Mi Propio Camino (Finding My Own Way): Personalized Approaches to Improve Blood Pressure Control
Phase: NA
Conditions: Hypertension, Medication Adherence
Sponsor: University of California, Irvine

#20174025 - Mi Propio Camino: Personalized approaches to
improve blood pressure control
Protocol Information
Approval Comment
The IRB Approval Letter and any approved documentation (e.g. stamped consent forms) can be 
downloaded in the Attachments section of the protocol.
Protocol Amendment Form
Amendment Instructions
Review Type
Expedited
Status
Approved
Approval Date
Feb 03, 2023
Continuing Review
Date
--
Expiration Date
Jun 07, 2025
Initial Approval Date
Apr 16, 2021
Initial Review Type
Expedited
Feedback
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Project Details
Specify the study title (this title should not exceed more than 100 words):
Mi Propio Camino: Personalized approaches to improve blood pressure control
Lead Researcher/Investigator:
John T Billimek

Enter the Lead Unit:
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Submit a Human Subject Protocol for UCI Institutional Review Board (IRB)
Review
Will this protocol be reviewed under a sIRB process?
No, there is no reliance involved. UCI serves as the IRB of record
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identifiable biospecimens (no subject contact)?
No
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Check all sites where UCI investigator(s) will conduct research activities (e.g., recruitment,
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about participants):
UCI Facilities or Sites (e.g. school, hospital or clinics, etc.)
***IR-7115 - HEALTH POLICY RESEARCH (Lead Unit)***

Provide a non-technical summary of the project that can be understood by IRB/hSCRO members
with varied research backgrounds, including non-scientists and community members (this
summary should not exceed more than 250 words):
28% of patients who are prescribed medications to control their high blood
pressure never ¦ll the ¦rst prescription, and another 28% discontinue the
medication within the ¦rst year. Many of these patients are reluctant to start
the new medication because they feel the drugs are not likely to work for them,
or may cause harm to them in the future. Yet very few patients discuss the
concerns they have about their medications with the doctor, or even report that
they have stopped taking the medication. The proposed pilot study will
examine the feasibility of a mobile health software application called MediCom
to improve patient-provider communication regarding concerns about
medications, and to help address patients’ hypothetical concerns about a
treatment that is new to them. The MediCom application will allow patients,
with clinical supervision, to use mobile devices to record their medication
taking behavior, blood pressure and symptoms of common side effects each
day for a trial period. At the end of the period, this monitoring data will be
downloaded and compiled into an intuitive report that the patient and a
pharmacist can review during a follow-up visit to guide a personalized
discussion of the bene¦ts and disadvantages of continuing the medication.
First, in a series of pilot studies (Study 1, 2 and 3), we will examine whether
patients ¦nd the application and symptom monitoring protocol feasible and
acceptable, and to gather preliminary data on patients’ medication-related
beliefs, medication adherence, and blood pressure control to guide the design
of a de¦nitive effectiveness trial for the intervention. Then, we will conduct the
de¦nitive effectiveness trial (Study 4) to determine the effect of Mi Propio
Camino (MPC), a 4-session group education intervention employing the
MediCom mHealth software to improve blood pressure medication adherence
by addressing negative beliefs about medications. MPC will be compared to a
traditional 4-session blood pressure group education class. The primary
endpoint of medication adherence will be assessed at 6-month follow-up.
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Type of Research
The purpose, specific aims or objectives of the research is:
Biomedical
The research protocol is:
Investigator-Initiated
Does the investigator-initiated study have any industry support?
No
Does this study include a Master Protocol or detailed project proposal?
No
Is this study an extension of a UCI IRB approved study (e.g., resubmission of ongoing exempt
research; Open Label Extension) or is it otherwise related to a UCI IRB approved study?
No

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only):
04585594
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NIH-funded Clinical Trial
STOP! All clinical trials must be conducted under the auspices of an Organized Lead Unit (OLU).
Please update. Go to Project Details and choose the appropriate OLU for the trial.
Level of Review
Minimal Risk - No more than minimal risk to subjects
Select the applicable category(ies):
4. Collection of data through noninvasive procedures (not involving general
anesthesia or sedation) routinely employed in clinical practice, excluding
procedures involving x-rays or microwaves
5. Research involving materials (data, documents, records, or specimens) that
have been collected, or will be collected solely for nonresearch purposes (such
as medical treatment or diagnosis)
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not limited to, research on perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies
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have previously been collected for nonresearch purposes
Study Funding

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Department or campus funds (includes department support, unrestricted
funds, start-up funds, personal funds, campus program awards, etc.)
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Undergraduate Research Opportunities Program (UROP)
Select the sponsor type(s) (check all that apply):
Health and Human Services (HHS) (includes National Institutes of Health (NIH)
List below all extramural proposals or awards that will support the study (if applicable):
IMPORTANT! Skip this table if extramural funding is not available.
Sponsor Name
NIH/NHLBI
Title of Proposal/Award (if different from study title):
Mi Propio Camino (My Own Way): Addressing negative beliefs about
medication to improve adherence among Hispanic adults with hypertension
Proposal or Award #:
R01 HL142964
Sponsor Name
NIH/NHLBI
Title of Proposal/Award (if different from study title):
Mi Propio Camino (My Own Way): Addressing negative beliefs about
medication to improve adherence among Hispanic adults with hypertension
Proposal or Award #:
R56 HL142964
Scienti¦c/Scholarly Review

Is the research Sponsor-Initiated?
No
Is the research cancer-related?
No
The proposed research qualifies as minimal risk research. The Department Chair, Division Chief,
or Institute Director provides assurance that the research uses procedures consistent with sound
research design, the study design can be reasonably expected to answer the proposed question,
and the importance of the knowledge expected to result from the research is known.
Check here to con¦rm the above assurance
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If any of the following hazardous materials are involved in this research please check below:
N/A
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Study Team

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navigate to the Permissions tab on top-right-hand-side of form. All ACs must
complete the requisite Human Research Protections CITI Training.
 
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Eligibility page for study to be approved.
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to serve as LR-- the FS must be eligible to be LR.
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the LR considers to be key personnel for conducting the research study. These individuals
work closely with the LR to design, conduct, and/or report on the research.
 
• Research Personnel (RP): List RP as required per the Research Personnel Heat Map. For
those RP who do not need to be listed on the protocol, they may be tracked by alternative
methods, see below.
 
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Study Team Tracking Log (or equivalent); instead, follow the Single IRB Reliance (sIRB)
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• Collaborative Institutional Training Initiative (CITI) Human Research Protections Training
Courses
• Confirm CITI training is complete and current for all study team members.
• Incomplete or expired CITI training will delay IRB approval.
• For more information, visit HRP Training and Education.
Researcher
John T Billimek

Training
To promote the objectivity of the research, all researchers are required to disclose their related
disclosable financial interests, per the IRB COI Policy. If you have any questions about the COI
process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any disclosable
financial interests* (i) that would reasonably appear to be affected by this research study; or (ii)
in entities whose financial interests would reasonably appear to be affected by this research
study?"
No
Degree
PhD
Position/Title
Assistant Professor
Department
Affiliation
UCI Faculty
Researcher Role
Lead Researcher
GCP - Social and Behavioral Research Best
Practices for Clinical Research - Basic Course
06/26/20 - 06/26/23
Expired
Biomedical Investigators - Basic Course
03/21/16 - 03/20/21
Expired
Social/Behavioral Investigators - Basic Course
05/16/17 - 05/15/22
Expired
Biomedical Investigators - Refresher Course
12/03/21 - 12/02/26
***IR-6096 - FAMILY MEDICINE (Lead Unit)***

Permissions
Full Access
Duties
Oversight of Research
Research Procedures
Screen/Recruit Subjects
Finalize Informed Consent
Access/Analyze Identi¦able Information
Describe additional research procedures below:
He will oversee all aspects of the proposed study including study design,
supervision of the research procedures, study personnel, analysis and
interpretation of study results. He will lead team meetings, monitor study
progress, train personnel in research procedures, and work with project staff
to ensure regulatory compliance with IRB procedures, safety monitoring and
adverse event reporting to all required parties.
Specify relevant training and experience for the referenced duties/responsibilities:
He will have primary responsibility for overseeing the data collection at the
study clinics, including serving as the liaison for all ¦eld operations, and
training and supervising the research staff. Pro¦cient in Spanish, Dr. Billimek
also will oversee the development and translation of the intervention and
control materials by native speakers. As the lead statistical expert for the
Health Policy Research Institute, he will have access to study identi¦able
data, and will oversee data analysis, and manuscript preparation in
conjunction with other the study investigators.
Researcher
David Bruce Kilgore

Training
To promote the objectivity of the research, all researchers are required to disclose their related
disclosable financial interests, per the IRB COI Policy. If you have any questions about the COI
process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any disclosable
financial interests* (i) that would reasonably appear to be affected by this research study; or (ii)
in entities whose financial interests would reasonably appear to be affected by this research
study?"
No
Degree
MD
Position/Title
Clinical Professor
Department
Affiliation
UCI Faculty
Researcher Role
Co-Researcher
GCP - Social and Behavioral Research Best
Practices for Clinical Research - Basic Course
09/18/20 - 09/18/23
GCP for Clinical Trials with Investigational Drugs
and Medical Devices (U.S. FDA focus) - Basic
Course
08/11/17 - 08/11/20
Expired
Social/Behavioral Investigators - Refresher Course
01/25/22 - 01/24/27
Social/Behavioral Investigators - Basic Course
06/03/16 - 06/02/21
Expired
IR-7453 - MEDICINE

Permissions
Full Access
Duties
Oversight of Research
Research Procedures
Screen/Recruit Subjects
Finalize Informed Consent
Access/Analyze Identi¦able Information
Describe additional research procedures below:
Dr. Kilgore is a Family Medicine Physician with extensive expertise in
community engaged research and developing culturally congruent health
promotion interventions in diverse low-income communities including Latino
communities in Southern California.
Specify relevant training and experience for the referenced duties/responsibilities:
Pro¦cient in Spanish, Dr. Kilgore will provide clinical oversight to the study,
will participate in the intervention development activities,
screening/recruiting of participants, and will participate in data analysis and
preparation of manuscripts. As needed, he may also ¦nalize informed
consent for some participants. Finally, as an experienced provider in group
patient education activities, Dr. Kilgore will lead, alongside a Group Facilitator,
group education activities in the study intervention, and will train and
supervise the Group Facilitators that will co-lead these education sessions.
Researcher
Training
Sergio Gago Masague
GCP - Social and Behavioral Research Best
Practices for Clinical Research - Basic Course
01/24/22 - 01/23/25
Social/Behavioral Investigators - Refresher Course
05/30/18 - 05/29/23
Expired

To promote the objectivity of the research, all researchers are required to disclose their related
disclosable financial interests, per the IRB COI Policy. If you have any questions about the COI
process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any disclosable
financial interests* (i) that would reasonably appear to be affected by this research study; or (ii)
in entities whose financial interests would reasonably appear to be affected by this research
study?"
No
Degree
Other
Degree Other
please update
Position/Title
assistant professor
Department
Affiliation
UCI Faculty
Researcher Role
Co-Researcher
Permissions
Full Access
IR-8061 - COMPUTER SCIENCE

Duties
Oversight of Research
Research Procedures
Access/Analyze Identi¦able Information
Describe additional research procedures below:
Dr. Gago Masague is a project scientist and expert in human-computer
interaction who will contribute to all aims of the project. He led the
development of the MediCom web application and mHealth smartphone app
that will be used in the study, and will lead the effort to adapt and maintain
the applications for the proposed study intervention.
Specify relevant training and experience for the referenced duties/responsibilities:
Dr. Gago Masague will work with students and project personnel on
analyzing and improving the software applications and implementing the
feedback collected from patients and health care providers. With the other
investigators, Dr. Gago Masague will assist in analyzing the results of the
study and he will contribute to article and conference presentations.
Are RP tracked outside the approved protocol, in accordance with the RP Heat Map?
Yes, RP are tracked on a Study Team Log or other comparable log
Supplemental Documents
Does this study include supplemental documents?
No
Background & Purpose of the Research

Describe the purpose, specific aims or objectives and specify the hypotheses or research
questions to be studied:
Study 1 has two speci¦c aims: ● Aim 1: assess the feasibility and acceptability
of the MediCom software application and medication experience monitoring
protocol for Latino patients with high blood pressure. ● Aim 2: Collect pilot
data on beliefs about medications, medication adherence and blood pressure
control to guide the design of a de¦nitive effectiveness trial. Questionnaire
study entitled Study 2 (potential participants: 300) Study 2 aims to investigate
perceptions patients may have about controlling blood pressure, concerns
patients may have about taking medications, and experiences discussing
concerns about medications with health providers. Study 3 aims to examine
the feasibility and acceptability of a brief, multi-session educational
intervention employing mHealth and small group discussions to address
concerns patients might have about strategies to improve blood pressure
control. Study 4 aims to evaluate the effectiveness of a culturally appropriate
intervention in a randomized controlled trial comparing two sets of group
education sessions that differ in the focus on addressing negative beliefs
about medications and through emplying mHealth.

Provide the scientific or scholarly rationale for the research and describe the relevant background
information and the specific gaps in current knowledge that this study intends to address:
Background Information More than 50% of patients with chronic health
conditions exhibit medication nonadherence.1 That is, they do not take their
medications as prescribed. Many low-income patients, and patients from
ethnic minority populations have unfavorable beliefs about medications (e.g.,
believing they do not need them, that alternative therapies are superior, or that
the medication will cause side effects).2 Patients who have more negative
beliefs about medications—both in terms of speci¦c experiences with the
medication, and general, hypothetical concerns, are less likely to adhere to
their medication therapy.3 As a result, many patients are reluctant to start a
new medication, or are curious to know how their body would react if they
discontinue it1, but few patients discuss these kinds of beliefs with their
providers.4 Mobile symptom monitoring has been employed as a patient-
centered approach to guide a productive patient-provider discussion about a
speci¦c individual’s response to a medication—in terms of treatment response,
side effects and treatment burden.5 Rather than discussing “average effects”
of a medication in the population, this approach allows a provider and patient
to have an informed discussion of the speci¦c effect of the medication on that
individual patient. Gaps in knowledge Although the connection between beliefs
and medication adherence is well established, the utility of mobile symptom
monitoring to help guide patient-provider discussion about medications to
promote more positive beliefs is not well-studied. We posit that, for patients
who have concerns about hypothetical consequences of taking a speci¦c
medication, having a concrete discussion about the patient’s actual response
to a drug may result in more positive beliefs about the medication, and
consequently, better adherence. Or if the experience is unfavorable, it may
encourage the patient and physician to try different options until a satisfactory
drug is selected.

Provide relevant preliminary data (animal and/or human):
Unpublished data from a recently completed pilot study conducted by the Lead
Researcher at UC Irvine Health suggest that the majority of Latino patients
taking medication for diabetes rate hypothetical concerns such as worry about
future adverse as their largest concern, whereas relatively few patients report
concerns about adverse effects that they have actually experienced. Focus
groups conducted by the Lead Researcher with patient advisory group of
Latino patients with chronic health conditions at the study clinic indicate that
patients would be interested to try mobile symptom monitoring to improve
communication with the provider about concerns about medication. The
MediCom application We have developed a web-based application called
MediCom that can aggregate data from multiple mobile health monitoring
devices, and a protocol for patients to self-monitor their experience with a
speci¦c medication. The MediCom web-based application and the
accompanying SymTrack mobile symptom monitoring application are
described in Appendix K. In short, the MediCom software is used to integrate
data collected by patients about their own health and behaviors from multiple
sources. For this study, we will invite patients to collect data about their
experiences trying to lower their blood pressure using (1) a mobile diary
application (SymTrack) that we developed, (2) a portable blood pressure cuff,
(3) a wearable activity and sleep tracker and (4) a pill bottle cap monitor to
track medication-taking. Each of these devices are described in Appendix K.
Users can then display visualizations of day-to-day changes (as a line graph)
and summary displays (as a bar graph showing averages across multiple days)
of the patient’s experiences with medication-taking, blood pressure, symptoms,
physical activity, and sleep quality. More importantly, relationships between the
observed variables can be presented in an intuitive display to show, for
example, trends in blood pressure control over time, or comparisons of the
patient’s monitoring data on days they took their medication versus days they
did not take it. The software allows providers and patients to access and
visualize the data on their own, or for a designated user approved by the
provider and patient to facilitate access to the data visualizations. The
feasibility of this protocol and the application have not yet been evaluated. To
guide development of an intervention employing the application, we aim to
conduct a pilot study to assess the feasibility of the approach, and gather
preliminary data to guide the design of a subsequent effectiveness trial.
Preliminary Data from Studies 1, 2 and 3: Study 1 protocol adherence data: We
approached 18 Spanish-speaking community health center patients we

approached to pilot test the mHealth protocol, of whom 10 (56%) consented to
complete two group discussions with a 7 to 14 day home monitoring period in-
between. During these home monitoring periods, the protocol adherence was
excellent with 92/102 (90%) of the scheduled home BP readings recorded, and
96/102 (94%) of the scheduled diary entries completed. Nine of ten (90%) of
participants completed at least one phone contact between the two group
discussions. Almost all participants of the pilot test were very interested to
continue home monitoring after the dry run was over, and asked to be included
in the RCT. Study 2 baseline questionnaire data:. We recently deployed the
baseline questionnaire in English and Spanish to be collected on tablets and
have begun to collect questionnaires from participants. Of the 31 patients we
have approached in the clinic, 27 (87%) met all eligibility criteria of whom 26
(96%) consented and completed the questionnaire. 50% have BMQ scores
above the threshold for “very negative beliefs”, and 46% reported intentional
nonadherence related to beliefs, similar to the rates we observed in a prior
study of beliefs and adherence in Hispanic patients with diabetes.6 We have
asked the last 20 participating patients if they would be interested to be
contacted about the upcoming RCT, and all 20 (100%) said yes. Study 3 focus
group ¦ndings: We have convened four focus group sessions with Spanish-
speaking community members and patients affected by hypertension. In all
four groups, participants expressed enthusiasm about the project, citing the
importance of empowering individuals with home monitoring tools and skills
to communicate and build mutual trust with the doctor. They made numerous
valuable suggestions about the project, including that successful recruitment
depends more on the personal relevance of the study to participants (including
the control group) rather than a monetary incentive on its own, that the
amounts of the monetary incentives for participants are appropriate, that
providing a BP monitor for participants at the end of the study would enhance
engagement, and while there was lots of interest in using a smartphone app,
they recommended also having a paper version of the diary available. We have
implemented all of these suggestions into the study plan.

Describe the primary outcome variable(s), secondary outcome variables, and predictors and/or
comparison groups as appropriate for the stated study objectives/specific aims:
Study Measures Primary Outcome: Medication-related beliefs. Beliefs will be
assessed with the Beliefs about Medications Questionnaire (BMQ).10 The
BMQ has been translated into Spanish, validated in Spanish-speaking adults
with chronic health conditions, and been successfully used in other studies.
Secondary Outcomes: Medication adherence. The main outcome variable is
medication nonadherence, which will be assessed in two ways. First, daily
adherence (percent of doses taken) will be assessed with the MEMS bottle cap
monitors during the 4 week outcome assessment period and with a validated
11-item self-report adherence measure that is used in current practice.7 Blood
pressure control: Systolic and diastolic blood pressure will be measured during
the study visit using an automatic sphygmomanometer (blood pressure cuff).
Feasibility/Acceptability: Feasibility will be assessed by counting the
proportion of days that the patient completed entries in the mobile symptom
diary application (Symtrack, see Appendix K). Time to complete each study
visit will also be recorded. Acceptability will be assessed with a short post-
session survey asking patients for ratings of ease-of-use and usefulness of the
monitoring devices. The research team and a subset of patients will be
interviewed about their experience with the application for insights on its
strengths and weaknesses. (Nov 2018) This IRB e-modi¦cation is to add an
additional set of study measures as part of “Study 2” in this on-going
investigation. Study 2 will consist of the recruitment of up to 300 adults with
uncontrolled hypertension to complete a questionnaire. This procedure of
administering the questionnaire will be done at the clinic by a member of the
study team. These participants will also have their most recent blood pressure
measurements extracted from the electronic health record. The measurements
that are extracted will include blood pressure measurements and other
relevant cardiometabolic indicators (HbA1C lipids and Body Mass Index),
sociodemographic information (age, gender, ethnicity, race, language
preference, health insurance type) and healthcare utilization (number of
outpatient and inpatient visits, prescription medications, and performance of
recommended health management processes). Study 2 will not include the
use of the approved mHealth devices from Study 1. Study 2 measures will be:
Primary Outcome: Medication-related beliefs. Beliefs will be assessed with the
Beliefs about Medications Questionnaire (BMQ).10 The BMQ has been
translated into Spanish, validated in Spanish-speaking adults with chronic
health conditions, and been successfully used in other studies. (Same as Study

1) Secondary Outcomes: Medication adherence. The main outcome variable is
medication nonadherence, which will be assessed with a validated 11-item
self-report adherence measure that is used in current practice.7 (Same
questionnaire measure as Study 1, however the MEMS pill bottle cap monitors
will not be used in Study 2). Blood pressure control: Unlike Study 1, blood
pressure control will be assessed by extracting, from the electronic health
record, all blood pressure measurements collected in the 12 month up to and
including the date of the study visit. Other cardiometabolic indicators (HbA1C
lipids and Body Mass Index) will be extracted from the medical record,
sociodemographic information (age, gender, ethnicity, race, language
preference, health insurance type), and healthcare utilization (number of
outpatient and inpatient visits, prescription medications, and performance of
recommended health management processes). Study 3 measures will be:
Primary Outcome: Medication-related beliefs. Beliefs will be assessed with the
Beliefs about Medications Questionnaire (BMQ).10 Same as Study 2.
Secondary Outcomes: Medication adherence. The main outcome variable is
medication nonadherence, which will be assessed with a validated 11-item
self-report adherence measure that is used in current practice.7 Same as
Study 2. Feasibility/Acceptability: Feasibility will be assessed by counting the
proportion of study visits attended, proportion of days that the patient
completed entries in the mobile symptom diary application (Symtrack, see
Appendix K). Time to complete each study visit will also be recorded.
Acceptability will be assessed with a short post-session survey asking patients
for ratings of ease-of-use and usefulness of the monitoring devices. The
research team and a subset of patients will be interviewed about their
experience with the application for insights on its strengths and weaknesses.
(May 2019) This IRB e-modi¦cation is to add an additional set of study
measures as part of “Study 4” in this on-going investigation. Study 4 measures
will be: Primary Endpoint: Daily Adherence (objective) will be assessed with the
Medication Event Monitoring System (MEMS) pill bottle cap monitors, an
objective “standard” measure for pill-taking behavior. Daily adherence is
de¦ned as the proportion of days that the prescribed number of doses was
taken by patient during a 30-day period. Same as Study 1. Secondary
Outcomes: Medication-related beliefs. Beliefs will be assessed with the Beliefs
about Medications Questionnaire (BMQ).10 Same as Study 3. Daily Adherence
(subjective): Will be assessed with a validated measure, the Morisky
Medication Adherence Scale (8-item MMAS). Medication-related knowledge:
Will be assessed with two measures, adapted from validated measured the

Medication Knowledge Questionnaire (MKQ) to assess patients level of
information about their medications and the PROMIS Self-E¨cacy for
Managing Chronic Conditions Manage Medications/Treatment scale to assess
behavioral skills. Blood pressure control: Systolic and diastolic blood pressure
will be measured during the study visit using an automatic
sphygmomanometer (blood pressure cuff). Same as Study 1. Self-E¨cacy:
Self-E¨cacy will be assessed through the Medication Adherence Strategies
Inventory (ASI), measuring activation of behavioral strategies for adherence.

List up to ten relevant references/articles to support the rationale for the research:
1. Kettani, F.-Z. et al. Impact of a better adherence to antihypertensive agents
on cerebrovascular disease for primary prevention. Stroke 40, 213–220 (2009).
2. Bailey, J. E., Wan, J. Y., Tang, J., Ghani, M. A. & Cushman, W. C.
Antihypertensive Medication Adherence, Ambulatory Visits, and Risk of Stroke
and Death. J GEN INTERN MED 25, 495–503 (2010). 3. Billimek, J. & Sorkin, D.
H. Food insecurity, processes of care, and self-reported medication underuse
in patients with type 2 diabetes: results from the California Health Interview
Survey. Health Serv Res 47, 2159–2168 (2012). 4. Ngo-Metzger, Q., Sorkin, D.
H. ., Billimek, J., Green¦eld, S. & Kaplan, S. H. The Effects of Financial
Pressures on Adherence and Glucose Control among Racial/Ethnically Diverse
Patients with Diabetes. J Gen Int Med 27(4), 432–7 (2012). 5. Fischer, M. A. et
al. Primary Medication Non-Adherence: Analysis of 195,930 Electronic
Prescriptions. J GEN INTERN MED 25, 284–290 (2010). 6. Steiner, J. F. et al.
Sociodemographic and Clinical Characteristics Are Not Clinically Useful
Predictors of Re¦ll Adherence in Patients With Hypertension. Circ Cardiovasc
Qual Outcomes 2, 451–457 (2009). 7. Billimek, J. & August, K. J. Costs and
Beliefs: Understanding Individual- and Neighborhood-Level Correlates of
Medication Nonadherence Among Mexican Americans With Type 2 Diabetes.
Health Psychol 33, 1602–5 (2014). 8. Design and Implementation of N-of-1
Trials: A User’s Guide. (Agency for Healthcare Research and Quality (US),
2014). at <http://www.effectivehealthcare.ahrq.gov/N-1-Trials.cfm> 9. Morisky,
D. E., Ang, A., Krousel-Wood, M. & Ward, H. J. Predictive Validity of a
Medication Adherence Measure in an Outpatient Setting. The Journal of
Clinical Hypertension 10, 348–354 (2008). 10. Jimenez, K, Vargas C, Garcia K,
Guzman H, Angulo M, and Billimek J. “Evaluating the Validity and Reliability of
the Beliefs About Medicines Questionnaire in Low-Income, Spanish-Speaking
Patients With Diabetes in the United States.” The Diabetes Educator 43, no. 1
(February 2017): 114–24.
Subject Population(s) (Individuals/Records/Biospecimens)

Check all subject populations/data sources that apply to the research:
Adults Competent to Provide Informed Consent
Subjects who are unable to communicate in English
UCI Inpatients or Outpatients (Receiving Diagnosis/Treatment/Surgery)
Maximum and Expected Number of Persons/Records/Biospecimens to be Enrolled
1. Click "Add Line" button above Enrollment Table to add a Category/Group
a. To change visibility of columns, click "Columns" button above Enrollment Table and
select which Column rows to view.
2.  Specify the maximum and expected numbers of individual-level information and/or
biospecimens to be accessed/analyzed within each Category/Group
Category/Group
Study 1. Adult Spanish or English-speaking primary care patients
Age Range
Over 18 years old
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
128
Number Expected to Complete the Study or Needed to Address the Research Question
72
Category/Group
Study 2. Adult Spanish or English-speaking primary care patients
Age Range
Over 18 years old
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
700
Number Expected to Complete the Study or Needed to Address the Research Question
500

Category/Group
Study 3. Adult Spanish or English speaking primary care patients
Age Range
Over 18 years old
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
60
Number Expected to Complete the Study or Needed to Address the Research Question
36
Category/Group
Study 4. Adult Spanish or English speaking primary care patients who
participated in study 2 (questionnaire study)
Age Range
Over 18 years old
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
500
Number Expected to Complete the Study or Needed to Address the Research Question
400
Will this study only take place at UCI and does not involve other sites?
Yes
Eligibility Factors (Inclusion/Exclusion Criteria)
1. Click "Add Line" button above Eligibility Factors Table to add a inclusion/exclusion criteria
a. To change visibility of columns, click "Columns" button above Eligibility Factors Chart
and select which Column rows to view.
2. Identify the factors for limited eligibility and provide a scientific rationale. Include additional
rows for factors, as needed.

Category/Group Eligibility
Adult Spanish or English-speaking primary care patients
Inclusion Criteria
Hispanic adults (age 18+), speaking English or Spanish, with blood pressure
> 140/90 mmHg and currently receiving care at the UC Irvine Health
Ambulatory Clinics.
Exclusion Criteria
Diagnosis of with stage 4 or 5 chronic kidney disease (CKD)
Is eligibility based on age, gender, pregnancy/childbearing potential, social/ethnic group, or
language spoken (e.g., English Speakers only)?
Yes
Limited Eligibility Factors (Special Populations)
1. Click "Add Line" button above Limited Eligibility Factors Table to add a special population
a. To change visibility of columns, click "Columns" button above Limited Eligibility Factors
Table and select which Column rows to view.
2. Identify the special populations and provide a scientific rationale. Add additional rows, as
needed.
Eligibility Limited to the Following Factors
Age
Specify the rationale for this group:
Over 18 years old
Pre-Screening and Determining Eligibility without Informed Consent
Will Identifiable information be obtained for the purpose of screening, recruiting, or determining
eligibility of prospective subjects?
No

Recruitment Methods
Will this study involve NO direct contact with participants (i.e., passive observation of public
behavior)?
No
Indicate all methods that will be used to recruit subjects for this study:
Recruitment Method
Clinicaltrials.gov
Confirm that the ClinicalTrials.gov statement is in all applicable consent documents
Recruitment Method
Study team will contact potential subjects who have given prior permission
to be contacted for research studies
Specify how these individuals granted permission and enter HS#:
Permission was granted by indicating their preference to be contacted for
future studies in the Study 2 consent form under this protocol, IRB
#20174025
Recruitment Method
Other recruitment methods
Specify 'Other' recruitment methods:
Study team members will approach their own patients, students, employees
for participation in the study.
Informed Consent Process
Does this study involve the creation, use, or disclosure of Protected Health Information (PHI)?
Yes

Methods of Health Insurance Portability and Accountability Act (HIPAA) Authorization
Identify the HIPAA authorization process (Check all that apply):
Partial waiver of HIPAA authorization for screening/recruitment purposes only.
Signed authorization obtained prior to further access to PHI
Methods of Informed Consent
Identify the consent or assent process as applicable for each participant population (check all
that apply):
Paper-based signed informed consent/assent
Paper-based Signed Informed Consent
Indicate the paper-based signed informed consent/assent (check all that apply):
Signed Informed Consent
Does this recruitment method include all subjects?
Yes
REQUIRED! Submit the Adult Consent Form, Child Assent Form and/or Parental Permission
Form in the Attachments Section.
Circumstances of Consent
Indicate the location where the consent process will take place (check all that apply):
Group setting
Other
Private room
Waiting room
Specify 'Other' location:
In a group setting (for study 4, Informed Consent will be ¦nalized at the ¦rst
intervention group session)

Specify how the research team will assure that subjects, their parents, or their legally authorized
representative (LAR) have sufficient time to consider whether to participate in the research:
Subjects or their LAR will be allowed to take home the unsigned consent form
for review prior to signing it
What type of consent process will be used for Non-English Speaking Participants?
The English version of the consent materials will be translated for non-English
speaking participants or their LAR once IRB approval is granted. An interpreter
will be involved in the consenting process
Indicate how non-English speaking subjects or their LAR will be consented in their language and
who will be responsible for interpreting and facilitating the informed consent discussion for the
non-English speaking subjects:
At least one member of the study team is §uent in the language that will be
used for communication, and that study team member(s) will be available
during emergencies.
Waiver of HIPAA Authorization
You requested a Partial Waiver of HIPAA Authorization
When a partial waiver is requested, the Lead Researcher is requesting the HIPAA research
authorization be waived for a portion of the study, such as a waiver for subject identification or
recruitment purposes.
Please specify for what purpose the partial waiver is requested:
A partial waiver is needed for the subject identi¦cation process to determine
patient eligibility for the study.
Justification for a Waiver of HIPAA Authorization
 
Does the use or disclosure of personal health information involve more than minimal risk?
No

Would the granting of the waiver adversely affect privacy rights and welfare of the individuals
whose records will be used or disclosed?
No
Explain (justify) the answer:
Records will only be used to determine subject eligibility for the study and will
be kept in a secure location.
Could the research practicably be conducted without a waiver of HIPAA authorization?
No
Explain the answer:
It would not be practical to identify eligible subjects without access to medical
records data.
Could the research practicably be conducted without access to, use or disclosure of the personal
identifiers listed in the PHI question?
No
Explain the answer:
The research could not practicably be completed without access. A proper
screening is required to ensure only eligible patients can enroll in the study.
Are the privacy risks reasonable relative to the anticipated benefits of the research?
Yes
Describe the risk/benefit analysis performed to explain the answer above:
There are minimal privacy risks involved in the research. The bene¦ts of PHI
use for subject recruitment include the ability to practicably conduct the
research with potential societal bene¦ts. All study identi¦able information will
be stored electronically in REDCap and all hard copy versions of the study data
will be kept in a secure and location in the o¨ce of the lead researcher. PHI
used for recruitment purposes will be destroyed as soon as the study team has
veri¦ed the eligibility status of the individual whose PHI will be used.

Describe the plan to protect the personal identifiers from improper use and disclosure (i.e.,
describe data security methods):
To minimize the risk, PHI will be screened and used to generate a list of
individuals eligible for recruitment to the study, with contact information.
Aggregate data on the number of cases screened, and the number screened
positive with basic aggregated descriptors (such as mean age, gender mix)
etc. will be stored for purposes of documenting methodological rigor. The list
of eligible individuals will be stored on a secured, password protected server
behind the UC Irvine Health ¦rewall, and will not include any health related
information. As soon as recruitment status is determined, all individual-level
health information will be deleted, leaving only a list of potential subjects with
contact information, therefore leaving no PHI being stored.
Describe the plan to destroy the personal identifiers at the earliest opportunity, or provide a health
or research justification for retaining the identifiers:
As soon as recruitment status is determined for the list of individuals whose
PHI is used, all individual-level health information will be deleted, leaving only a
list of potential subjects with contact information, therefore leaving no PHI
being stored. Members of this list of eligible individuals will be assigned a
study identi¦er. Once an individual on the list has been contacted, and declined
to participate in the study, all personal identi¦ers will be immediately deleted.
For those that consent to the study, their contact information will be stored
until he or she completes the study procedures or withdraws from the study, at
which point the personal identi¦ers will be deleted.

Describe how potential subjects will be identified:
Potential participants are identi¦ed from the UCI Health Electronic Health
Record using an automated query conducted by UC Irvine Health Enterprise
Data and Analytics, selecting patients meetings the following criteria: -
INCLUDE if: ---Age 18-75 years ---Has a scheduled physician appointment in a
UC Irvine Health Ambulatory Clinic in next 30 days ---Diagnosis of Hypertensive
disease (ICD10 I10 OR ICD9 401) ---Most recent Systolic BP > or = 140 OR
Most recent Diastolic BP > or = 90 ---Hispanic OR Non-Hispanic Ethnicity -
EXCLUDE if ---any Laboratory Result Glomerular Filtration Rate (GFR) <30 (But
do not exclude if there is no GFR value) ---OR Stage 4 or 5 Chronic Kidney
Disease (ICD10: N18.4 OR N18.5) ---OR End stage Renal disease (ICD10:
N18.6) This query is run once per week, and the list of patients it generates is
sent to the study team via the UCI Health Share Drive. The list includes only the
following data elements, which are necessary to contact the patients to recruit
them for the study: -Medical Record Number -Last Name and First Name -
Ethnicity -Gender -Preferred language -Phone number -Date and time of
upcoming UCI Health ambulatory clinic appointment -Appointment location -
Appointment provider’s name
Research Procedures
Check all boxes that apply to the research:
Analysis of Existing Identi¦able or Coded Data, Specimens, Records, Charts,
and Datasets
Surveys/Questionnaires/Interviews/Oral Histories
Will deception or incomplete disclosure be involved in the research?
No

Study Design
Include an explanation of the study design (e.g., randomized placebo-controlled, cross-over,
cross-sectional, longitudinal, etc.) and, if appropriate, describe stratification/
randomization/blinding scheme:
Study 1 Design: Longitudinal observational pilot study consisting of a 4 week
observation period. Results from this pilot study will guide design of an
intervention trial to determine the effect of the intervention on medication-
related beliefs, medication adherence and blood pressure control. Study 2
Design: Cross sectional observational study examining topics including
concerns patients have about taking medications, perceptions about
controlling blood pressure, and experiences discussing concerns about
medications with health providers. (May 2019) This IRB e-modi¦cation is to
add an additional set of study procedures, “Study 4”, in this on-going
investigation. Study 4 Design: Randomized controlled trial evaluating a
culturally appropriate intervention to improve adherence to antihypertensive
medications. To ensure balance on the “Beliefs about medications
questionnaire (BMQ)” measure, randomization will be strati¦ed by high versus
low BMQ subgroup.

Provide precise definitions of the study endpoints and criteria for evaluation; if the primary
outcomes are derived from several measurements (i.e., composite variables) or if endpoints are
based composite variables, then describe precisely how the composite variables are derived:
Feasibility assessment: Study 1, 3 and 4 Protocol adherence will be assessed
by counting the proportion of patients who successfully complete each stage
of the protocol. Study 1, 3 and 4 Acceptability will be assessed with a short
post-intervention satisfaction survey. Other outcomes for pilot study Study 1
and 4 Daily adherence (objective measure) will be assessed with Medication
Event Monitoring System (MEMS) pill bottle cap monitors (MWV/WestRock),
an objective, “gold-standard” measure for pill-taking behavior. MEMS caps can
be a¨xed to a medicine bottle in place of the original cap to record each time
the bottle is opened, indicating when the patient took the medication. Daily
adherence is de¦ned as the proportion of days that the prescribed number of
doses was taken by the patient during a 30-day period. Study 1, 2 and 4. Daily
adherence (self-report) will be assessed with a validated Spanish translation of
the Morisky Medication Adherence Scale (8-item MMAS), coded
dichotomously (low vs. high adherence) using published cutoffs. Study 1, 2
and 4. Medication-related beliefs will be assessed with the Beliefs about
Medicines Questionnaire (BMQ). A Spanish translation of the BMQ has been
validated for use by Latino patients in the U.S. Study 1, 3 and 4. Blood pressure
will be measured by a trained research assistant using an automated
sphygmomanometer. Study 2 and 3. Blood pressure control will be assessed
by extracting, from the electronic health record, all blood pressure
measurements collected in the 12 month up to and including the date of the
study visit. The measurements that are extracted will include blood pressure
measurements and other relevant cardiometabolic indicators (HbA1C lipids
and Body Mass Index), sociodemographic information (age, gender, ethnicity,
race, language preference, health insurance type) and healthcare utilization
(number of outpatient and inpatient visits, prescription medications, and
performance of recommended health management processes). (January
2023: Adding waist circumference measurement) Study 4. Waist
circumference will be measured as a marker of cardiometabolic risk and
allostatic load one time using the Multi-Ethnic Study of Atherosclerosis
assisted (MESA-assisted) protocol. For the MESA assisted technique, a trained
research assistant can complete the measurement or can coach the
participant to complete the measurement. Prior to measurement, a study team
member will remind the participant that they may opt out of the WC
measurement, and will con¦rm that they consent to the measurement. The

measurement will be done in a private area, over street clothing using a
measuring tape with Gulick spring attachment at the level of the umbilicus.
Waist circumference measurements will be used for descriptive and
exploratory analysis to add to external validity of the study, primarily by
characterizing the distribution of waist circumference values within the study
sample compared to other study populations. See:
https://www.cdc.gov/nchs/data/series/sr_02/sr02_182-508.pdf (May 2019)
Data from Studies 1, 2 and 3 have been used to inform the design of Study 4, a
de¦nitive effectiveness trial (RCT) evaluating the effect of the Mi Propio
Camino intervention on daily medication adherence. Primary endpoint and
seconday outcomes are listed below: Primary Endpoint: Daily Adherence
(objective) will be assessed with the Medication Event Monitoring System
(MEMS) pill botthe cap monitors, an objective “standard” measure for pill-
taking behavior. Daily adherence is de¦ned as the proportion of days that the
prescribed number of doses was taken by patient during a 30-day period.
Same as Study 1. Secondary Outcomes: Medication-related beliefs. Beliefs will
be assessed with the Beliefs about Medications Questionnaire (BMQ).10 Same
as Study 3. Daily Adherence (subjective): Will be assessed with a validated
measure, the Morisky Medication Adherence Scale (8-item MMAS).
Medication-related knowledge: Will be assessed with two measures, adapted
from validated measured the Medication Knowledge Questionnaire (MKQ) to
asses patients level of information about their medications and the PROMIS
Self-E¨cacy for Managing Chronic Conditions Manage Medications/Treatment
scale to assess behavioral skills. Blood pressure control: Systolic and diastolic
blood pressure will be measured during the study visit using an automatic
sphygmomanometer (blood pressure cuff). Same as Study 1. Self-E¨cacy:
Self-E¨cacy will be assessed through the Medication Adherence Strategies
Inventory (ASI), measuring activation of behavioral strategies for adherence.
Statistical Considerations
Is a statistical analysis plan appropriate for this qualitative study design?
Yes

Describe the statistical methods for the stated specific aims and hypotheses. Your analysis plans
should match the stated study specific aims and hypotheses:
The Speci¦c Aims and study hypotheses for Study 4 are: Aim 1: To evaluate
the e¨cacy of a theory-based intervention to modify negative medication
beliefs and promote medication adherence through direct and vicarious
experiences with a medication. --H1: The intervention, based on the tenets of
the elaboration likelihood model (ELM) of persuasion, will increase patients’
adherence to medication (primary endpoint) --H2: The intervention will reduce
patients’ negative beliefs about medications (secondary endpoint) --H3: The
intervention will be associated with improved blood pressure control
(secondary endpoint) --H4: Change in negative medication beliefs will mediate
the impact of the intervention on patients’ adherence to medication.
(mediation analysis) --H5: The intervention effect will be signi¦cantly larger in
the subgroup of patients with the most negative medication-related beliefs at
baseline compared to those with more positive baseline beliefs. (moderation
analysis) Aim 2: To test prospectively a theoretical model by which beliefs
about medication at baseline predict subsequent use of behavioral strategies
to improve adherence. --H6: Independent of intervention condition, beliefs at
the conclusion of the intervention predict the use of behavioral strategies to
improve adherence at 6-month follow-up. (secondary aim) The statistical plan
and sample size calculations were developed in consultation with the
Biostatistics, Epidemiology and Research Design (BERD) Unit under the
Institute for Clinical and Translational Science (ICTS)
Describe the statistical method(s) that will be used to analyze the primary outcome(s) or
endpoints:
H1: The primary endpoint, objective measure of MEDICATION ADHERENCE (%
of doses adherent from MEMS cap measurement) at 6-month post
intervention will be examined with an independent-sample t test for a mean
difference between MPC and comparison groups.

If appropriate describe secondary or post hoc analyses of primary outcome(s) or other
exploratory analysis and if necessary, provide a breakdown of the methods used per outcome or
endpoint:
H2, 3, 4: Secondary endpoints include self-reported measure of adherence to
medication at 30-days and 6-months post intervention, change in belief about
medication from baseline to intervention conclusion ), and change in systolic
BP from baseline to 6-month post intervention. For each of these three
hypotheses, independent-sample t tests will be used to test for differences in
these study outcomes between intervention and comparison groups. H5: We
will test this hypothesis of a moderation effect (wherein baseline medication
beliefs act as an effect modi¦er on the interaction effect) using two-way
analysis of variance (ANOVA), entering intervention group and baseline beliefs
subgroup as the two factors in the analysis. We will also conduct exploratory
analysis of the intervention effect strati¦ed by medication beliefs subgroup
using independent samples t-tests. H6: Use of behavioral strategies will be
operationalized as use of at least one of the strategies assessed in the
measure. Anticipating a threshold effect of beliefs, we will use Fisher’s exact
test to compare the proportion of participants using at least one strategy
between individuals with positive versus negative beliefs, de¦ned by median
split. For all between group analyses (H1-6), balance on important
sociodemographic, cardiometabolic, and health care utilization factors will be
assessed between intervention and comparison group using t-tests and chi
squared tests. When imbalance is found, t-test analyses will be corroborated
with multiple regression analysis controlling for those imbalanced factors.

Sample Size Determination: Explain how the overall target sample size was determined (e.g.,
power analysis; precision estimation), providing justification of the effect size for the primary
outcome based on preliminary data, current knowledge/literature and/or cost consideration; if
appropriate, provide sample size justification for secondary outcomes. Power analysis should (at
least) match the primary outcome/endpoint:
The study is powered on the primary endpoint. We aim to accrue an overall
sample of n=400, evenly divided between the positive beliefs and negative
beliefs subgroups due to the strati¦ed randomization. To account for an
estimated 20% attrition rate due to loss to follow-up at 6 month post
intervention, a total of 500 patients will be randomized into the study
intervention and control groups. Assuming a standard deviation for baseline
adherence of 0.25, comparable to values observed in an RCT using the same
outcome measure1, a sample size of n=400 patients would yield 80% power to
detect an intervention effect as small as 0.05 at 5% signi¦cance level in the
entire sample, and an effect as small as 0.11 in each of the two subgroups (of
n=200 each).

Research Procedures
Provide a detailed chronological description of the clinical or treatment plan:
Study 1 - Pilot Study Overview Participants will complete two study visits
approximately 30 days apart. They will be invited and trained to use
inexpensive mobile devices (provided by the study team) to track their own
medication taking, health behaviors, symptoms, side effects, and blood
pressure changes for a 30-day “medication experience monitoring” period.
Data from the mHealth devices will be aggregated and displayed to the patient
and study team members for discussion using a web application previously
developed by the investigators. Pilot data from the medication experience
monitoring period and feasibility data collected at the end of the monitoring
period will be analyzed. Medication experience monitoring period Initial visit
(approximately 45 minutes) The ¦rst study visit will be held in a private room at
the clinic. After obtaining informed consent, a member of the study team will
administer a baseline questionnaire including the self-reported adherence
measure and beliefs about medications questionnaire. A member of the study
team will then provide each participant a “kit” consisting of four mHealth
devices: • MEMS bottle cap monitors, • a wearable sleep/activity monitor (FitBit
Charge HR), • a smartphone with the MediCom symptom diary app installed (or
if they have their own compatible smartphone, will be allowed to load the
symptom diary app on their own phone and use it for the study), and • a
portable blood pressure (BP) monitor. A member of the study team will
con¦gure the kits and train the participants to use the devices. The symptom
diary app will be con¦gured for each patient to (1) track up to ¦ve symptoms of
concern, selected by the patient (including symptoms they associate with
hypertension and side effects they think may emerge), (2) track up to ¦ve
lifestyle factors they think may impact their BP (e.g. eating salty foods), also
selected by the patient and (3) send reminders to complete the symptom diary
and BP reading at least once daily. The patient will be asked to place a 30-day
supply of a tablet/capsule for a medication or supplement he or she is
currently taking at least once per day in a labelled pill bottle with a MEMS cap
monitor to track when each dose is taken. If a patient prefers not to place an
actual active medication in the pill bottle, they may instead use a hard shelled
candy or breath mint to simulate a medication for purposes of this pilot study.
Study personnel will not handle patients’ medications. An appointment for the
second and ¦nal study visit, approximately 30 days from the ¦rst, will be made
at this time. Between visits Participants will be asked to carry the smartphone

and wear the sleep/activity monitor. They will be prompted by the smartphone
app to measure BP at the same time each day at home with the portable BP
monitor, and to complete the symptom & lifestyle tracking diary at least once
daily. They will be asked to take their antihypertensive medications directly
from the study pill bottles with MEMS cap monitors (rather than transferring
the pills to a pill box) to track medication-taking. A member of the study team
will call the patient twice per week to encourage them to follow the protocol, to
ensure the devices are correctly charged and used, and to answer questions. If
there are concerns about adverse effects, the study team member will page
the participant’s personal physician, or if unknown, the study physician
(Kilgore) immediately to respond to the patient. Final visit (approximately 45
minutes) The patient will return to the clinic for a 30-Day Follow-Up Visit to
return the mHealth devices and complete self-report adherence and beliefs
questionnaire, the feasibility/acceptability questionnaire and BP measurement.
A study team member will upload data from each of the mobile devices to the
“MediCom” portal web server as a .csv ¦le using a secure connection under
SSL protocol and user/password identi¦cation. The .csv ¦les will include no
identifying information other than the participant’s study identi¦er and
time/date stamps for when each data element (e.g. blood pressure) was
collected. The participant will be given $80 in cash or gift card as
compensation for their participation at the end of this ¦nal visit. Study 2 -
Questionnaire Study Overview Participants will complete one study visit in a
private room at the clinic. After obtaining informed consent, a member of the
study team will administer a baseline questionnaire including the self-reported
adherence measure and beliefs about medications questionnaire. Blood
pressure data will be abstracted from the electronic health record. The
participant will be given a $30 in cash or gift card as compensation for
participation. Participants who complete the Study 2 Questionnaire study will
be asked to grant permission to be contacted to be recruited for the Study 4
RCT. Study 3 - Home Monitoring Pilot Study Overview Participants who
completed Study 2 and granted permission to be contacted about future
studies will be recruited to participate in Study 3. Study 3 participants will
complete a brief educational intervention including 3 study visits, each of
which is a group education session facilitated by two members of the study
team—a primary care physician and a staff member acting as a Group
Facilitator. The proposed study will evaluate a culturally appropriate and novel
intervention to improve adherence to antihypertensive medications among
low-income Hispanic/Latino Americans with diabetes and uncontrolled

hypertension. The intervention, called Mi Propio Camino (MPC, Spanish for “My
Own Way”), empowers patients to (1) monitor their own individual experience
with blood pressure lowering strategies (including BP changes and side
effects), (2) discuss those experiences with peers and providers in a group
education setting, and (3) engage in future discussion with their own primary
physician providers about barriers and concerns about their BP-lowering
approach. MPC will consist of 4 group education sessions, facilitated by a
primary care physician and a trained Group Facilitator with three medication
experience monitoring periods, one between Group Sessions 1 and 2, a second
between Group Sessions 2 and 3 and a third between Group Sessions 3 and 4.
Each Group Session includes three sections: a check-in, an educational activity,
and a goal setting activity. Group Session 1 (3 hours). Participants will meet in
a group activity room at the clinic with the Group Facilitator and physician,
supported by the assistant project coordinator and student researchers.
Patients will be asked to bring their BP medications to the session. The
session will begin with discussion of the ground rules of the Group Session.
These rules have been developed and are routinely used in group health
education activities provided routinely at the study clinics. Group Session
Ground Rules 1. Because it is a group discussion, con¦dentiality of what is
shared during the session cannot be guaranteed. 2. Sharing of personal
information is not mandatory 3. Others’ personal information should not be
discussed outside of the Group Session. Activities for Group Session 1 include:
1) during check-in, discuss patients’ current BP-lowering strategies (including
medications) and concerns about medications; 2) during the education activity,
introduce principles of healthy eating (e.g. DASH diet) and ways to increase
physical activity to complement medications to reduce BP; and 3) during goal-
setting, identify a BP-lowering strategy, incorporating the patients previously
prescribed medications (from their personal physicians as part of their usual
care) with healthy lifestyle changes, that the patient is willing to try for a ¦nite
period. At the end of Session 1, the study team will provide each patient a “kit”
of mHealth devices: MEMS pill bottle cap monitors, and a portable BP monitor.
Each kit will be con¦gured by a study team member. Further, the patients will
be asked to install the SymTrack symptom tracking application (see Appendix
K) to their own smartphone, or if they prefer, to carry a smartphone provided by
the study team. Participants will be trained on how to use the devices. The
symptom tracking app will be con¦gured for each patient to 1) track up to ¦ve
symptoms of concern, selected by the patient, 2) track up to ¦ve lifestyle
factors they think may impact BP (e.g. eating salty foods), also selected by the

patient and 3) send reminders to complete the symptom diary and BP reading
at least once daily. The study physician will teach patients how to place a 3-
week supply of each BP medication in a labeled pill bottle with a MEMS cap
monitor to track when doses are taken. Medication Experience Monitoring
Period 1 (approximately 2 weeks). For the period in between Group Sessions 1,
2 and 3 (approximately 2-4 weeks), participants will be asked to carry the
smartphone and track their medication-taking and blood pressures at home.
The smartphone app will prompt them to measure BP at home once daily with
the portable BP monitor. Prompts include a symptom and lifestyle tracking
diary at least once daily. They will be asked to take their antihypertensive
medications directly from the study pill bottles with MEMS cap monitors to
track medication-taking. If the patients prefer to use a pill box organizer or to
store their pills outside of a pill bottle, they will be asked to keep the empty pill
bottle with the MEMS cap monitor next to their pill organizer and to simply
open and close the empty bottle to record the pill-taking on the device. A
coordinator or volunteer research assistant will call patients twice per week to
encourage them to follow the protocol, to ensure the devices are correctly
charged and used, and to answer questions. If concerns about adverse effects
arise, a study team member will contact the patient’s physician immediately to
respond to the patient. Group Session 2 (2 hours). Patients will return to the
group activity room and give their mHealth kits to the coordinator. Research
assistants will ensure data are synced with the MediCom web portal (See
Appendix K). During check-in, the facilitators will lead a discussion about the
patients’ experiences with the medications and lifestyle changes, and show the
patients how to view their mHealth data on the smartphone to review their own
adherence, changes in BP, and occurrence of symptoms of concern. During
this time, patients will be invited to display their data on a large screen for
group discussion about experiences, concerns, and strategies to maintain
adherence, Participants will be reminded of the ground rules established in
Group Session 1 that sharing of personal information is not mandatory and
others’ personal information should not be discussed outside of the GMV.
During the education activity, facilitators will discuss questions about the role
of herbal supplements in BP control, teach simple relaxation techniques and
stress management strategies and review recommendations to support
healthy sleep. During goal setting, the patients will opt to continue the BP
lowering strategy they began after Session 1, or to make changes to their
strategy, including adjustments to the medication regimen. Finally, the
assistants will set up each patient’s mHealth kit as in Session 1. Medication

Experience Monitoring Period 2 (approximately 2 weeks). Patients will repeat
the Medication Experience Monitoring protocol for the BP-lowering strategy
chosen in Group Session 2 until Group Session 3 is scheduled. Group Session
3 (2 hours). Similar to the prior session, Group Session 3 will begin with review
of patients’ mHealth data and their experiences with the regimen during check-
in. The education activity will focus on behavioral strategies recommended by
the American Heart Association to reduce forgetting and confusion about
medications. During goal setting, patients will focus on setting a SMART goal
incorporating medications with healthy lifestyle changes that the patient is
willing to try or a ¦nite period of time. Medication Experience Monitoring
Period 3 (approximately 2 weeks). Patients will repeat the Medication
Experience Monitoring protocol for the BP-lowering strategy chosen in Group
Session 3 until Group Session 4 is scheduled. Group Session 4 (2 hours).
Similar to the prior session, Group Session 4 will begin with review of patients’
mHealth data and their experiences with the regimen during check-in. The
education activity will focus on behavioral strategies recommended by the
American Heart Association to reduce forgetting and confusion about
medications. During goal setting, patients will have two options: 1) complete
an additional monitoring period and GMV session (possibly with a new group
of patients) to explore other BP-lowering strategies or 2) graduate from the
intervention with encouragement to continue discussing concerns with their
primary doctor. Finally, all mHealth devices will be collected from MPC patients
by study team members. Participants will complete a follow-up questionnaire
including the BMQ and medication adherence measures, and the post-
intervention satisfaction survey. At the end of this session, the participants will
be given $100 in cash or gift card. Since all Study 3 participants will have
completed Study 2 already, this amounts to a total of $130 compensation for
completing the two studies, which was considered to be appropriate
compensation by an advisory group of community stakeholders who work with
patients in this community. Completion of the above activities in Group
Session 4 marks the end of the participant’s participation in Study 3. (May
2019) This IRB e-modi¦cation is to add an additional set of study procedures,
“Study 4”, in this on-going investigation. Study 4 is an RCT comparing the IRB-
approved MPC intervention (group education sessions augmented with
mHealth) pilot tested in Study 3 to a comparison intervention (traditional group
education sessions with no mHealth component). Study 4 RCT participants
will be recruited from those individuals who completed the Study 2
questionnaire study. Study 4 - Intervention RCT Study 4 is similar to Study 3

using the same mHealth devices and study questionnaires, but including the
following additions: (1) RCT design to randomly allocate participants to the
MPC intervention (described in Study 3) or a comparison intervention, (2) a six-
month follow-up visit. For completeness, both intervention conditions and all
study procedures for Study 4 are described below. Overview Participants who
completed the Study 2 Questionnaire study and granted permission to be
contacted about future studies will be recruited to participate in Study 4. Study
4 participants will be randomly allocated to complete either the MPC
intervention or the comparison intervention, each of which consists of 4
biweekly sessions facilitated by members of the study team. The proposed
study will evaluate a culturally appropriate and novel intervention to improve
adherence to antihypertensive medication among low-income Hispanic/Latino
adults with uncontrolled hypertension. The intervention, called Mi Propio
Camino (MPC, Spanish for “My Own Way”), empowers patients to (1) monitor
their own individual experience with blood pressure lowering strategies
(including BP changes and side effects), (2) discuss those experiences with
peers and providers in a group education setting, and (3) engage in future
discussion with their own primary physician providers about barriers and
concerns about their BP-lowering approach. The comparison intervention, will
focus on information and behavioral skills but will not address negative beliefs
through direct and vicarious experience using mHealth. Both intervention
groups will consist of 4 group education sessions with two follow up
appointments, at one month and six months post intervention sessions. MPC
will be facilitated by a primary care physician and a trained Group Facilitator
with three medication experience monitoring periods, one between Group
Sessions 1 and 2, a second between Group Sessions 2 and 3 and a third
between Group Sessions 3 and 4. The comparison intervention group will be
facilitated by a trained Health Coach experienced in leading group education
sessions with Spanish-speaking Latino patients with limited health literacy.
Each Group Session includes three sections: education activities, goal setting
and take home activities. Session 1 will include a discussion of ground rules
and an ice breaker activity. In Sessions 2-4, check-in will include small group
discussions of observations from the prior Personal Experience Monitoring
Session. For participants randomized to MPC: Participants in the MPC
condition will follow the procedure described for the 4 MPC intervention visits
with Medication Experience Monitoring Sessions described in Study 3, above.
In brief: Education activities will emphasize discussions to address commonly
held negative beliefs about medications. For example, concerns about harms

vs. bene¦ts will be addressed by focusing the ways medication and lifestyle
work synergistically, the distinction between temporary symptoms/side effects
and permanent harm, and how monitoring experiences with BP-lowering
strategies helps individuals ¦nd a personalized approach that works for them.
Concerns about provider overuse of medications or unwillingness to respond
to patient concerns will be addressed by discussion about insights on how
providers think about selecting BP lowering strategies and responding to side
effects, and how bringing in information from home monitoring can empower
patients to collaborate with their physician more effectively. Finally, based on
our successful experience training Spanish-speaking patients to use the
mHealth kits during our dry run sessions, we will dedicate a full hour of
Session 1, to train participants to use the kits to complete the subsequent
Personal Experience Monitoring Sessions. Goal setting focuses on setting a
SMART goal incorporating medications with healthy lifestyle changes that the
patient is willing to try for a ¦nite period and monitor at home between GMV
sessions. Although participants will be allowed to try a BP lowering strategy
that does not involve medications, no participants in our dry run sessions have
opted for this option. Take-home activity: Personal Experience Monitoring
Period (2 weeks). At the end of GMV Session 1, the coordinator and assistants
will provide each patient a “kit” of two mHealth devices: MEMS pill bottle cap
monitors, a portable BP monitor, each con¦gured by a member of the study
team. Additionally, the patients will be given the option to (1) install the
SymTrack symptom tracking application to their own smartphone, (2) to carry
a smartphone provided by the study team or, (3) based on feedback from
feasibility testing, use a paper-based diary to collect data that a study team
member can input into the web portal. Participants will be trained on how to
use the devices, include the appropriate protocol to take BP reliably, and asked
to set a daily reminder (either in the app or on their own phone or watch) for a
consistent time they think they will have 5 quiet minutes to complete the
symptom diary and BP reading. The symptom diary app will be con¦gured for
each patient to track their BP, overall energy level, and up to ¦ve lifestyle
factors they think may impact their BP (e.g. eating salty foods) selected by the
patient. The study physician will teach patients to place a 2-week supply of
each BP medication in a labeled pill bottle with a MEMS cap monitor to track
when doses are taken. Participants will be asked to take their BP meds directly
from the study pill bottles with MEMS caps (rather than transferring the pills to
a pill box) to track medication-taking. A study team member will call patients
twice between GMV sessions to encourage them to follow the protocol, to

troubleshoot the mHealth devices, and to answer questions. If concerns about
adverse effects arise, a study team member will contact the patient’s physician
immediately to respond to the patient. During the monitoring period,
participants will be asked to ¦nd a time once per day to sit quietly for 5
minutes, re§ect on the day, and complete the diary. Then, they will follow the
instructions in the kit to take their BP. When patients return to the group activity
room for the next GMV session, they will give their mHealth kits to the research
assistants, who will help compile and summarize the data for the patient.
During check-in, the facilitator will lead a discussion about the patients’
experiences with the medications and lifestyle changes, and show the patients
how to view their mHealth data on the smartphone to review their own
adherence, BP changes, and occurrence of symptoms of concern. Patients will
be invited to display their data on a large screen for group discussion about
experiences, concerns, and strategies to maintain adherence, and will be
reminded of the ground rules established in Session 1. For participants
randomized to the comparison intervention: Participants allocated to the
comparison group will complete a traditional 4-session BP health education
class, based on American Heart Association curriculum materials, developed
under the supervision of the study physician, and similar to a class currently
offered at the study site. Like the MPC Study Intervention, the comparison
intervention will include 4 in-person sessions over two months, with take-home
activities in between. Unlike the MPC intervention, the comparison intervention
will focus on information and behavioral skills, but will not address negative
beliefs through direct and vicarious experience using mHealth. Education
activities. Instead of focusing on addressing negative beliefs, the Education
Activities will include detailed presentations on the speci¦c health threats
(complications) associated with uncontrolled BP, and teaching seven speci¦c
lifestyle strategies related to the “Changes You Can Make to Manage High BP”
described by the American Heart Association including healthy eating, physical
activity, etc. In each session, behavioral strategies to reduce
confusion/forgetting in medication-taking will be discussed. Goal-Setting (and
subsequent Check-Ins) will focus on setting a SMART Goal for a behavioral
change related to the subject of the day’s lesson to implement in the Take-
Home Activity. Take-Home Activity: Instead of Personal Experience Monitoring,
the Take-Home activity in the comparison intervention will focus on
implementing their SMART goal for a behavior change without offering the
mHealth kit or explicit guidance about how to monitor one’s experience with
the strategy. They will receive two phone contacts during each interval

between In-Person Sessions to provide encouragement and help with problem-
solving related to implementing the goals. Follow up visits One-month follow
up. For session 4 in both groups, participants will be asked to bring a 30-day
supply of their currently prescribed blood pressure medications and asked to
take every dose of those medications for the next 30 days directly from the
MEMS cap monitors to measure daily adherence for that period, the patient
will return for a 30-Day Follow-Up Visit to return the MEMS cap, complete a
blood pressure measurement and complete a brief questionnaire. Five-month
follow-up. Approximately 5 months after session 4, patients will complete a
second follow-up visit to complete a brief questionnaire and blood pressure
measurement, and receive another MEMS pill bottle cap monitor with
instructions for the second 30-day adherence monitoring session Six-month
follow up. At six months post intervention sessions, the coordinator will meet
the patient at the clinic to take a ¦nal blood pressure measurement, collect a
¦nal survey including self-reported adherence and complete a second 30-day
adherence monitoring using MEMS caps, following the same procedure as for
the one month follow up. Completion of the above activities over the six month
follow up period marks the end of the participant’s participation in Study 4.

Specify the total duration of a subject’s participation in the study and clearly outline the duration
of participation for each study visit and sub-study, as applicable:
Study 1. The subject will participate in two study visits, of approximately 45
minutes each, with a 30 day home monitoring period in between during which
they will complete a daily smartphone diary, wear a Fitbit sleep/activity monitor
and check their own blood pressure. Study 2. The subject will participate in one
study visit, approximately 45 minutes in length. Study 3. The subject will
participate in 3 study visits, consisting of interactive group education sessions
lasting a total of approximately 7 hours. In between the study visits, they will
complete three home monitoring periods of approximately two weeks each,
during which they will complete a daily smartphone diary, will check their own
blood pressure daily and will receive approximately two brief reminder calls per
week. These home monitoring activities (at 5 minutes per day) and reminder
calls (at 5 minutes per call) are expected to take no more than 4 hours in total
for the whole study period. Study 4. Participants will attend four group
education sessions over a period of approximately 1 month, and three follow
up appointments, at 1 month, 5 months and 6 months after the last group
education session. For the four group education sessions, Session 1 will be
approximately three hours long, and Sessions 2 through 4 will be two hours
long each. The one-month, ¦ve-month and six-month follow-up sessions will be
approximately one hour each. In total, participants would spend approximately
15 hours engaged in study activities at the clinic over a seven-month span.
Additionally, participants will complete home monitoring and follow-up phone
calls outside the clinic totaling 5 hours. Combined, total participation time at
clinic and at home will be 20 hours over the 7 months.
List data collection tools (e.g., measures, questionnaires, observational tool) below by clicking the
'Add Line' button. Include additional rows for study instruments, as needed:
The 'Columns' button allows you to display or hide columns in the Study Instrument List.
Name of Tool:
Beliefs about medicines questionnaire (BMQ)
Is the data collection tool standardized or validated?
Yes

Please provide data collection tool citation:
Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire:
the development and evaluation of a new method for assessing the cognitive
representation of medication. Psychology and health 1999;14(1):1–24.
Name of Tool:
Morisky Medication Adherence Scale
Is the data collection tool standardized or validated?
Yes
Please provide data collection tool citation:
Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive Validity of A
Medication Adherence Measure in an Outpatient Setting. J Clin Hypertens
(Greenwich) 2008;10(5):348–54.
Name of Tool:
Medication Knowledge Questionnaire (MKQ)
Is the data collection tool standardized or validated?
Yes
Please provide data collection tool citation:
Mayberry LS, Osborn CY. Empirical validation of the information-motivation-
behavioral skills model of diabetes medication adherence: a framework for
intervention. Diabetes Care 2014;37(5):1246–53.
Name of Tool:
PROMIS Self-E¨cacy for Managing Chronic Conditions Manage
Medications/Treatment scale
Is the data collection tool standardized or validated?
Yes

Please provide data collection tool citation:
Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the
PROMIS® measures of self- e¨cacy for managing chronic conditions. Qual
Life Res 2017;26(7):1915–24.
Name of Tool:
Medication Adherence Strategies Inventory (ASI)
Is the data collection tool standardized or validated?
Yes
Please provide data collection tool citation:
Boron JB, Rogers WA, Fisk AD. Everyday Memory Strategies for Medication
Adherence. Geriatr Nurs 2013;34(5):395–401.
Name of Tool:
Safran Reasons for Nonadherence Scale
Is the data collection tool standardized or validated?
Yes
Please provide data collection tool citation:
Safran DG, Neuman P, Schoen C, et al. Prescription drug cover- age and
seniors: ¦ndings from a 2003 national survey. Health Aff (Millwood).
2005;Suppl Web Exclusives:W5.152-W5.166.
Name of Tool:
Demographics and other general items (full survey provided)
Is the data collection tool standardized or validated?
No, submit a copy of the draft or ¦nal tool in the Attachments Section
Name of Tool:
Arizona Lifestyle Index

Is the data collection tool standardized or validated?
Yes
Please provide data collection tool citation:
Brooks A, Dodds S, Cook P, Maizes V, Lebensohn P. Psychometric Analyses of
the Arizona Lifestyle Inventory: A Multi-Dimensional Integrative Medicine
Measure to Assess Wellness Behaviors. The Journal of Alternative and
Complementary Medicine. 2014 May 1;20(5):A133-.
Name of Tool:
InCharge Financial Distress/Financial Well-Being Scale
Is the data collection tool standardized or validated?
Yes
Please provide data collection tool citation:
AD Prawitz, ET Garman, B Sorhaindo , etal: Incharge ¦nancial
distress/¦nancial well-being scale: Development, administration, and score
interpretation Fin Couns Plan 17: 34– 50,2006
Will this study require clinical items/ services from UC Irvine Health?
No
Does the research involve the use of identifiable private information?
Yes
Use of Identifiable Private Information as Part of the Main Study
Indicate the types/sources of identifiable private information (Check all that apply):
UCI Health Medical Records
Indicate whether the information was originally collected for research purposes:
Not originally collected for research
Explain how the information were originally collected (e.g., clinical care):
Routine clinical care

Provide a complete list of the data points, variables, and/or information that will be collected (i.e.
data abstraction form):

Or specify variables or information required here:
The study team will request speci¦c patient information/data from UCI Health
Honest Broker Services. The dataset will contain the following data elements:
1. Sociodemographic characteristics: To describe the sample and to use as
covariates in data analysis -Age -Gender -Race/ethnicity -Preferred language -
Marital status -Health insurance type 2. Healthcare utilization: To account for
differential utilization of health services when testing study hypotheses. -
Number of inpatient stays -Total inpatient length of stay -Number of
emergency department visits -Number of scheduled ambulatory primary care
appointments -Number of attended ambulatory primary care appointments -
Dates of the following preventive services: --All COVID-19 vaccine doses --All
in§uenza vaccination doses --A1C test --Lipid panel --Kidney function testing --
Diabetic Foot exam --dilated eye exam 3. Cardiometabolic Indicators: To
assess the secondary endpoint of blood pressure control and account for
differences in cardiometabolic risk factors when testing study hypotheses -
Blood pressure -Laboratory data for a two-year period: ---Lipid panel results
(LDL; HDL; Total cholesterol; Triaglycerides) ---Hemoglobin A1C -Body Mass
Index Each result will be listed in a separate row for all study patients. 4.
Chronic health conditions: To account for patients’ disease burden in the
analysis, the dataset will include a list of relevant diagnoses noted in the
medical record to allow us to compute the Charlson comorbidity index score.
The following diagnoses, and any available comorbidity summary scores, will
be included in the dataset: --Myocardial infarction/heart disease --Congestive
heart failure --Peripheral vascular disease --Dementia --Cerebrovascular
disease --Chronic lung disease -Connective tissue disease --Ulcer --Chronic
liver disease --Diabetes --Hemiplegia --Moderate or severe kidney disease --
Diabetes with end organ damage --Tumor --Leukemia --Lymphoma --Moderate
or severe liver disease --Malignant tumor and metastasis 5. Medication orders:
To validate patient reported and objectively collected medication adherence
data, and to account for differences in treatment intensity in analysis of study
outcomes, all medication orders noted in the EMR will be included, each in a
separate row, identi¦ed by a study identi¦er. The data elements to include will
be: --Date of medication order/prescription (NOTE: all dates will be converted
into “Days From Start of Observation Period” so that no actual dates will be
stored in the dataset). --Type of order (e.g. initiate, re¦ll, discontinue) --
Medication brand name --Medication generic name(s) (combination
medications may include more than one generic medication) --Medication
class(es) --Number of units ordered (e.g. number of pills prescribed) --Dose

count (number of units per dose, e.g. take ____ pills…) --Dose frequency
(number of times per day to be taken) --Unit dose (e.g. milligrams per pill/unit)
--Dose form (pills, injectable, ointment, inhaler, etc.) --Notes (special
instructions like “take with food”) Once the data are obtained, the investigator
will conduct data analyses to describe the sample and the distribution of study
variables, and to test the study hypotheses. please update
Specify the time-frame of the data to be accessed (e.g. January 2002 to 2024):
All results noted in the medical record for the 1-year period before the consent
date and for two years after the ¦nal study visit date will be included, with the
date of the test and the result (NOTE: all dates will be converted into “Days
From Start of Observation Period” so that no actual dates will be stored in the
dataset), and the study identi¦er.
This study will use medical records, indicate the source:
Study team will access their own UCI patients’ records and abstract data
directly from those records
Does the research involve the use of identifiable biospecimens?
No
Sharing Results with Subjects
Will Individual results be shared with subjects?
No
Will overall study results will be shared with subjects?
N/A, ¦nal study results will not be shared with subjects
Risk Assessment

Risks and Discomforts
1. Describe and assess any reasonably foreseeable risks and discomforts associated with each
procedure for each subject population — physical, psychological, social, legal or other:
2. If this study will involve the collection of identifiable private information, even temporarily, for
which the disclosure of the data outside of the research could reasonably place the subjects at
risk, include the risk of a potential breach of confidentiality:
Breach of Confidentiality: Study 1, 2, 3 and 4. Because we are operating in a clinic setting, consent
documents and data collection instruments will be transported from the clinic to the research
offices.  
Study 1, 3 and 4. Participants will also be collecting health data using mobile health devices.  
Therefore, there is a minimal, but non-zero, risk that participant data stored at the research offices or
stored/transmitted using the mobile devices could be compromised. From prior experience in similar
studies, we expect the frequency to be rare (<1%).
Study 3 and 4. Because the study intervention involves voluntary group discussion of health matters,
we cannot assure that confidentiality will be maintained for information that participants choose to
disclose in front of others. This potential for disclosure of personal information by other group
participants is assumed in routine patient group health education activities that are routinely held at
the study clinic.
Study 1, 2 , 3 and 4.  
Discussion of potentially sensitive issues. During the pre-visit session, the patient and study team
member could discuss health issues or personal issues that raise concern for the patient. From prior
experience in similar studies, we expect the frequency to be rare (<1%). 

Discuss what steps have been taken and/or will be taken to prevent and minimize any
risks/potential discomforts to subjects:
Breach of con¦dentiality. Study 1, 2 , 3 and 4. To minimize this risk, all data
collection instruments will be assigned unique study identi¦ers. Identi¦ers,
including patient’s name, address, telephone number and study identi¦er will
be stored electronically in REDCap, a secure web-based research platform, with
access limited to key study personnel. All study personnel will be trained in
con¦dentiality protocol procedures. All hard copy versions of study data
collection materials will be transported in a locked briefcase, and maintained
in secure, locked, ¦ling cabinets, in o¨ces of the lead researcher. For Study 3,
because the study intervention involves voluntary group discussion of health
matters, we cannot assure that con¦dentiality will be maintained for
information that participants choose to disclose in front of others. For this
reason, we discuss and establish ground rules at the beginning of each group
session for the study intervention, indicating that: 1. Because it is a group
discussion, con¦dentiality of what is shared during the session cannot be
guaranteed. 2. Sharing of personal information is not mandatory 3. Others’
personal information should not be discussed outside of the Group Session.
Study 1, 2 , 3 and 4. Data collected using mobile devices or stored on any 3rd
party server other than REDCap will be identi¦ed only by the participant’s study
identi¦er, both on the devices themselves, and on the study’s “MediCom” web
server. In addition, data will be protected as it moves along the communication
pathways (from participant to server) using a secure protocol: Secure Sockets
Layer (SSL). All users and admin accounts to access and manage the web
services are password protected. Data will also be stored securely in a central
database hosted in a server at Calit2 as part of the UCI network, which
storages and encrypts the information retrieved from the devices. This server
is behind the UCI Firewall. The server is protected by automatic updates,
antivirus and monitoring of activities and users. Study 1, 2 , 3 and 4.
Discussion of potentially sensitive issues. Because the research encounters
will occur at the patient’s medical clinic, they will have the opportunity to
address any such issues with a health providers on staff at the clinic.
Certificate of Confidentiality
Is the research partially or wholly funded by NIH (including NIH Institutes and Centers), or does
the research involve identifiable sensitive information that require CoC protections?
No

Potential Benefits
Is there the prospect of a direct benefit anticipated for subjects?
Yes
Describe the potential benefits subjects may expect to receive from participation in this study:
Potential bene¦ts include learning about medication adherence, beliefs about
medication, and one’s own changes in blood pressure over time. Studies 3 and
4 also offers the opportunity for participants to learn about recommended
strategies to manage blood pressure and to communicate with their personal
doctors about concerns and barriers they face in managing blood pressure.
Specify the expected potential societal/scientific benefit(s) of this study:
Study 1, 2 , 3 and 4 have the expected societal bene¦t of increasing
understanding of health related beliefs that may in§uence medication
adherence. Further, Studies 1, 3 helps establish the feasibility of using mobile
devices to help address negative hypothetical beliefs about medications,
which will guide future investigations of this approach. Study 4 has the
expected societal/scienti¦c bene¦t of testing a theoretically grounded health
education intervention designed to address negative beliefs about medications
to improve adherence to blood pressure medications and subsequent blood
pressure control in a population facing signi¦cant disparities on these
outcomes.
Alternatives to Participation
Describe the alternatives to participation in the study available to prospective subjects. Include
routine (standard of care) options as well as other experimental options, as applicable (check all
that apply):
No alternatives exist. The only alternative to study participation is not to
participate in the study
Participant Compensation

Will subjects be compensated?
Yes
Specify whether compensation is applicable and, if so, the method, amount and schedule of
compensation (Check all that apply):
Other
Specify 'Other' compensation method:
Cash or gift card (depending on patient preference)
Other schedule:
Other
Specify the 'Other' compensation 'Other' schedule:
Study 1. Subjects will be compensated with the following schedule and
amounts: Total compensation of up to $80 will be offered for participation.
$20 will be handed to patient at completion of the ¦rst study visit and $60
will be handed to the participant at completion of the second visit. Study 2.
$30 cash/gift card will be given to patient at completion of the study
procedure in person. Study 3. $100 will be given to patient at completion of
the study procedure, in person. (January 2023) - To provide greater
incentive to participate and respond to great barriers to participation since
the start of the COVID-19 pandemic, total compensation for Study 4 is
being increased from $180 to $240 dollars, following the schedule of
payments listed below. Study 4. Subjects will be compensated with the
following schedule and amounts. Total compensation up to $240 will be
offered for participation and completion of study components. -$40 will be
handed to patient upon completion of session 1. -$10 will be given upon
completion of session 2. -$10 will be given upon completion of session 3.
-$40 will be given upon completion of session 4 -$40 at completion of 1
month follow up visit and $100 upon completion of 6 month follow up.
Compensation to participants will be handed in person. Because all Study
4 participants will have already completed Study 2, please note that the
total compensation for Study 4 is in addition to compensation the
participants will have received for Study 2.

Will the 'Other' compensation method include all subjects?
Yes
Will subjects be reimbursed for out-of-pocket expenses?
No
Participant Costs
Will subjects or their insurers be charged for study procedures?
No
Con¦dentiality of Research Data
Information and/or Biospecimens Storage
Indicate how information and/or biospecimens (including signed consent forms) will be stored
(check all that apply):
Information will be maintained electronically. Information will be password
protected and maintained in an encrypted format
Information will be maintained on an UCI enterprise cloud platform
Encrypted Format
Specify where the information will be maintained electronically:
In addition to the Enterprise cloud platforms listed below, P4 data will also
be stored securely behind password protection on:REDCap, UCI Qualtrics,
UCI Protected Research Environment server
Enterprise Cloud Platform

For enterprise cloud storage, select the location that adheres to the UCI Protection Level
required for the research information:
Microsoft OneDrive
Microsoft Teams
Microsoft SharePoint
Microsoft OneDrive
Will subject/patient identifiers be collected or retained?
Yes
Subject/Patient Identifiers
Will any subject/patient identifiers be collected or retained for data analysis, recruitment,
consenting and/or compensation (check all that apply)?
All elements of dates (except year) for dates that are directly related to an
individual: birth date, admission date, discharge date, death date, and all ages
over 89
All geographic subdivisions smaller than a state: street address, city, county,
precinct, ZIP code, and geocodes
Email addresses
Medical record numbers
Names
Telephone numbers
Will a code be used to link subject/patient identifiers with the information and/or biospecimens?
A code will be used. Subject/Patient identi¦ers will be kept separately from the
information and/or biospecimens. The code key will be destroyed at the
earliest opportunity, consistent with the conduct of this research
Will research data/biospecimens be transported or maintained on portable devices (e.g., laptop,
smartphone, external hard drive, etc.)?
No

Specify who will have access to subject/patient identifiable information/biospecimens as part of
this protocol (check all that apply):
Authorized UCI personnel (such as the research team) and appropriate
institutional o¨cials: such as the O¨ce of Human Research Protections
(OHRP) Regulatory entities such as the Food and Drug Administration (FDA),
the National Institutes of Health (NIH)
Specify whether subject/patient identifiers be disclosed in presentations and/or publications:
Subject/Patient identi¦ers will be disclosed. Text regarding the disclosure will
be included in the consent document and speci¦c permission to disclose will
be discussed with subjects/patients
Specify how long all subject/patient identifiers will be retained. This includes identifiers stored in
paper format, stored electronically as well as video recordings, audio recordings, photographs,
etc.:
Other
Specify 'Other' time frame and provide rationale:
Participants will be asked to indicate on the Consent Form whether they grant
permission for our study team to contact them about future studies. Time
frame: For those participants who grant this permission, we will maintain their
personal identi¦ers and contact information until the end of this study
protocol. Rationale: Maintaining this information will allow us to reduce
potential participant burden by eliminating the need to collect questionnaire
data multiple times for subjects participating in more than one of the sub-
studies. It also gives greater §exibility to participants by allowing them to
participate in the sub-studies that are most relevant to them on a schedule
they choose.
Research Information and/or Biospecimens Retention
Indicate how long research information/biospecimens will be retained:
Other

Specify time frame and provide the rationale for research information and/or biospecimens
retention:
Will be retained for six years as this research involves Protected Health
Information (PHI) (e.g., IRB documentation, consent/assent forms – NOT the
actual PHI). Investigators must destroy PHI at the earliest opportunity,
consistent with the conduct of this study, unless there is an appropriate
justi¦cation for retaining the identi¦ers or as required by law.
Will research information and/or biospecimens be shared?
No
Attachments
If required documentation is not provided, the submission is incomplete and your Application will be
returned to you. Be sure to upload each document as required. If changes are needed, go back to the
sub-section to revise your selections.
Maximum file size is 30MB
All UCI templates are available on the Human Research Protections Applications & Forms page or
Human Stem Cell Research Applications & Forms page.
To access approval documents where UCI will rely on another IRB, including commercial IRBs, visit
their respective online portals. Frequently used commercial IRB portals include:
• WIRB Copernicus Group's WCG IRB Connexus
• Advarra’s CIRBI
• SMART Online Reliance System (ORS)
Attachment
Attachment Type
Other
File Comments
Reference Only
2017-4025 APPENDIX K MEDICOM APPLICATION 05-23-18_NORMAL_333168.DOC

File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Other
File Comments
Reference Only
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Other
File Comments
Reference Only
File Name
Status (IRB/hSCRO Use Only)
2017-4025 APPENDIX K SYMTRAK MOBILE SYMPTOM DIARY 05-23-
18_NORMAL_333169.DOC
2017-4025 APPENDIX K FITBIT CHARGE HR. 05-23-18_NORMAL_333170.DOC

Attachment
Attachment Type
Other
File Comments
Reference Only
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Other
File Comments
Reference Only
File Name
Status (IRB/hSCRO Use Only)
Attachment
2017-4025 APPENDIX K BP MONITOR 05-23-18_NORMAL_333171.DOC
2017-4025 APPENDIX K MEMS CAP 05-23-18_NORMAL_333172.DOC
2018-4025 PRODUCT BROCHURE - FITBIT CHARGE HR 05-23-18_NORMAL_333173.PDF

Attachment Type
Medical Device Instructions (User Manual/Product Brochure)
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Medical Device Instructions (User Manual/Product Brochure)
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Medical Device Instructions (User Manual/Product Brochure)
File Comments
2018-4025 PRODUCT BROCHURE - OMRON BLOOD PRESSURE MONITOR 05-23-
18_NORMAL_333174.PDF
2018-4025 PRODUCT BROCHURE - MEMS 05-23-18_NORMAL_333175.PDF

File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Data Collection Tool/Instrument
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Other
File Comments
File Name
Status (IRB/hSCRO Use Only)
2017-4025 DATA ABSTRACTION SHEET 05-23-18_NORMAL_333178.DOCX
2017-4025 FEASIBILITY SURVEY 05-23-18_NORMAL_333180.DOCX

Attachment
Attachment Type
Other
File Comments
Reference Only
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
APPENDIX K - MEDICOM DATA AGGREGATION AND WEB PORTAL SOFTWARE 07-05-
19_NORMAL_363003.DOCX
2017-4025 PHONE AND EMAIL 12-12-18_APPROVED_346851.PDF
2017-4025 PHONE AND EMAIL SCRIPT (SPANISH) 04-05-19_APPROVED_356468.PDF

Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Data Collection Tool/Instrument
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Recruitment Material
File Comments
MPC_BASELINE_QUESTIONNAIRE.PDF
20174025 PHONE RECRUITMENT SCRIPT 03-23-22.DOCX

File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
Stamped English Version
File Name
20174025 PHONE RECRUITMENT SCRIPT 03-23-22.PDF
ENGLISH MPC FLYER.PDF

Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
20174025 STUDY 2 AND 4 RECRUITMENT FLYER 03-23-22.PDF
20174025 SPANISH STUDY 2 AND 4 RECRUITMENT FLYER 03-23-22.PDF

Attachment
Attachment Type
Translated Consent Form
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
HIPAA Research Authorization Form
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
20174025 SPANISH STUDY 2 CONSENT FORM 09-23-22.DOCX
20174025 UCI HIPAA FORM 6-8-22.DOCX
20174025 IRB APPROVAL LETTER 6-8-22.PDF

Attachment Type
UCI IRB Approval Letter
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
HIPAA Research Authorization Form
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Translated Consent Form
File Comments
20174025 SPANISH HIPAA FORM.DOCX
20174025 SPANISH STUDY 2 CONSENT FORM + HIPAA 09-23-22.PDF

File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Translated Consent Form
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Consent Form
File Comments
English study 2 consent form approved
File Name
20174025 SPANISH STUDY 4 CONSENT FROM + HIPAA 2-2-23.PDF
20174025 STUDY 2 MAIN CONSENT (QUESTIONNAIRE STUDY) 6-8-22 (5).PDF

Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Consent Form
File Comments
English study 2 word doc
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Translated Consent Form
File Comments
Updated consent form to match the compensation in that was updated in the
English consent form for study 4
File Name
20174025 STUDY 2 MAIN CONSENT (QUESTIONNAIRE STUDY) 6-8-22.DOCX
20174025 SPANISH STUDY 4 CONSENT FORM 2-2-23.PDF

Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Other
File Comments
Translator letter
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Consent Form
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
TRANSLATOR LETTER_TANYA_01312023.PDF
20174025 STUDY 4 MAIN CONSENT 01-25-2023.PDF

Attachment
Attachment Type
Consent Form
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
UCI IRB Approval Letter
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
20174025 STUDY 4 MAIN CONSENT 01-25-2023.DOCX
20174025 AMENDMENT APPROVAL LETTER 01-25-2023.PDF
SPANISH MPC FLYER.PDF

Attachment Type
Recruitment Material
File Comments
Stamped Spanish Version
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Recruitment Material
ENGLISH MPC FLYER.DOC
SPANISH MPC FLYER.DOC

File Comments
File Name
Status (IRB/hSCRO Use Only)
Lead Researcher Certi¦cation

Investigator's Assurance
As Lead Researcher, I have ultimate responsibility for the performance of this study, the protection
of the rights and welfare of the human subjects, and strict adherence by all co-investigators and
research personnel to all Institutional Review Board (IRB) requirements, federal regulations, and
state statutes for research involving human subjects.
I hereby assure the following:
1. The information provided in this application is accurate to the best of my knowledge.
2. The information provided in this application has been discussed and shared with my
Department Chair. Any requests for changes based on this discussion are included in this
application upon submission or will be initiated by the research team either during the IRB
review process or via an amendment.
3. All named individuals on this project have read and understand the procedures outlined in
the protocol and their role on the study.
4. All named individuals on this project have completed the required Educational research
tutorials and have been made aware of the "Common Rule" (45 CFR Part 46), applicable
Food and Drug Administration (FDA) regulations (21 CFR Parts 50, 56, 312 and 812), have
read the Belmont Report, and UCI's Federalwide Assurance (FWA) that are available on the
Human Research Protections Program (HRP) website.
5. All experiments and procedures involving human subjects will be performed under my
supervision or that of another qualified professional listed on this protocol.
6. I understand that, if the study described in this IRB application is supported by a federal
award or used as a basis for a proposal for funding, it is my responsibility to ensure that the
description of human subjects activities in the proposal/award is identical in principle to
that contained in this application. I will submit modifications and/or changes to the IRB as
necessary to assure the proposal/award and application are identical in principle.
I and all co-investigators and research personnel agree to comply with all applicable
requirements for the protection of human subjects in research including, but not limited to, the
following:
1. Obtaining the legally effective informed consent of all human subjects or their legally
authorized representatives (unless waived) and using only the currently approved, stamped
consent form (if applicable).
2. Per federal regulations, once a human research study has received IRB approval, any
subsequent changes to the study must be reviewed and approved by the IRB prior to
implementation except when necessary to avoid an immediate, apparent hazard to a
subject. See Reporting of Unanticipated Problems.
3. Reporting any unanticipated problems involving risk to subjects or others, including protocol
violations per UCI IRB policy. In addition, HIPAA privacy violations must be PROMPTLY
disclosed to the UCI Privacy Officer. There are time requirements for reporting these
breaches of confidentiality, which, if not met, may result in monetary damages to the
researcher and the institution.
4. Responding appropriately to subjects' complaints or requests for information about the
study; and reporting to the IRB any subject complaints that are not resolvable by the study
team.

5. Promptly providing the IRB with any information requested relative to the project.
6. Assuring the appropriate administration and control of investigational test articles (i.e.,
investigational drugs, biologics or devices) by a qualified investigator or other appropriate
individual or entity (e.g., UCI Health pharmacy), and assuring use and maintenance of an
Investigational Drug/Biologic Accountability Log or Device Accountability Log.
7. Registering applicable clinical trials with clinicaltrials.gov. For more information about this
topic, visit the ClinicalTrials.gov web page or the HRP webpage. The consequences of not
meeting the registration and reporting requirements include monetary damages to the
researcher and the institution.
8. Obtaining continuing review prior to study expiration (I understand if I fail to apply for
continuing review, approval for the study will automatically expire, and all human research
activities must cease until IRB approval is obtained).
9. Promptly and completely complying with an IRB decision to suspend or terminate its
approval for some or all research activities.
10
. Submitting to a routine review of human subject research records. The Compliance &
Privacy Office at UCI Health performs ongoing routine reviews of open biomedical research
protocols, in an effort to ensure in part that human subject research activities are conducted
in accordance with regulations, laws and institutional policies regarding the protection of
human subjects. In addition, the HRP unit of the Office of Research has developed the
Education Quality and Improvement Program (EQUIP). Through EQUIP, HRP staff conduct
periodic quality improvement monitoring and educational outreach.
11
. For clinical trials initially approved by the IRB on or after January 21, 2019, posting one (1)
IRB-approved clinical trial consent form at a publicly available federal website. The consent
form must be posted after recruitment closes, and no later than 60 days after the last study
visit. For additional guidance, refer to the OHRP FAQs on Informed Consent.
12
. Filing a final report with UCI HRP at the conclusion of this project.
As the Lead Researcher, I assure all of the above

Financial Disclosure
Investigators' Disclosure of Financial Interest
 
In order to inform research subjects of circumstances that may affect their decision to participate
in this study, all researchers are required to disclose their financial interests with outside
institutions.  
             
The Lead Researcher of the protocol must ask the following question of all study team
members:     
 
“Do you, your spouse/registered domestic partner, and dependent children together have any
disclosable financial interests (i) that would reasonably appear to be affected by the research; or
(ii) in entities whose financial interests would reasonably appear to be affected by the
research?"  
 
A member of the study team who answers in the affirmative will be contacted by the Conflict of
Interest Oversight Committee (COIOC) to obtain additional information regarding their specific
financial interest(s). 
 
IMPORTANT! If there has been a change in the financial disclosures of the LR or the study team,
please also request a 'Change in Financial Interests'.
As Lead Researcher, I certify that the disclosures for all study team members
are accurate
End of form. Please review responses for accuracy and
completeness.
Please ignore the Admin Details Section below. This section is for
IRB/hSCRO use only.

Administrative Details Form
Project Status
Committee:
IRB D
Project Status: 
Approved
Date of Project Determination:
December 31, 1969
Amendment Status:
Approved
Date of Amendment Determination:
February 2, 2023
Date of ERA Transcription:
January 19, 2022
Pre-2018 Common Rule:
No
Date of Transition to 2018 Common Rule:
December 31, 1969