at all 
Only a very slight 
problem 
Somewhat 
of a problem 
A very big 
problem 
8. During the past month, how much 
of a problem has it been for you to 
keep up enough enthusiasm to get 
things done? 
 
 
 
 
 
Very good 
Fairly good 
Fairly bad 
Very bad 

 
 
178
9. During the past month, how would 
you rate your sleep quality overall? 
 
 
 
 
 
No bed 
partner or 
roommate 
Partner/roommate 
in other room 
Partner in 
same room 
but not 
same bed 
Partner in 
same bed 
10. Do you have a bed partner or 
roommate? 
 
 
 
 
 
Not during 
the past 
month 
Less than once a 
week 
Once or 
twice a 
week 
Three or 
more times a 
week 
If you have a roommate or bed 
partner, ask him/her how often in the 
past month you have had: 
 
 
 
 
a. Loud snoring 
 
 
 
 
b. Long pauses between breaths 
while asleep 
 
 
 
 
c. Legs twitching or jerking while you 
sleep 
 
 
 
 
d. Episodes of disorientation or 
confusion during sleep 
 
 
 
 
e. Other restlessness while you sleep, 
please describe: 
 
 
 
 
 
 
 
 
 
 

 
 
179
Scoring the PSQI 
 
The order of the PSQI items has been modified from the original order in order to fit the first 9 
items (which are the only items that contribute to the total score) on a single page. Item 10, 
which is the second page of the scale, does not contribute to the PSQI score. 
 
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 
(severe difficulty). The component scores are summed to produce a global score (range 0 to 
21). Higher scores indicate worse sleep quality. 
 
Component 1: Subjective sleep quality—question 9 
Response to Q9  
 
Component 1 score 
Very good 
 
 
 
 0 
Fairly good  
 
 
 
 1 
Fairly bad  
 
 
 
 2 
Very bad  
 
 
 
 3 
Component 1 score:_____ 
 
 
Component 2: Sleep latency—questions 2 and 5a 
Response to Q2  
 
Component 2/Q2 subscore 
< 15 minutes   
 
 
0 
16-30 minutes  
 
 
1 
31-60 minutes  
 
 
2 
> 60 minutes   
 
 
3 
 
Response to Q5a  
 
Component 2/Q5a subscore 
Not during past month  
 
0 
Less than once a week  
 
1 
Once or twice a week  
 
2 
Three or more times a week   
3 
 
Sum of Q2 and Q5a subscores  
Component 2 score 
0  
 
 
 
 
0 
1-2  
 
 
 
 
1 
3-4  
 
 
 
 
2 
5-6  
 
 
 
 
3 
Component 2 score:_____ 
 
Component 3: Sleep duration—question 4 
Response to Q4  
 
Component 3 score 
> 7 hours  
 
 
 
0 
6-7 hours  
 
 
 
1 
5-6 hours  
 
 
 
2 
< 5 hours  
 
 
 
3 
Component 3 score:_____ 
 
 
 

 
 
180
Component 4: Sleep efficiency—questions 1, 3, and 4 
Sleep efficiency = (# hours slept/# hours in bed) X 100% 
# hours slept—question 4 
# hours in bed—calculated from responses to questions 1 and 3 
 
Sleep efficiency  
 
Component 4 score 
> 85%   
 
 
 
0 
75-84%  
 
 
 
1 
65-74%  
 
 
 
2 
< 65%   
 
 
 
3 
Component 4 score:_____ 
 
 
Component 5: Sleep disturbance—questions 5b-5j 
Questions 5b to 5j should be scored as follows: 
Not during past month  
 
0 
Less than once a week  
 
1 
Once or twice a week  
 
2 
Three or more times a week   
3 
 
Sum of 5b to 5j scores  
Component 5 score 
0  
 
 
 
 
0 
1-9  
 
 
 
 
1 
10-18   
 
 
 
2 
19-27   
 
 
 
3 
Component 5 score:_____ 
 
Component 6: Use of sleep medication—question 6 
Response to Q6  
 
Component 6 score 
Not during past month 
 
 0 
Less than once a week  
 
 1 
Once or twice a week  
 
 2 
Three or more times a week   
 3 
Component 6 score:_____ 
 
Component 7: Daytime dysfunction—questions 7 and 8 
Response to Q7  
 
Component 7/Q7 subscore 
Not during past month  
 
0 
Less than once a week  
 
1 
Once or twice a week  
 
2 
Three or more times a week   
3 
 
Response to Q8  
 
Component 7/Q8 subscore 
No problem at all  
 
 
0 
Only a very slight problem  
 
1 
Somewhat of a problem  
 
2 
A very big problem  
 
 
3 
Component 7 score:_____ 
 
Global PSQI Score: Sum of seven component scores:___________ 

 
 
181
 
Copyright notice: The Pittsburgh Sleep Quality Index (PSQI) is copyrighted by Daniel J. Buysse, 
M.D. Permission has been granted to reproduce the scale on this website for clinicians to use in 
their practice and for researchers to use in non-industry studies. For other uses of the scale, the 
owner of the copyright should be contacted. 
 
 
Citation: Buysse, DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ: The Pittsburgh Sleep 
Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry 
Research 28:193-213, 1989 
 

 
 
182
Post-ambulatory Blood Pressure Monitoring Questionnaire 
For the following questions, please circle the answer that corresponds to your response 
on a scale from ‘Not at all’ to “A lot”: 
1. Did you find the monitor heavy? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot  
 
2. Did you find the monitor uncomfortable to wear? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
3. Did you find the monitor straightforward to use? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
4a. Did you find the monitor cumbersome or awkward to wear?  
Not at all 
 
 
A little   
 
A moderate amount  
A lot  
 
4b. If you did not answer ‘Not at all’ in question 4a, did you find the monitor cumbersome 
or awkward to wear… (Check all that apply): 
 
 
 
At home 
 ☐ 
 
 
 
At work 
 ☐ 
 
 
 
While driving  ☐ 
 
 
 
At other times    ☐ 
 
5a. Did the noise of the monitor disturb you? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot  
 

 
 
183
5b. If you did not answer ‘Not at all’ in question 5a, did the noise of the monitor bother 
you… (Check all that apply): 
 
 
 
At home 
 ☐ 
 
 
 
At work 
 ☐ 
 
 
 
While driving  ☐ 
 
 
 
At other times    ☐ 
 
6. Did the noise of the monitor disturb others? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
7. Did you find the monitor embarrassing to wear? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
8. Did you find the monitor interfered with your normal sleeping pattern? 
No 
 
 
 
Yes 
 
9a. If you answered ‘Yes’ to Q8, how much was your sleep disturbed? 
A little   
 
A moderate amount  
A lot 
 
9b. If your sleep was disturbed, did the monitor wake you up after you had fallen asleep? 
No 
 
 
 
Yes 
 
 
 
 
 

 
 
184
10. Did the monitor disturb you so much that you removed it during the day while 
awake? 
No 
 
 
 
Yes  
 
11. Did the monitor disturb you so much during the night while asleep that you removed 
it? 
No 
 
 
 
Yes 
 
12. How much pain did you experience while wearing the monitor? 
None  
 
A little   
 
A moderate amount  
A lot 
 
13. How much irritation did you experience while wearing the monitor? 
None  
 
A little   
 
A moderate amount  
A lot 
 
14. How much bruising did you experience while wearing the monitor? 
None  
 
A little   
 
A moderate amount  
A lot 
 
 
 
 

 
 
185
Post-sleep Blood Pressure Monitoring Questionnaire 
For the following questions, please circle the answer that corresponds to your response 
on a scale from “Not at all” to “A lot”: 
 
1. Did you find the monitor heavy? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
2. Did you find the monitor comfortable to wear? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
3. Did you find the monitor straightforward to use? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
4. Did you find the monitor cumbersome or awkward to wear? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
5. Did the noise of the monitor disturb you? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
6. Did the noise of the monitor disturb others? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 
7. Did you find the monitor embarrassing to wear? 
Not at all 
 
 
A little   
 
A moderate amount  
A lot 
 

 
 
186
8. Did you find the monitor interfered with your normal sleeping pattern? 
No 
 
 
 
Yes 
 
9a. If you answered ‘Yes’ to Q8, how much was your sleep disturbed? 
A little   
 
A moderate amount  
A lot 
 
9b. If your sleep was disturbed, did the monitor wake you up after you had fallen asleep? 
No 
 
 
 
Yes 
 
 
10. Did the monitor disturb you so much during the night that you removed it? 
No 
 
 
 
Yes 
 
 
 
 
 
11. How much pain did you experience while wearing the monitor? 
None  
 
A little   
 
A moderate amount  
A lot   
 
12. How much irritation did you experience while wearing the monitor? 
None  
 
A little   
 
A moderate amount  
A lot  
 
13. How much bruising did you experience while wearing the monitor? 
None  
 
A little   
 
A moderate amount  
A lot  
 
 
 
 

 
 
187
Comparability questionnaire 
 
Ambulatory blood pressure monitoring involves wearing a device that measures blood pressure 
every 30 minutes during a 24-hour period. Home blood pressure monitoring involves you taking 
your own two blood pressure measurements in the morning and two blood pressure 
measurements in the evening, each day for one week (a total of 28 blood pressure 
measurements). 
 
1. If your doctor thought it would be helpful to have information about what your 
blood pressure was during sleep,  
 
a. How willing would you be to perform a 24-hour ambulatory blood pressure 
recording? 
0 
1 
2 
3 
4 
 
Not at all 
A little 
Moderately 
Very 
Completely 
 
willing  
willing  
willing  
willing  
willing 
 
 
b. How willing would you be to wear the home blood pressure monitor for 
one night?  
0 
1 
2 
3 
4 
 
Not at all 
A little 
Moderately 
Very 
Completely 
 
willing  
willing  
willing  
willing  
willing 
 
 
 
2. If your doctor thought it would be helpful to have information about what your 
blood pressure was outside the clinic,  
 
a. How willing would you be to perform a 24-hour ambulatory blood pressure 
recording? 
0 
1 
2 
3 
4 
 
Not at all 
A little 
Moderately 
Very 
Completely 
 
willing  
willing  
willing  
willing  
willing 
 
b. How willing would you be to perform home blood pressure monitoring for a 
week?  
0 
1 
2 
3 
4 
 
Not at all 
A little 
Moderately 
Very 
Completely 
 
willing  
willing  
willing  
willing  
willing 
 

 
 
188
 
3. Which device would you prefer to wear if you had to repeat this study? 
a. Ambulatory blood pressure monitor 
b. Home blood pressure monitor 
c. Neither  
 
 

 
 
189
State Anxiety Questionnaire 

 
190 
 
Trait Anxiety Questionnaire 
 
 
 

 
191 
 
Expectations of Outcomes Questionnaire 
 
 
 

 
192 
 
ABPM Device Log 
 
ID:  _________ 
 
 
 
 
Date: ___/___/___ 
It is important for us to know approximately what time you went to sleep and what time 
you woke up in the morning 
Time went to sleep 
 
  _____:_____   AM  PM  (circle one) 
Time woke up in the morning   _____:_____   AM  PM  (circle one) 
 
If you took a nap during the monitoring period, please write down the time you went to 
sleep for your nap and the time you woke up from your nap 
First Nap 
Nap time went to sleep 
  _____:_____   AM  PM  (circle one) 
Nap time woke up 
 
  _____:_____   AM  PM  (circle one) 
Second Nap 
Nap time went to sleep 
  _____:_____   AM  PM  (circle one) 
Nap time woke up 
 
  _____:_____   AM  PM  (circle one) 
 
It is also important that we know what times, if any, you removed ABPM device.  Please 
record these times in the following table. 
 
 
 
 
 
Time 
AM / PM 
(circle one) 
Comment (why did you remove it?) 
Time removed 
: 
AM   PM 
 
Time put back on 
: 
AM   PM 
 
 
 
 
Time removed 
: 
AM   PM 
 
Time put back on 
: 
AM   PM 
 
 
 
 
Time removed 
: 
AM   PM 
 
Time put back on 
: 
AM   PM 
 
 
 
 
Time removed 
: 
AM   PM 
 
Time put back on 
: 
AM   PM 
Please be sure to return this piece of paper when you return the equipment.   

 
193 
 
HBPM Device Log 
 
ID:  _________ 
 
 
 
 
Date: ___/___/___ 
It is important for us to know approximately what time you went to sleep and what time 
you woke up in the morning 
Time went to sleep 
 
  _____:_____   AM  PM  (circle one) 
Time woke up in the morning   _____:_____   AM  PM  (circle one) 
 
It is also important that we know what times, if any, you removed the HBPM device 
during the night.  Please record these times in the following table. 
 
 
 
 
 
Time 
PM/AM 
(circle one) 
Comment (why did you remove it?) 
Time removed 
: 
PM   AM 
 
Time put back on 
: 
PM   AM 
 
 
 
 
Time removed 
: 
PM   AM 
 
Time put back on 
: 
PM   AM 
 
 
 
 
Time removed 
: 
PM   AM 
 
Time put back on 
: 
PM   AM 
 
 
 
 
 
 
Please be sure to return this piece of paper when you return the equipment 
 
 
 

APPENDIX 6. REMINDER CARDS  
194 
 
ABPM Reminder Card  
 
• Stand or sit still and do not talk when blood pressure readings are being taken. 
 
• Keep your arm relaxed or supported during the blood pressure readings. 
 
• The blood pressure cuff should be 1 inch above your elbow, and should be snug.  
 
• The arrow on the cuff should be pointed towards the inner part of your elbow. 
 
• Keep the blood pressure monitor and watch dry. 
 
 
If you have trouble getting successful readings, please contact Julia Medina at: (205) 
975-4455 
 
 
Return to the clinic tomorrow on: ___________________ at ________ AM   PM 
 
 

APPENDIX 6. REMINDER CARDS  
195 
 
HBPM Reminder Card  
 
• Remember to press and hold the on/off button for 3 seconds to begin initial 
reading. 
 
• The blood pressure cuff should be 1 inch above your elbow, and should be snug.  
 
• The arrow on the cuff should be pointed towards the inner part of your elbow. 
 
• Keep the blood pressure monitor and watch dry. 
 
 
If you have trouble getting an initial reading, please contact Julia Medina at: (205) 975-
4455 
 
 
Return to the clinic tomorrow on: ___________________ at ________ AM   PM 
 
 
 

APPENDIX 7. PHYSICAN FAX NUMBERS  
196 
 
Physician Fax Numbers  
 
Hoover Clinic  
• 
Fax line (205) 989-4202 
Leeds Clinic 
• 
Front desk-205.699.0662 
• 
Nurses Station #1-205.699.4189 
• 
Nurses Station #2-205.699.4191 
Gardendale Clinic 
• 
Front desk – 608-7001 
• 
Fax- 631-3173 
• 
Fax- 443-1752 
Internal Medicine I/ 3 West 
113050 
705714 
Michael Skellie, RN Manager  
801-8359 
pager: 9514 
Provider Teams 
Extension 
Fax 
Stephen Bell, MD 
1-8368 
801-5775 
James Williams, MD 
1-7810 
801-8118 
Brittany Payne, MD 
1-7073 
801-8118 
Paige Harkness, CRNP 
1-7397  
801-8118 
Stuart Cohen, MD 
1-7398 
801-5776 
Patricia Garver, MD 
1-8311 
502-9936 
Mark Stafford, MD 
1-8321 
801-5776 
Hayley Entrekin, CRNP 
1-8350 
502-9936 
Michael Geer, MD 
1-8543 
801-5777 
Jennifer Vigil, MD 
1-9037 
801-5778 
Linda Kirkman, DNP 
1-5503 
801-5778 

APPENDIX 7. PHYSICAN FAX NUMBERS  
197 
 
  
  
  
Front Desk 
Extension 
Fax 
PES 
1-8303 
801-5779 
Ebony Allen 
1-8115 
801-5779 
 
Internal Medicine II/ 2 West 
113075 
705715 
RN Manager (Jillian Stone) 
801-8392 
pager: 1472 
Doctors 
Extension  
Fax 
Alan Gruman, MD 
1-8278 
801-7945 
David Gettinger, MD 
1-8320 
801-7945 
Carla Stefanescu, MD 
1-8006 
801-7553 
Allison G. Wilkin, MD 
1-9934 
801-7553 
James V. Davis, MD 
1-8310 
801-8897 
Larry Steven Hunt, MD 
1-8497 
801-7833 
Hernando D. Carter, MD 
1-8955 
801-7833 
Murkta Tripathi, MD 
1-8340 
  
Nurse Practitioner 
  
  
Heather Hardy Williams, CRNP 
1-8308 
  
Joanne Shaughnessy, CRNP 
1-8254 
801-7945 
 
 
Internal Medicine III/ 2 East 
113080 
705716 
Jillian Stone, RN Manager 
801-8560 
pager: 3331 
Doctors 
Extension 
Fax 
Mary Balkovetz, MD 
1-8748 
583-8058 

APPENDIX 7. PHYSICAN FAX NUMBERS  
198 
 
  
  
  
Laurie Hall, MD 
1-8314 
583-8058 
Rachel Labovitz, MD 
1-8325 
583-8058 
Stephen Stair, MD 
1-7776 
801-8806 
Sarah French, MD 
1-5326 
801-8522 
 
Residents Clinic- Internal 
Medicine 4 
801-7440 
113375 
 
Jillian Stone, RN Manager 
801-8560 
pager: 3331 
 
Tamara Underwood, LPN 
1-7756 
fax: 801-7441 
 
ShirDonna Banks, CMA 
1-8186 
  
 
Dorothea Rutledge RN  
1-7442 
  
 
General Internal Medicine 
934-9638 
113010 
705713 
 
 
 
Fax: 801-8067 
Jillian Stone, RN Manager 
801-8560 
pager: 3331 
Fax: 975-7797 
 

ID __ __ __ __ __ 
199 
 
Ambulatory Blood Pressure Monitor - Participant Instructions 
How to care for the Ambulatory Blood Pressure 
Monitor 
Remember to keep the Ambulatory Blood Pressure 
Monitor in the dark blue plastic case (Picture 1). It 
is important that the monitor does not get wet. We 
prefer that you do not remove the monitor.  
However, if you will be showering, swimming or 
exercising, you must remove the monitor.     
How to take the Ambulatory Blood Pressure 
Monitor off 
 When removing the monitor, pull the velcro flap on 
the cuff away from your body and slide the cuff off 
your arm. Gently take the white tube and pull 
it over your head and away from your body. 
Be careful not to disconnect the white tube 
from the monitor. Lastly, when taking off the 
monitoring, remember to put the monitor on 
“Casual mode” by switching it from 
“Ambulatory mode” to “Casual mode”. The 
switch button is on the side of the device 
(Picture 2).  
How to put the Ambulatory Blood Pressure 
Monitor back on 
When putting the equipment back on, place the 
cuff on the same arm you removed the 
equipment from. The cuff should be worn with 
the white tube facing up toward your shoulder 
(Picture 3). Place the tube around the back of 
your neck and down the front of the opposite 
shoulder. Check to make sure that the arterial 
mark (the red arrow is pointing to it in Picture 
4) on the cuff is lying directly on and situated 
over the brachial artery. The research assistant 
marked where your brachial artery is located 
with their finger by the crease of your elbow 

ID __ __ __ __ __ 
200 
 
(Picture 4).  Be sure that the bottom of the cuff 
is situated about one to two inches above the 
crease in your elbow, and that the cuff is snug 
and is equally tight at the top and bottom. 
Check that you are able to place 1 finger easily 
and 2 fingers snugly under the cuff at the top 
and bottom of the cuff (Picture 5). Lastly, 
please remember to switch the monitor to 
“Ambulatory mode”. The switch button is on the 
side of the device (see Picture 2).  
 
Frequently Asked Questions about 
the Ambulatory Blood Pressure 
Monitor 
1. What do I do when the monitor is 
taking a reading? The monitor is 
going to take a reading every 30 
minutes, both during the day and at 
night, for example: 5PM, 5:30PM, 6PM, 
etc. When you feel the cuff inflate, 
please remain motionless, with your 
arm relaxed either gently by your side 
or bent (as if in a sling), or gently resting on a table/desk so that your arm is elevated at 
heart level. We also ask that you do not talk while the monitor is taking a blood pressure 
reading.    
2. How often will the monitor take a reading? The monitor is going to take a reading 
every 30 minutes, both during the day and at night, for example: 5PM, 5:30PM, 6PM, 
etc. There will be a half inflation to notify you that the device will take a reading in one 
minute so that you can prepare yourself for the reading.  
3. What should I do if a reading fails? If a reading fails (usually because of motion, 
including during driving/riding, or because the arm is not relaxed), the monitor will 

ID __ __ __ __ __ 
201 
 
attempt to repeat the reading 2 minutes later (shown on the device as 120 seconds). If 
the 2nd attempt fails, the monitor will attempt to repeat the reading 4 minutes later 
(shown on the device as 240 seconds). The monitor will attempt to take a total of 3 
readings. If the 2nd attempt fails, no further attempts will be made until the next 
scheduled reading (30 minutes later). If the readings continue to fail when you are 
motionless and your arm is relaxed, check that the cuff is positioned properly two inches 
above your elbow, with the “artery mark” lying directly on and situated over the brachial 
artery. If the readings continue to fail, even after you have remained still and have 
positioned the cuff properly, please call us at (205) 586-0383. 
4. What should I do if the cuff does not deflate after a reading? In the very unlikely 
event that the cuff inflates and does not deflate properly, you can abort the reading by 
changing the device to “Casual mode” from “Ambulatory mode” using the switch on the 
device’s right side (see Picture 2) and disconnecting the white tubing connected to the 
device’s left side. Reconnect the tubing back to the device and take a test-reading in 
“Casual mode.” If the cuff re-inflates and the device is working properly, switch the 
device settings back to “Ambulatory mode” (see Picture 2). If this does not work, please 
call us at (205) 586-0383. 
5. What should I do if the cuff or monitor gets wet?  There is no personal danger to 
you if the monitor or cuff gets wet. The cuff will be uncomfortable if it gets wet, but there 
will be no permanent damage. If the monitor gets wet, please wipe it down with a towel. 
If it does not turn on or if it does not take a reading 30 minutes after the monitor got wet, 
please call us at (205) 586-0383. 

ID __ __ __ __ __ 
202 
 
In Picture 6, the monitor is worn in a plastic 
case. A strap is attached to both corners of 
the dark blue plastic case and acts as a 
harness for the bag. Picture 6 demonstrates 
the final placement of the monitor if worn in a 
harness bag. 
Please note that you can place the blood 
pressure cuff, strap holding the monitor, and 
tubing underneath your shirt          
 
 
 
 
 
 
In Picture 7, the monitor inside the dark blue 
plastic case is worn on a belt. In the back of 
the dark blue plastic case there is a belt loop 
in which the belt can be inserted in to hold 
the monitor. Picture 7 demonstrates this final 
placement of the monitor worn as a belt. 
Please note that you can place the blood 
pressure cuff, plastic case holding the 
monitor, and tubing underneath your shirt          
 
 

ID __ __ __ __ __ 
203 
 
Home Blood Pressure Device - Participant Instructions 
How to care for the Home Blood Pressure Device  
Remember to keep the Home Blood Pressure Device 
(Picture 1) in a safe area, where it does not get 
damaged due to a fall (e.g., not near the corner of the 
bed). It is important that the monitor does not get wet. 
We prefer that you do not remove the cuff during the 
night.  However, if the cuff is causing you pain, you 
may remove it.     
How to take the Home Blood 
Pressure Cuff off 
When removing the cuff, pull the 
velcro flap on the cuff away from 
your body and slide the cuff off 
your arm. Gently take the white tube and pull it away from your body. Be careful not to 
disconnect the white tube from the monitor. Lastly, remember to put the monitor on 
“Usual mode” by switching it from “Nocturnal mode” to “Usual mode”. The switch button 
is on the side of the device (Picture 2). 
How to put the Home Blood Pressure Cuff on  
When going to bed put the blood pressure cuff 
on. You should place it on the same arm you 
removed the equipment from during your Visit. 
The cuff should be worn with the white tube 
facing down toward your elbow/hand (Picture 3). 
Check to make sure that the arterial mark on the 
cuff is lying directly on and situated over the 
brachial artery. The research assistant marked 
where your brachial artery is located with a red 
arrow (Picture 4). Be sure that the bottom of the 
cuff is situated about one to two inches above the 
crease in your elbow, and that the cuff is snug 

ID __ __ __ __ __ 
204 
 
and is equally tight at the top and bottom. Check that 
you are able to place 1 finger easily and 2 fingers 
snugly under the cuff (both at the top and bottom) 
(Picture 5).  
Take your first test reading on Nocturnal mode by 
pressing the on/off button for three seconds when 
you are going to lie in bed and about to go to 
sleep. It will take your first blood pressure reading 
immediately. If you cannot get a valid reading, check 
if the cuff is too loose, if there is a kink in the tubing, 
or the tubing is not securely connected to the home 
blood pressure device, then retry the reading. Once 
you get a valid reading, place the device under your 
pillow or on somewhere on your bed in a safe area 
where it will not fall or cause the device damage. The 
monitor will take 3 readings at 2 hours, 3 hours, and 4 
hours after your first test reading.  
Frequently Asked Questions about the Home 
Blood Pressure Device  
1. What do I do when the device is taking a 
reading? The device will be taking three readings 
while you are sleeping. Make sure before you go to 
sleep that the tubing is not compressed or obstructed 
and that you do not sleep on the arm where the cuff 
is placed. If you feel the cuff inflate and wake up, 
please remain motionless and do not talk while the 
monitor is taking a blood pressure reading.    
2. How often will the device take a reading? After 
your first test reading, the monitor is going to take a 
total of three readings, two hours, three hours, and 
four hours later. For example, if you take your test 
reading at 10:30PM, the monitor will take one reading 
at 12:30AM, 1:30AM and 2:30AM.  
3. What should I do if a reading fails? If a reading 
fails (usually because of motion, the tube being obstructed, or the cuff not being 
properly placed), the monitor will NOT attempt to repeat the reading. If you happen to 
wake up and realize there is an error reading, please adjust the cuff and check that the 

ID __ __ __ __ __ 
205 
 
cuff is positioned properly two inches above your elbow with the arrow pointing to your 
brachial artery. If the readings continue to fail, and you are aware of such even after you 
have remained still and have positioned the cuff properly, please call us at (205) 586-
0383 in the morning. 
5. What should I do if the device or cuff gets wet?  Please try to keep the monitor 
dry. There is no personal danger to you if the monitor or cuff gets wet. The cuff will be 
uncomfortable if it gets wet, but there will be no permanent damage. If the monitor gets 
wet, please wipe it down with a towel. If it does not turn on or if it does not take a test 
reading after the monitor gets wet, please call us at (205) 586-0383. 
 
 

ID __ __ __ __ __ 
206 
 
Wrist Activity Monitor - Participant Instructions 
 
ACTIWATCH (Wrist Activity Monitor)  
Instructions for the Actiwatch 
Remember to keep the Actiwatch on your non-dominant arm wrist. It is important that 
the device does not get wet. We prefer that you not remove the device. Remember to 
press the side button of the Actiwatch when you go to sleep and when you wake up to 
measure the time you woke up and when you went to bed. 
How to care for the Actiwatch  
It is important that the monitor does not get wet. We prefer that you do not remove the 
monitor.  However, if you will be showering, swimming or exercising, you should remove 
the monitor.  Please write down the times on the Device Log that you took the monitor 
off and put it back on.  
Frequently Asked Questions about the Actiwatch  
1. What does the Actiwatch measure? The primary purpose of this monitor is to 
provide information about movement during sleep. This is why it is desirable that you 
wear the monitor to bed. During waking hours, it also provides a measure of physical 
activity.   
2. Should I wear the Actiwatch to bed? Yes, we would like you to wear the wrist 
activity monitor to bed. It will not disturb your sleeping. 
 
 
 
 

ID __ __ __ __ __ 
207 
 
 
Instructions for Sonographers  
 
1. In the server, please store the participant information as follows:  
a. Last Name – ‘BetterBP’  
b. Patient ID – Participant ID Number (located on the participant appointment card)  
c. Exam Performed by – Please enter your initials  
d. Leave all other fields blank  
2. Following the procedure, please download the scan to the two CDs enclosed within the 
envelope. 
a. NOTE: Please make sure the worklist is not pulled up before downloading the 
scan. 
3. Once downloaded, please return the two CDs to the envelope and give to the study 
coordinator.  

 
208 
 
 
 
 
 
 
 
 
 
 
Results Packet 
 

 
UAB Hypertension Research Clinic  
 
Paul Muntner, PhD 
933 19th Street S, CHB19-115 
 
Principal Investigator  
University of Alabama at Birmingham 
 
Tel: 205-975-8077 
Birmingham, AL 35294 
 
Fax: 205-975-7058 
 
209 
 
Letter to Participants (Physician) 
 
Dear [Participant Name],  
 
Thank you for participating in the Better BP study. Enclosed you will find your results from the 
study including your blood pressure values, lab results, and the results of your echocardiogram.  
 
If any of your lab values are above or below normal ranges, please contact your health care 
provider. If you do not have a health care provider, please contact the study physician, Dr. 
Suzanne Oparil, at (205)-934-5951. 
 
You indicated that you would like a copy of your results sent to your healthcare provider. We will 
fax them to the physician that you have noted on file with us within the next 3-5 business days. 
 
If you have not received payment for completing the study or you have received a bill from UAB 
hospital regarding your echocardiogram, please contact the Better BP study staff at (205)-975-
7653 or (205)-975-4455.  
 
If you have any additional questions or concerns, please feel free to reach out to us at the 
numbers listed above or email us at bpstudy@uab.edu. 
 
Thank you again for your participation in the Better BP study. We hope that you will consider 
participating in future studies. 
 
Sincerely,  
 
Paul Muntner, PhD 
 
 
 
Suzanne Oparil, MD  
Professor 
 
 
 
 
Professor 
Department of Epidemiology  
 
Department of Medicine 
School of Public Health 
 
 
School of Medicine 
University of Alabama at Birmingham 
University of Alabama at Birmingham  

 
UAB Hypertension Research Clinic  
 
Paul Muntner, PhD 
933 19th Street S, CHB19-115 
 
Principal Investigator  
University of Alabama at Birmingham 
 
Tel: 205-975-8077 
Birmingham, AL 35294 
 
Fax: 205-975-7058 
 
210 
 
Letter to Participants (No Physician) 
 
Dear [Participant Name],  
 
Thank you for participating in the Better BP study. Enclosed you will find your results from the 
study including your blood pressure values, lab results, and the results of your echocardiogram.  
 
If any of your lab values are above or below normal ranges, please contact your health care 
provider. If you do not have a health care provider, please contact the study physician, Dr. 
Suzanne Oparil, at (205)-934-5951. 
 
If you have not received payment for completing the study or you have received a bill from UAB 
hospital regarding your echocardiogram, please contact the Better BP study staff at (205)-975-
7653 or (205)-975-4455.  
 
If you have any additional questions or concerns, please feel free to reach out to us at the 
numbers listed above or email us at bpstudy@uab.edu. 
 
Thank you again for your participation in the Better BP study. We hope that you will consider 
participating in future studies. 
 
Sincerely,  
 
Paul Muntner, PhD 
 
 
 
Suzanne Oparil, MD  
Professor 
 
 
 
 
Professor 
Department of Epidemiology  
 
Department of Medicine 
School of Public Health 
 
 
School of Medicine 
University of Alabama at Birmingham 
University of Alabama at Birmingham  
 
 
 

 
UAB Hypertension Research Clinic  
 
Paul Muntner, PhD 
933 19th Street S, CHB19-115 
 
Principal Investigator  
University of Alabama at Birmingham 
 
Tel: 205-975-8077 
Birmingham, AL 35294 
 
Fax: 205-975-7058 
 
211 
 
Blood Pressure Measurement Results 
 
Date of Visits: _____________________ 
Participant’s Last Name: _____________________ 
Participants’ First Name: _____________________ 
 
Your blood pressure measurements: 
*Average of six blood pressure measurements. 
 
 
Based on 2017 guidelines from the American College of Cardiology and American Heart 
Association, categories of clinic blood pressure are defined as follows: 
Blood Pressure Category 
Systolic Blood Pressure 
 
Diastolic Blood Pressure 
Normal 
<120 mm Hg 
and 
<80 mm Hg 
Elevated 
120-129 mm Hg 
and 
<80 mm Hg 
Hypertension 
 
 
 
Stage 1 
130-139 mm Hg 
or 
80-89 mm Hg 
Stage 2 
≥140 mm Hg 
or 
≥90 mm Hg 
This is based on average of the blood pressure readings taken during your first two clinic visits. 
Attended Blood Pressure* 
Unattended Blood Pressure* 
 
Systolic Blood Pressure:  ___________ mmHg 
Diastolic Blood Pressure:  __________ mmHg 
Heart Rate: _______ beats per minute 
 
Systolic Blood Pressure:  ___________ mmHg 
Diastolic Blood Pressure:  __________ mmHg 
Heart Rate: _______ beats per minute 

 
UAB Hypertension Research Clinic  
 
Paul Muntner, PhD 
933 19th Street S, CHB19-115 
 
Principal Investigator  
University of Alabama at Birmingham 
 
Tel: 205-975-8077 
Birmingham, AL 35294 
 
Fax: 205-975-7058 
 
212 
 
Echocardiogram and Lab Test Results 
 
Participant’s Last Name: _____________________ 
Participants’ First Name: _____________________ 
Date of Collection: _________________ 
 
 
Date of Echocardiogram: _____________ 
 
TEST NAME 
IN RANGE 
OUT OF 
RANGE 
 
REFERENCE 
RANGE 
---ECHOCARDIOGRAM--- 
 
 
 
 
LEFT VENTRICULAR MASS 
INDEX 
 
 
 
Women: <96 m2 
Men: <116 m2 
 
 
 
 
 
LEFT VENTRICULAR 
EJECTION FRACTION 
 
 
 
> 50% 
 
 
 
 
 
---BLOOD TESTS--- 
 
 
 
 
 
 
 
 
 
METABOLIC PANEL 
 
 
 
 
   CREATININE 
 
 
 
0.7-1.3 mg/dL 
   eGFR 
 
 
 
>=60 
ml/min/1.73m² 
 
 
 
 
 
LIPID PANEL 
 
 
 
 
   CHOLESTEROL, TOTAL 
 
 
 
<200 mg/dL 
   HDL CHOLESTEROL 
 
 
 
40-60 mg/dL 
 
 
 
 
 
GLYCOSYLATED HEMOGLOBIN 
 
 
 
 
       HbA1C 
 
 
 
<6.5% 
 
 
 
 
 
---URINE TESTS---- 
 
 
 
 
   CREATININE 
 
 
 
 
   MICROALBUMIN 
 
 
 
 
MICROALB/CREAT RATIO 
 
 
 
<30 mg/g 

 
213 
 
ABPM Results Guide 
 
We appreciate you taking time to participate in the Better BP study. In this study, we recorded your 
blood pressure every 30 minutes for as long as you wore the ambulatory blood pressure monitor 
(ABPM).  Attached is a report that details your results.   
Here is a guide to your ABPM report: 
Top Left Panel  
• 
We provide your personal information, the day and night time period as set by the ABPM device 
software, and the awake and asleep times you reported on your ABPM device log. 
• 
The last box in the top left panel is the level (threshold) for defining high daytime and nighttime 
blood pressure by national hypertension guidelines. 
 
Graph of Blood Pressure Values 
• 
The top red line is your systolic blood pressure (i.e., top number of the blood pressure), the 
bottom red line is your diastolic blood pressure (i.e., bottom number of your blood pressure), 
and the gray line at the bottom of the graph is your heart rate (HR). These are the values taken 
over the course of the day from when you put on to when you took off the blood pressure cuff.  
The blue box represents the nighttime period as set by the ABPM device software.  
 
Middle Box  
• 
This box contains your average blood pressure values and heart rate for 24-hours, awake 
readings, and asleep readings. 
• 
Everyone’s blood pressure varies between measurements. SD stands for standard deviation 
and this number represents how much your blood pressure varied throughout the period when it 
was being measured. 
 
Here is how to interpret your readings: 
Based on 2017 guidelines from the American College of Cardiology and American Heart Association, 
high average blood pressure on ambulatory blood pressure monitoring is defined by: 
High 24-hour blood pressure 
Systolic (sys) blood pressure greater than or equal to 125 mm Hg or 
diastolic (dia) blood pressure greater than or equal to 75 mm Hg 
This is based on blood pressure readings taken over the entire period that you wore the device. 
High awake blood pressure 
Systolic (sys) blood pressure greater than or equal to 130 mm Hg or 
diastolic (dia) blood pressure greater than or equal to 80 mm Hg 
This is based on blood pressure readings taken during the period that you were awake. 
High asleep blood pressure 
Systolic (sys) blood pressure greater than or equal to 110 mm Hg or 
diastolic (dia) blood pressure greater than or equal to 65 mm Hg 
This is based on blood pressure readings taken during the period that you were asleep. 
Bottom of the page, we provide all of the individual blood pressure readings that were obtained for 
you, the time they were taken and your heart rate. The readings in red represent blood pressure 
values that were greater than the pre-defined blood pressure level (threshold) shown in the last box in 
the top left panel.  You shouldn’t worry if a few readings were high as blood pressure varies from beat 
to beat. 

Analysis Plan: Evaluating novel approaches for estimating awake and sleep blood pressure (The Better BP 
Study) 
 
Aims and hypotheses 
Primary Aim 1: To examine whether measuring unattended clinic BP with an automated device will provide a 
more accurate estimate of awake BP on ABPM than measuring attended clinic BP with an automated device.  
Hypothesis 1a: The absolute difference with awake BP will be smaller for unattended vs. attended clinic BP.  
Hypothesis 1b: The agreement between hypertension status using BP measured in the clinic and on ABPM 
while awake will be higher when clinic BP is measured unattended vs. attended. Also, the prevalence of both 
white coat and masked hypertension will be lower when measuring unattended clinic BP.  
 
Primary Aim 2: To examine whether a new HBPM device provides an accurate approach for measuring sleep 
BP.  
Hypothesis 2a: Sleep BP on HBPM will provide an accurate estimate of sleep BP on ABPM.  
Hypothesis 2b: HBPM will be better tolerated (e.g., less awakening during sleep, pain, bruising) than ABPM.  
 
Primary Aim 3: To compare the associations of unattended versus attending clinic BP, unattended clinic BP 
versus awake BP on ABPM, and sleep BP on HBPM versus ABPM with two markers of end-organ damage, left 
ventricular mass index (LVMI) and urinary albumin-to-creatinine ratio (ACR).  
Hypothesis 3a: The association with end-organ damage will be stronger for unattended vs. attended clinic BP.  
Hypothesis 3b: The association with end-organ damage will be similar for unattended clinic BP and awake BP.  
Hypothesis 3c: The association with end-organ damage will be similar for sleep BP by HBPM and ABPM. 
 
Objectives: 
1. Determine the absolute mean difference in awake systolic and diastolic BP, separately, between attended 
and unattended BP; awake BP from ABPM and attended BP; and awake BP from ABPM and unattended 
BP.  
2. Determine the prevalence of hypertension, white coat hypertension, and masked hypertension on attended, 
unattended, and ABPM BP measurements.   
3. Determine the agreement between hypertension phenotypes on ABPM and clinic BP (i.e., attended and 
unattended). 
4. Determine the absolute mean difference in asleep systolic and diastolic BP, separately, between asleep BP 
measurements from ABPM and HBPM.  
5. Determine the tolerability of ABPM and HBPM.  

6. Determine the associations of unattended versus attending clinic BP, unattended clinic BP versus awake BP 
on ABPM, and sleep BP on HBPM versus ABPM with left ventricular mass index (LVMI) and urinary 
albumin-to-creatinine ratio (ACR). 
 
 
The following  will be conducted using data from the Better BP study. 
 
Data management:  
Create the following variables to define hypertension:  
1. Create the variable ABPM_HYPER by assigning 1 to those with mean awake ABPM ≥135 mm Hg (systolic 
BP) or 85 mm Hg (diastolic BP) and 0 if otherwise.  
2. Create the variable ATTENDED_HYPER by assigning 1 to those with mean attended BP ≥140 mm Hg 
(systolic BP) or 90 mm Hg (diastolic BP) and 0 if otherwise. 
3. Create the variable UNATTENDED_HYPER by assigning 1 to those with mean unattended BP ≥135 mm 
Hg (systolic BP) or 85 mm Hg (diastolic BP) and 0 if otherwise. 
4. Identify the following individuals: 
1. HYP_AB_ATTEND should equal 1 if ABPM_HYPER = 1 and ATTENDED_HYPER = 1, and 0 if 
otherwise.  
2. HYP_AB_UNATTEND should equal 1 if ABPM_HYPER = 1 and UNATTENDED_HYPER = 1, 
and 0 if otherwise.  
3. WHIT_AB_ATTEND should equal 1 if ABPM_HYPER = 0 and ATTENDED_HYPER = 1, and 0 
if otherwise. 
4. WHIT_AB_UNATTEND should equal 1 if ABPM_HYPER = 0 and UNATTENDED_HYPER = 1, 
and 0 if otherwise. 
5. MASK_AB_ATTEND should equal 1 if ABPM_HYPER = 1 and ATTENDED_HYPER = 0, and 0 
if otherwise. 
6. MASK_AB_UNATTEND should equal 1 if ABPM_HYPER = 1 and UNATTENDED_HYPER = 0, 
and 0 if otherwise. 
 
 
Statistical analysis:  
 
1. Calculate the distribution of the variables in Table 1, overall, and separately for participants who were 
attended then unattended, unattended then attended, as well as participants who underwent ABPM before 
HBPM, and HBPM before ABPM.  
 
2. Do the following analysis for Table 2 for those with complete BP data on ABPM, attended, and unattended:  
a. For awake systolic BP, calculate the mean (with standard deviation) BP on ABPM, attended, and 
unattended  
b. Calculate the absolute mean difference with 95% confidence intervals for ABPM vs. attended, 
ABPM vs. unattended, and attended vs. unattended, using mixed model to determine the difference 
between the differences.  
c. Repeat items 2a and 2b for awake diastolic BP on ABPM, attended and unattended.  

 
3. Do the following analysis for Table 3 for those with complete BP data on ABPM, attended, and unattended:  
a. Calculate the percentage (with 95% confidence interval) of participants with hypertension on awake 
ABPM (i.e., ABPM_HYPER = 1) 
b. Calculate the percentage (with 95% confidence interval) of participants with hypertension on 
attended BP measurements (i.e., ATTENDED_HYPER = 1).  
c. Calculate the percentage (with 95% confidence interval) of participants with hypertension on 
unattended BP measurements (i.e., UNATTENDED_HYPER = 1).  
d. Calculate the percentage (with 95% confidence intervals) of participants with hypertension on 
attended and awake ABPM (i.e., HYP_AB_ATTEND = 1).  
e. Calculate the percentage (with 95% confidence intervals) of participants with hypertension on 
unattended and awake ABPM (i.e., HYP_AB_UNATTEND = 1).  
f. Calculate the percentage (with 95% confidence intervals) of participants with white coat 
hypertension on ABPM and attended BP (i.e., WHIT_AB_ATTEND = 1). 
g. Calculate the percentage (with 95% confidence intervals) of participants with white coat 
hypertension on ABPM and unattended BP (i.e., WHIT_AB_UNATTEND = 1) 
h. Calculate the percentage (with 95% confidence intervals) of participants with masked hypertension 
on ABPM and attended BP (i.e., MASK_AB_ATTEND = 1). 
i. Calculate the percentage (with 95% confidence intervals) of participants with masked hypertension 
on ABPM and unattended BP (i.e., MASK_AB_UNATTEND = 1) 
 
4. Do the following analysis for those with complete BP data on ABPM, attended, and unattended: 
a. Table 4, use a 2 x 2 table to determine the agreement hypertension on ABPM and clinic BP (i.e., 
HYP_AB_ATTEND versus HYP_AB_UNATTEND); provide the p-value from kappa statistics.  
b. Table 5, use a 2 x 2 table to determine the agreement white coat hypertension on ABPM and clinic BP 
(i.e., WHIT_AB_ATTEND versus WHIT_AB_UNATTEND); provide the p-value from kappa statistics.  
c. Table 6, use a 2 x 2 table to determine the agreement masked hypertension on ABPM and clinic BP 
(i.e., WHIT_AB_ATTEND versus WHIT_AB_UNATTEND); provide the p-value from kappa statistics. 
 
5. Do the following analysis for Table 7 for those with complete sleep BP data on ABPM and HBPM:  
a. For sleep systolic BP, calculate the mean BP (with standard deviation) on ABPM and HBPM.  
b. Calculate the absolute mean difference with 95% confidence intervals for ABPM vs. HBPM, using a 
paired T-test.  
c. Repeat items 5a and 5b for sleep diastolic BP on ABPM and HBPM.  
 
6. Table 8. Calculate the number and percentage of side effects and tolerability (listed in Table 8) that 
occurred in ABPM only, HBPM only, both ABPM and HBPM, and occurred for neither ABPM nor HBPM.  
7. Table 9. Restrict the analysis to those with complete data on attended and unattended BP and 
complete data on left ventricular mass index . 
a. Use linear regression to determine the relationship between attended SBP with left ventricular mass 
index. 
b. Repeat the analysis for attended DBP, unattended SBP, unattended DBP with left ventricular mass 
index, separately. 

 
8. Table 10. Restrict the analysis to those with complete BP data on unattended and awake ABPM and 
complete data on left ventricular mass index. 
a. Use linear regression to determine the relationship between unattended SBP with left ventricular 
mass index. 
b. Repeat the analysis for unattended DBP, awake SBP on ABPM, awake DBP on ABPM with left 
ventricular mass index, separately. 
 
9. Table 11. Restrict the analysis to those with complete sleep BP data on ABPM and HBPM and 
complete data on left ventricular mass index. 
c. Use linear regression to determine the relationship between sleep SBP on ABPM with left 
ventricular mass index. 
d. Repeat the analysis for sleep DBP on ABPM, sleep SBP on HBPM, and sleep DBP on HBPM with 
left ventricular mass index, separately. 
 
10. Table 12. Restrict the analysis to those with complete data on attended and unattended BP and 
complete data on urinary albumin-to-creatinine ratio. 
c. Use linear regression to determine the relationship between attended SBP with urinary albumin-to-
creatinine ratio. 
d. Repeat the analysis for attended DBP, unattended SBP, unattended DBP with urinary albumin-to-
creatinine ratio, separately. 
 
11. Table 13. Restrict the analysis to those with complete BP data on unattended and awake ABPM and 
complete data on urinary albumin-to-creatinine ratio. 
e. Use linear regression to determine the relationship between unattended SBP with urinary albumin-
to-creatinine ratio. 
f. Repeat the analysis for unattended DBP, awake SBP on ABPM, awake DBP on ABPM with urinary 
albumin-to-creatinine ratio, separately. 
 
12. Table 14. Restrict the analysis to those with complete sleep BP data on ABPM and HBPM and 
complete data on urinary albumin-to-creatinine ratio. 
g. Use linear regression to determine the relationship between sleep SBP on ABPM with urinary 
albumin-to-creatinine ratio. 
h. Repeat the analysis for sleep DBP on ABPM, sleep SBP on HBPM, and sleep DBP on HBPM with 
urinary albumin-to-creatinine ratio, separately. 
 
 
 

Table 1. Characteristics of Better BP participants by randomization. 
 
Overall 
N = 603 
Attended then unattended,  
N = 301 
Unattended then attended,  
N = 302 
ABPM then HBPM,  
N =302 
HBPM then ABPM,  
N = 301 
Age, yrs,  
Mean (SD) 
Median (min – max) 
 
38.6 (15.1) 
34.0 (18.0 - 83.0) 
 
39.4 (16.0) 
35.0 (19.0 - 83.0) 
 
37.9 (14.1) 
34.0 (18.0 - 83.0) 
 
39.2 (15.7) 
35.5 (18.0 - 79.0) 
 
38.1 (14.5) 
33.0 (19.0 - 83.0) 
Women, % 
382 (63.3) 
190 (63.1) 
192 (63.6) 
191 (63.2) 
191 (63.5) 
Race, % 
Hispanic 
Non-Hispanic, Asian 
Non-Hispanic, Black 
Non-Hispanic, White 
Other non-Hispanic race/ethnicity 
 
39 (6.5) 
 90 (14.9) 
132 (21.9) 
291 (48.3) 
51 (8.5) 
 
24 (8.0) 
39 (13.0) 
64 (21.3) 
150 (49.8) 
24 (8.0) 
 
15 (5.0) 
51 (16.9) 
68 (22.5) 
141 (46.7) 
27 (8.9) 
 
22 (7.3) 
47 (15.6) 
61 (20.2) 
148 (49.0) 
24 (7.9) 
 
17 (5.6) 
43 (14.3) 
71 (23.6) 
143 (47.5) 
27 (9.0) 
Body Mass Index  
  Mean (SD) 
  Median (min – max) 
 
27.2 (5.9) 
25.9 (13.0 - 55.5) 
 
26.8 (5.9) 
25.6 (13.0 - 55.5) 
 
27.5 (5.8) 
26.5 (17.2 - 53.0) 
 
27.2 (5.6) 
26.0 (13.0 - 53.0) 
 
27.2 (6.1) 
25.9 (17.3 - 55.5) 
Attended office blood pressure 
 
 
 
 
 
Systolic BP  
Mean (SD) 
Median (min – max) 
 
119.4 (12.0) 
118.2 (92.2 - 179.5) 
 
118.9 (12.1) 
117.5 (92.2 - 179.5) 
 
120.0 (12.0) 
118.7 (95.2 - 170.7) 
 
119.7 (11.9) 
118.3 (94.2 - 161.2) 
 
119.2 (12.2) 
117.8 (92.2 - 179.5) 
Diastolic BP  
Mean (SD) 
Median (min – max) 
 
72.7 (7.8) 
71.5 (53.5 - 97.7) 
 
72.5 (7.9) 
71.0 (53.5 - 97.7) 
 
72.9 (7.8) 
71.7 (54.8 - 96.3) 
 
72.7 (7.5) 
71.6 (53.5 - 95.5) 
 
72.7 (8.1) 
71.3 (59.2 - 97.7) 
Unattended office blood pressure  
 
 
 
 
 
Systolic BP  
Mean (SD) 
Median (min – max) 
 
118.7 (11.8) 
117.3 (90.5 - 179.8) 
 
118.2 (11.8) 
116.8 (90.5 - 179.8) 
 
119.2 (11.8) 
117.8 (95.2 - 179.0) 
 
119.0 (11.6) 
117.7 (91.7 - 158.5) 
 
118.3 (12.1) 
116.8 (90.5 - 179.8) 
Diastolic BP  
Mean (SD) 
Median (min – max) 
 
72.2 (7.7) 
71.0 (47.2 - 98.5) 
 
71.8 (7.8) 
70.8 (47.2 - 98.5) 
 
72.5 (7.6) 
71.4 (55.7 - 96.8) 
 
72.1 (7.5) 
71.3 (47.2 - 94.5) 
 
72.2 (7.9) 
70.8 (57.8 - 98.5) 

Table 1 continued.  
Ambulatory blood pressure 
monitoring 
 
 
 
 
 
Awake systolic BP 
Mean (SD) 
Median (min – max) 
 
118.7 (10.2) 
117.8 (87.6 - 172.8) 
 
118.4 (10.4) 
117.3 (87.6 - 172.8) 
 
119.1 (9.9) 
118.3 (97.5 - 154.5) 
 
119.2 (10.0) 
118.3 (96.7 - 154.5) 
 
118.3 (10.4) 
117.5 (87.6 - 172.8) 
Awake diastolic BP 
Mean (SD) 
Median (min – max) 
 
74.2 (7.0) 
73.3 (52.9 - 98.9) 
 
73.8 (7.0) 
73.1 (52.9 - 94.0) 
 
74.6 (7.0) 
73.7 (60.3 - 98.9) 
 
74.4 (6.8) 
73.5 (60.3 - 91.3) 
 
74.0 (7.2) 
73.1 (52.9 - 98.9) 
Asleep systolic BP 
Mean (SD) 
Median (min – max) 
 
104.1 (10.5) 
103.2 (72.3 - 145.0) 
 
104.0 (10.5) 
103.0 (77.1 - 145.0) 
 
104.1 (10.5) 
103.3 (72.3 - 139.4) 
 
104.7 (10.6) 
103.6 (78.6 - 145.0) 
 
103.4 (10.3) 
102.8 (72.3 - 136.1) 
Asleep diastolic BP 
Mean (SD) 
Median (min – max) 
 
60.3 (7.5) 
59.7 (42.1 - 95.4) 
 
60.3 (7.7) 
59.6 (43.2 - 95.4) 
 
60.3 (7.4) 
60.2 (42.1 - 89.3) 
 
60.4 (7.4) 
59.7 (45.1 - 95.4) 
 
60.1 (7.6) 
59.9 (42.1 - 89.3) 
Home blood pressure monitoring  
 
 
 
 
 
Asleep systolic BP 
Mean (SD) 
Median (min – max) 
 
106.3 (11.6) 
106.0 (74.0 - 159.0) 
 
106.5 (11.3) 
107.0 (74.0 - 155.0) 
 
106.2 (12.0) 
105.0 (81.0 - 159.0) 
 
105.7 (11.7) 
106.0 (80.0 - 159.0) 
 
106.9 (11.6) 
107.0 (74.0 - 155.0) 
Asleep diastolic BP 
Mean (SD) 
Median (min – max) 
 
62.3 (8.3) 
62.0 (38.0 - 88.0) 
 
62.5 (8.1) 
62.0 (42.0 - 85.0) 
 
62.1 (8.5) 
62.0 (38.0 - 88.0) 
 
61.8 (8.3) 
61.0 (38.0 - 88.0) 
 
62.9 (8.3) 
62.0 (44.0 - 86.0) 
Hypertension, % 
40 (6.6) 
25 (8.3) 
15 (5.0) 
17 (5.6) 
23 (7.6) 
High cholesterol, % 
56 (9.3) 
28 (9.3) 
28 (9.3) 
29 (9.6) 
27 (9.0) 
Diabetes, %  
10 (1.7) 
2 (0.7) 
8 (2.6) 
5 (1.7) 
5 (1.7) 
Asthma or hey fever, % 
68 (11.3) 
32 (10.6) 
36 (11.9) 
32 (10.6) 
36 (12.0) 
Married, % 
213 (35.3) 
105 (34.9) 
108 (35.8) 
102 (33.8) 
111 (36.9) 
Not living alone, % 
152 (25.2) 
77 (25.6) 
75 (24.8) 
78 (25.8) 
74 (24.6) 
Smoking status, % 
Never  
Former  
Current 
 
509 (84.6) 
79 (13.1) 
14 (2.3) 
 
250 (83.1) 
44 (14.6) 
7 (2.3) 
 
259 (86.0) 
35 (11.6) 
7 (2.3) 
 
260 (86.1) 
35 (11.6) 
7 (2.3) 
 
249 (83.0) 
44 (14.7) 
7 (2.3) 

Table 1 continued.   
Current drinker, % 
405 (67.2) 
202 (67.1) 
203 (67.2) 
202 (66.9) 
203 (67.4) 
Good self-reported sleep quality, 
% 
179 (30.1) 
87 (29.4) 
92 (30.8) 
89 (30.0) 
90 (30.2) 
Self-reported physical activity per 
week, % 
Mean (SD) 
Median (min – max)  
 
2.8 (2.0) 
3.0 (0.0 - 20.0) 
 
2.9 (2.1) 
3.0 (0.0 - 20.0) 
 
2.8 (2.0) 
3.0 (0.0 - 10.0) 
 
2.8 (2.1) 
3.0 (0.0 - 20.0) 
 
2.9 (1.9) 
3.0 (0.0 - 10.0) 
 
 

Table 2. Mean difference in awake systolic and diastolic BP, separately, with ABPM vs. attended BP, ABPM vs. unattended BP, and Attended vs. Unattended BP, N=569  
 
 
ABPM 
Mean (SD) 
Median (min – max) 
Attended 
Mean (SD) 
Median (min – max) 
Unattended 
Mean (SD) 
Median (min – max) 
Mean difference for 
ABPM vs. Attended BP 
(95% CI) 
Mean difference for 
ABPM vs. Unattended BP 
(95% CI) 
Mean difference for 
Attended vs. Unattended BP 
(95% CI) 
P (difference 
in differences 
= 0) 
Awake systolic 
BP 
118.7 (10.2) 
117.8 (87.6 - 172.8) 
119.4 (12.1) 
117.8 (92.2 - 179.5) 
118.7 (11.9) 
117.2 (90.5 - 179.8) 
-0.69  
(-1.36, -0.03) 
-0.004  
(-0.64, 0.64) 
0.69  
(0.39, 0.99) 
<.0001 
Awake diastolic 
BP 
74.2 (7.0) 
73.3 (52.9 - 98.9) 
72.7 (7.8) 
71.3 (53.5 - 97.7) 
72.2 (7.7) 
71.0 (47.2 - 98.5) 
1.55  
(1.08, 2.03) 
2.03  
(1.55, 2.51) 
0.47  
(0.25, 0.69) 
<.0001 

Table 3. The prevalence of hypertension by awake ABPM, attended, and unattended BP reading, N=569 
Hypertension 
Prevalence (95% CI) 
ABPM hypertensive range 
10.0 (7.7,12.8) 
Attended clinic BP in hypertensive range 
7.2 (5.2,9.7) 
Unattended clinic BP in hypertensive range 
14.1(11.3,17.2) 
ABPM and attended clinic BP in hypertensive range 
4.6 (3.0,6.6) 
ABPM and unattended clinic BP in hypertensive range  
6.9 (4.9,9.3) 
White coat hypertension 
 
Hypertensive attended clinic BP with normal ABPM 
2.6(1.5,4.3) 
Hypertensive unattended clinic BP with normal ABPM 
7.2 (5.2,9.7) 
Masked hypertension  
 
Hypertensive ABPM with normal attended clinic BP 
5.5 (3.7,7.6) 
Hypertensive ABPM with normal unattended clinic BP 
3.2 (1.9,5.0) 
Hypertension will be defined as:  
Awake ABPM readings ≥135 or 85 mm Hg 
Attended: SBP/DBP readings ≥140 or 90 mm Hg 
Unattended: SBP/DBP readings ≥135 or 85 mm Hg 
 
 
 
 

Table 4. Agreement between hypertension on ABPM and clinic BP, N=569 
 
 
ABPM and unattended clinic BP in hypertensive range 
 
 
 
Yes, % 
No, % 
N (%) 
ABPM and attended clinic 
BP in hypertensive range 
Yes, % 
25 (4.4) 
1 (0.2) 
26 (4.6) 
No, % 
14 (2.5) 
529 (93.0) 
543 (95.4) 
 
N (%) 
39 (6.9) 
530 (93.2) 
569 (100) 
Kappa: 0.76 

Table 5. Agreement between white coat hypertension on ABPM and clinic BP, N  
 
 
Hypertensive unattended clinic BP with normal ABPM 
 
 
 
Yes, % 
No, % 
N (%) 
Hypertensive attended clinic 
BP with normal ABPM 
Yes, % 
15 (2.6) 
0 (0.0) 
15 (2.6) 
No, % 
26 (4.6) 
528 (92.8) 
554 (97.4) 
 
N (%) 
41(7.2) 
528 (92.8) 
569 (100) 
Kappa: 0.52 

Table 6. Agreement between masked hypertension on ABPM and clinic BP, N 
 
 
Hypertensive ABPM with normal unattended clinic BP 
 
 
 
Yes, % 
No, % 
N (%) 
Hypertensive ABPM with 
normal attended clinic BP 
Yes, % 
17 (3.0) 
14 (2.5) 
31 (5.5) 
No, % 
1 (0.2) 
537 (94.4) 
538 (94.6) 
 
N (%) 
18 (3.2) 
551 (96.8) 
569 (100) 
Kappa: 0.68 

Table 7. The difference between sleep BP on HBPM versus sleep BP on ABPM, N = 547 
 
ABPM 
Mean (SD) 
Median, (min – max) 
HBPM 
Mean (SD) 
Median (min – max) 
 
Mean difference, 
(95% CI) 
 
P (difference = 0) 
Sleep systolic BP 
104.1 (10.5) 
103.3 (72.3 - 145.0) 
106.4 (11.5) 
106.0 (74.0 - 159.0) 
-2.3 (-3.0, -1.5) 
<.0001 
Sleep diastolic BP 
60.4 (7.5) 
59.8 (42.1 - 95.4) 
62.3 (8.3) 
62.0 (38.0 - 88.0) 
-1.9 (-2.5,-1.4) 
<.0001 

Table 8. Side effects and tolerability of HBPM versus ABPM, N = 603. 
 
 
Occurred with 
ABPM only, N (%) 
Occurred with 
HBPM only, N (%) 
Occurred with both 
ABPM and HBPM, N (%) 
Didn’t occur for 
ABPM or HBPM, N (%) 
Side effects 
 
 
 
 
Pain while wearing the monitor 
160 (26.5) 
37 (6.1) 
128 (21.2) 
278 (46.1) 
Irritation while wearing the monitor 
178 (29.5) 
26 (4.3) 
232 (38.5) 
167 (27.7) 
Bruising while wearing the monitor 
84 (13.9) 
19 (3.2) 
54 (9.0) 
446 (74.0) 
Tolerability 
 
 
 
 
Monitor was heavy to wear 
133 (22.1) 
57 (9.5) 
139 (23.1) 
274 (45.4) 
Monitor was uncomfortable to wear 
109 (18.1) 
68 (11.3) 
399 (66.2) 
27 (4.5) 
Monitor was straightforward to use 
12 (2.0) 
6 (1.0) 
578 (95.9) 
7 (1.2) 
Monitor was cumbersome or awkward to wear 
130 (21.6) 
27 (4.5) 
377 (62.5) 
69 (11.4) 
Noise of the monitor was disturbing to me 
91 (15.1) 
71 (11.8) 
102 (16.9) 
339 (56.2) 
Noise of the monitor disturb others 
67 (11.1) 
24 (4.0) 
43 (7.1) 
469 (77.8) 
Monitor was embarrassing to wear 
212 (35.2) 
10 (1.7) 
93 (15.4) 
288 (47.8) 
Monitor interfered with normal sleeping pattern 
124 (20.6) 
56 (9.3) 
219 (36.3) 
204 (33.8) 
Removed monitor due to disturbance while sleeping 
23 (3.8) 
23 (3.8) 
16 (2.7) 
541 (89.7) 
 
 

Table 9. The relationship between attended and unattended clinic BP with left ventricular mass index (g/m2), N=587. 
 
Model 
Unstandardized 
beta 
Lower limit of 95% confidence 
intervals for beta 
Upper limit of 95% confidence 
intervals for beta 
Standard Error 
t-statistic 
P-value 
Standardized beta 
Attended clinic systolic BP 
0.43 
0.32 
0.55 
0.06 
7.55 
<.001 
0.30 
Attended clinic diastolic BP 
0.42 
0.24 
0.60 
0.09 
4.66 
<.001 
0.19 
Unattended clinic systolic BP 
0.44 
0.33 
0.56 
0.06 
7.50 
<.001 
0.30 
Unattended clinic diastolic BP 
0.37 
0.19 
0.55 
0.09 
4.04 
<.001 
0.16 
Dependent variable: left ventricular mass index (g/m2) as continuous variable 
 

Table 10. The relationship between unattended clinic BP versus awake BP on ABPM with left ventricular mass index (g/m2), N=554  
 
Model 
Unstandardized 
beta 
Lower limit of 95% confidence 
intervals for beta 
Upper limit of 95% confidence 
intervals for beta 
Standard Error 
t-statistic 
P-value 
Standardized beta 
Unattended systolic BP 
0.44 
0.32 
0.56 
0.06 
7.38 
<0.001 
0.30 
Unattended diastolic BP 
0.38 
0.19 
0.56 
0.09 
3.99 
<0.001 
0.17 
Awake systolic BP on ABPM  
0.61 
0.47 
0.74 
0.07 
8.69 
<0.001 
0.35 
Awake diastolic BP on ABPM 
0.45 
0.25 
0.66 
0.10 
4.36 
<0.001 
0.18 
Dependent variable: left ventricular mass index (g/m2) as continuous variable 
 

Table 11. The relationship between sleep BP on HBPM versus ABPM with left ventricular mass index (g/m2), N=533  
 
Model 
Unstandardized 
beta 
Lower limit of 95% confidence 
intervals for beta 
Upper limit of 95% confidence 
intervals for beta 
Standard Error 
t-statistic 
P-value 
Standardized beta 
Sleep systolic BP on HBPM 
0.31 
0.19 
0.44 
0.06 
4.98 
<0.001 
0.21 
Sleep diastolic BP on HBPM 
0.23 
0.05 
0.40 
0.09 
2.54 
0.01 
0.11 
Sleep systolic BP on ABPM 
0.45 
0.32 
0.59 
0.07 
6.63 
<0.001 
0.28 
Sleep diastolic BP on ABPM 
0.36 
0.16 
0.55 
0.10 
3.64 
<0.001 
0.16 
Dependent variable: left ventricular mass index (g/m2) as continuous variable 
 
 

Table 12. The relationship between attended and unattended clinic BP with urinary albumin-to-creatinine ratio (mg/g), N=555. 
 
Model 
Unstandardized 
beta 
Lower limit of 95% confidence 
intervals for beta 
Upper limit of 95% confidence 
intervals for beta 
Standard Error 
t-statistic 
P-value 
Standardized 
beta 
Attended clinic systolic BP 
-0.2 
-0.47 
0.08 
0.14 
-1.39 
0.17 
-0.06 
Attended clinic diastolic BP 
-0.28 
-0.7 
0.15 
0.22 
-1.27 
0.20 
-0.05 
Unattended clinic systolic BP 
-0.26 
-0.55 
0.02 
0.14 
-1.84 
0.07 
-0.08 
Unattended clinic diastolic BP 
-0.37 
-0.8 
0.06 
0.22 
-1.68 
0.09 
-0.07 
Dependent variable: : urinary albumin-to-creatinine ratio (mg/g) as continuous variable 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Table 13. The relationship between unattended clinic BP versus awake BP on ABPM with urinary albumin-to-creatinine ratio (mg/g), N=523. 
 
Model 
Unstandardized 
beta 
Lower limit of 95% confidence 
intervals for beta 
Upper limit of 95% confidence 
intervals for beta 
Standard Error 
t-statistic 
P-value 
Standardized beta 
Unattended systolic BP 
-0.18 
-0.44 
0.07 
0.13 
-1.39 
0.16 
-0.06 
Unattended diastolic BP 
-0.09 
-0.49 
0.31 
0.20 
-0.45 
0.65 
-0.02 
Awake systolic BP on ABPM  
0.01 
-0.29 
0.31 
0.15 
0.07 
0.94 
0.00 
Awake diastolic BP on ABPM 
0.22 
-0.21 
0.66 
0.22 
1.01 
0.31 
0.04 
Dependent variable: urinary albumin-to-creatinine ratio (mg/g) as continuous variable 
 
 
 
 
 

Table 14. The relationship between sleep BP on HBPM versus ABPM with urinary albumin-to-creatinine ratio (mg/g), N=505. 
Model 
Unstandardized 
beta 
Lower limit of 95% confidence 
intervals for beta 
Upper limit of 95% confidence 
intervals for beta 
Standard Error 
t-statistic
P-value
Standardized beta 
Sleep systolic BP on HBPM 
-0.01
-0.28
0.26 
0.14 
-0.08
0.94 
-0.00
Sleep diastolic BP on HBPM 
-0.02
-0.40
0.36 
0.20 
-0.09
0.93 
-0.00
Sleep systolic BP on ABPM 
0.09 
-0.21
0.40 
0.15 
0.61 
0.54 
0.03 
Sleep diastolic BP on ABPM 
0.26 
-0.16
0.68 
0.21 
1.20 
0.23 
0.05 
Dependent variable: urinary albumin-to-creatinine ratio (mg/g) as continuous variable 

The standard approach to measuring blood pressure (BP), in the clinic with an observer present (attended BP 
measurement), results in the misdiagnosis of hypertension for many adults.1 Among adults with high BP in the 
clinic (systolic BP [SBP]/diastolic BP [DBP]  ≥ 140/90 mm Hg), ~20% to 30% do not have high BP (SBP/DBP 
<135/85 mm Hg) while awake outside of the clinic, a phenotype called white coat hypertension.2  White coat 
hypertension is not associated with increased cardiovascular disease (CVD) risk.3, 4 Also, 15% to 30% of 
people without high BP (SBP/DBP <140/90 mm Hg) when measured by an observer in the clinic have high BP 
6%3'%3 ≥155 mm Hg ZhLOH aZaNH RXtVLGH RI thH FOLnLF5, 6  This phenotype, called masked hypertension, 
is associated with high CVD risk.5, 7  Due to the high degree of misclassification of hypertension when using 
clinic BP, the US Preventive Services Task Force recommends out-of-clinic BP measurement be performed to 
exclude the presence of white coat hypertension before initiating antihypertensive treatment.2   
 
Data from non-randomized studies from Canada suggest that using an automated oscillometric BP (AOBP) 
device without an observer present (unattended BP) results in lower clinic BP compared to attended 
measurements taken using the auscultatory method.8, 9  The 2017 Canadian hypertension guideline 
recommended measuring unattended BP in clinical practice for reducing the risk of white coat hypertension but 
acknowledged the low level of evidence supporting this recommendation (i.e., Grade D, “very low quality” and 
“expert opinion”).10 Currently, obtaining unattended BP has not been adopted in US guidelines. Few studies 
have compared unattended clinic BP to attended clinic BP measured with an oscilometric device, which is 
increasingly being used for measuring BP in the US. In an analysis of the Systolic Blood Pressure Intervention 
Trial (SPRINT) data, there was no difference in BP when measured unattended and attended (personal 
communication, S. Oparil). Thus, there is equipoise as to whether unattended BP reduces the risk of white coat 
hypertension. Further, the effect of unattended BP measurement on masked hypertension risk is also unclear. 
 
Nocturnal hypertension, t\SLFaOO\ GHILnHG E\ mHan VOHHS 6%3'%3 ≥ 100 mm Hg affects ~1 in 3 adults and 
is associated with increased CVD risk, independent of clinic and awake BP.11-13 Therefore, a comprehensive 
approach to diagnosing hypertension requires measuring sleep BP in addition to awake BP. Ambulatory BP 
monitoring (ABPM) is a procedure wherein people have their BP measured automatically every 15 to 30 
minutes, typically for 24 hours, outside of the clinic setting.  ABPM is widely considered to be the reference 
standard for diagnosing hypertension. However, ABPM is not available in most clinics in the US and is poorly 
tolerated by patients.14-16 Recently, home BP monitoring (HBPM) devices have been developed that measure 
BP during sleep. These devices may be better tolerated than ABPM as they are only worn at night and fewer 
BP measurements are obtained. We propose to compare novel non-ABPM approaches for measuring BP 
and diagnosing hypertension with ABPM, the reference standard.2  The study aims are: 
 
Aim 1. Test whether measuring unattended clinic BP with an automated device will provide a more 
accurate estimate of awake BP on ABPM than measuring attended clinic BP with an automated device.  
Hypothesis 1a: The absolute difference with awake BP will be smaller for unattended vs. attended clinic BP. 
Hypothesis 1b: The agreement between hypertension status using BP measured in the clinic and on ABPM 
while awake will be higher when clinic BP is measured unattended versus attended.  Also, the prevalence of 
both white coat and masked hypertension will be lower when measuring unattended versus attended clinic BP.  
Aim 2. Test whether a new HBPM device provides an accurate approach for measuring sleep BP.   
Hypothesis 2a: Sleep BP on HBPM will provide an accurate estimate of sleep BP on ABPM.   
Hypothesis 2b: HBPM will be better tolerated (e.g., less awakening during sleep, pain, bruising) than ABPM.  
 
Aim 3. Compare the associations of unattended versus attended clinic BP, unattended clinic BP versus 
awake BP on ABPM, and sleep BP on HBPM versus ABPM with two markers of end-organ damage, left 
ventricular mass index (LVMI) and urinary albumin-to-creatinine ratio (ACR). 
Hypothesis 3a: The association with end-organ damage will be stronger for unattended vs. attended clinic BP. 
Hypothesis 3b: The association with end-organ damage will be similar for unattended clinic BP and awake BP. 
Hypothesis 3c: The association with end-organ damage will be similar for sleep BP by HBPM and ABPM. 
 
We will enroll 630 adults, not taking antihypertensive medication, with screening clinic SBP of 110 to 159 mm 
Hg and DBP of 70 to 99 mm Hg in New York, NY and Birmingham, AL. Participants will undergo unattended 
and attended clinic BP measurements, in a random order, and 24-hour ABPM and sleep HBPM, in a random 
order.  Health behaviors, psychosocial factors, anthropometrics, LVMI, and ACR will also be assessed.  
 
Public Health Significance: This study will help determine whether the conduct of unattended BP 
measurement in the clinic can reduce the need for measuring awake BP on ABPM, and also test whether a 
HBPM device can replace ABPM for measuring sleep BP. These data will inform whether these novel non-
ABPM approaches for measuring BP and diagnosing hypertension should be used in clinic practice.      
Contact PD/PI: Muntner, Paul
Specific Aims                                                                                                 
Page 73

B. SIGNIFICANCE. The significance of the proposed study is summarized in Table 1. 
B.1. Clinic BP as a CVD risk factor. 
Compared with other risk factors, elevated 
BP is associated with more CVD events and 
disability-adjusted life years lost in the US 
and worldwide.17, 18 To identify patients with 
hypertension and monitor their BP while 
taking antihypertensive medication, most 
US guidelines and scientific statements 
recommend BP be measured in the clinic 
setting by a trained healthcare 
professional.19-21  This recommendation is 
supported by extensive data, demonstrating 
that elevated BP, measured using this 
approach, is associated with increased risk 
for CVD and renal disease events.22, 23 In 
clinical practice and research studies 
conducted in the US, BP is almost 
universally measured in the clinic with an 
observer present (attended clinic BP). 
B.2. Measuring BP outside of the clinic. 
Several studies have found that compared 
with attended clinic BP, BP measured 
outside of the clinic is a better predictor of a 
person’s CVD risk.4, 24 The US Preventive 
Services Task Force (USPSTF) and the UK 
National Institute for Health and Care 
Excellence recommend that elevated BP 
measured in the clinic be confirmed by out-
of-clinic BP measurements prior to 
diagnosing hypertension.2, 25 ABPM is the 
reference standard for out-of-clinic BP 
assessment and making the diagnosis of 
hypertension.4, 26, 27  ABPM monitors are compact, worn on a belt or in a pouch, and connected to a BP cuff on 
the upper arm by a tube. The monitors are programmed to obtain readings using the oscillometric method, 
every 15 to 30 minutes, typically for 24 hours, throughout the day and night.  
B.3. Mismatch between clinic and out-of-clinic BP. In some people, there is a transient BP increase that 
occurs in the clinic setting (i.e., white coat effect).28, 29 For others, BP is lower in the clinic when compared to 
measurements obtained outside of the clinic environment (i.e., masked effect).7, 30  White coat hypertension is 
defined as hypertension based on clinic-mHaVXUHG %3 ≥ 1400 mm Hg EXt nRt ZhHn mHaVXUHG RXtVLGH RI 
the clinic setting (awake BP < 135/85 mm Hg). In most ABPM studies, white coat hypertension has not been 
associated with increased CVD risk.3, 31 In contrast, masked hypertension, defined as not having hypertension 
based on BP measured in the clinic setting (< 140/90 mm Hg) but hypertension based on out-of-clinic 
mHaVXUHmHntV aZaNH %3 ≥ 155 mm Hg is associated with a markedly increased CVD risk.5, 7 Among 
aGXOtV ZLth 6%3'%3 ≥ 1400 mm Hg GHILnHG XVLng attHnGHG %3 mHaVXUHG Ln thH FOLnLF 0 tR 0 haYH 
white coat hypertension.4, 32 Additionally, between 15% and 30% of adults with SBP/DBP < 140/90 mm Hg, 
defined using attended BP measured in the clinic, have masked hypertension.6, 33   
B.4. Sleep BP.  There is a diurnal pattern of BP, which normally falls to its lowest level during sleep.34-36 
1RFtXUnaO h\SHUtHnVLRn GHILnHG E\ haYLng hLgh mHan VOHHS %3 6%3'%3 ≥ 100 mm Hg LV aVVRFLatHG 
with an increased risk for CVD events, independent of BP measured in the clinic and awake BP on ABPM.37-39  
Assessing sleep BP may be particularly important for African Americans, a population with high CVD risk and 
approximately two times higher prevalence of nocturnal hypertension compared with whites.40-42 In the Jackson 
Heart Study (JHS), a cohort comprised exclusively of African Americans, 60% of participants had nocturnal 
hypertension and the multivariable-adjusted hazard ratio for CVD events was 1.84 (95% CI: 1.00, 3.38) 
comparing participants with and without nocturnal hypertension.  Also, a high percentage of African Americans 
with nocturnal hypertension do not have hypertension based on clinic BP or awake BP on ABPM (Figure 1).41, 
Table 1. Significance of the proposed study. 
BP, measured by an observer in the clinic, does not provide an 
accurate estimate of a person’s true BP and hypertension status. 
• Out-of-clinic BP assessment by ABPM is widely recommended to: 
• Identify white coat hypetension and masked hypertesion. 
• Identify hypertension during sleep. 
• Many clinics in the US do not have access to ABPM. 
• Many patients do not tolerate ABPM. 
• It has been suggested that ABPM can be replaced by BP measured 
in the clinic using an automated device without an observer 
present. 
Prior studies of BP measurement with automated devices without 
an observer present have major limitations. 
• The order of BP measurement (observed or unobserved occurring 
first) was not randomized. 
• Observer measured BP was most commonly performed using a 
mercury sphygmometer, which is no longer the recommended 
approach for measuring BP in clinic practice. 
• Select patients with high BP or treated hypertension were enrolled. 
Studies of sleep BP using HBPM vs. ABPM have major 
limitations. 
• Sleep BP is associated with sub-clinical and clinical CVD events. 
• The ordering of HBPM and ABPM was not randomized. 
• Studies have focused on patients on antihypertensive medication. 
• No data are available in the US including among African 
Americans, who have a high prevalence of nocturnal hypertension. 
Potential solutions to be tested in the proposed study: 
• Measuring clinic BP without an observer to assess awake BP. 
• Will this reduce the need to screen for white coat hypertension? 
• What is the effect of this approach on masked hypertension? 
• Using a novel HBPM device to measure asleep BP. 
• Does this accurately assess sleep BP / nocturnal hypertension? 
• Is HBPM better tolerated than ABPM in assessing sleep BP? 
Contact PD/PI: Muntner, Paul
Research Strategy                                                                                             
Page 74

43 Until recently, ABPM has been the only method that could assess sleep BP (Section B.6.2.1.).   
B.5. Challenges with ABPM. The misdiagnosis of hypertension when BP is measured by an observer in the 
clinic versus by ABPM is well recognized by guidelines, scientific statements, and position papers.1, 24  
However, there are several challenges that have prevented the 
wide-spread use of ABPM in clinical practice. 
B.5.1. Health care provider perspective. Recently, we conducted 
a nominal groups study, a qualitative research approach, with 40 
physicians in Alabama and New York to identify barriers to 
performing ABPM.44 Reported barriers included need for staff 
training, time constraints in patient preparation, and lack of 
infrastructure and inaccessibility of equipment and specialists to 
whom providers could refer their patients for the ABPM procedure.15 
Also, ABPM devices cost over $2,000 each, insurance companies 
do not commonly reimburse for indications other than white coat 
hypertension, and when reimbursed, the compensation is low.14, 45  
B.5.2. Patient perspective. Low patient tolerability for ABPM has 
been reported in previous studies.16, 46, 47  For example, in one study, 
side effects associated with ABPM ranged from 7% for bruising to 
70% for the device awakening the participant during sleep.16  
B.6. New approaches for diagnosing hypertension. Given the real world limitations of ABPM, novel 
approaches are needed for measuring awake and sleep BP.  
B.6.1. New approach for assessing awake BP. An emerging method that has been proposed for estimating 
awake BP is to measure BP in the clinic using a fully automated oscillometric device (AOBP) without an 
observer being present (unattended clinic BP measurement). 
 B.6.1.1. AOBP. There are currently two validated oscillometric devices available in the US (Omron HEM-
907XL and Microlife’s Watch BP office) that can be programmed to measure BP automatically without an 
observer being present.48-50  Using these devices, the technician or healthcare provider leaves the room after a 
person has a BP cuff placed on their arm and they are positioned for measurements. After a minute rest, the 
device inflates the cuff and BP is measured.  AOBP devices can obtain several BP measurements at preset 
(e.g., one minute) intervals. The maker of BPTru, a third device, went out of business in 2017.   
 B.6.1.2. Can unattended clinic BP measurements replace the need for assessing awake BP on ABPM? 
Canadian studies suggest that patients with hypertension have lower unattended BP compared with attended 
BP.8, 9, 51-53  Therefore, the use of unattended clinic BP may result in a lower prevalence of white coat 
hypertension.  In a pooled analysis of 8558 adults, the mean clinic BP was 10/7 mm Hg lower with unattended 
AOBP versus BP recorded by a provider in clinical practice by auscultation and a mercury sphygmometer.54 In 
the only randomized study of AOBP published to date, the difference between BP when measured observed 
and unobserved was small (< 5 mm Hg).8 In 2017, the Hypertension Canada guideline recommended 
unattended BP (i.e., AOBP) as the preferred method of clinic BP measurement.10  However, this 
recommendation was based on a Grade D level of evidence (i.e. quality of evidence is very low, based on 
expert opinion, no direct research evidence, and studies had very severe limitations). US guidelines do not 
currently recommend AOBP for use in clinic practice.  Recently, in a post-hoc analysis of SPRINT data, there 
was no difference in clinic BP between sites that measured it unattended versus attended (manuscript under 
review at Hypertension, personal communication, S. Oparil). At each visit, SPRINT participiants did not have 
both unattended and attended BP measurements; there was no randomization; information about the conduct 
of unattended or attended BP measurements was obtained retrospectively after study end; and no comparison 
to ABPM was made. Table 2 summarizes the major limitations of published studies on AOBP. There is 
currently equipoise as to whether unattended clinic BP provides an accurate estimate of awake BP on ABPM.  
B.6.1.3. Can unattended BP be successfully implemented in clinical practice?  Two issues have been 
raised as barriers to implementing AOBP in clinical practice: the time it takes to perform this procedure and the 
need for dedicated space. Although AOBP takes longer than unstandardized clinic BP measurement (clinic BP 
taken without following guideline-recommended approaches), AOBP takes a shorter amount of time than clinic 
BP measurements taken following American Heart Association (AHA) recommendations.52 Further, 
unstandardized clinic BP measurements are very common in clinical practice, generate poor estimates of BP, 
and interventions targeted at observers to obtain standardized clinic BP have been largely unsuccessful.55 
Having a dedicated room to perform unattended BP has been reported as a barrier to AOBP. However, if clinic 
space is not available, unattended AOBP can be successfully performed while a patient is in a waiting room.56  
3%
14%
4%
32%
17%
49%
0%
20%
40%
60%
CARDIA
JHS
Clinic hypertension
Awake hypertension
Sleep hypertension
Figure 1. Hypertension based on attended clinic BP, 
awake BP and sleep BP in African Americans.
Muntner 2014 (ref 52), Thomas, 2017 (ref 54)
Contact PD/PI: Muntner, Paul
Research Strategy                                                                                             
Page 75

 B.6.2. New approach for assessing sleep BP. Recently, home BP monitors (HBPM) have been adapted to 
measure asleep BP.  As described below, there are compelling preliminary data supporting this approach. 
B.6.2.1. A novel HBPM device for measuring sleep BP. Until recently, sleep BP could only be assessed by 
ABPM.  HBPM devices have been developed that measure BP automatically during sleep.  These devices 
have been previously validated for accuracy.49, 58 Before going to sleep, a person attaches a BP cuff to their 
arm and turns on the HBPM device, which is programmed to take BP measurements while the person is 
asleep. In a prior study conducted in Japan, an HBPM device (Omron HEM-5001) was programmed to obtain 
BP measurements at 2am, 3am and 4am.59 Given that only three readings are obtained during the sleep 
period and that a prior study demonstrated the feasibility for measuring sleep BP, there is great potential for 
using these HBPM devices for accurately measuring sleep BP with less burden than ABPM. Table 3 shows the 
major limitations of published studies using HBPM to assess sleep BP. In the current study, we will test 
whether HBPM is an accurate and better tolerated approach for measuring sleep BP than ABPM.59   
 C. INNOVATION. The proposed study has several innovative features: 
• 
We will enroll patients with a wide range of clinic BP and who are not taking antihypertensive medication. 
The study examines unattended clinic BP measurement for the diagnosis of hypertension.  
• 
The study will use a within-subjects randomized design which will control for order effects and regression to 
the mean. Participants will be randomized to have their BP measured in the clinic attended or unattended 
in counterbalanced order (i.e. attended followed by unattended or vice versa).  Additionally, participants will 
be randomized to have their sleep BP measured first by ABPM then by HBPM or vice-versa. The lack of 
randomized controlled data on BP measured unattended versus attended has resulted in a low grade of 
evidence (Grade D) in the Canadian hypertension guideline.  
• 
The study will compare unattended clinic BP versus attended clinic BP using the same oscillometric device. 
In prior studies, attended clinic BP was measured by auscultation. The use of oscillometric BP devices is 
becoming more widespread in clinical practice as mercury sphygmomanometers have environmental 
concerns and the need for frequent calibration of aneroid devices is recognized as a major problem.  
• 
We will test whether BP during sleep can be accurately measured using an HBPM device and whether this 
device is better tolerated than ABPM. To our knowledge this HPBM device has not been tested in the US 
and there are no data on sleep BP from HBPM for race/ethnicity groups (i.e. African Americans or 
Hispanics). The study will enroll a multi-ethnic sample of white, African American and Hispanic participants 
in the Northeast and Southeast US, which will increase the generalizability of the results.  
• 
We will determine the prevalence of both white coat hypertension and masked hypertension using 
Table 2. Limitations of published studies comparing attended and unattended BP versus awake BP on ABPM 
1. The order of clinic BP measurement (attended and unattended clinic BP) was not randomized.  In prior studies, unattended 
clinic BP was performed after attended clinic BP. Thus, order effects cannot be excluded. 
2. Attended clinic BP was not measured in a standardized way (guideline recommendations). The difference in unattended 
and attended BP could be explained by poor measurement techniques when obtaining attended BP.  
3. Attended clinic BP was measured by auscultation using a mercury sphygmometer. In the US, this method is no longer 
performed, and oscillometric devices have become a common method for BP measurement in practice.  
4. Enrollment was restricted to patients with high clinic BP. Enrollment of patients with only high clinic BP makes it impossible 
to separate the effect of unattended clinic BP measurements from regression to the mean.  Few data are available comparing 
unattended and attended clinic BP among adults with normal clinic BP or prehypertension. 
5. Patients often were taking antihypertensive medication. The role of unattended clinic BP measurement for the initial 
diagnosis of hypertension (which is the focus on the proposed study) remains unclear. 
6. Studies have focused on the diagnosis of white coat hypertension. Scarce data are available from studies evaluating the 
effect of measuring unattended BP on masked hypertension.  An unintended consequence of unattended BP is that it may 
increase the prevalence of masked hypertension as individuals who would have previously been identified as having sustained 
hypertension (elevated clinic BP and awake BP on ABPM) will now have masked hypertension because clinic BP is no longer 
elevated.57 However, if unattended clinic BP measurement provides an accurate estimate of awake BP on ABPM, then the 
prevalence of masked hypertension should decrease. 
Table 3. Limitations of prior studies comparing sleep BP on HBPM versus ABPM 
1. The order of home monitoring and ABPM to assess sleep BP was not randomized. In prior studies, patients chose the order 
in which they completed home monitoring and ABPM to assess sleep BP.  
2. Studies did not include US populations. Sleep BP and nocturnal hypertension have not been compared between HBPM and 
ABPM in African Americans, a population with a high prevalence of nocturnal hypertension.  
3. Over 80% of patients were taking antihypertensive medication. Prior studies have primarily included people taking 
antihypertensive medication, with some people taking medication before bedtime. The role of home monitoring to assess sleep 
BP has not been evaluated among people not taking antihypertensive medication.  
4. The agreement of nocturnal hypertension defined using HBPM versus ABPM was not reported. Prior studies have only 
reported the correlation and mean difference in sleep BP levels on HBPM and ABPM. 
5. The tolerability of assessing sleep BP on HBPM was not assessed. Sleep HBPM may be better tolerated than ABPM. 
Contact PD/PI: Muntner, Paul
Research Strategy                                                                                             
Page 76

unattended clinic BP versus attended clinic BP measurements.  
• 
We will determine the predictive value of unattended clinic BP by comparing its association with LVMI and 
ACR, two validated measures of hypertension-related end-organ damage, versus the associations of 
attended clinic BP and awake BP on ABPM with these end-organ damage measures.  
• 
 We will also determine the prognostic value of sleep BP assessed on HBPM by comparing its association 
with LVMI and ACR, with sleep BP assessed by ABPM.  
D. APPROACH. 
D.1. Overall strategy of proposed study. This study consists of two 
parallel cross-over randomized controlled trials conducted in the same 
participants. A schematic showing the study design is provided in 
Figure 2. We will recruit 630 community-dwelling participants from 
centers in Birmingham, AL and New York, NY (n=315 at each site). We 
will enroll a population with a sufficient number of whites, African 
Americans, and Hispanics to investigate differences in BP 
measurement techniques by race/ethnicity. Also, information on 
tolerability of the ABPM and HBPM devices will be collected, and a brief 
examination and an echocardiogram, will be conducted. A random spot 
urine sample will be collected to measure the ACR. 
D.2. Proposed Timeline. Funding for the study is being requested for 
four years (July 1, 2018 to June 30, 2022).  During the first six months, 
we will finalize the study protocol, develop the randomization 
assignment and study databases, and conduct staff training.  From 
January 2019 through December 2021, we will enroll 630 participants 
(n=105 participants per site annually) and conduct study visits.  The 
preparation of data for analysis, including clinic BP, ABPM and sleep 
BP on HBPM, will be conducted throughout the study, and the final six 
months (January through June 2022) will be dedicated to analyses and 
preparation of manuscripts and presentations. 
D.3. Feasibility of conducting the proposed study at two sites. 
Drs. Muntner and Shimbo (co-PIs) have collaborated for 10 years. Their strong collaboration is demonstrated 
by co-funded grants and over 80 published papers including many related to BP measurement. Studies with 
primary data collection have included 888 participants enrolled in the Masked Hypertension (MHT) Study and 
408 participants enrolled in the Improving the Detection of Hypertension (IDH) Study, which are both part of a 
NIH/NHLBI Program Project. Dr. Shimbo was responsible for successfully leading the echocardiography core 
laboratory for the assessment of LVMI in the MHT Study and IDH Study. In the AHA Strategically Focused 
Research Network (AHA-SFRN) center on hypertension, they conducted clinic BP measurements and ABPM 
in 835 participants over a 12-month period. Additional details of the investigators’ experience is provided in 
their biosketches. Overall, the proposed study is highly feasible.  
D.4. Recruitment. We will enroll a racially/ethnically diverse sample of 630 adults (50% men; 50% women) 
who are ≥ 19 years of age. We will identify participants from patients visiting their physician for outpatient care 
at UAB or Columbia University. BP is measured at all outpatient visits at both institutions. We will query the 
I2B2 data warehouse at UAB and the CUMC data warehouse at Columbia University on a weekly basis and 
extract BP, medical history regarding the exclusion criteria, and pharmacy/medication data from electronic 
clinic health records.  We will obtain Institutional Review Board (IRB) and HIPAA waiver approvals for the 
search.  With the permission of the physician who conducted the clinic visit, we will be able to contact 
individual patients directly, briefly describe the study, and determine their interest in participating. People who 
are interested will be administered a brief telephone questionnaire to confirm their eligibility. Those who 
continue to be eligible will be invited to attend a screening visit and, if eligible, they will initiate the study. 
D.4.1. Eligibility criteria. To increase the generalizability of the study, a limited number of exclusion criteria 
are being applied. Inclusion criteria are: 
• 
$gH ≥ 19 years and ability to speak English or Spanish. 
• 
Mean screening SBP of 110 to < 160 mm Hg and mean screening DBP of 70 to <100 mm Hg based on the 
two most recent outpatient clinic visits, extracted from clinical records. As people with clinic SBP < 110 mm 
Hg and DBP < 70 mm Hg are very unlikely to have masked hypertension, we will not include these 
participants in our study.60, 61  Also, people with clinic 6%3 ≥ 10 mm Hg RU '%3 ≥ 100 mm Hg are typically 
referred for additional BP management with a high percentage initiated on antihypertensive medication.   
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Research Strategy                                                                                             
Page 77

Exclusion criteria are: 
• 
Lack of willingness to provide written informed consent.  
• 
Use of antihypertensive or other medications that substantially affect BP (e.g., NSAIDS, steroids). 
• 
History of CVD or major arrhythmias (e.g. atrial fibrillation, ventricular tachycardia). 
• 
Individuals who work second shift or overnight, as diurnal BP patterns may be different for this group, or 
with jobs that will not allow the ABPM device to measure BP every 30 minutes (e.g., truck drivers).  
• 
History of sleep apnea by self-report, identified in their clinic records, and/or a score ≥ 3 on the STOP-
BANG questionnaire. The sensitivity of a STOP-BANG score ≥ 3 for identifying sleep apnea is 90%. 
• 
Orthostatic hypotension assessed during the screening visit (Section D.5). Mean awake BP on ABPM may 
be affected by hypotensive episodes during standing or walking. 
• 
Pregnancy (as no ABPM devices have been validated in pregnant women). 
Although there is no estimated glomerular filtration rate (eGFR) exclusion criteria, we anticipate the prevalence 
of an eGFR < 60 ml/min/1.73 m2 will be low.  Only 3% of US adults not taking antihypertensive medication in 
NHANES 2011-2014 had an eGFR < 60 ml/min/1.73 m2. We will adjust for eGFR in multivariable analyses. 
D.4.2. Recruitment by race-ethnicity. Nighttime BP differs substantially by race/ethnicity.41, 42 We will not 
exclude people on the basis of race/ethnicity. To provide statistical power to detect differences in the validity of 
study results by race-ethnicity, we will recruit at least 160 white, 160 African American and 160 Hispanic 
participants. In a preliminary query of the I2B2 database, there were over 50,000 whites, 40,000 African 
Americans and 3,000 Hispanics who met the eligibility criteria at UAB in 2016. At Columbia, over 550 African 
Americans and 900 Hispanics have been enrolled in our recent studies of ABPM and HBPM. 
D.4.3. Recruitment by BP levels. To ensure a broad range of clinic BP values for the current study, we will 
UHFUXLt 50 RI RXU VamSOH tR haYH 6%3 ≥ 140 mm Hg RU '%3 ≥ 0 mm Hg based on the average of the most  
 recent two clinic visits in their medical record. 
D.5. Screening visit. Participants will have BP measured three times in 
each arm (as recommended by AHA guidelines) to determine which 
arm (one with higher mean BP) to use for assessing clinic BP and to 
confirm participants do not have orthostatic hypotension.  The arm with 
the higher BP will be used for all BP measurements obtained during the 
study. For assessment of orthostatic hypotension, additional readings 
will be obtained after the participant has been supine for at least 5 
minutes and after both 1 and 3 minutes of standing.62 Orthostatic 
hypotension will be defined as a maximum decline in SBP from supine 
to standing ≥ 20 mmHg. We will use the STOP-BANG Questionnaire to assess the probability of having sleep 
apnea.63 Those with a STOP-BANG score ≥ 3 will be considered to have a high probability of sleep apnea and 
excluded from enrollment.  
D.6. Study visits. After obtaining consent, the protocol involves eight domains of data collection (Table 4). 
Data will be collected over one to two weeks during four study visits (Figure 3). The protocol is similar in 
complexity to ones we have implemented in the IDH and MHT studies and the AHA-SFRN.64-66  
D.6.1. Study Visit 1. Study staff will log onto the secure HIPAA-compliant study website to enter the 
participant’s eligibility information and receive their randomization assignment for ordering of clinic BP 
measurement (i.e., randomization 1 in Figure 2).  Section D.10.1 has descriptions of the study database and 
website. Clinic BP will be measured unattended and then attended or attended then unattended with the order 
determined by the randomization assignment (see Section D.7).  Next, participants will complete a brief 
physical examination and questionnaires on health behaviors, psychosocial factors, and sleep.  This 
examination will include anthropometrics and fasting blood and urine specimen collection. 
D.6.2. Study Visit 2.  The second study visit will occur the day after the first visit. During the second study visit, 
participants will have their clinic BP measured three times attended then three times unattended or vice-versa 
depending on their randomization assignment.  After completion of the clinic BP measurements, staff will 
obtain the participant’s randomization assignment for measurement of ABPM or HBPM (i.e., ABPM followed by 
HBPM or HBPM followed by ABPM; randomization 2 in Figure 2) from the study website.  Depending on their 
randomization assignment, participants will be fitted with the ABPM device and given instructions on the 
procedure (Section D.8.4.2.) or given the HBPM device and instructed in its use (Section D.8.4.3.). All 
participants will be fitted with an Actiwatch (wrist actigraph) and given an ABPM or HBPM Device Log.       
D.6.3. Study Visit 3. Study Visit 3 will occur the day after Study Visit 2 and will follow one of two protocols 
contingent on whether participants were randomized to have ABPM then HBPM or HBPM then ABPM. 
D.6.3.1. Participants randomized to undergo ABPM then HBPM. At Study Visit 3, participants will have the 
Table 4. Domains of data collection 
1. Unattended clinic BP 
2. Attended clinic BP 
3. 24-hour ABPM with actigraphy 
4. One night of HBPM with actigraphy 
5. Questionnaires including HBPM and  
    ABPM tolerability 
6. A brief physical examination 
7. Spot urine to assess albuminuria 
8. Transthoracic echocardiogram 
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Research Strategy                                                                                             
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ABPM monitor and actigraph removed.  Data will be downloaded onto computers dedicated to the current 
study. The ABPM recording will be checked for completeness. If a complete recording is not obtained, 
participants will be asked to repeat the ABPM procedure. Once a complete ABPM is confirmed, participants 
will fill out the ABPM tolerability questionnaire (Section D.8.5). This questionnaire will be self-administered 
unless participants are unable to read, in which case, it will be interviewer administered. Participants will be 
given an HBPM device and instructed in its use as described in Section D.8.4.3. 
D.6.3.2. Participants randomized to undergo HBPM then ABPM. At Study Visit 3, participants will return the 
HBPM device and have the actigraph removed.  Data will be downloaded onto computers dedicated to the 
current study and the recording will be checked for completeness. Next, participants will be asked to fill out a 
questionnaire on the tolerability of HBPM (Section D.8.5). This questionnaire will be self-administered unless 
participants are unable to read, in which case, it will be interviewer administered. Participants will be fitted with 
an ABPM device and instructed in its use as described in Section D.8.4.2. 
D.6.4. Study Visit 4.  Identical activities will occur at Study Visits 3 and 4 (i.e., the ABPM or HBPM devices will 
be returned, checked for a complete recording, and a tolerability questionnaire will be filled out).  At the 
conclusion of Study Visit 4, participants will be escorted by study staff to the laboratory for an echocardiogram. 
Upon completion of the echocardiogram, participants will have successfully completed the study.   
D.7. Randomization. Each participant will be randomized two times in the current study.  At Study Visit 1, we 
will randomize participants to have their clinic BP measured either unattended and then attended or attended 
and then unattended.  After the assessment of clinic BP at Study Visit 2, participants will be randomized to 
complete ABPM then HBPM or HBPM then ABPM.  Each randomization will be separate and independent.  
Randomization will be performed by site (i.e., UAB and Columbia University) and we will use block sizes of 2, 
4, or 8.  Randomization assignments will be generated by a statistician at UAB using SAS Version 9.4 and 
stored in a RedCap database created and maintained by a programmer at UAB (Section D.10.1).   
D.8. Measures. A brief examination will occur at the end of Study Visit 1.  This exam will include 
anthropometrics, fasting blood and urine collection, and completion of questionnaires. 
D.8.1. Anthropometric measures. With participants wearing a gown provided by the study, a calibrated scale 
will be used to measure weight. Height will be measured with the participants’ shoes off using a metal 
centimeter tape-measure. A flexible tape measure will be used to measure waist circumference midway 
between the lowest ribs and the iliac crest and neck circumference at the level of the cricothyroid membrane. 
D.8.2. Blood and urine measurements. A fasting blood draw will be performed by a research coordinator with 
phlebotomist training, and participants will also be asked to provide an untimed (spot) urine sample.  Total and 
HDL cholesterol, triglycerides, serum creatinine, hemoglobin A1c, and glucose will be assayed. Serum 
creatinine will be measured using an IDMS-traceable approach. eGFR will be estimated using the CKD-EPI 
equation.67 Urinary albumin and creatinine will be measured using nephelometry.  
D.8.3. Questionnaires. Questionnaires will be self-administered.  English and Spanish versions of the 
questionnaires will be used.  For participants who cannot read, questionnaires will be interview administered. 
D.8.3.1. Sociodemographic factors and medical history.  Age, race/ethnicity, sex, household income, 
education, medical history (e.g., history of diabetes) and medication use will be determined by questionnaires. 
We will adapt questionnaires from our prior NIH- and AHA-SFRN funded studies for administration.  
D.8.3.2. Psychosocial factors. Depressive symptoms will be assessed using the 20-item Centers for 
Epidemiologic Studies of Depression (CES-D)68; discrimination by a questionnaire used in the Coronary Artery 
Risk Development in Young Adults (CARDIA) study69, 70; perceived stress by the Perceived Stress Scale71; and 
trait anxiety by the State-Trait Anxiety Inventory –Trait Scale (TAI).72 These scales are written at less than the 
8th grade level, should take 20 minutes to complete and have been validated in multi-ethnic populations.73 
D.8.3.3. Sleep duration and quality. Sleep duration and quality will be assessed using the Pittsburgh Sleep 
Quality Index (PSQI), a validated instrument that provides a measure of global sleep quality and sleep duration 
over the previous month.74  
D.8.3.4. Seasonal temperature.  High and low outdoor temperatures will be recorded using National Oceanic 
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and Atmospheric Administration data for the ABPM and home sleep BP monitoring periods.  We will use these 
data to investigate whether temperature affects the association of unattended versus attended clinic BP with 
ABPM and the correlation of sleep BP on ABPM compared with HBPM.  The temperature of the room where 
clinic BP is measured will be kept at 72 degrees and checked prior to each participant’s clinic visits. 
D.8.4. Blood pressure. 
D.8.4.1. Clinic BP. We will assess clinic BP on two separate occasions, on consecutive days. Every effort will 
be made to conduct clinic BP measurements at the same time of day with the morning preferred for all 
participants.  At each visit, BP will be measured three times attended and three times unattended using the 
arm with higher BP during the screening visit. The ordering of approaches will be randomized so that 50% of 
participants have attended BP measured first and unattended BP measured second at Study Visit 1 and the 
remaining 50% of participants will have unattended BP measured first followed by attended BP measurements 
at Study Visit 1. We selected to use the Omron HEM-907XL, rather than the Watch BP Office automated 
device as it has been used in US studies including a sub-study of NHANES participants and SPRINT.75-77  We 
are not using the BPTru automated BP device as its manufacturer went out of business in September 2017.   
D.8.4.1.1 Attended clinic BP. For assessment of attended clinic BP, three readings will be obtained from the 
arm with higher BP during the screening visit, using an appropriate-sized cuff and the Omron HEM-907XL 
(Omron, Bannockburn, IL, USA), an oscillometric device, by a trained BP technician.  The Omron HEM-907XL 
device has been previously validated against a mercury sphygmomanometer.49, 50 This device comes with 
small, regular, large and extra-large cuff sizes and the proper BP cuff size will be determined by measuring the 
participant’s arm circumferences at the mid-point between the acromion and olecranon. Participants will be 
asked to sit quietly for at least 5 minutes, in a comfortable posture, with feet flat on the floor prior to their BP 
measurement with the technician in the room. Three BP readings separated by one minute will be obtained 
with the participant seated with their back supported and their arm positioned at heart level. The BP technician 
will initiate each reading by pushing the “Start” button on the device.  The three BP readings will not be visible 
to the technician or participant until after the procedure is complete.  
D.8.4.1.2. Unattended clinic BP. We will obtain unattended clinic BP measurements using the same Omron 
device used for attended clinic BP measurements (Omron HEM-907XL). It has a memory chip that stores the 
individual BP readings. The device will be programmed to take three BP readings automatically, spaced one 
minute apart from the same arm as the attended readings. After positioning the participant, the technician will 
program the BP device to wait one minute prior to initiating the three readings.  The BP technician will then 
leave the room (i.e., at the start of the one minute resting period).  The BP technician will stay outside of the 
room for 5 minutes to ensure that all three unattended BP measurements are obtained without interruption.  To 
avoid possible reactive effects in the participant, the three BP readings will not be visible to participants. 
D.8.4.2. ABPM and Actigraphy. ABPM will be performed in the same arm used to measure clinic BP. An 
appropriate BP cuff size will be selected based on the measurement of each participant’s arm circumference. 
The monitor (SpaceLabs 90227) will be initialized, and the participant fitted with it. The SpaceLabs 90227 
monitor has been previously validated and we have used this device in a prior project.78 The ABPM device will 
be programmed to take readings every 30 minutes over the 24-hour monitoring period. BP readings on the 
ABPM will not be visible to participants.  Each participant will be instructed to keep his/her arm still and in the 
neutral position from the time that s/he feels the arm cuff begin to inflate until it is fully deflated. Participants will 
also be fitted with an Actiwatch activity monitor (Philips Respironics, Bend, OR) on their wrist to wear during 
the 24-hour ABPM period. Actigraphy will provide estimates of sleep and awake times. The actigraphy data will 
be merged with the corresponding BP measurements, based on the synchronized time stamps recorded by 
both devices. Participants will be given a phone number to speak with a staff member if a problem with the 
monitor occurs. Participants will fill out the ABPM Device Log, which will confirm sleep and awake times.  
D.8.4.3. Sleep HBPM and Actigraphy. The participant will be given a sleep HBPM device (HEM-7080IC, 
Omron, Bannockburn, IL, USA) with appropriate-sized cuff and instructed in how to put on the cuff and use the 
monitor properly. Participants will be instructed to put the HBPM device on the same arm used for all other 
study procedures, the evening they leave the clinic visit.  They will also be fitted with an Actiwatch activity 
monitor on their wrist to wear during the HBPM period. Participants will be instructed to put on the HBPM 
device before going to bed and to keep it on until they wake up in the morning (i.e., after 5am).  The device will 
be programmed to take 3 readings, at 2am, 3am, and 4am.  Participants will be trained to fill out the HBPM 
Device Log, which documents sleep and awake times.  BP readings on the HBPM will not be visible to 
participants.  One night of sleep HBPM will be conducted. 
D.8.5. Tolerability of ABPM and HBPM. Tolerability for undergoing ABPM and HBPM will be assessed using 
a 15-item questionnaire.16  This questionnaire has items assessing the comfort with wearing the devices and 
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disturbances resulting from completing ABPM and HBPM.  Additionally, there are questions on pain, skin 
irritation and bruising resulting from wearing the devices.  Eight of the questions are answered with a Likert-
type scale (e.g., Did you find the monitor interfered with your normal sleeping pattern? With response options 
of 0 “Not at all”, 5 “Somewhat”, 10 “Extremely”). The remaining 7 questions have response options of “yes” or 
“no” (e.g., “Did you experience pain from wearing the monitor?”).  
D.8.6. Echocardiogram. Standard high-quality echocardiograms (M-mode, 2D, and Doppler) will be 
performed by certified research sonographers at UAB and Columbia University using a Phillips iE33 ultrasound 
machine. All images will be recorded and stored digitally for offline analysis at the Cardiovascular Physiology 
Research Laboratory at Columbia (Director, Dr. Shimbo). Cardiac measurements will be obtained according to 
the 2015 recommendations of the American Society of Echocardiography (ASE) and European Association of 
Cardiovascular Imaging (EACVI).79 Left ventricular (LV)  measurements for LV end-diastolic dimension 
(LVEDd), septal wall thickness (SWTd), and posterior wall thickness (PWTd) will be obtained. LVM (grams) will 
be determined using the ASE formula. LVMI will be calculated as LVM divided by body surface area (g/m2) and 
secondarily by dividing by height2.7 (g/m2.7). Left ventricular hypertrophy (LVH) will be examined as an outcome 
in exploratory analyses, GHILnHG aV /90, ≥  gm2 Ln IHmaOHV anG ≥ 11 gm2 in males RU /90, ≥ 45 gm2.7 in 
IHmaOHV anG ≥ 49 g/m2.7 in males, when LVM is indexed to height2.7). Per ASE/EACVI guidelines, the method 
for LV mass estimation and the definition of LVH does not differ by race. Table 5 shows additional measures. 
D.8.7. Albuminuria.  The urine sample collected during the first visit will be used for the measurement of 
creatinine and albumin. Consistent with prior research, urinary albumin excretion rate will be calculated using 
the formula: urinary albumin in milligrams per liter / (k * urinary creatinine in grams per liter) (denoted A/kC), 
where k adjusts for race and sex differences in typical daily creatinine excretion. Urinary creatinine 
concentration in men will be multiplied by 0.68 and by 0.88 for African Americans.80  This approach will allow 
the use of 25 mg/g as the A/kC cut-point for microalbuminuria regardless of a participant’s race and sex.  
D.9. Staff training. Prior to initiation of recruitment, Drs. Shimbo, Schwartz, Muntner, and Oparil will conduct 
centralized training of study staff from each site in the conduct of all study measures including clinic-measured 
BP, ABPM, HBPM, and echocardiography. Once data collection begins, they will monitor data collection and 
confirm that the study protocol is being followed. Annual centralized re-training will be conducted.  
D.10. Data management. The Pharmacoepidemiology and Economics Research (PEER) Unit (Dr. Muntner – 
co-director) at UAB will provide coordination and logistical support for all aspects of the proposed study. The 
PEER Unit has 3 program coordinators, 2 systems analysts/programmers, 15 PhD and Master’s level 
statisticians and 4 research associates with experience designing data collection systems and analyzing data, 
including ABPM, from epidemiology studies.  
D.10.1. Study database. Data collection for this study will occur electronically through a system and website 
developed in RedCap by Lei Huang MS, a programmer in the UAB PEER Unit.  RedCap provides a secure, 
password protected, web application that will be accessible to staff at UAB and Columbia University. For the 
current study, our programmer will develop an online database for randomizing participants and electronic 
web-based forms for conducting data collection.  The RedCap platform is HIPAA compliant and we have used 
RedCap in prior studies of ABPM.81 Data collection through RedCap will be converted to SAS Version 9.4.  
D.10.2. Data transfer.  
D.10.2.1. ABPM, sleep HBPM, actigraphy, and Device Logs. Upon return of the ABPM, HBPM, actigraph, 
and Device Logs, data will be downloaded to a computer and then backed up to a secure network server. Data 
will be transferred daily to the PEER Unit at UAB using DatAnywhere, a HIPAA compliant file transfer protocol 
that we used in our AHA-SFRN study. Monthly reports that track data quality will be generated. If data issues 
are identified (e.g., frequent ABPM or HBPM reading errors), staff will be re-trained.   
D.10.2.2. Echocardiographic measures. The echocardiographic studies (with unique study identifiers; i.e. de-
identified) will be saved to DVD/CD, and backed up to secure research servers at each site. The studies at 
UAB will be sent to the Cardiovascular Physiology Research Laboratory at Columbia for analysis.  
D.10.3. Data management and cleaning. All data cleaning will be managed by a statistician at the UAB 
PEER Unit supervised by Dr. Muntner. A uniform data editing algorithm, established by Drs. Shimbo and 
Schwartz and used in prior studies, will be implemented to confirm acceptability of the ABPM data and exclude 
extreme outliers. Minimal editing is the general rule; less than 0.1% of readings are typically excluded. The 
awake and sleep periods on ABPM will be defined by the actigraphy recording, complimented by self-report 
Table 5. Additional echocardiographic measures. 
LV diastolic function: E/A ratio, E’ (m/s), A’ (m/s), E/E’ ratio, isovolumetric relaxation time (ms), deceleration time, ms 
LV systolic function defined by LV ejection fraction (LVEF, %) = 100 x (LVEDV-LVESV) / LVEDV. 
Other parameters: Shortening (FS, %); left atrial dimension (cm) and volume (cm2).  
Hemodynamics: stroke volume (SV, mL) = VTI x cross-sectional areaLVOT; heart rate (HR); cardiac output (L/min) = SV x HR.  
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awake and sleep periods from the Device Log.64, 82 For sleep BP on HBPM, we will confirm that participants 
were asleep when the the BP readings were obtained using actigraphy data and the HBPM Device Log.  
D.10.4. Minimum number of BP readings required on ABPM and HBPM. No consensus exists on the 
number of readings required to consider an ABPM recording complete.36 Consistent with our prior studies, we 
will require 14+ awake BP readings, and 5+ sleep BP eadings, and ≥ 80% of the planned 48 readings (39+ 
total valid readings). We will require three SBP and DBP readings for a sleep HBPM recording to be complete. 
We will continue recruitment until 600 participants have complete ABPM and sleep HBPM readings. 
D.10.5. Phenotypic measures on ABPM and HBPM. Awake and sleep BP values will be computed using the 
average of all BP readings from the awake and sleep periods, respectively.  In addition to studying mean BP 
levels, we will calculate three BP phenotypes: white coat hypertension, masked hypertension, and nocturnal 
hypertension (Table 6). Unattended clinic BP thresholds are based on the Canadian guidelines.83 
D.11. Statistical analysis. All data will be analyzed by a statistician blinded to participants’ randomization 
assignments and a code (e.g., 0 or 1) will be used to represent different randomization assignments. 
Assignments will be unmasked after completion of the statistical analyses. The distribution of each BP 
measure, covariate, and echocardiographic measure will be calculated.  Variables will be explored for outliers 
and when identified the staff in the field sites will be asked to investigate them further.  
D.11.1 Missing data. Missingness in our prior studies has been uncommon.  Our primary approach to missing 
data is to collect complete data. We will examine missing data and use multiple imputation, as appropriate.84, 85 
D.11.2 Multivariable adjustment.  Several analyses will include multivariable adjustment.  Multivariable 
adjustment will be guided by biologic plausibility and will be contingent on the specific hypothesis being tested.  
In general, we plan two levels of adjustment. An initial model will include adjustment for age, race/ethnicity, sex 
and clinic site (UAB or Columbia). A second model will include additional adjustment for education, body mass 
index, smoking, physical activity, alcohol consumption, stress, anxiety, outdoor temperature, sleep quality, 
diabetes, eGFR, and 10-year predicted CVD risk. Co-linearity will be assessed using variable inflation factors. 
D.11.3. Exploratory statistics comparing unattended and attended BP. We will calculate characteristics of 
participants by randomization assignment: unattended then attended clinic BP measurement or attended then 
unattended clinic BP measurement at the first visit.  Scatterplots will be assembled to show the relationship 
between unattended clinic BP versus awake BP and attended clinic BP versus awake BP. For each 
comparison, intraclass correlation coefficients will be calculated. The statistical significance of the difference in 
the correlation coefficients will be calculated using the Fisher r-to-z transformation accounting for the 
correlation between attended and unattended clinic BP.86, 87 We will also assemble Bland-Altman plots showing 
the differences between unattended and attended BP, separately, versus awake BP on ABPM.  
D.11.4. Aim 1. Test whether measuring unattended clinic BP with an automated device will provide a 
more accurate estimate of awake BP on ABPM than measuring attended clinic BP with an automated 
device. Our primary analyses for Hypothesis 1 will be tested using the first three clinic BP measurements 
obtained at Visits 1 and 2.  In sensitivity analyses, we will use the fourth through sixth BP measurements from 
these visits. Separate analyses will be performed for SBP and DBP. 
D.11.4.1. Hypothesis 1a: The absolute difference with awake BP will be smaller for unattended vs. 
attended clinic BP.  The absolute difference between mean unattended clinic BP and awake BP and mean 
attended clinic BP and awake BP, separately, will be calculated. We will test whether these differences are 
statistically significantly different from zero using paired t-tests. Next, we will determine whether the absolute 
difference between unattended clinic BP and awake BP is smaller than the absolute difference between 
attended clinic BP and awake BP by calculating if the difference in differences (i.e., absolute difference 
between unattended clinic BP and awake BP minus the absolute difference between attended clinic BP and 
awake BP) is less than zero using a paired t-test.  If the absolute differences between unattended and 
attended clinic BP and awake BP differs by randomization assignment, we will use a mixed model with 
randomization assignment as a covariate. This analysis will be performed in the overall population and in sub-
groups defined by age (categorized in tertiles), race/ethnicity (white, African American, Hispanic) and sex.   
D.11.4.2. Hypothesis 1b: The agreement between hypertension in the clinic and awake hypertension 
will be higher for unattended versus attended clinic BP.  Also, the prevalence of both white coat and 
masked hypertension will be lower when BP is measured unattended versus when it is measured 
Table 6. Phenotypes to be evaluated in the proposed study. 
Phenotype 
Attended clinic SBP/DBP  
Unattended clinic SBP/DBP  
Out-of-clinic SBP/DBP  
White coat Hypertension 
≥140/90 mm Hg 
≥135/85 mm Hg 
Awake <135/85 mm Hg 
Masked Hypertension 
<140/90 mm Hg 
<135/85 mm Hg 
Awake ≥135/85 mm Hg 
Nocturnal Hypertension 
Not applicable 
Not applicable 
Sleep ≥ 120/70 mm Hg 
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Research Strategy                                                                                             
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attended in the clinic. Using the first three clinic BP measurements obtained at each visit and awake BP from 
ABPM, we will calculate the prevalence of clinic hypertension, based on unattended and attended 
measurements separately, and awake hypertension.  We will calculate overall agreement and agreement 
above that expected by chance alone (i.e., the Kappa statistic) between (1) clinic hypertension, measured 
attended, and awake hypertension and (2) clinic hypertension, measured unattended, and awake 
hypertension. We will calculate the prevalence of white coat hypertension and masked hypertension defined 
using unattended and attended clinic BP, separately, and awake BP from ABPM.  The statistical significance of 
the differences in these statistics when BP is measured unattended versus attended will be calculated using 
McNemar tests and bootstrapping techniques as these measures are not independent. 
D.11.5. Aim 2. Test whether a new HBPM device provides an accurate approach for measuring sleep 
BP.  We will calculate the characteristics of participants randomized to have their sleep BP measured by (1) 
ABPM then HBPM or (2) HBPM then ABPM.  The statistical significance of differences across the 
randomization assignments will be calculated using t-tests and chi-square tests, as appropriate.   
D.11.5.1. Hypothesis 2a: Sleep BP on HBPM will provide an accurate estimate of sleep BP on ABPM.   
We will assemble a scatterplot of mean sleep SBP on HBPM versus ABPM and a intraclass correlation 
coefficient will be calculated. The statistical significance of the difference in mean sleep SBP on HBPM versus 
ABPM will be calculated using paired t-tests. The analysis will be repeated using sleep DBP on HBPM versus 
ABPM. We will create Bland-Altman plots showing the difference between sleep BP on HBPM versus ABPM 
by ABPM sleep BP level.  We will calculate the percentage of participants who have a 10 mm Hg or larger 
absolute difference in their mean sleep SBP or a 5 mm Hg or larger absolute difference in their mean sleep 
DBP when measured by HBPM versus ABPM.  Differences in mean sleep BP (SBP and DBP, separately) 
measured on HBPM versus ABPM will be calculated within age, race/ethnicity and sex sub-groupings.  We will 
calculate the overall agreement and Kappa statistic between nocturnal hypertension on HBPM and ABPM, and 
test for a difference in prevalence using McNemar’s test.  We will compare differences in mean sleep SBP and 
DBP by randomization assignment using t-tests.  If differences are statistically significant, analyses will include 
adjustment for randomization assignment. 
D.11.5.2. Hypothesis 2b: HBPM will be better tolerated than ABPM. An overall score on the HBPM/ABPM 
tolerability questionnaire will be calculated by summing the scores on the eight Likert-type items after reverse 
coding positively-framed items (i.e., those with higher scores indicating better tolerability).  Consistent with the 
approach of Viera, pRRU tROHUanFH ZLOO EH GHILnHG aV an RYHUaOO VFRUH ≥5th percentile on the results for ABPM.16  
The cut-point identified for ABPM will be applied to define poor HBPM tolerability.  Also, the percent of 
participants who report “pain”, “skin irritation” and “bruising” from the ABPM device, and separately, the HBPM 
device will be calculated.  The statistical significance of differences in responses to these items when wearing 
the HBPM and ABPM devices will be calculated using McNemar tests.  
D.11.6. Aim 3. Compare the associations of unattended versus attended clinic BP, unattended clinic BP 
versus awake BP on ABPM, and sleep BP on HBPM versus ABPM with two markers of end-organ 
damage, LVMI and ACR. 
Hypothesis 3a: The association with end-organ damage will be stronger for unattended vs. attended clinic BP.  
Hypothesis 3b: The association with end-organ damage will be similar for unattended clinic and awake BP.  
Hypothesis 3c: The association with end-organ damage will be similar for sleep BP by HBPM and ABPM. 
Below we describe the analysis plan for testing Hypothesis 3a.  The analysis plan will be identical for 
Hypotheses 3b and 3c. We will calculate the intraclass correlation coefficients between (1) attended clinic BP 
and (2) unattended clinic BP with LVMI. The statistical significance of the difference in the correlation 
coefficients will be calculated using the Fisher r-to-z transformation accounting for the within-person correlation 
between unattended and attended BP measurements.86, 87  Also, the association between clinic BP, measured 
unattended and attended, separately, and LVMI will be calculated using linear regression.  For these models, 
clinic BP will be modeled in categories, using restricted quadratic splines, and, if appropriate, as a continuous 
variable (e.g., per 10 mm Hg higher SBP).  Two levels of adjustment will be performed as described in Section 
D.11.2.  For secondary testing of Hypothesis 3, we will model the outcome of LVH GHILnHG aV an /90, ≥  
g/m2 Ln ZRmHn anG /90, ≥ 11 gm2 in men using Poisson regression with robust standard errors and two 
levels of adjustment (Section D.11.2).  The analyses will be repeated for the outcome of the ACR. When 
modeled as a continuous variable, ACR will be log-transformed due to its skewed distribution. As a 
dichotomous variable, albuminuria will be defined as an sex/race-adjusted ACR > 25 mg/g.80 
D.12. Sample size/minimum detectable effects. 
D.12.1. Aim 1. Sample size and minimal detectable difference calculations were based on 80% statistical 
power and a two-sided alpha level of 5%.  These calculations were performed using simulations and R version 
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Research Strategy                                                                                             
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3.3.2. We estimate that a sample size of 600 participants (630 
enrolled participants with 30 participants [5%] not completing 
the study) will allow us to detect small but clinically relevant 
differences for each aim. 
D.12.1.1. Sample size considerations for hypothesis 1a. 
Figure 4 shows the minimal detectable difference in differences 
with awake ABPM comparing unattended vs attended clinic BP. 
With 600 participants we can detect that the absolute difference 
with awake ABPM is 1.5 and 1.2 mm Hg smaller for unattended 
vs attended clinc BP assuming a correlation of 0.5 and 0.7, 
respectively between clinic BP and awake BP on ABPM. In a 
sub-group of 160 participants (e.g., African Americans), we can 
detect that the absolute difference with awake ABPM is 3.1 and 
2.4 mm Hg smaller for unattended vs. attended clinic BP. 
Smaller absolute differences can be detected if the correlation 
between attended and awake BP is higher. 
D.12.1.2. Sample size considerations for hypothesis 1b. If 85% of participants have the same 
concordance/discordance status for both comparisons (i.e., attended clinic hypertension versus awake 
hypertension and unattended clinic hypertension versus awake hypertension), enrollment of 600 participants 
will provide 80% statistical power to detect a difference of 5% in the two overall agreements (e.g., 70% vs. 
75%). If the expected agreement is 50%, we will have an 80% statistical power to detect a difference between 
Kappa statistics of 0.4 and 0.5 using a two-sided alpha level of 0.05. With 600 participants and a phenotype 
prevalence of 15%, we can detect a difference in the prevalence of 4% when clinic BP is measured unattended 
versus attended. In a sub-group of 160 participants, we can detect a difference of 8%. Based on these 
estimates, we chose to enroll 630 participants in the proposed study (n=600 with complete data). 
D.12.2. Aim 2 
D.12.2.1. Minimum detectable effect size - hypothesis 2a. We assumed a standard deviation of sleep SBP 
of 15 mm Hg and sleep DBP of 10 mm Hg when measured using ABPM and HBPM. Also, the correlation 
between sleep BP on ABPM and HBPM was assumed to be 0.5 for SBP and DBP.  For this analysis, we are 
testing that mean sleep BP is equivalent when measured by HBPM and ABPM.  A sample size of 600 
participants will provide 80% statistical power to exclude an absolute mean difference equal to or larger than 
2.1 mmHg for SBP or 1.4 mmHg for DBP comparing ABPM versus HBPM exists.  In a sub-group of 160 
participants, we can exclude an absolute mean difference equal to or larger than 4.0 mmHg for SBP or 2.7 
mmHg for DBP. If the correlation of sleep BP on ABPM and HBPM is higher (e.g., 0.7 or 0.9), we can exclude 
smaller absolute differences.  A sample size of 600 participants will provide narrow confidence intervals for the 
observed agreement and kappa statistic for nocturnal hypertension comparing HBPM and ABPM. For 
example, the 95% confidence interval for an observed agreement of 80% and 90% would be 77%-83% and 
88%-92%, respectively, and for a kappa statistic of 0.6 and 0.8 would be 0.54-0.66 and 0.75-0.85, respectively. 
D.12.2.2. Minimum detectable effect size - hypothesis 2b. By definition, 25% of participants will have poor 
tolerance to ABPM. The minimum detectable difference in the prevalence of poor tolerance comparing HBPM 
versus ABPM depends on the percentage of participants who have poor tolerance to one method but not to the 
other. With a sample size of 600 participants, we can detect a difference in poor tolerance of ABPM and HBPM 
of 3% (25% versus 22%) if 20% of participants report poor tolerance to both methods (e.g., if 5% has poor 
tolerance to ABPM but not to HBPM, and 2% has poor tolerance to HPBM but not to ABPM). Assuming 5% of 
participants experience bruising with both ABPM and HBPM, we will have 80% power to detect a difference in 
the prevalence of bruising of 3% or larger comparing ABPM and HBPM. 
Table 7. Minimal detectable correlation coefficients between BP measurements and LVMI. 
Correlation between standard and 
alternative BP measurements† 
Correlation coefficient between standard BP measurements and LVMI 
0.30 
0.50 
0.60 
0.5 (n=600) 
0.11 
0.09 
0.08 
0.7 (n=600) 
0.08 
0.07 
0.07 
0.5 (n=160) 
0.18 
0.15 
0.13 
0.7 (n=160) 
0.14 
0.12 
0.11 
80% power; 2-taLOHG Į 005 †For example, standard measurement may be attended BP and alternative is unattended BP.  
D.12.3. Aim 3. Table 7 shows minimum detectable differences in correlation coefficients for hypotheses 3a, 3b 
and 3c with the full population (n=600) or a sub-group (n=160) of participants. For example, if the correlation 
between attended and unattended clinic BP is 0.5, and the correlation between attended BP and LVMI is 0.3, 
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Research Strategy                                                                                             
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we will have 80% power to detect a difference in the correlation between attended and unattended BP and 
LVMI of 0.11 or larger (e.g., 0.30 versus 0.41). Detectable differences in the correlation coefficients will be 
modestly larger in sub-groups of 160 participants. The detectable differences will be smaller if the correlation 
between attended and unattended clinic BP is higher (e.g., 0.7).  
D.13. Potential problems and alternative strategies. 
D.13.1. Why we are not examining individuals with treated hypertension. The focus of this application is 
on the diagnosis of hypertension. Many guidelines and scientific statements recommend ABPM for confirming 
the diagnosis of hypertension.2, 38  Although ABPM can also be used to monitor on-treatment BP for people 
with hypertension and who are taking antihypertensive medication, this is a less common recommendation.   
D.13.2. Why is ABPM and not HBPM the reference standard for awake BP.  We have chosen to use ABPM 
rather than HBPM to assess awake BP because it is widely considered the reference standard for out-of-clinic 
BP assessment and confirming hypertension status.4 Further, conducting HBPM to assess awake BP was not 
practical for the proposed study because it requires up to 7 days of measurements, which will confound the 
ability to assess the tolerability of the HBPM device for assessing sleep BP, based on a single night.   
D.13.3. Why we are not comparing BP dipping and morning surge assessed using HBPM versus ABPM. 
We are not studying BP dipping and morning surge because the prognostic value of these phenotypes is 
unclear.  Some studies have reported associations of these phenotypes with outcomes while others have 
not.88-90  Additionally, the reproducibility of these phenotypes is poor.91-93  Finally, these phenotypes are not 
widely used in clinical practice particularly for the diagnosis of hypertension.  
D.13.4. Hypotheses in Aim 1 but not Aim 2 (or vice versa) are confirmed. If the hypotheses in Aims 1 and 
2 are confirmed, there will be a unified approach to accurately diagnose hypertension without ABPM (i.e., 
conduct unattended BP for detecting awake hypertension and HBPM for detecting sleep hypertension). If the 
hypotheses for only one aim are confirmed, then our study would inform when unattended BP or sleep HBPM 
should be used. For example, if Aim 1 but not Aim 2 is confirmed, unattended BP measured in the clinic can be 
used to assess awake hypertension but an abbreviated form of ABPM (conducted during the sleep period) is 
needed. If Aim 2 but not Aim 1 is confirmed, ABPM can be used during the awake period to exclude awake 
hypertension while sleep HBPM, if better tolerated, can be used for assessing sleep hypertension.  In both 
scenarios, the burden of performing ABPM during a 24-hour period is reduced.  
D.14. Translation into practice.  Upon completion of the study, we will conduct a stakeholders meeting with 
clinical leaders in the field of hypertension to develop a statement on the use of unattended BP and sleep 
HBPM assessment in clinical practice. This meeting will include committee members from the AHA’s Scientific 
Statement on BP measurement, which Dr. Muntner and Dr. Shimbo co-chair.  Dr. Muntner is director of the 
Lister Hill Center for Health Policy at UAB and will use center funds for this meeting.  
D.15. Reproducibility and transparency. We will post the aims, methods, and original analytical plan prior to 
data collection on the Open Science Framework website, which is hosted by the recently founded Center for 
Open Science (funded in part by the NIH and the National Science Foundation; https://osf.io), and is open to 
the public to view. Once the proposed study has been completed and before data analyses are initiated, we 
will post the code for derivation of study variables and the final sample size (with a flow diagram on how the 
final sample was derived). For each abstract and manuscript, all coding will be carefully labeled and linked to 
the final versions of each document. None of the posted documents will contain participant identifiers.  
D.16. Consideration of sex and other biological variables. We will make every effort to recruit equal 
numbers of men and women. As noted above, we will conduct exploratory analyses stratifying by age group, 
sex, and race/ethnicity (white, African American, and Hispanic; a minimum of 160 each). 
D.17. Summary. In clinical practice, BP is typically measured in the clinic by a technician/healthcare provider. 
This approach often leads to an inaccurate diagnosis of hypertension. Several guidelines and scientific 
statements recommend the use of ABPM, which measures BP during the awake and sleep periods, for 
confirming the diagnosis of hypertension.27, 38, 94 However, ABPM is not being done in clinical practice due to 
several barriers that limit its widespread use. Therefore, new and innovative approaches for diagnosing 
hypertension without conducting ABPM are needed. Some data suggest that BP measured unattended versus 
attended is closer to awake BP on ABPM.  However, these data were derived from uncontrolled, non-
randomized studies of select patients and were considered sufficiently low quality in the Canadian Guidelines 
to warrant a Grade D level of evidence. Another approach is to use a new HBPM device that has been 
developed to assess sleep BP. Using a randomized controlled trial design, the study will rigorously test these 
two non-ABPM approaches for determining awake and sleep BP. The novel approaches being tested can be 
adopted in clinical practice and may become the standard-of-care for diagnosing hypertension if our 
hypotheses are confirmed. 
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Research Strategy                                                                                             
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E. HUMAN SUBJECTS 
E.1. Protection of Human Subjects 
E.1.1. Risks to the Subjects 
Human subjects involvement and characteristics:  The proposed study will include 630 participants from 
Birmingham, AL (N=315) and New York, NY (N=315).  Study participants will be recruited between 2019 and 
2022.  Participants will be ≥1 years of age.  No participants will have hypertension and no participants will 
have cardiovascular disease.  We plan for the overall sample to include an equal percentage of men (50%) 
and women (50%) and at least 25% of the population will be white, 25% African Americans and 25% Hispanic. 
Sources of materials:  Research material for the study includes self-report and physiological data, both of 
which are collected specifically for the purpose of the study.  The physiological measurements consist of the 
assessment of orthostatic hypotension (from supine and standing blood pressure measurements), noninvasive 
measurement of blood pressure in the clinic during two study visits and outside of the clinic using ambulatory 
blood pressure monitoring and home blood pressure monitoring during sleep, a blood and urine sample, 
actigraphy and an echocardiogram.  Height, weight and waist and neck circumference will be measured during 
a study visit by trained staff. Some participants may experience discomfort during the blood pressure 
measurements. However, the discomfort that is experienced is no more than that experienced during a routine 
outpatient doctor’s visit.  In our experience conducting ambulatory blood pressure monitoring on over 5,000 
participants, none have experienced a serious injury.  Participants will also complete questionnaires that asks 
about stress and psychosocial factors. 
Potential risks:  The physical risks of the studies are minimal, as no invasive procedures are proposed. Some 
discomfort may occur due to the use of the ambulatory blood pressure arm cuff or home blood pressure cuff, 
and no/minimal discomfort is expected with using the actigraph device (it is worn on the wrist like a watch).  
The discomfort, if it occurs, is minimal and temporary. Also, some patients may experience discomfort (i.e., 
dizziness) from the assessment of orthostatic hypotension.  Patients may experience discomfort answering 
questions about stress and psychosocial risk factors.  Study physicians will be available to discuss discomfort 
with patients and if necessary, participants will be referred to their doctor to discuss psychosocial factors. If the 
patient does not have a doctor, we will find a doctor for them to see.  Data will be stored on encrypted 
computers at the field centers and at the University of Alabama at Birmingham (the coordinating center for this 
study).  All data will be stored in locked filing cabinets to protect against the risk of a patient being identified.  
All findings will be presented in aggregate to ensure the confidentiality of all participants.  After study 
completion, the clinic BP, ABPM and HBPM results will be given to the participants and invited to share it with 
their physician. If the participant does not have a physician, he/she will be referred to a physician for follow-up. 
E.1.2. Adequacy of Protection Against Risks 
Recruitment and informed consent:  Participants for the proposed study will be enrolled following IRB-
approved approaches.  Potential participants for our study will be attending outpatient clinics affiliated with the 
University of Alabama at Birmingham or Columbia University. With IRB approval, potential participants will be 
contacted following a routine clinic by phone and screened for eligibility for the proposed study and, if eligible, 
will be told about the study, its goals, activities involved, and potential risks.  Those who remain interested will 
be invited to participate. They will be provided with an informed consent for this study.  The informed consent 
that will be used will be written at the sixth grade level and in a language that potential participants can 
understand. Individuals will be given time to read over the consent thoroughly and will be encouraged to ask 
questions to help them clarify any issues they might have. The principal investigators, co-investigators and 
staff at both sites (UAB and Columbia University) have substantial experience conducting research that 
includes explaining a study’s purpose and potential risks and benefits to a broad range of participants.   
Protection against risks:  The physical risks of the studies are minimal, as no invasive procedures are 
proposed.  Some discomfort may occur due to the use of the arm cuff for measuring blood pressure, and 
no/minimal discomfort is expected with using the actigraph device. The discomfort from the blood pressure 
cuffs, if it occurs, is temporary and should disappear when the cuffs are removed.   Any discomfort, if it occurs, 
is minimal and temporary. The risks of having blood drawn include soreness and bruising at the puncture site, 
and sometimes there may be discomfort during the procedure. Occasionally participants feel lightheaded or 
faint. This may occur with the assessment of orthostatic hypotension as well.  The assessment of orthostatic 
hypotension and the blood draw will occur in the presence of trained technicians with training handling safety 
issues for participants. A minimal risk to participants arises from the release of study data.  To minimize this 
risk, staff conducting study visits will be trained in the protection of human subjects.   In addition, all study 
information and the study computer will be kept in a locked room in at the participating field center and 
University of Alabama at Birmingham.  The computer databases will be encrypted and protected by a 
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Protection of Human Subjects                                                                                  
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password available only to study investigators and other personnel who need access.  The link between 
patient identity and a unique study identification number will be destroyed after the study is completed.  
Published reports will contain only aggregate and statistical results, and no individual results or patient 
identifiers will be disclosed.  These safeguards make the possibility of a breach of confidentiality or invasion of 
privacy remote.  
Very high or low clinic BP. Individuals with mean screening SBP of 110 to < 160 mm Hg and mean 
screening DBP of 70 to <100 mm Hg (based on the two most recent outpatient clinic visits, extracted 
from clinical records) will be included. Therefore, we are not including individuals with severely high or 
low clinic BP. Among enrolled participants, if clinic BP at any of the study visits ≥10100 mmHg RU 
<110/70 mmHg they will be referred to their health care provider for evaluation and excluded from the 
study for safety reasons.  
 
E.1.3. Potential Benefits of the Proposed Research to the Subjects and Others 
There is a limited direct benefit to the study participants.  Participants will receive a report containing 
information from their clinic blood pressure measurements, 24-hour ambulatory blood pressure monitoring and 
sleep blood pressure. This report will contain mean blood pressure from ambulatory monitoring, information on 
the presence of masked and white coat hypertension as well as information on the level of their blood pressure 
variability and diurnal blood pressure patterns. Drs. Muntner, Oparil, Shimbo, and Schwartz have over 50 years 
of cumulative experience preparing reports with results and interpretation for study participants. Although 
ambulatory blood pressure monitoring is not commonly used in clinical practice, some participants (and their 
physicians) may find the results of the ambulatory blood pressure monitoring helpful.  Reports will be provided 
to participants within one month of completion of their study visit.  As the risks to subjects are minimal, and 
important prognostic medical information not typically accessible to subjects will be made available, the 
benefits are considered to outweigh the risks.   
E.1.4. Importance of the Knowledge to be Gained 
In terms of benefits to others, the proposed research is an attempt to better measure blood pressure. Over 80 
million US adults have hypertension. Studies from Canada have reported that blood pressure measured in the 
clinic by a technician do not represent the true blood pressure a patient experience as they go about their daily 
activities.  However, the gold standard approach to measuring blood pressure, ambulatory blood pressure 
monitoring, is not readily available and, when available, not well tolerated by patients. We aim to determine 
whether measuring blood pressure using an automated device without a technician/healthcare provider 
present can provide a better estimate of blood pressure.  Also, we will test whether a novel home blood 
pressure measurement device can measure blood pressure during sleep.  The proposed study may provide 
data that transforms how blood pressure is measured and hypertension is diagnosed in the United States.  We 
will assess whether using a novel home blood pressure measurement device is better tolerated for assessing 
sleep blood pressure compared with ambulatory blood pressure monitoring. Therefore, not only will we provide 
data on how blood pressure should be measured, this approach may be better tolerated by patients.  
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Protection of Human Subjects                                                                                  
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Data Safety Monitoring Plan 
A DSMP is proposed even though it is not required by NIH Policy as the study does not pose a 
greater than minimal risk to the participant. The proposed study does not meet the NIH definition for a 
clinical trial (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) since we are not 
testing the effects of BP measurement on “health-related biomedical or behavioral outcomes.” A Data 
Safety and Monitoring Board (DSMB) is not needed as the study is not a Phase III trial, does not 
included a high-risk intervention, and does not enrolled a highly vulnerable patient population 
(https://www.nhlbi.nih.gov/research/funding/human-subjects/data-safety-monitoring-policy). The MHT 
Study and IDH Study enrolled participants (with similar eligibility criteria as the proposed study) who 
underwent a BP measurement protocol (including clinic BP measurement, ABPM, and HPBM) over 
several study visits and had echocardiogram and laboratory measures). These studies were 
approved by the IRB, who deemed these two studies as having minimal risk.  
 
The purpose of the DSMP is to monitor study safety, ensure the safety of participants (identify, 
review, and report adverse events to the IRB and/or NHLBI and ensure appropriate medical follow 
up), minimize research-associated risk, and protect the confidentiality of participant data. IRB 
approval will be obtained. The DSMP will contain the following elements: an appropriate monitor 
(person or group), monitoring procedures, frequency of monitoring, collection and reporting of serious 
adverse events and adverse events, reporting mechanisms of adverse events/ serious adverse 
events to the IRB and NHLBI, reporting mechanisms of the IRB actions to NHLBI, reporting 
mechanisms for changes or amendments to the protocol or consent form, potential risks and benefits 
to subjects, management of serious adverse events or other study risks, conflicts of interest, data 
acquisition and transmission, data analysis plans, trial stopping rules, and plans for interim analysis. 
Dr. Muntner (UAB site) and Dr. Shimbo (CUMC site) will be responsible for ensuring participants’ 
safety on a daily basis. The PIs will be informed of unanticipated problems or unexpected serious 
adverse events that may be related to the study protocol as soon as they occur, and they will notify 
the IRB, and/or NHLBI in compliance with their policies. Personnel involved in monitoring activities 
will include the following: (1) Along with Dr. Muntner, Dr. Oparil, a board-certified cardiologist will be 
responsible for overseeing medical risks during the study and will review adverse medical events at 
the UAB site. (2) Dr. Shimbo, a board-certified cardiologist will be responsible for overseeing medical 
risks and will review adverse medical events at the CUMC site.    
 
Participants who have any problems or suspected adverse events during the course of the study will 
be instructed to contact the research coordinator or appropriate study personnel immediately. Site-
specific research coordinators will contact the respective PIs if any problems or suspected adverse 
events are reported by participants. If the participant needs immediate medical attention, he/she will 
be sent to the emergency room for further evaluation. If the participant does not require immediate 
medical attention, he/she will be scheduled to see their physician. If the participant does not have a 
physician, he/she will be referred to a physician for follow-up.  
 
On an annual basis, the PIs will submit a progress report that: (1) Confirms adherence to the DSMP. 
(2) Includes a summary of any data and safety monitoring issues that occurred since the previous 
reporting  period. (3) Describes any changes in the research protocol or the DSMP that may or does 
affect risk. (4) Provides all new and continuing IRB approvals.   
  
ClinicalTrials.gov requirements. ClinicalTrials.gov registration is not required as this study is not a clinical 
trial as defined by NIH (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). 
 
 
Contact PD/PI: Muntner, Paul
Data Safety Monitoring Plan                                                                                   
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E.1.6 Women and Minority Inclusion in Clinical Research 
E.1.6.1. Inclusion of Women 
We will not exclude women for any reason from this research besides having a current known pregnancy. 
Pregnancy is an exclusion because ABPM devices have not been validated for pregnant women.  We will 
not be conducting pregnancy testing because we think that unknown pregnancies will be rare and ABPM 
devices should be valid in the early stages of pregnancy.  We will aim to have a 50%:50% women:men 
enrollment. 
 
E.1.6.2. Inclusion of Minorities 
We will include participants of all race/ethnicities.  As we propose conducting analyses for the overall 
population and for whites, African Americans and Hispanics, separately, we plan to enroll at least 25% 
(n=160) of our sample to be white, at least 25% (n=160) to be African American and at least 25% (n=160) 
to be Hispanic. We will track enrollment into our study to ensure that our goal is achieved.  The diversity of 
the populations at Columbia University and UAB is a major strength of this study, and will enhance the 
generalizability of our results. 
 
Our prior studies at Columbia University (with similar eligibility criteria as the currently proposed study) have 
enrolled the following percentages of Non-Hispanic Black and Hispanics: 20% to 36% and 29% to 64%, 
respectively.  Our prior studies at UAB (with similar eligibility criteria as the currently proposed study) have 
recruited equal percentages of men and women and whites and non-Hispanic blacks. Also, Birmingham, 
Alabama has a rapidly growing Hispanic population facilitating the recruitment of member of this group into the 
proposed study. 
 
Contact PD/PI: Muntner, Paul
Inclusion of Women and Minorities                                                                             
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PHS Inclusion Enrollment Report
This report format should NOT be used for collecting data from study participants.
OMB Number:0925-0001 and 0925-0002
Expiration Date: 10/31/2018
              
Tracking Number:
Funding Opportunity Number: PA-16-160. Received Date:
*Study Title:
Evaluating novel approaches for estimating awake and sleep blood pressure
*Delayed Onset Study?
❏Yes
❏✔No
If study is not delayed onset, the following selections are required:
Enrollment Type
❏✔Planned
❏Cumulative (Actual)
Using an Existing Dataset
or Resource
❏Yes
❏✔No
Enrollment Location
❏✔Domestic
❏Foreign
Clinical Trial
❏Yes
❏✔No
NIH-Defined Phase III
Clinical Trial
❏Yes
❏✔No
Comments:
Racial Categories
Ethnic Categories
 
 
Not Hispanic or Latino
Female
Male
Unknown/
Not Reported
 
Hispanic or Latino
Female
Male
Unknown/
Not Reported
Unknown/Not
Reported Ethnicity
Female
Male
Unknown/
Not Reported
Total
American Indian/Alaska Native
0
0
0
0
0
Asian
0
0
0
0
0
Native Hawaiian or
Other Pacific Islander
0
0
0
0
0
Black or African American
105
105
0
0
210
White
105
105
105
105
420
More than One Race
0
0
0
0
0
Unknown or Not Reported
Total
210
210
105
105
630
Report 1 of 1
Contact PD/PI: Muntner, Paul
                                                                                                             
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