Feasibility of a Novel Systems Approach for Improving Utilization of Alzheimer's Disease Services Among Latinos Attending Primary Care Practices
Phase: PHASE1
Conditions: Dementia
Sponsor: University of Kansas Medical Center

Official Title:  Feasibility of a Systems Approach for Alzheimer's Services Among Latinos Attending Primary 
Care Practices 
 
NCT Number: NCT04418232 
 
Date of Consent Form Approval: 10/6/2022 
 
 

 
Feasibility of a Novel Systems Approach for Improving Utilization of Alzheimer's Disease Services 
Among Latinos Attending Primary Care Practices 
SPECIFIC AIMS  
Alzheimer’s disease and related dementias (ADRD) are a major cause of mortality and disability in later 
life and cost the US healthcare system more than cancer or heart disease.1,2 The National Alzheimer's Plan 
Act and the National Institutes of Health have identified ADRD disparities among ethnic minorities as a public 
health priority.3-5 Latinos with ADRD experience substantial disparities with reduced rates of early diagnosis 
and lower quality care compared to their non-Latino white peers, which put them at an increased risk for 
steeper cognitive decline, morbidity, mortality and higher caregiver burden.6-9 A number of barriers conspire to 
create these disparities including a lack of an evidence-based strategy to address ADRD in clinics, patient and 
primary care provider (PCP) reduced ADRD knowledge, negative attitudes regarding ADRD, PCP’s lack of 
time, cultural and language barriers and health insurance status.10-19 To improve healthcare delivery to Latinos 
with ADRD, we need to redesign current ADRD detection and care systems to follow evidence-based 
recommendations for early detection and culturally appropriate chronic care.  
The overall aim of this proposal is to enhance the delivery of ADRD services to Latinos in primary care 
through a scalable systems approach that includes evidence-based recommendations.20 Primary care clinics 
are the ideal setting to provide ADRD services, as 93% of older Latinos have a usual source of healthcare. The 
novel systems approach (Alianza Latina/Latino Alliance) will enhance timely ADRD diagnosis and optimal care 
to minimize behavioral symptoms and cognitive decline among Latinos in a linguistically and culturally-
appropriate way. Alianza Latina will use the Collaborative Care Framework 21-24 that capitalizes on PCPs and 
Health Navigators. 1) PCPs will undergo evidence-based training to enhance timely and culturally appropriate 
diagnosis and implement it in their work routine. 2) PCPs will detect, treat and refer Latino ADRD patients to a 
bilingual Health Navigator to provide chronic care management, which will reduce PCP time burden.  
This proposal is a natural progression of my work in the Latino community throughout my Diversity 
Supplement 25 and in line with my long-term goal to establish an independent research program to address 
disparities in ADRD experienced by Latinos. I have strong interdisciplinary expertise in epidemiology, aging 
and health disparities. During my Diversity Supplement, I gained relevant experience in ADRD assessment 
and community-engaged research with Latino community centers. This K01 will provide me with unique formal 
and hands-on training in 1) evidence-based ADRD care, 2) health systems research and 3) qualitative 
research. I will address these gaps guided by the mentorship of Drs. Burns, Greiner and Williams. This award 
will provide the necessary training to become an independent researcher via mentored research, formal 
coursework, directed readings, seminars, conferences and other career development activities. 
Aim 1: Examine the current primary care models of ADRD care to identify what services are 
offered and how they are delivered across a variety of settings. We will conduct semi-structured 
interviews among clinic staff, older Latinos with ADRD and their caregivers in primary care clinics from 
diverse regions. Our goal is to understand the barriers (and facilitators) that Latinos may encounter in 
primary care clinics regarding ADRD detection and care including: 1) currently offered ADRD services, 
2) adherence to best practices, 20,26 3) linguistic and cultural barriers to ADRD service access and 4) 
geographic differences in these services and barriers.  
Aim 2: Test the feasibility and acceptability of Alianza Latina. Aim 2.a: We will train PCPs from 10 
Kansas City clinics to enhance skills in cultural competence, ADRD detection, treatment and referral to 
a Health Navigator among Latinos 65 and older with ADRD. Aim 2.b. The Health Navigator will provide 
100 patients/caregiver dyads referred by Alianza Latina PCPs or other sources (e.g., flyers, online 
advertising) with care management, psychosocial support and links to relevant community resources. 
We will assess the feasibility and acceptability 27,28 of 1) PCP training and 2) patient and caregiver 
ADRD care. Feasibility outcomes will provide the necessary information to further refine the intervention 
in preparation for a fully-powered R01 RCT comparing the efficacy and cost-effectiveness of Alianza 
Latina vs Standard Care in the state of Kansas, a state where 11% of the population identifies as Latino 
and 13 counties have a Latino population of more than 20%.29  
This proposal is innovative, as there is a lack of healthcare systems developed to address disparities in 
ADRD diagnosis and care among Latinos. Alianza Latina may reduce costs by reducing the need for highly 
specialized memory clinics, emergency room visits and other avoidable healthcare use and by prioritizing 
crisis-prevention rather than reaction. 30-37 This proposal will have a significant impact given its potential high 

cost-effectiveness and the fact that it focuses on Latinos, the largest ethnic minority and fastest growing older 
group in the USA.38    
 

SIGNIFICANCE 
The impact of Alzheimer’s disease 
 
Alzheimer’s disease and related disorders (ADRD) pose a serious public health threat in the USA. 
The share of American older adults is increasing and the risk of ADRD increases with age.39,40 ADRD is the 
fifth leading cause of mortality and its associated disability has increased substantially in the past two 
decades.41-43 Individuals with ADRD have more chronic conditions, polypharmacy use and hospitalizations 
than older adults without ADRD.41 Caregivers of people with ADRD often experience disproportionate 
depression (~34%) and anxiety (~44%).44 ADRD costs exceed those of cancer and heart disease. 2,41  
A timely detection and optimal care can optimize the prognosis for patients with ADRD and is a 
priority for National Alzheimer’s Project Act (NAPA).3 Though there are no treatments that prevent or stop 
the progression of ADRD, there is evidence that pharmacologic and behavioral interventions can stabilize 
and delay the progression of cognitive, functional and behavioral outcomes, improving the lives of 
individuals with ADRD and their families.45,46 Given the progressive nature of ADRD, early diagnosis may 
allow both the patient and family to participate in their care plan and begin more efficacious interventions.47 
Early detection and care also has economic benefits at the individual, familial and societal levels.48-50 
Why focus on improving ADRD diagnosis and care among Latinos? 
Addressing ADRD disparities among Latinos is a federal public health priority. Ethnic health and ADRD 
disparities are core targets of major USA agencies including Healthy People 2020,51 the National Institute on 
Minority Health and Health Disparities,5 National Institute on Aging 4 and NAPA.3 Latinos are the largest 
ethnoracial US minority (18%) 52 and are the fastest growing elder group, projected to increase more than 
sevenfold by 2060.38,40 Latinos have worse levels of ADRD risk factors than non-Latino Whites including 
education and cardiovascular health 53-66 and earlier ADRD onset.38,67-74  
Latinos experience substantial disparities in ADRD diagnosis and care. Compared to non-Latino 
Whites, disparities in ADRD diagnosis and care among Latinos include: 
• 
Lower detection of memory disorders by providers.6  
• 
Higher severity and duration of ADRD symptoms at time of first diagnosis.75-77  
• 
Higher risk of behavioral and psychological symptoms (BPSD)78 and more BPSD unmet needs.79 
• 
Higher risk of becoming an informal caregiver of a relative with ADRD and higher caregiver burden.80  
• 
Lower probability to use caregiver support services and anti-dementia medication. 7-9,81,82 
What barriers to ADRD diagnosis and care do Latinos experience?  
Data from 2011-2013 suggests that most older Latinos (93%) have a usual source of healthcare.83 
However, multiple factors contribute to the poor ADRD detection and care Latinos receive. Healthcare barriers 
include the lack of strategies to provide early ADRD diagnosis and care in primary care clinics.84,85 For 
example, since its inception in 2011, no-cost fee-for-service Medicare Annual Wellness Visits require a 
cognitive screening among other relevant health assessments for older adults. However, these visits are 
under-implemented in minority-affluent clinics and do not require the use of validated tests for screening.86 
Some healthcare providers have poor attitudes towards addressing ADRD due to lack of ADRD knowledge on 
potential benefits of appropriate diagnosis and care.11,12 Some health providers also lack the knowledge and 
skills to diagnose, provide care for or refer to frequently fragmented community resources.11,12 Healthcare 
providers also experience time constraints.11,12 These barriers are more prevalent among Latinos, as many 
providers lack cultural and linguistic proficiency and knowledge of validated tools for assessment and care.12-15  
At the individual level, Latinos are the group with the lowest ADRD knowledge and most misconceptions, which 
may hinder effective assessment and care-seeking behaviors on behalf of individuals with ADRD and their 
relatives.12,17 For example, a lack of ADRD knowledge can lead to misconceptions such as thinking that ADRD 
is a normal part of aging.17-19 At the socio-economic level, Latinos are the highest underinsured ethnic group 
leading to higher out-of-pocket costs that may result in a suboptimal ADRD assessment and care.16 The 
current proposal will test the feasibility of a health systems approach to address ADRD healthcare, individual 
and socio-economic barriers experienced by Latinos. Reducing these barriers has the potential to reduce the 
disproportionate impact of ADRD among Latinos.  
INNOVATION  
ADRD research with culturally diverse populations is critical; however, most ADRD research among 
Latinos is observational.69,73,87,88 Research on health systems interventions to address barriers leading to 
disparities in ADRD diagnosis and care among Latinos is lacking. This proposal will implement a health 
systems intervention (Alianza Latina-Latino Alliance) based on the Collaborative Care Framework 21-24 to 

address healthcare, individual and socio-economic level barriers. The Collaborative Care Framework offers a 
guide for higher-quality chronic illness management within primary care in which informed, activated patients 
interact with prepared, proactive practice teams. Interventions based on this framework have shown to be 
effective in improving patient outcomes.89 The intervention capitalizes on the potential of primary care 
providers (PCPs) to be the point of access to healthcare for Latino older adults, as most of them are insured 
(96%) and have a usual source of healthcare (93%).10,83 Focusing on PCPs may reduce the cost and 
saturation of expensive and highly specialized memory clinics. The intervention also capitalizes on Health 
Navigators. While interventions have used Health Navigators to address health disparities among minorities,90 
to our knowledge, no intervention has implemented these models to address disparities in ADRD care. Health 
Navigators may reduce costs by addressing complications that lead to avoidable healthcare use such as 
emergency room visits and institutionalization and prioritizing crisis-prevention rather than reaction. 30-37 Table 
1 shows how Alianza Latina will address barriers to ADRD diagnosis and care among Latinos using the 
Collaborative Care Framework. Health Navigators will provide chronic care relieving PCP time burden and 
ensuring central Latino values and barriers are taken into account in the care process (i.e. educating the family 
on ADRD, promoting warm communication and tailoring messages in line with participants’ literacy levels).91   
SUSTAINABILITY PLAN 
Alianza Latina will be built to be sustainable. Aim 1 will examine what ADRD care services are currently 
being offered to Latinos in primary care clinics to accommodate evidence-based recommendations to their 
workflow. Alianza Latina will capitalize on Medicare billing. First, PCPs will be encouraged to use Medicare 
Annual Wellness visits to screen Latinos 65+. The Medicare Annual Wellness Visit is important as most 
Latinos 65+ have Medicare. These visits bring more revenue to clinics than the typical problem-based visit, 
and both the Annual Wellness Visit and problem-based visits can be billed concurrently.86 Second, Alianza 
Latina will provide chronic care coordination services built around Medicare’s Chronic Care Management 
system, which will allow billing services through Medicare.92,93 These services include establishing a plan for 
monthly in-person and telephone case management.  
PRELIMINARY STUDIES 
I have the necessary experience, training and environment to achieve my overall research aim of 
enhancing the delivery of ADRD services to Latinos in primary care through a scalable systems approach that 
includes evidence-based recommendations. During my first postdoctoral position, I developed interventions for 
Latinos using the Collaborative Care Framework.94-96 The efficacy of these interventions has informed the use 
of the same framework in the development of Alianza Latina. During my fellowship training at the KU ADC, I 
have developed, tested and implemented an intervention to increase ADRD knowledge in the Latino 
community.25 In this study, the Latino community identified use of ADRD services as a top need in the Latino 
community informing the development of Alianza Latina. Because our ADRD educational presentation was 
effective in increasing knowledge among Latinos,25,97 PCPs and Health Navigators in Alianza Latina will use it 
to educate patients and families. The KU ADC has a growing PCP collaborative care network program led by 
social work navigators to handle the complex needs of ADRD in the community. This program is directed by 
my primary mentor and Michelle Niedens (LSCSW) both appointed to the Kansas Governor’s Work Group to 
establish a statewide plan to address ADRD. The goal of this program is to extend across Kansas. I will 
leverage this program’s connections, materials and staff to implement Alianza Latina.  
APPROACH  
The research proposal comprises two inter-related studies that aim to identify novel methods for 
improving diagnosis and care services among Latinos in primary care (See Figure 1). This project builds 
upon my connections with the Latino community and my mentors’ PCP connections, infrastructure, and 
Table 1. Barriers among Latinos in ADRD services addressed by the Collaborative Care Framework 
Barriers in ADRD services 
Collaborative Care Framework components 
Healthcare barriers:  
  Lack of clinics’ strategies to provide ADRD detection & care 
  Lack of PCP knowledge and nihilistic attitudes 
  Linguistic & cultural barriers 
  Fragmented community resources 
  Time constraints 
Use of evidence-based recommendations for timely ADRD 
detection and optimal care; PCP education in cultural proficiency 
and ADRD knowledge, detection and care skills and attitudes; 
linguistically and culturally proficient Health Navigators who 
manage ADRD chronic care and refer to culturally appropriate 
community resources 
Individual barriers: 
  Lack of patient and family ADRD knowledge 
PCPs and Health Navigators provide culturally appropriate patient 
and family ADRD education  
Insurance barriers: 
  Underinsurance 
Health Navigators refer patients to existing financial assistance 
programs for ADRD expenses if needed 

experiences in transforming healthcare systems. The project will be implemented over five years and will 
use mixed-methods spanning formative and intervention research. Results from Aim 1 will inform the 
logistics of the intervention proposed on Aim 2. Results from Aim 2 will help refine Alianza Latina and will 
inform the subsequent R01 study design proposal of a randomized clinical trial to assess its efficacy.     
Recruitment Sites. Aim 1 will be conducted in primary care clinics in the Kansas City region and other 
regions. Including clinics in different regions will increase generalizability of results as they vary in 
readiness to serve Latinos and patient ancestry (i.e. Mexican/Caribbean). Most clinics have already 
established a partnership with my mentors and are committed to participate (see letters of support). Aim 2 
will include clinics (urban and rural) in the Kansas City region. I will establish partnerships with additional 
clinics meeting with administrators and highlighting the potential benefits of Alianza Latina to their clinic 
(i.e. PCP training and lower time burden in ADRD care) and their patients and relatives (i.e. improved care 
at no additional cost). I will send clinics bi-weekly newsletters with information on key issues in ADRD 
management and program elements to keep them engaged in our partnership. It is important to note that 
the role of all clinics -including those at the KU Medical Hospital- is purely as recruitment sites (of clinic 
staff and individuals with ADRD and their caregivers). No clinic will consent or interview participants or 
analyze data of any type for aims 1 or 2 of this study. These tasks will be conducted solely by Dr. Perales 
and his Research Assistant (RA).   
Figure 1. Research strategy 
 
 Aim 1. Examine the current primary care models of ADRD care to identify what services are offered 
and how they are delivered across a variety of settings. 
Overview. This study will use mixed-methods, a methodology increasingly used by health systems researchers. 
Mixed-methods refers to collecting, analyzing and mixing quantitative and qualitative methodologies in a project.26 
This approach is required given the scarce literature on ADRD services among Latinos in primary care and has 
been used to understand barriers to guideline adherence in other conditions resulting in descriptions that helped 
develop important recommendations for improvement.98 Aim 1 is tightly linked to my training goals, as I will 
assess the implementation of evidence-based ADRD care and will use methods from health systems and 
qualitative research. We will conduct: 
1. Focus groups with a Community Advisory Board (CAB) to incorporate Latino, PCP and ADRD care 
perspectives into existing ADRD care evidence-based recommendations.  
2. Semi-structured interviews with Latino ADRD patients and clinic staff to understand ADRD services 
currently used in clinics and how they could be tailored to address the needs of ADRD Latino patients.  
Community Advisory Board (CAB). During my Diversity Supplement, I convened a CAB to incorporate their 
perspectives in our research. The CAB will include national and local leaders of the Latino community: Jason 
Resendez (Director of the national advocacy group LatinosAgainstAlzheimer’s), Diane Rojas (Director of the 
Guadalupe Senior Center), Cielo Fernández (Director of Latino outreach at the Swope Clinic) and Erica Andrade 
(Chief Program Officer of El Centro Community Center). The CAB will also include leaders in primary and ADRD 
care: Dr. Burns (Primary Mentor), Dr. Greiner (Secondary Mentor) and Natalia Loskutova, the Director of 
Evaluation at American Academy of Family Physicians, who has a special interest in the implementation of ADRD 
care in primary care clinics. CAB members will receive $100 per meeting.   
 
 
Year 1 
(Preparation).
• Train RA in research
• CAB meetings 1-3 
(guideline adaptation)
• Develop clinic 
partnerships
• Prepare Aim 1 bilingual 
materials
Year 2 (Aim 1).
• CAB meeting 4 
(recruitment)
• Recruit PCPs and 
participants
• Plan and implement 
interviews
• Analyze data
Year 3 (Aims 1 & 2).
• CAB meeting 5 
(refinement)
• Develop materials
• Train RA in Health 
Navigation
• Implement Alianza Latina
• Start data collection
Year 4 (Aim 2).
• CAB meeting 6 
(recruitment)
• Continue to implement 
Alianza Latina
• Continue data collection
• Start data analysis
Year 5 (R01 
preparation).
• CAB meeting 7 
(refinement)
• Conclude data analysis
• Disseminate results
• Apply for R01 and related 
grants

CAB members will be asked to participate in three focus groups in Year 1 and one annually in the following 
years. In Year 1, as representatives of the Latino community and ADRD care, the CAB will examine the ACT on 
Alzheimer’s evidence-based ADRD detection and care recommendations that will be implemented in Aim 2 and 
identify gaps in the needs of Latino patients.20 The goal of the focus groups is to discuss the recommendations 
in hopes of understanding of the unique needs representative of Latino patients and modify the recommendations 
to include the CAB’s suggestions. The CAB will discuss copies of the evidence-based recommendations syllabus, 
interactive course materials and themes. Semi-structured discussion will include, but will not be limited to, the 
following questions: What materials/content seems essential? What materials are missing to address the Latino 
patient situation? What materials are useful but need to be changed to better address these needs? After this 
focus group, the RA and I (PI) will revise the materials and curriculum and present them to the CAB who will 
evaluate revisions via semi-structured discussion and Likert scales. Year 2 and 4 will address how to optimize 
recruitment and retention. Years 3 and 5 will address how to refine Alianza Latina considering the study’s findings. 
I will facilitate all focus groups by asking clear, open-ended questions, balancing the participation of all participants 
avoiding few people to dominate the discussion, redirecting the discussion if it strays far off topic and checking 
with participants to ensure their message is understood. I will audiotape all focus groups.  
PCP and patient interviews. These 60-minute semi-structured interviews will gather information about the 
ADRD care services currently in place and how they could be tailored to address the needs of ADRD Latino 
patients. We will recruit a purposive sample of PCPs and Latino ADRD patients from clinics in Kansas City 
Metro, San Antonio, TX and Ft Meyers, FL. The RA and I will develop open-ended discussion guides and 
conduct the interviews. A HIPAA-compliant company will transcribe the audiotaped interviews. We will complete 
a checklist in all clinics to assess adherence to ADRD evidence-based recommendations.20 Participants will 
give signed consent. ADRD patients will receive a $40 pre-paid card and PCPs will receive $40 for their time. 
Semi-structured discussion with clinic staff will include, but will not be limited to, the following questions: 
1) Can you describe the typical service a patient 65 and older would receive in a yearly visit? 2) How are people 
with ADRD usually detected in this clinic? 3) What care do people with ADRD usually receive in this clinic? 4) 
Are there any particularities about that service with Latino patients? 5) What are some of the challenges to 
ADRD detection and care experienced with Latino patients?  
 
Semi-structured discussion with Latino ADRD patients and caregivers will include, but will not be limited 
to, the following questions: 1) Can you describe the ADRD services received in this clinic? 2) What went well 
with these services and what could be improved? 3) How relevant to your situation as a Latino patient were the 
services received? 4) What are some of the additional challenges that should be considered in these services?   
Data Analysis and Dissemination. My mentor Dr. Williams has extensive expertise conducting mixed-
methods research. She will assist me with analyses of findings on Aim 1. Focus groups and interviews will be 
transcribed by a HIPAA-compliant professional transcription company. Central tendency estimates, frequencies 
and percentages will describe quantitative data on R Software.99 Qualitative analyses will employ content, 
domain and taxonomic analysis.100,101 Transcribed content and notes will be coded and analyzed using ATLAS-
ti software.102 We will first open-code transcripts by identifying keywords, themes and descriptions of behavior 
within the text.103 Later, we will group the themes into coding categories and develop a code map to categorize 
and retrieve comments on each theme. Two independent coders will code the transcripts, and their agreement 
will be measured using kappa coefficient. Findings will be disseminated in peer-reviewed journals and results 
will inform the refinement of Alianza Latina.  
Aim 2. Test the feasibility and acceptability of Alianza Latina.  
Overview. This study will be a one-arm clinical trial to examine the feasibility and acceptability of Alianza 
Latina, a health systems intervention to improve ADRD diagnosis and care among Latinos. The intervention will 
be conducted at the same 10 Kansas City clinics as Aim 1. Alianza Latina will use the Collaborative Care 
Framework (Table 1) and 21-24 will partner with primary care clinics to 1) provide PCPs with training and tools for 
timely ADRD diagnosis, optimal treatment and cultural competence and 2) incorporate Health Navigators to 
enhance ADRD care and reduce PCP burden (See Figure 2). Feasibility and acceptability outcomes will be 
obtained from metrics and surveys with PCPs, Latino patients with MCI and ADRD and their caregivers. Aim 2 
is tightly linked to my training goals, as PCPs and Health Navigators will implement evidence-based ADRD care 
in primary care and measure outcomes using semi-structured interviews. The one-arm design will allow testing 
most types of study feasibility while focusing on the newly designed intervention.      

 Intervention. The main components of Alianza Latina are 1) providing PCPs with education, training and tools 
for timely ADRD diagnosis and optimal treatment and 2) providing Latino ADRD patients with enhanced chronic 
care through bilingual Health Navigators. These two components will be assessed in two separate sub-aims. 
Aim 2.a. Providing PCPs with education, training and tools for timely ADRD diagnosis and optimal treatment. 
Alianza Latina will partner with 10 primary care clinics 
who serve Latino older adults. We will train PCPs in 
cultural competence and ADRD knowledge, skills 
and attitudes.104 For Cultural Competence Care, 
PCPs will complete an online course by the US 
Department of Health & Human Services.105 For 
ADRD knowledge, skills and attitudes, PCPs will 
receive a standardized online or in-person training 
modeled after Minnesota’s “ACT on Alzheimer’s“ 
ADRD Curriculum and a specific training developed 
by our research team.20 The online ACT on 
Alzheimer’s ADRD Curriculum is free, self-directed 
and consists of 10 modules (understanding 
dementia; demographics; societal impact; early 
detection; screening; assessment and diagnosis; 
interventions; caregiver support; behavior as 
communication and philosophy of care). The in-
person training will take one day, will be delivered by 
Dr. Burns’ ADRD collaborative care team and me 
and will cover the same topics as the online training. 
Both trainings will include specifics about ADRD 
detection and care among Latinos, including 
validated tools for Spanish speakers. All three 
courses provide Continuing Medical Education 
credits upon completion, which may incentivize PCP 
participation in Alianza Latina. In April, the KU ADC 
delivered a similar training event to 13 rural 
providers, all of which have started implementing the 
evidence-based recommendations among their 
patients. 
PCPs will be trained to follow culturally and linguistically appropriate diagnostic and treatment algorithms using 
an evidence-based approach to timely screening, diagnosis and management of dementia intended to 
decrease the need for sub-specialty care.20  PCPs will be trained to administer an evidence-based ADRD 
screener to all Latinos 65+. We will suggest using the Mini-Cog, as it is freely available, takes only three 
minutes to administer and has shown excellent psychometric properties in a multilingual US sample.106 PCPs 
will be trained to follow-up with a more comprehensive cognitive test for those who screen positive. We will 
suggest using the Montreal Cognitive Assessment (MoCA), as it is also freely available, short and has been 
shown to detect ADRD and MCI among US English and Spanish speaking individuals.107,108 Those screened 
positive will undergo a dementia work-up (i.e. family and medical history, physical exams, behavioral 
symptoms) which will use Latino-validated tools when possible. This information will inform ADRD diagnosis 
and prescription of anti-dementia medication as needed. PCPs will be trained to refer ADRD patients to our 
bilingual Health Navigator following diagnosis. Verbal consent to share PHI with the Health Navigator is 
acquired by the PCP and explicitly stated in the referral.  
Assessment Procedures and Measures. Feasibility and acceptability assessments will include metrics and 
survey information from PCPs following standard criteria for feasibility studies (Table 3).27,28 Metrics will assess 
PCP completion of training, assessments and referrals. PCPs will complete a baseline (BL) survey before 
training and a follow-up (FU) survey after they have detected and referred enough Latino ADRD patients to fill 
Aim 2.b’s enrollment in approximately seven months (100 Latino MCI/ADRD patients receiving chronic care 
services from the Health Navigators though Alianza Latina). FU surveys will assess implementation of 
screening in PCPs’ regular workflow and their satisfaction with the Alianza Latina training.      
Figure 2. Flow chart of Alianza Latina feasibility study design 

Aim 2.b. Providing Latino ADRD patients with enhanced ADRD chronic care through Health Navigators. The 
Health Navigator will be the single-point-of-contact between the patient and the PCP. The Health Navigator will 
be a Bachelor’s degree-level individual with experience working with the Latino community in health-related 
projects and will be trained and supervised closely by Dr. Burns’ Social Worker team. The training will include 
the ACT on Alzheimer’s online course for care managers, a Dementia Intensive one-day course from the KU 
ADC and progressive shadowing to achieve independence supervised weekly by Dr. Burns’ team. The KU ADC 
recently had a highly successful Dementia Intensive training for Social Workers drawing nearly 100 social work 
students from 7 colleges in the region and significantly increasing their levels of objectively assessed ADRD 
knowledge. The first Health Navigator visit will be in-person and will coincide with the BL assessment. The 
Health Navigator will perform a Clinical Intake Assessment using validated instruments when possible including 
the Brief Neuropsychiatry Inventory Questionnaire, Geriatric Depression Scale or the Functional Assessment 
Questionnaire.109 The initial Clinical Intake 
Assessment will result in a written “Chronic Care 
Plan” that will be provided to the dyad and 
encouraged to be shared with their PCP. The Health 
Navigator will enroll the co-participant in CuidaTEXT a 
culturally tailored text message program to educate 
Latino caregivers on ADRD care.110 Educating 
families is important among Latinos as decision-
making is more likely to be shared by multiple 
relatives.111 Given that Latinos are among the groups 
with the lowest income in the USA,112 Health 
Navigators will inform participants about available 
financial assistance applications for ADRD expenses. Further visits will continue the Chronic Care Plan, which 
will address the most pressing needs reported by the patient and caregiver. Table 2 includes potential patient 
and caregiver needs depending on ADRD stage.113 The Chronic Care Plan will use evidence- and consensus-
based recommendations to address those needs,20 including Gitlin’s non-pharmacologic management of 
behavioral symptoms protocol,46 the Reducing Disability in Alzheimer’s Disease community program to promote 
functioning and caregiver support,114 the At the Crossroads kit for driving safety for individuals with ADRD 115 
and other resources. Community resources referred to by the Health Navigator will either provide bilingual 
services or include interpreters. If there is no other option, the Health Navigator will assist with interpretation. 
Recruitment and retention. We will provide Alianza Latina Health Navigator-services to all Latinos diagnosed 
with ADRD by Alianza Latina PCPs, other clinicians, or the research team. Outreach will include multiple in-
person (i.e., clinic referrals and health events) and remote methods (i.e., calls from research registries, online 
advertising and flyers). We will enroll 100 Latino ADRD patients. The Health Navigator will contact participants 
to schedule a consent and BL appointment during their first visit. Participants who sign the informed consent will 
be enrolled. To reduce attrition, we will collect contact information from an alternate contact person and staff will 
keep flexible hours and allow home visits. Participants will receive $40 pre-paid cards for completing 
assessments at BL and FU. All materials developed by the research team will be bilingual and follow World 
Health Organization translation and back translation guidelines.116  
Eligibility Criteria: 1) identify as Latino, 2) community dwelling, 3) diagnosed with MCI or ADRD by Alianza 
Latina PCPs, other clinicians, or the research team, 5) have a caregiver 18 years old or older and 6) access to 
a privately-owned cell phone with a flat rate fee for text messages.      
Recruitment Estimates. Based on the primary care population of our clinics, each serves an average of 12 
Latino individuals/day. We expect 12% to be 65 and older based on the Census.117 In 261 working days, they 
will serve 376 Latinos 65+. Because ADRD prevalence among Mexican-Americans is 10%, we expect 38 
Latinos 65+ with ADRD per year per clinic.72 In a conservative scenario, 66% of those with ADRD have never 
been diagnosed (28 per clinic). Research shows that 74% of ADRD patients are willing to participate in Health 
Navigator services,30 which reduces the number to 18 per clinic. Because there will be approximately 10 
clinics, the time needed to recruit 100 participants will be approximately seven months.  
Assessment Procedures and Measures. Assessments will include metrics and survey information to Latino 
ADRD patients and their caregivers based on standard criteria for outcomes in feasibility studies (Table 3).27,28 
BL surveys will include sociodemographic data: age, gender, marital status, educational level, insurance type, 
household income, Latino origin and caregiver relationship 118 and acculturation: English preference, place of 
birth and years in the USA.119 Metrics will assess enrollment in Health Navigator services, six-month retention, 
Table 2. ADRD needs addressed by the Chronic Care Plan 
MCI 
  Patient 
Prevent behaviors, slow cognitive decline, 
engagement, legal planning 
  Caregiver 
Caregiver support, legal planning & training 
Early & 
moderate ADRD 
  Patient 
Safety, security, engagement, functioning, 
behavioral management, pain, sleep co-
morbidities, legal planning 
  Caregiver 
Caregiver support and training, respite, stress 
reduction, legal planning 
Severe ADRD 
  Patient 
Stress, anxiety, agitation, pain 
  Caregiver 
Caregiver support, end of life care, counseling, 
role resumption 

completion of BL and FU assessments (i.e. BPSD and quality of life scales) and adherence to Health Navigator 
visits. FU surveys will assess satisfaction with the Alianza Latina Health Navigator services. 
Data analysis and sample Size Justification. Drs. Burns and Mahnken will guide me in the analysis of Aim 2. 
We will use R software to upload and analyze quantitative data.99 All electronic data will be stripped of 
identifiers and stored in password-protected files at the KU ADC and will be accessible only to research staff. 
Alianza Latina’s primary outcomes will be assessed using simple descriptive statistics. The primary quantitative 
feasibility/process endpoints are dichotomous measures, so the proportions will be estimated as the main 
statistical results. Results will include 95% confidence intervals based on an exact binomial distribution. With an 
anticipated 50/100 PCPs integrating Alianza Latina screenings to their regular workflow and 100/135 newly 
referred Latino ADRD dyads who enroll in Health Navigator services, our confidence intervals will be within 
approximately ±11.0% and ±7.4%, respectively, of their estimated proportions. These proportions have been 
chosen based on clinically significant levels estimated in consensus between my mentors and I and from the 
literature.30 Because this is a feasibility study, the sample size was not fully-powered to test a hypothesis but 
allow a sufficiently accurate estimation of these important processes measures to inform the subsequent R01 
application. At the end of the study, my mentors, consultants and I will meet and review all results to make 
modifications to the intervention and study design and calculate the appropriate sample.   
Table 3. Feasibility and acceptability outcomes in Aim 2 
Outcome 
Data source 
Operationalization  
PCP training 
  Feasibility 
Metrics (recruitment) 
Number of PCPs who agree to be trained per month 
Metrics (retention) 
% of PCPs followed up  
PCP FU survey & metrics (fidelity) 
% able to implement screenings in regular workflow; 
Number of referrals to Health Navigator per month 
Metrics (assessment process) 
% of PCPs who complete BL and FU surveys about ADRD 
knowledge, attitudes and skills 
Metrics (treatment adherence) 
% of PCPs who complete training 
  Acceptability  
PCP FU survey 
5-item Likert scales on satisfaction with training 
ADRD care 
  Feasibility  
Metrics (recruitment) 
% of referred Latino ADRD dyads who enroll in Health Navigator 
services 
Metrics (retention) 
% of referred Latino ADRD dyads followed up at 6m 
Metrics (assessment process) 
 
% of planned BL and FU survey ratings completed including 
BPSD 109 and quality of life 120,121 
Metrics (treatment adherence) 
% of referred Latino ADRD dyads who attends at least 50% of 
Health Navigator visits   
  Acceptability 
Dyad FU survey (6m) 
5-item Likert scales on satisfaction with clinic and Health 
Navigator services 
 CONSIDERATIONS, POTENTIAL PITFALLS, AND LIMITATIONS 
This study aims to assess the feasibility of Alianza Latina to inform the design and implementation of 
future, larger scale efficacy randomized controlled trials.28 Because feasibility studies are not hypothesis 
testing studies, we have not planned to include a control group to evaluate efficacy. In this study we will 
administer pre- and post-intervention measures that will serve as efficacy outcomes in future randomized 
control trials (i.e. BPSD, quality of life). However, the main objective of those measurements in the current 
study is to evaluate assessment feasibility. If feasibility findings are favorable, we will conduct a fully-powered 
R01 RCT to assess efficacy and cost-effectiveness. If not favorable, we will use the qualitative information 
gathered in the study and new research to refine the intervention and test its new feasibility before conducting 
an efficacy trial. We have estimated that 10 clinics will recruit 100 ADRD participants in seven months. If 
recruitment is slow, we will identify Latino older adults in the community through our center’s recurrent ADRD 
educational events, the Latino community network and the participant pool I developed during my Diversity 
Supplement and attempt to train their PCPs in the Alianza Latina services to speed up the process. A previous 
study trained and used abstracters to assess adherence to ADRD services recommendations at the clinics at 
all times.122 This approach is not financially feasible for this project but will be considered for a future study. 
Because this intervention is multicomponent, it will not allow disentangling effects of specific components. We 
will attempt to deconstruct the intervention in future studies if results are favorable. Most information gathered 
is focused on the person with ADRD. Though we plan to gather more information from caregivers in the future, 
this is secondary. We acknowledge that the involvement of caregivers in the aid of people with MCI or mild 
ADRD might be much lower than that of moderate and late stages, which may affect feasibility and 
acceptability outcomes.  
 

 
 
PROTECTION OF HUMAN SUBJECTS 
 
Aim 1: Examine the current primary care models of ADRD care to identify what services are offered and 
how they are delivered across a variety of settings 
 
1. Risks to Human Subjects 
1.a. Human Subjects Involvement, Characteristics, and Design.  
Aim 1 will assess the implementation of evidence-based ADRD care and will use methods from health systems 
and qualitative research. None of the studies will require protected health information. Dr. Perales will lead all 
interviews and focus groups with PCPs, patients and the CAB. The Research Team will conduct: 
1. 
Focus groups with a Community Advisory Board (CAB) to incorporate Latino and ADRD care 
perspectives into existing ADRD care guidelines.  
2. 
Semi-structured interviews with Latino ADRD patients and PCPs to understand ADRD protocols 
currently used in clinics and how they could be tailored to address the needs of ADRD Latino patients. 
 
Eligibility criteria:  
• 
Patients: 
1) Self-identify as Latino, 
2) Proficient in English or Spanish, 
3) Willing to participate in study. 
 
• 
PCPs: 
1) 18 years old and older, 
2) working as PCP in a primary care clinic. 
 
1.b. Study Procedures, Materials, and Potential Risks 
 
Treatment: None.  
Assessment.  
• 
CAB Focus groups. CAB members will be asked to participate in three focus groups in Year 1 and one 
annually in the following years. In Year 1, as representatives of the Latino community and ADRD care, 
the CAB will examine the ACT on Alzheimer’s evidence-based ADRD detection and care 
recommendations that will be implemented in Aim 2 and identify gaps in the needs of Latino patients.20 
The goal of the focus groups is to discuss the recommendations in hopes of understanding of the unique 
needs representative of Latino patients and modify the recommendations to include the CAB’s 
suggestions. The CAB will discuss copies of the evidence-based recommendations syllabus, interactive 
course materials and themes. Semi-structured discussion will include, but will not be limited to, the 
following questions: What materials/content seems essential? What materials are missing to address 
the Latino patient situation? What materials are useful but need to be changed to better address these 
needs? After this focus group, the RA and the PI will revise the materials and curriculum and present 
them to the CAB who will evaluate revisions via semi-structured discussion and Likert scales. Year 2 
and 4 will address how to optimize recruitment and retention. Years 3 and 5 will address how to refine 
Alianza Latina considering the study’s findings. The PI will facilitate all focus groups by asking clear, 
open-ended questions, balancing the participation of all participants avoiding few people to dominate the 
discussion, redirecting the discussion if it strays far off topic and checking with participants to ensure 
their message is understood. The PI will audiotape all focus groups.  
• 
PCP and patient interviews. These 60-minute semi-structured interviews will gather information about 
the ADRD care services currently in place and how they could be tailored to address the needs of 

ADRD Latino patients. The Research team will recruit a purposive sample of PCP and Latino ADRD 
patients from clinics in Kansas City Metro, San Antonio, TX and Ft Meyers, FL. The RA and the PI will 
develop open-ended discussion guides and conduct the interviews. A HIPAA-compliant company will 
transcribe the audiotaped interviews The Research Team will complete a checklist in all clinics to 
assess adherence to ADRD evidence-based recommendations.20  
o Semi-structured discussion with PCP will include, but will not be limited to, the following 
questions: 1) Can you describe the typical service a patient 65 and older would receive in a 
yearly visit? 2) How are people with ADRD usually detected in this clinic? 3) What care do 
people with ADRD usually receive in this clinic? 4) Are there any particularities about that service 
with Latino patients? 5) What are some of the challenges to ADRD detection and care 
experienced with Latino patients?  
o  
Semi-structured discussion with Latino ADRD patients and caregivers will include, but will 
not be limited to, the following questions: 1) Can you describe the ADRD services received in 
this clinic? 2) What went well with these services and what could be improved? 3) How relevant 
to your situation as a Latino patient were the services received? 4) What are some of the 
additional challenges that should be considered in these services?   
 
Data analysis. Interviews and focus groups will be recorded and analyzed employing content, domain, and 
taxonomic analysis. The Research Team will code content using ATLAS-ti. They will open-code transcripts by 
identifying keywords, themes, and descriptions of behavior within the text. Later, they will group the themes into 
coding categories and develop a code map to categorize and retrieve comments on each theme. Two 
independent coders will code the transcripts and their agreement will be measured using kappa coefficient. 
Central tendency estimates, frequencies and percentages will describe quantitative data on R Software.  
 
Investigators/Institutions. The team of investigators include Drs. Perales, Burns, Greiner, and Williams. The 
study will be conducted at KUMC and all source documents will be housed at KUMC. All investigators have 
completed the required human subjects training.  
 
Potential Risks. Procedures in Aim 1 involve minimal risks. Participants may find the questions boring, 
embarrassing or uncomfortable. For example, when interviewing patients with ADRD, talking about their 
condition might be perceived as sad or stressful. Providing and storing health information for future research 
participation comes with inherent privacy risks. These risks are mitigated using information security 
recommendations and data servers behind the University firewall. These risks are conveyed during the consent 
process. All staff interacting with participants are trained on HIPAA and privacy protections. 
 
2. Adequacy of Protection Against Risks 
2.a. Informed Consent and Assent 
The Research Team will translate the informed consents from English to Spanish using translation-back 
translation guidelines from the World Health Organization. Signed informed consent will be obtained by 
designated, trained staff, and the purposes of the study, its assessment procedures, and risks and benefits will 
be explained. Informed consent will be obtained either through a paper signature or via REDCap.  
 
2.b. Protections Against Risk 
Regarding potential perception of boring, embarrassing or uncomfortable of questions, interviewers are trained 
to be empathetic to minimize concerns, the consent will stress the volunteer nature of the study and of 
answering any questions as well as inform them of the risks of participating before obtaining consent. The 
information collected cannot put participants at legal or physical risk of any kind. All studies will undergo IRB 
approval. Identifiable information will be kept in secure file cabinets in a locked office and databases under 
password protection from the computer and the database. Digital audiotapes will be stored on secured 
university data servers. Audio files will be shared with the transcription company via encrypted email to be 
transcribed and all word processing files will be labeled with participant ID-codes only and stored in locked 
cabinets inside locked study offices. These databases will not be linked to interview information. 
 

Additionally, the following policies will be adopted to assure the safety of the participants in this study: 
1. Strict adherence to institutional regulations for conducting clinical research 
2. The involved support staff will be adequately trained to conduct human research and will have 
completed the necessary institutional web-based training prior to the study 
3. The Research Team will comply with HIPPA regulation and commit to maintaining the patient 
confidentiality. 
4. Any research presentations or publications from the proposed studies will not disclose any personal 
identity information. 
 
3. Potential Benefits of the Proposed Research to Research Participants and Others 
Given the non-interventional nature of Aim 1, this aim will have no direct potential benefits for participants. Aim 
1 however, has the potential to benefit the refinement of Alianza Latina which might improve the lives of many 
people with ADRD, their relatives and the society through reducing physical, emotional and financial costs. 
Research scientists and clinicians may be able to use the knowledge gained from this study as it will increase 
our ability to test dementia therapies. 
 
4. Importance of the Knowledge to be Gained 
Society benefits from research advances in aging and the improvement of life quality through research that has 
adequate numbers of participants. This study will enhance our understanding on how to improve the delivery of 
ADRD services among Latinos in primary care clinics. 
5. Data Safety Monitoring Plan  
The purpose of the Data Safety Monitoring Plan is to ensure the safety of study participants and the validity of 
data, in compliance with NIH requirement for Data Safety Monitoring for Clinical Research.  
Data Monitoring Plan: Data will be collected using laptop computers and directly entered into a password 
protected Microsoft Access Database that will be stored on study network folder at the University of Kansas 
Medical Center that is only accessible to study staff. The codes sheet that links the study identification number 
with participant names will be stored separately from data in a password protected Microsoft Excel 
spreadsheet on a study network folder that is only accessible by study staff.  
Outcome data will be investigated using thorough descriptive statistics. The PI and Dr. Williams will monitor 
Data quality weekly. They will resolve any issues related to data and modify data collection procedures to 
improve data quality. 
Safety Monitoring Plan: Adverse events will not be monitored as there is no intervention. In the event of a data 
or privacy breach, the occurrence will be immediately reported to the PI, and the Human Participants 
Committee per KUMC Human Participant Committee reporting policies. 
Conflict of Interest: The researchers involved in this study do not have any known conflict of interest issues in 
this Data and Safety Monitoring Plan.  
 
 
 

Aim 2: Test the feasibility and acceptability of Alianza Latina 
 
Risks to Human Subjects 
1.a. Human Subjects Involvement, Characteristics, and Design.  
Aim 2 will be a one-arm clinical trial to examine the feasibility and acceptability of Alianza Latina, a health 
systems intervention to improve ADRD diagnosis and care among Latinos. The intervention will be conducted in 
the same 10 Kansas City Latino-affluent primary care clinics as Aim 1. Alianza Latina will enhance timely ADRD 
diagnosis and optimal care to minimize behavioral symptoms and cognitive decline among Latinos in a 
linguistically and culturally-appropriate way. Alianza Latina will use the Collaborative Care Framework that 
capitalizes on PCPs and Health Navigators. 1) PCPs will undergo training in evidence-based recommendations 
to enhance timely and culturally appropriate diagnosis and implement it in their work routine. 2) PCPs will 
detect, treat and refer Latino ADRD patients to a bilingual Health Navigator to perform a Clinical Intake 
Assessment and subsequent ADRD Chronic Care Plan, which will reduce PCP time burden. The PI will lead all 
interviews with PCPs, patients and Latino older adults.  
 
Eligibility criteria: 
• 
Latino patients: Eligible participants will 
o Identify as Latino, 
o Community dwelling, 
o Diagnosed with MCI or ADRD by Alianza Latina PCPs, other clinicians, or the research team 
o Have a caregiver 18 or older, 
o Have access to a privately-owned cell phone. 
 
1.b. Study Procedures, Materials, and Potential Risks 
 
Treatment. The main components of Alianza Latina are 1) providing PCPs with education, training and tools for 
timely ADRD diagnosis and optimal treatment and 2) providing Latino ADRD patients with enhanced chronic 
care through bilingual Health Navigators. These two components will be assessed in two separate sub-aims. 
• 
Providing PCPs with education, training and tools for timely ADRD diagnosis and optimal treatment. 
Alianza Latina will partner with 10 primary care clinics who serve Latino older adults. The Research 
team will train PCPs in cultural competence and ADRD knowledge, skills and attitudes.104 For Cultural 
Competence Care, PCPs will complete an online course by the US Department of Health & Human 
Services.105 For ADRD knowledge, skills and attitudes, PCPs will receive a standardized online or in-
person training modeled after Minnesota’s “ACT on Alzheimer’s“ ADRD Curriculum and a specific 
training developed by the research team.20 The online ACT on Alzheimer’s ADRD Curriculum is free, 
self-directed and consists of 10 modules (understanding dementia; demographics; societal impact; early 
detection; screening; assessment and diagnosis; interventions; caregiver support; behavior as 
communication and philosophy of care). The in-person training will take one day, will be delivered by Dr. 
Burns’ ADRD collaborative care team and me and will cover the same topics as the online training. Both 
trainings will include specifics about ADRD detection and care among Latinos, including validated tools 
for Spanish speakers. All three courses provide Continuing Medical Education credits upon completion, 
which may incentivize PCP participation in Alianza Latina. In April, the KU ADC delivered a similar 
training event to 13 rural providers, all of which have started implementing the evidence-based 
recommendations among their patients. PCPs will be trained to follow culturally and linguistically 
appropriate diagnostic and treatment algorithms using an evidence-based approach to timely screening, 
diagnosis and management of dementia intended to decrease the need for sub-specialty care.20  PCPs 
will be trained to administer an evidence-based ADRD screener to all Latinos 65+. The Research team 
will suggest using the Mini-Cog, as it is freely available, takes only three minutes to administer and has 
shown excellent psychometric properties in a multilingual US sample.106 PCPs will be trained to follow-
up with a more comprehensive cognitive test for those who screen positive. The Research Team will 
suggest using the Montreal Cognitive Assessment (MoCA), as it is also freely available, short and has 
been shown to detect ADRD and MCI among US English and Spanish speaking individuals.107,108 Those 
screened positive will undergo a dementia work-up (i.e. family and medical history, physical exams, 

behavioral symptoms) which will use Latino-validated tools when possible. This information will inform 
ADRD diagnosis and prescription of anti-dementia medication as needed. PCPs will be trained to refer 
ADRD patients to the bilingual Health Navigator following diagnosis. Verbal consent to share PHI with 
the Health Navigator is acquired by the PCP and explicitly stated in the referral. 
• 
Providing Latino ADRD patients with enhanced ADRD chronic care through Health Navigators. The 
Health Navigator will be the single-point-of-contact between the patient and the PCP. The Health 
Navigator will be a Bachelor’s degree-level individual with experience working with the Latino community 
in health-related projects and will be trained and supervised closely by Dr. Burns’ Social Worker team. 
The training will include the ACT on Alzheimer’s online course for care managers, a Dementia Intensive 
one-day course from the KU ADC and progressive shadowing to achieve independence supervised 
weekly by Dr. Burns’ team. The KU ADC recently had a highly successful Dementia Intensive training 
for Social Workers drawing nearly 100 social work students from 7 colleges in the region and 
significantly increasing their levels of objectively assessed ADRD knowledge. The first Health Navigator 
visit will be in-person and will coincide with the BL assessment. The Health Navigator will perform a 
Clinical Intake Assessment using validated instruments when possible including the Brief 
Neuropsychiatry Inventory Questionnaire, Geriatric Depression Scale or the Functional Assessment 
Questionnaire.109 The initial Clinical Intake Assessment will result in a written “Chronic Care Plan” that 
will be provided to the dyad and encouraged to be shared with their PCP. The Health Navigator will 
enroll the co-participant in CuidaTEXT a culturally tailored text message program to educate Latino 
caregivers on ADRD care.110 Educating families is important among Latinos as decision-making is more 
likely to be shared by multiple relatives.111 Given that Latinos are among the groups with the lowest 
income in the USA,112 Health Navigators will inform participants about available financial assistance 
applications for ADRD expenses. Further visits will continue the Chronic Care Plan, which will address 
the most pressing needs reported by the patient and caregiver. Table 2 includes potential patient and 
caregiver needs depending on ADRD stage.113 The Chronic Care Plan will use evidence- and 
consensus-based recommendations to address those needs,20 including Gitlin’s non-pharmacologic 
management of behavioral symptoms protocol,46 the Reducing Disability in Alzheimer’s Disease 
community program to promote functioning and caregiver support,114 the At the Crossroads kit for 
driving safety for individuals with ADRD 115 and other resources. Community resources referred to by the 
Health Navigator will either provide bilingual services or include interpreters. If there is no other option, 
the Health Navigator will assist with interpretation. 
 
Recruitment. The Research Team will provide Alianza Latina Health Navigator-services to all Latinos diagnosed 
with ADRD by Alianza Latina PCPs. The Research Team will enroll 100 Latino ADRD patients. The Health 
Navigator will contact participants to schedule a consent and BL appointment during their first visit. Participants 
who sign the informed consent will be enrolled. Contacts can be either via KUMC-contracted Zoom videocalls, 
phone calls or in-person, depending on the participants’ preferences.   
 
Eligibility, consent, enrollment and baseline assessment. Eligibility criteria includes 1) identify as Latino, 2) 
community dwelling, 3) diagnosed with MCI or ADRD by Alianza Latina PCPs, other clinicians, or the research 
team, 4) have a caregiver 18 years old or older and 5) access to a privately-owned cell phone. Based on the 
primary care population of our clinics, each serves an average of 12 Latino individuals/day. We expect 12% to 
be 65 and older based on the Census.117 In 261 working days, they will serve 376 Latinos 65+. Because ADRD 
prevalence among Mexican-Americans is 10%, we expect 38 Latinos 65+ with ADRD per year per clinic.72 In a 
conservative scenario, 66% of those with ADRD have never been diagnosed (28 per clinic). Research shows 
that 74% of ADRD patients are willing to participate in Health Navigator services,30 which reduces the number 
to 18 per clinic. Because there will be 10 clinics, the time needed to recruit 100 participants will be 
approximately seven months.  
Assessments will include metrics and survey information to Latino ADRD patients and their caregivers based on 
standard criteria for outcomes in feasibility studies (Table 3).27,28 BL surveys will include sociodemographic 
data: age, gender, marital status, educational level, insurance type, household income, Latino origin and 
caregiver relationship 118 and acculturation: English preference, place of birth and years in the USA.119 Metrics 
will assess enrollment in Health Navigator services, six-month retention, completion of BL and FU assessments 

(i.e. BPSD and quality of life scales) and adherence to Health Navigator visits. FU surveys will assess 
satisfaction with the Alianza Latina Health Navigator services. 
  
Retention and reimbursement. To reduce attrition, the Research Team will collect contact information from an 
alternate contact person and staff will keep flexible hours and allow home visits. Participants will receive $20 
pre-paid cards for completing assessments at BL and FU. All materials developed by the research team will be 
bilingual and follow World Health Organization translation and back translation guidelines.116 
 
Investigators/Institutions. The team of investigators include Drs. Perales, Burns, Greiner, and Williams. The 
study will be conducted at KUMC and all source documents will be housed at KUMC. All investigators have 
completed the required human subjects training.  
 
Potential Risks. Procedures in Aim 2 involve minimal risks. Participants may find the questions boring, 
embarrassing or uncomfortable. For example, when interviewing patients with ADRD or their relatives, talking 
about their condition might be perceived as sad or stressful. Providing and storing health information for future 
research participation comes with inherent privacy risks. These risks are mitigated using information security 
recommendations and data servers behind the University firewall. These risks are conveyed during the consent 
process. All staff interacting with participants are trained on HIPAA and privacy protections. Health Navigators 
may provide education and advice that can affect patients negatively. 
 
 
2. Adequacy of Protection Against Risks 
2.a. Informed Consent and Assent 
The Research Team will translate the informed consents from English to Spanish using translation-back 
translation guidelines from the World Health Organization. Informed consent will be obtained by designated, 
trained staff. The informed consent will explain purposes of the study, its assessment procedures, and risks and 
benefits. The original signed consent form is kept with the participant’s confidential file and a copy is given to 
the participant. 
 
2.b. Protections Against Risk 
Regarding potential perception of boring, embarrassing or uncomfortable questions, interviewers are trained to 
be empathetic to minimize concerns, the consent will stress the voluntary nature of the study and of answering 
any questions as well as inform them of the risks of participating before signing the consent. The information 
collected cannot put participants at legal or physical risk of any kind. Although participants’ identifying 
information will be collected in the informed consent and for incentive purposes, this data will be kept separate 
from study data. All studies will undergo IRB approval. Identifiable information will be kept in secure file cabinets 
in a locked office and databases under password protection from the computer and the database. Digital 
audiotapes will be stored on secured university data servers. Audio files will be transcribed and all word 
processing files will be labeled with patient ID-codes only and stored in locked cabinets inside locked study 
offices. These databases will not be linked to interview information. Text messages will not contain personal 
identity information. Study participants will be advised to protect their phone and turn off preview features that 
allow a preview of the message to be automatically displayed on the screen. Recipients will be told how to opt-
out of receiving text messages in a timely manner. We will hire a text message vendor with built-in security 
features that will protect information. The Health Navigator will be comprehensively trained by taking the 
courses specified in the candidate section and shadowing Dr. Burns’ experienced Health Navigators. The 
Health Navigator will follow specific guidelines for the management of ADRD and will be directly supervised by 
Dr. Burns’ team.  
 
Additionally, the following policies will be adopted to assure the safety of the participants in this study: 
1. Strict adherence to institutional regulations for conducting clinical research 
2. The involved support staff will be adequately trained to conduct human research and will have 
completed the necessary institutional web-based training prior to the study 

3. The Research Team will comply with HIPPA regulation and commit to maintaining the patient 
confidentiality. 
4. Any research presentations or publications from the proposed studies will not disclose any personal 
identity information. 
 
 
 
3. Potential Benefits of the Proposed Research to Research Participants and Others 
ADRD Participants will be able to speak with a Health Navigator with experience in implementing evidence and 
consensus-based guidelines to address problems associated with ADRD. Clinical Intake Assessments will 
include behavioral symptoms, safety at home, driving, legal issues and others. Alianza Latina also has the 
potential to detect ADRD timely for early provision of care, which may improve patients’ and caregivers’ quality 
of life. In addition, participants will be given the opportunity to contribute to finding better ways of improving the 
quality of life among people with ADRD and their caregivers by participating in this study. Participants will be 
compensated for assessments and will be informed that incentives are not contingent on any outcome. 
 
4. Importance of the Knowledge to be Gained 
Society benefits from research advances in aging and the maintenance of cognitive and brain health through 
research that has adequate numbers of participants. This study will enhance our understanding on how to 
improve the delivery of ADRD services among Latinos in primary care clinics. 
5. Data Safety Monitoring Plan  
This Human Subjects Research meets the National Institutes of Health (NIH) definition of a clinical trial. An 
appropriate Data Safety Monitoring Plan has been developed. The purpose of the Data Safety Monitoring Plan 
is to ensure the safety of study participants and the validity of data, in compliance with NIH requirement for 
Data Safety Monitoring for Clinical Research.  
Data Monitoring Plan: Data will be collected using laptop computers and directly entered into a password 
protected Microsoft Access Database that will be stored on study network folder at the University of Kansas 
Medical Center that is only accessible to study staff. The codes sheet that links the study identification number 
with participant names will be stored separately from data in a password protected Microsoft Excel 
spreadsheet on a study network folder that is only accessible by study staff.  
Outcome data will be investigated using thorough descriptive statistics. Me (PI) and Dr. Burns will monitor Data 
quality weekly. The Research Team will resolve any issues related to data and modify data collection 
procedures modified to improve data quality. 
Safety Monitoring Plan: Health Navigators will continually monitor participants for unanticipated problems. The 
PI will review Satisfaction survey responses, texts received from participants, and any complaints submitted to 
the REDCap database on a monthly basis. Unanticipated problems will be reported to the IRB within 5 working 
days and to NIMHD within 48 hours of determining they meet reportability criteria. A report of any complaints 
that were assessed will be prepared by the study team and sent to the NIMHD program officer semi-annually.  
This report will also delineate those complaints that were reported as unanticipated problems to the IRB and 
the NIMHD within the expedited timeframes listed above. 
Conflict of Interest: The researchers involved in this study do not have any known conflict of interest issues in 
this Data and Safety Monitoring Plan.  
Content of the Data Safety Monitoring Report: A report of any complaints that were assessed will be prepared 
by the study team and sent to the NIMHD program officer semi-annually. This report will also delineate those 
complaints that were reported as unanticipated problems to the IRB and the NIMHD within the expedited 
timeframes listed above.