A Patient-Centered Framework to Test the Comparative Effectiveness of Culturally and Contextually Appropriate Program Options for Latinos With Diabetes From Low-Income Households
Conditions: Diabetes Mellitus
Sponsor: University of New Mexico

PROTOCOL TITLE:  Comparing Program Options for Latinos with Diabetes
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PROTOCOL TITLE:
Official Title:
A Patient-Centered Framework to Test the Comparative Effectiveness of 
Culturally and Contextually Appropriate Program Options for Latinos with 
Diabetes from Low-Income Households
Short Title Also Used on Consents and Participant Documents:
Comparing Program Options for Latinos with Diabetes
PRINCIPAL INVESTIGATOR:
Name
Janet Page-Reeves
Department
Family & Community Medicine
Telephone Number
505-306-3041
Email Address
JPage-Reeves@salud.unm.edu
VERSION NUMBER:
V.5
DATE:
8-3-17

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Table of Contents
1.0
Objectives* ...............................................................................................................3
2.0
Background*.............................................................................................................3
3.0
Inclusion and Exclusion Criteria* ..........................................................................10
4.0
Study-Wide Number of Subjects*..........................................................................12
5.0
Study-Wide Recruitment Methods* .......................................................................12
6.0
Multi-Site Research* ..............................................................................................13
7.0
Study Timelines*....................................................................................................13
8.0
Study Endpoints*....................................................................................................14
9.0
Procedures Involved* .............................................................................................14
10.0
Data and Specimen Banking*.................................................................................20
11.0
Data Management*.................................................................................................21
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*.........................31
13.0
Withdrawal of Subjects*.........................................................................................31
14.0
Risks to Subjects*...................................................................................................32
15.0
Potential Benefits to Subjects* ...............................................................................32
16.0
Vulnerable Populations*.........................................................................................33
17.0
Community-Based Participatory Research*...........................................................33
18.0
Sharing of Results with Subjects* ..........................................................................36
19.0
Setting.....................................................................................................................36
20.0
Resources Available ...............................................................................................38
21.0
Prior Approvals.......................................................................................................41
22.0
Recruitment Methods..............................................................................................42
23.0
Local Number of Subjects ......................................................................................46
24.0
Confidentiality ........................................................Error! Bookmark not defined.
25.0
Provisions to Protect the Privacy Interests of Subjects ..........................................47
26.0
Compensation for Research-Related Injury............................................................49
27.0
Economic Burden to Subjects.................................................................................49
28.0
Consent Process......................................................................................................50
29.0
Process to Document Consent in Writing...............................................................53
30.0
Drugs or Devices ....................................................................................................54

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1.0
Objectives*
1.1
Describe the purpose, specific aims, or objectives.
The purpose of the data collected through this project is to investigate the 
comparative effectiveness of two evidence-based models for creating 
program cultural competency in diabetes self-management programming. 
We will compare two diabetes self-management programs that serve a 
large low-income Latino population and that employ different evidence-
based models of culturally competent health promotion. A priori, we 
believe patient populations for each program will be similar, yet we will 
compare sample characteristics and assess treatment differences after 
adjusting for possible population differences within our statistical models 
to mitigate self-selection bias and possible confounding. We will use a 
quasi-experimental design with an embedded, mixed-method approach. 
Specific Aims: 
Aim #1:  Characterize the ways that two culturally competent diabetes 
self-management programs interface with patient culture and 
socioeconomic context 
Aim #2:  Measure and compare improvement in patient capacity for 
diabetes self-management
Aim #3:  Measure and compare patient success at self-management   
1.2
State the hypotheses to be tested.
INFLUENCING FACTOR                PRIMARY PATIENT-REPORTED OUTCOME                  SECONDARY 
OUTCOME
The hypothesis of our study is that diabetes self-management programs 
are most successful if their design is culturally and contextually 
“situated.”36–38 Trickett proposes that cultural competence entails 
integrating components of an intervention “into the local expression of 
culture as reflected in the multiple levels of the ecological context.”38 
Rather than merely “tailoring” an existing intervention to target a specific 
context or population (for example, by offering recipes for healthy meals 
using Latino cuisine or providing educational materials in Spanish), he 
emphasizes the need for interventions to be “situated” to fit 
synergistically within broader community dynamics (culture and socio-
Effective Programmatic 
Interface w/ Patient Culture 
and Socioeconomic Context
Measured through program 
inventory and patient & social 
support participant 
perceptions of program 
cultural competence
Improved Capacity for 
Diabetes Self-Management 
      Measured through 
improvement in patient 
diabetes-related 
knowledge and self-activation
Successful Diabetes 
Self-Management
Measured through 
decrease in patient A1c and 
improvement in depression 
index score and BMI

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economic context). Following Trickett, and reflecting input from our 
patient partners, we believe that getting people to adopt lifestyle and 
behavior changes outlined in guidelines for diabetes self-management 
requires positively leveraging the cultural values and accommodating the 
socio-economic circumstances of a patient population in a way that 
creates synergy with specific social dynamics that define patients’ 
everyday lives.22–29,32,33
2.0
Background*
2.1
Describe the relevant prior experience and gaps in current 
knowledge.
The Specter of Uncontrolled Diabetes. Diabetes is among the Institute of 
Medicine’s top 25 national priorities for Comparative Effectiveness 
Research (CER).1 Twenty-nine million people or 9.3% of the U.S. 
population have type 2 diabetes.2 If trends continue, one third of U.S. 
adults will develop diabetes by 2050.2 While statistics this large can seem 
remote and impersonal, the patient members of our project team can put 
a human face on the numbers. Each of them has life-altering personal 
experience with diabetes. Not only do they have diabetes or pre-diabetes 
themselves, they also have family members or multiple family members 
with diabetes. Grimly, because uncontrolled diabetes is widespread 
among Latinos from low-income households, our patient team members 
have witnessed the terrible consequences of the disease: death, 
amputations, blindness, debilitating depression, and shattered lives. They 
report that diabetes is so common in the Latino community that people 
just assume that they will get it, and if they are diagnosed with diabetes, 
given what they have seen happen to their family and friends, they believe 
that diabetes is a death sentence about which there is nothing that they 
can do. So most of the time, they do nothing. As researchers, we were 
starkly confronted by this reality when two individuals affiliated with our 
preliminary patient-engaged research project died one month apart from 
complications of uncontrolled diabetes. These deaths were deeply 
disturbing and underscored the gravity of our work to understand the 
most effective way to help people develop the skills for diabetes self-care. 
Our patient team members fear diabetes not only for themselves and 
their adult family members, but also for the future that awaits their 
children growing up with the specter of diabetes but without the 
knowledge, capacity, or skills to take control of their own health destiny. 
Our proposed project seeks to disrupt this fatalistic dynamic of despair.  
As such, our partners, who are Latino patients from low-income 
households, their family members, and healthcare providers who serve 
this population of patients recognize effective diabetes self-management 
as a matter of life-and-death.
Diabetes Health Disparities. Although diabetes is a national health crisis, 
risk is not the same for everybody. Individuals from minority and ethnic 

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populations and those with low-income status are at significantly higher 
risk.3 This disparity brings the life-and-death reality of diabetes discussed 
in the preceding section even more negatively into relief. For example, 
Latinos are more likely (12.8%) than non-Hispanic whites (7.6%) to be 
diagnosed with diabetes,2 and Latino youth have the fastest growing rate 
of diabetes.4 According to an analysis of data from the U.S. National 
Longitudinal Mortality Study, Latinos are also 28% more likely to die from 
diabetes, with Mexican Americans (representing 33.5 million people or 
64.6% of U.S. Latinos and the overwhelming majority of the patients 
associated with the proposed research)5 50% more at risk.6 Not 
surprisingly, a recent national poll by Harvard, NPR, and the Robert Wood 
Johnson Foundation found that diabetes is the top health concern for 
Latino families.7 Similarly, poverty has an impact on diabetes risk. 
Research shows that individuals from low-income communities 
experience higher rates of diabetes.8–11 Analysis of National Health 
Interview Survey data found that the “greatest disparities [for diabetes 
risk] were experienced by the groups who had the lowest level of 
education, were living below the Federal Poverty Level (FPL), or both.”3 
This is a troubling concern for Latinos given the high level of Latino 
poverty (23.2%).12 In New Mexico, where Latinos make up 47% of the 
population,13 ethnicity and poverty both play a significant role in diabetes 
health and health disparities. For Latinos, rates for diabetes diagnoses 
(11.9%) and the diabetes death rate (45.9 per 100,000) are both more 
than twice those for non-Hispanic whites (5.3% and 22.5).14,15 Similarly, 
New Mexico is the second-poorest state in the nation after Mississippi, 
with poverty among Latinos (24% for 18-64 year-olds and 37% for 17-and-
under) significantly higher than among non-Hispanic whites (12% and 
13%).16 Individuals in New Mexico from low-income households are nearly 
three times more likely to be diagnosed with diabetes (14%) than 
individuals from households making more than $50,000 (5.2%),17 meaning 
that given the Latino poverty rate, diabetes risk for individuals from low-
income Latino households is disproportionately high.
Gaps in Evidence Related to Health Promotion Models for Diabetes Self-
Management. Biomedical approaches to diabetes care are well-
established, but pharmacologic therapies are often extremely costly, may 
have problematic health side effects, do not always result in the intended 
improvement in patients’ diabetes health, and regimens are not always 
easy to follow given social and environmental barriers faced by low-
income patients. Instead, health guidelines emphasize the important role 
of patient self-care over narrow reliance on medical treatments for 
reducing the health impact of diabetes and improving diabetes health 
outcomes. The Guide to Community Preventive Services instructs 
individuals to engage in lifestyle changes based on combined diet and 
physical activity improvements as the best way to prevent and manage 
type 2 diabetes.18 The Michigan Quality Improvement Consortium 
Guidelines for Management of Diabetes Mellitus recommend that 

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individuals be given “comprehensive diabetes self-management 
education.”19 Recommended Lifestyle and Self-management Guidelines 
from the American Diabetes Association discuss the importance of 
individualized education, monitoring, and counseling.20 We know how 
individuals can self-manage their diabetes or prevent pre-diabetes from 
becoming full diabetes – patient self-care through daily physical activity, a 
healthy diet, minimizing stress, and for those with full diabetes, regular 
glucose self-monitoring.21 But these are not things that can happen in the 
clinic or via prescription; they are things that the patient must do to care 
for him- or herself every day. The various guidelines tell us what needs to 
happen, but diabetes health outcomes are not improving.2 The guidelines 
do not provide a roadmap for getting individuals to embrace necessary 
self-care practices. However, systematic reviews have repeatedly 
demonstrated that culturally competent health promotion approaches 
that account for culture and the social context of poverty can be key to 
improving health outcomes.22–31 In particular, culturally competent self-
management interventions have been shown to significantly improve 
both glycemic control and behaviors related to diet and physical activity, 
and also to increase diabetes-related knowledge. As a result, “cultural 
competence” has become a buzz phrase in diabetes health promotion. A 
variety of different models have been developed to create “culturally 
competent” diabetes self-management programming. 22–31 Yet, there is no 
agreement on what cultural competence actually means or entails, and 
because of a continued emphasis on individual behavior in approaches to 
diabetes health promotion, the design of self-management programs 
does not always create cultural competence in a way that makes sense in 
relation to patients’ lives or improves their health.
2.2
Describe any relevant preliminary data.
How We Selected Appropriate Interventions and Comparators. 
We are collaborating on this project with two diabetes programs in 
Albuquerque. We selected these programs as comparators because they 
represent distinct evidence-based models for culturally competent 
diabetes self-management programming. We chose two sites 
implementing these models that actively serve a large number of Latino 
diabetes patients from low-income households in Albuquerque, New 
Mexico. Following Trickett,37,38 we believe that the program model that 
interfaces most synergistically with patient’s culture and everyday life 
circumstances will have the best diabetes health outcomes. 
Comparator #1. 
The Diabetes Self-Management Support Empowerment Model (DSMS).41 
The Center for Diabetes Education at the University of New Mexico 
Hospital (CDE-UNMH) bases its program on the Diabetes Self-
Management Support Empowerment Model (DSMS).41 The CDE-UNMH 
follows National Standards for Diabetes Self-Management Education,20 is 
certified by American Diabetes Association,42 and is accredited by the 
American Association of Diabetes Educators (AADE).43 The DSMS 

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Framework: The DSMS is a patient-centered, theoretically based 
educational framework. The DSMS combines a series of clinically informed 
group didactic sessions that use a patient self-determination approach to 
empower patients to take control of their own diabetes health with 
follow-up supports to sustain self-management gains achieved during the 
sessions. The AADE requires that educators acquire proficiency in 
culturally competent supportive care across the lifespan as one of five 
domains for certification so that educators can be informed about and 
aware of specific challenges that might accrue in the patient’s diabetes 
self-management experience. This program represents the gold standard 
for diabetes self-management education focusing on changing eating and 
physical activity behaviors, self-monitoring, risk reduction, and stress 
management. 
Implementation of the DSMS at CDE-UNMH: The CDE-UNMH program 
uses the DSMS group education approach. Patients attend a six-week 
group instructional session with nine hours of class plus a one-on-one 
follow-up with a certified diabetes educator to provide individualized 
support by creating a customized education plan. The group sessions have 
discussion supported by didactic conversation “maps” where the 
facilitator guides but does not control the conversation based on session 
thematic goals. Patients then complete self-assessment forms. This 
format is the foundation of the DSMS Model for creating patient 
empowerment and program cultural competence.
Comparator #2. 
The Chronic Care Model (CCM).31,44  The One Hope Centro de Vida Health 
Center Diabetes Program (One Hope) is based on the Chronic Care Model 
(CCM).31,44 The Chronic Care Model Framework: The CCM is “a systematic 
approach to restructuring medical care to create partnerships between 
health systems and communities”44 by addressing not only the medical 
but also the cultural and linguistic needs of patients through the inclusion 
of cultural competence in the delivery system design.31  The CCM involves 
six synergistic domains: 1.) Improved access to care, 2.) Patient self-
management support, 3.) Patient decision support, 4.) Care coordination, 
5.) Integrated health information systems, and 6.) Access to community 
resources. The use of the CCM framework has been shown to yield 
significant results in the treatment of diabetes and is being used widely in 
chronic disease management.45 To create a holistic care regime, the CCM 
focuses on addressing social determinants of health by meeting the 
medical, cultural, and linguistic needs of patients through integration of 
cultural norms and social relationships from the patient population into 
program design.31 
Implementation of the CCM at One Hope: The One Hope program is 
designed to address the specific needs of Latino patients from low-income 
households32,33 by creating comprehensive, integrated, wrap-around 
services focused on culturally competent care.31,44 One Hope emphasizes 
Spanish as the language for service provision33 and access to care 

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regardless of ability to pay. The One Hope facility provides a physical 
environment that reflects the lifestyle and economic capacity of patients 
to make them feel comfortable and that they “belong” (in contrast to 
more clinical, corporate, or academic medical settings). One Hope is a 
community-run clinic with a director and staff who are members of the 
community and who are culturally and economically similar to the 
patients they serve, reducing the hierarchical power relationship that 
generally exists between patients and providers. This approach is evident 
in the way that doctors at One Hope share decision-making by engaging 
the patient and their family members in creating a plan for diabetes self-
management.46,47 In addition, patients, caregivers and family members 
participate in a variety of program activities including cooking and 
nutrition workshops, zumba classes, and citas compartidas sessions 
(“shared appointments”).30,47–49  These shared appointment sessions allow 
patients, social supports and family members to share their stories and 
experiences in a peer support setting with facilitation by medically trained 
providers. But providers also “co-learn” from the patients.27,35,36 Through 
shared decision-making and shared appointments, providers learn about 
the realities of patients’ lives and their daily struggles at a level that goes 
beyond the interaction that normally occurs in a clinic. This helps the 
provider to be culturally competent by understanding diabetes from the 
perspective of the patient. Sharing experiences with peers and providers 
and including family members in activities offers a different level of social 
support for the patient by creating an enhanced feeling of intimacy and 
inclusion within the program. Innovative salidas (exit interviews), 
conducted routinely with all patients by a bilingual health navigator 
ensures that the patient understands and feels capable of implementing a 
doctor’s instructions, and integrates health system information by 
allowing the health navigator to communicate details of patient status 
back to the provider.32 
Using the CCM model, One Hope has had many patients improve their 
health, including individuals who have been able to reduce or stop taking 
their diabetes medication. One Hope staff note that people participating 
in the diabetes program have changed their food- and physical activity-
related behaviors and attitudes. Lowered blood sugar levels and improved 
diabetes self-maintenance have been reported anecdotally. One Hope 
conducted a preliminary analysis of patient medical records and found 
that CCM diabetes patients demonstrated statistically significant 
decreases in A1c values at months #5, 8, 11, 14, 18 and 22 after they 
joined One Hope’s program.102 
Our comparator choice will reduce the potential for biases and allow for 
direct comparisons.  The two comparator sites are distinct in their 
diabetes management program models, thus allowing (after controlling 
for other factors) for direct comparison of the effects of the program on 
the primary and secondary outcomes. This choice of comparators will 

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reduce the potential for bias for the following reasons: 1.) The two 
comparators serve relatively similar populations in terms of socio-
demographic attributes. 2.) Diabetes self-management program models in 
use at the two comparator sites have program attributes that are 
sufficiently distinct to allow contrast and comparison. And, 3.) Each of the 
comparator sites is implementing a program in a “real life” setting, thus 
providing the opportunity for a pragmatic assessment of the comparative 
effectiveness of the program models under externally valid and 
generalizable conditions. 
2.3
Provide the scientific or scholarly background for, rationale for, 
and significance of the research based on the existing literature and how 
will it add to existing knowledge.
Different models are being used to make diabetes self-management 
programs culturally competent. However, this variation creates 
uncertainty for a patient with diabetes who does not understand that 
programs can differ significantly, how they differ, or which programs offer 
them the best option. For Latino patients from low-income households, it 
is not clear which type of culturally competent self-management 
programming most effectively integrates their culture and accommodates 
their socio-economic circumstances in a way to best improve their 
diabetes health. The proposed research will help to fill this gap by using 
patient-identified issues of importance as measures for directly comparing 
different evidence-based models for culturally competent diabetes self-
management health promotion being implemented by programs that are 
currently available to Latino patients from low-income households in 
Albuquerque, New Mexico. PCORI supported us to develop this 
application through two “pipeline” awards (Tier I 2014 & Tier II 2015) to 
engage our patient stakeholders in conceptualizing CER to investigate 
“Culturally Appropriate Options for Diabetes Prevention and Care for Low-
Income Latinos.” Outside of our Tier I and Tier II projects, the cultural and 
contextual framework for research that we present here has not 
previously received PCORI funding. This framework aligns with PCORI’s 
interest in inclusiveness for under-served minorities.  Our patient-engaged 
preliminary research and the work of our PCORI Tier projects suggests 
that the proposed project will offer significant benefit to patients trying to 
find support for developing the knowledge and capacity to self-manage 
their diabetes.32,33 Our Patient Advisors recognize the imperative of 
everyday diabetes self-care stragegies. But the reality is that too many 
lack the skills to leave behind fatalistic attitudes regarding diabetes as 
their destiny and they have no way to develop the knowledge and 
capacity to successfully adopt the changes outlined in the guidelines, 
improve their Hemoglobin A1c (glycosylated hemoglobin), or successfully 
control their diabetes. Improving models and approaches for diabetes 
self-care health promotion is critical to the health of our Advisors, their 
adult family members, and their children. The results of this research have 

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implications for other Latino populations, for other minority patients, and 
for models for self-management for other chronic conditions.
How the Research is Focused on Questions that Affect Outcomes of 
Interest to Diabetes Patients and their Caregivers. 
“I have diabetes, but I am not just a patient. I am a person. I 
have cultural values and concrete realities that shape my 
everyday life. Both need to be considered for me to be able to 
feel that my care is making me well and to make it more likely 
that I can control my A1c. With this in mind, which of two self-
management programs is the most culturally and contextually 
appropriate option for me to take the best care of myself in 
relation to my diabetes?”[Translation from Spanish]
We co-developed this research question with a 10-member Patient 
Advisory Board of patients, social supports and researchers through our 
PCORI Tier I and II awards. Diabetes has been identified by our patient 
partners as a health issue of extreme urgency. Specifically, they are 
concerned about the failure of diabetes self-management programming 
to account for important dimensions of Latino culture or the social 
context created by poverty. At our PCORI Tier I Patient Advisory Board 
meetings, patients and social supports discussed these issues with us 
extensively and with emotion. What they had to say supported what we 
heard in previous conversations with patients and community members, 
and in our preliminary research.32,33 Patients, social supports and 
community members report: a.) A lack of cultural competence on the part 
of providers, b.) A lack of programming in Spanish, c.) Failure of program 
design to understand or accommodate the dynamics of Latino culture 
related to core values that prioritize both the importance of social 
relationships and the need to avoid personal conflict,34,35 d.) Poor program 
accommodation of the fact that patients lack resources,36 and e.) A lack of 
attention to the extent to which poverty results in low diabetes health 
literacy, low capacity to deal with chronic disease, and high stress.36 All of 
these factors influence patients’ ability to comply with recommendations 
regarding drugs, diet, and physical activity to self-manage their diabetes. 
We will use the above question and patient-reported outcome measures 
to guide a mixed-method comparative study of the effectiveness of two 
models of diabetes self-management programming currently being used 
by programs that serve a large population of Latino patients from low-
income households in Albuquerque, New Mexico. Each program employs 
a distinct evidence-based approach to create program cultural 
competence.  
3.0
Inclusion and Exclusion Criteria*
3.1
Describe how you individuals will be screened for eligibility.
Staff & Providers (n=36): 

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   Our Program Liaison at each site will identify up to 6 key program staff 
and/or providers per site each year for assessment interviews that will 
contribute to our understanding of the program sites. Our Research 
Manager will contact them using an IRB-approved script to invite them to 
participate and schedule appointments with those interested. At the 
appointment, the Research Manager will ask them to sign the consent and 
complete the contact portion of the Data Sheet only, and then will 
conduct the interview. 
Patient (n=240) & Social support (n=240) participants: 
    All patient participants will be individuals who have been identified by a 
provider as having pre-diabetes (A1c 5.7-6.4) or diabetes (A1c 6.5 or 
above) and are newly entering one of the two programs involved in this 
study (CDE-UNMH or One Hope). We will not enroll individuals who have 
already been participating at the sites as this would not allow us to gather 
data in line with our data collection protocol (baseline, 3, 6, and 12 
months). 
    At CDE-UNMH, when patients register for the program, CDE-UNMH 
staff will tell them about the study using an IRB-approved script and a 
flyer with pull-off tabs will be posted in the CDE office. An invitation with 
further detail about the research and contact information for our PDCSs--
the Patient Data Collection Specialists (PDCSs)--will be sent in a mailing 
that all new patients receive from CDE-UNMH with their class schedule 
confirmation and logistics. A staff person at CDE-UNMH or a member of 
the research team will phone new participants to tell them about the 
study. For those who indicate that they are interested, the staff person 
will ask the patient’s permission to release their name and contact 
information to our PDCSs. If the patient agrees, a member of the research 
team will contact the patient. Interested patients can also contact the 
PDCS using the information on the mailing. For all interested patient 
participants, the PDCS will screen them per our recruitment criteria. 
    At One Hope, participants will be identified in three ways: 1) New 
patients who call the clinic and indicate that they need to see a provider 
specifically about diabetes will be told about the study using an approved 
script, 2) Every patient seen at the clinic has an exit interview (salida) 
conducted by a Community Health Worker. For patients who have been 
told by their provider to have their A1c checked or that they have a 
diagnosis of diabetes or prediabetes, they will be told about the study 
using an approved script, and 3) Flyers about the study will be posted in 
the One Hope waiting room. For those who indicate interest in 
participating, a PDCS will contact them, inform them about the research 
per IRB requirements, and screen them for eligibility. For those who are 
eligible, the PDCS will schedule an appointment to consent them and 
gather baseline data. 

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    At both sites, interested patients who qualify will provide contact 
information for a person that they identify from their social network 
(family or friend) whom they consider as their primary “social support.” A 
member of the research team will contact the social support, provide 
them with information about the study, and invite them to participate. 
The PDCS will schedule an appointment with supports who are interested. 
   At the appointment, the PDCS will ask all participants to sign the 
consent, collect the information in the Participant Data Sheet, and collect 
responses to the baseline survey questions. The PDCS will also obtain a 
blood sample, measure BMI, and gather a hair sample for the patient 
only. 
    Subset of Patient and Social support Participants for Interviews (72) and 
Focus Groups (72): At each of the sites, the PDCS will identify a 
convenience sample of interviewees and focus group participants from 
those already recruited to be in the study and invite them to participate. 
Our Research Manager will contact those interested to schedule.
3.2
Describe the criteria that define who will be included or 
excluded in your final study sample.
Staff & Providers will be individuals who work at one of the two 
sites. 
Patients will be screened by a member of the research team. Patients will 
be adults (men and women) who have been identified by a provider as 
having pre-diabetes (A1c 5.7-6.4) or diabetes (A1c 6.5 or above) and: 1.) 
Enter one of the two diabetes programs during the study; 2.) Self-identify 
as “Latino;” 3.) Can identify a social support or key member of their social 
network who will agree to participate with them; 4.) Are not pregnant 
(participants who become pregnant during the study will be excluded); 
and 5.) Have household income 250% of the FPL or below. Participants 
who become pregnant during the study will be excluded. Additionally, we 
have discovered that there is a difference between the A1c test that CTSC 
runs and the test run at Quest or TriCore. The test CTSC uses is reliably .2 
lower and this is cited in the literature. Therefore, it is appropriate for us 
to enroll individuals who have a test at another lab that shows them to be 
pre-diabetic (A1c 5.7-6.4) even if our baseline lab comes back lower (5.5-
6.2). However, any individual whose blood gathered by our data collectors 
at baseline returns with an A1c below 5.5 will be disenrolled. 
Social supports will be adult individuals who are identified by the 
patient participants and who agree to participate.
Advisory Board Members will be seven members of our Project 
Patient Advisory Board.

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3.3
Indicate specifically whether you will include or exclude 
each of the following special populations: (You may not 
include members of the above populations as subjects in your 
research unless you indicate this in your inclusion criteria.)
1.
Adults unable to consent
2.
Individuals who are not yet adults (infants, children, 
teenagers)
3.
Pregnant women
4.
Prisoners
We will not recruit: 
Adults unable to consent
Individuals who are not yet adults (infants, children, 
teenagers)
Prisoners
Pregnant women. 
At enrollment, we will screen to specifically exclude participants 
who are pregnant. There is no risk to a pregnant woman or a fetus 
entailed in participation in this study because the study only 
involves data collection from individuals who have been 
instructed to participate in a diabetes self-management program 
by their provider. However, we will exclude pregnant individuals 
because we recognize that pregnancy could impact outcomes in a 
way that will influence our scientific analysis of diabetes self-
management. At each data collection point, we will ask female 
participants if they are pregnant. If we discover that a participant 
has become pregnant during the course of the study, they will be 
given an end–of-study visit to end their participation and their 
data will be excluded.  Co-I Burge will give them a referral to the 
UNM specialty prenatal clinic for high-risk pregnancies. It will be 
made clear to them that ending their participation in our study 
does not affect their ability to continue participating in the 
diabetes program that they attend.
This study involves regular screening for A1c levels.  For A1c (>10), 
we will notify the participant’s PCP. If we see a lab value that 
could indicate an emergency (Glucose > 400 mg/dl, < 60 mg/dl), 
we will contact the participant to make sure they are aware of 
their A1c status and that they are receiving appropriate care. If 
the participant would like more information about what to do, Co-
Investigator Dr. Mark Burge will advise them. For women with an 
elevated A1c, when we contact them to tell them about their 
elevated test results we will inquire whether or not they are or 
think they might have become pregnant since entering the study.  

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If so, Co-Investigator Burge will provide them with a referral to 
UNM’s High Risk Obstetrics Clinic.
4.0
Study-Wide Number of Subjects*
4.1
If this is a multicenter study, indicate the total number of 
subjects to be accrued across all sites.
N/A
5.0
Study-Wide Recruitment Methods*
If this is a multicenter study and subjects will be recruited by 
methods not under the control of the local site (e.g., call 
centers, national advertisements) describe those methods.  
Local recruitment methods are described later in the 
protocol.
N/A
6.0
Multi-Site Research*
6.1
If this is a multi-site study where you are the lead 
investigator, describe the processes to ensure communication 
among sites, such as:
N/A
6.2
Describe the method for communicating to engaged 
participating sites:
N/A
6.3
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for 
maintenance of confidentiality.
N/A
7.0
Study Timelines*
7.1
Describe:
1.
The duration of an individual subject’s participation in 
the study.
Each year up to 12 staff or provider participants (6 per site) 
will be enrolled to do one 2-hour interview.

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Each patient and social support participant will be enrolled 
for 12 months.  We will gather data at baseline, 3 months, 
6 months and 12 months.  Data collection appointments 
will last approximately 1 hour. A subset of patient and 
social support participants will be invited to do an 
interview or a focus group. Interviews and focus groups 
will last approximately 1-2 hours.
Seven Patient Advisory Board members will be asked to 
participate in a series of interviews between June 1, 2017 
and August 4, 2017. Interviews will last 1-3 hours. 
2.
The duration anticipated to enroll all study subjects.
Enrollment will begin in month 3 of the study. 
Enrollment will end in month 22. 
Data collection will end in month 34.
3.
The estimated date for the investigators to complete this 
study (complete primary analyses)
This study is a 3-year project. It is slated to end in month 36.  
The study was funded to begin November 1, 2016 and the 
official end date is October 31, 2019. We anticipate 
continuing to analyze data for six months to one year 
following the official end of the project.
8.0
Study Endpoints*
8.1
Describe the primary and secondary study endpoints.
Participation is voluntary and participants may continue 
participation or stop at any point with no safety concerns.  This 
study involves data collection only.  We are not asking anyone to 
participate in health-related activities as an intervention.  They 
are participating in a diabetes self-management program 
recommended to them by their doctor and we are inviting them 
to help us understand their experience with that. There are no 
drug or device interventions for this research project. Women 
who become pregnant during the study will be given an end-of-
study meeting and their participation will end. Additionally, we 
have discovered that there is a difference between the A1c test 
that CTSC runs and the test run at Quest or TriCore. The test 
CTSC uses is reliably .2 lower and this is cited in the literature. 
Therefore, it is appropriate for us to enroll individuals who have 
a test at another lab that shows them to be pre-diabetic (A1c 
5.7-6.4) even if our baseline lab comes back lower (5.5-6.2). 
However, any individual whose blood gathered by our data 

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collectors at baseline returns with an A1c below 5.5 will be 
disenrolled.
8.2
Describe any primary or secondary safety endpoints.
See above 8.1.
9.0
Procedures Involved*
9.1
Describe and explain the study design.
This project adheres to PCORI methodological standards. Patient-reported 
outcomes measured with validated and reliable instruments will be the 
basis for us to compare the effectiveness of two distinct evidence-based 
models for culturally competent diabetes health promotion through 
research with two diabetes self-management programs that each 
currently serve a large Latino patient population from low-income 
households in Albuquerque, New Mexico. Data will be gathered at 
baseline, and 3, 6, and 12 months by paid PDCSs (PDCSs) from the target 
patient population who will be members of the research team. A priori, 
we believe patient populations for each program will be similar, yet we 
will compare sample characteristics and assess treatment differences 
after adjusting for possible population differences including the use of 
propensity scores in our statistical models to mitigate self-selection bias, 
possible confounding, and heterogeneity of treatment effects. Trickett’s 
conceptualization of “cultural situated-ness” discussed above provides the 
theoretical framework for this study.37,38 We follow National Institutes of 
Health (NIH) standards for mixed method research set by Creswell and 
colleagues39 in our “embedded mixed method” research approach, 
integrating data from quantitative and qualitative components of the 
study in an iterative fashion.39 Our quasi-experimental research design 
with pre-/post-testing will accommodate the fact that we are working 
with existing programs at two sites and that we will recruit patients who 
enter those programs during the study.40 Our sample size (N=240) and 
power estimates are based on realistic evaluation of effect size. We 
provide a detailed project timeline with specific deliverables that include 
scientific and engagement milestones. We have assembled a research 
team with the expertise and experience in patient-engaged research 
necessary to conduct the proposed study and we have an institutional 
infrastructure that supports our academic and community partnerships.
9.2
Provide a description of all research procedures being 
performed and when they are performed, including 
procedures being performed to monitor subjects for safety or 
minimize risks.
Data Collection.  
We have created a high-quality and feasible data collection plan. The 
purpose of the data collected will be to investigate the comparative 
effectiveness of two evidence-based models for culturally competent 

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diabetes self-management programming. We are obtaining approval for 
this study from the UNM Human Research Protections Office and we will 
obtain written informed consent from all participants. 
Pre-Screening: Potential patient participants at the CDE-UNMH program 
will be called by a CDE-UNMH staff member or a member of the research 
team and asked if they might be interested in participating in the study. If 
they say yes, they will be asked for their contact information to be 
contacted for an eligibility screening appointment. The information will be 
collected on a Pre-Screening form and given to the Patient Engagement 
Coordinator, who will enter it into the Pre-Screening project in REDCap. 
Eligibility Screening: potential participants who agree to being screened 
for eligibility will be contacted by a member of the research team and 
asked the eligibility screening questions, including requesting information 
about a potential social support partner. The patient participant will be 
offered the opportunity to contact their potential social support partner 
to inform him or her that a research team member will be in contact to 
conduct an eligibility screening. When the patient partner gives 
permission to contact the potential social support partner, a member of 
the research team will contact the potential social support partner and 
conduct the eligibility screening. If both the patient participant and his or 
her social support partner are deemed eligible, baseline data collection 
appointments will be scheduled with both participants. The information 
collected during the eligibility screening will be hand-written on an 
Eligibility Screening form and given to the Patient Engagement 
Coordinator, who will enter it into REDCap in the Eligibility Screening 
project. The Patient Engagement Coordinator will then create a record for 
the participant in the PCORI Diabetes Project in REDCap and assign a 
participant ID (PID) to the participant. The Patient Engagement 
Coordinator will keep a master list of the participants’ names and PIDs 
both electronically and in hard copy. The electronic copy will be saved on 
her password-protected laptop, which is stored in a locked cabinet at One 
Hope when not in use. The hard copy will also be stored in a locked 
cabinet at One Hope. 
Data Collection: at the baseline data collection appointment, the PDCS will 
collect and enter contact and demographic information into separate data 
collection instruments in the PCORI Diabetes Project in REDCap. At the 
baseline and all three follow-up appointments, the PDCSs will also 
administer the survey instrument to the participants, responses to which 
will be entered into a third data collection instrument in the same project. 
The PCDSs will also collect BMI measurements (weight and height) and 
draw blood for A1c testing at the baseline and all follow-up appointments 
and will collect a hair sample at the baseline and six-month follow-up 
appointment. The BMI measurements will be entered into a fourth data 
collection instrument in the PCORI Diabetes Project by the PDCS during 

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each appointment. The A1c results will be entered into a fifth data 
collection instrument and the hair cortisol results entered into a sixth in 
the same project by the Data Manager when the results are provided to 
her by the respective labs. 
The contact and demographic information data collection instruments are 
the only data collection instruments in the PCORI Diabetes Project that 
contain personally identifying information. The data collection 
instruments that contain the participant’s survey responses and biological 
measures do not contain any personally identifying information. Each 
participant’s data is linked across the six data collection instruments in the 
PCORI Diabetes Project by his or her unique Study ID, which is 
automatically generated by REDCap when the Patient Engagement 
Coordinator generates the initial record (when assigning the PID). 
In sum, there will be three separate projects in REDCap: the Pre-Screening 
project, the Eligibility Screening project, and the PCORI Diabetes Project, 
which contains the participant contact information, demographic 
information, survey responses, BMI measurements, A1c results, and hair 
cortisol results in six separate data collection instruments. The PID that is 
generated before the baseline data collection appointment will be 
retroactively added to the relevant record in both the Pre-Screening and 
Eligibility Screening projects by the Research Manager or the Data 
Manager to allow for tracking of recruitment, enrollment, and attrition. 
This will be the only link across the three projects. 
Participants’ personally identifying information will be gathered and 
entered into REDCap at all three stages – pre-screening, eligibility 
screening, and baseline data collection. We will protect and limit access to 
this information in the following ways: 
   1) after the Patient Engagement Coordinator enters the information 
from the hard copy pre-screening and eligibility screening forms into 
REDCap, the hard copies will be turned over to the Research Manager, 
who will file them in a locked filing cabinet in a locked office at the UNM 
HSC OCH; 
   2) Access to the data in both the Pre-Screening project and the Eligibility 
Screening project will be limited to the Patient Engagement Coordinator, 
the Data Manager, the Research Manager, the PIs, the Senior Statistician, 
and the Biostatistician for purposes of entering data (Patient Engagement 
Coordinator) and exporting data for quality control, and data analysis (PIs, 
Data Manager, Research Manager, Senior Statistician, and Biostatistician. 
Any data resulting from the quality control or analysis processes that will 
be shared with others on the research team will be de-identified before 
sharing.); 
   3) Access to the instruments within the PCORI Diabetes Project can be 
limited. Access to all the data (including identifying information) in all the 

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data collection instruments will be limited to the Data Manager, the 
Research Manager, the PIs, the Senior Statistician, and the Biostatistician 
for purposes of quality control and data analysis (any data resulting from 
these processes that will be shared with others on the research team will 
be de-identified before sharing). The Patient Engagement Coordinator, 
the PI and the Co-I will have access to de-identified data in this project. 
Appointments will be scheduled and tracked in this project using the 
Calendar tool in REDCap. In order to be able to provide the data collectors 
with the information necessary to meet with participants, the 
appointments in the Calendar tool will include the participant’s name, 
phone number, and address (if meeting the participant in his/her home). 
REDCap is a safe place to store personally identifying information because 
it is a password-protected site that is stored behind the UNM HSC firewall. 
In order for research team members to access it from on-campus, they 
must be logged into the HSC secure wifi; off-campus (i.e., outside the 
firewall), they must use the Cisco virtual private network (“VPN”), access 
to which is only allowed after being approved by the university’s 
Information Technologies Department. Access to the REDCap database is 
further secured by the fact that the iPads used by the data collectors and 
the laptops or desktops used by other members of the research team 
(with user rights) are password-protected. In addition, project 
administrators have the ability to limit access to data collection 
instruments or projects for other members of the research team.
The length of participation in the project for each individual participant is 
12 months. All study activities will be conducted in English or Spanish, 
depending on the language preference of the participant. For each 
component of the study (e.g., survey/A1c/BMI data collection/hair data 
collection, interviews, focus groups, etc.), the participant will receive a 
$50 incentive. We will use a variety of data sources including program 
inventories, surveys, interviews, focus groups, and patient physical 
measures. Domains of inquiry for both quantitative and qualitative 
methods include: a.) Program accommodation of patients’ language 
preference, cultural values, and socio-economic limitations, b.) Program-
related interpersonal interaction and communication, c.) Program design 
to encourage social support among participants, d.) Social “fit” with and 
social support from program peers, e.) Social support from program staff, 
f.) Diabetes health knowledge, g.) Diabetes self-activation, h.) Stress 
management, i.) A1c control, and j.) Lifestyle changes to support diabetes 
health. Program assessment data will allow us to characterize the nature 
of each program and its approach to cultural competence. Survey 
responses and clinical test results from a large sample at each site will 
yield empirical (quantitative) data on patient-reported outcomes. 
Interviews and focus groups with a subset of participants will provide rich, 
in-depth, empirical (qualitative) data regarding the domains of inquiry 
from the perspective of patients, social supports, and program 

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staff/providers. It is not possible to gather this latter type of data through 
a survey or in quantity.  Both quantitative and qualitative data are 
necessary for us to achieve the understanding entailed in comparing the 
effectiveness of the two models for creating program cultural competence 
in relation to the domains of inquiry.  
Programmatic assessment. We will inventory each program regarding 
program design, size, structure, operation, and theoretical/philosophical 
orientation; professional qualifications/training of program providers; 
activities or resources available through the programs; strategies in place 
for Spanish language use or acceptance, inclusion of social supports and 
family, accommodation of challenges created by patients’ limited 
socioeconomic circumstances, and the inclusion of stress management 
techniques; and data on referrals to the program, sign-ups, participation, 
no-shows, and attrition. We will conduct up to 36 interviews with key 
staff and/or providers (6/year x 2 sites x 3 years) to obtain their 
perspectives on implementation of the programs during the period of the 
study. Interview questions will be semi-structured to allow participants to 
contribute to the direction of the interview in relation to issues and ideas 
that they consider to be most relevant and important. Interviews will be 
audio-recorded and transcribed. We will assess patient and social support 
perceptions of the program interface using a cultural competence 
survey88,89  that asks about physician bias, inter-cultural understanding, 
respectful interactions, language barriers, experiences of discrimination, 
and issues of trust. Administration of the survey is described in the 
paragraph immediately below this one. The cultural competence portion 
of the survey will not be administered at baseline as the participant will 
not yet have experience with which to rate the program. To gather 
qualitative information, we will include questions on programmatic 
interface in interviews and focus groups with patients and social supports 
that are described two paragraphs below.
Surveys. We will hire four individuals from the population of study to work 
as PDCSs. The PDCS at each site will administer a survey orally to all 
patient and social support participants at baseline (when they enter the 
study), with follow-up at 3, 6, and 12 months. The survey will consist of 
questions from or modified from four validated and reliable tools: 1.) The 
Consumer Assessment of Healthcare Providers and Systems Cultural 
Competence Set (CAHPS-CC)88,89 [as part of the programmatic assessment 
discussed in the preceding paragraph—will be administered at 3, 6 and 12 
months only]; 2.) The Diabetes Knowledge Questionnaire (DKQ)51–53,112; 3.) 
The Patient Activation Measure (PAM-13)55–62,113; and 4.) The Patient 
Health Questionnaire 9 (PHQ-9).70–73 
Interviews with patient and social support participants. We will conduct 
72 interviews with patients and social supports (12/year x 2 sites x 3 
years). Following Guest, Bunce and Johnson,112 and Janet’s own 
experience with interview data, we believe that data sets of 12 interviews 
per site per year will capture a sufficient range of responses to achieve 

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thematic saturation. Our sampling frame for each set of 12 interviews will 
include six patients and six social supports. Interviews will be conducted 
with the social supports who correspond to the six patient interviewees. 
Interviews will follow the same format described in the programmatic 
assessment above. Spanish transcripts will be translated into English for 
analysis.
Focus groups. We will conduct 12 focus groups (2/year x 2 sites x 3 years). 
Focus group participants will be distinct from those recruited to 
participate in the interviews described in the preceding paragraph.  Focus 
groups will include six distinct participants each (three patients and their 
corresponding social supports per focus group x 12 focus groups = 72 
participants). The focus group questions and protocol will be an 
adaptation of that described above for the interviews.
Physical Measures. These measures will be obtained from patients at 
baseline with follow-up at 3, 6, and 12 months: 
     A1c: The PDCSs will be trained in phlebotomy. The PDCS will draw 
blood samples at the same time they administer the survey. The UNM 
Clinical and Translational Science Center (CTSC) Clinical Research 
Laboratory will provide the collection kits for specimen collection. 
Blood will be drawn, labeled and stored using standard phlebotomy 
protocols, and the Patient Engagement Coordinator will deliver 
specimens to the CTSC lab where they will be tested on whole blood 
following the lab’s “Hemoglobin A1c” procedure using the DCA 
Vantage 2000 analyzer91. After testing, specimens will be disposed of 
according to CTSC lab protocol. For A1c (>10), we will notify the 
participant’s PCP. If we see a lab value that could indicate an 
emergency (Glucose > 400 mg/dl, < 60 mg/dl), we will contact the 
participant to make sure they are aware of their A1c status and that 
they are receiving appropriate care. For women with an elevated A1c, 
when we contact them to tell them about their elevated test results 
we will inquire again whether or not they are or think they might be 
pregnant.  If so, Co-Investigator Dr. Mark Burge will provide them with 
a referral to UNM’s High Risk Obstetrics Clinic. Additionally, we have 
discovered that there is a difference between the A1c test that CTSC 
runs and the test run at Quest or TriCore. The test CTSC uses is 
reliably .2 lower and this is cited in the literature. Therefore, it is 
appropriate for us to enroll individuals who have a test at another lab 
that shows them to be pre-diabetic (A1c 5.7-6.4) even if our baseline 
lab comes back lower (5.5-6.2). However, any individual whose blood 
gathered by our data collectors at baseline returns with an A1c below 
5.5 will be disenrolled.
     Body Mass Index (BMI): The PDCS will document patient 
participant height and weight and calculate his or her BMI. Height and 
weight measurements will be taken using a standardized protocol. 
Height measurements will be collected using SHORR boards against 

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flat walls on level, firm (not carpeted) flooring. Weight measurements 
will be collected using calibrated, research-grade SECO scales. Two 
measurements will be taken for height and two for weight for each 
participant at each data collection point. An average of the two 
measures of height and an average of the two measures of weight will 
be used in the BMI calculation. 
     Hair cortisol: We will measure patient stress levels by testing hair 
samples to identify circulating levels of cortisol as a biological marker 
for chronic stress. Hair will be gathered from patients only and not 
from social supports, and will only be gathered at two timepoints: 
baseline and 6 months. Hair cortisol is an emerging valid biomarker 
for chronic stress.92 Alternations in cortisol have been uniformly 
identified in various forms of chronic stress.93–97 Cortisol inhibits 
glucose uptake, and as an anabolic hormone, it activates glucose 
production. Cortisol levels are altered in people with chronic stress 
(sometimes low, but most often higher than normal). Chronic levels of 
cortisol can be measured in hair, similar to chronic levels go glucose 
measure in A1c. Recently, measurements of cortisol levels in hair have 
proven useful to determine the long-term effects of stress.83,92,99,100 
Typical hair growth rate is 1 cm per month. Thus, by testing 1 cm of 
100-150 strands of hair from the crown of the head (a thickness less 
than that of a pencil), an average cortisol level over the corresponding 
month can be obtained. This measure will provide important novel 
data because we believe that a culturally competent diabetes self-
management program would help people deal with not only the 
stress of having diabetes and feeling like it is a death sentence by 
learning everyday self-management strategies, but also because 
having a feeling of connectedness through a health promotion 
program can provide emotional support and relief and thereby 
decrease the stress and decrease insulin resistance (which is the 
pathophysiological basis of diabetes type 2 in most a cases). 
      Co-I Bearer will lead analysis of hair samples. In preliminary studies 
Bearer's group has found that more than 90% of subjects agree to hair 
samples. The PDCS will use scissors to collect a pencil-width of hair 
from the crown of the head. One centimeter of hair closest to the 
scalp will be used to measure hair to determine the average cortisol 
level over the previous month. The hair will be stored in a plastic bag 
in a cool locked drawer in the office of the PI. In Bearer’s lab at UNM, 
hair will be pulverized in a Retsch Mixer Mill Type MM 400 100-240V 
50/60HZ an, extracted in methanol overnight, dried and resuspended 
in buffer. Cortisol concentration is measured by an immunoassay or 
by high-pressure liquid chromatography. Control samples containing 
specific amounts of cortisol are provided by the vendor with each 
assay kit, and we also use an internal control. We will use an 
automated colorimetric 96-well plate reader to measure the results. 
Cortisol levels are compared with average levels from normal 
subjects. The Bearer group has determined the normal average levels 

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and the 95% confidence interval. Control measurements are done 
with random hair samplings from non-diabetic individuals combined 
and used as a standard for all measurements. Measurements are 
compared to the average and determined to be within normal limits 
or not. This is a standard method for reporting all clinical pathology 
laboratory measurements diagnostically.
Interviews with Project Patient Advisory Board members. Our Summer 
Research Intern will conduct a series of interviews with the seven 
members of our Patient Advisory Board during June and July 2017, and we 
will hold a quarterly meeting of the Advisory Board in July. The interviews 
will be designed to obtain information about their personal experience 
with diabetes, their experience on our Patient Advisory Board and 
working on a research project, and how they would like to deepen their 
involvement over the next three years in this new phase of the research. 
At the end of July we have a Patient Advisory Board meeting scheduled.  
Patient Advisors normally attend these meetings. At the July meeting, our 
Research Intern will present her findings and a poster she is required to 
create based on her research back to the group.
9.3
Describe:
1.
Procedures performed to lessen the probability or 
magnitude of risks.
We do not foresee any major risks, hazards or side effects to the 
subjects related to participation in the research.  Risk of a breach of 
privacy is low because of procedural safeguards in place and 
because RedCAP is a secure data capture system and because 
access to identifying information will be limited.   Some individuals 
feel anxious when they answer questions about themselves or their 
experiences and perspectives. To minimize the risk of this, before 
gaining informed consent of individuals, investigators will clearly 
explain the research, the risks to participants, and the procedures 
for safeguarding their privacy. Participants will be informed that 
they can refuse to answer any questions and stop the survey, 
interview, data collection, or participation in a focus group at any 
time. The investigators will have training and will understand the 
importance of these issues and their responsibility for maintaining 
high ethical standards and they will have current human subjects 
research training certification. In relation to A1c, participating in our 
study will not impact A1c levels, but because we will be gathering 
information about patient A1c, we have developed a response 
protocol if we detect elevated A1c levels: For A1c (>10), we will 
notify the participant’s PCP. For A1c (>10), we will notify the 
participant’s PCP. If we see a lab value that could indicate an 
emergency (Glucose > 400 mg/dl, < 60 mg/dl), we will contact the 
participant to make sure they are aware of their A1c status and that 

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they are receiving appropriate care. For women with an elevated 
A1c, when we contact them to tell them about their elevated test 
results we will inquire again whether or not they are or think they 
might be pregnant.  If so, Co-Investigator Dr. Mark Burge will 
provide them with a referral to UNM’s High Risk Obstetrics Clinic 
and they will be excluded from the study.
2.
All drugs and devices used in the research and the 
purpose of their use, and their regulatory approval 
status.
N/A
3.
The source records that will be used to collect data 
about subjects. (Attach all surveys, scripts, and data 
collection forms.)
Attached please find:
1.
One Hope Waiting Room Flyer 
2.
One Hope Patient Recruitment Script (Revised)
3.
CDE-UNMH Patient Recruitment/Consent Script 
(Revised)
4.
CDE-UNMH Patient Recruitment Letter
5.
Social Support Recruitment Script (Revised)
6.
Staff & Provider Interview Recruitment Script
7.
Patient Advisory Board member interview Recruitment 
Script (English and Spanish)
8.
Consent Form (Revised)
9.
Advisory Board Consent Form (English and Spanish)
10. Participant Data Sheet (Revised)
11. Survey Instrument (Revised)
a.
The Consumer Assessment of Healthcare 
Providers & Systems Cultural Competence Set 
(CAHPS)
b.
The Diabetes Knowledge Questionnaire (DKQ)
c.
The 13-Question Patient Activation Measure 
(PAM-13)
d.
The Patient Health Questionnaire #9 (PHQ-9)
e.
Stress and Hair Questionnaire 
f.
Additional questions for survey (English and 
Spanish)
12. Key Provider/Staff Interview Questions
13. Patient Interview Questions
14. Social Support Interview Questions
15. Focus Group Questions
16. Advisory Board Interview Questions (English and 
Spanish)

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17. Risk of Self Harm Protocols in English and Spanish
9.4
What data will be collected including long-term follow-up.
Consent forms, Contact sheets, Participant Data Sheets, responses to 
the Survey Instrument, Interview Data, Focus Group data, patient 
A1c, patient BMI, patient hair samples for cortisol testing, program 
inventory data from both sites.
9.5
For HUD uses provide a description of the device, a 
summary of how you propose to use the device, including a 
description of any screening procedures, the HUD 
procedure, and any patient follow-up visits, tests or 
procedures.
N/A
10.0
Data and Specimen Banking*
10.1 If data or specimens will be banked for future use, describe 
where the specimens will be stored, how long they will be 
stored, how the specimens will be accessed, and who will 
have access to the specimens.
Hair samples are being collected as part of the data collection for this 
project. We are seeking funding to allow us to analyze the hair samples. 
Hair samples can be stored for up to two years before being analyzed.  We 
will store hair samples in plastic bags in a cool, locked drawer in the office 
of the PI. The PDCS will gather the sample, wrap it in tin foil to keep the 
sample in a coherent bunch, place the foil-wrapped sample in a plastic 
bag, label it with the PID and give the bag to the Patient Engagement 
Coordinator. The Patient Engagement Coordinator will transfer the 
sample to the UNM Research Manager. When we obtain funding for the 
analysis, we will send the de-identified numerically labeled samples to the 
UNM lab of Co-I Bearer for analysis.  The names correlating with the ID 
will be kept in a locked drawer in the PI’s office.
In general, we are committed to making our data available to other 
researchers to contribute to knowledge about cultural competence and 
diabetes self-management program models. Following the end of the 
study, the quantitative data will be de-identified within nine months and 
made available to PCORI and to researchers by request. Interview and 
focus group transcripts will not be shared because this data will have been 
gathered from a small sample that represents a small community and will 
contain a large amount of personal information that would identify the 
participant.
The UNM CTSC Bioinformatics Data Warehouse will assist us in assuring all 
the quantitative data is properly de-identified at the end of the project.  
Blood samples will be destroyed following analysis.  Hair samples will be 

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stored until they can be analyzed. After analysis, any left over hair will be 
stored until we are certain that we had enough of a sample for testing. 
The data gathered for the A1c analysis, BMI, and hair cortisol will include 
the participants’ study ID but no personally identifying information that 
could be linked to the participant. 
The de-identified data will then be placed in the UNM data repository, 
LoboVault and embargoed for at least five years. LoboVault is a 
designated long-term digital archive resource maintained by the 
University of New Mexico Libraries. In addition to the use of Dublin Core 
for descriptive metadata, the archive provides daily file integrity and 
format verification and will additionally create and maintain technical and 
administrative metadata using the widely adopted Metadata Encoding 
and Transmission Standard (METS) and Preservation Metadata 
Implementation Strategies (PREMIS) metadata standards. These 
additional metadata include digital file signatures and checksums for 
bitwise integrity validation and chain of custody documentation. Primary 
responsibility for curating and preparing the data for archiving rests on 
the Data Librarians at the University of New Mexico Libraries. As a 
publishing and sharing platform, LoboVault is an instance of the widely 
adopted DSpace repository application (http://www.dspace.org/). Data 
will be embargoed for a specified period of time, during which descriptive 
information and metadata are discoverable but the data and content files 
themselves can only be accessed via an email request to the authors. 
Should a researcher be interested in accessing the data, he or she would 
then request access by emailing the PI and/or members of the research 
team chosen by the PI. When a request to access the project data is 
received, we will implement the following data sharing protocol, which 
conforms to the data sharing standards established by the NIH. We will 
provide the opportunity for data sharing through the following avenues:  
1.) We will share all research data as requested in accordance with federal 
regulations and the Freedom of Information Act (FOIA).  2.) We will share 
research tools and data with other researchers for analysis and/or 
replicating the research. The Research Team will review requests from 
researchers and, after approval from our patient partners, we will work 
with the requesting researchers to create a data-sharing agreement per 
NIH protocol, policies and procedures.  3.) We will make the data and 
associated documentation available to users only under a Data-Sharing 
Agreement that:  a.) defines a commitment to using the data only for 
research purposes and not to identify any individual participant; b.) 
defines a commitment to securing the data using appropriate computer 
technology; c.) demonstrates a high-quality research proposal 
(significance, innovativeness, approach, and community benefit); d.) 
proposes a comprehensive dissemination plan (to community and 
scientific audiences); e.) covers administrative costs to prepare data and 
related documentation requested; f.) demonstrates appropriate approvals 
of research protocols by the institutional Human Research Review 
Committee; g.) demonstrates certification in research ethics, including the 

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HIPAA Research Training Course and the Collaborative Institutional 
Training Initiative (CITI) Human Subjects Protection Training; and h.) 
demonstrates a commitment to destroying or returning the data after 
analyses are completed. The requesting researchers will be required to 
acknowledge our project, research team, our patient partners, and PCORI 
as a funder in any presentations, abstracts, or publications developed 
from use of the shared data.
10.2 List the data to be stored or associated with each specimen.
Hair samples will be labeled with the PID assigned to the participant.
Hair samples labeled with the PID will be stored in a locked drawer in the 
office of the PI until they can be analyzed.  They will not be associated 
with data. Results that are obtained from analysis of the hair samples will 
be stored on a secure database in REDCap. Results of the hair analysis will 
be stored together in REDCap with data obtained from: Results of patient 
A1c analysis, patient height and weight, psychosocial data from survey 
results, and participant data sheet information. Information about 
participation in interviews and focus groups will also be stored in REDCAP 
but the transcripts will be stored separately. The Patient Engagement 
Coordinator will keep a master list of the participants’ names and PIDs 
both electronically and in hard copy. The electronic copy will be saved on 
her password-protected laptop, which is stored in a locked cabinet at One 
Hope when not in use. The hard copy will also be stored in a locked 
cabinet at One Hope.
10.3 Describe the procedures to release data or specimens, 
including: the process to request a release, approvals 
required for release, who can obtain data or specimens, and 
the data to be provided with specimens.
Co-I Bearer will be in charge of all analysis of hair samples. Analysis will be 
conducted by her lab staff in her lab at UNM. Part of the hair samples will 
be destroyed in the process of testing with solvents. We will retain left-
over hair samples with PID markers for three years following the end of 
the study to ensure that we have enough hair to complete the analysis. 
We will not release the hair samples or share them with anyone other 
than Dr. Bearer and her lab staff. We will not use the hair for purposes 
other than cortisol testing as indicated in this protocol. Results of the 
cortisol testing will be entered into our project database.
Blood samples will be delivered to the CTSC lab for analysis. Following 
analysis, remaining blood will be destroyed using good lab procedures. 
Result of the A1c testing will be stored on REDCap.
In general, we are committed to making our data available to other 
researchers to contribute to knowledge about cultural competence and 
diabetes self-management program models. Following the end of the 

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study, the quantitative data will be de-identified within nine months and 
made available to PCORI and to researchers by request. Interview and 
focus group transcripts will not be shared because this data will have been 
gathered from a small sample that represents a small community and will 
contain a large amount of personal information that would identify the 
participant.
The UNM CTSC Bioinformatics Data Warehouse will assist us in assuring all 
the quantitative data is properly de-identified at the end of the project. 
The data gathered for the A1c analysis, BMI, and hair cortisol will include 
the participants’ PID but no personally identifying information that could 
be linked to the participant. 
The de-identified data will then be placed in the UNM data repository, 
LoboVault and embargoed for at least five years. LoboVault is a 
designated long-term digital archive resource maintained by the 
University of New Mexico Libraries. In addition to the use of Dublin Core 
for descriptive metadata, the archive provides daily file integrity and 
format verification and will additionally create and maintain technical and 
administrative metadata using the widely adopted Metadata Encoding 
and Transmission Standard (METS) and Preservation Metadata 
Implementation Strategies (PREMIS) metadata standards. These 
additional metadata include digital file signatures and checksums for 
bitwise integrity validation and chain of custody documentation. Primary 
responsibility for curating and preparing the data for archiving rests on 
the Data Librarians at the University of New Mexico Libraries. As a 
publishing and sharing platform, LoboVault is an instance of the widely 
adopted DSpace repository application (http://www.dspace.org/). Data 
will be embargoed for a specified period of time, during which descriptive 
information and metadata are discoverable but the data and content files 
themselves can only be accessed via an email request to the authors. 
Should a researcher be interested in accessing the data, he or she would 
then request access by emailing the PI and/or members of the research 
team chosen by the PI. When a request to access the project data is 
received, we will implement the following data sharing protocol, which 
conforms to the data sharing standards established by the NIH. We will 
provide the opportunity for data sharing through the following avenues:  
1.) We will share all research data as requested in accordance with federal 
regulations and the Freedom of Information Act (FOIA).  2.) We will share 
research tools and data with other researchers for analysis and/or 
replicating the research. The Research Team will review requests from 
researchers and, after approval from our patient partners, we will work 
with the requesting researchers to create a data-sharing agreement per 
NIH protocol, policies and procedures.  3.) We will make the data and 
associated documentation available to users only under a Data-Sharing 
Agreement that:  a.) defines a commitment to using the data only for 
research purposes and not to identify any individual participant; b.) 
defines a commitment to securing the data using appropriate computer 

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technology; c.) demonstrates a high-quality research proposal 
(significance, innovativeness, approach, and community benefit); d.) 
proposes a comprehensive dissemination plan (to community and 
scientific audiences); e.) covers administrative costs to prepare data and 
related documentation requested; f.) demonstrates appropriate approvals 
of research protocols by the institutional Human Research Review 
Committee; g.) demonstrates certification in research ethics, including the 
HIPAA Research Training Course and the Collaborative Institutional 
Training Initiative (CITI) Human Subjects Protection Training; and h.) 
demonstrates a commitment to destroying or returning the data after 
analyses are completed. The requesting researchers will be required to 
acknowledge our project, research team, our patient partners, and PCORI 
as a funder in any presentations, abstracts, or publications developed 
from use of the shared data.
11.0
Data Management* and Confidentiality
11.1 Describe the data analysis plan, including any statistical 
procedures.
Descriptive statistics will be calculated to summarize patient 
characteristics. Means and standard deviations or medians and quartiles 
will be calculated for continuous variables and will be compared across 
site by ANOVA or Kruskal-Wallis test, depending on the distribution of the 
data. Frequencies and percentages will be calculated for categorical 
variables and will be compared with the chi-square test or Fisher’s exact 
test, as appropriate. Significant differences will be noted and to adjust for 
possible confounding, those variables will be considered for inclusion as 
covariates in the analyses for the primary and secondary outcomes in 
addition to other clinically meaningful variables and their interactions. We 
expect patient characteristics to be similar across the two treatment sites; 
however, to control for potential differences in the populations, we will 
adjust for potential confounding covariates by using propensity scores to 
stratify subjects into groups based on the probability that they attended a 
particular treatment site given particular demographic characteristics 
including sex, age, primary language, level of education, nativity, and type 
of insurance. Patients will be grouped by quintile of propensity score for a 
total of five strata and each will be analyzed for the primary and 
secondary outcomes independently. Analyses will be performed in 
standard statistical software such as SAS 9.4, R 3.1, and/or Stata 14. 
Propensity score matching allows for causal inference in our non-
experimental settings by selecting similar subsets of comparison units 
between treatment groups across a high-dimensional set of pretreatment 
characteristics. 
We will complement our quantitative analyses by conducting a rigorous, 
disciplined, empirical analysis of data from key staff/provider interviews 
(Aim #1), patient/social support interviews and focus groups (Aims #1 & 
2), and Patient Advisory Board interview transcripts.

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We will create a database with all interview and focus group transcripts. 
We will conduct a theory-driven qualitative content analysis. We will read 
through transcripts to identify conceptual categories and patterns related 
to specified domains of inquiry, create a qualitative codebook, and 
develop conceptual summaries for each transcript. Following review and 
summary, we will code transcripts for systematic themes and sub-themes 
within the domains. We will explore interconnections between theme 
categories and develop a holistic interpretation of the data. 
Statistical Analysis Aim 3. We will conduct analyses to assess successful 
patient management of their diabetes (Aim #3), our secondary outcomes, 
by measuring their A1c from blood samples drawn, BMI calculations, 
cortisol from hair samples, and PHQ-9 scores obtained at baseline, 3, 6, 
and 12 months. Clinical analysis of blood samples will use A1c tested on 
whole blood as described previously. Change in A1c over the four time 
points in each of the diabetes self-management program models will be 
evaluated by fitting a linear mixed model to A1c with the primary 
independent variable treatment site while adjusting for demographic 
covariates, social support and knowledge, the measures hair cortisol 
indicating stress levels, and participant and social support scores on the 
CAHPS-CC. An interaction between time and site will be included to 
explore how A1c scores change over time. For the secondary endpoint 
analysis, REML-adjusted least-squares mean estimates of change in A1c 
from baseline to 6 months post-intervention will be reported along with 
their 98.3% confidence intervals (the significance level includes a 
Bonferroni adjustment for three secondary outcomes). A model 
incorporating the 12 month time point will also be evaluated. BMI and 
depression scores will be analyzed similarly. 
11.2 Provide a power analysis.
Hypothesized Effect Size for Intervention on Main Patient-Centered 
Outcome. We hypothesize that the CCM model, because following 
Trickett it is more effectively situated with patient culture and socio-
economic context,37,38 will be superior to the DSMS in its ability to 
increase diabetes knowledge and patient activation, lower A1c, and 
improve depression scale scores and BMI among participants. Using the 
CCM model, One Hope has had many patients improve their health, 
including individuals who have been able to reduce or stop taking their 
diabetes medication. One Hope staff note that people participating in the 
diabetes program have changed their food- and physical activity-related 
behaviors and attitudes. Lowered blood sugar levels and improved 
diabetes self-maintenance have been reported anecdotally. One Hope 
conducted a preliminary analysis of patient medical records and found 
that CCM diabetes patients demonstrated statistically significant 
decreases in A1c values at months #5, 8, 11, 14, 18 and 22 after they 
joined One Hope’s program.102 

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The quantitative Primary Outcome for this study is improved patient 
capacity for diabetes self-management: 
 1.) Diabetes knowledge will be measured using the DKQ summed score. 
Hypothesis: The CCM model will result in a larger increase in DKQ 
summed scores from baseline to 6 months with a Cohen’s f effect size (ES) 
= 0.09 as compared to the DSMS. Previously published studies evaluating 
culturally competent diabetes management programs report meaningful 
changes in DKQ summed scores with effect sizes of 0.03 to 0.16 in studies 
ranging in sample sizes per arm from 10 to 189.51,53,54,103
 2.) Patient activation will be measured using the PAM-13 raw score. 
Hypothesis: The CCM model will result in a larger increase in PAM-13 raw 
scores from baseline to 6 months with Cohen’s f ES = 0.07 as compared to 
the DSMS. Previously published studies evaluating culturally competent 
diabetes management programs report changes in PAM-13 raw scores 
with meaningful effect sizes of 0.01 to 0.16 in studies ranging in sample 
size per arm from 26 to 133 (per Shah, Co-I Burge, and colleagues104).66,105–
107 
The quantitative Secondary Outcome for this study is successful diabetes 
self-management as measured by improvement in A1c, BMI, and PHQ-9.
Self-management will be measured through change in A1c, BMI, and 
depression index (PHQ-9). 
1.) Hypothesis: The CCM model will result in a larger decrease in percent 
A1c from baseline to 6 months with Cohen’s f ES = 0.06 as compared 
to the DSMS.  Previously published studies and institutional 
experience evaluating culturally competent diabetes management 
programs report changes in percent A1c with effect sizes of 0.01 to 
0.06 in studies ranging in sample size per arm from 26 to 133.66,105–107
2.) Hypothesis: The CCM model will result in a larger decrease in BMI 
from baseline to 6 months than DSMS with a clinically meaningful 
difference of 1.5 kg/m2 between the groups (Cohen’s f ES = 0.06).67,68
3.) Hypothesis: Compared to DSMS, CCM will result in a larger decrease 
(by 3 points) in PHQ-9 scores from baseline to 6 months (Cohen’s f ES 
= 0.06).107–109 
Note: It is coincidental that the effect sizes (and power) are the same 
for each of the three secondary outcomes
Power Calculations. We will recruit N=240 patient-social support pairs 
(n=120 per site) with anticipated 20% attrition to obtain complete data on 
at least n=96 per site. Comparing response changes on the DKQ, PAM-13, 
and DHQ-9 from baseline to 6 months between the CCM to the DSMS, the 
two-sided Type I error rate was adjusted for the number of comparisons 
made (four comparisons for the co-primary outcomes) using a Bonferroni 
correction (α=0.0125). The power analyses for detecting site differences 
among change scores were based on multiple linear regression models 
including demographic characteristics, participants’ perceived cultural 
competence of providers (CAHPS-CC), and social supports’ change scores 
on the DHQ, PAM-13, and DHQ-9 as covariates. We report Cohen’s f effect 
sizes based on the regression method.110,111

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The power for the primary endpoints with n=96 per site and α=0.025 are 
as follows: 
1.) Change in DKQ summed score: ΔCCM-DSCS = 2.2 (SD = 3.8), power = 96%, 
Cohen’s f effect size (ES) = 0.09 
2.)  Change in PAM-13 raw score: ΔCCM-DSCS = 12.7 (SD = 24.8), power = 
85%, Cohen’s f ES = 0.07
The power for the secondary endpoints with n=96 per site and α=0.017 
for comparing the CCM to the DSMS:
1.) Change in A1c: ΔCCM-DSCS = -0.5 (SD = 1.0), power = 84%, Cohen’s f 
ES=0.06.
2.) Change in BMI: ΔCCM-DSCS = -1.5 (SD = 3), power = 84%, Cohen’s f 
ES=0.06.
3.) Change in depression scores (PHQ-9): ΔCCM-DSCS = -3 (SD = 6), power = 
84% Cohen’s f ES = 0.06.
Note: It is coincidental that the power (and effect sizes) are the same 
for each of the three secondary outcomes
11.3 Describe the steps that will be taken secure the data (e.g., 
training, authorization of access, password protection, 
encryption, physical controls, certificates of confidentiality, 
and separation of identifiers and data) during storage, use, 
and transmission.
Training Requirement for Members of the Research Team:  All 
members of the Research Team will receive training in research 
on human subjects. Each will take the online Human Subjects 
Research Training Modules from the Collaborative Institutional 
Training Initiative (CITI) which fulfill the requirement for NIH 
human subjects training. They will also take a HIPAA compliance 
training. PDCSs will be trained in phlebotomy.  The CTSC Clinical 
Research Laboratory’s ASCP-certified Medical Laboratory Scientist 
will also provide additional Good Laboratory Training and 
Competency to assist with site-specific collection and quarterly 
technical competency testing through direct observations of the 
PDCS phlebotomists at each site. A certified phlebotomist at One 
Hope, will be available to provide technical assistance to the 
PDCSs in an ongoing way. All Data Collectors will also receive a 2-
day Mental First Aid training (Training was conducted in Spanish 
in April 2017 by a certified trainer).
Certificate of Confidentiality: We have obtained a Certificate of 
Confidentiality (CoC) from the National Institutes of Health (NIH). 
CoC’s are issued by NIH to protect the privacy of research subjects 
by protecting investigators and institutions from being compelled 

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to release information that could be used to identify subjects with 
a research project. The process for obtaining a CoC is that we 
must first obtain approval from the UNM HSC HRPO and then we 
submit the approved consent form to NIH for their approval.  We 
obtained our approved CoC on December 1, 2016 (see 
attachment).
Data Handling and Storage:  Guidelines for the protection of 
participant privacy and confidentiality will be followed in all cases. 
All members of the research team will maintain current Human 
Subjects training.  They will understand the importance of privacy 
issues and their responsibility to maintain the highest research 
ethical standards in all respects. Surveys, blood-draws, BMI data 
gathering, hair sampling, interviews and focus groups will be 
conducted at a location to provide privacy. Prior to beginning 
each focus group, the facilitator will instruct participants 
regarding group privacy measures. All participants will be asked to 
sign a receipt for a merchandise card incentive which will be used 
for project accounting purposes only and will not be linked with or 
associated with research data. Consent Forms will be stored in a 
locked cabinet in the office of the PI. Consent Forms will be kept 
for 3 years following the end of the project, at which time they 
will be destroyed.  Participant information will be considered 
confidential and will not be shared. De-identified project data will 
be shared only per our Data Sharing Protocol. De-identified 
project data will be kept for at least 5 years.
Data Management: Consent Forms will be stored in a locked 
cabinet in the office of the PI. De-identified data from REDCap will 
be exported and stored on a secure, managed network share 
maintained by our university’s Health Sciences Library and 
Informatics Center’s IT services. Blood will be destroyed following 
analysis. A1c results will be entered into REDCap. Hair samples 
will be stored in plastic bags in a locked drawer in the office of the 
PI. Some hair will be destroyed in the process of analyzing the 
sample. We will continue to store remaining hair for 3 years after 
the end of the study to ensure that we have had a sufficient 
sample for analysis. Results of hair cortisol testing will be entered 
into REDCap. Data from interviews and focus groups will be 
captured on an audio-recording device and transcribed.  If in 
Spanish, transcripts will be translated into English for analysis.  
Following transcription/translation, audio-recordings will be 
destroyed. Transcripts of interviews and focus groups will be 
identified by the project ID. Electronic transcript files will be 
stored on secure UNM computers, accessible only to the 
researchers via their password-protected machines. Hard copy 
data will be stored in binders in the locked offices of the PI.

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11.4 Describe any procedures that will be used for quality control 
of collected data.
The Patient Engagement Coordinator will provide daily oversight 
of the PDCSs that enrollment and data collection are occurring on 
schedule and per our protocol
The Co-PI will provide oversight and guidance at regular meetings 
with the Patient Engagement Coordinator regarding this process.
The Research Manager will check-in with the Patient Engagement 
Coordinator and the staff at CDE-UNMH once a week to ensure 
that enrollment is occurring per our protocol.
The Data Manager and Research Manager will conduct quality 
checks on the data being entered into all three of the projects in 
REDCap and will work with the Patient Engagement Coordinator 
to address any issues that are identified. 
The Office for Community Health Accountant will meet with the 
One Hope Finance Manager to reconcile information about 
incentives to ensure budget compliance.
The CTSC Lab will provide baseline and quarterly QC training for 
good laboratory/phlebotomy procedure.
The Phlebotomy supervisor will be available to provide technical 
assistance to PDCSs.
11.5 Describe how data and specimens will be handled study-
wide:
1.
What information will be included in that data or 
associated with the specimens?
i. Programmatic assessment. We will inventory each program 
regarding program design, size, structure, operation, and 
theoretical/philosophical orientation; professional 
qualifications/training of program providers; activities or resources 
available through the programs; strategies in place for Spanish 
language use or acceptance, inclusion of social supports and family, 
accommodation of challenges created by patients’ limited 
socioeconomic circumstances, and the inclusion of stress 
management techniques; and data on referrals to the program, 
sign-ups, participation, no-shows, and attrition. We will conduct up 
to 36 interviews with key staff and/or providers to obtain their 
perspectives on implementation of the programs during the period 
of the study. Interview questions will be semi-structured to allow 
participants to contribute to the direction of the interview in 
relation to issues and ideas that they consider to be most relevant 
and important. Interviews will be audio-recorded and transcribed. 
We will assess patient and social support perceptions of the 

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program interface using a cultural competence survey that asks 
about physician bias, inter-cultural understanding, respectful 
interactions, language barriers, experiences of discrimination, and 
issues of trust. To gather qualitative information, we will include 
questions on programmatic interface in interviews and focus groups 
with patients and social supports.
ii. Surveys. The PDCS at each site will administer a survey to all 
patient and social support participants at baseline (when they enter 
the study), with follow-up at 3, 6, and 12 months. The survey will 
consist of questions from or modified from four validated and 
reliable tools: 1.) The Consumer Assessment of Healthcare Providers 
and Systems Cultural Competence Set (CAHPS-CC) [as part of the 
programmatic assessment discussed in the preceding paragraph]; 
2.) The Diabetes Knowledge Questionnaire (DKQ); 3.) The Patient 
Activation Measure (PAM-13); and 4.) The Patient Health 
Questionnaire 9 (PHQ-9). Because the CAHPS-CC is an assessment of 
program cultural competence and requires participant experience 
with the program, it will not be administered as part of the baseline 
survey.
iii. Interviews. We will conduct 72 interviews with patients and 
social supports. Our sampling frame for each set of 12 interviews 
will include six patients and six social supports. Interviews will be 
conducted with the social supports who correspond to the six 
patient interviewees. Interviews will follow the same format 
described in the programmatic assessment above. Spanish 
transcripts will be translated into English for analysis.
iv. Focus groups. We will conduct 12 focus groups. Focus group 
participants will be distinct from those recruited to participate in 
the interviews described in the preceding paragraph.  Focus groups 
will include six distinct participants each. The focus group questions 
and protocol will be an adaptation of that described above for the 
interviews.
v. Physical Measures. These measures will be obtained from 
patients at baseline with follow-up at 3, 6, and 12 months: 
     1.) A1c: For patients from CDE-UNMH, we will obtain baseline 
A1c results from the CDE program files. For One Hope patients, the 
PDCS who will be trained in phlebotomy will draw blood samples at 
the same time they administer the baseline survey. For patients 
from both sites, the PDS will draw blood samples at the 3-month, 6-
month and 12-month data collection sessions. Blood will be drawn, 
labeled and stored using standard phlebotomy protocols, and the 
Patient Engagement Coordinator will deliver specimens to the CTSC 
lab where they will be tested for A1c. 
     2.) Body Mass Index (BMI): The PDCS will document patient 
height and weight and calculate his or her BMI. Height and weight 

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measurements for all participants will be taken using a standardized 
protocol. Height measurements will be collected using SHORR 
boards against flat walls on level, firm (not carpeted) flooring. 
Weight measurements will be collected using calibrated, research-
grade SECO scales. Two measurements will be taken for height and 
two for weight for each participant at each data collection point. An 
average of the two measures of height and an average of the two 
measures of weight will be used in the BMI calculation. 
   3.) Hair cortisol: We will measure patient stress levels using 
testing of hair samples to identify circulating levels of cortisol as a 
biological marker for chronic stress. We will only gather hair 
samples from patient participants and not from social supports, and 
hair will only be gathered at two time points: baseline and six 
months. Cortisol is an an insulin antagonist and may contribute to 
insulin resistance in diabetes type 2. The PDCS will use scissors to 
collect a pencil lead-width of hair from the crown of the head of 
patient participants. One centimeter of hair closest to the scalp will 
be used to measure hair to determine the average cortisol level 
over the previous month. The hair will be stored in a plastic bag in a 
cool, locked drawer in the office of the PI. We are seeking to obtain 
funding from the CTSC to analyze hair samples from this project. Co-
I Bearer will lead analysis of hair samples. In preliminary studies 
Bearer's group has found that more than 90% of subjects agree to 
hair samples. Hair will be pulverized in a Retsch Mixer Mill Type MM 
400 100-240V 50/60HZ an, extracted in methanol overnight, dried 
and resuspended in buffer. Cortisol concentration is measured by 
an immunoassay or by high-pressure liquid chromatography. 
Control samples containing specific amounts of cortisol are 
provided by the vendor with each assay kit, and we also use an 
internal control. We will use an automated colorimetric 96-well 
plate reader to measure the results. Cortisol levels are compared 
with average levels from normal subjects. The Bearer group has 
determined the normal range of human cortisol hair levels . Control 
measurements are done with random hair samplings from non-
diabetic individuals combined and used as a standard for all 
measurements. Measurements are compared to the average and 
determined to be within or outside normal limits. Comparision to 
normal limits is the standard method for reporting clinical pathology 
laboratory measurements diagnostically.
vi. Interviews with Project Patient Advisory Board members. Our 
Summer Research Intern will conduct a series of interviews with the 
seven members of our Patient Advisory Board during June and July 
2017, and we will hold a quarterly meeting of the Advisory Board in 
July. The interviews will be designed to obtain information about 
their personal experience with diabetes, their experience on our 
Patient Advisory Board and working on a research project, and how 
they would like to deepen their involvement over the next three 

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years in this new phase of the research. At the end of July we have a 
Patient Advisory Board meeting scheduled.  Patient Advisors 
normally attend these meetings. At the July meeting, our Research 
Intern will present her findings and a poster she is required to 
create based on her research back to the group.
2.
Where and how data or specimens will be stored?
Consent forms will be kept for 3 years following the end of 
the project, at which time they will be destroyed. Contact 
information for all study participants will be maintained in 
REDCap during the project to allow us to follow-up with 
participants for interviews, if they have a high A1c, and for 
the end-of-project event. Contact information for all 
participants in the project (name, phone number(s), and the 
name and contact information of the person identified as 
someone who would be able to help contact them) will be 
downloaded and stored in a locked cabinet in the office of 
the PI for at least five years to allow the research team to 
invite them to participate if we conduct a follow-up study.
Participant information will be considered confidential and 
will not be shared. Research data will be de-identified and 
kept for at least 5 years. Data from REDCap will be exported 
and stored on a secure, managed network share maintained 
by our university’s Health Sciences Library and Informatics 
Center’s IT services. Blood will be destroyed following 
analysis. A1c results will be entered into REDCap. Hair 
samples will be stored in plastic bags in a locked drawer in 
the office of the PI. Some hair will be destroyed in the 
process of analyzing the sample. Remaining hair will be 
stored for 3 years to ensure that we have a sufficient 
sample for analysis. Results of hair cortisol testing will be 
entered into REDCap. Data from interviews and focus 
groups will be captured on an audio-recording device and 
transcribed.  If in Spanish, transcripts will be translated into 
English for analysis.  Following transcription/translation, 
audio-recordings will be destroyed. Transcripts of 
interviews and focus groups will be identified by the project 
ID. Electronic transcript files will be stored on secure UNM 
computers, accessible only to the researchers via their 
password-protected machines. Hard copy data will be 
stored in binders in the locked offices of the PI.
3.
How long the data or specimens will be stored?
Research data in REDCap and transcripts will be de-
identified and kept for at least 5 years. Following 
transcription/translation, audio-recordings will be 

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destroyed. Following A1c analysis, blood samples will be 
destroyed.  Remaining hair samples will be stored for 3 
years following the end of the project.  Participant 
identifying information will be kept on REDCap with limited 
access. Consents will be kept for 3 years following the end 
of the project, at which time they will be destroyed.
4.
Who will have access to the data or specimens?
Only members of the research team will have access to the 
data.
5.
Who is responsible for receipt or transmission of the 
data or specimens?
The PDCSs will gather contact and demographic 
information, survey responses, BMI data, hair and blood 
samples. The contact and demographic information, survey 
response, and BMI measurements will be entered into 
REDCAp by the PDCSs at the time of collection.
Hair samples will be gathered in plastic bags and labeled 
with the PID.  The PDCS will give the bags to the Patient 
Engagement Coordinator.  The Patient Engagement 
Coordinator will give the bags to the Research Manager.  
The Research Manager will store them in a locked drawer in 
the office of the PI. When funding is obtained, the Research 
Manager will give them to Dr. Bearer for analysis in her lab.  
Some of the hair samples will be destroyed in the process of 
analysis. Remaining hair will be stored for 3 years following 
the end of the project. The hair cortisol results will be 
entered by the Data Manager into the PCORI Diabetes 
Project on REDCap once received from the lab.
The PDCSs will draw the blood and label it with the PID. The 
PDCS will transport the blood in a padded biohazard blood 
storage bag and deliver them to the Patient Engagement 
Coordinator. The Patient Engagement Coordinator will have 
a set schedule for delivering the blood 3x a week to the 
CTSC lab. Following analysis, the blood samples will be 
destroyed using good lab protocol.
The lab will transmit electronic A1c results to the PI and the 
Data Manager and will send the PI the results as hard copy 
documents. The A1c results will be entered by the Data 
Manager into the A1c data collection instrument in the 

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PCORI Diabetes Project on REDCap once received from the 
lab.
The Research Manager or the PI will upload audio 
recordings from interviews and focus groups onto his/her 
computer as MP3 files and will send those to the 
transcriptionist/translator consultant via a secure UNM FTP 
process.  The consultant will return the transcripts as an 
email attachment to the Research Manager.
The Research Intern will be responsible for obtaining 
interview data.
6.
How data and specimens will be transported?
The PDCSs will gather data from the participants for the contact 
information, the participant data sheet and the survey orally and 
enter the answers directly into password-protected tablet. If the 
tablet is able to be connected to wireless internet at the location, 
then the data will be entered directly into the secure UNM REDCap 
data storage system using a database created specifically for this 
project. BMI data will also be entered into the tablet.  If there is no 
wireless internet connection at the data collection point, the PDCS 
will upload the data when there is. If entering the data onto the 
tablet is not possible for some reason, the PDCS will use paper 
copies of the instruments and later the responses will be double 
data entered by the Project Coordinator and the Co-PI into REDCap, 
where the Data Manager will conduct a double data entry analysis 
to ensure quality.
Blood will be gathered for A1c testing and labeled with the PID. 
Blood samples will be transported in a padded biohazard transport 
bag. They will be stored at room temperature at One Hope Clinic in 
a locked office. Three times a week, the Patient Engagement 
Coordinator will deliver the blood samples to the UNM CTSC lab for 
testing.  Following testing, the lab will destroy the blood samples 
using standard laboratory protocol.  Results of the blood testing will 
be sent to both the PI and the Data Manager in hard copy (the 
results sheet will not include any identifying information, only the 
PID). The PI will ensure that the Data Manager has entered the 
results into the database, and then the hard copies of results will be 
stored in a locked filing cabinet in the Data Manager’s locked office 
for three years (for quality check purposes) when it will be 
destroyed.
The PDCS will use scissors to collect a pencil lead-width of hair from 
the crown of the head. One centimeter of hair closest to the scalp 
will be used to measure hair to determine the average cortisol level 

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over the previous month. The hair will be placed in a plastic bag and 
labeled with the PID. Hair samples will be stored in a plastic bag in a 
cool, locked drawer in the office of the PI. When we obtain funds for 
analysis, hair will be pulverized in a Retsch Mixer Mill Type MM 400 
100-240V 50/60HZ, extracted in methanol overnight, dried and 
resuspended in buffer. Cortisol concentration is measured by an 
immunoassay or by high-pressure liquid chromatography. Control 
samples containing specific amounts of cortisol are provided by the 
vendor with each assay kit, and we also use an internal control. We 
will use an automated colorimetric 96-well plate reader to measure 
the results. Cortisol levels are compared with average levels from 
normal subjects. 
Interview and focus group data will be gathered using a 
small, hand-held electronic audio recorder.  Audio-
recordings will be uploaded as MP3 files onto the computer 
of the Research Manager. The Research Manager will 
upload the MP3 audiofiles into a secure electronic file for 
transmission to the transcriptionist/translator contractor. 
The transcriptionist/ translator contractor will download the 
audio recording.  Following transcription/translation, the 
contractor will destroy the copy of the audiofile and send 
the transcript to the Research Manager as an email 
attachment.  Once the Research Manager receives the 
transcript, the original audiofile on the Research Manager’s 
computer will be destroyed.  
12.0
Provisions to Monitor the Data to Ensure the Safety of 
Subjects*
This section is required when research involves more than 
Minimal Risk to subjects.
N/A
13.0
Withdrawal of Subjects*
13.1 Describe anticipated circumstances under which subjects 
will be withdrawn from the research without their consent.
We do not anticipate that individuals will be withdrawn without 
their consent. 
13.2 Describe any procedures for orderly termination.

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Participation for women who become pregnant during the study 
will be ended.  They will be given an end-of-study visit where we 
will inform them that we are unable to continue their 
participation in the study and we will thank them for their 
participation. They will be told that their participation in the 
diabetes program they attend will not be affected by the fact that 
they have ended participation in the study.
13.3 Describe procedures that will be followed when subjects 
withdraw from the research, including partial withdrawal 
from procedures with continued data collection.
Participation for women who become pregnant during the study 
will be ended.  They will be given an end-of-study visit where we 
will inform them that we are unable to continue their 
participation in the study and we will thank them for their 
participation. They will be told that their participation in the 
diabetes program they attend will not be affected by the fact that 
they have ended participation in the study.
Our Data Manager will create a separate project on REDCap to track 
individuals who have withdrawn themselves, been withdrawn due to 
pregnancy, or who have discontinued as a result of attrition.
Statistical methods using validated methods to handle missing data (MD-
2, MD-3). As described above, all attempts to minimize missing data will 
be made. Despite these attempts, we realistically expect there to be some 
degree of missingness. Of particular interest is whether participants are 
missing any outcome data. We will determine whether it is missing 
completely at random (MCAR), missing at random (MAR), or missing not 
at random (MNAR). MCAR is defined as missingness that is independent of 
the observed and unobserved data (example: A1c measurement not 
obtained due to random machine failure); MAR is defined as missingness 
dependent only on an observed variable within the data (example: 
participant accidentally skips one question on the PAM-13); and MNAR is 
a systematic pattern to or a reason for the missingness (example: many 
participants exclude answering a question on the DKQ for a specific 
reason, either accidentally or intentionally). For MNAR, we will perform 
sensitivity analyses such as conducting the primary and secondary 
analyses on the intention-to-treat and per-protocol populations and 
compare the results. Under the assumption that most missing data is MAR 
or MCAR, we may use multiple imputation126–129 to create imputed data 
sets containing estimates from a random sample of missing values for 
each observation based on other non-missing covariates for each subject. 
Each imputed data set is then analyzed as described in the statistical 
analysis plans for the outcome measures, and the results from each 
analyzed data set are combined for statistical inference. Multiple 

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imputation will be performed using PROC MI and PROC MIANALYZE in SAS 
9.4 or in Stata 13.1 or higher.
14.0
Risks to Subjects*
14.1 List the reasonably foreseeable risks, discomforts, hazards, 
or inconveniences to the subjects related the subjects’ 
participation in the research. Include as may be useful for the 
IRB’s consideration, describe the probability, magnitude, 
duration, and reversibility of the risks. Consider physical, 
psychological, social, legal, and economic risks.
The risks involved in participating in this study are minimal and we do not 
think that the participant will experience any negative consequences or 
effects.  However, there are risks of stress, emotional distress, inconvenience 
and possible loss of privacy and confidentiality that can happen in any 
research study where the participant answers questions about themself, 
their experiences, and their opinions, or where they provide blood samples, 
BMI information, or hair samples. We have obtained a Certificate of 
Confidentiality from NIH to further protect participant privacy.
14.2 If applicable, indicate which procedures may have risks to 
the subjects that are currently unforeseeable.
N/A
14.3 If applicable, indicate which procedures may have risks to an 
embryo or fetus should the subject be or become pregnant.
N/A
14.4 If applicable, describe risks to others who are not subjects.
N/A
15.0
Potential Benefits to Subjects*
15.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may 
be useful for the IRB’s consideration, the probability, 
magnitude, and duration of the potential benefits.
Participants may find the experience of being interviewed and 
thinking about their own personal experience during the 
Interview to be interesting.  Patient participants will receive 
information about their blood sugar levels when we provide them 
with results of the A1c test.

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15.2 Indicate if there is no direct benefit. Do not include benefits 
to society or others.
Participants may find the experience of participating and thinking 
about their own personal experience to be interesting.  Patient 
participants will receive information about their blood sugar levels 
when we provide them with results of the A1c test. All 
participants will be invited to an end-of-study presentation of 
study results.
16.0
Vulnerable Populations*
16.1 If the research involves individuals who are vulnerable to 
coercion or undue influence, describe additional safeguards 
included to protect their rights and welfare.
N/A
17.0
Community-Based Participatory Research*
17.1 Describe involvement of the community in the design and 
conduct of the research.
1. PLANNING THE STUDY
       a. Patient partners participated in identification of diabetes as a 
focus for research. The idea for this study came from our patient 
partners. In 2009, a One Hope staff member who knew Janet, already a 
trusted partner to their work, asked her to help figure out how to address 
problems related to diabetes. In 2011, Janet and her colleague, Shiraz (a 
Co-Investigator for the project), obtained funding to conduct pilot 
research to assess the dimensions of the problem and to obtain 
community input regarding diabetes health and ideas for prevention. 
      b. Patient partners participated in pilot research.  Patient partners 
participated in the conceptualization, implementation, and translation of 
preliminary research for the project. Janet and Shiraz worked with One 
Hope to implement a pilot study. Lidia was the Project Coordinator for the 
pilot and a member of the pilot Research Team. The pilot research 
involved GIS data mapping of secondary data, a survey and blood analysis 
for A1c with 100 people, interviews with key community stakeholders, 
and a series of focus groups with patients and social supports. Lidia 
administered the survey, facilitated the focus groups, and participated in 
the analysis of the data. We had a Patient Advisory Board consisting of 
patients and caregivers who participated in designing focus 
group/interview questions and interpreting findings. Findings from the 
pilot provided a roadmap for the diabetes self-management initiative that 
One Hope has since developed and implemented. We presented data 

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about the research to the Patient Advisory Board, to the broader 
community,136 and at professional conferences.137 Lidia was a presenter at 
both community and professional venues. We published two articles in 
peer-reviewed journals, and Lidia is a co-author on both.32,33 One of our 
articles is among the top 10 most-downloaded articles for that journal.32
      c. Patient partners participated in our PCORI Tier I & II Awards, and in 
planning for the proposed study. The experiences described above 
provided the foundation for us to receive PCORI Tier I (2014) and Tier II 
(2015) awards. One Hope was the applicant for both, with Lidia as the PI 
and Janet as the Co-PI. Janet and Lidia collaborated to develop the study, 
obtaining input and commitment from stakeholders from different 
diabetes programs and from university researchers. Patients and social 
supports were involved through a Patient Advisory Board and Lidia was 
the lead in the planning process. The Patient Advisory Board generated 
the research question, and identified the outcomes and measures.
   2. CONDUCTING THE STUDY
      a. Patient partners will participate as integral parts of the Research 
Team. Patients, caregivers, and other patient partners will participate as 
paid members of the Research Team, including six people with diabetes. 
Mary Johnston, the CDE-UNMH diabetes education program Manager, 
although she has chosen not to be a member of the Research Team per 
se, will be a Program Liaison for the project. Patients and caregivers 
involved in our PCORI Tier I and II awards will participate as members of 
the Patient Advisory Board for this research. In addition to Lidia (the Co-PI 
and a patient) and Janet (the PI), the Advisory Board includes seven 
patients and caregivers, plus Maria (our Patient Engagement 
Coordinator).
      b. Patient partners will participate in data collection and analysis. We 
will hire four individuals from our patient population to work as paid 
PDCSs to gather data from participants. They will be trained in Human 
Subject and HIPAA research ethics and protocols, and will learn how to 
recruit and consent participants, to conduct surveys, to gather clinical 
data and samples, and to handle blood specimens according to project 
protocol. Patients who are members of the Research Team and members 
of the Patient Advisory Board will all have structured opportunities to 
participate in analyzing and interpreting the data.
   3. DISSEMINATING THE STUDY RESULTS
      a. We value patient partner participation in dissemination of results 
of the research. Lidia participated in dissemination of the results of the 
pilot study. We made a conscious effort for her to be involved in and 
often take the lead on both community and academic presentations, and 
she was a co-author on publications.32,33 
      b. We place a high value on ensuring that our research is not only 
relevant from a patient partner perspective, but that the results of 

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research get shared with patient partners and other community 
members. We will present our work at academic and professional 
conferences, but we will also look for community venues at which we can 
present it. A number of local organizations support our work and provide 
us with venues for dissemination. We presented results of the pilot at 
their meetings and we plan to present there with future research findings. 
We also were explicit in producing a version of findings from the research 
in lay language that was disseminated to community members who would 
not have been interested in or had the capacity to utilize a jargon-filled 
academic manuscript. 
   4. PRINCIPLES FOR ENGAGEMENT
      a. How We Created Reciprocal Relationships.
i. We created a Project Patient Advisory Board involving patient partners. 
The 10-member Patient Advisory Board will meet quarterly to provide 
guidance and oversight for the research. Lidia will facilitate the meetings.
ii. We provide a respectful and culturally appropriate environment for 
Patient Advisory Board meetings through our choice of default language. 
Our Board includes individuals who are not comfortable speaking in 
English or who do not understand English.  Patient Advisory Board 
meetings are conducted in Spanish as the default language. The PI is 
fluent in Spanish and the Co-PI has Spanish as her first language. If we 
bring in content experts or researchers who do not speak Spanish, we 
provide them with an English translation, but we still hold the meetings in 
Spanish to acknowledge patients as the core of the process. For the 
proposed research we have members of the Research Team who do not 
speak Spanish but we will continue to prioritize Spanish as the primary 
language for the project, requiring the researchers to make the extra 
effort to experience meetings in translation rather than always expecting 
patient partners to be the ones who have to operate in a language that is 
not their own. 
iii. In our PCORI Tier 1 award, we budgeted to be able to create an 
electronic internal communication infrastructure that would involve smart 
phone, social media, and email messaging.  However, in consultation with 
our Patient Advisory Board, we made a decision not to pursue this 
approach. Members of our Board were unanimous in their belief that an 
electronic communications infrastructure is not only unnecessary but it 
would be culturally and contextually inappropriate and counter-
productive. The majority of our Advisory Board members do not have a 
smart phone, a computer, or their own internet service, and few even 
have an email account, so they do not necessarily know how to use or 
have easy or continuous access to electronic messaging systems. Instead, 
it was decided as a group that an old-fashioned approach is preferable 
and more likely to be effective. Maria, our project Patient Engagement 
Coordinator, contacts Advisory Board members by phone (and email if the 
person has an email account) to tell them about logistics. 
     b. How We Incorporate Co-learning.

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i. During the planning process created by our Tier I and Tier II awards, we 
endeavored to provide trainings and to help our Patient Advisory Board 
develop their capacity to participate in and contribute to the research. 
When we applied for PCORI Tier I and II awards, we were concerned 
about our patient partner stakeholders understanding the concept of 
research and the methodological approaches we are required to use to 
make a study scientifically valid. During our Tier I award in 2014, we 
brought content experts, including Co-I Burge, to attend our Advisory 
Board meetings to provide training and instruction to our Board members. 
Building the capacity of Advisory Board members to understand and 
participate in research has been a foundational activity for both of our 
Tier projects.
ii. We believe that researchers and health providers have much they can 
learn from patient stakeholders. This is a fundamental precept of the 
innovative model of diabetes self-management that has been developed 
at One Hope and that forms the foundation for our PCORI Tier projects. 
We are committed to making sure that researchers participating in our 
study are cognizant of the perspective and everyday reality of patient 
partner members. Lidia uses her skill at facilitation to lead meetings in a 
way that accomplishes this. Listening is a core skill that we nurture in our 
meetings.
18.0
Sharing of Results with Subjects*
18.1 Describe whether results (study results or individual subject 
results, such as results of investigational diagnostic tests, 
genetic tests, or incidental findings) will be shared with 
subjects or others (e.g., the subject’s primary care 
physicians) and if so, describe how it will be shared.
We will actively disseminate knowledge gained from this patient-engaged 
and community-based research to all partners in language that will be 
understandable and respectful. We place a high value on ensuring that 
our research is not only relevant from a patient partner perspective, but 
that the results of research get shared with patient partners and other 
community members. To this end, we not only present our work at 
academic and professional conferences, but we look for community 
venues where we can present. Local groups partner with us, and they 
support our research efforts. We presented results of our pilot research at 
local meetings and we plan to do so with future research findings. 
Community-based dissemination activities will include, but not be limited 
to, presentations at the International District Healthy Communities 
Coalition, the Healthy Here Coalition, the Bernalillo County Community 
Health Council, and community centers, as well as at information 
dissemination sessions at community-sponsored events, and press 
releases to local media. We will hold an end-of-study event to present 
findings to a lay audience and we will invite all participants to attend.

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Interviews with Project Patient Advisory Board members. Our Summer 
Research Intern will conduct a series of interviews with the seven 
members of our Patient Advisory Board during June and July 2017, and we 
will hold a quarterly meeting of the Advisory Board in July. The interviews 
will be designed to obtain information about their personal experience 
with diabetes, their experience on our Patient Advisory Board and 
working on a research project, and how they would like to deepen their 
involvement over the next three years in this new phase of the research. 
At the end of July we have a Patient Advisory Board meeting scheduled.  
Patient Advisors normally attend these meetings. At the July meeting, our 
Research Intern will present her findings and a poster she is required to 
create based on her research back to the group.
19.0
Setting
19.1 Describe the sites or locations where your research team will 
conduct the research.
1.
Identify where your research team will identify and 
recruit potential subjects
The purpose of the data collected through this project is to 
investigate the comparative effectiveness of two evidence-
based models for creating program cultural competency in 
diabetes self-management programming. We will compare 
two diabetes self-management programs that serve a large 
low-income Latino population and that employ different 
evidence-based models of culturally competent health 
promotion. We will gather data from participants at One 
Hope Centro de Vida Health Center in Albuquerque’s 
International District and the Center for Diabetes Education 
at the University of New Mexico Hospital located on 
University Avenue near the Pitt.
2. Identify where research procedures will be 
performed.
Most One Hope data collection will occur on the premises 
of One Hope, although if participants would like to have an 
appointment off-site at a location of their convenience, that 
will be possible.
Data collection from participants at CDE UNMH will occur at 
the facilities of CDE UNMH or at a location of convenience 
to the participant.
Interviews will be conducted at a location of convenience to 
the participant.

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Focus Groups will be held at the facilities of One Hope.
Blood analysis will be conducted at the CTSC lab.
Analysis of hair samples will be conducted in the UNM lab 
of Co-I Bearer in Department of Pathology, on the UNM-HSC 
campus, Fitz Hall rm 329.
3.
Describe the composition and involvement of any 
community advisory board.
We created a Project Patient Advisory Board involving patient 
partners. The 11-member Patient Advisory Board will meet 
quarterly to provide guidance and oversight for the research. The 
Advisory Board consists of 4 Latino diabetes patients and 3 
caregivers for people with diabetes, plus the PIs, the Patient 
Engagement Coordinator, and Dr. Will Kaufman. We formed this 
board with support from 2 PCORI Tier Awards and members of the 
board met once a month over a two year period to plan this 
research. The patient and caregiver members identified the 
research question and the measures for this study.
4.
For research conducted outside of the organization and 
its affiliates describe:
N/A
20.0
Resources Available
20.1 Describe the qualifications (e.g., training, experience, 
oversight) of you and your staff as required to perform their 
role. When applicable describe their knowledge of the local 
study sites, culture, and society. Provide enough information 
to convince the IRB that you have qualified staff for the 
proposed research.
RESEARCH TEAM AND ENVIRONMENT
Research Team 
Member
Title & Institutional Affiliation
Expertise
Role on Project
Janet Page-
Reeves, Ph.D.
Research Assistant Professor
UNM Office for Community Health 
(OCH)
Department of Family & 
Community Medicine
Cultural Anthropology,  
Community/Patient-
Engaged Research 
PI
+ Senior Qualitative 
Researcher
Lidia Regino, 
BS
Diabetes Patient +
Director, One Hope Centro de Vida 
Health Center
Diabetes, Latino Health, 
Cultural Competency
Patient & Co-PI
+ Patient-Engagement Expert

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Virginia 
Sandoval, 
Blanca Pedigo, 
Denisse 
Guerrero, and 
Loida Varela
Patient Data Collection Specialists 
(PDCSs)
Diabetes
Researchers from the 
patient population (4)
Mark Burge, 
MD
Professor, Medicine, Endocrinology 
& Metabolism
+ Deputy Director, CTSC
Endocrinology, Diabetes 
Mentor to PI & 
Diabetes Research Expert
Elaine Bearer
MD, Ph.D.
The Harvey Family Professor
Department of Pathology
Social Determinants of 
Health
Project Laboratory 
Scientist
+ Senior Researcher
Erik Erhardt, 
Ph.D.
Assistant Professor
Department of Mathematics & 
Statistics
Statistics
Senior Statistician 
Cristina 
Murray-Krezan, 
MS
Research Assistant Professor
Epidemiology, Biostatistics & 
Preventive Medicine
Biostatistics
Biostatistician
Shiraz Mishra
MBBS, Ph.D.
Professor, Department of Pediatrics 
+
Director of Community-Engaged 
Research, CTSC
Methodology
Project Research 
Methodologist 
+ Senior Researcher
Maria Tellez
Community Coordinator, One Hope
Patient-Engagement
Patient Engagement 
Coordinator
+ Data Collection Supervisor
Molly Bleecker, 
MA
Research Scientist III, OCH
Data Management,
Qual/Quant Research
Project Data Manager 
+ Qualitative Researcher
Hannah Cole-
McGrew
Masters Level Research Manager
Research Project 
Management
Research Project Manager 
at UNM
Hannah Cole-
McGrew
Qualitative Researcher
BS/BA or above
Qualitative Researcher
Samantha Katz
Research Intern
Undergraduate Research 
Assistant through the UPN
Research Intern
Research Team Expertise.  Janet (the PI) and Lidia (the Co-PI) have a close 
partnership and have assembled a seasoned multi-disciplinary team at UNM that 
includes collaboration with the two sites. The investigators have extensive 
experience working on issues of health disparity and demonstrated ability to 
conduct research in Spanish-speaking contexts, including with the population of 
study. The diverse composition of the Research Team will create a powerful, 
complementary blend of patient-engagement, knowledge, and experience; 
academic and medical knowledge; and research acumen. This synergistic skill set 
will make this unique project successful.
Describe other resources available to conduct the research: For example, as 
appropriate:
1.
Justify the feasibility of recruiting the required number 
of suitable subjects within the agreed recruitment 
period. For example, how many potential subjects do 
you have access to? What percentage of those potential 
subjects do you need to recruit?
21.0

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Our recruitment plan is feasible based on our previous experience. 
Below we provide a detailed presentation of our recruitment rate 
and plans for follow-up. We attempted to create a realistic 
recruitment plan that would fit seamlessly with the work required 
for all parts of the study. Below is the recruitment detail:
Year
Month
total
Baseline
# participants recruited and 
appointments each month
3 
months
# of 
appointm
ents each 
month
6 months
# of 
appointm
ents each 
month
12 
month
# of 
appointm
ents each 
month
Total 
# of 
appoint
ments 
each 
month
Total 
Appoint-
ments for each 
data collector 
each month
Jan
Feb
32
32
8
Mar
64
32
32
8
Apr
96
32
32
16
May
128
32
25% achieved
32
64
16
Jun
160
32 
32
64
16
Jul
192
32
32
96
24
Aug
224
32
32
32
64
24
Sept
256
32
50% achieved
25% required
32
32
96
24
Oct
288
32 
32
32
96
24
Nov
320
32
32
32
96
24
2017
Dec
352
32
32
32
96
24
Jan
384
32 
75% achieved
50% required
32
32
32
128
32
Feb
416
32
32
32
32
128
32
Mar
448
32
32
32
32
128
32
Apr
480
32 
100% achieved
32
32
32
128
32
May
32
32
32
96
24
Jun
 75% required
32
32
32
96
24
Jul
32
32
32
96
24
Aug
32
32
64
16
2018
Sept
100% required
32
32
64
16

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Oct
32
32
64
16
Nov
32
32
8
Dec
32
32
8
Jan
32
32
8
Feb
32
32
8
Mar
32
32
8
Apr
32
32
8
May
Jun
Jul
All data collection will be complete
Aug
Sept
2019
Oct
1.
Describe the time that you will devote to conducting 
and completing the research.
This project is funded for 3 years.
2.
Describe your facilities.
One Hope is a clinic just north of Central in the International 
District in NE Albuquerque.  CDE UNMH is a program of 
UNM Hospital located at the UNMH facility on University 
Avenue near the Pitt.
3.
Describe the availability of medical or psychological 
resources that subjects might need as a result of an 
anticipated consequences of the human research.
We do not anticipate that any participants will require 
medical or psychological resources as a result of their 
participation in this research since we are not asking them 
to “do” anything--our research is about a program that has 
been prescribed to them by their doctor and we are merely 
gathering survey, BMI, blood, hair, interview and focus 
group data regarding their participation in that program.  
However, as we are gathering A1c data, if results of the A1c 
analysis indicate a situation of concern, we will use that 
information to contact the patient and their provider.  In a 
case where a patient needs a referral, team member Dr. 
Mark Burge will provide one. If the patient is pregnant, Dr. 
Burge will provide a referral to the UNM high risk maternity 
clinic.

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4.
Describe your process to ensure that all persons 
assisting with the research are adequately informed 
about the protocol, the research procedures, and their 
duties and functions.
Training Requirement for Members of the Research Team:  
All members of the Research Team will receive training in 
research on human subjects. Each will take the online 
Human Subjects Research Training Modules from the 
Collaborative Institutional Training Initiative (CITI) which 
fulfill the requirement for NIH human subjects training. 
They will also take a HIPAA compliance training. PDCSs will 
be trained in phlebotomy.  The CTSC Clinical Research 
Laboratory’s ASCP-certified Medical Laboratory Scientist will 
provide additional Good Laboratory Training and 
Competency to assist with site-specific collection and 
quarterly technical competency testing through direct 
observations of the PDCS phlebotomists at each site. A 
certified phlebotomist at One Hope, will be available to 
provide technical assistance to the PDCSs in an ongoing 
way. PDCSs will meet regularly with the Patient Engagement 
Coordinator to make sure they are following protocol and to 
trouble-shoot any challenges.
22.0
Prior Approvals
22.1 Describe any approvals that will be obtained prior to 
commencing the research. (E.g., school, external site. 
funding agency, laboratory, radiation safety, or biosafety 
approval.)
N/A
23.0
Recruitment Methods
23.1 Describe when, where, and how potential subjects will be 
recruited.
Staff & Providers (36): Our Program Liaison at each site will identify up to 
12 key program staff and/or providers each year for assessment 
interviews that will contribute to our understanding of the program sites. 
Our Research Manager will contact them using an IRB-approved script to 
invite them to participate and schedule appointments with those 
interested. At the appointment, she will ask them to sign the consent and 
complete the Data Sheet, and then she will conduct the interview. 
Patient (240) & Social support (240) participants: 

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    At CDE-UNMH, when patients register for the program, CDE-UNMH 
staff will tell them about the study using an IRB-approved script and a 
flyer with pull-off tabs will be posted in the CDE office. An invitation with 
further detail about the research and contact information for our PDCSs--
the Patient Data Collection Specialists (PDCSs)--will be sent in a mailing 
that all new patients receive from CDE-UNMH with their class schedule 
confirmation and logistics. A staff person at CDE-UNMH or a member of 
the research team will phone new participants to tell them about the 
study. For those who indicate that they are interested, the staff person or 
research team member will ask the patient’s permission to release their 
name and contact information to our research team. If the patient agrees, 
a research team member will contact the patient. Interested patients can 
also contact the research team using the information on the mailing. For 
all interested patient participants, the research team member will screen 
them per our recruitment criteria. 
At One Hope, participants will be identified in three ways: 1) New patients 
who call the clinic and indicate that they need to see a provider 
specifically about diabetes will be told about the study using an approved 
script, 2) Every patient seen at the clinic has an exit interview (salida) 
conducted by a Community Health Worker. For patients who have been 
told by their provider to have their A1c checked or that they have a 
diagnosis of diabetes or prediabete, they will be told about the study 
using an approved script, and 3) Flyers about the study will be posted in 
the One Hope waiting room. For those who indicate interest in 
participating, a PDCS will contact them, inform them about the research 
per IRB requirements, and screen them for eligibility. For those who are 
eligible, the PDCS will schedule an appointment to consent them and 
gather baseline data. 
    At both sites, interested patients who qualify will provide contact 
information for a person that they identify from their social network 
(family or friend) whom they consider as their primary “social support.” A 
member of the research team will contact the social support, provide 
them with information about the study, and invite them to participate. 
The PDCS will schedule an appointment with supports who are interested. 
   At the appointment, the PDCS will ask all participants to sign the 
consent, collect the information in the Participant Data Sheet, and collect 
responses to the baseline survey questions. The PDCS will obtain a blood 
sample and measure BMI for the patient only. 
    Subset of Patient and Social support Participants for Interviews (72) and 
Focus Groups (72): At each of the sites, per our sampling frame described 
above, the PDCS will identify interviewees and focus group participants 
from those already recruited to be in the study and invite them to 

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participate. Our Research Manager will contact those interested to 
schedule.
23.2 Describe the source of subjects.
We will recruit patients from two sites: The Center for Diabetes Education 
at UNMH and One Hope Clinic. Patients will identify a corresponding 
social support participant to be invited.  We will also identify site staff and 
provides to participate in interviews.
23.3 Describe the methods that will be used to identify potential 
subjects.
    At CDE-UNMH, when patients register for the program, CDE-UNMH 
staff will tell them about the study using an IRB-approved script and a 
flyer with pull-off tabs will be posted in the CDE office. An invitation with 
further detail about the research and contact information for our PDCSs--
the Patient Data Collection Specialists (PDCSs)--will be sent in a mailing 
that all new patients receive from CDE-UNMH with their class schedule 
confirmation and logistics. A staff person at CDE-UNMH or a member of 
the research team will phone new participants to tell them about the 
study. For those who indicate that they are interested, the staff person or 
research team member will ask the patient’s permission to release their 
name and contact information to our research team. If the patient agrees, 
a member of the research team will contact the patient. Interested 
patients can also contact the research team using the information on the 
mailing. For all interested patient participants, the research team will 
screen them per our recruitment criteria.
   At One Hope, participants will be identified in three ways: 1) New 
patients who call the clinic and indicate that they need to see a provider 
specifically about diabetes will be told about the study using an approved 
script, 2) Every patient seen at the clinic has an exit interview (salida) 
conducted by a Community Health Worker. For patients who have been 
told by their provider to have their A1c checked or that they have a 
diagnosis of diabetes or prediabetes, they will be told about the study 
using an approved script, and 3) Flyers about the study will be posted in 
the One Hope waiting room. For those who indicate interest in 
participating, a PDCS will contact them, inform them about the research 
per IRB requirements, and screen them for eligibility. For those who are 
eligible, the PDCS will schedule an appointment to consent them and 
gather baseline data. 
    At both sites, interested patients who qualify will provide contact 
information for a person that they identify from their social network 
(family or friend) whom they consider as their primary “social support.” A 
member of the research team will contact the social support, provide 

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them with information about the study, and invite them to participate. 
The PDCS will schedule an appointment with supports who are interested. 
   At the appointment, the PDCS will ask all participants to sign the 
consent, collect the information in the Participant Data Sheet, and collect 
responses to the baseline survey questions. The PDCS will also obtain a 
blood sample, measure BMI and gather a hair sample for the patient only. 
    Subset of Patient and Social support Participants for Interviews (72) and 
Focus Groups (72): At each of the sites, per our sampling frame described 
above, the PDCS will identify interviewees and focus group participants 
from those already recruited to be in the study and invite them to 
participate. Our Research Manager will contact those interested to 
schedule.
The seven patient members of our Patient Advisory Board will be invited 
to participate in the Advisory Board Member interviews.
23.4 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed 
advertisements. When advertisements are taped for 
broadcast, attach the final audio/video tape. You may submit 
the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the 
IRB reviews the final audio/video tape.)
    At CDE-UNMH, when patients register for the program, CDE-UNMH 
staff will tell them about the study using an IRB-approved script and a 
flyer with pull-off tabs will be posted in the CDE office. An invitation with 
further detail about the research and contact information for our PDCSs--
the Patient Data Collection Specialists (PDCSs)--will be sent in a mailing 
that all new patients receive from CDE-UNMH with their class schedule 
confirmation and logistics. A staff person at CDE-UNMH or a member of 
the research team will phone new participants to tell them about the 
study. For those who indicate that they are interested, the staff person or 
research team member will ask the patient’s permission to release their 
name and contact information to our research team. If the patient agrees, 
a member of the research team will contact the patient. Interested 
patients can also contact the research team using the information on the 
mailing. For all interested patient participants, the research team will 
screen them per our recruitment criteria. 
At One Hope, participants will be identified in three ways: 1) New patients 
who call the clinic and indicate that they need to see a provider 
specifically about diabetes will be told about the study using an approved 
script, 2) Every patient seen at the clinic has an exit interview (salida) 

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conducted by a Community Health Worker. For patients who have been 
told by their provider to have their A1c checked or that they have a 
diagnosis of diabetes or prediabetes, they will be told about the study 
using an approved script, and 3) Flyers about the study will be posted in 
the One Hope waiting room. For those who indicate interest in 
participating, a PDCS will contact them, inform them about the research 
per IRB requirements, and screen them for eligibility. For those who are 
eligible, the PDCS will schedule an appointment to consent them and 
gather baseline data.
    At both sites, interested patients who qualify will provide contact 
information for a person that they identify from their social network 
(family or friend) whom they consider as their primary “social support.” A 
member of the research team will contact the social support, provide 
them with information about the study, and invite them to participate. A 
member of the research team will schedule an appointment with supports 
who are interested.
   At the appointment, the PDCS will ask all participants to sign the 
consent, collect the information in the Participant Data Sheet, and collect 
responses to the baseline survey questions. The PDCS will also obtain hair 
and blood samples, and measure BMI for the patient only. 
    Subset of Patient and Social support Participants for Interviews (72) and 
Focus Groups (72): At each of the sites, per our sampling frame described 
above, the PDCS will identify interviewees and focus group participants 
from those already recruited to be in the study and invite them to 
participate. Our Research Manager will contact those interested to 
schedule.
   For staff and provider interviews, the Research Manager will obtain 
names from our site liaison and will invite them using an approved script.
For Patient Advisory Board interviews, we already have names and 
contact information for the seven patient members of our Patient 
Advisory Board. We will invite them to participate using an approved 
script. 
23.5 Describe the amount and timing of any payments to subjects.
Research Appointments
For patients and social supports, Research Appointments to gather survey, 
blood BMI, and hair data will last approximately 1 hour.
Patient and Social Support Interviews
Interviews will last approximately 1-2 hours. 
Focus Groups

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Focus Groups will last 1-2 hours. 
Advisory Board Interviews
Interviews will last 1-3 hours.
Compensation
For each component of the research, the participant will receive a 
merchandise card: 

For patients and social supports, for each of the 4 Research 
Appointments, they will receive a Walmart card worth $50

For patients and social supports invited to do an interview or focus 
group, they will receive a Walmart card worth $50 

For staff and provider interviewees, if they are not UNM 
employees, they will receive an Amazon card worth $50
Following the data collection appointment, interview or focus group, when 
we give a participant a card, we will ask them to sign a receipt and provide 
some information for our financial record files using the UNM research 
participant receipt form. Apart from a signature to verify they received the 
card, they do not have to provide any information that they do not care to 
share. 
While we hope that they will complete each activity they agree to, and it is 
best for our study results to have complete information from each activity, 
they will receive the merchandise card if they participate in a research 
activity even if they have to leave early or if they decide to stop in the 
middle.  
24.0
Local Number of Subjects
24.1 Indicate the total number of subjects to be accrued locally.
Local Comparator Sites:  We will compare 2 diabetes self-management 
program models used by many Latino patients from low-income 
households in Albuquerque, New Mexico: 1) The Diabetes Self-
Management Support Empowerment Model at the University of New 
Mexico Hospital and 2) The Chronic Care Model at One Hope Centro de 
Vida Health Center.
Subjects:  We will recruit a total of 240 patient-social support pairs from 
the two program sites: patients (N=240: 120 at each site) and a 
corresponding social support of each enrolled patient (N=240 – 120 at 
each site). We will also recruit up to 6 staff and providers from each site 
each year to participate in interviews. 
In addition, we will recruit the seven members of our Patient Advisory 
Board.

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24.2 If applicable, distinguish between the number of subjects who 
are expected to be enrolled and screened, and the number of 
subjects needed to complete the research procedures (i.e., 
numbers of subjects excluding screen failures.)
Our experience with successful recruitment leads us to believe that we 
will be successful enrolling according to the plan we have laid out.  Based 
on our experience working with this population in Albuquerque, our 
retention rates average 80-85%, which are consistent with other studies 
involving a similar population. To assure a conservative estimate, we 
estimated an attrition rate of 20% in our target recruitment. 
Our previous study experience has demonstrated that we have the 
capacity to retain participants. We would like to emphasize our expertise 
and skill working with this patient population.  The PI and the Co-PI have a 
strong record of working closely with individuals in the community and we 
have a cultural, linguistic and intellectual understanding of things that are 
important to patients and how to engage them.  This makes a huge 
difference in the way that we, as researchers, interact with patient 
participants. Moreover, our PDCSs at both sites will be members of the 
patient population—Latino diabetes patients from low-income 
households.  We believe that this will make a significant difference in the 
way that participants respond to and interact with our research project.  
These factors will assist us in retaining participants.
25.0
Provisions to Protect the Privacy Interests of Subjects
25.1 Describe the steps that will be taken to protect subjects’ 
privacy interests. “Privacy interest” refers to a person’s 
desire to place limits on whom they interact or whom they 
provide personal information.
Privacy and Confidentiality: Guidelines for the protection of participant 
privacy and confidentiality will be followed in all cases. All members of the 
research team will maintain current Human Subjects training.  They will 
understand the importance of privacy issues and their responsibility to 
maintain the highest research ethical standards in all respects. Surveys, 
blood-draws and other clinical data gathering, interviews and focus 
groups will be conducted at a location to provide privacy. Prior to 
beginning each focus group, the facilitator will instruct participants 
regarding privacy measures. All participants will be asked to sign a receipt 
for a merchandise card incentive which will be used for project accounting 
purposes only and will not be linked with or associated with research 
data. Potential participants’ contact and eligibility screening information 
will be kept in separate projects on REDCap. Enrolled participants’ contact 
information, demographic information, survey responses, and biological 
measures will be entered and stored in separate data collection 
instruments within a third project in REDCap. The PID assigned to eligible 

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participants will be retroactively assigned to these participants’ records in 
the Pre-Screening and Eligibility Screening projects, making this the only 
link across the three projects. The Study ID generated by REDCap will be 
the only link across the data collection instruments within the PCORI 
Diabetes Project. User rights to the three projects will be limited such that 
personally identifying information is only accessible to a few members of 
the research team. All biological samples will be uniquely labeled with the 
Participant ID.
We need to be able to maintain a link between the participant and the 
data to be able to notify participants if their A1c level is dangerously high 
or to be able to notify the participant’s PCP if their A1c is above 10, to 
schedule follow-up appointments at 3, 6, and 12 months, and to be able 
to invite the participant to the end-of-study presentation of project 
results. 
Consent Forms will be stored in a locked cabinet in the office of the PI and 
with access only by the investigators. The contact information, 
demographic information, and research data for all study participants will 
be stored electronically on our secure REDCap database. Contact 
information will be kept for five years after the end of the project to be 
able to invite the participant to participate in future follow-on studies. 
Consent Forms will be kept for 3 years following the end of the project, at 
which time they will be destroyed.  Participant information will be 
considered confidential and will not be shared. De-identified project data 
will be shared only per our Data Sharing Protocol. Transcripts from 
interviews and focus groups will not be shared. De-identified project data 
will be kept for at least 5 years.
25.2 Describe what steps you will take to make the subjects feel at 
ease with the research situation in terms of the questions 
being asked and the procedures being performed. “At ease” 
does not refer to physical discomfort, but the sense of 
intrusiveness a subject might experience in response to 
questions, examinations, and procedures.
PDCSs will be members of the patient community/population and will be 
fluent Spanish speakers.  Data collection will not be hurried.  PDCSs will 
spend time building rapport with participants.
25.3 Indicate how the research team is permitted to access any sources 
of information about the subject
Pre-Screening: Potential patient participants at the CDE-UNMH program 
will be called by a CDE-UNMH staff member of the research team and 
asked if they might be interested in participating in the study. If they say 
yes, they will be asked for their contact information to be contacted for an 
eligibility screening appointment. The information collected will be hand-

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written on a Pre-Screening form and later given to the Patient 
Engagement Coordinator, who will enter it into the Pre-Screening project 
in REDCap. 
Eligibility Screening: potential participants who agree to being screened 
for eligibility will be contacted by a member of the research team and 
asked the eligibility screening questions, including requesting information 
about a potential social support partner. The patient participant will be 
offered the opportunity to contact their potential social support partner 
to inform him or her that a research team member will be in contact to 
conduct an eligibility screening. When the patient partner gives 
permission to contact the potential social support partner, a member of 
the research team will contact the potential social support partner and 
conduct the eligibility screening. If both the patient participant and his or 
her social support partner are deemed eligible, a baseline data collection 
appointment will be scheduled. The information collected during the 
eligibility screening will be hand-written on an Eligibility Screening form 
and given to the Patient Engagement Coordinator, who will enter it into 
REDCap in the Eligibility Screening project. The Patient Engagement 
Coordinator will then create a record for the participant in the PCORI 
Diabetes Project in REDCap by assigning a PID to the participant. The 
Patient Engagement Coordinator will keep a master list of the 
participants’ names and PIDs both electronically and in hard copy. The 
electronic copy will be saved on her password-protected laptop, which is 
stored in a locked cabinet at One Hope when not in use. The hard copy 
will also be stored in a locked cabinet at One Hope.
Data Collection: at the baseline data collection appointment, the PDCS will 
collect and enter contact and demographic information into separate data 
collection instruments in the PCORI Diabetes Project in REDCap. At the 
baseline and all three follow-up appointments, the PDCSs will also 
administer the survey instrument to the participants, responses to which 
will be entered into a third data collection instrument in the same project. 
The PCDSs will also collect BMI measurements (weight and height) and 
draw blood for A1c testing at the baseline and all follow-up appointments 
and will collect a hair sample at the baseline and six-month follow-up 
appointment. The BMI measurements will be entered into a fourth data 
collection instrument in the PCORI Diabetes Project by the PDCS during 
each appointment. The A1c results will be entered into a fifth data 
collection instrument and the hair cortisol results entered into a sixth in 
the same project by the Data Manager when the results are provided to 
her. 
The contact and demographic information data collection instruments are 
the only data collection instruments in the PCORI Diabetes Project that 
contain personally identifying information. The data collection 
instruments that contain the participant’s survey responses and biological 

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measures do not contain any personally identifying information. Each 
participant’s data is linked across the six data collection instruments in the 
PCORI Diabetes Project by his or her unique Study ID, which is 
automatically generated by REDCap when the Patient Engagement 
Coordinator generates the record. 
In sum, there will be three separate projects in REDCap: the Pre-Screening 
project, the Eligibility Screening project, and the PCORI Diabetes Project, 
which contains the participant contact information, demographic 
information, survey responses, BMI measurements, A1c results, and hair 
cortisol results in six separate data collection instruments. The PID that is 
generated before the baseline data collection appointment will be 
retroactively added to the relevant record in both the Pre-Screening and 
Eligibility Screening projects by the Research Manager or the Data 
Manager to allow for tracking of recruitment, enrollment, and attrition. 
This will be the only link across the three projects. 
Participants’ personally identifying information will be gathered and 
entered into REDCap at all three stages – pre-screening, eligibility 
screening, and baseline data collection. We will protect and limit access to 
this information in the following ways: 
     1) After the Patient Engagement Coordinator enters the information 
from the hard copy pre-screening and eligibility screening forms into 
REDCap, the hard copies will be turned over to the Research Manager, 
who will file them in a locked filing cabinet in a locked office at the UNM 
HSC OCH; 
     2) Access to the data in both the Pre-Screening project and the 
Eligibility Screening project will be limited to the Patient Engagement 
Coordinator, the Data Manager, the Research Manager, the PIs, the Senior 
Statistician, and the Biostatistician for purposes of entering data (Patient 
Engagement Coordinator) and exporting data for quality control, and data 
analysis (PIs, Data Manager, Research Manager, Senior Statistician, and 
Biostatistician. Any data resulting from the quality control or analysis 
processes that will be shared with others on the research team without 
their own access to these data will be de-identified before sharing.); 
     3) Access to the instruments within the PCORI Diabetes Project can be 
limited. Access to all the data (including identifying information) in all the 
data collection instruments will be limited to the Data Manager, the 
Research Manager, the PIs, the Senior Statistician, and the Biostatistician 
for purposes of quality control and data analysis (any data resulting from 
these processes that will be shared with others on the research team will 
be de-identified before sharing). The Patient Engagement Coordinator, 
the PI and the Co-I will have access to de-identified data in this project. 
Appointments will be scheduled and tracked in this project using the 
Calendar tool in REDCap. In order to be able to provide the data collectors 
with the information necessary to meet with participants, the 

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appointments in the Calendar tool will include the participant’s name, 
phone number, and address (if meeting the participant in his/her home). 
REDCap is a safe place to store personally identifying information because 
it is a password-protected site that is stored behind the UNM HSC firewall. 
In order for research team members to access it from on-campus, they 
must be logged into the HSC secure wifi; off-campus (i.e., outside the 
firewall), they must use the Cisco virtual private network (“VPN”), access 
to which is only allowed after being approved by the university’s 
Information Technologies department. Access to the REDCap database is 
further secured by the fact that the iPads used by the data collectors and 
the laptops or desktops used by other members of the research team 
(with user rights) are password-protected. In addition, project 
administrators have the ability to limit access to data collection 
instruments or projects for other members of the research team.
A1c results will be sent electronically from the CTSC lab to the PI and the 
Data Manager, and the PI will also receive hard copy results. The Data 
Manager will enter those data into the secure UNM REDCap database and 
then destroy the hardcopy documents.
Hair samples will be stored in plastic bags in the office of the PI.  When 
funding for analysis is obtained, the Research Manager will give them to 
Dr. Bearer for analysis in her UNM lab. Remaining hair will be stored for 
up to two years after the project to ensure we had a sufficient sample for 
analysis.
Interviews and focus groups will be audio recorded. The Research 
Manager will upload audio recordings from the recording device into 
his/her password protected UNM computer as MP3 files. Once this has 
been done, the Research Manager will delete the files from the recording 
device. 
The MP3 files will be stored on the secure password-protected UNM 
computer of the Research Manager. The Research Manager will send 
those audio recordings to the transcriptionist/translator using a secure 
UNM FTP electronic file process.  The transcriptionist/ translator will send 
back the transcription/translation as an electronic doc file. Once the 
Research Manager receives the electronic doc file of the audio recording, 
he/she will destroy the original MP3 file. 
The electronic doc files of the interview and focus group transcripts will be 
stored on the password protected UNM computers of the Qualitative 
Research team. Hard copies of transcripts used for coding will be stored in 
a locked cabinet in the PIs office.
26.0
Compensation for Research-Related Injury

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26.1 If the research involves more than Minimal Risk to subjects, 
describe the available compensation in the event of research 
related injury.
This research does not involve more than Minimal Risk to 
subjects.
26.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury.
This research does not involve more than Minimal Risk to 
subjects. We do not anticipant any situation where participants 
could be injured as a result of their participation in this research.
27.0
Economic Burden to Subjects
27.1 Describe any costs that subjects may be responsible for 
because of participation in the research.
Patients may experience impacts on their time, they may incur 
travel expenses or require that others who provide travel to them 
wait while they have their appointment with us, they may have to 
miss work, and they may have child care expenses or have to 
expend social capital to call on others to watch their children. 
28.0
Consent Process
28.1 Indicate whether you will you be obtaining consent, and if so 
describe:
1.
Where will the consent process take place
Consent will be obtained at One Hope Clinic, UNMH 
Diabetes Education Program or at a location of convenience 
to the participant.
2.
Any waiting period available between informing the 
prospective subject and obtaining the consent.
We do not plan to schedule a specific waiting period, as we 
do not forsee any major risks, hazards or side effects to the 
participants related to participation in the research. 
Participants have the ability to withdraw from the study at 
any time.
3.
Any process to ensure ongoing consent.

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At each data collection appointment, interview or focus 
group, before beginning the data collection, the research 
team member conducting the data collection event will 
remind the participant about the consent they signed and 
the fact that they have the capacity to withdraw at any 
time.
4.
Whether you will be following “SOP: Informed Consent 
Process for Research (HRP-090).” If not, describe:
o
The role of the individuals listed in the 
application as being involved in the consent 
process.
To recruit participants from CDE-UNMH, the CDE staff 
member or research team member who calls the patient to 
tell them about the study and inquire if they might be 
interested will use an approved recruitment script. If the 
patient indicates interest, the staff or research team member 
will ask for oral permission from the patient to release the 
patient’s name and contact information to the research team 
so that the PDCS can contact the interested patient and 
conduct the screening to determine eligibility. Oral permission 
will not be used for consent to participate, only for consent to 
share the patient’s name and contact information for 
recruitment.
For actual participation in the study, we will obtain written 
consent from all participants. 
If both the patient participant and his or her social support 
partner are deemed eligible, a baseline data collection 
appointment will be scheduled, at which time the participant 
will be consented into the study. At the baseline data 
collection appointment the research team member will 
provide information about the study and about the nature 
and length of the participant’s involvement, and let them 
know that their participation and the data they provide will be 
considered confidential. The research team member will go 
over the Consent Form individually with each participant, 
making sure that they understand the research and their 
participation in it.  The research team member doing the 
consenting of patient and social support participants will be 
required to be bilingual to accommodate English and Spanish-
speaking participants. The research team member will ensure 
that participants understand that their participation is 
voluntary and that they can choose not to participate or to 
withdraw their participation at any point in the study. Both 

PROTOCOL TITLE:  Comparing Program Options for Latinos with Diabetes
Page 65 of 78
Revised: August 3, 2017
the participant and the research team member will sign the 
consent form.  The participant will be given a copy of the 
consent to keep for their files. In addition, participants will be 
asked to provide contact information and demographic 
information. The contact information will be kept in a 
separate data collection instrument on REDCap from the 
demographic data and research data from the participant. 
The contact information will be used to schedule 3-, 6-, and 
12-month follow-up appointments, to contact patients in case 
of elevated A1c results, to invite the participant to an end-of-
project presentation of data to participants, and to invite the 
participant to participate in future follow-up research. We do 
not anticipate any reason for participants to be withdrawn 
from the research without their consent.
o
The time that will be devoted to the consent 
discussion.
We anticipate that the consent discussion will take 15 to 20 
minutes.
o
Steps that will be taken to minimize the possibility 
of coercion or undue influence.
The research team member will go over the Consent 
Form individually with each participant, making sure 
that they understand the research and their 
participation in it.  The research team member doing 
the consenting of patient and social support 
participants will be required to be bilingual to 
accommodate English and Spanish-speaking 
participants. The research team member will ensure 
that participants understand that their participation 
is voluntary and that they can choose not to 
participate or to withdraw their participation at any 
point in the study.
o
Steps that will be taken to ensure the subjects’ 
understanding.
Consent documents will be available in English or 
Spanish depending on the preference of the 
participant. The research team member will go over 
the Consent Form individually with each participant, 
making sure that they understand the research and 
their participation in it.  The research team member 
doing the consenting of patient and social support 

PROTOCOL TITLE:  Comparing Program Options for Latinos with Diabetes
Page 66 of 78
Revised: August 3, 2017
participants will be required to be bilingual to 
accommodate English and Spanish-speaking 
participants. The research team member will ensure 
that participants understand that their participation is 
voluntary and that they can choose not to participate 
or to withdraw their participation at any point in the 
study.
Non-English Speaking Subjects
5.
Indicate what language(s) other than English are 
understood by prospective subjects or representatives.
This is a study with participants from the Latino community 
in Albuquerque.  We anticipate that some participants will 
speak Spanish. Some Spanish-speaking participants will be 
fluently bilingual in English and Spanish, others will not 
speak or understand English well.
6.
If subjects who do not speak English will be enrolled, 
describe the process to ensure that the oral and written 
information provided to those subjects will be in that 
language. Indicate the language that will be used by 
those obtaining consent.
All of our study participant materials will be available in 
English or Spanish. The participant will be able to choose 
the language they prefer.  In addition, all of our PDCSs will 
be fluent in Spanish.
7.      Waiver or Alteration of Consent Process (consent will 
not be obtained, required information will not be 
disclosed, or the research involves deception)
To recruit participants from CDE-UNMH, the CDE staff member who 
calls the patient to tell them about the study and inquire if they 
might be interested will use an approved recruitment script. If the 
patient indicates interest, the staff member will ask for oral 
permission from the patient to release the patient’s name and 
contact information to the research team so that the PDCS can 
contact the interested patient and conduct the screening to 
determine eligibility. 
Oral permission will not be used for consent to participate, only 
for consent to share the patient’s name and contact information 
for recruitment.

PROTOCOL TITLE:  Comparing Program Options for Latinos with Diabetes
Page 67 of 78
Revised: August 3, 2017
For actual participation in the study, we will obtain written 
consent from all participants. 
8.     Subjects who are not yet adults (infants, children, 
teenagers)
N/A
9.     Cognitively Impaired Adults
N/A
10.
Adults Unable to Consent
N/A
11.
For HUD uses provide a description of how the patient 
will be informed of the potential risks and benefits of 
the HUD and any procedures associated with its use.
N/A
29.0
Process to Document Consent in Writing
29.1 Describe whether you will be following “SOP: Written 
Documentation of Consent (HRP-091).” If not, describe 
whether and how consent of the subject will be documented 
in writing.
To recruit participants from CDE-UNMH, the CDE staff member who calls 
the patient to tell them about the study and inquire if they might be 
interested will use an approved recruitment script. If the patient indicates 
interest, the staff member will ask for oral permission from the patient to 
release the patient’s name and contact information to the research team 
so that the PDCS can contact the interested patient and conduct the 
screening to determine eligibility. 
Oral permission will not be used for consent to participate in the study, 
only for permission to share the patient’s name and contact information 
for recruitment.
For actual participation in the study, we will obtain written consent from 
all participants. 

PROTOCOL TITLE:  Comparing Program Options for Latinos with Diabetes
Page 68 of 78
Revised: August 3, 2017
29.2 If your research presents no more than minimal risk of harm 
to subjects and involves no procedures for which written 
documentation of consent is normally required outside of the 
research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.
We plan to obtain written consent.
29.3 (If you will document consent in writing, attach a consent 
document. If you will obtain consent, but not document 
consent in writing, attach a consent script. Review 
“CHECKLIST: Waiver of Written Documentation of Consent 
(HRP-411)” to ensure that you have provided sufficient 
information. You may use “TEMPLATE CONSENT 
DOCUMENT (HRP-502)”to create the consent document or 
script.)
See attached CDE-UNMH Recruitment Consent Script for 
permission for CDE to release patient name and contact 
information to the research team. 
See attached consent form for participation in the study.
30.0
Drugs or Devices
30.1 If the research involves drugs or device, describe your plans 
to store, handle, and administer those drugs or devices so 
that they will be used only on subjects and be used only by 
authorized investigators.
N/A
30.2 If the drug is investigational (has an IND) or the device has 
an IDE or a claim of abbreviated IDE (non-significant risk 
device), include the following information:
N/A

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