Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool
Phase: NA
Conditions: Hypertension
Sponsor: Paula Gardiner

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1. Study Protocol 
Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool 
 
2. NCT Number 
NCT03974334 
 
3. Submitted 
8/14/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. TITLE 
Reducing Disparities in the Treatment of Hypertension using the OWL mHealth Tool 
(H00015619) 
 
2. EXTERNAL IRB REVIEW HISTORY* 
NA  
This study has not been submitted to an external IRB. 
 
3. PRIOR APPROVALS: 
NA 
 
4. OBJECTIVES* 
This is a one-year study with a no-cost extension until 7.31.20. The objectives are: 
1) To engage 26 socio-economically diverse subjects (2 cohorts of 13) with a current diagnosis 
of hypertension in beta testing an on-line mHealth platform (Our Whole Lives: an e-Health 
toolkit) that is being adapted to help manage and reduce high blood pressure and other cardiac 
risk factors by introducing mindfulness skills and lifestyle modification.  
 
2) To identify barriers and facilitators of using OWL at home for self-monitoring and self-
management of blood pressure and other cardiac risk factors. This is an 8-week pilot study that 
will assess the usability of a refined e-health platform for managing hypertension and other 
cardiac risk factors. There will be three in-person medical group visits to provide feedback on the 
refined system. 
 
3) To redesign the OWL Orientation Session (OWL-O) by engaging 10 subjects from our 
existing OWL-H cohort(s) to quantitatively beta test and to complete a qualitative 
interview/focus group on an adapted version of the Orientation Session, based on their previous 
feedback. 
 
5. BACKGROUND* 
Nearly 80 million adults in the United States have high blood pressure. Few studies have 
specifically targeted minority populations with hypertension.1,2 Subject preferences, access to 
care, and socioeconomic/cultural determinants all add layers of complexity to this type of 
research. Dr. Gardiner developed and tested OWL for Chronic Pain (OWL CP) in subjects with 
chronic pain and chronic conditions with funding from the Patient Centered Outcomes Research 
Institute (2013-2017).3 OWL CP was also tested in a sample of 46 with funding from the Aetna 
Foundation. 
Preliminary results from the Aetna foundation study showed a reduction in cardiac risk 
factors such as systolic blood pressure, stress, unhealthy eating, and sedentary behavior among 
subjects participating in the self-management program delivered by the OWL platform.4 OWL 
uses an innovative online community and self-management program to provide access to stress 
reduction, mind-body techniques, nutrition, exercise, and peer support. OWL provides 
educational materials including videos of clinician-led talks (stress reactivity, nutrition, 
movement, etc.). OWL also provides subjects a facilitated community blog, private journal, peer 
support, and an extensive resource library. OWL can be successfully accessed on a cell phone, 
tablet, or desktop.   

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For this study, we refined the OWL CP platform to specifically address cardiac risk 
factors and hypertension, creating OWL for reducing Hypertension and Cardiac Risk Factors 
(OWL-H). Due to the proposed mixed methods, a transdisciplinary team reviewed quantitative 
and qualitative outcomes and will assist with refinement to the system. Based on preliminary 
findings and the availability of additional funding, we are taking the opportunity to make much-
needed updates to the OWL-H website, particularly the Orientation Session, in order to increase 
the usability and user experience of the site. These changes will aid our team’s long term plans of 
a large RCT to test the OWL-H platform’s success in reducing hypertension and cardiac risk 
factors. 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
We consented 25 subjects with self-reported high blood pressure. We collected baseline data on 
24 subjects and 22 completed the protocol for the study (two participants were lost to follow-up 
and 1 withdrew). We will reach back out to those 22 subjects and plan to recruit 10 to complete 
beta testing and a qualitative interview/focus group on the updated Orientation Session. As these 
10 participants will have already met the below listed criteria recently, and we are asking them to 
beta test the new Orientation Session only (and not collecting new data from the participants, we 
will not rescreen them. 
 
Inclusion criteria: 
 
1. Male and female subjects of all races and ethnicities who are English-speaking adults 
over the age of 18 and who have a current diagnosis of hypertension. OWL is currently 
only available in English. 
2. Subjects’ physical and mental health status will be sufficient to be able to comprehend 
instructions and participate in the interventions.  
3. Subjects must be able to access computer technology (cellular phone, desktop, laptop) 
and the internet to utilize the online OWL-H platform.  
 
Note: We will be videotaping the 3 cooking demonstrations (to take place during the group 
medical visits) to add this content to the OWL-H platform. This has been added to our fact 
sheets. We will ask patients to sign a release to allow us to film them during the cooking classes. 
If they choose not to consent to filming, they will still be able to take part in the class off camera.  
  
Exclusion criteria with rationale: 
 
1. Serious underlying systemic or co-morbid disease, including psychotic or manic 
symptoms, which preclude physical or cognitive ability to participate in the intervention. 
The risk-benefit ratio of the interventions for these individuals may be potentially higher 
than acceptable. 
2. Active substance abuse, given that individuals who have active substance abuse pose a 
higher risk both to themselves and other members of the groups. 
3. Beginning new hypertension treatments in the past week or planning to begin new 
hypertension treatments in the next few weeks or planning a major medical event in the 
next few weeks, which would interfere with accurately determining the effect of the 
intervention on impact in this study. 

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4. Subjects who are pregnant or actively trying to become pregnant will be not included in 
this study given that the risk-benefit ratio of this intervention may be higher than 
acceptable for these individuals due to the potential onset of non-study related gestational 
diabetes and/or gestational hypertension. Determination of pregnancy status will be based 
upon subject self-report. 
5. Subjects who are not willing to participate in the intervention or attend the group 
visits/interview/focus group. 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
NA 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
NA  
 
9. STUDY TIMELINES* 
This is a one-year open feasibility pilot study with an extension until July 2020. Planning 
and recruitment activities took place during months 1-3. In months 4-8, two cohorts participated 
in beta testing of the on-line OWL-H platform eight-week modules followed by a focus group 
convened at the end of the online component. During each cohort, we invited the subjects to 3 
group visits to re-enforce the key content of OWL-H and answer questions on how to use the 
OWL system and get feedback about the system. During those visits, the subjects will also be 
invited to participate in three cooking classes that will be videotaped. These videos will be 
uploaded into the OWL-H system in months 9 to 12. Data analysis will be completed during 
months 9-12. Concurrently, during months 9-12, we will be re-enrolling 10 repeated subjects to 
beta test an updated version of the OWL-H Orientation Session. Once testing and data collection 
are complete, we will analyze and send our findings to BrightOutcome to make any final needed 
updates to the Orientation Session. 
 
Time Line – one year 
 
Q1 
Q2 
Q3 
Q4 
IRB completed 
X 
 
 
 
Revision and Addition of new 
content to OWL by Bright outcomes 
and Dr. Gardiner 
X 
 
 
 
Beta Testing of OWL by Bright 
outcomes and Dr. Gardiner 
X 
 
 
 
Recruitment  
 
X 
X 
 
Pilot testing of the new  
OWL-H 
 
X 
X 
 
Focus Group  
 
 
X 
X 
 
Revision of OWL-H 
 
 
 
X 
Preliminary Data Analysis  
 
 
 
X 
Re-Consent of 10 OWL-H Subjects 
 
 
 
X 
OWL-O Focus Groups/Interviews 
 
 
 
X 

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Full Data Analysis 
 
 
 
X 
Final Revision of OWL-H 
 
 
 
X 
Preparation of Grant Proposals  
 
 
 
X 
Publications 
 
 
 
X 
 
10. STUDY ENDPOINTS* 
Our primary outcome is successful refinement of the OWL platform, based upon 
participant utilization and focus group feedback, to deliver information on self-management of 
hypertension and other cardiac risk factors, and to encourage self-monitoring of blood pressure.  
 
Specific Aim 1 - To pilot test the OWL-H platform for 8 weeks with 26 patients with 
hypertension (2 cohorts) to refine its utility for home self-monitoring (number of times patients 
record home blood pressure and input this data onto OWL and engagement of self-management 
tools (i.e. # of logins, # of mind body sessions completed, # of times modules accessed each 
day)). Hypothesis 1: Eighty percent of patients will log in and record their blood pressures. 
 
Specific Aim 2 - At the end of each cohort, conduct a focus group to obtain information about: 
1) the barriers and facilitators of using the OWL platform and using OWL to self-monitor blood 
pressure at home, 2) satisfaction with OWL, 3) how OWL helped with reduction of number of 
cardiac risk factors (e.g., smoking, eating habits, perceived stress, and amount of exercise and 
health-related quality of life). 
 
Specific Aim 3 – Using the previously collected feedback from the above aims, make key 
updates to the OWL Orientation Session. Re-consent 10 participants from the original OWL-H 
project to beta test and participate in a focus group/interview on the updated session, either on 
the UMMS campus or through a secure teleconference platform like Zoom. Implement changes 
as needed based on that feedback and testing. 
 
11. PROCEDURES INVOLVED*   
 
Recruitment  
 
Primary OWL-H Project: Subjects were recruited from the Worcester area with a focus on the 
adult primary care clinics. 
 
Subjects self-referred or were referred by their primary care provider. Subjects were contacted by 
the study RC via phone or e-mail to schedule a convenient time to complete the screening 
consent, review study objectives, and review eligibility criteria. An individual’s name and 
contact information was kept separate from collected and stored data by utilizing a password 
protected spreadsheet on a school server and the OnCore patient and study tracking system. This 
information will be destroyed when feasible (the spreadsheet will be deleted immediately 
following completion of the study time period). 
 
A HIPAA waiver was requested and approved to perform a medical record review to confirm 
eligibility, which was used to enroll the first 11 enrolled subjects in the study. The RC conducted 
a medical record review by querying the subject in EPIC by name and birthdate. The RC then 

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confirmed that there was a high blood pressure medication listed on the medication chart and 
there was a diagnosis of hypertension on the problem list. With the current criteria not requiring 
a medication use, and self-reported instead of an official diagnosis of hypertension, a chart 
review is no longer required. 
 
Once eligibility was determined, the study RC contacted the subject by phone or in-person to 
review the study fact sheet, obtain verbal consent for participation using that fact sheet, and to go 
over the HIPAA authorization and photo consent forms. The staff member who explained the 
study fact sheet and obtained verbal consent signed and dated the bottom of the fact sheet to 
provide confirmation of received consent. A copy of the study fact sheet, HIPAA authorization 
(for participation in group medical visits), and photo consent forms were provided to the subject 
prior to first group visit through the avenue of their choice (e.g., blank copies sent through email 
for their reference; hard copies mailed; or hard copies provided at individual in-person meeting). 
If possible, signed copies of the forms were collected prior to the first group visit. If not possible, 
they were collected during the check-in process at the first group visit. Before or during the first 
group visit, subjects were administered a baseline questionnaire (socio-demographic and general 
health information). Subjects were given the option of completing the questionnaire online 
(REDCap database) before the first group visit; in-person with a study staff member at an 
individual meeting or during the first group visit; or over the phone with a study staff member. 
No data was collected without completed consents from the subject. 
 
OWL-O: The study RC will re-contact OWL-H participants that completed the entire protocol 
(i.e., were not lost to follow-up or withdrew) to make them aware of this project extension and 
ask whether they would like to participate in the updated orientation testing. Those that desire to 
will be consented with the OWL-O Beta Addendum Consent Fact Sheet. The study RC will sign 
and date the fact sheets to provide confirmation of consent. 
 
OWL-H Orientation to Intervention (Week 1 – 8/21/19 and 10/30/19) 
 
Eligible subjects were asked to participate in 3 in-person sessions. Participants had three 
options for data collection. They could fill out the baseline questionnaire online (REDCap) prior 
to the orientation, in-person with a study staff member prior to orientation, or during the first 
thirty minutes of the orientation. They also completed their photo consent and HIPAA 
authorization forms during that time, if it was not completed before this first group visit. 
Participants had baseline weight, height, waist circumference, pulse, and blood pressure readings 
completed at the orientation in a private room.  
 
As part of this first group visit and cooking class session, a tutorial on how to use the 
OWL technology was demonstrated, participants were given their login information, and all 
participants were taught to take their blood pressures. As participants arrived, they were given 
the OWL-H Group Visit Check-In Form, which asked them basic questions about healthy 
lifestyle habits, any changes in medication, pain and mood rating, etc. This form was strictly for 
guiding the group leader (PI Dr. Paula Gardiner) in her discussion with each patient individually, 
to track any potential AEs throughout the study, and to help guide the discussion. While this 
form collected data that assisted in the conduction of our research project (e.g., identifying 
potential AEs), any information identified as needing to be kept (again, solely the case for AEs 

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or a note to file for a medication change (as the goal was for participants’ meds to stay the same 
during the course of the study, though we in no way would ask them to go against their doctor’s 
advice)) was recorded on a different form. This Group Visit Check-In Form was stored 
separately from any recorded data in a locked filing cabinet in a locked study staff member’s 
office and was shredded after review by the PI and research staff (for potential mention of any 
AE or needed NTFs. If a potential AE was discovered using this form, the PI discussed it with 
the patient in private at each group visit, then completed the study adverse event log form 
(which, as previously approved by the IRB and in line with HRP-801, will guide the decision of 
when it needs to be reported to the IRB) if it was determined to be an adverse event. 
Each participant received a blood pressure cuff and was asked to sign the Blood Pressure 
Cuff Return Agreement. All participants were observed taking their blood pressure prior to 
leaving the session with their cuff. Finally, we conducted and video recorded a cooking class on 
healthy food choices for reducing HTN during this time. Any subjects who did not consent to 
being video recorded were able to sit out of the scope of the camera during this presentation.  
 
Mid-Session Feedback Group Visit (Week 4 – 9/11/19 and 11/20/19) 
 
During week 4, subjects first filled out the OWL-H Group Visit Check-In Form, then 
completed the Midpoint Survey to answer questions about use of the OWL technology and to get 
feedback. They then participated in a short educational discussion regarding what they had 
learned so far using OWL. A second cooking demonstration took place during this session, 
which was video recorded, excluding on film anyone who did not consent to be video recorded. 
Any adverse events were recorded by the RC and PI.   
 
Final Session (Week 8) and Focus Group (10/9/19 and 12/18/19) 
 
During week 8, subjects again filled out the OWL-H Group Visit Check-In Form and 
participated in a group visit and cooking class to reinforce key content and provide certificates of 
completion. During this visit, a follow-up weight, height, waist circumference, and blood 
pressure were obtained and entered into REDCap. At the completion of the group visit, subjects 
were asked to complete a follow-up questionnaire, to return their blood pressure cuffs, and to 
participate in a one-hour focus group discussion with a facilitator who collected information 
about their experiences using OWL. If subjects did not come to the group, they were asked to 
come in to meet with the RC to obtain this data and return their cuff.  
 
Updated OWL Orientation Testing and Feedback Session (Spring 2020) 
 
 
Based on feedback collected from the OWL-H project surveys and focus groups (for both 
cohorts) and the availability of extra funding from our sponsor, we are making needed updates to 
the OWL-H Orientation Session to increase usability of the platform. Specifically, we plan to 
create tutorial videos that will be embedded in the session to familiarize participants with the 
various aspects of the OWL-H platform. We will also use this funding to create new Resource 
Section content (e.g., Healthy Shopping Guide, How to Eat Healthy When Eating Out, and lists 
of specific local resources for hypertension management), based on previous participant 
feedback. 

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Ten subjects who previously consented to be part of the OWL-H project and completed 
the entire protocol will have the opportunity to take part in the quantitative beta testing and 
qualitative focus group/interview data collection for this updated Orientation Session. They will 
be asked to attend a research session, which will be held in a computer lab on the UMass campus 
or remotely by using a teleconference platform like Zoom, to complete a structured quantitative 
beta testing of the new session content. They will then be asked to participate in a semi-
structured focus group/interview to collect qualitative feedback on the updated session. This 
research session should not last more than 2 hours. 
 
OWL-H Platform 
 
OWL is maintained on a HIPAA compliant server. All patients were given a username 
and password that was not linked to their real name or any health information. We will do the 
same for the OWL-O research session(s). At the orientation class for the OWL-H project, 
participants were given a blood pressure cuff for home use to monitor their blood pressure 
throughout the study. They were taught to use their blood pressure cuffs and were asked to 
measure and record blood pressure readings prior to logging into OWL.   
The OWL platform is set up so that upon login a box appears to collect the participants 
daily blood pressure and pulse values, as well as information on their HTN medication use (if 
taking medication). For the OWL-O research session(s), participants will be given false values to 
enter in this daily reading box. The OWL-H intervention included watching a weekly 10-minute 
health topic video and interacting with a 15 to 20-minute meditation or body scan or gentle 
mindful movement at home. Additionally, there was a participant blog for participants to interact 
on. This was monitored daily by the research staff and Dr. Gardiner. For the OWL-O session(s), 
participants will be asked to only interact with the login screen, daily reading box, Orientation 
Session, and new education content. 
 
12. DATA AND SPECIMEN BANKING* 
NA 
 
13. Data Analysis and Management* 
The data collected from the study will be used to further adapt/revise the OWL-H 
technology for use in a larger study. We are using preliminary findings to update the OWL 
Orientation Session and will collect further data through focus groups/interviews and beta testing 
in order to further improve and revise that session, as needed. We are basing the sample size for 
both projects on the number of subjects whose feedback we need to revise the system. 
Qualitative data will be gathered from focus groups held at the end of each 8-week 
session and the end of the OWL-O research session(s). Qualitative data analysis methods will be 
used to identify themes from questions related to website utilization, including identification of 
barriers, facilitators, and practice techniques.  
Quantitative data was collected from baseline, midpoint, and follow-up assessments and 
include socio-demographic, health status, and general health knowledge and high blood pressure. 
Only study staff included on the IRB project have access to the raw data. Data analysis will 
include the initial calculation of descriptive statistics (means, proportions, and standard 
deviations) and baseline to follow-up measurement analysis including T tests and chi squares for 
normally distributed data. Quantitative data regarding the updated Orientation Session will be 

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collected during the OWL-O session(s) using a structured beta-testing tool that measures 
usability. 
Data was collected on the utilization of the OWL website, use of home practices, use of 
mindfulness practices, and any adverse events since beginning to use OWL. Data regarding the 
use of the OWL website was also gathered—length of time spent on each page, number of times 
the patient logs in, links the participant clicked on, activities used on the website (such as 
listening to the body scan recording or watching health videos), any text which was inputted on 
the website, and any content that was downloaded.  
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
Since OWL-H was a minimal risk study, we did not be developing a formal data safety 
monitoring committee, but instead had the below data safety monitoring plan. Performing 
activities suggested on the website had a slight possibility of causing participants to have muscle 
soreness from doing mindful movement or to feel light-headed or sleepy from the 
mindfulness/meditation activities. All participants were warned of these risks and told they were 
able to discontinue any activities as soon as they felt discomfort. Dr. Gardiner monitored all 
blood pressure readings at all group visits and daily on the platform and referred subjects with 
blood pressure readings of >160/100 to the emergency room, as needed. Since all patients were 
either on HTN medications or did not meet the threshold to take medications, as recommended 
by their PCP, we did not anticipate that patients’ blood pressures would meet this criterion. 
 
OWL-O (Spring 2020) 
 
As participants of OWL-O will only be conducting a beta test and interview regarding the 
updated Orientation Session and not being asked to do any physical activities or provide blood 
pressure readings, the above risks are not associated with the OWL-O session(s). 
However,participants are able to contact the principal investigator, Dr. Paula Gardiner, for advice 
on any potential study-related problems that might arise. Dr. Gardiner will regularly review any 
issues brought by subjects to the study staff, looking for systematic trends suggestive of risk and 
clinically important issues. Participants were and will be told during the consent process that 
they are study volunteers, and that they do not have to answer any study questions which make 
them uncomfortable. They were and will be reminded of this information by the Research 
Coordinator if a question on any study surveys appears to make the participant uncomfortable. 
The RC will contact Dr. Gardiner regarding any safety concerns. 
All written data and forms were and will be stored in a locked file cabinet that is 
accessible by the Principal Investigator and study team members only. All computer files were 
and will be password protected on a UMMS server, and all study subjects will be designated by a 
unique ID number only (the same ID will be assigned to the repeat OWL-O participants as they 
had in OWL-H). Any data downloaded for analysis will be scrubbed for identifying information 
by a study staff member before being exported from REDCap. Study subject’s unique identifiers 
were and will be linked to their name only in a password protected spreadsheet on a school 
server and on the secure OnCore system. Data will be handled with the same confidentiality 
accorded to patient’s medical records. All project staff have been trained in procedures to ensure 
patient confidentiality. 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 

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The principal investigator or sponsor may discontinue participation in the study even if 
the subject does not want to leave. This may happen if it is determined that the study will 
produce negative effects, or if the sponsor stops the study. 
 
16. RISKS TO SUBJECTS* 
The potential risks to subjects are minimal. These risks include slight embarrassment or 
discomfort in response to some health or personal information survey questions and potential 
loss of privacy and confidentiality. Subjects may have felt/feel uncomfortable sharing 
information in the focus group/interview at the end of the study. Subjects may also experience 
minor discomfort resulting from mindful movement, a small risk of muscle strain from mindful 
movement, and feel lightheaded or sleepy from engaging in mindfulness/meditation activities 
(though these risks do not apply to OWL-O).  
Subjects who choose to participate in the focus group/interview at the end of the OWL-H 
8-week session can choose not to answer any questions or not to participate in videotaping. 
Focus groups were audio and video-taped, and the tapes were destroyed after information was 
transcribed. Subjects participating in the OWL-O sessions must consent to having their on screen 
participation video recorded (not their likeness, only the computer screen) and their audible 
feedback audio recorded, as this will be key in capturing usage/usability and feedback data as the 
beta testing and focus group are occurring. They may choose not to answer any questions they 
wish but must participate in both the beta testing and focus group/interview in order to complete 
study requirements. This is all stated in our OWL-O consent fact sheet. 
 
Protections Against Risk 
 
All subjects were and will be informed of potential risks during the consent process. 
Subjects were and will be advised to discontinue activities as soon as they feel discomfort, 
though this risk is unlikely during the OWL-O session(s). Potential risks to confidentiality of 
data collected throughout the study were and will be addressed as follows: All written data and 
forms were and will be stored in a locked file cabinet that will be accessible only to relevant 
study staff. All computer files with protected health information were and will be password 
protected, and all study subjects were and will be designated by a unique ID number only. The 
master list linking subject identities with their ID numbers was and will be kept on a password 
protected spreadsheet on a school server and on OnCore. Data was and will be handled with the 
same confidentiality accorded to subject’s medical records. Specific procedures protecting 
participant confidentiality include staff training in procedures to ensure confidentiality. All 
reports did and will preserve the subjects’ anonymity. Any breach of confidentiality will be 
subject to a root cause analysis and preventive measures taken as appropriate. 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
Participation in this study may provide subjects with practical knowledge for monitoring 
and self-managing their high blood pressure. Additionally, participants may gain experience in 
meditation techniques. 
 
18. VULNERABLE POPULATIONS* 
NA 
 

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19. MULTI-SITE RESEARCH* 
NA 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
NA 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
NA  
 
22. SETTING 
We primarily recruited subjects from the adult primary care medicine clinics at 
the UMass Medical School. Outreach to Worcester-area community health centers was 
initiated  due to recruitment difficulties. All recruitment procedures did and will strictly 
adhere to HIPAA regulations. The group visits, cooking classes, and focus group 
meetings took and will take place at the medical school in a room with a closed door to 
ensure confidentiality. Focus groups were and will be audio and videotaped. Transcripts 
were and will be retained on a password protected server. All tapes were and will be 
destroyed after transcripts have been reviewed and verified for accuracy. Video tapes of 
the cooking classes will be uploaded to the OWL-H website. 
 
23. RESOURCES AVAILABLE 
Principal Investigator: Dr. Paula Gardiner is Associate Research Director and Associate 
Professor in the Department of Family Medicine and Community Health, and Medical Group 
Visit Program Director in the Center for Integrated Primary Care. As PI, she will provide 
research leadership and oversee study implementation. She will supervise all research staff, 
monitor budget activities, communicate with Institutional Review Board (IRB) staff, and 
complete all IRB required reports.   
 
Co-investigator and Cooking class Instructor: Barbara Olendzki, RD, MPH, Associate Professor 
and Director of the Center of Applied Nutrition will devote effort to the OWL-H study. She will 
be responsible for providing three healthy cooking classes. 
 
Research Coordinator: Ariel Villa will devote time to study activities. She will facilitate all 
facets of study implementation including recruitment, subject consent, training, and creation of 
data tracking systems.   
 
24. LOCAL RECRUITMENT METHODS 
We recruited a total of 25 subjects with a current diagnosis of hypertension for the OWL-
H project and plan to re-enroll 10 of those participants for OWL-O. We will strictly adhere to 
HIPAA regulations. OWL-H recruitment materials, including flyers, brochures, and patient 
handouts, were distributed to and made available to potential subjects receiving health care 
services in the adult primary care medicine clinics located at UMass Memorial system. Subjects 
were able to self-refer or be referred by their primary care provider. Outside recruitment will not 
be necessary for OWL-O, as it is a repeated subjects design. 
For OWL-H, research staff coordinated a meeting with primary care providers to review 
study procedures, risks and benefits to subjects, and data collection methods. The presentations 

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educated providers and staff about OWL, broadly defined the inclusion criteria, detailed methods 
of recruitment, and encouraged providers to distribute flyers and brochures to their patients with 
hypertension. All questions were answered thoroughly by the investigator. Subjects who were 
referred by their provider at the time of their medical appointment or who self-referred were 
contacted by the study RC. The RC provided subjects with a study fact sheet and obtained verbal 
consent. 
OWL-H subjects received $25.00 for completing baseline, midpoint, and follow-up 
questionnaires and an additional $25.00 for participating in the focus group. OWL-O subjects 
will receive $50.00 for completing beta testing of the updated Orientation Session and a focus 
group/interview session on the same.  
 
25. LOCAL NUMBER OF SUBJECTS 
We  recruited 25 subjects who were eligible to participate. Of those, 22 completed the entire 
protocol. From those 22, we plan to recruit 10 to beta test the updated OWL Orientation Session. 
 
26. CONFIDENTIALITY  
All participating subjects were and will be assigned a specific study code. We did and 
will use the REDCap secure online database to gather and store participant data. Subjects were 
and will be assigned a project identification number to protect privacy. Data is and will be stored 
in locked cabinets in a designated locked research office. Data is and will also be stored on 
UMMS privacy/password protected servers. Only study staff on a strictly need-to-know basis 
will have access to data. 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
OWL-H research subjects had the opportunity to complete pre-, mid-, and post-study data 
on-line via REDCAP or in-person. Collection of baseline and follow-up physical data (vitals, 
weight, height, waist circumference) was conducted in a private room by research study staff. 
Refused or Declined choices on all surveys allow for voluntary skipping of questions.  
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
NA 
 
29. ECONOMIC BURDEN TO SUBJECTS 
There may be minimal costs to participate (i.e. childcare, transportation). As needed, both OWL-
H and OWL-O have funds in the budget to assist with patient transportation and parking costs. 
 
30. CONSENT PROCESS 
For OWL-H, subjects who were referred by their clinician at the time of appointment and 
expressed interest in participating in the study were contacted by the study RC at that time to 
confirm eligibility and obtain verbal consent. Since both projects are minimal risk, a fact sheet 
was and will be provided to all potential subjects in lieu of a formal written consent. The RC did 
and will obtain verbal consent from subjects interested in participating to confirm eligibility. If 
eligible, the study protocol was and will be explained along with potential risks and benefits and 
measures taken to protect privacy and confidentiality. All questions were and will be answered to 
subject satisfaction.  

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
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For OWL-H, if the subject was unable to meet with the RC at the time of their 
appointment, alternative arrangements suitable to the subject were made. For subjects who self-
referred, the study RC contacted subjects by phone to confirm eligibility to participate and to go 
over the study fact sheet and obtain verbal. 
We consented individuals according to inclusion/exclusion criteria, and will continue to 
do so for OWL-O. Research study staff were trained to follow all consent procedures as outlined 
in SOP HRP 802: Investigator Guidance: Informed Consent.   
During the orientation class and focus group session of OWL-H, participants reviewed 
and discussed the guidelines about confidentiality. As participants are not providing any clinical 
or personal information during the OWL-O research session(s), and will have consented to be 
part of a group beta-testing session and focus group, this will not be done for OWL-O. 
  
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
This is a minimal risk study, and we did and will obtain verbal consent to determine eligibility 
using a study-specific fact sheet.   
 
32. DRUGS OR DEVICES 
NA 
 
References 
 
1 Bartolome, R. E., Chen, A., Handler, J., Platt, S. T., & Gould, B. (2016). Population Care 
Management and Team-Based Approach to Reduce Racial Disparities among African 
Americans/Blacks with Hypertension. Perm J, 20(1), 53-59. doi:10.7812/tpp/15-052 
 
1 Fang, J., Yang, Q., Ayala, C., & Loustalot, F. (2014). Disparities in access to care among US 
adults with self-reported hypertension. Am J Hypertens, 27(11), 1377-1386. 
doi:10.1093/ajh/hpu061 
 
1 Gardiner, P., Dresner, D., Barnett, K. G., Sadikova, E., & Saper, R. (2014). Medical group 
visits: a feasibility study to manage subjects with chronic pain in an underserved urban 
clinic. Glob Adv Health Med, 3(4), 20-26. doi:10.7453/gahmj.2014.011 
 
1 Gardiner, P., Lestoquoy, A. S., Gergen-Barnett, K., Penti, B., White, L. F., Saper, R., . . . 
Liebschutz, J. M. (2017). Design of the integrative medical group visits randomized 
control trial for underserved subjects with chronic pain and depression. Contemp Clin 
Trials, 54, 25-35. doi:10.1016/j.cct.2016.12.013