Mastering the Challenges of Dementia Family Caregiving in a Time of COVID-19: An Online Course
Phase: NA
Conditions: Caregiver Stress Syndrome
Sponsor: Emory University

Protocol 
 
Title: Mastering the Challenges of Dementia Family Caregiving in a Time 
of COVID-19: An Online Course 
 
 
NCT Number: NCT04939714 
 
 
Protocol Date: July 29, 2021 
 

Protocol Title: Mastering the Challenges of Dementia Family Caregiving in a Time of COVID-19
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PROTOCOL TITLE: Mastering the Challenges of Dementia Family Caregiving in a Time of 
COVID-19: An Online Course
PRINCIPAL INVESTIGATOR:
Carolyn Clevenger, DNP
School of Nursing
 
VERSION:  2.0 on 7/29/2021
FUNDING SOURCE: National Institute on Aging (pending)
REVISION HISTORY
Revision #
Version 
Date
Summary of Changes
1
09/03/2020
Updated honorarium to $25
2
10/19/2020
Clarifies that only Aim 2 involves human subject research
Reduces number of participants in focus groups
Clarifies number of focus groups versus interviews
3
07/29/2021
Updates methods of Recruitment using Emory On-Hold 
Services, Social Media. 

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Table of Contents
1.
Study Summary .......................................................................................................................3
2.
Objectives................................................................................................................................3
3.
Background .............................................................................................................................4
4.
Study Endpoints ......................................................................................................................5
5.
Study Intervention / Design ....................................................................................................5
6.
Procedures Involved................................................................................................................5
7.
Data and Specimen Banking....................................................................................................9
8.
Sharing of Results with Participants......................................................................................10
9.
Study Timelines .....................................................................................................................10
10.
Subject Population.............................................................................................................10
11.
Vulnerable Populations .....................................................................................................10
12.
Local Number of Participants ............................................................................................11
13.
Recruitment Methods........................................................................................................11
14.
Withdrawal of Participants................................................................................................12
15.
Risks to Participants...........................................................................................................12
16.
Potential Benefits to Participants......................................................................................13
17.
Data Analysis, Management and Confidentiality...............................................................14
18.
Provisions to Monitor the Data to Ensure the Safety of Participants .............................N/A
19.
Provisions to Protect the Privacy Interests of Participants and Confidentiality of 
Participants’ identifiable data.......................................................................................................15
20.
Economic Burden to Participants ......................................................................................16
21.
Consent Process.................................................................................................................16
22.
Setting................................................................................................................................17
23.
Resources Available...........................................................................................................17
24.
Multi-Site Research when Emory is the Lead Site...........................................................N/A
25.
References.........................................................................................................................18

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1. Study Summary
Study Title
Mastering the Challenges of Dementia Family 
Caregiving in a Time of COVID-19: An Online Course
Study Design
Two group waitlist control design
Primary Objective
Develop a prototype pandemic caregiver training and 
education course
Secondary Objective(s)
Conduct a waitlist-control design test of the prototype 
course
Research 
Intervention(s)/Interactions
Self-paced asynchronous online course
Study Population
Dementia Family Caregivers
Sample Size
100
Study Duration for 
individual participants
24 weeks
Study Specific 
Abbreviations/ Definitions 
COVID-19: Coronavirus Disease 2019
PLWD: Person living with dementia
CES-D: Center for Epidemiological Studies-Depression
RMBPC: Revised Memory and Behavior Problems 
Checklist
MPI: Multiple principal investigator
Funding Source (if any)
National Institute on Aging (pending)
2. Objectives
Aim 1: Develop a prototype pandemic caregiver training and education course.  Through 
iterative Design Studio sessions with dementia family caregivers, program faculty, COVID-19 
specialists, and other clinical experts, we will design a competency-based course curriculum 
that applies a psychoeducation framework to the design. Based on this process, we will 
storyboard and script a course with 30-35 brief video- and text-based instructional modules.  
After final revisions, we will produce the instructional text and videos and finalize the self-
paced course to be tested in Aim 2 activities.  Aim 1 activities do not constitute human subject 
research; they are intended solely to gather input from a variety of perspectives, including from 
individuals similar to those with whom the eventual program will be tested, to assist in program 
design.
Aim 2: Conduct a waitlist-control design test of the prototype course.  We will identify a diverse 
set of dementia family caregivers (N=100; 1/4 African American) whom we will ask to enroll in 
the course to participate in formative and summative research related to it.  The test will gather 
information about the usability and salience of the course as well as its preliminary efficacy. The 
course faculty and research team’s observation of participants’ responses to the course and the 

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embedded interactive exercises and the results of semi-structured interviews with a subsample 
of 20 participants will enable us to further refine the course.
3. Background
Family caregivers, the backbone of care for the upwards of 7 million community-
dwelling individuals living with Alzheimer’s disease in the U.S., provide at least 85% of 
the care these individuals receive,1 at some risk to their own well-being,9.10 and are 
instrumental in navigating healthcare systems. Without their care, it is almost certain 
that PLWD would have much higher rates of acute and emergency care use than their 
age-matched peers, perilous venues for them in the best of times, potentially deadly 
during this pandemic.11-14  With COVID-19 restrictions, the amount of care they provide 
and the expertise needed to provide the care will increase. Typically, caregivers are 
strangers in healthcare and pandemic landscapes, but they are now called on to enact 
home care and safety measures and navigate an intricate, complex, and opaque system 
without the benefit of a compass or a translator – and largely without understanding 
their role in or having the skills for navigating the system.  A variety of interventions, 
including our own, have demonstrated benefit in enhancing caregivers’ caregiving 
capacities, with resulting positive outcomes for both caregivers and care recipients.15-18  
Only a few of these useful interventions, Tele-Savvy among them, have employed 
distance delivery means, thus enabling rural caregivers and others precluded by 
circumstance from attending in-person programs to take part in the intervention 
programs.19,20 
Early findings from the synchronous/asynchronous online three-arm randomized Tele-
Savvy trial provide encouraging support for this project. The online Tele-Savvy 
psychoeducational caregiving course we propose appears to work and caregivers do 
fully participate in its asynchronous component. We used multilevel mixed models to 
test for group, time, and group-by-time effects for each of the outcomes. Results from 
the first 220 participants in the baseline to six-month segment of this three-arm trial 
indicate that Tele-Savvy participants had statistically significant group-by-time 
reductions in depression and strain and statistically significant group-by-time increases 
in caregiver mastery, compared to those in the other two study arms. We found a 
significant group-by-time effect on CES-D-assessed caregiver depression (p<.001) with 
the active group showing significant decreases over time (p<.001).  We found a 
significant group-by-time effect on caregiver perceived strain (p<.001) with the active 
group demonstrating significant reductions over time (p<.001) and the waitlist control 
group demonstrating significant increases (p=.010). Likewise, there was a significant 
group-by-time effect (p=.001) on caregivers’ reactions to care recipient behaviors 
(RMBPC) with significant reductions over time among the active caregivers (p=.001). 
Caregiver competence likewise demonstrated a significant group-by-time effect (p-
.009), with the active group demonstrating significant increases over time (p<.001). 
Findings regarding caregivers’ mastery were comparable: a significant group-by-time 
effect (p=.003) with the active group demonstrating significant increases over time 

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(p<.001).  Canvas-based analytics indicate that participants were highly adherent in 
viewing the 36 asynchronous 8-15 minute daily video lessons, spending, on average, 
more than 8 hours watching the videos over the course of the 43-day program.
Much of the “normal work” of caregiving involves guiding PLWD through days at home 
and in the community that are as calm, engaging, and event-free as possible, and that 
has been the mastery-development focus of much of MPI Hepburn’s work.21  The 
COVID-19 pandemic, however, brings into stark focus caregivers’ need to acquire the 
knowledge, skills, and competence to maintain care recipients’ safety and ensure their 
safe navigation of the healthcare system. Functioning as a public health/infection 
control expert and healthcare system navigator requires skills and knowledge that 
family members do not possess as a matter of course.  
4. Study Endpoints 
The key study outcomes are measures of caregiver psychological well-being and 
confidence in their ability to provide effective care to the PLWD. The study ends after 
participants complete the online course and the follow-up interviews conducted to 
gather these study endpoints/outcomes .
5. Study Intervention / Design 
The proposed study is a two-group waitlist control design to study a psychoeducational 
intervention for dementia caregivers. The study has two phases: 1) course development 
and 2) testing.
Our overall approach to course development and testing is one that we have used 
successfully in MPI Hepburn’s work to produce video instructional content for dementia 
family caregivers.  End-users are engaged throughout in both developing the broad 
outlines of an instructional curriculum, crafting the granular elements of the curriculum 
(e.g., text and video content for individual lessons), and providing formative feedback 
on the prototype product.  The approach to co-production of care that informs the 
sense of mastery to be developed is one that MPI Clevenger has successfully deployed 
in MPI Clevenger’s Integrated Memory Care Clinic (IMCC),22 Emory’s patient-centered 
medical home for PLWD.  
6. Procedures Involved
Aim 1 [Weeks 0-24].  Table 1 below outlines the activities in which we will engage to 
stand up the caregiver education course we will test in Aim 2.  Guided by a Design 
Studio process, we will engage in an iterative process of curriculum development, 
course design, and materials production that will involve a diverse group of dementia 
family caregivers, our core pilot project team, other clinical and caregiver experts, and 
our educational design consultant.  The Design Studio’s process is deeply grounded in 
the early and frequent involvement of potential end users in product design and uses a 
variety of brainstorming techniques to challenge and refine an emerging product – like 

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this course.  This process it will play an important role in developing the Aim 1 prototype 
pandemic caregiving course.  This is a design, not a research, activity.
The Design Studio activities will be conducted in three stages using focus group 
methods. To facilitate group discussion by all participants, the sample size for each 
Design Studio session will be limited to 8-10 participants per group, an average of nine 
per group. Drs. Epps and Perkins (co-Investigators) will lead these discussions with one 
acting as moderator and the other as trained observer. The observer will assist with the 
process and record observations of participants’ nonverbal interactions and behaviors. 
Design Studio sessions will last approximately 60-90 minutes and be audio-recorded and 
transcribed verbatim.
Table 1. Activities to be Undertaken in Aim 1
Project Weeks
Aim 1 Activities
0
4
8
12
16
20
24
• Project team develops preliminary course content table
 ----x
• In collaboration with educational consultant, develop 
preliminary course design
------------x
• Design Studio #1, 
        -------x
• Course content and design revisions (team and educational 
consultants) some scripting
              ---------x
• Design Studio #2, 
                    ------x
• Course revisions, storyboarding, video scripting continues
                       ------------x
• Design Studio #3,
                                 ------x
• Finalization, including scripting, video production, 
placement on Canvas platform
                                     -----------------x
• Aim 2 recruitment and consenting begins
                                       -----------------
Table 2 below represents the broad initial draft outline of the key sections and up to 36 
specific topics we believe to be essential segments in the course.  The outline will serve 
as the basis for course design activities with our instructional designers and specialists, 
and these together – the topic outline and rough course design – will provide the 
material for our first Design Studio exercise. We emphasize the draft nature of this 
outline.  The Design Studio process emphasizes empathy with the end-user experience 
as the driver of end-product design.23-27 We will use the empathize/define phases of 
design thinking to understand how generally to design the course and associated 
elements and use ideation/prototyping techniques to clarify what should be included or 
not included in more detail. Constructed as it has been from an “expert” perspective, 
the draft document likely omits significant elements of and perspectives on caregiver 
mastery development that will need to be incorporated into the eventual design of the 
proposed course.
In the first audio-recorded Design Studio exercise, to be held online if necessary, we will 
engage IMCC Advisors and a diverse group of other caregivers in an initial exploration of 
the overall objectives and the preliminary form and content of the course. After the first 
group, the team, led by investigators Epps and Perkins, will analyze the transcripts, using 
a thematic analysis approach,28 an iterative process that will involve deconstructing text, 
identifying salient themes, conceptualizing relationships, and synthesizing results. Two 
primary coders (Epps and Perkins) will independently code the first transcript. A 

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secondary coder (Clevenger) will review the coding and reconcile any differences. Codes 
will be discussed among the entire project team to ensure concordance and reliability. 
This analysis will guide refinements of the course and course materials as well as 
development of draft text and video scripts for two topic segments.
Table 2.  Preliminary Draft of COVID-19 Course Curriculum Content
Key Sections
Topics Within Sections
Introduction
Caregiving as Skilled Work
Caregiver: Co-producer of Care
COVID-19: An introduction
Infection Control 101
Hand washing and sanitizing
Masks and gloves?  Really?  When?
When guests/workers enter the home
Going out and coming back in
The threats of sheltering in place: isolation
Falls Prevention – avoiding the ER
Longer days of caregiving
Care when person is in other settings
Quality of life: threats and choices
What’s the plan for the person’s care?
Caregiving for 
a Person 
Living with a 
Dementia 
Disorder 
during a 
Pandemic 
(COVID-19) 
A crisis plan: What if you become ill?
Reliable Information, Fake News, and Scams
How providers hear you
SBAR – Talk like a nurse
Asserting your standing in the case
Prepping for telemed/out-patient visits
Safe Use of the Emergency Department
Packing for an emergency
When the person is hospitalized
Coordinating input from multiple providers
Transferring back home
How to best use home care
Navigating 
the Health 
Care System 
for a Person 
Living with a 
Dementia 
Disorder
Getting jargon translated
Case Management: think like a Social Worker
The “clinical role” of the caregiver
Designing engaging tasks and activities
Think and process like a Nurse
Care of chronic conditions
Guiding and 
Managing 
Daily Life
Caregiver self-care
Using other resources
These materials will serve as the stimuli for the next audio-recorded Design Studio 
convened with IMCC caregiver Advisors, other caregivers, and also clinicians and Roybal 
Center Advisors.  In this session, the revised outline will be subject to group scrutiny and 
suggestions. Again, team analysis of the results of the exercise will address key 
development questions: 
•
What’s missing? 
•
Where is emphasis needed? 
•
What’s irrelevant? 
•
What is/are key takeaway lesson(s)? 
•
Do educational methods encourage involvement and promote the specific 
caregiving mastery at which we are aiming? 
Following analysis comparable to that employed after the first Design Studio session, we 
will produce a near-final course design, attending to issues of the “feel” and readability 
of the course, the exercises and opportunities for interactivity to be included, and the 
methods by which the instructor will monitor and provide feedback.  We will also 
develop penultimate versions of course text and video asset scripts and begin 
production of caregiver and instructor manuals and other course materials. 
These materials will provide the grist for the third Design Studio exercise, again an 
audio-recorded session convened primarily with caregiver participants but with some 
clinical and educational expert participation. We ask the same “What do you think?” 
questions about the content, structure, format, and mode of delivery of the course and 

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the proposed instructional videos (e.g., Is a lecture format acceptable?  Should there be 
a combination of graphics and voiceover? Would some kind of embedded enactment be 
useful? What exercises might prompt interaction and foster mastery?).  
Following an analysis comparable to those described above, the team will go into full 
production mode.  We will work with the School of Nursing instructional design team to 
finalize scripting for the possibly as many as 36 segments, finalize the look, feel, and 
flow of the course, embed it on Canvas, a cloud-based learning management platform 
used by our School of Nursing, and move to the production of an accompanying 
caregiver manual and other associated course materials. The team will shoot the video 
assets – likely small (4-8 minute) mini-talks provided by our team and other experts – 
that will introduce and reinforce the text and pictorial content of the course.  Based on 
previous experience, video production should take no more than 3-5 days, then editing 
and integrating these materials into the final course should take no more than three 
weeks.
Aim 2 [Weeks 16-52].  Drawing on the recruitment resources identified above, we will 
recruit 100 caregivers in two waves of 50 each to participate in a waitlist-control design 
pilot test.  When 50 individuals are identified for the first wave, we will contact them, 
obtain their consent for participation, and, using established instruments delineated in 
Table 3 below to assess depression, anxiety, burden, and mastery,  gather, through 30-
minute phone or video interviews, baseline quantitative data on mood and caregiving 
competency. Once all participants in each wave have completed their baseline 
quantitative interviews, we will randomly assign half (25) to immediately enroll in and 
begin the course; we will inform the other half of the group (25) that the course will be 
open for their enrollment after a waiting period of approximately eight weeks, the time 
it will take the immediate participants to complete the course.  All participants will again 
be interviewed at that 8-week point, following the immediate group’s course 
completion and prior to the wait-list group’s enrollment. All will be interviewed again 8 
weeks later.  This same pattern of data collection and random assignment will be 
followed with the second wave participants.
Table 3. Scales to be Used in Qualitative Interviews
Outcome Domains/Scales
Description of Validated Scales
The CES-Depression Scale29
21-item self-report depression scale
Stait-Trait Anxiety Inventory30 
20-item self-report scale of positive and negative anxiety experiences
Perceived Stress31
16-item scale of self-reported caregiving stress
Revised Memory and Behavior Problem 
Checklist (RMBPC)32
24-item scale reporting on frequency of disturbing care recipient 
behaviors and severity or caregiver reactions to these behaviors.
Zarit Burden Scale33
22-item scale of objective and subjective caregiver burden
Caregiver Mastery Scales34
3 3-5 item scales of caregiver mastery of caregiving situations
Caregiver Competency Self-
Assessment35
18-item caregiver self-assessment of perceived capacity to manage 
care situations

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The Aim 2 baseline, midpoint, and final instrument-based interviews for all participants and 
audio-recorded semi-structured follow-up formative evaluation interviews with selected 
participants will be conducted by phone or videoconference by an interviewer trained and 
supervised by Co-Investigator Perkins; a protocol used in Hepburn’s Tele-Savvy study will be 
employed to identify and respond to indications of extreme caregiver stress.  Focus groups (Aim 
1 ) will be conducted online, led by Perkins and Epps.  
Three sources of information will enable us to move forward with the preparation of a revised 
course.  The interactive elements of the course (discussion board, exercises and reflections) and 
the course instructor’s observations will enable us to gauge caregivers’ understanding of, 
reactions to, and apparent benefit from individual segments of the course.  The Canvas 
platform allows us to monitor caregivers’ course behaviors (e.g., time spent on segments, 
repeated viewing of segments, extent of participation in interactive components). This 
information may point to the relative importance of segments as well as the usability of 
interactive components. The post-course qualitative interviews with caregivers will provide 
extensive information about topic matter and the usability and acceptability of course material 
and overall course design.  Data from these sources will begin to flow from the point of the 
gathering of baseline data from the first wave of participants (approximately week 22) and will 
continue through the qualitative interviews with course participants (approximately week 48).  
MPI Clevenger will lead the team’s efforts to distill these data strands into practical course 
revision design activities with the instructional design consultant team to map the steps needed 
to produce a final course version by project’s end.  
7. Data and Specimen Banking
De-identified interview-gathered questionnaire data regarding caregivers’ psychological well-
being and self-asessment of competency will be stored in REDCap for analysis. De-identified 
transcriptions of audio-recorded Aim 2 open-ended qualitative interviews will be stored on 
Emory’s instance of Box, accessible only to the study investigators. All study participants will be 
assigned ID numbers. The file linking identities to IDs will be stored separately on the PI’s 
encrypted work computer. De-identified transcriptions of audio-recorded Aim 1 design sessions 
will also be stored on Emory’s instance of Box, accessible only to the study investigators.
The final dataset will include standardized measures of caregiver well-being and competence 
and will be stored in PI Clevenger’s office in the Emory University Nell Hodgson Woodruff 
School of Nursing in Atlanta, Georgia. Data from this study will be available to qualified 
researchers through a data sharing agreement that is fully consistent with NIH data sharing 
policies and applicable laws and regulations as well as official policies and practices established 
by the Roybal Center at Emory. Although these data will be de-identified prior to release for 
sharing, there remains a possibility of deductive disclosure of participants with unusual 
characteristics. Therefore, this data sharing agreement will require: 1) a commitment only to 
use the data for research purposes and not to identify any individual participant; 2) a 
commitment to securing the data using appropriate computer technology; and 3) a 
commitment to destroy or return the data after analyses are completed.

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8. Sharing of Results with Participants
Results of each Design Studio will be shared with participants as each iteration of the course is 
developed. At study’s end, we will prepare a lay report detailing the results of the study and 
distribute this report to study participants.
9. Study Timelines
For those caregivers engaged in the Aim 1 portion of the study, this will be a one-time 
involvement, lasting only during their participation in one of the Design Studio exercises.  This 
will take approximately 1-2 hours
For any caregiver engaged in the Aim 2 wait-list control trial of the prototype developed in Aim 
1, participation will last approximately 5 months.
We expect Aim 1 recruitment and enrollment to occupy a span of approximately 5 months, and 
Aim 2 recruitment and enrollment – which will begin while we are still engaged in Aim 1 
activities – is expected to span about 5 months, from project month 4-9.
The study as a whole will take one year.  Aim 1 activities will be complete by the end of the fifth 
month; Aim 2 activities will be completed by project’s end.
10. Subject Population
We will seek to enroll family members (or friends) who self-identify as a principal caregiver and 
the principal companion of a community-dwelling PLWD during healthcare encounters.  We will 
provide verbal and written instructions in how to access and use the course, provide a schedule 
for their completion of the course over the next 6-8 weeks, and mail out course materials.  At 
the end point of each wave, we will purposively select 10 caregivers to participate in semi-
structured interviews (total n=20) based on varying caregiver characteristics and findings from 
baseline quantitative data (e.g., stress levels, gender, race/ethnicity). Interviews will last 
approximately 45 minutes and will ask questions about the overall contribution of the course to 
their own perceived sense of competence as caregivers and healthcare navigators during the 
pandemic. We will also seek their responses to the course (Acceptable? Usable? Relevant? 
Enough? Too much? What’s missing? How to improve?). We will provide $25 gift cards for 
participation in each baseline focus group and post-intervention semi-structured interview.  
Caregivers would be excluded if their loved one is institutionalized or receiving hospice services 
or there are plans to do so within the next three months. Participants must also be able to read 
and speak English and be able to access the online course materials. 
11. Vulnerable Populations

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The study does not include individuals who lack decision-making capacity or may be 
susceptible to undue influence or coercion.
12. Local Number of Participants
We plan to recruit 30 participants in phase 1 of the study, designing the course, and 100 
participants in phase 2, testing the course. All participants will be recruited from networks in 
Georgia. 
13. Recruitment Methods
Core pilot team members can draw on their multiple involvements as recruitment 
sources for a diverse group of caregiver to address Aims 1 and 2. MPI Clevenger’s IMCC 
has patient panel of >600 and a very active Family Advisory Board that has been 
integrally involved in the development and vetting of all aspects of the IMCC. The 
statewide Georgia Memory Net serves >300 dementia families, many in rural Georgia 
(Hepburn). Emory’s NIA-supported Alzheimer’s Disease Research Center (Hepburn, Co-I) 
maintains a large registry of caregivers willing to be contacted. Core team members’ 
ongoing work with African American church communities (Epps), MCI empowerment 
activities (Hepburn), and MPI Hepburn’s near-completed Tele-Savvy project can further 
ensure successful recruitment from program completers (25% African American).
Direct care providers (physicians, nurse practitioners) will not recruit participants.
Recruitment and Recruitment Materials for Aim 1 Design Studio Activities.
Caregivers who engage in the Design Studio process of developing the Caregiving During 
Crisis are not taking part in the research study.  We will use the personal and 
organizational contacts described in the paragraph above to identify participants.  For 
example, we expect to draw on advisory board members from the IMCC and MCI 
empowerment center, as well as community advisors to the Emory Roybal Center to 
take part in these design activities.  Invitations will be made through phone calls and 
emails directly to these individuals.
Recruitment and Recruitment Materials for the Aim 2 Randomized Control Trial.
We plan to draw on the contacts available to each of the study investigators and to the 
broader networks with which they are affiliated (e.g., the national Alzheimer’s Disease 
Centers and Roybal Centers) to provide information to potential participants.  Potential 
subjects will be contacted by email if they have indicated their willingness to receive 
information about studies that might be of possible interest.  
We will advertise online, through Social media, such as Twitter, Facebook and 
Instagram, and through Emory Healthcare on-hold message services. We will ask 
organizations in our network to use their normal methods of communication (e.g., their 
newsletters) provide a link to the study announcement which will be posted on our 
Roybal Center website (emorycaregiving.org).  These announcements and scripts are 
attached to this application in the Recruitment Materials section.

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Eligibility Determination
Screening will be conducted by distance means (phone or videoconference) by 
investigators Clevenger or Hepburn or Roybal Program Manager Reed. 
 Is the potential subject providing care for a family member or friend? If so:
o Does that person have a confirmed diagnosis of dementia?
o Is the person living in the community?
o Is the caregiver co-residing with the person?
o Is the caregiver the main caregiver for the person?
 Does the caregiver have a computer with internet access?
 Can the person read and understand English?
The screening calls or videoconferences will not be recorded. No identifying information 
about the screening calls, including the person’s IP address, will be recorded.
Payments to Participants.
We will provide $25.00 gift cards (e.g., Visa cards) to participants for each interview in 
which they take part.  All trial participants will be asked to take part in a baseline 
interview and then subsequent interviews 3 and 5 months later.  About 20% will be 
asked to take part in focus groups prior to their enrollment in the course, and about 
20% will be asked to take part in semi-structured interviews following course 
completion.  Thus, the maximum payment for any participant would be $100.00
14. Withdrawal of Participants
Aim 2 study participants may request, verbally or via course message or email, to withdraw 
from the study at any time. Likewise, the study team may also withdraw a participant if their 
caregiving situation changes (e.g., if the person for whom they are providing care is 
institutionalized or dies).
15. Risks to Participants
We believe that caregivers taking part in the trial of the Caregiving During Crisis program will be 
exposed to very low risks.  The two main risks are of transient emotional distress and breach of 
confidentiality.  These are described below.
Transient emotional distress.  As persons providing care to a person living with dementia and 
doing so under the strains of the threat and restrictions of a pandemic, subjects in this study 
are already very likely to be experiencing a higher than normal level of stress and distress.  The 
content of the course will draw their attention to their situation in ways that might make them 
more acutely aware of their distress or cause them to lower the defenses they might have 

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erected to fend off the distress.  Likewise, the subject matter raised and the questions posed in 
the research interviews, the focus groups, and semi-structured interviews may also call 
attention to distressing matters and situations.
 Based on our research experience with similar study subjects and the same questions and 
methods, we judge the occurrence of such distress to be relatively infrequent (perhaps in 25% 
of cases), of low magnitude (perhaps a 2 on a scale of 10, where 10 is the highest), of very brief 
duration, and fully reversible.  The research interviewer will be trained to recognize such events  
and to provide ways to back away from and calm them.  The participating investigators who 
would conduct the focus groups or semi-structured interviews are experienced in working with 
dementia caregivers and in managing such transient events in ways that permit the caregiver to 
work through them in a brief, respectful, and calming manner.
We can see no procedures in the study that might produce currently unforeseeable risks, and 
we can see no procedures that might put others at risk who are not in the study.
Threats to Confidentiality.
The Aim 2 study will gather personal information on all participants (name, email, address, 
etc.). This information will not be attached to any research study file.  A unique ID number will 
be assigned to each participant, and all research documents pertaining to that participant (the 
data stored in REDCap or the transcriptions of the focus groups and individual interviews) will 
only be stored using that ID number.  The file with baseline personal information and the file 
that links personal identifiers to ID numbers will be stored separately in the Emory encrypted 
computer in PI Clevenger’s office.  Any later sharing of data from the study will be done 
according to an NIH-compliant data and resource sharing agreement, and those data will be 
completely de-identified.
16. Potential Benefits to Participants
Although we are careful not to assert this to potential study participants, we believe the 
program will provide them with knowledge and skills that will help them to better negotiate the 
additional dementia caregiving challenges they face during this time of Coronavirus pandemic – 
and in possible future crises. 
In terms of a knowledge contribution to the field: If this trial demonstrates positive preliminary 
efficacy in reducing caregiver distress and enhancing caregiver mastery, it will add to the 
evidence that a psychoeducational approach (developing skills, knowledge, and competence 
through an active and interactive learning strategy) is effective with this important population. 
This study’s approach is aligned with other work by the investigators and with investigators 
supported by the Emory Roybal Center for Dementia Caregiving Mastery and with clinical 
practice at the IMCC that developing caregiver competence reduces caregiver distress.  

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In terms of the caregiver knowledge that would be strengthened: the program aims to increase 
caregivers’ knowledge about ways to manage day-to-day life with a person living with 
dementia, knowledge about infection control practices to minimize risk of viral infection; and 
knowledge about navigating the healthcare system.
As noted in #13, above, participants will receive a $25.00 gift card (e.g., Visa card) for each 
research interview, focus group, and/or semi-structured interview in which they take part. 
17. Data Analysis, Management and Confidentiality
Quantitative data will be entered at the time of each Aim 2 interview directly into the dedicated 
project tablet computer and saved on Emory’s secure REDCap platform.  All data entry screens 
are set up in REDCap and, where possible, include data delimiters (i.e., skip patterns, valid 
range limits) to ensure correctness and minimize missing data.  Data will be exported weekly 
and analyzed for data cleaning and verification. Upon completion of each cohort data-gathering 
point, all data will be merged for scale computation, aggregation, and analysis. We will use 
NVIVO 12 software to store and manage all qualitative data and to facilitate data analysis.  
For quantitative analysis, we will test for group, time, and group-by-time effects for each of the 
outcomes (caregiver anxiety, depression, burden, stress, and mastery). In preliminary analyses, 
descriptive statistics and frequency distributions will be examined to identify outliers and 
ensure integrity of all data.  For all multi-item scales, internal consistency will be examined 
using Cronbach’s alpha and associated statistics (e.g., item-total correlations, alpha if item 
deleted).  Preliminary analyses will examine baseline differences among completers and non-
completers and by study arm (immediate/delayed) as a randomization check using 2-group 
comparison tests (t-tests and non-parametric equivalent tests for continuous variables 
(normally or non-normally distributed) and Chi-Square tests for categorical variables). The 
association of predisposing factors (demographics, Caregiving history, relationship and care 
recipient status at baseline) with changes in outcomes over time will be examined to identify 
significant covariates.  Where significant associations with baseline measures are detected, 
these potential confounders will be controlled for in subsequent analyses using covariate model 
adjustments.
We will use repeated measures analysis to test 2 time by 2 group intervention (Immediate 
Participation in wave1 + immediate participation in wave 2) vs waitlist control (wave 1 + wave 
2) change from baseline to post intervention at 8 weeks elapsed. Given final expected sample 
sizes of 45 subjects in each group (assuming 10% attrition), we will be powered at 80% with a 
5% level of significance to detect moderate-to-large effect sizes for the group (f=0.297), time 
(f=0.300), and group-by-time (f=0.300) effects. To examine intervention effects over time for 
the combined intervention groups (Immediate wave 1 (week 16-24) + Immediate wave 2 (week 
24-32) + waitlist wave 1 participants after course participation (week 24-32)), we will use 
repeated measures mainly focused on pre-to-post intervention effects for the 3 groups 
combined, however a group effect will be tested to ensure that the WLC1 had no  placebo 
carryover effect that altered  their “baseline at 24 weeks” from the other 2 groups. Given the 

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sample sizes of 25 subjects in each of these 3 groups, we will be powered at 80% with a 5% 
level of significance to detect moderate-to-large effect sizes for the group (f=0.381), time 
(f=0.381), and group-by-time (f=0.381) effects.
To address Aim 2 formative questions, Co-Investigator Perkins will lead the team in a thematic 
analysis28 of the transcribed baseline focus group and post-intervention semi-structured 
interviews.  We hope to pursue three lines of inquiry in this analysis that will be crucial for the 
next steps in our work: (1) In what ways might the overall concept of caregiver as healthcare 
navigator be sharpened?  (2) In what ways might the delivery mechanism of the course be 
enhanced to improve caregiver learning (e.g., more interactivity)?  (3) In what ways might 
individual components of the course be enhanced to improve caregiver learning (e.g., different 
formats; additional videos)? We expect that these analyses will provide compelling evidence for 
the feasibility, acceptability, and usability of the course.  
18. Provisions to Protect the Privacy Interests of Participants and Confidentiality of 
Participants’ identifiable data
Protection of Privacy Interests.
There are very few threats to participants’ privacy interests involved in the study, and 
below we describe how we will minimize and manage those threats:
 Except in the focus groups in which we will ask 20% of subjects to take part, there is 
no direct contact between and among study subjects.  Participation in these focus 
groups is entirely voluntary; no identification is provided about participants to 
other participants, and participants can choose to take part without video.
 The only personal information to be obtained will be gathered in baseline 
interviews; we have described above the measures we will take to remove 
identifiers from the data stored in REDCap
 The research interviewer will be trained by investigator Hepburn in techniques 
designed to make participants feel at ease with the questions being asked in the 
research interviews.  Training will involve simulated research interviews conducted 
with project investigators by the research interviewer in which the interviewer will 
be expected to react effectively to situations in which the interviewee exhibits signs 
of feeling discomforted or intruded upon. 
 The focus groups and semi-structured interviews will be conducted by study 
investigators, all of whom are experienced in interacting with caregivers and 
helping them to feel at ease in situations that might feel intrusive or distressing.
The only member of the research team who will have access to sources of private 
information about the participants will be PI Clevenger; no other team member will 
have or be granted access to that information.
As noted above in #15, all confidential data will be separated from REDCap files and 
transcripts, all of which will use ID numbers, and the confidential material will be stored 

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separately in PI Clevenger’s Emory encrypted computer.  None of the data from the 
study will be entered into participant’s medical records.
We will follow NIH policies in retaining and destroying identified study information. 
Audio-recordings will be destroyed at study’s end.
19. Economic Burden to Participants
Participants are asked to contribute their time to the study but no cost to participants is be 
expected.
20. Consent Process
The consent process will occur through distance means, by phone or videoconference, 
in the following manner:
1.  Appointment-Making. A potential subject will contact, by phone or email, one of the 
three study team members identified on the project recruitment document (Clevenger, 
Hepburn, and Reed).  If the contact is by email, a return email or phone call (if the 
person provides a number) will be made in order to set the time for a longer call.
2.  Consent Call.  This call initiates the consent process
 In this call, following a brief description of the study, the study team member will 
establish the eligibility of the person for the study (see # 13, above)
 If the person is eligible, the team member will more fully describe the study, study 
procedures (what is being asked), and study risks and protections; at each point, we 
will ask if the person has questions or if we can provide additional information
 To ensure understanding, we will ask potential subjects to describe back what they 
understand the study to be about and what they will be expected to do
 At the end of the call, we will determine if the person wishes to voluntarily consent 
to participation in the trial. If so, we will describe the next steps.
We anticipate these conversations will take approximately 30 minutes.
3.  Consent Documentation.    
 If the person indicates agreement to participate, we will inform him or her that we 
will be sending, by mail or email (at the person’s preference) the consent document 
(two copies if mailed) that will include all of the information discussed in the 
Consent Call.
 When the person receives the consent document s/he will be asked to either sign 
the document and mail it back to us or to sign and scan the signature page and email 
that page back to us.
 We will make it clear both in the Consent Call and in our mailed or emailed 
transmission of the consent document, that we are available to answer any 
additional questions s/he might have before completing the consent process.

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 We will also make clear, in the Consent Call and the consent documentation process 
that we are available throughout the study to address any questions or concerns the 
person might have about the study or participating in it.
The interval between the Consent Call and Consent Documentation process could be a 
matter of hours, if email is the vehicle of transmission, to days (if mail is used).  This 
interval should allow sufficient time for participant reflection about consent – as well as 
the generation of additional questions the person might have about participation.
There is nothing in the recruitment or consent process that could lend itself to pressure 
potential participants, either through coercion or undue influence, into participation, 
and the compensation offered for participation is modest, at best.  
21. Setting
As noted in #13, above, recruitment of participants will leverage the study investigator 
team’s networks of dementia care practices throughout the state of Georgia as well as 
national Alzheimer’s Disease Center and Roybal Center networks.  Recruitment will 
occur entirely online. The Recruitment document will be posted on the Emory Roybal 
Center’s website (see above).
The Caregiving During Crisis course will be entirely online, delivered via a secure Canvas 
platform.
Research interviews, focus groups, and semi-structured interviews will be conducted on 
Emory’s encrypted version of Zoom
The project will not have a community advisory board.
22. Resources Available
The research is being conducted as an administrative supplement to Emory’s Roybal 
Center for Caregiving Mastery; as such, it will have administrative support through the 
Center.  It is, as described above, also being conducted within the context of the study 
team members’ several involvements in local, state, and national engagements, all of 
which are directly related to issues of dementia care and the support and development 
of the capacity of family caregivers to provide effective care to community-dwelling 
persons living with Alzheimer’s disease and related disorders.
Recruitment of 100 study participants seems very feasible.  Within the immediate reach 
of the study team there are at least 1,000 eligible caregivers, and our extended reach, 
especially through the NIA-supported network of Alzheimer’s Disease Centers (with a 
number of which we have worked closely) there are many thousands more. 
The administrative supplement adds effort in the Roybal Center to both investigators 
Clevenger and Hepburn, and it provides time for investigator Epps.

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All study personnel are currently working from home, but in a phase 3 or 4 relaxation of 
restrictions situation, the Center has designated space in the School of Nursing, and all 
investigators have private offices and Emory encrypted computers.  Under both 
scenarios, the facilities are appropriate for conducting this fully online study.
We have described above the measures we will take to ensure that any transient 
emotional distress participants might experience can and will be handled at the time of 
occurrence, and we do not foresee the need for any additional psychological resources.  
The study does not involve procedures that might require medical resources.
This is a small study with only an interviewer and Center Program Manager involved 
beyond the investigators.  The procedure for training the interviewer was described 
above.  The PI will train the Program in the conduct of the Eligibility procedure and the 
Consent Call, should she be the team member to handle either or both of these.
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