Developing a Distance Education System to Train Savvy Caregiver Program Interventionists: Extending Access and Capacity in Community-Based Delivery of Evidence-Based Interventions
Phase: NA
Conditions: Caregiver Burnout, Dementia
Sponsor: Emory University

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Developing a Distance Education System to Train Savvy 
Caregiver Program Interventionists: Extending Access 
and Capacity in Community-Base Delivery of Evidence-
Based Interventions
Short title: Savvy System Project
NCT : NCT04060355 
Principal Investigator: Ken Hepburn
Funded by: NIH/NIA, RO1AG061971
Protocol Version Date: 9.13.2021

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1. Internal (Emory) Collaborators
Team Member
Area of Expert Contribution
IRB Review
Monica Parker
ADRC Minority Engagement Core Director Emory
Kate Yeager
Qualitative methods
Emory
Adarsh Char
Instructional Designer
Emory
Melinda Higgins
Statistician
Emory
Carolyn Clevenger
Dementia care provider; distance educator
Emory
Lai Reed
Research Coordinator
Emory
2. External (non-Emory) Collaborators
Team Member
Institution/Organization
IRB Review
Carey Sherman
University of Michigan
Emory
Marsha Lewis
University of Buffalo
Emory
Christy Nishita
Native Hawaiian Aging
Emory
Margaret Moss
University of British Columbia
Emory
Poki’I Balaz
Savvy Caregiver Master Trainer
Emory
Clint Dye
Savvy Caregiver Master Trainer
Emory
Lucas Morgan
Savvy Caregiver Master Trainer
Emory
Ann O’Sullivan
Savvy Caregiver Master Trainer
Emory
John Hobday
Healthcare Interactive, Inc
Emory
3. Background and Significance
This application proposes a four-year Stage I intervention development project, submitted in response to RFA-
AG-18-030.  We propose to develop a web-based system that uses distance education methods and provides 
manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy 
Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program.  The 
system will greatly increase the scalability of Savvy.  Replacing the need for in-person interventionist training, 

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it will enable organizations – large or small; community-based or statewide – to offer Savvy to their ever more 
diverse constituents.  Provided to groups of 8-12 (typically) individuals caring for family members living with 
Alzheimer’s disease or related dementias (PLWD), Savvy employs a well-established mechanism of action 
based in Social Cognitive theory to promote caregivers’ solution-focused coping behaviors through the 
acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery. The 
system will provide sponsoring organizations with guidelines and materials for administering Savvy, a 
program to train and certify staff or volunteer interventionists to lead and locally tailor Savvy, and a process by 
which to monitor the fidelity of interventionists’ performance.  Well-trained Savvy interventionists who 
faithfully embrace the program’s core principles and its curriculum and are able to adapt program terms, 
concepts, and even delivery processes to fit the culture and values of caregiver participants are the key to 
scaling Savvy up to make it widely available to the growing number of dementia family caregivers in the U.S.  
The number of PLWD in the U.S. will rise from 5.7 million to 14 million by 2050, and the number of family 
caregivers who maintain these persons in the community will rise proportionately from 15 million at present. 
Several psychoeducation programs, including Savvy, have successfully ameliorated the adverse effects of 
caregiving, but these programs are only minimally available and accessible. Present in 15 states, principally 
through Administration for Community Living support, Savvy has served more than 15,000 caregivers over the 
last decade; this represents only one one-thousandth of the U.S. caregiver population.  So far, Savvy has been 
exclusively disseminated through on-site in-person interventionist training by Savvy authors. This costly 
procedure has limited dissemination to large agencies that have obtained external grant support. The 
development of this proposed web-based system will take advantage of ubiquitously available distance 
education methods and platforms to greatly expand access to Savvy for the many organizations, especially 
small and local organizations that serve the growing number of diverse PLWD and their family caregivers.
The activities proposed focus principally on developing and testing the preliminary efficacy of the web-based 
system. Manuals, slides, handouts, and workbooks will be concurrently developed/revised to harmonize with 
the system and guide organizations in administering the Savvy program.
4. Goals/Aims

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Aim 1. Develop a prototype web-based system for Savvy interventionist training and certification and 
an accompanying performance fidelity monitoring process. Development efforts will yield web-based 
components delivered through freely available course management and survey applications (e.g., Canvas; 
Articulate Rise) that will enable sponsoring entities to train and certify interventionists who can locally tailor 
Savvy, monitor the fidelity of their performance in delivering Savvy, and assess the program’s impact on 
caregivers.
Aim 2. Establish the field-readiness of the system.  We will engage three community entities serving 
culturally, ethnically, and geographically diverse constituencies to collaborate with the study team and expert 
advisory panel in a highly participatory formative test of the prototype system developed through Aim 1 
activities.  Results and feedback will inform finalization of materials for the Aim 3 trial. 
Aim 3.  Conduct a field trial of the system.  The trial will test the effectiveness of the system and 
examine its preliminary efficacy in producing expected outcomes (i.e. well-being, mastery) in a diverse group 
of caregivers participating in programs delivered by newly trained interventionists.  Six culturally or 
organizationally diverse sponsors will recruit 2 individuals each to be trained as Savvy interventionists (12 
interventionists) and each sponsor will then recruit at least 20 caregivers to take part in a wait-list, no control 
group study (N=120) of the performance of the interventionists and the preliminary efficacy of the Savvy 
program provided by them. 
The figure below provides a broad timeline for project activities. While we will begin some Aim 2 activities 
before all of the Aim 1 activities are complete and some Aim 3 activities before all of the Aim 2 activities are 
complete, we expect Aim 1 activities to be complete by project month 12 and Aim 2 activities to be complete 
by the end of the second project year.

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Year 1
Year 2
Year 3
Year 4
Project startup activities
Preliminary Syllabus & Materials
Storyboard Content & Delivery
Materials Production
Recruit/orient 3 organizations
Train interventionists
Interventionists provide Savvy
Evaluate & revise
Recruit 6 organizations
Train interventionists
Recruit for trial
Conduct wait-list trial
Analysis & Finalization
We expect dissemination activities – conference presentations; journal manuscripts – to take place across and 
beyond the life of the project.
5. Study Design
This will be a three-phase project, the goal of which is to establish the readiness of the online learning system 
for a future Stage III or IV trial that can lead the way to broader use and dissemination of Savvy. In the first 
project phase, we will develop a prototype web-based system for Savvy interventionist training and 

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certification and an accompanying performance fidelity monitoring process. This phase will occupy the 
project’s first 14 months and will involve no human subject research participation. Phases 2 and 3 of the study 
involve human subject research participation. All human subject research activities will be conducted by 
members of the Emory study team, identified above; no non-Emory study team members will have any contact 
with Phase 2 and 3 research subjects. The second project phase, which will begin in project month 9 and 
extend through project month 24, will involve a formative evaluation of the prototype web-based system. In 
this phase, administrators and interventionists-in-training from 3 collaborating organizations and 36 informal 
dementia caregivers from these organizations will participate as research subjects.  The administrators and 
interventionists will take part in semi-structured evaluation interviews; the caregivers will be asked to 
participate in Savvy programs offered by the newly-trained interventionists and they (the caregivers) will be 
asked to complete pre- and post-Savvy participation interviews both about the effect of the program on them 
and about their evaluation of the program.  Phase 2 results will enable us to revise the interventionist training 
system, as needed.  Once the system is deemed ready, we will, in phase 3, conduct a field test of the system 
implemented in six culturally and/or organizationally diverse sponsoring agencies. This test will again involve 
administrators, interventionists-in-training, and 120 dementia caregivers from participating organizations as 
research participants. The Aim 3 test will principally assess the effectiveness of the system in training 
interventionists who maintain fidelity to Savvy core principles; this portion of the test involves semi-structured 
interviews with the administrators, interventionists and a sample of caregivers.  The test will also assess the 
preliminary efficacy of programs led by system-trained interventionists in producing anticipated outcomes in 
caregiver participants – reduced depression and burden and enhanced caregiving mastery.  In this portion of the 
test, caregivers will be randomly chosen to participate immediately in a Savvy program offered by one of the 
organization’s newly trained interventionists or to participate after a waiting period of 4 months.  Those who 

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take part in the program immediately will be asked to take part in 3 interviews (baseline and then 3 and 6 
months after the start of the program.  Those in the delayed start group will be asked to take part in 4 
interviews (baseline (at the point of signing up for a later program), immediately prior to the beginning of the 
program and then 3 and 6 months after the start of the program. Standard instruments will be used to assess 
burden, mood (anxiety and depression), caregiving confidence and mastery, and care recipient well-being.  
Organizational structure of the study team
The study was proposed by the Nell Hodgson Woodruff School of Nursing at Emory University, the academic 
home of the PI/PD, Dr. Hepburn.  Although there are investigators involved from a number of institutions and 
organizations, Emory is the sole site for all research activity associated with the study, and therefore the Emory 
IRB is the only IRB involved in providing oversight for human research activities.  The study is funded by the 
National Institute on Aging at NIH.  The overall goal of the study – and therefore the expectation of the 
funding agency – is the successful demonstration of an internet-based system that will enable organizations 
such as state agencies or private entities (e.g., health systems or churches) to implement an evidence-based 
dementia family caregiver psychoeducation program (the Savvy Caregiver) and make it available to their 
constituents.  The system will include an organizational on-boarding component, a component that will enable 
the organizations to adapt the Savvy Caregiver to fit the values and customs of their constituents, and a large 
component designed to train Savvy Caregiver program leaders.  The project involves investigators from Emory 
and also from the University of Buffalo, the University of British Colombia, and two private organizations, 
HealthCare Interactive, and Family Care Strategies, LLC. Each of the investigators will play three main roles: 
1) collaborate in the development of the system; 2) assist in identifying entities (organizations) that would be 
willing to engage in two phases of testing of the system; and 3) assist in reviewing and interpreting the results 

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of the evaluation of system feasibility, acceptability, and preliminary efficacy that the Emory team will 
conduct.  As described in the grant application budget, funds flow, per subcontract, to the home 
institutions/organization of the collaborating investigators to support their roles in the project.
Setting and location
The first phase of the study, linked to Aim 1, does not involve human subject research.  It only involves the 
study team, key consultants, and expert advisors who will work at their respective institutions. 
The phase 2 and 3 studies are conducted from a single site, the School of Nursing at Emory University.  We 
will centrally and via Zoom videoconferencing software (from Emory) consent the organizational leaders, 
interventionists trained by the system we developed and dementia family caregivers engaged in Savvy 
Caregiver programs provided by system-trained interventionists to participation in a wait-list design study in 
which caregivers from each site will be randomly assigned to immediate participation in a Savvy program 
offered by one of the newly trained interventionists or to delayed participation in Savvy (after 4 months).  Each 
participant will be asked to complete the same post-program participation survey via Zoom videoconferencing 
software (from Emory) as in the Phase 2 study, and each will be asked to take part in four phone or video 
interviews in which Emory staff will administer well-established and validated questionnaires to assess burden, 
depression, anxiety, and caregiver competence and mastery as well as care recipient well-being.  As in the 
phase 2 study, a sub-sample of caregiver participants (N=18) will be asked to participate in semi-structured 
interviews – also completed via Zoom videoconferencing software - focused on their perceptions of the 
interventionist’s program leadership skills, any adaptation experiences, and on ways in which they met their 
own needs and expectations. In both phases (2 and 3) organizational leaders and system-trained 

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interventionists will be asked to take part in qualitative formative evaluation interviews conducted by Emory 
study staff.
Population to be studied
Inclusion Criteria:
Organizational Leaders
a) Able to understand and speak English
b) Affiliated with an organization serving caregivers for family members living with 
Alzheimer’s disease or related dementias
c) 18 years or older
Interventionists  
a) Able to understand and speak English
b) Affiliated with a participating organization
c) 18 years or older
Caregivers
a) Able to understand and speak English
b) Caregiver for a person living with Alzheimer’s disease or related dementias (PLWD) who is 
providing informal care for at least 3 hours a day. PLWD should not be bound for 
institutional care within the next 6 months. 
c) 18 years or older
Exclusion Criteria:

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Not applicable.
Community Participation
In developing the adaptation element for the interventionist training system, we will employ established 
models for adapting evidence-based programs. The starting point for these models is an anchoring in an 
understanding of a program’s theory-base and mechanism and the key parts of the program. Such anchoring is 
central to the organizational on-boarding and interventionist training system.  The adaptation models then use 
dialogue with end users to accomplish adaptation. The adaptation element we will develop will train 
interventionists to identify concerns among Savvy participants or possibly within the larger community about 
Savvy terms, concepts, or delivery processes and to arrive at “translation” that makes Savvy more available 
and acceptable to the populations they serve while maintaining the integrity of the core principles and 
mechanisms.  For example, Savvy originally stressed that caregivers gradually have to assume more control of 
the care recipient’s behavior.  Through interactions with caregivers from a variety of backgrounds and 
advocates of person-centered care, we now speak in terms of a caregiver’s need to provide more guidance (or 
assume more responsibility) for what the person does during the day. Savvy interventionists in Hawaii are 
finding that adding a “session zero” – a prelude to Savvy – allows Native Hawaiian elders to engage in “talk 
story,” a culturally important process that sets the stage for these elders to give permission to (typically) 
younger interventionists to train and coach them.  No core principles are bent in either case, but the adaptations 
promote learner receptivity.  An adaptation team, consisting of key study team faculty (Nishita, Moss, and 
Parker) and the project’s Master Trainer consultants (Belaz Dye, Morgan, and O’Sullivan) will take the lead in 
formulating the content and delivery method for this training element.

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Recruitment
Each of the three types of recruitment and retention efforts is described below:
Sponsoring Organizations.  We seek to recruit 3 organizations for our Aim 2 activities and 6 
organizations for our Aim 3 activities; the Aim 2 organizations will be able to continue as Aim 3 organizations.  
Since these sponsoring organization leaders will be involved in the Aim 2 and 3 studies, we will seek their 
informed consent for participation in the studies. We are specifically seeking to recruit organizations serving 
the targeted minority groups, as well as those serving a more mixed or majority clientele.  Several of the study 
team members and program advisors are either directly involved with or have strong contacts with potential 
sponsoring organizations, and we have already identified preliminary organizational interest in taking part in 
the project.  Beyond those specific contacts, the project Co-PIs, Hepburn and Sherman, can draw on their 
extensive networks for organizational recruitment.  Past experience with organizations that have adopted 
Savvy testifies to the long-lasting involvement with the program: once adopted, Savvy remains a regular part 
of the organization’s portfolio, so we do not expect organizational retention to prove a problem.  Procedures in 
our Aim 2 and 3 approach involve considerable interaction between the project team and sponsor organization 
leadership, including the provision of information and feedback that can help these organizations to improved 
Savvy uptake among their clients.  This interaction will also promote retention in the project.  
Interventionists.  It will be the sponsoring organizations who will identify individuals – from their 
existing staff or from volunteers whom they recruit – to be trained as Savvy interventionists by the system we 
develop and to lead Savvy programs that the sponsors organize.  Guided by orientation and administrative 
materials and protocols that we will provide, the sponsors will organize the training, organize the Savvy 
programs, and conduct regular debriefings with the interventionists.  Since these interventionists will be 
involved in the Aim 2 and 3 studies, we will seek their informed consent for participation in the studies.  In 

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addition to sponsor-based debriefings, the semi-structured interviews we will conduct with the interventionists 
during the Aim 2 and Aim 3 studies will also provide a linkage for them to the overall study and will, 
hopefully, provide them with a sense of ownership in the developing system.
Caregivers.  It will only be family caregivers who will be part of the clinical trial component of this 
study (in Aims 2 and 3).  Recruitment into the studies will be through referral from the sponsoring 
organizations.  Each organization will recruit caregivers to take part in Savvy programs provided by 
interventionists trained in the system we are developing.  We will provide organizations with materials they 
can use to announce Savvy and the studies; we will encourage the organizations to insert these materials into 
their own standard informational templates (i.e., standard logo and graphics).  For caregivers willing to do so, 
their contact information will be provided to the Emory study team. We will arrange a phone or video call with 
each during which we will explain the study (Aim 2 or Aim 3 – a caregiver will not be able to take part in 
both), explain eligibility criteria, and seek informed consent (verbally) for participation. We do not anticipate 
attrition to be a problem in the Aim 2 study; research contact, following consent, will occur over a very brief 
period of time. All who consent to the Aim 2 study will take part immediately in a Savvy program and in an 
on-line survey and (for some) in-person interview conducted by phone or video right after the program.  
Prolonged retention will be more of a challenge in the Aim 3 study.  Those taking part will enter a Savvy 
program either immediately or after a delay based on scheduling at the individual agencies. For those taking 
part immediately a series of 3 phone or video interviews will bracket their Savvy participation (at baseline then 
at 3 and 6 months following baseline. For those with a delayed start, we will conduct 4 interviews (upon sign 
up, immediately prior to the start of the program and then 3 and 6 months after program completion).To foster 
engagement with the project, we will prepare and distribute to participants a monthly project newsletter, 

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featuring tips on exercise and healthy eating and profiles of the study team.  We will also send birthday and 
seasonal holiday cards, as appropriate.
Field Methods
Data Collection and Management.  Emory study staff will use an IRB-approved phone or video consent 
process to enroll individuals from the three groups that are targets for our formative evaluation activities, and 
study staff and team members will gather data from them in the ways described below:
Interventionists.  We will conduct three recorded semi-structured video interviews with each 
interventionist. One will occur immediately after training; this will focus on their sense of the completeness 
and adequacy of the training program, including the training methods, videos, and materials, and their 
perceived readiness to lead the program.  We will also interview them immediately after the conduct of each of 
the two Savvy programs they lead, asking them to report on their own performance as interventionists, 
including any adaptation processes in which they might have engaged, and to reflect on ways the training 
might be improved to strengthen their skills, including for adaptation. In total: 18 interviews.
Savvy Participants.  Using an on-line survey method, we will ask each caregiver to complete the post-
program fidelity monitoring survey (see Appendix) that seeks responses to the program (feel more 
knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist’s 
performance and verify that certain key elements of the program were covered (N=36; 6 in 6 groups). We will 
also conduct recorded semi-structured video interviews with a small sample of participants (N=8-12), selected 
to achieve maximum variability of relationship to care recipients, gender, racial/ethnic heritage, and rating of 
the program and the interventionists.  Interviews will focus on caregivers’ perceptions of the interventionist’s 

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program leadership skills, any adaptation experiences, and on ways in which they met their own needs and 
expectations.
Organizational Leaders.  We will conduct recorded semi-structured video interviews with sponsoring 
organizations’ key contact persons immediately after the interventionist training and then after each of two 
Savvy offerings.  The conversation will focus on identifying ways to strengthen and improve the training, 
certification, and fidelity monitoring system.  We will also seek information about time and resource costs of 
the program, caregiver demand, and caregiver recruitment and feedback (3 interviews per organization).
Results from Savvy participant quantitative fidelity monitoring surveys will be compiled in a simple spread 
sheet to allow us to see whether there are any notable problems in interventionist performance either within or 
across sites or in or across interventionists.  Likewise, we will be able to compare caregivers’ responses about 
knowledgeability and competence with responses we have received from other caregivers in Savvy programs 
provided by interventionists who were trained in person by Hepburn or Sherman.
Once a cohort of 20 consented caregivers has been formed at any local organization, participants will be 
assigned (through a random procedure administered by Emory staff) to take part immediately in one of the 
Savvy programs offered by either of the 2 interventionists or to take part in one of the 2 interventionists’ 
programs after 4 months; follow-up phone or video interviews will be conducted at 2, 4, and 6 months lasting 
each 1-1.5 hours in length. The audio files from interviews will be saved on Emory School of Nursing’s secure 
share-drive within a password protected folder for 5 years post-study completion.
Measures

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The table below describes the well-established instruments to be used in caregiver interviews.
Informed Consent Process
Recruitment
Category
Instrument
Instrument Description
Psychometrics
Demographic Information
Demographic sheet 
Caregiving History
SES, Person living with dementia information, 
length of caregiving, co-residence with 
recipient.
Study-developed form 
(Baseline only)
[Caregiver Vars]
Depression
Center for Epidemiological 
Studies-Depression 
A 20 item Likert scale scored 0-3 with somatic 
and psychological subscales
Alpha=.85; validity well-
established104
Anxiety
State-Trait Anxiety 
Inventory
A 20-item 4-point Likert scale is sensitive to 
changes in transitory anxiety 
STAI state sensitive 
reliability reported at .94105
Burden
the Zarit Burden Inventory 
(ZBI), 
A 22-item 4-point Likert scale, widely used in 
caregiving studies
Used in multiple studies 
with well-established 
validity106
Caregiver Mastery
Pearlin Mastery, Loss, and 
Competence 
6 brief (3-6 item) Likert scales assessing 
mastery and loss dimensions
Alpha coefficients from 
.71-.92.107  
Caregiver Skill
Caregiver Assessment of 
Behavioral Skill
17-item self-report assessment of behavioral 
management skills
Chronbach alphas from 
0.75-0.94 with good 
validity
[PLWA]
BPSD
Revised Memory and 
Behavior Problem Checklist
22-item Likert scale that assesses patient 
behaviors and caregiver responses to them
Reliabilities of .84-.90 
reported for behavior and 
reaction.108

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Caregivers in the Aim 2 and 3 studies will learn about the studies from the local organization that is sponsoring 
Savvy interventionist training and offering the Savvy program to its constituents, using its usual modes and 
methods of providing information to these constituents.  We will provide all collaborating organizations with 
materials they can use to announce Savvy and the studies; we will encourage the organizations to insert these 
materials into their own standard informational templates (i.e., standard logo and graphics).  These 
organizations will explain their role in the development project and secure individuals’ permission for the 
Emory study staff to contact them with additional information about the studies; alternately, the announcement 
materials will provide contact information for the project director at Emory, so individuals can also call 
directly.  Under either scenario, the project will arrange a phone or video conversation with these individuals to 
assess for study eligibility.  
Once eligibility has been established, the project director will provide more information about the components 
of the relevant study (i.e., Aim 2 or Aim 3).  She will allow time for questions, verbally summarizing the 
material with the subject, and asking subjects to answer a few questions to gauge understanding. For those who 
remain interested in taking part in the study, we will conduct an IRB-approved phone- or video-based consent 
procedure. In that procedure, the project director documents, on a pre-established form, that the consent 
procedure has occurred, the individual has been provided the opportunity to raise questions, has been informed 
of the voluntary nature of participation and the ability to withdraw from the study without prejudice at any 
point, and has been told that s/he may continue to raise questions at any point during the study.  A copy of the 
document that the project director signs is then sent to the consenting participant. The original will be retained 
in a locked cabinet within a locked research room within the School of Nursing. The person will be given 
information (also on the consent document) about study leadership and how to contact the Project Director, the 
study Co-PIs, and a neutral informant at Emory.  

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Participant Discontinuation/Withdrawal from the Study
Participants are free to withdraw from participation in the study at any time upon request. The reason for 
participant discontinuation or withdrawal from the study will be recorded on the study REDCap. Subjects who 
receive all or part of the study intervention will not be replaced.
Lost to Follow Up
A caregiver participant will be considered lost to follow-up if he or she fails to complete the scheduled post-
intervention follow-up and is unable to be contacted by the study site staff within four weeks of the timepoint.
The following actions must be taken if a participant is determined to be lost to follow-up:

The research staff will attempt to contact the participant and reschedule the missed appointment 
for 4 weeks and ascertain if the participant wishes to continue in the study.

Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods).

These contact attempts will be documented in the participant’s record in REDCap. 
Should the participant continue to be unreachable, he or she will be considered to have withdrawn from the 
study with a primary reason of lost to follow-up.

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6. Potential Risks/Discomforts to Study Participants
Activities during the first phase of the study do not involve human subject research.  The studies in phases 2 
and 3 pose very low risks to study participants.  The involvement of the participating organizations’ 
administrators and interventionists in training is much in the nature of a quality improvement project; they are 
openly engaged in a process designed to refine the Savvy interventionist training system, so there are no threats 
to confidentiality or other forms of injury or harm.  For the caregivers involved in the studies, the two main 
possible risks are to confidentiality and to minor emotional upset that might occur in answering study 
questions.  
Based on prior experience with Savvy Caregiver program research and its implementation in community 
agencies, we cannot identify any expected serious adverse effects – as defined in the NIA Adverse Event and 
Serious Adverse Event Guidelines – that might occur to phase 2 and 3 caregiver study participants.  Likewise, 
we cannot identify any expected serious adverse events occurring to those who are trained to become Savvy 
interventionists or those who administer the organizations within which Savvy is offered.
7. Potential Benefits
For the participating organizations and interventionists, the main potential benefit will be the addition of a 
capacity for serving clients.  The organization will be able to offer an evidence-based program (Savvy), and the 
interventionist will acquire a new skill.  More broadly, the system will be poised to extend the capacity of a 
wide range of other organizations to offer Savvy.  For caregivers who take part in the phase 2 or phase 3 study, 
they will all have the opportunity to take part in the Savvy Caregiver program, a program that has repeatedly 

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demonstrated positive outcomes in the areas of caregiver well-being and caregiving competence. But 
caregivers may or not receive any benefit to taking part in the study.
8. Compensation
Caregiver study participants will receive a $25 honorarium in the form of a gift card following each each data 
collection event. The gift cards will be sent by mail.
9. Data Analysis: Data Management and Monitoring
Data Collection and Management.  Emory study staff will use an IRB-approved phone or video consent 
process to enroll individuals from the three groups that are targets for our formative evaluation activities, and 
study staff and team members will gather data from them in the ways described below:
Data Collection
Interventionists.  We will conduct three recorded semi-structured video interviews with each 
interventionist. One will occur immediately after training; this will focus on their sense of the completeness 
and adequacy of the training program, including the training methods, videos, and materials, and their 
perceived readiness to lead the program.  We will also interview them immediately after the conduct of each of 
the two Savvy programs they lead, asking them to report on their own performance as interventionists, 
including any adaptation processes in which they might have engaged, and to reflect on ways the training 
might be improved to strengthen their skills, including for adaptation. In total: 18 interviews.

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Savvy Participants.  Using an on-line survey method, we will ask each caregiver to complete the post-
program fidelity monitoring survey (see Appendix) that seeks responses to the program (feel more 
knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist’s 
performance and verify that certain key elements of the program were covered (N=36; 6 in 6 groups). We will 
also conduct recorded semi-structured video interviews with a small sample of participants (N=8-12), selected 
to achieve maximum variability of relationship to care recipients, gender, racial/ethnic heritage, and rating of 
the program and the interventionists.  Interviews will focus on caregivers’ perceptions of the interventionist’s 
program leadership skills, any adaptation experiences, and on ways in which they met their own needs and 
expectations.
Organizational Leaders.  We will conduct recorded semi-structured video interviews with sponsoring 
organizations’ key contact persons immediately after the interventionist training and then after each of two 
Savvy offerings.  The conversation will focus on identifying ways to strengthen and improve the training, 
certification, and fidelity monitoring system.  We will also seek information about time and resource costs of 
the program, caregiver demand, and caregiver recruitment and feedback (3 interviews per organization).
Results from Savvy participant quantitative fidelity monitoring surveys will be compiled in a simple spread 
sheet to allow us to see whether there are any notable problems in interventionist performance either within or 
across sites or in or across interventionists.  Likewise, we will be able to compare caregivers’ responses about 
knowledgeability and competence with responses we have received from other caregivers in Savvy programs 
provided by interventionists who were trained in person by Hepburn or Sherman.

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Data Management
Data will be entered at the time of each 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.  In 
preliminary analyses, descriptive statistics and frequency distributions will be examined to identify outliers and 
ensure integrity of merged files.  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, CG history, relationship and 
care recipient status at baseline) at baseline data 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.
Monitoring

22
The School of Nursing at Emory University will maintain close contact with every entity within the study and 
will monitor study activities. We will use a common study web-portal using the Research Electronic Data 
Capture (REDCap) created and managed in Emory SON. We will create and update study participants’ data 
through REDCap. During data entry, automated checks will be performed that will immediately flag 
problematic data (e.g., missing, out of range, inconsistent), allowing for the research staff member to address 
any discrepant data promptly thus increasing data quality. Data entered into the web-based form are 
immediately stored in a study database and tracked through a journaling process where they are accessible for 
review by the study team. Suspicious data can be flagged through a query management system, and automated 
alerts provided to the sites. A complete audit trail is stored for each database modification. Any discrepant data 
identified through analytic manipulations will be communicated to the sites. Once all queries have been 
resolved and the database has been deemed “clean”, it will be officially locked. All permissions to make 
changes (append, delete, modify or update) to the database will be removed at that time. 
Record keeping and data collection are the responsibilities of the research staff under the supervision of the PI. 
The investigator is responsible for ensuring the accuracy, completeness, legibility (if hardcopies of worksheets 
are used), and timeliness of the data reported.
All study’s written records will be stored in a locked cabinet for 5 years. Study data will be de-identified and 
shared with future researchers per written request and IRB approval (Resource and Data Sharing Plans).
10. Plans for analysis
Multi-level mixed effects models (MLM) with random (participant) and fixed (cohort) effects will be 
employed to test for linear (and non-linear) trajectories of change for the Intervention group versus waitlist 

23
group focusing on the group-by-time effect. To address the primary effect of the Savvy intervention, the 
Immediate group will be compared to the waitlist delay group, using the first 2 time points (0m-2m) to test for 
differences between the 2 groups’ changes post intervention. Additionally, the combined Savvy intervention 
effects will be assessed using a paired t-test for the combined immediate group’s first 2 time points (0m-2m) 
with the waitlist delay group’s 2 time points before and after beginning Savvy (4m-6m). If there are significant 
differences between the 2 groups at the time point immediately prior to receipt of the intervention, these 
“baseline” effects will be included and adjusted for a final analysis of covariance (ANCOVA) model for these 
change scores.  Given that the immediate group will have 3 post-intervention measurements (2m-4m-6m), 
MLM longitudinal models will also be employed to assess the overall time effects plus planned post hoc 
comparisons for both the immediate intervention effect and the longer term and sustained effects. Sidak Type-I 
error rate adjustment (which has higher power than Bonferroni) will be applied for the multiple pairwise time 
point comparisons. The proposed study design also has the advantage of capturing “baseline” time points for 
the delay group (0m-2m-4m) which will provide an excellent opportunity to evaluate what if any potential 
“placebo” effects there may be from being enrolled in this type of study. These initial data captured at 0m-2m-
4m for the delay group will also be used to evaluate any potential decline occurring during this time period. All 
model assumptions will be tested; grand mean centering used to help combat multi-collinearity between 
variables; and standard diagnostic tests and influence statistics used to test the distributions of the residuals. 
MLM models utilize all available data for all participants at each time point and have the advantage of 
adjusting for the missing data over time, where repeated measures ANOVAs do not. Further covariate 
predictors of missingness (mainly due to attrition) over time will be included to additionally adjust for these 
confounders124 SPSS v.24 will be used for all analyses at the 5% significance level.

24
We will use a meta inference process to answer the central question of this project: Can the system train 
interventionists to maintain fidelity to core SAVVY principles and demonstrate the ability to tailor the 
implementation to match cultural values of the community? This inference procedure examines both the 
process (System Effectiveness Study) and the outcomes (preliminary Efficacy Study). The research team will 
follow a series of analytic steps to create meaning out of the relatively large amount of collected data, 
incorporating both the quantitative and qualitative components in a dynamic and interactive manner.  We will 
look first at the results interventionists’ ability to provide Savvy faithfully and in a manner congruent with 
local values: What conclusions or trends do fidelity monitoring, caregiver surveys, and interviews with all 
parties yield? Next we examine the impact of Savvy on participating caregivers to further establish the 
effectiveness of the system.  If caregiver outcomes improve, this will provide a demonstration that system-
trained interventionists can faithfully deliver Savvy in such a manner that its mechanism of action can have an 
expected effect on caregiver participants. If the outcomes do not support the effectiveness of this new system 
on either or both questions, we have the data to inform further system development work. The outcome of this 
process will be a finalized interventionist training system, one informed by a contextual understanding of the 
effects of the system and ready for a next step, a Stage III or IV intervention trial. 
11. Training of study team
The Project Director will oversee the training of all staff members on the team, ensuring that they have 
completed or renewed CITI trainings at appropriate intervals. She will also develop standard operating
procedures (SOPs) to ensure that study staff maintains the highest standards of data protection and
management. For any staff members who will have participant contact, the project director will provide

25
opportunity for them to practice interview technique prior to any contacts with human subjects. They will also
be monitored regularly to ensure best practices are maintained for data collection. The SOPs will be updated
regularly in order to reflect current practices by study staff. 
12. Plans for monitoring the study for safety
The project PI (Hepburn) and the project Co-PI (Sherman) will be responsible for ensuring participants’ safety 
in this minimal risk, single-site study.  Per concurrence of the NIA Program Officer, because this study is 
being conducted at a single site, involves fewer than 200 subjects, and is not a clinical trial it does not require a 
Data Safety and Monitoring Board.  Instead, the Associate Dean for Research at the Nell Hodgson Woodruff 
School of Nursing (Dr. Elizabeth Corwin) has agreed to serve as the Safety Officer for the project.
Frequency of Data and Safety Monitoring
The PI will be informed of any deaths as soon as they occur and will notify the NIA Program Officer and the 
Safety Officer (SO) within 24 hours of notification; the PI will also inform the Emory IRB of any such events 
within the time frame specified by the IRB. Beginning with the initiation of study phase 2 activities, the PI 
(Hepburn) will be responsible for providing quarterly summary reports of SAEs to the NIA Program Officer 
and the SO. Beginning with the initiation of phase 2 activities, safety reports will be sent to the SO twice a year 
and will include a detailed analysis of study progress, data and safety issues.  Such reports will be developed 
by the co-PIs but reviewed by key study personnel and, as appropriate, study consultants and advisors.  
Content of Data and Safety Monitoring Report

26
The study PI (Hepburn) will provide semi-annual data safety and monitoring reports to the NIA Program 
Officer and the SO.  Each report will update the previous report.  Each report will summarize:

Overall study status

Study participant characteristics

Study recruitment and retention statistics

Data completeness

Summary statistics on caregiver and care recipient outcome measures

Deployment of the risk protocol based on observations or scale scores

Unanticipated Serious Adverse Events, including Deaths.
DSMB Membership and Affiliation
The Safety Officer for this study will be:
Elizabeth Corwin, PhD, RN, FAAN
Associate Dean for Research
Nell Hodgson Woodruff School of Nursing, Emory University
Dr. Corwin is a well-established researcher, currently supported by an RO1 and a P30 grant from NINR, with 
an extensive track record of completed externally-supported research.  As Associate Dean for Research within 
the School of Nursing, she heads the Office of Nursing Research; as such, she has at her disposal a variety of 
methodological and statistical experts, should she need them to fulfill her responsibilities as Safety Officer.
The SO will:

27

Review the research protocol, informed consent documents and plans for data safety and 
monitoring;

Recommend subject recruitment be initiated after receipt of a satisfactory protocol;

Evaluate the progress of the trial, including periodic assessments of data quality and timeliness, 
recruitment, accrual and retention, participant risk versus benefit, performance of the trial sites, 
and other factors that can affect study outcome;

Consider factors external to the study when relevant information becomes available, such as 
scientific or therapeutic developments that may have an impact on the safety of the participants 
or the ethics of the trial;

Review study performance, make recommendations and assist in the resolution of problems 
reported by the Principal Investigator;

Protect the safety of the study participants;

Report to NIA on the safety and progress of the trial;

Make recommendations to the NIA and the Principal Investigator concerning continuation, 
termination or other modifications of the trial based on the observed beneficial or adverse 
effects of the treatment under study;

If appropriate, review interim analyses in accordance with stopping rules, which are clearly 
defined in advance of data analysis and have the approval of the SO;

Ensure the confidentiality of the study data and the results of monitoring; and,

Assist the NIA by commenting on any problems with study conduct, enrollment, sample size, 
and/or data collection.

28
13. Confidentiality
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, and 
the sponsor. The study documentation, data, videotaped interviews, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any unauthorized 
third party without prior written approval of the sponsor. 
All research activities will be conducted in as private a setting as possible.
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional Review 
Board (IRB), regulatory agencies may inspect all documents and records required to be maintained by the 
investigator for the participants in this study. The clinical study site will permit access to such records.
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be 
directly entered into and stored in the password-protected excel database. Individual participants and their 
research data will be identified by a unique study identification number.  All information collected during the 
study will be secured and password protected. At the end of the study, all study databases will be de-identified 
and archived at the Emory School of Nursing.
The study participant’s contact information will be securely stored in a separate password protected excel 
database for internal use during the study. This document will provide a linkage between name of participant 

29
and a unique study identification number. At the end of the study, this linkage document all paper records will 
continue to be kept in a secure location for as long a period as dictated by the reviewing IRB, Institutional 
policies, or sponsor requirements.
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