Virtual Training for Latino Caregivers to Manage Symptoms of Dementia
Phase: NA
Conditions: Caregiver Burden, Alzheimer Disease, Dementia, Behavioral Symptoms
Sponsor: University of Washington

 
Protocol Template, Version 6.0  
Clinical Interventional Study  
Protocol Template 
 
 

 
Protocol Template, Version 6.0 
 
PREFACE 
The Clinical Intervention Study Protocol Template is a suggested format for clinical trials 
sponsored by the National Institute on Aging (NIA). Investigators are encouraged to use this 
format, as appropriate, when developing protocols for their studies. Large multi-site 
observational studies will also benefit from this protocol template. 
Note that instructions and explanatory text are indicated by italics and should be replaced in 
your protocol with appropriate text.  Section headings and template text formatted in regular 
type should be included in your protocol document as provided in the template. 
The goal of this template is to provide a general format applicable to all single- and multicenter 
clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc).  
As you can see the version number and date are on the bottom of each page. When making 
changes to an approved and “final” protocol, please provide a summary of the changes, with the 
date, at the front of the protocol. 
 
 

 
Protocol Template, Version 6.0 
 
 
VIRTUAL TRAINING FOR LATINO CAREGIVERS TO 
MANAGE SYMPTOMS OF DEMENTIA 
 
Study Chairman or Principal Investigator: Magaly Ramirez, PhD, MS, MS, 
Assistant Professor, University of Washington School of Public Health, 
Department of Health Services 
Supported by: 
The National Institute on Aging 
Study Intervention Provided by: N/A 
Sponsor of IND/IDE: N/A 
Version 6 
September 21, 2023
 
 

 
Protocol Template, Version 5.0 
ii 
TABLE OF CONTENTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
PAGE 
PREFACE ....................................................................................................................................... i 
VIRTUAL Training for Latino Caregivers to Manage Symptoms of Dementia .................... ii 
TABLE OF CONTENTS ............................................................................................................. ii 
PRÉCIS ......................................................................................................................................... iv 
Study Title .................................................................................................................................. iv 
Objectives .................................................................................................................................. iv 
Design and Outcomes ................................................................................................................ iv 
Interventions and Duration ......................................................................................................... v 
Sample Size and Population........................................................................................................ v 
STUDY TEAM ROSTER............................................................................................................. 1 
Principal Investigator: Magaly Ramirez, PhD, MS, MS .......................................................... 1 
Co-Investigator:  Robert Penfold, PhD .................................................................................... 1 
Research Coordinator: Celeste Garcia, CHES ......................................................................... 1 
    Research Assistant:      JP Lopez Garcia ……...………………………………………………..2 
PARTICIPATING STUDY SITES ............................................................................................. 2 
Study Site Investigator: Magaly Ramirez, PhD, MS, MS ........................................................ 2 
1 
Study objectives ..................................................................................................................... 3 
1.1 
Primary Objective ........................................................................................................... 3 
1.2 
Secondary Objectives...................................................................................................... 3 
2 
BACKGROUND AND RATIONALE ................................................................................ 3 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 3 
2.2 
Study Rationale ............................................................................................................... 6 
3 
STUDY DESIGN ................................................................................................................... 7 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................ 9 
4.1 
Inclusion Criteria ............................................................................................................ 9 
4.2 
Exclusion Criteria ........................................................................................................... 9 
4.3 
Study Enrollment Procedures ......................................................................................... 9 

 
Protocol Template, Version 5.0 
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5 
STUDY INTERVENTIONS .............................................................................................. 10 
5.1 
Interventions, Administration, and Duration ................................................................ 10 
5.2 
Handling of Study Interventions ................................................................................... 10 
5.3 
Concomitant Interventions ............................................................................................ 11 
5.4 
Adherence Assessment ................................................................................................. 11 
6 
STUDY PROCEDURES .................................................................................................... 11 
6.1 
Schedule of Evaluations ................................................................................................ 12 
6.2 
Description of Evaluations ............................................................................................ 13 
6.2.1 Screening Assessment ............................................................................................... 13 
6.2.2 Baseline Assessment ................................................................................................. 13 
6.2.3 Module Assessment .................................................................................................. 13 
6.2.4 Final Assessment ...................................................................................................... 13 
7 
SAFETY ASSESSMENTS ................................................................................................. 14 
7.1 
Potential Risks and Benefits for Participation .............................................................. 14 
7.2 
Adverse Event (AE) and Serious Adverse Event (SAE) Collection and Reporting ..... 14 
7.2.1 AE/SAE Definitions.................................................................................................. 14 
7.2.2 Classification of Severity and Study Relatedness ..................................................... 15 
7.2.3 AE/SAE Reporting.................................................................................................... 16 
8 
INTERVENTION DISCONTINUATION........................................................................ 16 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 17 
9.1 
General Design Issues ................................................................................................... 17 
9.2 
Sample Size and Randomization .................................................................................. 17 
9.3 
Interim analyses and Stopping Rules ............................................................................ 17 
9.4 
Outcomes ...................................................................................................................... 17 
9.4.1 Primary outcome ....................................................................................................... 17 
9.4.2 Secondary outcomes ................................................................................................. 18 
9.5 
Data Analyses ............................................................................................................... 18 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 18 
10.1 
Data Collection Forms .................................................................................................. 18 
10.2 
Data Management ......................................................................................................... 18 
10.3 
Quality Assurance ......................................................................................................... 19 
10.3.1 
Training ................................................................................................................. 19 
10.3.2 
Quality Control Committee................................................................................... 19 

 
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10.3.3 
Metrics .................................................................................................................. 19 
10.3.4 
Protocol Deviations ............................................................................................... 19 
10.3.5 
Monitoring ............................................................................................................ 19 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 19 
11.1 
Institutional Review Board (IRB) Review .................................................................... 19 
11.2 
Informed Consent Form ................................................................................................ 20 
11.3 
Participant Confidentiality ............................................................................................ 20 
11.4 
Study Discontinuation ................................................................................................... 20 
12 ETHICAL CONSIDERATIONS ....................................................................................... 20 
13 COMMITTEES................................................................................................................... 21 
14 PUBLICATION OF RESEARCH FINDINGS ................................................................ 21 
15 REFERENCES .................................................................................................................... 21 
16 SUPPLEMENTS/APPENDICES ...................................................................................... 24 
 
I. Outcome Measures 
  
II. Informed Consent Form  
  
PRÉCIS 
Study Title  
Virtual Training for Latino Caregivers to Manage Symptoms of Dementia 
Objectives  
The objectives of this study are to: (1) culturally and linguistically adapt the STAR-VTF 
online training modules for Latino caregivers of people living with dementia (PLWD), 
(2) pilot test Latino caregivers’ responses to the adapted online training modules, and (3) 
develop a REDCap survey to pragmatically collected caregiver outcomes in a future 
study. 
Design and Outcomes   
The study will use a single-arm pilot trial design with Latino caregivers of PLWD. We 
will assess self-reported outcomes at baseline and 6-8 weeks post-enrollment using a 
REDCap survey. Outcome measures will include the Revised Memory and Problem 
Behavior Checklist and Preparedness for Caregiving Scale. In addition, we will assess 
caregivers’ perceived usability of the online training modules, and we will conduct 

 
Protocol Template, Version 5.0 
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qualitative interviews 6-8 weeks post-enrollment. The interviews will assess caregiver 
satisfaction with and acceptability of the adapted online training modules. 
Interventions and Duration  
For 6-8 weeks, caregivers will complete online training modules asynchronously. They 
will access the modules via email or text message. There are 7 online training modules. 
Caregivers will be instructed to complete one module per week. The content of the 
modules is as follows: Module 1 provides an understanding and overview of dementia; 
Module 2 introduces caregivers to the behavioral treatment of dementia, realistic 
expectations, and effective communication; Module 3 covers the ABC (antecedents, 
behaviors, consequences) approach to problem-solving, including rationale and 
development of an ABC plan; Module 4 instructs caregivers to review the ABC plan and 
revise as needed; Module 5 covers pleasant events and managing negative thinking; 
Module 6 instructs caregivers to review the ABC plan, pleasant activities schedule, and to 
revise as needed; Module 7 covers coping with caregiving and maintaining gains. Each 
module takes about 15 minutes to complete. The modules use text, pictures, and 
illustrations with a voiceover presentation. Caregivers will receive the online training 
modules in their preferred language (English or Spanish). They will also receive a 
workbook to accompany the lesssons. The total length of time each caregiver will be in 
the study is approximately 8 weeks.  
Sample Size and Population  
Participants will: be aged 18 years or older, live with PLWD or within 5 miles, provide at 
least 8 hours of care per week, provide care to PLWD who lives at home, and self-
identify as Hispanic/Latino. We expect to enroll up to 20 participants. The primary 
objective of this study is to pilot test the adapted online training modules. Therefore, it is 
not powered to detect an effect of the intervention.  

 
Protocol Template, Version 5.0 
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STUDY TEAM ROSTER  
Principal Investigator: 
Magaly Ramirez, PhD, MS, MS 
Hans Rosling Center for Population Health: Department of Health 
Services 
3980 15th Ave NE, Fourth Floor 
Box 351621 
Seattle, WA 98195 
maggiera@uw.edu 
206-543-9773  
 
Dr. Ramirez will provide overall direction and oversight of the 
research study. Responsibilities will include culturally and 
linguistically adapting the online training modules, reviewing Spanish 
translations of materials, designing the interview guide, managing 
recruitment and data collection, conducting analysis and 
interpretation of results, and refining online training modules based 
on the results. In addition to overall project responsibility, Dr. 
Ramirez will supervise the research coordinator working on the 
project. 
Co-Investigator:  
 
Robert Penfold, PhD 
Kaiser Permanente Washington Health Research Institute 
1730 Minor Ave, Suite 1600 
Seattle, WA 98101-1466 
Robert.B.Penfold@kp.org 
206-287-2232 
 
Dr. Penfold will consult on the project, provide access to all existing 
STAR-VTF intervention materials, and provide input and guidance 
on the adaptation of the STAR-VTF online training modules. Dr. 
Penfold will also collaborate on planned analyses and the preparation 
of presentations and manuscripts. To accomplish these tasks, Dr. 
Penfold will participate in regular team meetings. 
 
Research Coordinator: Celeste Garcia, CHES 
Hans Rosling Center for Population Health: Department of Health 
Services 
3980 15th Ave NE, Fourth Floor 
Box 351621 
Seattle, WA 98195 
celesg@uw.edu 
509-305-5966 

 
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Celeste Garcia will assist with the human subjects application, 
adaptations of the online training modules, programming of REDCap 
survey, recruitment of study participants, providing study participants 
with access to online training modules and REDCap survey, helping 
to address any technical issues encountered by study participants, data 
collection and analysis, and management of participant incentives. In 
addition, Ms. Garcia will coordinate with a translation company for 
Spanish translations of all materials. 
Research Assistant:  
Lily Zavala 
Hans Rosling Center for Population Health: Department of Health 
Services 
3980 15th Ave NE, Fourth Floor 
Box 351621 
Seattle, WA 98195 
lilyz123@uw.edu 
 
Lily Zavala will assist with the programming of REDCap surveys, 
recruitment of study participants, providing study participants with 
access to online training modules and REDCap survey’s, data 
collection and analysis, and management of participant incentives. 
 
 
PARTICIPATING STUDY SITES  
All human subjects activities will be conducted at the University of Washington. 
Study Site Investigator: Magaly Ramirez, PhD, MS, MS 
Hans Rosling Center for Population Health: Department of Health 
Services 
3980 15th Ave NE, Fourth Floor 
Box 351621 
Seattle, WA 98195 
maggiera@uw.edu 
206-543-9773  
 
 
 

 
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1 
STUDY OBJECTIVES 
1.1 Primary Objective 
This pilot study is not testing hypotheses. 
1.2 Secondary Objectives 
The objectives of this study are to: (1) culturally and linguistically adapt the STAR-VTF 
online training modules for Latino caregivers of PLWD, (2) pilot test Latino caregivers’ 
responses to the adapted online training modules, and (3) develop a REDCap survey to 
pragmatically collected caregiver outcomes in a future study. 
 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Latinos are more likely to develop Alzheimer’s disease and related dementias 
(ADRD). Driven by the growing population of older Latino adults in the U.S., the number 
of Latino PLWD is projected to increase more than nine fold from 379,000 in 2012 to 3.5 
million by 2060.1 Older Latino adults have a higher incidence and prevalence of ADRD 
compared to older White adults.2 These differences are due in large part to the health 
conditions (e.g., diabetes) and socioeconomic factors (e.g., chronic exposure to economic 
and social adversity, lower levels and quality of education, and discrimination) that are 
more prevalent in Latino populations and that are associated with cognitive decline.3,4 
Despite Latinos being 1.5 times more likely to develop ADRD than White adults,2  there is 
currently a lack of culturally-competent, accessible, and scalable interventions for Latino 
families. 
Latino PLWD have a higher prevalence of behavioral and psychological symptoms of 
dementia (BPSD) and their caregivers have a higher risk of depression, yet they 
remain underrepresented in research. Among community-dwelling PLWD, the 
prevalence of BPSD is higher among Latinos compared to White people, even after 
adjusting for age, gender, education, income, cognitive and functional status, and caregiver 
characteristics.5 Prevalence of behavior problems in older adults is positively associated 
with caregiver burden and depression.6 Furthermore, behavior problems play a larger role 
in predicting caregiver burden and depression than do the physical and cognitive 
impairments of older adults, hours per week providing care, number of care tasks, and 
duration in the caregiver role. Latino caregivers of PLWD are at higher risk for and have 
higher levels of depression compared to White caregivers.7–11 Despite these disparities, 
Latinos are continually underrepresented in dementia research. Dozens of interventions for 
managing BPSD in PLWD and for improving the well-being of their caregivers have been 
developed and tested in the U.S.12 However, these interventions have been tested 
predominantly with White caregivers. To address ethnic disparities in health and research, 
a pragmatic trial design must include the recruitment of Latino caregivers of PLWD. 

 
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Latinos experience worse quality of care and discrimination when accessing ADRD 
care. Compared to White people, Latinos are less satisfied in their communication with 
healthcare providers, are more likely to perceive that providers fail to provide needed 
information, and are more likely to report having a problem understanding healthcare 
providers.13–15 Spanish-speaking Latinos report much worse experiences with healthcare 
than White people.13,15–17 In a national survey, nearly 60% of Latino caregivers of PLWD 
report having faced discrimination when navigating healthcare settings for PLWD.18 For 
85% of Latino caregivers in the survey, it was important that healthcare providers treating 
ADRD understand their ethnic background, but less than 60% felt confident about having 
access to culturally-competent healthcare. Our preliminary work indicates that providers 
miss opportunities to identify Latino caregivers that need supportive services for managing 
BPSD. Barriers include caregiver-provider language discordance and differences in 
communication styles, particularly as it relates to the topic of BPSD. For this reason, 
culturally and linguistically adapting evidence-based interventions, like STAR-VTF, is a 
critical aspect in the design of pragmatic trials. 
Latino caregivers face barriers in seeking ADRD healthcare. Like other minority 
caregivers of PLWD, Latinos tend to attribute memory loss to normal aging, normalize 
behavioral and psychological symptoms, and hide problems with symptoms to avoid 
stigmatization of their family member.19 This stems from the lack of culturally- and 
linguistically-competent information about dementia that is available in these communities, 
rather than from culturally-influenced beliefs. The normalization of symptoms and the 
stigmatization of the disease is a major barrier to seeking ADRD healthcare. Other major 
barriers for Latino caregivers include clinicians’ lack of knowledge about the differences 
between normal aging and early signs of dementia, lack of Spanish-speaking clinicians, and 
experience of discrimination in healthcare settings.18–20 Our preliminary work indicates that 
Latino caregivers hesitate to raise concerns about BPSD with healthcare providers due to 
language discordance and health literacy factors. Interventions such as STAR-VTF 
embedded in healthcare systems can help to raise Latino caregivers’ awareness about the 
availability of culturally-competent, nonpharmacological treatments for improving 
management of BPSD at home. 
STAR-VTF is an evidence-based virtual intervention to support caregivers in 
managing BPSD. STAR-C Virtual Training and Follow-up (STAR-VTF) is a virtual 
adaptation of a systematic and standardized behavioral approach – known as the Seattle 
Protocols – to training caregivers to reduce BPSD in community-dwelling PLWD. The 
Seattle Protocols teach caregivers the ABCs of behavior change – a process that involves 
identifying specifics about the problem under consideration, identifying possible 
environmental or interpersonal factors that lead up to and sustain their occurrence, and 
systematically altering those factors to reduce problems.21 The Seattle Protocols were 
consolidated into the STAR-C program wherein coaches (master’s degree or equivalent in 

 
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psychology, social work, or a related field) visit caregivers at home to deliver the training.22 
The condensed 6-week program involves 4 in-home sessions and 2 telephone sessions.23,24 
A randomized controlled trial was conducted to compare STAR-C to routine medical care 
in English-speaking, predominantly White participants.23 The study population included 
only 1 Latino caregiver (randomized to control arm). At 6 months, caregivers randomized 
to the intervention arm had significantly lower depression, subjective burden, and caregiver 
reaction scores. 
To ease translation, STAR-VTF was developed and is now being tested in a pragmatic trial 
at Kaiser Permanente Washington (KPWA).25,26 STAR-VTF delivers the same content as 
STAR-C but in an entirely virtual environment.26 For 6-8 weeks, caregivers complete 6 
online training modules asynchronously and have 6 30-minute weekly telephone check-ins 
with a coach (social worker or mental health counselor). The 6 modules cover the same 
content as STAR-C (Table 1). The modules are hosted on the Kaiser Permanente School of 
Allied Health Sciences learning management system. Currently, only caregivers 
participating in the ongoing pragmatic trial at KPWA have access to this website. Our 
preliminary data identified potential areas of misfit between STAR-VTF and Latino 
caregivers. The modules: do not sufficiently address dementia literacy, use 
language/semantics that could be insensitive, and do not reflect Latino cultural values that 
could influence family structures and views of caregiving. 
 
Table 1. STAR-VTF Modules 
1 
Introduction to behavioral treatment of dementia, realistic 
expectations, & effective communication 
2 
ABC approach to problem-solving, including rationale & 
development of an ABC plan 
3 
Review of ABC plan and revise if needed 
4 
Increasing pleasant events & managing negative thinking 
5 
Review of ABC plan, pleasant events schedule, & revise if 
needed 
6 
Coping with caregiving and maintaining gains 
 
Table 2. Adapted STAR-VTF Modules 
1 
Understanding and overview of dementia 
2 
Introduction to behavioral treatment of dementia, realistic 
expectations, & effective communication 
3 
ABC approach to problem-solving, including rationale & 
development of an ABC plan 
4 
Review of ABC plan and revise if needed 
5 
Increasing pleasant events & managing negative thinking 
6 
Review of ABC plan, pleasant events schedule, & revise if 
needed 
7 
Coping with caregiving and maintaining gains 

 
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2.2 Study Rationale 
We conducted qualitative interviews with 44 stakeholders (e.g., Latino caregivers, 
frontline clinicians, and health educators). The stakeholders were not involved in the 
ongoing STAR-VTF pragmatic trial at KPWA and only viewed prototypes of the 
modules. Our analysis revealed that healthcare systems are not providing adequate 
education about dementia and support in managing BPSD. In fact, most Latino caregivers 
were unaware that healthcare providers could help with this matter. Stakeholders 
expressed interest in STAR-VTF, but there were concerns with particular aspects of the 
modules. Based on feedback from stakeholders, we have identified three adaptations to 
the STAR-VTF modules that would better serve Latino caregivers. 
Increase knowledge about dementia to reduce normalization of symptoms and 
stigmatization of PLWD. Similar to other studies of racial and ethnic minority 
caregivers, our preliminary data reveal that Latinos tend to: believe dementia is a normal 
part of aging; attribute behavioral and psychological symptoms to normal aging or to 
their family member’s personality; attribute the development of dementia to emotions; 
believe that dementia is a mental health disorder, and therefore, perceive PLWD as being 
loco (crazy); view pharmacological treatment of BPSD as accepting that their family 
member is loco (crazy); and believe that dementia can be healed or its symptoms 
managed through herbal remedies, praying, and therapy.  
Module 1 includes a 7-minute section titled “Overview of Dementia.” It covers the links 
between dementia and behavior, common causes of dementia, how dementia affects a 
person’s ability to do daily tasks, and how changes in behavior are progressive and not 
intentional. The first adaptation of our proposed study will be to expand the content in 
this section. The goal is to reduce normalization of BPSD and the stigma associated with 
ADRD. For example, when discussing common causes of dementia, we will add content 
about the differences between normal age-related forgetfulness and serious memory 
problems. We will also explain that dementia is a physical (not mental) illness. 
 
Eliminate stigmatizing, offensive, and culturally irrelevant language. We found that 
Latinos tend to prefer the term pérdida de la memoria (memory loss) instead of 
“Alzheimer’s disease” or “dementia.” Furthermore, stakeholders were concerned with 
program materials describing behavior symptoms as “challenging,” “problematic,” and 
“bothersome.” It could be misinterpreted as describing PLWD (as opposed to their 
symptoms). In addition, stakeholders explained that Latinos tend to place the needs of the 
person they are caring for over their own needs. It is a way of expressing the Latino 
cultural value of familismo (familism). Thus, stakeholders strongly advised against 
program materials describing caregiving as burdensome. Finally, Latinos rarely identified 
with the label “caregiver.” The translated word (cuidador) does not appear to be 
commonly-used. It is sometimes misinterpreted to refer to a formal caregiver or to an 
informal/family caregiver who gets paid to provide care. Latino caregivers we 
interviewed preferred to simply use kinship terms (e.g., daughter, daughter-in-law, wife 
of person with memory loss) to describe their role. 
 

 
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Based on these findings, the second adaptation of our proposed study will be to revise the 
language used across all modules. The goal is to eliminate any language that could be 
stigmatizing, offensive, and culturally irrelevant. For example, we will replace 
“dementia” with “memory loss,” eliminate negative descriptions of BPSD, avoid the term 
“caregiver burden,” and replace the label “caregiver” with kinship terms. 
 
Incorporate Latino family structure and the nature of caregiving in Latino families. 
Stakeholders stressed the importance of targeting the family unit, as opposed to a primary 
caregiver, in ADRD healthcare for Latinos. A bilingual and bicultural social worker said, 
“It's not necessarily just one person [caring for PLWD]. Because our families come in 
packs… I think being able to be flexible in some of the norms that an education program 
will have, whether that means two people or more -- because usually, it's a family.” In the 
vast majority of cases, Latino caregivers we interviewed described receiving extensive 
support from family members (including small children). They lived in multigenerational 
households or within close proximity of relatives, facilitating frequent help with care 
responsibilities and emotional support. In addition, there was a strong aversion to using 
formal respite services, driven by cultural, language, and economic factors.  
 
In module 7, caregivers learn that enlisting the help of family members and formal respite 
care providers could help them better cope with caregiving. It assumes most caregivers 
live alone with PLWD and that other family members provide minimal support. The third 
adaptation of our proposed study is to incorporate content that reflects the structure of 
Latino families (i.e., multigenerational households, living near family) and how 
caregiving is often a shared responsibility within the family unit. Furthermore, when 
suggesting use of formal respite care services, we will be sensitive to culturally-
influenced preferences. We will also address concerns about the lack of bilingual, 
bicultural, and affordable services. 
 
Intervention Regimen: For 6-8 weeks, caregivers will complete the 7 online training 
modules asynchronously. They will access the video modules sent to them through text 
message or email. As described in Table 2, the content of the modules includes an 
overview of dementia, realistic expectations, effective communication, using the ABC 
approach to problem-solve BPSD, and planning pleasant events. Each module takes 
about 15 minutes to complete. The modules use text, pictures, and illustrations with a 
voiceover presentation. They will also receive a printed workbook to go along with the 
lessons. While the STAR-VTF intervention incorporates a coaching component, the 
present study will only pilot test the adapted online training modules. The full STAR-
VTF intervention – adapted modules coupled with coaching – will be tested in a future 
study with Latino caregivers. 
 
3 
STUDY DESIGN 
Objective 1: Culturally and linguistically adapt the STAR-VTF online training 
modules for Latino caregivers of PLWD 
Findings from our stakeholder interviews indicate that no major changes to the 
intervention’s core components are required. Instead, we need to improve the content and 

 
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language used in the online training modules. The first adaptation will be to expand the 
content in the “Overview of Dementia” section of module 1. The content will address 
common beliefs and attitudes about dementia that result in families normalizing dementia 
symptoms and stigmatizing PLWD. The second adaptation will be to revise the language 
across all modules. We will eliminate any language that stakeholders suggested could be 
stigmatizing, offensive, and culturally irrelevant. We will rewrite the content to a 6th 
grade or lower reading level – a suggestion made by frontline clinician and health 
educator stakeholders. The content of the modules will be translated and the voiceover 
presentations recorded in Spanish. The third adaptation will be to incorporate content into 
module 7 that reflects the structure of Latino families (e.g., tendency to live 
multigenerational households) and how caregiving can often be a shared responsibility 
within the family unit.  
The PI will lead this adaptation work with support from the study’s staff member. 
Feedback on draft adaptations will be obtained from stakeholders, including Latino 
caregivers of PLWD and Spanish-English bilingual and bicultural health educators. 
These individuals are members of a community advisory board. We will refine 
adaptations based on stakeholder feedback.   
 
Objective 2: Pilot test Latino caregivers’ responses to the adapted online training 
modules 
The study will use a single-arm pilot trial design. Participants will be up to 20 caregivers 
of PLWD. We will target individuals who are: aged 18 years or older, live with PLWD or 
within 5 miles, provide at least 8 hours of care per week, provide care to PLWD who 
lives at home, and self-identify as Hispanic/Latino. 
Caregivers will complete a baseline survey using a REDCap link that will be delivered to 
caregivers via email or text message. The survey will include sociodemographic 
characteristics and the outcome measures (i.e., Revised Memory and Problem Behavior 
Checklist and Preparedness for Caregiving Scale). We will collect outcome measures 
from caregivers again 6-8 weeks post-enrollment using the same data collection method. 
Sociodemographic characteristics will include: caregiver age, occupational status, 
whether caregiver works outside of the home, number of people living in caregiver’s 
home, educational attainment, English fluency, preferred language, languages spoken at 
home, race, gender, annual household income, device ownership, Internet access at home, 
health insurance status of caregiver and PLWD, relationship to PLWD, age of PLWD, 
gender of PLWD, number of years in caregiving role, whether caregiver lives in same 
household as PLWD, and hours per week providing care. 
After completing the baseline survey, caregivers will begin participation in the 
intervention. The intervention tested in this study will only involve the self-directed 
training component of the STAR-VTF intervention. We will provide caregivers with the 
video modules via text messgae or email. We will also mail each participant a copy of the 
adapted version of the STAR-VTF workbook in their preferred language. There are 
handouts and resources to along with each lesson. Caregivers will be instructed to 
complete 1 module per week for 7 weeks (Table 2). 

 
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After 6-8 weeks, we will schedule an exit interview with caregivers. The interview will 
happen virtually (phone or videoconferencing) and will be under 1 hour. We will ask 
participants semi-structured questions to understand their experience with the online 
training modules and with completing the survey via REDCap. 
 
Objective 3: Develop a REDCap survey to pragmatically collected caregiver 
outcomes. We will create a REDCap survey that will facilitate collection of caregiver 
outcomes pragmatically in a larger pilot study and full-scale embedded pragmatic clinical 
trial that we plan to conduct in the future. The REDCap instrument will include the 
English and Spanish versions of the Revised Memory and Problem Behavior Checklist 
and the Preparedness for Caregiving Scale. In the future, this functionality will allow 
remote collection of caregiver outcomes that can be securely linked back to the patient 
electronic medical record – solving the issue with health information management laws 
that make it difficult or impossible to collect caregiver outcomes as part of a patient’s 
electronic medical record. In the present study, we will pilot the REDCap survey by 
asking caregivers to complete it at baseline and 6-8 weeks post-enrollment. 
 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria  
Participants will be eligible if the meet the following criteria: 
• Age 18 years or older 
• Live with PLWD or within 5 miles 
• Provide at least 8 hours of care per week 
• Self-identify as Hispanic/Latino 
• Caregiver self-report of PLWD having ≥ 3 BPSD occurring ≥ 3 in past week 
 
4.2 Exclusion Criteria  
Participants will be excluded if: 
• PLWD lives in assisted living or skilled nursing facilities 
 
4.3 Study Enrollment Procedures  
We will identify potential study participants using a variety of strategies. First, we will 
contact Latino caregivers of PLWD who receive care at UW Medicine. These individuals 
participated in a previous study led by Dr. Ramirez and agreed to be contacted again for 
participation in future studies. Second, we will distribute recruitment flyers in federally 
qualified health centers and across primary care clinics that are part of the WWAMI 
(Washington, Wyoming, Alaska, Montana and Idaho) region Practice and Research 
Network. Next, we will advertise the study in Spanish language media (e.g., radio 

 
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stations and newspapers). Finally, we will recruit via the Alzheimer’s Prevention 
Registry. 
For caregivers who are interested in study participation, the study staff members, Celeste 
Garcia and Lily Zavala, will schedule a phone call to answer any questions they may 
have and screen for eligibility. We will email or mail the consent form to caregivers who 
are eligible. After mailing these materials, study staff will contact caregivers by phone to 
review the consent form and answer any questions. Caregivers will sign the consent form 
electronically or by paper and mail it to staff members. After receiving the signed consent 
form, caregivers will receive an email or text message asking them to complete the online 
baseline survey. Participants who do not sign the consent form will not be allowed to 
participate in the study. We will use a screening log to document reasons for ineligibility 
and for non-participation of eligible candidates. 
 
 
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
For 6-8 weeks, caregivers will complete the 7 online training modules asynchronously. 
As described in Table 2, the content of the modules includes an overview of dementia, 
realistic expectations, effective communication, using the ABC approach to problem-
solve BPSD, and planning pleasant events. Each module takes about 15 minutes to 
complete. We will instruct caregivers to complete one module per week. The modules 
use text, pictures, and illustrations with a voiceover presentation. The modules also 
include an adapted workbook with for participants to complete. While the STAR-VTF 
intervention incorporates a coaching component, the present study will only pilot test 
the adapted online training modules. The full STAR-VTF intervention – adapted 
modules coupled with coaching – will be tested in a future study with Latino caregivers. 
We believe there is minimal risk associated with participating in the study. The 
intervention is an education and training program to give caregivers more tools and better 
knowledge for minimizing and responding to BPSD. The primary risk with the 
intervention is discomfort with the intervention content. The intervention’s 
recommendations based on the best available clinical evidence and has already been 
extensively tested in prior research. Core elements of the intervention have been proven 
in previous research to significantly improve average clinical outcomes. Nevertheless, 
treatment recommendations that improve care on average may have adverse 
consequences for any individual patient. Participants will be fully informed of the risks 
and their right to decline or withdraw from the study or specific activities. 
 
5.2 Handling of Study Interventions  
From home, caregivers will access the asynchronous, self-directed modules via a website 
hosted on the Kaiser Permanente School of Allied Health Sciences learning management 
system. Caregivers will log in to the website from their preferred web browser using an 
email address and user-generated password.  

 
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5.3 Concomitant Interventions 
The intervention is an adjunct to usual care. No services that are usually available to 
PLWD or their family caregivers will be withheld. 
 
5.4 Adherence Assessment  
Caregiver adherence data will be captured automatically via the Kaiser Permanente 
School of Allied Health Sciences learning management system. There are built-in metrics 
that track how users interact with the website, which we will utilize to determine 
caregiver completion rates for each module. We will use descriptive statistics to 
characterize caregiver adherence to completing the modules. 
 
6 
STUDY PROCEDURES 

 
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6.1 
Schedule of Evaluations 
 
 
Assessment 
Screening Assessment  
(Week 0) 
Baseline Assessment  
(Week 0) 
Module Assessments 
(Weeks 1-6) 
Final Assessment  
(Weeks 7-8) 
Inclusion/Exclusion Criteria 
X 
 
 
 
Informed Consent Form   
X 
 
 
 
Enrollment 
X 
  
 
  
Sociodemographic 
characteristics 
 
X  
 
  
Revised Memory and 
Problem Behavior Checklist 
 
X 
 
X  
Preparedness for 
Caregiving Scale 
 
X 
 
X 
Perceived Usability of 
Modules 
 
 
X 
 
Qualitative Assessment of 
Intervention Acceptance 
 
 
 
X 

 
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6.2 Description of Evaluations  
6.2.1 Screening Assessment 
For caregivers who are interested in study participation, the study staff members will 
schedule a phone call to answer any questions they may have and screen for 
eligibility. Study staff will use a structured screening survey to ask potential 
participants their age, whether they live with PLWD or within 5 miles, the number of 
hours of care they provide each week, their race/ethnicity, and whether PLWD lives 
in assisted living or skilled nursing facilities.  
We will email an e-consent form to caregivers who are eligible. After emailing these 
materials, study staff will contact caregivers by phone again to review the e-consent 
form and answer any questions. Caregivers will be instructed to sign the e-consent 
form. Enrollment will begin when the study staff members receive the e-consent 
forms signed by caregivers. 
 
6.2.2 Baseline Assessment 
After receiving the signed e-consent form, caregivers will receive an email or text 
message asking them to complete the REDCap baseline survey that contains: 
• Sociodemographic questionnaire  
• Revised Memory and Problem Behavior Checklist  
• Preparedness for Caregiving Scale 
 
6.2.3 Module Assessment 
At the end of each online training module, there is a short survey that caregivers are 
asked to complete. The survey contains: 
• System Usability Scale 
 
6.2.4 Final Assessment 
After 6-8 weeks post-enrollment, caregivers will receive an email or text message 
asking them to complete the REDCap baseline survey that contains: 
• Revised Memory and Problem Behavior Checklist  
• Preparedness for Caregiving Scale 
 
In addition, study staff members will schedule an exit interview with participants. The 
interview will happen virtually (phone or videoconferencing) and will be under 1 
hour. We will ask participants semi-structured questions to gauge their acceptance of 
the online learning modules and their experience completing the REDCap survey.  
 

 
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7 
SAFETY ASSESSMENTS  
7.1 Potential Risks and Benefits for Participation 
Potential Risks: We believe there is minimal risk associated with participating in the 
study. The primary risks to participation are: 
• Breach of confidentiality 
• Discomfort in answering survey or interview questions 
• Discomfort with the intervention content 
Potential Benefits: We anticipate that this research will yield important new information 
regarding the delivery of culturally competent support to Latino caregivers of PLWD. 
The results of the study will help to improve future care for Latino caregivers. 
 
7.2 Adverse Event (AE) and Serious Adverse Event (SAE) Collection and Reporting 
7.2.1 AE/SAE Definitions 
The study will adhere to the definitions for AEs and SAEs stipulated in the NIA Adverse 
Event and Serious Adverse Event Guidelines as outlined below. 
 
AE Definition: AE is any untoward or unfavorable medical occurrence in a human study 
participant, including increased stressed, inability to cope, or other emotional discomfort, 
temporally associated with the participants’ involvement in the research, whether or not 
considered related to participation in the research.  
 
AEs for this study include:   
This study is designed to pilot test a behavioral intervention with caregivers. As such, we 
believe it will pose minimal risk to participants because the probability and magnitude of 
harm or discomfort anticipated are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological 
examinations or tests. The risks of participating in this study may include feeling 
discomfort discussing personal matters during the intervention, survey, or exit interview, 
as well as frustration as caregivers attempt to implement the suggestions of the STAR-
VTF online learning modules.  
 
SAE Definition: SAEs consist of any adverse event that results in death; is life threatening 
or places the participant at immediate risk of death from the event as it occurred; requires 
or prolongs hospitalization; causes persistent or significant disability or incapacity; results 
in congenital anomalies or birth defects; is another condition which investigators judge to 
represent significant hazards 
 
SAEs for this study include:   
Research activities may identify immediate risk of harm or other urgent need. While we 
would not conclude that any such emergencies are consequences of study participation or 

 
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intervention content, there is still a clear obligation to report and respond appropriately to 
these urgent needs. 
 
7.2.2 Classification of Severity and Study Relatedness 
All data and safety monitoring reporting will classify SAEs and AEs as to their severity, 
expectedness, and potential relatedness to the study intervention as per the definitions 
below:  
 
Severity  
• Mild: Awareness of signs or symptoms, but easily tolerated and are of minor 
irritant type causing no loss of time from normal activities. Symptoms do not 
require therapy or a medical evaluation; signs and symptoms are transient. 
• Moderate: Events introduce a low level of inconvenience or concern to the 
participant and may interfere with daily activities, but are usually improved by 
simple therapeutic measures; moderate experiences may cause some interference 
with functioning 
• Severe:  Events interrupt the participant’s normal daily activities and generally 
require systemic drug therapy or other treatment; they are usually incapacitating 
Expectedness  
• Unexpected - nature or severity of the event is not consistent with information 
about the condition under study or intervention in the protocol, consent form, 
product brochure, or investigator brochure. 
• Expected - event is known to be associated with the intervention or condition 
under study.  
Unexpected events will be subject to expedited reporting requirements as 
described in the NIA Guidance on Clinical Trials and in Section 1.2.3, below. 
  
Relatedness   
• Definitely Related:  The adverse event is clearly related to the investigational 
agent/procedure – i.e. an event that follows a reasonable temporal sequence from 
administration of the study intervention, follows a known or expected response 
pattern to the suspected intervention, that is confirmed by improvement on 
stopping and reappearance of the event on repeated exposure and that could not 
be reasonably explained by the known characteristics of the subject’s clinical 
state. 
• Possibly Related:  An adverse event that follows a reasonable temporal sequence 
from administration of the study intervention follows a known or expected 
response pattern to the suspected intervention, but that could readily have been 
produced by a number of other factors. 
• Not Related:  The adverse event is clearly not related to the investigational 
agent/procedure - i.e. another cause of the event is most plausible; and/or a 
clinically plausible temporal sequence is inconsistent with the onset of the event 

 
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and the study intervention and/or a causal relationship is considered biologically 
implausible.  
7.2.3 AE/SAE Reporting 
The study will adhere to the reporting requirements for AEs and SAEs stipulated in the 
NIA Adverse Event and Serious Adverse Event Guidelines as outlined below. 
 
Process for identifying AEs and SAEs: The study staff members, Celeste Garcia and JP 
Lopez Garcia, will be in contact with participants while carrying out research activities 
and will be able to identify any AEs and SAEs that occur. When an adverse event is 
identified, Dr. Ramirez and study staff will follow NIA’s AE/SAE process flow. They 
will meet on a weekly basis throughout the project period and will review study progress 
and adverse events. NIA’s template for AEs and template for SAEs will be used to collect 
information about adverse events. 
 
Adverse event reporting schedule:  
• All adverse events that are both serious (SAE) and unexpected (i.e., have not 
been previously reported for the study’s intervention) will be reported to the 
IMPACT Collaboratory Regulatory and Data Team Leader (Julie Lima PhD), 
Advarra IRB, NIA IMPACT Collaboratory PO (Dr. Partha Bhattacharya), and the 
IMPACT Collaboratory DSMB Chair (or the project’s Safety Officer) within 48 
hours of the study’s knowledge of SAE.  
• The summary of all other SAEs will be reported to IMPACT Collaboratory 
Regulatory and Data Team Leader (Julie Lima PhD), Advarra IRB, NIA 
IMPACT Collaboratory PO (Dr. Partha Bhattacharya), and the IMPACT 
Collaboratory DSMB Chair (or the project’s Safety Officer) quarterly, unless 
otherwise requested by the DSMB Chair or a Safety Officer.  
• All deaths will be reported to IMPACT Collaboratory Regulatory and Data Team 
Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. 
Partha Bhattacharya), and the IMPACT Collaboratory DSMB Chair (or the 
project’s Safety Officer) and to the DSMB Chair (or project’s Safety Officer) 
within 24 hours of study’s knowledge of death.  
• AEs will be reported per IRB policies and also to IMPACT Collaboratory 
Regulatory and Data Team Leader (Julie Lima PhD), Advarra IRB, NIA 
IMPACT Collaboratory PO (Dr. Partha Bhattacharya), and the IMPACT 
Collaboratory DSMB Chair (or the project’s Safety Officer) and to the DSMB 
Chair (or project’s Safety Officer) at minimum every 6 months, or at a frequency 
requested by NIA and/or by the DSMB.  
 
8 
INTERVENTION DISCONTINUATION  
The intervention will be discontinued if they withdraw from participation in the study at 
any time and for any reason. We will document reason for discontinuation and, with their 

 
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permission, we will continue to follow-up with participants. We will replace participants 
who discontinue early (i.e., at enrollment).  
 
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
The overall objective of this pilot study is to prepare the culturally and linguistically 
adapted online training modules for Latino caregivers of PLWD and the REDCap survey 
that will be used to pragmatically collect caregiver outcomes in a future study. Thus, the 
study was not designed to test hypotheses. We have selected outcome measures that have 
already been translated and validated in Spanish: (1) Revised Memory and Behavior 
Problem Checklist27,28 and (2) Preparedness for Caregiving Scale.29  
9.2 Sample Size and Randomization 
This study does not involve randomization. We have selected a sample size of up to 20 
caregivers for study participation for pragmatic reasons (i.e., what can feasibly be 
accomplished given the study budget and timeline).  
9.3 Interim analyses and Stopping Rules 
We are not planning to conduct an interim analysis. Given the small sample of the pilot 
study, it is not possible to detect a significant positive or negative effect of the 
intervention to terminate recruitment early. Thus, we believe that a decision to 
prematurely terminate study recruitment or study intervention is not possible. 
We have allocated 4 months of our 12-month study to recruiting study participants. If we 
are unable to recruit at least 5 study participants during that 4-month period, we will stop 
the study due to slow accrual.  
9.4 Outcomes  
9.4.1 Primary outcome   
The primary outcomes are: (1) Revised Memory and Behavior Problem Checklist and 
(2) Preparedness for Caregiving Scale. We will collect these outcomes at baseline and 
6-8 weeks post-enrollment via a REDCap survey.  
1. Revised Memory and Behavior Problem Checklist.27,28 Caregivers will rate 
memory, depression, and disruptive behavior problems in the PLWD. The instrument 
contains 24 items (7 memory-related, 8 depressive, and 9 disruptive) that assess 
problem behaviors and are rated for frequency of occurrence during the past week 
and caregiver reaction to the problem behaviors.  
 
2. Preparedness for Caregiving Scale.29 Caregivers will rate how prepared they are for 
various aspects of caregiving. The instrument contains 8 items that ask caregivers 
how well prepared they believe they are to provide physical care, emotional support, 
deal with the stress of caregiving, and set up in-home support services. Each item is 
rated on a 5-point scale ranging from 0 (not at all prepared) to 5 (very well prepared).  

 
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9.4.2 Secondary outcomes   
The secondary outcomes the System Usability Scale. We will collect this outcome 
each time a caregiver completes an online training module. The instrument will be 
embedded within the modules.  
• 
System Usability Scale.30 Caregivers will rate how easy the online training modules 
are to use. The instrument contains 10 items. Each item is rated on a 5-point scale 
ranging from 0 (strongly disagree) to 7 (strongly agree).  
 
Secondary outcomes will also include caregivers’ acceptance of the online training 
modules, their experience completing the REDCap survey, and their adherence to the 
online training modules. We will develop a semi-structured interview guide to 
qualitatively assess, during exit interviews, caregiver acceptance and experience 
completing the REDCap survey. We will obtain caregiver completion rates of online 
training modules using built-in metrics from the Kaiser Permanente School of Allied 
Health Sciences learning management system. 
 
9.5 Data Analyses 
For analysis of quantitative outcomes, we will use descriptive statistics. For qualitative 
outcomes, we will use analytic procedures in qualitative research.31 Given the small 
sample size and study objectives, we will not perform subgroup analyses. 
 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
We will collect data on the Revised Memory and Behavior Problem Checklist and the 
Preparedness for Caregiving Scale via a REDCap survey. We will deliver a link to the 
survey via an email or text message. Caregivers will be instructed to follow the link and 
complete the survey. 
 
We will collect data on the System Usability Scale via a REDCap survey. We will deliver 
a link to the survey via an email or text message. Caregivers will be instructed to follow 
the link and complete the survey. 
 
We will collect qualitative data during exit interviews that will be conducted by Dr. 
Ramirez, Celeste Garcia, and/or JP Lopez Garcia. The interviews will be audio recorded, 
and we will also take notes during and after the interview. 
10.2 Data Management  
Data collection and management will be the responsibility of the University of 
Washington. All data collected from participants will be labeled with a unique study 
identification number and not the participant’s name or any other information that could 

 
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identify the participant. Only the study identification number will appear on data records 
and computer files. The contact information of study participants will be kept in a 
password-protected file and computer. All data collected from participants will be kept 
confidential and accessible only by Dr. Ramirez, Celeste Garcia, and JP Lopez Garcia at 
the University of Washington. Dr. Penfold will view only summaries of aggregated data. 
We will not use participants names in reports of study findings, REDCap surveys, or 
audio recordings of interviews. Instead, we will label everything with the study 
identification number. We will destroy data that identifies participants when we have 
finished recruitment. We plan to keep de-identified data indefinitely. 
10.3 Quality Assurance  
10.3.1 Training 
As is the case with all investigators, key personnel, and all those responsible for the 
design and conduct of research at the University of Washington, Dr. Ramirez, Celeste 
Garcia, and JP Lopez Garcia have received training on the protection of human 
subjects. Dr. Ramirez will be responsible for training study staff members on the 
study protocol. 
10.3.2 Quality Control Committee  
This study will not utilize a quality control committee. 
10.3.3 Metrics 
We will use a log to document whether and when caregivers enrolled in the study 
were prompted to complete outcome assessments via the REDCap survey. The log 
will also document whether and when an exit interview has been scheduled. We will 
review the log on a weekly basis.  
10.3.4 Protocol Deviations 
We will use a protocol deviation log. The log will enable us to capture a description 
of the protocol deviation, the deviation category (e.g., safety, informed consent, 
eligibility, protocol implementation), date the deviation occurred, and date the 
institutional review board was notified. 
10.3.5 Monitoring 
Dr. Ramirez will be responsible for regularly monitoring all aspects of the study to 
assure protocol compliance, data quality, etc.  
 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol and the informed consent document and any subsequent modifications will 
be reviewed and approved by the IRB responsible for study oversight.   

 
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11.2 Informed Consent Form 
Consent forms in English and Spanish will be IRB-approved and the participant will be 
asked to read and review the document. Using the language preferred by participants 
(English or Spanish), the study staff member will explain the research study to the 
participant and answer any questions that may arise. A verbal explanation will be 
provided in terms suited to the participant’s comprehension of the purposes, procedures, 
and potential risks of the study and of their rights as research participants. Participants 
will be informed that participation is voluntary and that they may withdraw from the 
study at any time, without prejudice, and that the quality of their medical care will not be 
adversely affected if they decline to participate in this study. Participants will have the 
opportunity to carefully review the electronic consent form and ask questions prior to 
signing. The participants will be given a copy of the informed e-consent form so that they 
may discuss the study with their family or surrogates or think about it prior to agreeing to 
participate. The informed e-consent process will be conducted and documented in 
REDCap (including the date), and the form e-signed, before the participant undergoes 
any study-specific procedures. A copy of the signed informed e-consent document will be 
sent to the participants for their records.  
11.3 Participant Confidentiality  
Any data, forms, reports, audio recordings, and other records will be identified only by a 
participant identification number to maintain confidentiality. All records will be kept in a 
locked file cabinet. All computer entry and networking programs will be done using 
participant identification numbers only. Information will not be released without written 
permission of the participant, except as necessary for monitoring by IRB, the FDA, the 
NIA, and the OHRP. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
12 
ETHICAL CONSIDERATIONS 
This study will follow the seven main principles that the NIH Clinical Center has 
described as guiding the conduct of ethical research:32 
• Social and clinical value 
• Scientific validity 
• Fair subject selection 
• Favorable risk-benefit ratio 
• Independent review 
• Informed consent 
• Respect for potential and enrolled subjects 
 

 
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13 
COMMITTEES 
This study will not utilize committees. 
 
14 
PUBLICATION OF RESEARCH FINDINGS 
We will adhere to the IMPACT publications, and resource and data sharing policies.  
15 
REFERENCES 
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2020 Alzheimer’s disease facts and figures. Alzheimer’s Dement. 2020;16(3):391-460. 
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Lines LM, Sherif NA, Wiener JM. Racial and Ethnic Disparities Among Individuals with 
Alzheimer ’ s Disease in the United States : A Literature Review. RTI Press Publ RR-
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Sink KM, Covinsky KE, Newcomer R, Yaffe K. Ethnic Differences in the Prevalence and 
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Pinquart M, Sörensen S. Associations of stressors and uplifts of caregiving with caregiver 
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Janevic MR, Connell CM. The Gerontologist Racial, Ethnic, and Cultural Differences in 
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Harwood D, Barker W, Cantillon M, Loewenstein D, Ownby R, Duara R. Depressive 
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Liu C, Badana ANS, Burgdorf J, Fabius CD, Roth DL, Haley WE. Systematic Review and 
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Pinquart M, S?rensen S. Ethnic Differences in Stressors, Resources, and Psychological 
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AHRQ. Care Interventions for People With Dementia (PWD) and their Caregivers. 

 
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Morales L, Cunningham W, Brown J, Liu H, Hays R. Are Latinos less satisfied with 
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Doty M. Hispanic Patients’ Double Burden: Lack of Health Insurance and Limited 
English.; 2003. 
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Weech-Maldonado R, Morales L, Spritzer K, Elliot M, Hays R. Racial and ethnic 
differences in parents’ assessments of pediatric care in Medicaid managed care. Health 
Serv Res. 2001;36:575-594. 
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Weech-Maldonado R, Morales L, Elliot M, Spritzer K, Marshall G, Hays R. 
Race/ethnicity, language, and patients’ assessments of care in Medicaid managed care. 
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Special Report -- Race, Ethnicity and Alzheimer’s in America.; 2021. 
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Accessed March 24, 2021. 
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Mahoney DF, Cloutterbuck J, Neary S, Zhan L. African American, Chinese, and Latino 
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Mukadam N, Cooper C, Livingston G. A systematic review of ethnicity and pathways to 
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Teri L, Logsdon R, McCurry S. The Seattle Protocols: Advances in Behavioral Treatment 
of Alzheimer’s disease. Res Pract Alzheimers Dis. 2005;10. 
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McCurry SM, Logsdon RG, Mead J, et al. Adopting Evidence-Based Caregiver Training 
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STAR Caregivers - Virtual Training and Follow-up (STAR-C-VTF) NCT04271046. 
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Published 2020. 
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Ramirez M, Duran MC, Pabiniak CJ, et al. Family Caregiver Needs and Preferences for 
Virtual Training to Manage Behavioral and Psychological Symptoms of Dementia: 
Interview Study. JMIR Aging. 2021;4(1):e24965. doi:10.2196/24965 
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Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of behavioral 
problems in dementia: the revised memory and behavior problems checklist. Psychol 
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Gonzalez Salvia M, Dawidowski A, Schapira M, et al. Spanish Revised Memory and 
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doi:10.1017/S1041610210002073 
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30.  
System Usability Scale (SUS). usability.gov. https://www.usability.gov/how-to-and-
tools/methods/system-usability-scale.html. Accessed June 2, 2021. 
31.  
Padgett D. Qualitative and Mixed Methods in Public Health. Thousand Oaks, CA: SAGE; 
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32.  
Ethics in Clinical Research | Clinical Center Home Page. 
https://www.cc.nih.gov/recruit/ethics.html. Accessed June 1, 2021. 
 

 
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16 
SUPPLEMENTS/APPENDICES 
I. Outcome Measures 
 
 

 
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II. Demographics Questionnaire 
 
 

 
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III.  Draft of Informed Consent Form  
 
 
Virtual Training for Latino Caregivers to Manage Symptoms of Dementia  
Informed Consent Form 
 
Researchers  
University of Washington School of Public Health 
 
Maggie Ramirez, MS, MS, PhD, Lead researcher  
206-543-9773 
Miriana Duran, MD, MPH, Research coordinator  
206-221-6206 
 
    
Key information about this study 

 
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We are asking you to be in a research study. This form explains the details of the study. Please 
read this entire form before agreeing to join the study. You do not have to be in this study. If you 
say yes, you can quit the study at any time.  
 
The study, Virtual Training for Latino Caregivers to Manage Symptoms of Dementia, is about an 
online program we are designing to better support family caregivers of people living with dementia 
(PLWD). Our goal is to learn how we can design the online program to better meet the needs of 
family caregivers. We will do this by asking family caregivers to use the online program. We will 
also ask caregivers to answer survey questions and participate in an interview. This study is being 
conducted by the University of Washington (UW) and is funded by the NIA IMPACT 
Collaboratory.  
 
This study may not help you personally, but we hope the results of this study will help improve 
care in the future. You might feel uncomfortable with the program materials or with answering 
some study questions. You may skip any part of the program you don’t want participate in. You 
may also skip any questions you don’t want to answer. In addition, the interview could last up to 
60 minutes. We can schedule the interview on a date and time that is convenient for you. It’s 
possible that someone other than the researchers could find out you were in the study or see your 
private information.   
 
What will happen if I take part in this study?  
If you are eligible and want to join the study, we will ask you to: 
 
Use an online program for a period of 6 weeks. The online program consists of 6 videos. You 
would watch the videos at home from any device that you prefer to use. We will ask you to watch 
one video per week. The videos will provide information to help you better manage behavioral and 
psychological symptoms of dementia (e.g., agitation, sleep disturbance, aggression). 
 
Complete online surveys. The surveys will ask you about the following: 
• Sociodemographic characteristics (e.g., age, gender, race, ethnicity) 
• Occurrence and frequency of dementia symptoms in the PLWD and your reactions to 
these symptoms 
• How prepared you feel for various aspects of caregiving 
• How easy or hard you think the online program is to use 
• How useful you think the online program is to use 
 
Take part in an in-person interview that will last up to 60 minutes. During the interview, a UW 
researcher will ask about your experience using the online program. They will also ask about your 
experience completing the online surveys. For example, what you liked about the program, what 
you did not like about the program, and how we can make the program better in the future. We will 
audio record the interview. Anything you say that could identify you will not be written down.  
 
The interview recording and other information about you that we collect through the surveys will 
be labeled with a code number instead of your name. 
 

 
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We will provide you with $40 to thank you for taking part in the study.  
 
Using Your Data in Future Research 
The interview recording and other information about you that we collect through the surveys 
may be used or distributed for future research studies without your additional informed consent.  
 
Will there be any costs to me? 
There will not be any costs to you.  
 
Will being in this study help me? 
This study will not help you personally, but we hope the results of this study will help improve 
care in the future. 
 
Can anything bad happen to me from being in this study?  
You might feel uncomfortable with the program materials or with answering some survey or 
interview questions. You may skip any part of the program you don’t want participate in. You may 
also skip any questions you don’t want to answer. 
 
It is possible that someone other than the researchers could find out you were in the study or see 
your private study information. The steps we take to keep this from happening are described 
below.  
 
How will you protect my confidentiality? 
This study is being done by researchers at the UW. They are listed above. These researchers sign a 
pledge at their institution that requires them to keep your information private. 
 
Your study responses (data) will be kept confidential by the UW. The researchers listed on the first 
page will use your study information for research only. We won’t use your name in study reports 
or write it on recordings of the interview. Instead, we will label everything with a code number 
only. We will store the interview recording and other information about you that we collect 
through the surveys in secure databases at the UW. We will destroy data that identifies you when 
we have finished recruitment. We plan to keep your de-identified study information as described in 
this form indefinitely.  
 
Do I have to be in this study? 
No, being in this study is up to you. You are free to say no now or to leave the study at any time 
later. Either way, there will be no penalty. Your decision won't affect the healthcare you receive or 
benefits that you are entitled to.  
  
What happens if I say yes, but change my mind later? 

 
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You may change your mind any time about letting us use your information for this study. If you 
change your mind, you may take back your consent by writing to:  
 
Maggie Ramirez, MS, MS, PhD  
Hans Rosling Center for Population Health  
Department of Health Services 
3980 15th Ave NE, Fourth Floor 
Box 351621 
Seattle, WA 98195 
maggiera@uw.edu 
 
If you take back your consent, it will not affect your healthcare or benefits. We may still use the 
study information we collected before we received the letter taking back your consent. But, we 
will destroy any record of your name or other information that could identify you. 
 
Who do I call if I have questions? 
• If you have questions about your rights as a research participant, please call [placeholder 
for IRB office] at [placeholder for phone number]. 
• If you have questions or concerns about the study, please call the research coordinator, 
Miriana Duran, at 206-221-6206. 
 
Subject’s Statement 
This study has been explained to me.  I volunteer to take part in this research.  If I change my 
mind later, I may leave the study at any time.  I’ve had a chance to ask questions, and they’ve 
been answered to my satisfaction.  If I have more questions later, I may call the researchers listed 
in this form or their staff.  I will get a copy of this form to keep. 
 
 
________________________________________ 
 
____________ 
Signature 
 
 
 
 
 
 
Date 
 
________________________________________ 
Please PRINT your name  
 
 
 
 
 
 
 
 
___  
 
 
 
Signature of study staff obtaining consent 
 
 
Date 
 
 
 
 
 
 
 
 
___  
 
Printed name of study staff obtaining consent