Role of Wrist Based Blood Pressure Monitoring in Clinical Practice
Conditions: Blood Pressure, Transitions of Care
Sponsor: Scripps Translational Science Institute

BP Pilot 
 
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Role of wrist-based blood pressure monitoring in clinical practice 
 
A pilot study to explore the feasibility and utility of around the clock wrist-based blood pressure 
measurements during patient transition of care 
______________________________________________________________________________ 
Study Protocol:  IRB-18-7223 
NCT03862742 
October 4, 2018 
Version 1.0 
Sponsor: 
Scripps Translational Science Institute (Scripps) 
10550 N. Torrey Pines Road 
La Jolla, CA 92037 
 
Laura Jane Nicholson, MD, PhD 
lnicho@scripps.edu 
 
Michael Y. Song, MD, PhD 
song.michael@scrippshealth.org 
 
Steven R. Steinhubl, MD 
steinhub@scripps.edu 
 
Eric Topol 
etopol@scripps.edu 
 
 
 
 
 
 

BP Pilot 
 
2 
 
 
A pilot study to explore the feasibility and utility of around the clock 
wrist based blood pressure measurements during patient transition of 
care 
 
DATE:  
 
 
 
 
 
 
10/4/18 
STUDY PROTOCOL 
 
 
Table of Contents 
1. Purpose .......................................................................................................................................... 3 
2. Background ................................................................................................................................... 3 
3. Study Design.................................................................................................................................. 3 
4. Endpoints ....................................................................................................................................... 5 
5. Subject Selection .......................................................................................................................... 5 
6. Inclusion and Exclusion Criteria ............................................................................................. 5 
7. Data Storage and Analysis ......................................................................................................... 6 
8. Possible Benefits .......................................................................................................................... 6 
9. Possible Risks ............................................................................................................................... 6 
10. Risk Management ...................................................................................................................... 7 
11. Informed Consent...................................................................................................................... 7 
12. Subject Withdrawal .................................................................................................................. 7 
13. Oversight and Monitoring of the Study ............................................................................... 8 
14. Record Retention ...................................................................................................................... 8 
15. Publication: ................................................................................................................................. 8 
16. Study Leadership: ..................................................................................................................... 8 
17. Cost and Compensation: .......................................................................................................... 8 
18. Participant Facing Text and Workflow: .............................................................................. 8 
19. References: ................................................................................................................................. 9 
20. Appendix: .................................................................................................................................... 9 

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1. Purpose 
We propose a pilot clinical study to test the overarching hypothesis that frequent and 
longitudinal blood pressure monitoring with FDA approved consumer wrist based device 
during the patient transition from inpatient to home to the first clinic visit will elicit 
valuable BP data that can assist in physician treatment of hypertension 
2. Background 
Wrist based health devices, often with mobile connectivity, that continuously or near 
continuously track heart rate, blood pressure, temperature, activity and sleep are growing 
in everyday popularity and beginning to enter the sphere of clinical relevance.  However, 
their accuracy and utility for clinical use is largely unstudied.  As these consumer devices, 
some of which are FDA approved, become more commonplace, it is paramount to 
understand their function, know their limitations, and be able to interpret results 
appropriately before incorporating them into our clinical practice.  The AHA/ACC 2017 
guideline makes a 1A recommendation for clinical use of out of office BP measurements(1).  
This recommendation is based on evidence that out of office BP and frequent and 
longitudinal BP measurements are important in predicting cardiovascular risk and 
monitoring treatment efficacy(2-5).  This trend towards consumer driven digital health 
monitoring and the new AHA/ACC guideline are essentially advancing a consumer based 
precision medicine strategy for diagnosis and monitoring of hypertension.  As this becomes 
commonplace in our patient population, we need rigorous clinical study of wrist base BP 
monitoring to better understand its role patient care. 
 
3. Study Design 
We will recruit patient volunteers from the Scripps Green Hospital and Scripps Memorial 
Hospital inpatient teaching services.  Inclusion criteria will be adults >18, with 
normotensive or hypertensive history, all races and genders.  Exclusion criteria will be 
patients for which an admission diagnosis is hypertensive urgency or emergency or are 
physically or mentally unable to manage the wrist based BP monitor.  The study is 
observational only, participation in the study will not affect routine care.  On the estimated 
last 24-48 hours of admission subjects will start wrist based blood pressure monitoring.  

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Wrist based BP measurements will be performed several times during the day and several 
times at night automatically. 
 
Healthcare workers will be briefed before the initiation of the study to not use wrist based 
blood pressure measurements in their management, and patients will be briefed that wrist 
based blood pressure monitoring is for study purposes only.  Wrist based BP monitoring 
will continue through discharge home until the first clinic visit, which we will attempt to 
schedule for approximately one week post discharge.  Patients will be briefed prior to 
initiation of study and at the end of the study.  They will be counselled not to adjust 
antihypertensive regimen without prior discussion with their primary care physician.  A 
24/7 phone number will be provided for study subjects to call with questions or concerns 
during and after the study.  Dr. Song and/or study coordinators will contact each 
participant by phone at least once during the study period to answer questions and as a 
reminder to frequently measure blood pressure. 
 
In the pilot phase, we plan to recruit 10 subjects to evaluate study design and generate 
preliminary data and calculate power.  In the second phase, we preliminarily estimate a 
sample size of 64 with a=0.05 and power (1-b) of 0.95, in order to obtain significance 
between day time mean BP and night time mean BP using SBP means and standard errors 
from the MAPEC trial(6).    
 
Following in person informed consent, participants will be supplied with the Omron 
HeartVue (v1.0) blood pressure monitoring device for use during the course of the study. 
Participants will return the study wristband at the completion of the study in a prepaid 
envelope or leave the device at their primary care physicians office.   
 
At the close of the study, study participants will be asked to fill out a post-study 
questionnaire.  The questionare will be given to participants on enrollment and 
participants will be asked to return the questionare along with the device at the completion 
of the study period.  The survey and the wrist based BP device will be returned by mail 
using a prepaid envelope.   
 

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Patient data will be de-identified using a code that can be deciphered only by Dr. Michael 
Song.  The key for the code will be destroyed at the completion of the study.  Patient date 
will be gathered from EPIC and inputted into a spreadsheet that will be stored on the 
Scripps Health database.  Wrist based BP, heart rate and activity data will be evaluated by 
the investigators and study coordinators/assistants and manually inputted in the 
previously mentioned spreadsheet.   
 
4. Endpoints 
The primary endpoints for this study are blood pressure measurements.  Blood pressure 
measurements will be sought using the Omron HeartVue, traditional hospital healthcare 
provider performed, ambulatory clinic blood pressure and home blood pressure as 
measured by traditionally available upper arm based device.  The Omron device will also 
measure heart rate, activity and sleep.   
 
5. Subject Selection 
Number of Subjects: A total of 10 + 64 (estimated) subjects will be enrolled.  
 
 
Nature of Study Population: Men and women 18 years and older will be eligible for 
participation. We aim to enroll 50% females across all age groups.  
 
6. Inclusion and Exclusion Criteria 
Individuals 18 years of age or older with and without the known diagnosis of hypertension 
(regardless of level of control or therapeutic regimen), able to operate HeartVue device, 
able to read, write, and speak English, level of “digital savviness” and owning an iOS or 
Android device will be recruited for participation in this pilot study.  
 
Inclusion Criteria: 
• Consortium members within the All of Us Research Program 
• ≥18 years of age 
• Own an iOS or Android device 

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Exclusion Criteria: 
• Inability to give informed consent 
• <18 years of age 
• Inability to understand written English language 
• Hypertensive urgency or emergency as an admission diagnosis 
 
7. Data Storage and Analysis 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to the data needed to investigate this study’s hypothesis and the clinical data typically 
used as covariates in the analysis of cardiovascular clinical studies. Access to data will be 
limited to those authorized by Principal Investigator and study sponsor. Individual blood 
pressure values will be securely transmitted to Omron servers via the Connect App interface.   
The ConnectApp data will only be accessible to the patient, Omron and investigators. 
 
8. Possible Benefits 
• There are no guaranteed health benefits to participants of this study. 
• Participants may learn new insights regarding the overall control of their blood 
pressures, which could potentially be used to fully optimize their medical and lifestyle 
interventions for blood pressure control.   
• Provide the research community with a better understanding of blood pressure 
changes in various non-clinical settings.  
 
9. Possible Risks 
The personal risk of harm from participation in this study is considered to be minimal.  The 
Omron HeartVue device has been cleared for personal use by the FDA for measuring blood 
pressure outside of the clinic. There are no experimental uses or procedures being tested in 
this protocol.   
 

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In spite of all the safety measures that we will use, we cannot guarantee that the subject’s 
identity will never become known. 
 
10. Risk Management 
Loss of Privacy 
Only Dr. Michael Song will have access to a research subject’s fully identified medical 
information.  The information that matches the code to the identifying information will be 
kept in a safeguarded database that is password protected and any paper files will be kept 
in a secure location. 
 
Information from analysis of de-identified medical information will be placed in a controlled-
access Scripps Health database.   
 
11. Informed Consent 
Study purpose, methods, materials, risks, benefits and alternatives will be available to the 
participant.  Informed consent will be obtained initially in person.   
  
12. Subject Withdrawal 
Subject participation is voluntary and the subject can discontinue participation at any time 
without loss of benefits or penalty.  If the decision to terminate study participation is 
reached, the subject will be asked to return their Omron HeartVue device at no charge to the 
subject and their app will be deactivated once the subject notifies our study team of the 
withdrawal.  Data that has already been collected will still be used in the study and cannot 
be deleted.  If the subject terminates the study early, there will be no penalty or loss of 
benefits to which they are otherwise entitled. The study oversight team has the option to 
recruit additional participants to replace any subjects that withdrew early from the study. 
 

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13. Oversight and Monitoring of the Study 
The Principal Investigator Dr. Nicholson and Dr. Song will be responsible for the oversight 
of this study and for the team of individuals conducting the study with the assistance of CRS.   
 
14. Record Retention 
De-identified clinical information will be stored in a safeguarded database that is password 
protected.   At the appropriate time, the code that links the participant to the clinical data 
will be destroyed.  Related health and trait information may be kept indefinitely.  
 
The electronic informed consent forms, including HIPAA authorization will be stored in a 
Scripps health database 
 
15. Publication 
The results of this research may be presented at meetings or in publication.  However, the 
subject’s identity will not be disclosed in those presentations. 
 
16. Study Leadership 
Dr. Nicholson 
Dr. Song 
Dr. Topol 
Dr. Steinhubl 
 
17. Cost and Compensation 
Subjects will not be paid for participation in the study. There is no cost to the subject for study 
participation.  After the study is closed, participants will be return the HeartVue device. When an 
updated FDA approved HeartVue device is released (plan for mid to late 2018) participants may 
be asked to utilize the new device, at no participant cost. 
 

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18. Participant Facing Text and Workflow 
See Section 20. Appendix. 
 
 
19. References 
 
 
 
 
 
1. 
e. a. Whelton PK, 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA 
Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in 
Adults (2017). 
2. 
P. Drawz, Clinical Implications of Different Blood Pressure Measurement Techniques. Curr 
Hypertens Rep 19, 54 (2017). 
3. 
E. O'Brien et al., European Society of Hypertension position paper on ambulatory blood pressure 
monitoring. J Hypertens 31, 1731-1768 (2013). 
4. 
R. C. Hermida, D. E. Ayala, J. R. Fernandez, A. Mojon, M. H. Smolensky, Hypertension: New 
perspective on its definition and clinical management by bedtime therapy substantially reduces 
cardiovascular disease risk. Eur J Clin Invest,  (2018). 
5. 
M. L. T. Jan A. Staessen, BSc; Robert Fagard, MD;, Predicting Cardiovascular Risk Using 
Conventional vs Ambulatory Blood Pressure in Older Patients With Systolic Hypertension. JAMA 
282, 539-546 (1999). 
6. 
R. C. Hermida, D. E. Ayala, A. Mojon, J. R. Fernandez, Decreasing sleep-time blood pressure 
determined by ambulatory monitoring reduces cardiovascular risk. J Am Coll Cardiol 58, 1165-
1173 (2011).