Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension
Phase: NA
Conditions: Hypertension
Sponsor: University of New Mexico

PROTOCOL TITLE: Evaluating the Effect of an Evidence-Based One Page with 
Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
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Protocol Version date: 8/10/20 
Template Version Date: 5/14/2019

PROTOCOL TITLE: Evaluating the Effect of an Evidence-Based One Page with 
Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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PROTOCOL TITLE: 
Evaluating the Effect of an Evidence-Based One Page with Supplemental Visual Aids on 
the Knowledge and Perceptions of Blood Pressure Management Among Adults with 
Hypertension 
 
PRINCIPAL INVESTIGATOR: 
Alexandra Herman, PharmD 
Department of Pharmacy Practice & Administrative Sciences  
VERSION NUMBER: 
1.0 
DATE: 
8/10/20 
REGULATORY FRAMEWORK: 
Please indicate all that apply: Not Applicable 
 
DOD (Department of Defense) 
 
DOE (Department of Energy) 
 
DOJ (Department of Justice) 
 
ED (Department of Education) 
 
EPA (Environmental Protection Agency) 
 
FDA (Food and Drug Administration) 
 
HHS (Department of Health and Human Services) 
 
VA 
 
Other:       
 
FUNDING: 
This protocol is unfunded.  
 
CLINICAL TRIALS 
Is this a clinical trial per the NIH definition of a Clinical Trial?   
 Yes   
 No 
NIH Definition of a Clinical Trial:  
A research study in which one or more human subjects are prospectively assigned to one 
or more interventions. An "intervention" is defined as a manipulation of the subject or 

PROTOCOL TITLE: Evaluating the Effect of an Evidence-Based One Page with 
Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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subject’s environment for the purpose of modifying one or more health-related 
biomedical or behavioral processes and/or endpoints. Examples include: drugs/small 
molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery 
systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related 
behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies (which may include placebo or 
other control) to evaluate the effects of those interventions on  health-related biomedical 
or behavioral outcomes.  
Use the following four questions to determine the difference between a clinical study 
and a clinical trial:        
 
Does the study involve human participants? 
 Yes   
 No 
 
Are the participants prospectively assigned to an intervention? 
 Yes   
 No 
 
Is the study designed to evaluate the effect of the intervention on the participants? 
 Yes   
 No  
 
 Is the effect being evaluated a health-related biomedical or behavioral outcome? 
 Yes   
 No 
 
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of 
a clinical trial, even if…  
• You are studying healthy participants 
• Your study does not have a comparison group (e.g., placebo or control) 
• Your study is only designed to assess the pharmacokinetics, safety, and/or 
maximum tolerated dose of an investigational drug 
• Your study is utilizing a behavioral intervention 
 
If yes to all 4 questions, please confirm that the research team is familiar with and agrees 
to comply with the investigator requirement to register the study on the ClinicalTrials.gov 
database. Additionally, the approved consent document(s) must be uploaded to the 
ClinicalTrials.gov database    
 Yes   
 No  
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu  
 

PROTOCOL TITLE: Evaluating the Effect of an Evidence-Based One Page with 
Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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Table of Contents 
1. 
Objectives .................................................................................................................... 6 
2. 
Background .................................................................................................................. 6 
3. 
Study Design…………………………………………………………………………8     
4. 
Inclusion and Exclusion Criteria ................................................................................. 8 
5. 
Number of Subjects ..................................................................................................... 9 
6. 
Study Timelines ........................................................................................................... 9 
7. 
Study Endpoints ......................................................................................................... 10 
8. 
Research Setting ........................................................................................................ 10 
9. 
Resources Available .................................................................................................. 10 
10. 
Prior Approvals ...................................................................................................... 11 
11. 
Multi-Site Research ............................................................................................... 11 
12. 
Study Procedures ................................................................................................... 12 
13. 
Data Analysis ......................................................................................................... 14 
14. 
Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 14 
15. 
Withdrawal of Subjects .......................................................................................... 14 
16. 
Data Management/Confidentiality ......................................................................... 15 
17. 
Data and Specimen Banking .................................................................................. 16 
18. 
Risks to Subjects .................................................................................................... 16 
19. 
Potential Benefits to Subjects ................................................................................ 17 
20. 
Recruitment Methods ............................................................................................. 17 
21. 
Provisions to Protect the Privacy Interests of Subjects .......................................... 17 
22. 
Economic Burden to Subjects ................................................................................ 17 
23. 
Compensation ........................................................................................................ 17 
24. 
Compensation for Research-Related Injury ........................................................... 17 
25. 
Consent Process ..................................................................................................... 17 
26. 
Documentation of Consent .................................................................................... 19 
27. 
Study Test Results/Incidental Findings ................................................................. 19 
28. 
Sharing Study Progress or Results with Subjects .................................................. 19 
29. 
Inclusion of Vulnerable Populations ...................................................................... 19 
30. 
Community-Based Participatory Research ............................................................ 19 
31. 
Research Involving American Indian/Native Populations ..................................... 19 
32. 
Transnational Research .......................................................................................... 20 
33. 
Drugs or Devices.................................................................................................... 20 
34. 
Principal Investigator’s Assurance ........................................................................ 20 
35. 
CHECKLIST SECTION ........................................................................................ 22 
36. 
Partial Waiver of Consent for Screening/Recruitment .......................................... 22 
37. 
Partial Waiver of HIPAA Authorization for Screening/Recruitment .................... 22 
38. 
Waiver of Documentation of Consent ................................................................... 22 
39. 
Alteration of Consent .............................................. Error! Bookmark not defined. 
40. 
Full Waiver of Consent/Parental Permission ......................................................... 23 

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Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
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41. 
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)
 
23 
42. 
Full Waiver of HIPAA Authorization (Checklist) ................................................. 23 
43. 
Other Waiver Types (Checklist) ............................................................................ 23 
44. 
Vulnerable Populations (Checklist) ....................................................................... 23 
45. 
Medical Devices (Checklist) .................................................................................. 23 
46. 
Export Control (Checklist) ..................................................................................... 23 
47. 
Data Transfer/Sharing (Checklist) ......................................................................... 23 
48. 
Specimen Transfer/Sharing (Checklist) ................................................................. 24 
 
 

PROTOCOL TITLE: Evaluating the Effect of an Evidence-Based One Page with 
Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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1. Objectives 
 
1.1 To evaluate changes in patient knowledge of blood pressure management and 
perceptions of making lifestyle changes to manage their blood pressure after 
implementation of an evidence-based one-page teaching protocol with supplemental 
handouts and optional use of suggested apps and web sites.  
 
1.2 The working hypothesis is that patients will improve their knowledge of blood 
pressure management and have more positive perceptions of making evidence-based 
lifestyle changes to manage their blood pressure after receiving education from 
PharmD students using a one-page teaching protocol with supplemental visual aids 
and optional use of suggested apps and web sites. 
 
2. Background 
 
2.1 Hypertension (HTN) affects as many as one in three adults in the United States 
(US); of those approximately 50 percent are managing their blood pressure in 
accordance with national guideline goals (Rodriguez, Friedberg, DiGovanni, Want, 
Whilie-Rosett, Hyound, & Natarajan, 2019).  There are many comorbid conditions 
that come with HTN such as end-stage kidney disease, stroke, or heart attack 
(Rodriguez et al., 2019).  Not only does living with untreated HTN lead to associated 
comorbid conditions that decrease the quality of life, but it also contributes to an 
astronomical cost the health care system to manage additional disease burden.  
Annual costs related to hypertension health care dollars has been reported as high as 
$55.9 billion (Benjamin et al., 2019). 
 
2.2 There has been confusion among health care providers over optimal blood 
pressure management due to discordance in national guidelines.  The Joint National 
Committee 7 guideline (JNC7) recommended treatment of high blood pressure 
regardless of age if blood pressure was greater than 140/90 (Lenfant, Chobanian, 
Jones, & Roccella, 2003).  JNC8 was considered to have “relaxed” the guidelines on 
early detection which would affect initiating treatment for people (not initiating 
treatment until systolic was over 150 if over age 60) (Armstrong, 2014).  The 
ACC/AHA/AAPA/ABC/ACPM/AGA/AphA/ASH/ASPC/NMA/PCNA Guideline 
helps reconcile this variance between the two standards while providing a very 
extensive road map on how to manage adults with HTN in all aspects of care 
(Whelton et al., 2018). 
There have been strides made to decrease disparities in treatment for ethnic 
minorities, however, there remains a 33 percent higher death rate for non-Hispanic 
blacks (NHB) for non-Hispanic blacks (NHB) for cardiovascular disease in the U.S. 
(Balfour, Rodriquez, & Ferdinand, 2015).  This is addressed in the 2017 ACC/AHA 

PROTOCOL TITLE: Evaluating the Effect of an Evidence-Based One Page with 
Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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Guideline with specific guidelines on appropriate treatment and management of 
hypertension for minority populations (Whelton et al., 2018).  New Mexico is a 
diverse and unique minority-majority state, making it necessary for 
clinicians/students to understand key treatment differences based on ethnicity. 
The 2017 ACC/AHA guideline also recommends HTN management to be provided in 
a collaborative manner (Whelton et al., 2018).  The Million Hearts Initiative is a 
method adopted by many schools and facilities in the US (Gawlik & Melnyk, 2015) 
with the goal to prevent 1 million heart attacks and strokes by 2017.  While 2017 has 
come and gone, this project is still being used to set the stage for population-driven 
health care accomplished through a collaborative team of health care providers 
(Gawlik & Melnyk, 2015).  The Centers for Disease Control (CDC) and Prevention 
recognize the value of the role of the pharmacist improving blood pressures in the 
community from a population health perspective. With the ever increasing aging 
population, the CDC created a comprehensive resource guide for pharmacists to use 
in order to improve blood pressure management in communities (Di Palo & Kish, 
2018).  There is strong published evidence/data that supports the critical role 
pharmacist play to improve hypertension management which includes:  medication 
management, patient-centered counseling, and disease state education (Di Palo, & 
Kish, 2018).  A well-established understanding in research is from the time of 
findings to implementation of findings there can be a span of 15 years or greater 
before the general medical community implements the most recent evidenced-based 
guidelines (White, Dudley-Brown, & Terhaar, 2016).  This study will add to the body 
of existing knowledge on how well patients with hypertension understand the new 
blood pressure goal which is lower than previous guidelines.  In other words, is the 
medical community translating evidence three years out from the most recent 
guideline update in 2017 well or not?   
 
2.3 A problem for blood pressure management specific to New Mexico is the lack 
primary care and specialty to identify and manage HTN.  Many clinics are not 
accepting new patients due to provider shortages (Abundis, 2019).  New Mexico is a 
poor state with over 50 percent of the population on some form of government 
assistance (Domrzalski, 2014).  Those in a lower socio economic status (SES) may 
have difficulty with access to care, transportation to appointments, or paying for their 
medications.  Additional research is needed on modes of improving blood pressure 
management in the setting of these provider shortages and health disparities.  
Pharmacists are ideally positioned in the community as part of the care team by 
reinforcing patient-centered teaching on hypertension education.  An example used in 
pharmacies are telephonic follow-ups or telehealth (text reminders for prescription 
pick up as an example) (Di Palo & Kish, 2018).  
Shared decision making (SDM) is recommended in one of the latest clinical 
guidelines to improve adherence to recommendations made by the clinician in order 
to improve patient’s agreement to follow through on given recommendations during 

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Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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the encounter (Langford et al., 2019).  The recognition of cultural differences in 
preferences for treatment is imperative in order to improve the disparity in care, and 
thereby improve blood pressure numbers for all adults in the US regardless of their 
ethnicity.  Using the model of SDM has shown benefit for patient compliance 
(Langford et al., 2019).   
Using the latest blood pressure guidelines set forth by the 2017 ACC/AHA 
recommendations (Whelton et al., 2018), and the Million Hearts Initiative guidelines 
(Gawlik & Melnyk, 2015) a comprehensive “one-page” with supplemental visual aids 
will be used.  The one-page will be in the format of a single page, double sided hand-
out that covers:  medications to avoid that can increase blood pressure, and self-
monitoring with the American Heart Association visual aide of how to take blood 
pressure on the front side.  The back-side will have information on:  diet, smoking 
cessation, and physical activity.  The diet section will have a visual aid from the 
National Heart, Lung, and Blood Institute specific to the DASH diet recommended 
from the 2017 ACC/AHA guideline (Whelton et al., 2018).  The smoking cessation 
will be addressed with the National 1-800-Quit-Now number with the participant 
encourage to have a separate appointment with their PCP should this be a primary 
focus for them.  For the purpose of this study, smoking cessation assistance requires 
more allocated time that what is planned for each participant.  The exercise section 
will have a visual aid from the American Heart Association about proper type of 
exercise and length of time to exercise. There will be a table provided for quick 
reference with evidenced based recommended websites and apps for the participant 
should they have access to the internet.  These handouts are included with this 
submission.   The one-page document is included with the submission as “My 
Planned Behavior for Managing my Blood Pressure.” 
 
3. Study Design 
3.1. Study design:  prospective clinical trial with human participants assigned to an 
intervention of a one-page handout with supplemental visual aids and optional use 
of suggested apps and websites as an educational intervention to improve their 
knowledge of blood pressure management through behavior changes recommended 
to them. 
3.2. N/A. There will be no blinding in this study. 
4. Inclusion and Exclusion Criteria 
4.1. Patients will be screened with an initial interview which will be conducted over the 
phone.  The interview script is included in this submission as “UNM HTN Phone 
Screen for Potential Participants.”  Their Walgreens medication profile will also be 
reviewed to verify that they are on medications for hypertension. 

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Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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4.2. The inclusion criteria will be: adults from 18 to 75 years old, ability to self-
consent, English-speaking, able to read/write English, currently prescribed at least 
one medication for treatment of essential primary hypertension.  
4.3. There will be no special populations in this study.  This study will not include 
adults unable to consent; individuals who are not yet adults (infants, children, 
teenagers); pregnant women; or prisoners. 
4.4. Pregnant women will be excluded due to the complexity of hypertension in 
pregnancy, which warrants management by an OB/GYN or other specialists.  
Potential participants will be asked if they are pregnant or planning to become 
pregnant using the screening document “UNM HTN phone screen for potential 
patients.” Children are excluded for three reasons: 1) the writer is only certified as 
an NP to work with adults; 2) the focus of this study is the population at greatest 
risk for high blood pressure which is adults; and 3) children with high blood 
pressure are rarely diagnosed with essential primary hypertension, and should be 
managed by a specialist.  We do not have the resources to provide adequate 
materials in Spanish or other languages commonly spoken in NM, and further 
research may be needed on the effect of the intervention for non-English speaking 
patients. 
5. Number of Subjects 
5.1. This is a single site study and will be done at one location, Walgreens Store #6587 
in Albuquerque, New Mexico. There will be 50 participants recruited. 
5.2. The number to be recruited will be 50. 
5.3. Based on statistical analysis from UNM Statistics Department, a sample size of at 
least 45 patients is needed.  The number to be recruited at the onset will be 50 to 
account for attrition.  
6. Study Timelines 
6.1.  
• Duration of individual’s participation in research: The total expected duration 
of participants’ active participation is less than 60 minutes.  The participants 
will have mailed to them at the start of the study:  one-page with supplemental 
handouts/visual aids, list of suggested apps and web sites, pre/post survey and 
pre/post-test with self-addressed stamped envelopes (SASE) to return their 
information, and a pill box.  
• Recruitment for this study will begin August-September 2020. Duration 
anticipated to enroll all subjects: 30 days 
• Total duration for researchers to complete the study: Recruitment will occur 
through end of Sept 2020; additional follow-up phone calls will occur through 

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Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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September-November 2020. Data analysis will occur during the month of 
December 2020.  Manuscript preparation and submission to scholarly 
publications will occur shortly thereafter with the target of January 2021. 
7. Study Endpoints 
7.1. Primary endpoint:  change in participant’s knowledge of blood pressure 
management;  change in participant’s perception of making lifestyle changes to 
manage their hypertension 
7.2. Describe any primary or secondary safety endpoints: N/A 
7.3. Describe any exploratory endpoints:  
1: Participants will be asked to rate the usefulness, ease of reading, and 
attractiveness/visual appeal of each handout they were provided.  
2: Participants who choose to use any apps or web sites will be asked for feedback 
on usefulness, ease of reading/access, and attractiveness/visual appeal for each app 
or web site used.  
3: The subset of participants who choose to use electronic resources will be 
compared to the subset of participants who do not to compare any differences in 
the primary outcome.   
 
8. Research Setting 
8.1. Site or location:  Walgreens Store #6587 in Albuquerque, NM. 
8.2. We will recruit potential subjects from Walgreens Store #6587 in Albuquerque, 
NM. Participants will be recruited over the phone.   
8.3. Research will be performed from Walgreens Store #6587 in Albuquerque, NM. 
8.4. Describe the composition and involvement of any community advisory board: N/A 
8.5. This is a partnership with UNM College of Pharmacy, Walgreens Pharmacy, and a 
Doctor of Nursing (DNP) student enrolled in the DNP program at Missouri State 
University (MSU).  Per MSU policy, once the IRB is submitted and approved 
through UNM, the IRB approval from UNM with a summary paragraph will be 
submitted to MSU for record.  Carla R. Kychik, DNP candidate, will be 
responsible for submitting the approved UNM IRB with summary paragraph to the 
MSU IRB board to complete this requirement.  A cede letter is included in this 
submission. 
9. Resources Available 
9.1. The PI is Dr. Alexandra Herman, PharmD with UNM College of Pharmacy, who 
has completed a two-year fellowship in Cardiovascular Pharmacotherapy and holds 
a Certificate in Clinical & Translational Research. 

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Carla R. Kychik, MSN, ANP-C (certification for adult care) is completing this 
project as part of a DNP program at MSU.  She will be responsible for 
diagnosing, managing care, ordering labs/diagnostics, and referrals to specialty 
care.  She has completed board certification by the American Nurse Association 
for Cardiovascular Nursing. 
Dr. Amy Bachyrycz PharmD: will act as preceptor and liaison between UNM 
College of Pharmacy and Walgreens Pharmacy.  Dr. Bachyrycz has extensive 
experience providing care in the community pharmacy setting.   
PharmD students who have an understanding they will participate in this study 
from the start/end of the study will work under the supervision of Dr. Bachyrycz.  
The students will be in the clinical rotation of their studies as P4 PharmD 
students.   
9.2. Carla R. Kychik MSN, ANP-C will be responsible for medical decisions, 
diagnoses, and referrals to other providers (e.g. cardiologist) if indicated.  
9.3. Describe other resources available to conduct the research: Walgreens store #6587 
fills approximately 750 prescriptions per day.  The store is located in a densely 
populated part of Albuquerque, NM in high business/traffic areas.  The goal of 50 
patients during recruitment is a feasible goal which can be met.  The facilities to 
conduct the research will be in an already established Walgreens Pharmacy that has 
individual/private space available for education implementation with each 
participant over the phone. 
10.  Prior Approvals 
10.1 DNP project chair from MSU has approved project proposal, and Dr. Bachyryz’s 
Walgreens supervisor has approved the project. 
 
10.2 Upload the required Departmental Review Form signed by your Department 
Chair (or authorized designee if the PI is the Department Chair) into Click under 
“supporting documents.” 
10.3 N/A; no radiation will be involved in this study. 
10.4 N/A: no biological specimens will be involved in this study.  
11 Multi-Site Research 
11.1 This site will occur as a collaboration between the UNM College of Pharmacy, 
Walgreens Pharmacy, and a Doctor of Nursing (DNP) student enrolled in the 
DNP program at Missouri State University (MSU). All research procedures will 
occur at Walgreens pharmacy.  
• All sites will maintain the most current version of the protocol, consent 
document, and HIPAA authorization. 

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• All approved IRB protocols will be maintained at each site.  
• All modifications will be communicated to sites, and approved (including 
approval by the site’s IRB of record) before the modification is implemented. 
• All engaged participating sites will safeguard data as required by local 
information security policies. Data will be stored in a locked filing cabinet at 
Walgreens Pharmacy Store #6587. The filing cabinet will be locked inside the 
pharmacy which is secured by an alarm system, and only accessible with 
those who have the authorized keys/codes. Data will be entered from paper 
copies and stored on UNM RedCap. Data will be analyzed at UNM. No data 
will  be sent to MSU, other than in final summary form. 
• All local site investigators will conduct the study appropriately. 
• All non-compliance with the study protocol or applicable requirements will 
reported in accordance with local policy. 
11.2 The method to communicate:  adverse events, problems, interim results, 
data/safety monitoring reports, and closure of the study will occur through 
UNM Redcap. 
11.3 N/A; this is not an FDA-regulated trial.  
12 Study Procedures  
12.1 This study will occur at Walgreens Store #6587 in Albuquerque, NM.  
Recruitment will occur during standard-of-care follow up phone calls at 
Walgreens Pharmacy.  If a patient would like to participate, the information will 
be mailed to them with a follow-up phone call to review all the information over 
the phone with them.  Phone calls will be made in a private room in the pharmacy.  
Dr. Amy Bachyrycz, PharmD will oversee the study procedures at Walgreens 
Walgreens Store #6587. 
12.2 Patients will be screened for eligibility for the study at Walgreens Store #6587, 
with pharmacists supervising the PharmD students.  Screening will be conducted 
with the Interview Guide included in this IRB submission as “UNM HTN 
Prescreen for Potential Participants.” Eligible potential participants will have 
consent forms read and given the opportunity to ask questions about the study. 
Participants may choose to enroll in the study at that time, or given more time to 
be mailed consent forms at home and decide at another time.  
Once the participant consents to participation, the materials will be mailed to the 
participant, and the participant will complete a pre-survey (“Pre-survey for UNM 
HTN Study”) and pre-test (“Pre-test for UNM HTN Study”) on blood pressure 
management. Participants will be provided a one-page education with 
supplemental visual aids on blood pressure management with education provided 
by PharmD students (“My Planned Behavior for Managing My Blood Pressure”). 
Participants will be provided a list of suggested apps and websites (“Evidence-

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Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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based Websites and Apps for Blood Pressure Management”) that they may use if 
they have a smartphone and/or internet access.   
After an initial teaching phone call performed by a PharmD student, a follow-up 
phone call will be conducted at week 4 and 8 of the participant’s enrollment. 
During each phone call, study personnel will use a telephone script titled “Phone 
Call Script for My Planned Behavior for Managing My Blood Pressure 
Participants” to discuss blood pressure goals, behavioral changes, and principles 
of blood pressure management.  
At week 8, participants will either answer their questions over the phone or be 
reminded to complete a post-test (“Post-test for UNM HTN Study”) and post-
survey (“Post-survey for UNM HTN Study”) and mail in using their SASE.   
12.3 The information will be collected prospectively and information will be collected 
at the onset of enrollment, during an initial teaching phone call, during phone calls 
at week  4, and 8, and from mailed in pre/post-test; pre/post surveys.   
12.4 Initial study activities will occur from the Walgreens Store #6587 in 
Albuquerque, NM by phone calls: recruitment, enrollment, and initial education.  
The rest of the information will be gathered by follow-up phone calls at 4 and 8 
week intervals, and mail-outs.  The phone calls will be made from the Walgreens 
Pharmacy clinic in a room where the investigator has privacy for the phone calls 
to speak with the participant. 
12.5 Describe, in chronological order, all research procedures and interventions 
being performed and when they are performed. Include: 
• Recruitment: Walgreens Store #6587 by phone 
• Screening interview: Walgreens Store #6587 by phone 
• Verbal consent and enrollment: Walgreens Store #6587 by phone 
• One-page educational intervention (“My Planned Behavior for Managing My 
Blood Pressure (One Page Handout)”) with supplemental visual aids (“DASH 
diet,” “AHA Healthy for Good,” and “AHA Blood Pressure Management”) 
will be sent to the mailing address given by the participant with a self-
addressed stamp envelope in order to return pre/post-test and pre/post-survey. 
• One-page educational intervention with supplemental visual aids: from 
Walgreens Store #6587 via mail. Education on blood pressure management 
will be provided to the participant by PharmD students via a phone call after 
enrollment once patient receives items in the mail. (“Phone call Script for My 
Planned Behavior for Managing My Blood Pressure Participants”). 
• Follow-up phone calls at 4 and 8 week intervals: Phone calls will be made to 
the phone number provided by the participant. Phone calls will be made from 
private rooms at Walgreens Store #6587. Study personnel will use a phone 
script (“Phone call Script for My Planned Behavior for Managing My Blood 

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Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure 
Management Among Adults with Hypertension 
 
 
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Pressure Participants”) to discuss blood pressure goals, behavioral changes, 
and principles of blood pressure management. 
• Post-test on blood pressure management (“Post-test for UNM HTN Study”): 
Walgreens Store #6587. The purpose of this test is to determine the 
participant’s knowledge of blood pressure management after the educational 
intervention. The patient may return the completed test by mail, or answer the 
questions over the phone if they are unable to mail their responses. 
• Post-survey (“Post-survey for UNM HTN Study”): Walgreens Store #6587. 
The purpose of this survey is to gauge the participant’s perspectives on 
engaging in behavioral changes after the educational intervention. The patient 
may return the completed test by mail, or answer the questions over the phone 
if they are unable to mail their responses. 
13 Data Analysis 
13.1 Descriptive statistics will be used with demographic information, and paired t-
tests will be used for the pre/posttest and pre/post surveys.  The UNM Statistics 
Department will assist with statistical analysis.  
13.2 Power analysis completed for the paired t-tests to detect difference in pre/post 
tests and surveys using:  one tail, moderate effect size of 0.5, alpha probability 
of error of 0.05, and power standard of .95 resulted in n=45 (GPower, 2019). 
 
14 Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
N/A. This study poses minimal risk to the patient as it utilizes only non-invasive 
screening interventions (education; surveys; follow-up phone calls). 
 
15 Withdrawal of Subjects 
15.1 A patient may be withdrawn from the study should they no longer meet 
inclusion criteria (for example, if they become pregnant during the study).  The 
patient may also be withdrawn if they are not following the study protocol as 
agreed upon at the onset of the study.  Should the patient no longer be able to be 
contacted after three phone call attempts, they will be withdrawn from the 
study.  Data obtained up to that point of no contact will be maintained, and used 
for the study analysis. 
15.2 The completion of this study will be on the final call to gather data & final post-
test and post-survey from the participant.  If they patient did make a behavior 
change of taking blood pressure at home, we will inquire at this time.  Upon 
completion of the study, the participant will be encouraged to continue to see 
their primary care physician or other medical provider for continued blood 
pressure management.  

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15.3 This is an education-only intervention, and the patient may choose to 
immediately withdraw from the study and decline any further education or 
follow up phone calls. Should the patient choose to withdraw at any time, they 
will be encouraged to follow-up with their primary care physician or other 
medical provider for continued blood pressure management.  
Should the patient no longer be able to be contacted after three phone call 
attempts, they will be withdrawn from the study.  Data obtained up to that point 
of no contact will be maintained, and used for the study analysis.   
Should there be unexpected circumstances such as pregnancy or hospitalization 
for a major cardiac event (stroke, myocardial infarction, or heart failure 
exacerbation), that participant’s data will be used up to the time of the event that 
causes withdraw.  
15.4 Collected data for any withdrawn participants will be maintained in accordance 
with study protocol. 
15.5 Participants will be informed in the consent process that they may choose to 
withdraw from the study at any time for any reason.  
16 Data Management/Confidentiality 
16.1 N/A Data will be entered and stored on UNM Redcap. 
16.2  The research team will have access to stored information about the subjects that 
will be maintained in a locked filing cabinet inside a pharmacy that is accessible 
only with keys and/or personal access codes. The research team will have 
access to the UNM Redcap Database.  
16.3 This research will involve the collection of patient’s name.  The patient’s name 
is needed for review of their medication profile at Walgreens and for making 
follow-up phone calls. Participants will be assigned an ID code to be placed on 
all documents. The ID code and the participant’s name will not be recorded on 
the same documents. The only link between ID code and participants’ names 
will be on a master list which will be stored in a locked filing cabinet which will 
be placed inside a pharmacy accessible only via personal access codes and keys. 
Information contained on envelopes that patients may mail back to the 
pharmacy (patient name and address) will be shredded upon receipt. 
16.4 This research will involve access to Protected Health Information (PHI), 
including the patient’s medication profile at Walgreens.   
16.5 The data is not publicly available. 
16.6 The data is not considered sensitive; information collected in this study will 
relate only to the patient’s blood pressure management and their behavior and 
behavioral changes to manage their blood pressure. 
16.7 This study will not utilize a Certificate of Confidentiality. 

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16.8 Data will be stored in locked filing cabinet inside a pharmacy that is only 
accessible with keys and/or personal access codes.  Data will be entered into 
UNM Redcap.  
16.9 N/A 
16.10 Data will not be transferred or transmitted to outside locations or entities. Data 
will be stored in locked filing cabinet inside a pharmacy that is only accessible 
with keys and/or personal access codes.  Data will be entered into UNM 
Redcap. No data will be sent to MSU, other than in final summary form. 
Information contained on envelopes that patients may mail back to the 
pharmacy (patient name and address) will be shredded upon receipt. 
16.11 Collected information will include answers to initial screening questionnaire, 
patient name, date of birth, gender, ethnicity, phone number, mailing address, 
pre/post-tests, pre/post-surveys, self-reported blood pressure readings, and self-
reported medication changes.  Data collected on hard copy forms will be input 
into UNM RedCap.  Data will be recorded onto a hard copy forms for initial 
screenings, pre/post-tests, pre/post surveys, consent/HIPAA forms.  Data will be 
stored for 6 years after initial consent.  Only study personnel will have access to 
data. 
16.12 N/A 
16.13 N/A-Data will not include audio or video recordings  
16.14 N/A-Data will not include photographs  
16.15 
Research records will be maintained for 6 years after initial consent and  
HIPAA authorization. 
16.16 
N/A – minors are not included in this study 
16.17 HIPAA Requirements: Records will be retained for 6 years after each 
subject’s initial consent. 
17 Data and Specimen Banking 
Data collected in this study will only be used for the completion of this project and 
not used in any future projects.  
No specimens will be collected/banked in this study. 
 
18 Risks to Subjects 
 
18.1 This study poses minimal risk to the participants, and uses only non-invasive 
interventions.  The intervention consists of education intended to assist the patient 
with behavioral changes that may result in improved blood pressure management.  
Participants may experience some discomfort when answering pre-test/survey or 
post-test/survey questions. Participants may experience a loss of confidentiality 

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and/or privacy.   
 
19 Potential Benefits to Subjects 
19.1 The potential benefit for the participant is to achieve a better understanding of 
positive behavior changes to continue management of their blood pressure after 
study ends. 
20 Recruitment Methods 
20.1 Participants will be recruited from Walgreens Store #6587 by phone call.  
Participants will be recruited through the end of September 2020. 
20.2 Potential participants are those who pick up their medications from the 
pharmacy, and during standard-of-care follow-up phone calls from Walgreens 
Pharmacy.  The participants’ medication profile will be reviewed and an initial 
interview will be conducted to determine if they meet study criteria. 
 
21 Provisions to Protect the Privacy Interests of Subjects 
21.1 Recruitment: Participants will be screened for interest by phone call during a 
standard-of-care follow-up phone call from Walgreens Pharmacy.  The person 
making the phone call to collect the data will be in a secure area with no 
other/outside people able to hear the conversation.  The person making the call 
will ask the participant at the onset of the call if this is a good time for them to 
talk so the receiver of the call also has their own privacy.   
21.2 All follow up will be conducted by phone calls or mail-in information.  The 
person making the phone call to collect the data will be in a secure area with no 
other/outside people able to hear the conversation.  The person making the call 
will ask the participant at the onset of the call if this is a good time for them to 
talk so the receiver of the call also has their own privacy.    
22 Economic Burden to Subjects 
22.1 There are no costs associated to the participant in this study.  
23 Compensation 
23.1 There is no compensation for participants.  There will be an incentive of one 
complimentary pill box, valued at approximately $5, for each participant. 
 
24 Compensation for Research-Related Injury 
24.1 There is no foreseeable injury as this study utilizes only non-invasive 
procedures and interventions. 
25 Consent Process 

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25.1 Participants will be verbally consented prior to participating in the study.  
25.1.1  Consent will be obtained by Dr. Amy Bachyrycz and the PharmD 
students (Chas Montoya, Jesse Robinson, Kyle Ortiz, Ryan Ault) at the 
onset of the project verbally with each participant using the attached 
consent document generated from HRPO template version December 2, 
2019. Study personnel participating in recruitment and consenting have 
completed CITI training.  The students will be trained on the consent 
process, to include provisions for ensuring patient privacy, verbally 
reviewing the consent form and answering the participant questions.  They 
will be using the teach-back method to ensure participant understanding.  
25.1.2 The verbal consent process will take place over the phone from a private 
area at Walgreens Pharmacy.   
25.1.3 The only incentive offered to the patients in this study is one pill box, 
valued at approximately $5.  No additional offers of incentives will be 
made to induce participation. 
25.1.4 Participants will be verbally consented.  Potential participants who wish to 
consider the consent for a longer may enroll at a later time during the 
enrollment period. 
25.1.5 Participants will be asked to verbally consent to their continued 
participation in the study at each follow-up phone call and their final visit. 
If patient does not consent to their continued participation, their 
participation in the study will be ended and no further data collected.  
25.1.6 Research personnel will verbally review the consent form with the 
participant to gauge the participant’s understanding of the study 
procedures.  Participants will have the opportunity to ask additional 
questions during the consent process.   
25.1.7 The teach-back method will be utilized to ensure participant understanding 
of the consent (e.g. “We’ve talked about a lot of information today.  If you 
were to tell a friend about this study, what would you tell them?”) 
Subjects not fluent in English – N/A; this study will only include English-
speaking, reading, and writing individuals.  
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative – N/A; this study will only include adults able to 
consent for themselves.  
Subjects who are not yet adults (infants, children, teenagers) – N/A; this study 
will only include adults. 

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Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of 
consent will be altered) – We are requesting a waiver of obtaining a signature 
from subjects on a consent form to document consent. We are requesting to obtain 
verbal consent only, as this study will not be conducted face-to-face.   
26. Documentation of Consent 
26.1 Consent will be obtained using the script and consent document generated from 
HRPO template version December 2, 2019, included in this submission.  
26.2 N/A 
26.3 N/A 
27 Study Test Results/Incidental Findings 
27.1 Individual Results will be from each participant’s responses to their pre/post-
test and pre/post survey, and responses to the phone script used during initial, 
week 4, and week 8 phone calls. 
27.2 Incidental Findings: We do not anticipate any incidental findings in this study.  
Participants have already been diagnosed with hypertension as per the inclusion 
criteria of the study. 
28.  Sharing Study Progress or Results with Subjects 
 
28.1 The progress of the study will be verbally shared with the participant 
during each follow-up phone call and during the final study visit upon the 
participant’s request.   
 
28.2 The results of the study will be shared with the public in the form of plain 
language summary of research findings when ready for publication. 
Participants may request a summary of the research findings at the 
conclusion of the study.   
 
29 Inclusion of Vulnerable Populations 
 
This study will not include vulnerable populations. 
 
30 Community-Based Participatory Research - N/A 
 
31 Research Involving American Indian/Native Populations - N/A 
 

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32 Transnational Research - N/A 
 
33 Drugs or Devices 
33.1 Drugs: The study procedures do not involve drugs. Patients in this study may 
take medications as part of their blood pressure treatment; however, this study 
does not involve any intervention for prescribing or providing medications to 
the participant.  Patients will only receive education aimed at behavioral 
changes that may improve their blood pressure management.  While patients 
may receive their medications from Walgreens as part of their usual course of 
care, study personnel will not prescribe, modify, or provide patient medications 
as part of the study intervention.  The patient will be encouraged to continue 
their care with their primary care physician or other medical provider for 
management of their blood pressure and medications. 
Devices: The study is not intended to study the safety of effectiveness any 
specific device.  
33.2 N/A 
33.3 N/A 
33.4 N/A 
33.5 N/A 
34 Principal Investigator’s Assurance 
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that: 
☒ The information supplied in this form and attachments are complete and correct.   
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements.  
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security 
Best Practices, including: 
1. Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap. 
2. Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include 
if the data is entered or stored using an untrusted device or storage. 

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3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to be 
carried out in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more of 
following safeguards: access logs, encryption keys, backups, business continuity 
and disaster recovery capabilities. 
4. Alternate storage media must be approve by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards. 
 
 

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35 CHECKLIST SECTION 
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research. 
36 Partial Waiver of Consent for Screening/Recruitment - N/A 
37. Partial Waiver of HIPAA Authorization for Screening/Recruitment 
Complete the following additional questions/attestations if the records you will review to identify 
potential subjects and/or determine eligibility include Protected Health Information (PHI). 
A. Will you be recording any PHI when conducting the records review to identify potential 
subjects and/or determine eligibility? 
            
 Yes. Describe:       
            
 No – The potential participant’s Walgreens pharmacy medication profile will be 
accessed to determine eligibility, but information from this profile will not be recorded.   
B. If you answered “Yes” to question 6 above, please describe when you will destroy 
identifiers (must be the earliest opportunity consistent with the conduct of the research) 
or provide justification for why they must be retained: 
      
C. The PHI accessed or recorded for identification/screening purposes will not be reused or 
disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI would be permitted under the Privacy Rule. 
 
      
 True 
            
 False 
38 Waiver of Documentation of Consent  
Complete this checklist if you intend to obtain consent verbally but will not be obtaining 
signatures from subjects on a consent form to document consent.  Waivers of 
documentation of consent are commonly requested when using scripts, information 
sheets, or email or survey introductions to present the elements of consent instead of 
using a traditional consent form. 
A. Are you requesting a waiver of documentation of consent for some or all 
subjects? 
 All 
 Some. Explain:       

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B. Provide justification for one of the following: 
i. 
That the only record linking the subject and the research would be the 
consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. Each subject will be asked 
whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern. 
N/A 
ii. 
That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context. 
This research poses no more than minimal risk to the participant, as it 
involves educational interventions only. Research procedures will 
occur only over the phone or via mailed-in materials. 
C. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form? 
 Yes. Please attach a copy to your submission in Click. 
 No – The consent form will be reviewed over the phone with the patient; 
research personnel will document verbal consent. The consent form will be 
mailed to the patient.  
39 Alteration of Consent - N/A 
40 Full Waiver of Consent/Parental Permission - N/A 
41 Full Waiver of Consent/Parental Permission (Public Benefit or Service 
Programs) - N/A  
42 Full Waiver of HIPAA Authorization (Checklist) - N/A  
43 Other Waiver Types (Checklist) - N/A 
 
44 Vulnerable Populations (Checklist) - N/A 
 
45 Medical Devices (Checklist) - N/A  
46 Export Control (Checklist) - N/A  
47 Data Transfer/Sharing (Checklist) 

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Complete this checklist if the research involves transferring/sharing of data with an external 
entity (institution, company, etc.).  
A. Will data be transferred/shared with an external entity (institution, company, etc.)?   
 Yes 
 No. The remainder of this section does not apply.  
 
48 Specimen Transfer/Sharing (Checklist) - N/A 
 
 

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