Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers
Phase: NA
Conditions: Alzheimer Disease, Dementia
Sponsor: Emory University

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STUDY PROTOCOL: 
Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers 
Short Title: Testing Tele-Savvy 
Dual PI:  Kenneth Hepburn 
School of Nursing 
Dual PI: Patricia Griffiths 
School of Medicine 
Co-I: Melinda Higgins 
Co-I: Glenna Brewster 
Co-I: Joe Nocera 
 
National Institute of Aging (NIA) 
NCT03033875 
Protocol version date: December 9, 2019 
 
 
AIMS. The backdrop for this application is our well-understood national reliance on family members to provide 
virtually all community-based care for 5.3 million persons living with Alzheimer’s disease and other dementias, 
a population that will likely triple in the next 35 years.1 Unless we soon find a way to prevent and cure 
dementing illnesses like Alzheimer’s, the country will continue to face an urgent need to find ways to sustain 
and bolster the capacity of these family caregivers to manage the multiple daily care challenges they face and 
to preserve their well-being while doing so. Without family caregivers, the burden of care could well overwhelm 
the formal components of our care system. This application seeks support for a randomized trial to test a 
program designed to meet this critical need. We seek to test Tele-Savvy, an internet-based program based on 
the widely disseminated, in-person Savvy Caregiver psychoeducation program,2 one of the effective, evidence- 
based programs identified in PAR -15-348 (Research on Informal and Formal Caregiving for Alzheimer’s 
Disease) to which this application is addressed. Delivered in scheduled videoconferences and independently 
viewed on-line video lessons, Tele-Savvy aims to develop/enhance caregivers’ skills and caregiving mastery, 
reduce adverse effects of caregiving, and improve the quality of the lives of caregivers and care recipients. Our 
pilot results support the fidelity of Tele-Savvy to its evidence-based platform, demonstrate benefits for 
caregivers, illustrate the program’s national reach, and support our readiness for the proposed larger trial.  
 
A number of psychoeducation programs for caregivers, including our own Savvy Caregiver program, have 
been effective in relieving distress, increasing self-efficacy, managing caregiving challenges, and enabling 
caregivers to sustain care over longer periods of time.3-6 However, many Alzheimer’s caregivers cannot take 
part in these programs because virtually all such programs require caregivers to arrange care for the care 
recipient while the caregivers travel to and attend the programs. These are obstacles in rural or remote areas 
where transportation issues further restrict caregivers’ already limited access to caregiver programs, but they 
are no less a problem in inner cities and suburbs. These obstacles highlight a substantial challenge to our 
ability to rely on caregivers as a continuing care resource for persons living with Alzheimer’s disease: we need 
theory-driven psychoeducation programs that can be made readily available to caregivers who may not be able 
to attend in-person programs.  
 
Tele-Savvy extends the growing use of distance means for program delivery. Over the past 15 years, 
telephone, videophone, and internet/web-based platforms have been used to deliver prevention, patient 
education, disease self-management, and caregiver education programs through a variety of methods for a 
variety of conditions.7-14 Distance methods for dementia caregiver education include: stand-alone, individually 
accessed material designed for self-study with no peer or expert contact;15-17 individually studied material with 
web-mediated expert contact;18-23 web-based one-on-one client-expert interaction, with or without ancillary 
asynchronous teaching/ learning material; and combinations of these modalities coupled with a variety of group 
interactions. The evidence for the positive effect of such programs on Alzheimer’s caregiver well-being is 
beginning to accumulate.24 Tele-Savvy represents a unique advance. Over six weeks, through weekly 
scheduled group videoconferences and daily email-delivered asynchronously viewed video lessons, it 
simulates the intense, interactive in-person six-week group experience of the Savvy Caregiver program. It is, 
virtually, an in-person psychoeducation program at a distance.  
 

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We seek to make an effective psychoeducation program widely available to family caregivers of persons living 
with Alzheimer’s disease and related disorders. Taking advantage of the growing use of and familiarity with the 
internet by persons of caregiving age, the project will advance us toward that goal. We will test the program in 
an established context of collaboration among the Outreach, Recruitment, and Education Cores of four NIA-
supported Alzheimer’s Disease Centers (ADC). We will employ a wait-list randomized design in which 18 
blocks of 15 caregivers each will be assigned either to immediate Tele-Savvy participation groups or to 
attention control or usual care groups that are invited to participate in Tele-Savvy six months after baseline 
data collection (total n=270). We will pursue 3 aims::  
 
Aim 1. Establish the effectiveness of Tele-Savvy in reducing or retarding the affective impact (burden, 
depression, anxiety) on caregivers associated with dementia family caregiving  
Aim 2. Establish the effectiveness of Tele-Savvy in promoting the quality of life of persons with Alzheimer’s 
(agitation; Quality of Life; affect) whose caregivers are trained by Tele-Savvy 
Aim 3. (a) Establish the effectiveness of Tele-Savvy in enhancing caregiver mastery and (b) test the mediating 
effect of mastery and enactment on Aim 1 & 2 outcomes  
 
We also propose, as an Exploratory Aim, to examine the comparability of the program’s efficacy across three 
racial/ethnic groups (African Americans, Caucasians, and Latino/Hispanics). 
 
Significance and Innovation.   
The Landscape.  Dementing conditions, including the most prevalent of these, Alzheimer’s disease, pose a 
large and growing problem nationally and worldwide.  Unless dramatic breakthroughs occur, the current 
population of 5.3 million persons living with these conditions will swell to at least 14 million by 2050.1 These 
persons are distributed across the landscape, in inner cities, in suburban areas, and in rural America; there is 
even some evidence that the current and future prevalence of Alzheimer’s in rural areas is disproportionate to 
the rural population’s share of the overall population.2-4 Care for these persons is costly. Total estimated cost of 
care in 2015 will be $216 Billion; by 2050, it could exceed $1 Trillion.1   
 
Alzheimer’s Family Caregivers. Persons living with Alzheimer’s disease and related illnesses spend most of 
the course of their illness in the community and receive most of their care from informal – usually family – 
caregivers.5 Currently, about 15 million adults annually provide 17.9 billion hours of family care for community-
dwelling persons living with Alzheimer’s and other illnesses (PLWA); this represents approximately 85% of the 
care they receive and it is estimated to be the equivalent of $218 Billion in paid care.1,30  As well as the more 
“domestic” work of maintaining a household and attending to the safety of the person, Alzheimer’s family 
caregiving entails chronic care management, a role typically filled by persons with clinical or professional 
training. Alzheimer’s family caregivers are responsible, for example, for medication management; behavior 
guidance and management; medical, legal and financial case management; treatment monitoring and 
provision; activity design and delivery; ADL assistance.  Moreover, since most PLWA are ≥ 65 years, most live 
with at least one other chronic illness; this adds to the caregiving role.  Few caregivers are trained for this work. 
 
The condition of family caregivers is well documented.  Despite possibly deriving satisfaction and reward from 
their work, caregivers pay a toll for the services they render.  The chronic stress of their role places them at 
greater risk for morbidity and mortality than peers who are not caregivers.31-33 The adverse effects on their 
psychological and physical well-being are extensive; there is well-established compromise to their immune 
systems.6 Economic strains (from loss of job productivity and out-of-pocket expenses), social isolation, and 
family conflicts and tensions further raise the toll of caregiving.35-37  Furthermore, in the face of these assaults, 
it appears that caregivers neglect their own care, increasing their own risk of morbidity, co-morbidity, and early 
mortality.38 Behavioral and psychological symptoms of dementia (BPSD) are the strongest predictors of 
negative caregiver outcomes and are consistently linked to negative outcomes for the person living with 
dementia (PLWA).39-43   Deployment of effective caregiving strategies appears to buffer caregivers’ stress.11  
 
Caregiver Intervention Programs. The condition of caregivers has drawn considerable attention over the 
past 2-3 decades, and many programs, usually in-person and often of a group nature, have demonstrated 
some positive benefit for caregivers’ overall well-being.4-6,45,46  While it is clear that not all needs have been 
met,47 a number of systematic reviews have identified the characteristics of interventions that appear to 
contribute to their success.4-6,45 Group programs focused on skill- and mastery-building and/or on improving 
enacted coping behaviors that respond to caregiving stress (e.g., managing BPSD)5,48 and that are interactive 
or adult-learner-focused appear to be especially beneficial.49  Several psychoeducational programs have been 

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singled out as particularly effective (like REACH,50 the NYU model,51 and the Savvy Caregiver2), and these 
have been designated as evidence-based by the US Administration for Community Living.52  Programs like 
these have spread, and the evidence-based designation facilitates federal support for their wider use. 
  
Challenges and Solutions.  Access to beneficial programs is problematic.  Although rural caregiving has 
been singled out as presenting particular problems for access,53-60 the issue of access is endemic.  Whether 
caregivers live in rural areas far distant from program sites or in inner cities – or in suburbs – they all face the 
same issues.61  They have to travel to programs, so transportation is an issue.  Distance in miles can be a 
barrier in rural areas, but distance in time on public transportation can be a barrier in urban areas – even if the 
program site is only a few miles away.  Time is a problem in other ways.  Most in-person programs involve 90-
180 minute sessions; add in travel time, and it may mean the caregiver has to commit a half day to 
participating.  Finally, and perhaps most importantly: what is the caregiver to do about the person for whom 
s/he provides care?  Arranging – and often paying for – care is a real and substantial barrier to participation.  
 
Technology – in particular, the internet – offers a possible solution to the problem of caregivers’ restricted 
access to beneficial programs.  The internet is no longer a scarce, rarely-available or difficult-to-use 
technology, and its use among middle-aged and older persons – the typical age range of caregivers – 
continues to rise.  In 2009 internet use in this group was 59%; most recently, it is 79-89%.62,62   While there is 
not, as yet, universal access, this trend of increasing availability and use is especially true for Alzheimer’s 
caregivers.63,63  The internet is a major source of information for Alzheimer’s caregivers; moreover, there 
appears to be an association between internet use and enhanced caregiving self-efficacy.65  
 
A variety of increasingly sophisticated, technologically-assisted delivery strategies have been employed to 
provide information and education to dementia family caregivers, but reviews lament the dearth of randomized 
trials (RCT).24 Early telephone-based programs, provided in group or one-on-one formats, sought to provide 
support and instruction.  A key feature of these programs was their ability to link caregivers to professionals at 
a distance.7-10,66,67  Stand-alone DVD and internet-based instructional and educational programs allowed 
caregivers to learn asynchronously about dementing conditions and caregiving strategies. Some programs 
were augmented by or linked with in-person contact with experts, generally through messaging or email.15-17  
Others linked on-line line asynchronous video educational material with one-on-one interaction (PRN or 
scheduled) with a coach/counselor through messaging or email.18-23  Recent technologically-assisted programs 
employ a group format, enabling professionally-led synchronous interaction among caregivers. Some program 
have been linked to home visits, have included asynchronous educational materials, and have involved chat 
functions, enabling off-line communication among caregivers and with experts.68-71 
 
Innovation.  To our knowledge, there have been no efforts to date to simulate, through distance means, the 
dynamic and temporal intensity of an in-person evidence-based psychoeducation program for Alzheimer’s 
family caregivers. Tele-Savvy is such a program. It combines asynchronous self-instruction and synchronous 
group coaching, teaching and interaction and does so over the same (six week) time period occupied by its 
evidence-based platform, the Savvy Caregiver program.  Tele-Savvy has the capacity to add a new dimension 
to telemedicine; it can enable newly emerging Alzheimer’s care delivery models embedded, for instance, in 
accountable care organizations or medical homes, to promote practice change by more fully and more 
effectively (and accessibly) partnering with caregivers to enhance the performance of these delivery models, to 
improve home-provided care, and to preserve the well-being of patients and caregivers.    
 
Preliminary Work.  The work we propose rests on the solid foundation of the project team’s experience with 
Alzheimer’s caregivers and the demonstrated performance of the program’s evidence-based platform, the 
Savvy Caregiver Program (SCP). Our prior work testifies to our ability to succeed at a project of this scope.  
Our pilot work with Tele-Savvy at the Atlanta VA and Emory’s Alzheimer’s Disease Research Center provides 
promising preliminary results to support further testing of Tele-Savvy.   
 
The Savvy Caregiver Program (SCP).  As depicted below, SCP is a 12-hour structured program offered in-  
person by trained facilitators, over six 
weeks in 2-hour group sessions. The SCP 
curriculum envisions the caregiving role 
as one demanding skill and knowledge, 
an outlook that could be considered 
clinical in nature.  Alzheimer’s caregivers 
Week 
Topics and Content 
Self-Management 
Behaviors 
1 
Introduction to dementing illnesses 
Cognitive losses and caregiving strategies  
 
 
Improved knowledge 
and understanding of 
 
2 
Stages of dementia 
The role of confusion in dementia 
Caregivers’ feelings and self-care 

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daily assist the PLWA with routine tasks.  
Choosing and carrying out an effective 
guidance strategy is a sophisticated task, 
and it is repeated multiple times each day. 
This involves understanding the person’s 
capacities and gauging the degree and 
kind of assistance that will be effective 
while also attending to the person’s 
emotional well-being, maintaining a  
3 
Tailoring tasks and activities to fit with stages 
of dementia 
dementia and 
caregiving role 
 
Acquisition, 
development, and 
enactment of effective 
caregiving strategies 
 
• Engagement in self-
care activities 
4 
Debriefing and further practice with tailoring 
tasks and activities 
5 
Further debriefing and practice with tailoring 
caregiving strategies 
Family roles in caregiving 
6 
Community resources for caregiving 
Summary of content and skills 
All 
Self-Care exercises 
reasonable level of behavioral calm, and helping the care recipient to have days that are relatively pleasant. 
Such guidance combines the acumen of a number of disciplines (e.g., nursing and occupational therapy).  SCP 
uses strategies and techniques from nursing,72-76 psychology,43,77-79 and occupational therapy80-83 to provide 
insight into Alzheimer’s and its effects and to suggest ways of succeeding in the work of caregiving. Guided 
imagery helps participants appreciate the way in which dementing disorders produce confusion and how 
confusion prompts eruptive responses.  Group exercises elicit participants’ feelings about caregiving and about 
strategies they have deployed to guide everyday tasks. 
 SCP seeks to promote caregivers’ appreciation for the scope of their own work; increase their skills and 
knowledge for caregiving; strengthen and appreciate their growing mastery in the role; adopt a more strategic 
(“clinical”) outlook about their caregiving; develop more 
effective strategies for caregiving; and improve their 
skills for self-care.  SCP draws on a broad chronic 
condition management framework84,85 that is aligned 
with social cognitive theory86,87 and the stress process 
model.44,88-90 Within this framework (see Figure, right), 
caregiving stress constitutes a basic threat to the well-
being of the dyad.  To affect primary appraisal, the SCP 
curriculum provides information about the progressive 
dementia-produced losses in thinking, emotional and 
behavioral control, and the ability to perform everyday 
tasks and about the impact of caregiving on caregivers.  
Instruction, practice, and coaching allow for the 
application of Bandura’s principles (successful 
demonstration of a desired behavior; observation of the 
performance of a desired behavior by a peer; and 
advocacy of a desired behavior by a respected authority86) to strengthen caregiving mastery (secondary 
appraisal), and promote development and enactment of a repertoire of self-derived successful caregiving and 
self-care/self-management coping behaviors. Debriefing offers the opportunity to report successful enactment of 
these behaviors. Gains in knowledge and skill, improvements in mastery, and deployment of effective caregiving 
strategies contribute to caregiver and care-recipient well-being (less distress; better quality of life for both; 
reduced BPSD). In sum: How the threats of caregiving are managed has an effect on the outcomes of the overall 
process (caregiver affect and PLWA quality of life), as mediated by mastery.   
 
Savvy Caregiver Program (SCP) Development and Testing. SCP is a fully manualized version of two NINR-
supported wait-list control trials of group psychoeducation programs provided in-person to family caregivers of 
PLWA (Minnesota Family Workshop (MFW: NR002971; PI: Ostwald; co-I: Hepburn) and Partners in 
Caregiving (PIC: NR04517; PI: Hepburn)). Both trials reported statistically significant improvements (with 
moderate effects) in caregiver burden, depression and anxiety and caregiver mastery.91-92  SCP was 
developed to enable community organizations to provide this psychoeducation program to caregivers. We 
tested SCP efficacy in an Alzheimer’s Association-supported wait-list control trial (IIRG-023946). At baseline 
and 5 months after enrollment, intervention subjects showed significant improvements on measures of distress 
(p=0.022), mastery (p=0.018), and caregiving competency (p=0.000) while control participants did not.  When 
compared with each other over time, the intervention group differed significantly (and in positive ways) from the 
control caregivers on the measures of distress (p=0.030), mastery (p=0.019), and loss of self to the caregiving 
role (p=0.042). Formative evaluation data confirmed the utility and usability of program materials.2,93   
 

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Savvy as a Widely Disseminated Program.  Savvy has been adopted by a wide variety of local, regional and 
statewide agencies in more than a dozen states (some through the federally-supported Alzheimer’s Disease 
Supportive Services Program). State-based evaluation results mirror those of the SCP trial. Maine’s SCP 
participants showed improved competence, mastery, and personal gain (p < 0.05) and a reduction in 
depressive symptoms and negative reactions to their person’s behavior (p < 0.05) at 5 and 12 months.94  
California reports similar improvements in caregiver well-being in a racially/ethnically diverse caregiver 
population.95  Program materials (trainer’s and caregiver’s manuals, the train-the-trainer programs, program 
fidelity monitoring capacity) support its continued implementation.  
Many sponsors have found ways to support the program’s 
Maintenance. SCP now has “defined status” in Michigan, making its 
provision eligible for federal reimbursement – a major step for SCP 
sustainability that can serve as a model for other states. 
 
Tele-Savvy.  Tele-Savvy engages groups of (on average) six 
dementia family caregivers in a program that extends over 43 days 
(see figure below).  The program begins with a scheduled 75-minute 
group videoconference led by one or two facilitators; similar group 
videoconferences then take place each of the next six weeks (i.e., 
seven video-conferences).  In between the video-conferences, 
caregivers receive daily emails with links to 5-20 minute on-line video lessons that they can watch on their own 
schedule and as often as they wish (there are 36 unique video lessons; the Tele-Savvy story board (Appendix 
A) delineates the content of these video lessons).  The curriculum includes all of the elements of SCP plus 
material from an advanced program (SCP-II)96 and from Co-PI Griffiths’ caregiver self-care projects (see 
below).  The videoconferences incorporate the coaching/debriefing feature of SCP to allow caregivers to report 
enactment of learned and self-developed management strategy behaviors into their own caregiving.  The 
videoconferences include talks and exercises and also allow caregivers to raise questions.  Each daily video 
presents a teaching point linked to the overall curriculum. All follow the same format: experts provide 
instruction about a topic, and the lesson is carried forward by brief, scripted talks by other experts or is enacted 
in brief vignettes in which a fictional family caring for a father living with Alzheimer’s demonstrates – at various 
stages of the illness – effective caregiving techniques linked to the day’s teaching points.  
 
Tele-Savvy Fidelity with Savvy Caregiver.  We asked six SCP experts (two of the original authors and four 
master trainers) to assess the extent to which Tele-Savvy accurately and faithfully embodied SCP.  Materials 
detailing the curriculum and delivery strategy and links to several of the daily video lessons familiarized the 
experts with the program.  We asked the experts to compare Tele-Savvy with SCP across ten dimensions 
(fidelity to theory; curriculum; time; concept development; teaching images; group interaction; caregiver 
interaction; design; use of homework; materials) and to rate the extent to which Tele-Savvy was equivalent to, 
improved on, or fell short of the original on each dimension. Reviewers saw Tele-Savvy as equal to or an 
improvement on SCP on all but one of the individual dimensions; these “improved” ratings appear to derive 
from the additions we made.  Several reviewers questioned whether a distance format could enable 
meaningful “connectedness” or interaction among the participants. We paid special attention to the issue of 
connectedness in the formative evaluation we conducted in the pilot studies. 
 
Preliminary Effectiveness.  Caregivers participating in pilot tests sponsored by the VA and the Emory ADRC 
were asked to complete questionnaires prior to and within two weeks of completing the Tele-Savvy program.  
The battery included the 12-item Zarit Burden Inventory-Short Form,97 the Center for Epidemiological Studies 
depression scale short form (CES-D 10),98 the State-Trait Anxiety Inventory (STA-I),99 several sub-scales from 
Pearlin’s Mastery scale,100 and the Revised Memory and Behavior Problem Checklist (RMBPC).101  Following 
the program, we also asked them to respond to evaluative statements such as “I believe I am more 
knowledgeable as a caregiver.”  Other items elicited caregivers’ perceptions of the quality (0-low to 10-high) of 
the overall program and its individual components (manual, videos, group classes, self-care sessions). We 
also sought suggestions for program improvements. 
 
In all, 58 caregivers completed both the VA pilot (22) and the ADRC pilot (36).  Combined results indicate 
significant reductions in BPSD and caregiver upset with symptoms (p=0.012), reduced caregiver burden 
(p=0.003) and depression (p=0.007) and increased caregiver competence (Mastery) (p=0.001). Significant 
effects sizes were medium (low of .40 for burden and high of .55 for BPSD upset).  Participants who used their 

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own computers and home internet (as in the proposed trial) encountered no technical difficulties, and only 2 
experienced bandwidth problems that interfered with video participation in the videoconferences (audio was 
fine).  Most caregivers (all but one “neutral”) ‘agreed’ or ‘strongly agreed’ that the program provided useful 
strategies and the content was personally meaningful to them and their situation.  There were no ratings of 
‘disagree’ or ‘strongly disagree’ with statements about feeling more knowledgeable, confident and skillful. 
Caregivers gave high ratings to the quality of each program component, including a high of 9.7+.7 for the daily 
video class modules. Over 90% gave a rating of 9 or 10 to the program overall, manual, group classes and 
daily video classes. The median viewing of daily modules was ~80%. 
 
Formative interviews with 19 ADRC trial participants sought their assessments of the program, including their 
experiences of “connectedness” (the expert reviewers’ concern) and of the delivery technology. All provided 
positive assessments for the overall program (all indicated they would recommend it to others). Almost all 
reported clear benefits: improved caregiver skills (strategies, assessment abilities, patience) and/or an 
enhanced self-care focus (methods and permission to engage in self-care).  Almost all felt connected both to 
the other caregiver participants and to the facilitators.  More than 3/4ths indicated a preference for the on-line 
format and would chose it over an in-person format.  They recommended improvements in the materials, and 
some whose PLWA were late in their illnesses or in the MCI stage recommended targeting the program to 
caregivers whose care recipients were in the early and middle stage of the illness.  These recommendations 
are reflected in our proposed materials refinements and subject targeting criteria. 
 
VA Tele-Rehabilitation and Caregiving.  Co-PI Griffiths has engaged in VA-supported studies using distance 
means to assess, prescribe and train caregiving dyads on the use of assistive technology for activities of daily 
living within the home environment (CG ASSIST-D7873-R (Hepburn, Co-I)) and to decrease stress in care 
dyads engaged in self-managing the stress of one or more chronic conditions (SLEEP-E Dyads study E7249W 
(Hepburn Co-I/Mentor)).  The studies have produced a library of video assets (i.e., guided meditations (GM), 
therapeutic breathing exercises) used to promote caregiver healthy behavior and well-being. Viewers (N=41) 
provided very positive ratings of four guided meditation videos (emotion recycling; inner sanctuary; breathing; 
and Metta meditation). Over 92% enjoyed the sessions and more than 83% agreed they felt more relaxed after 
each.102-103 Some of these materials developed by Dr. Griffiths are incorporated into Tele-Savvy.  
 
The Study Team and Collaboration Among Centers. The co-PIs, Drs. Hepburn and Griffiths, and the site 
co-Is, Drs. Boise, Morhardt, and Shah, lead or are members of the Outreach, Recruitment, and Education 
Cores of the participating ADCs, and all have collaborated previously through the Core network or other 
research work.  Each ADC site provides access to populations of interest. The Emory ADRC research registry 
(~500) is composed of ~30% African American participants.  The Oregon Health Science University ADC clinic 
last year served 648 unique patients, 47% of whom lived in rural areas.  The OHSU ADC collaborates with its 
medical system’s telemedicine and rural primary care practice-based research network. Co-I Boise’s work 
related to dementia and caregiving has explored barriers to assessment, caregiver attitudes to care, 
implementation of psychoeducation programs, and the use of distance technology in care.104-107 The Rush 
Alzheimer's Disease Center (RADC) offers patient care services at the Rush Memory Clinic, including 
neurological and psychological evaluations and consultation with Alzheimer’s specialists.  Through support as 
a State of Illinois Alzheimer’s Disease Assistance Center, the RADC manages the Rush Memory Clinic Data 
and Specimen Repository to link patients and their families to research opportunities. Approximately 1/3 of pre-
consented Alzheimer’s-diagnosed patients with MMSE ≥ 13 and with family caregivers are African American 
and 2/3 are Caucasian.  The Rush ADC Latino Core builds on established community links to promote 
research engagement by persons of Latino/Hispanic heritage who are living with Alzheimer’s disease and their 
family caregivers. The Cognitive Neurology and Alzheimer’s Disease Center at Northwestern University 
specializes in the care and scientific study of neurological diseases that interfere with cognition and behavior.  
The clinical core has a registry of over 300 patients and the Northwestern Neurobehavior and Memory Clinic’s 
multidisciplinary team sees over 500 new patients each year with a heterogeneity of dementia disorders, as 
well as Alzheimer’s disease and dementia with Lewy bodies.  The patient population is local to the Chicago 
area but a significant number, particularly those with a primary progressive aphasia, come from across the 
country.  The majority (88%) of patients with caregivers are Caucasian. 
 
Monthly team videoconferences will be conducted to discuss project progress, recruitment, data 
collection and analysis, and other issues.  The Emory coordinating team will meet weekly. The site co-

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investigators and Dr. Hepburn will also meet annually at the ADC Directors’ meeting. Additional Data Safety 
Monitoring Board committee meetings will be held mid-year in years 2 and 3. 
 
Scientific Approach 
Design.  We aim to enroll 375 subjects in 25 cohorts of 15 subjects each, starting in project month 9 (see 
project timeline). We expect to enroll, on average, four cohorts per quarter through project year 2 1/2. 
Recruitment of every 2 cohorts (30 participants total) is scheduled to take place every 6 weeks.   We will use a 
three-arm design with participants randomly assigned on a 2:2:1 ratio to immediate participation in the Tele-
Savvy intervention (N=108), immediate participation in an attention control condition (Healthy Living) (N=108), 
and a usual care condition (N-54). There will be five data-collection points evenly spaced across 12 months.  
Those in each cohort’s intervention condition will take part in Tele-Savvy immediately following baseline data 
collection.  Those in the attention control and usual care conditions will take part in Tele-Savvy after a delay of 
6 months (following the 6-month data collection point. Below, we describe the preparation activities in which we 
will engage (facilitator training and material revisions) and then describe the trial itself. Four NIA-supported 
Alzheimer’s Disease (Research) Centers will collaborate in recruitment, and Emory University will serve as the 
coordinating center.  Emory will be responsible for randomization of subjects (recruits from all sites will be 
pooled together for randomization), for delivery and fidelity monitoring of the intervention and attention control 
condition, and for all data gathering and analysis.   
 
Please see the added document for Amendment 8. 
 
 
Project Timeline, by Quarters 
 
Year 1 
Year 2 
Year 3 
Year 4 
Main Project Activities 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Staffing; Training; Finalizing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DSMB scheduled meetings 
   
   X 
 
 
  X 
 
 
 
  X 
 
 
 
  X 
 
 
 X 
Enroll 18 cohorts (15 each) + Acquisition 
30 
60 
 
90 
 
120 
 
150  180 
 
210 
 
240 
 
270 
 
 
 
 
 
Data Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Cleaning and Analysis  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preparation. 
Attention Control Condition Materials Preparation.  The attention control condition (see below) will involve the 
distribution of video and text materials on exercise and nutrition.  These are largely be materials from the NIA 
Go4Life program.  Dr. Nocera has led the effort of selecting and sequencing the materials and has worked with 
Drs. Griffiths and Hepburn and the Project Director to format them into an internet-delivered program. 
Finalization of these materials (curriculum development and mapping content for group, individual, and 
asynchronous elements) has occurred during the preparatory phase of this study. Go4Life content is well-
developed and is pertinent to caregivers, however, it does not address caregiving issues the way Tele-Savvy 
Program does. Go4Life provides a motivational framework for a healthier lifestyle, methods to track 
commitment and improvement, and more than 60 tip sheets on activities, nutrition, health benefits and safety 
around which daily video modules will be built. Additionally, videoconferences will be developed to incorporate 
on-line group interaction for attention-control participants to match the time in videoconferences (but not the 
content) among Tele-Savvy participants.  
 
Facilitator Training. Persons from a variety of backgrounds (nursing, social work, education, etc.) who have 
experience leading the in-person Savvy Caregiver program will facilitate the synchronous group components of 
the Tele-Savvy program. We will compile a facilitator’s manual, based on the material from the Savvy 
Caregiver’s trainer’s manual (see Appendix B) used in the Tele-Savvy pilot and the Tele-Savvy syllabus that 
delineates the content of the synchronous group videoconferences (Appendix A).  The manual will provide 
clear educational objectives, a time-linked agenda, and descriptions of (and supporting material for) the talks 
and exercises conducted in each session.  A training program (Dr. Hepburn’s Savvy Caregiver train-the-trainer 
program modified for Tele-Savvy) will be used. The training will engage facilitators in practicing the methods 
and material covered in the videoconferences, and will help facilitators to tailor to the videoconference format 
the coaching skills essential to facilitating the development of caregiver self-efficacy. It will also focus on the 
development and maintenance of “connectedness;” in this on-line environment, the facilitator can rely less on 

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non-verbal cues and has to employ a more directive style to manage group dynamics, such as “calling on” 
individuals to report on their home activities or to determine if they have questions. One or more facilitators will 
be trained to conduct the videoconference component of the “Healthy Living” attention control condition. Drs. 
Nocera and Griffiths will develop and conduct the training program for the attention control facilitator(s). As part 
of training, each facilitator will lead, as appropriate, a dry run of Tele-Savvy and the Healthy Living programs. 
The lead investigators will observe these dry runs, providing coaching and additional training, as needed.  
Former participants of the in-person Savvy Caregiver program will be invited to participate. 
 
Facilitators will be assigned to lead cohort-based Tele-Savvy groups based on their time availability; the leader 
will be consistent across the seven sessions of the cohort’s participation.  No facilitator will ever lead more than 
two groups at a time.  Over the course of the project, the investigators and the Project Coordinator will monitor 
Tele-Savvy and Healthy Living fidelity by observing and evaluating ≥ 3 individual group sessions per facilitator 
per cohort using a fidelity checklist. Fidelity will evidenced by ≥ 80% adherence to a group session compliance 
checklist. (Appendix D)  Compliance ratings < 80% and median caregiver ratings for session quality of < 8 will 
signal Hepburn and Griffiths to discuss with facilitators, conduct PRN remedial training and observe/participate 
in the next two sessions or until ratings adherence is achieved and maintained.   
 
Facilitators will be hired part-time or as consultants as a way to demonstrate that fidelity to the Tele-Savvy 
Program curriculum can be maintained across interventionists. Additionally, working with part-time facilitators 
in this study will provide evidence on the feasibility of similar employment of facilitators in other settings, such 
that Tele-Savvy may be administered by employees of existing organizations (e.g., social workers) as a part of 
their preexistent job description rather than their sole responsibility. Such incorporation of Tele-Savvy 
administration into the whole job description is more likely to make Tele-Savvy adoptable in a variety of 
settings rather than reliance on full-time facilitators. 
 
Materials Finalization. Tele-Savvy is ready for testing.  Our preliminary work has established the 43-day 
structure of the program and its delivery mechanisms. We have updated introductions and select content in the 
daily videos to include minority experts and actors for case examples. A course syllabus will be provided to 
participants to allow them to see the course as a whole and to link specific parts of the curriculum to the 
Caregiver Manual (Appendix C). Note page copies of the Powerpoint slides used in the videoconferences and 
daily lessons will be provided.  The guides to the use of the interactive communication technology used in the 
program will be upgraded, based on our pilot experiences. Materials from the NIA website for Go4Life has 
been adapted for use in the attention control condition (see below). We will be placing the Tele-Savvy and 
attention control material on two commercially available platforms (Vidyo and Canvas) for which Emory has 
licenses and provides technical assistance. Both require little technical know-how by users; both are accessed 
by links provided via emails that we will send to participants.  
 
Randomized Trial. 
Subjects. Participants will be informal caregivers (family/friends) of persons living with Alzheimer’s disease or 
another dementia. Participants must be providing at least 4 hours per day unpaid assistance, on average, for a 
person in the early-middle stage of illness (Clinical Dementia Rating of ≥ 1 by home ADC) who is community-
dwelling and for whom there is no established plan for institutionalization in the next six months. Caregiver may 
or may not reside with their care recipient, but care recipients must live in the community and not in an assisted 
living facility, nursing home, or another institutional setting.  The participant must not be involved in another 
caregiver training study and must not have participated in in-person Savvy Caregiver Program or Tele-Savvy 
previously. Each participant must have access to a computer or a mobile device with adequate internet 
connection, microphone, and speakers (to be able to participate in teleconferences) and be able to use email 
(this was not a serious barrier in the pilot studies).  Participants must be able to read, speak and understand 
English and have no uncorrectable vision or hearing deficits that might impede participation.  Questions posed 
after explaining the project during eligibility determination and the consent process will be used to gauge 
caregivers’ cognitive ability to take part in the project. Webcams will be mailed to those caregivers who do not 
have them for the duration of the entire program and caregivers will be asked to mail webcams back after 
participation in Tele-Savvy.  
 
Power Analysis and Sample Size Determination Several considerations enter into sample size 
determination: (1) our wish to accommodate as many caregivers as feasible given time/resources; (2) our 
experience and prior results from SCP trials; (3) sample and effect sizes/attrition rates in recent dementia CG 

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meta-analyses. With a final expected sample size of 215 (86, 86, 54 in Tele-Savvy (TS), attention control (AC), 
and usual care (UC) groups respectively), for the primary intervention test (group-by-time effect) comparing the 
outcomes of the three group changes from T1 to T2 to T3 (3-by-3 repeated measures design of three groups 
measured at three time points), at 80% power and 5% significance level, small-to-moderate effect sizes, 
Cohen’s f = 0.21-0.24 may be detected for the main effects for group, time and group-by-time interaction 
effects (given moderate correlation between measurement pairs of r=0.3-0.5) (power analysis using PASS 14 
Power Analysis and Sample Size Software (2015). NCSS, LLC. Kaysville, Utah, USA, 
ncss.com/software/pass). After adjusting for any potential group differences, the overall intervention effect of 
the Tele-Savvy program for the combined T1-to-T3 pre-post effects for the immediate Tele-Savvy group plus 
the T3-to-T5 pre-post effects from the AC and UC groups will yield a total estimated 215 subjects to perform a 
pre-post test to detect a small effect size of d=0.19 at 80% power and 5% significance level. With the pooled 
sample, we will be able to also test the mediating effects of mastery and self-efficacy on the Tele-Savvy 
program for the caregiver outcomes. As shown by Fritz and MacKinnon (2007), sample sizes of 148-196 were 
adequate to achieve 80% power to detect small-to-moderate effect sizes for the indirect effect of the 
independent variable on the dependent variable through the mediating variable considering both the Sobel test 
as well as percentile and bias-corrected bootstrapped approaches.108 Although our analytic strategy is robust 
to missing data we will enroll 270 CGs (108 for TS and AC groups and 54 for UC group) per consideration 1 
above (maximize accommodation) allowing for an expected 20% attrition. For the exploratory aim comparing 
the program’s efficacy across the 3 ethnicity groups, with an expected final sample size of 215 subjects and 
proportions of approximately 65% Caucasian, 20% African American, 15% Hispanic, at 80% and 5% level of 
significance, we will be able to detect moderate effect sizes Cohen’s f=0.19-0.23 (for 3-group by 2-time point 
RM-ANOVA for group, time and group-by-time effects).   
 
Recruitment and Consent.  To the extent possible, all sites will use existing research registries of PLWD and 
established community partnerships (e.g., with local Alzheimer’s Association chapters or other community 
agencies) to identify caregivers who might be interested in the study. All study sites have robust recruiting 
networks and strong recruiting track records; we expect a diverse participant group with 25-40% minority 
(African American and Latino/Hispanic) participation. All of the ADCs have extensive outreach capacity, so we 
expect candidates will be identified at a distance from, as well as close to the Centers; this was the case in the 
Tele-Savvy pilots which drew participants from the Atlanta area but also from as far away as California, 
Minnesota, and Maine.  We will employ the same enrollment and consent procedures as in the pilots.  
Caregivers will be informed about the study by the local coordinator or PI or, through referral, by Emory study 
staff.  If interested, the person will be screened for eligibility by Emory staff (by asking potential subjects to 
repeat information provided about the study).   Those eligible and still interested will be engaged in the consent 
process by Emory staff; the process will occur through a documented phone or video consent process.   
 
Computer Set-up and Research Interviews. Cohorts will be composed of consented individuals from the 
study sites (i.e., the cohorts are not site-specific). Once a consented caregiver cohort has been identified, an 
Emory research specialist (termed a “navigator”) will establish a time for a phone call to take him/her through 
the relatively straightforward steps of using email to follow URL links that open Vidyo, the videoconferencing 
application to be used in the project.  Following this and while the navigator and participant are still on the 
phone, the navigator will send a test email to initiate a Vidyo conference with the person.  [If we have had to 
send a webcam, the navigator will help the participant to install it.]   During the videoconference, the navigator 
will guide the participant through practice in the use of the basic videoconference operations: accepting an 
incoming conference invitation; muting and unmuting the microphone; muting and unmuting the video camera; 
using the chat function; and ending the conference. At the end of this call, the navigator will schedule a time for 
a data collection call (done in person on Vidyo).  These procedures were effective in the pilot.  
 
A second Emory research specialist will make the data collection call, providing another opportunity to practice 
using Vidyo.  All data collection will be done by a project research specialist at Emory, trained and supervised 
by the Emory Co-PIs.  This specialist will have no other contact with the subjects and will be blinded to and will 
ask subjects not to discuss their study condition.  For each instrument (or portion of each instrument), the 
interviewer will show the response options for the particular scale on the screen, so that the respondent does 
not have to keep those in mind (slides can be projected on the Vidyo platform).  We used this procedure in the 
ADRC pilot project; it worked well and sped up the time of the interviews. Based on experience with the Tele-
Savvy pilots, the research interview conference takes 40-60 minutes; it can extend over two calls, if necessary. 

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All patient records will be kept in a locked file cabinet in the research office at the School of Nursing (i.e. 
Wesley Woods) and will be accessible only to the PI and the research team. 
 
Subject Randomization, Coordination, and Retention.  Once a cohort of 15 consented subjects has 
been consented and interviewed, the study statistician (Higgins) will use a block randomization scheme to 
assign equal numbers of members of the cohort to immediate 
Tele-Savvy or attention control or usual care wait-list 
participation. As the figure to the right illustrates, the three 
groups will each, over 12 months, get the Tele-Savvy program.  
Attention control program will be administered solely to 
participants who have been randomized to be in attention-control 
condition initially. Thus, participants who have been randomized 
to be in Tele-Savvy condition initially or to usual care will not 
receive attention-control intervention at 6 months post-baseline 
Navigators will inform subjects of group assignment and will 
establish a schedule for participation.  For immediate Tele-Savvy 
participants, start time and time of day for the videoconferences 
will be set. For those in attention control, start time and time of 
day for the videoconferences will be set likewise.  For those in the usual care condition, an individual schedule 
of “empathic calls” will be established. Videoconferences for both Tele-Savvy and attention control will be 
offered on weekdays (during business hours and evenings) and on weekends to facilitate participation for 
caregivers who may not be able to join videoconferences on weekdays. Caregivers who might be best served 
by a Saturday or an evening program will be placed into a block and randomly assigned to Tele-Savvy or 
attention control conditions. Caregivers for whom weekday participation is non-problematic will be allocated to 
conditions as described above.  
After navigators inform caregivers about their condition assignment and establish a schedule for 
participation for those in immediate Tele-Savvy and attention control groups, navigators will conduct individual 
videoconferences to introduce them to Canvas, a widely used course management platform that will house the 
daily video lessons.  Canvas allows participants to view video lessons at their own convenience and as often 
as they wish, but it does not allow them to disseminate them.  It allows us to track individual use, so we can 
monitor the “dose” of each participant’s viewing.  Navigators will teach caregivers how to login and access 
materials in Canvas and will provide navigators’ contact information, reinforcing that caregivers should contact 
navigators for technical assistance at any time. Canvas also allows us to post evaluation questionnaires. The 
videoconference will provide participants with another opportunity to practice with Vidyo and to practice 
opening the lessons (during their participation in Tele-Savvy, navigators will send emails to remind them to 
access the lessons).  The procedure for orienting participants to Canvas will be provided to usual care group 
participants following the 6-month data collection point and prior to their entry to the Tele-Savvy program. In an 
effort to keep them engaged in the study, regardless of group assignment, all subjects will receive a monthly 
study newsletter that will provide information about practices to promote healthy living drawn from NIA’s 
Go4Life program.  The e-newsletters will be sent by local site coordinators. 
 
Immediate Participation Group Procedures. Prior to the first group videoconference, Tele-Savvy hard 
materials (caregiver manual; workbook; journal; resource list) will be mailed to participants.  Two days prior to 
the initial group videoconference (welcoming call), an email will be sent to participants asking them to view the 
orientation video lesson – the first lesson in the Canvas site.  The initial group videoconference will begin a 43-
day, six-week sequence of contact in which the daily video lessons are available to participants for 
asynchronous viewing in between the group videoconferences.  The group videoconferences will be led by one 
or two trained facilitators, last approximately 75 minutes, and follow a fixed agenda and syllabus (see Appendix 
A).  Vidyo allows all of the participants to see one another (they are also identified on the screen only by their 
first names); whoever is speaking is seen in the full-screen.  Vidyo allows participants to ask questions directly 
or through a chat function.  As with Savvy, an important function of the group meetings – following the 
introductory session – is to allow participants to demonstrate (or witness) successful implementation of 
effective caregiving strategies and to ask questions about the material presented during the week’s daily 
videos or during the conference itself.  The course syllabus and standardized slide decks structure each class 
in 15-20 minute increments: (1) Facilitators greet and check in with each of the CGs; (2) coaching and 
debriefing (e.g., hearing how (after the first week) CGs did with the homework, answering questions and/or 

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responding to feedback about the week’s material; (3) review of key points and concepts from the week’s video 
sessions and introduction of new material (lecture, video vignettes and/or exercise; (4) reports of self-care 
activities (5) provision of homework assignments and adjournment.  A project navigator will initiate and monitor 
each videoconference.  The navigator will keep attendance records and troubleshoot the conferences, 
providing real-time assistance, should any participant need it; assistance is also logged.  
 
All daily video lessons will be posted on the Canvas site, and participants will receive weekly email reminders 
to view them, at their convenience. Specifically, videos will be posted, by week, in the order they are listed in 
the syllabus (e.g., video 1 on day 1, then video 2 on day 2).  Caregivers are not under pressure to “keep up” 
with daily viewing; the program allows participants to view the videos when they are able and as often as they 
wish. Each daily lesson follows the same pattern: (1) Greeting by hosts (2) Slide presentation of educational 
content (3) caregiving vignettes (a telenovela-type portrayal of a wife and daughter helping to guide the days of 
a husband living with dementia; the vignettes were written and directed by the Co-Is and played by amateur 
actors whom we coached) or guest lecture (4) Recap of key points. The video lessons are 6-20 minutes in 
length, and they will remain available to participants for two weeks after program’s end.   
 
Wait List Attention Control Group Condition and Participation.  The attention control condition consists of 
video and text materials on exercise, diet, and healthy living drawn from the NIA Go4Life program.  While 
these materials provide important and beneficial information, we believe they will not affect our postulated key 
mediators (mood, mastery and care recipient quality of life). They will provide equal attention, but should not 
confound the trial.  The same number of brief modules as employed in Tele-Savvy (36) will be provided over 
the course of six weeks; videos will emerge on Canvas site weekly in a manner similar to the Tele-Savvy 
condition described above. Likewise, navigator will send attention control participants weekly reminder e-mails 
to log into Canvas and view daily videos.   All attention-control participants will convene weekly for a 
videoconference that will mirror Tele-Savvy videoconference in format and length but will differ in content. 
Specifically, attention control videoconferences will not contain any information on caregiving strategies, but 
rather will center on the application of healthy living strategies. A standard structure of each videoconference 
will be employed by attention-control facilitators: (1) Facilitators greet and check in with each of the caregivers; 
(2) coaching and debriefing (e.g., hearing how (after the first week) caregivers did with the homework, 
answering questions and/or responding to feedback about the week’s material; (3) review of key points and 
concepts from the week’s video sessions and introduction of new material; (4) reports on any activities that 
caregivers may have implemented based on the Go4Life materials; (5) provision of homework assignments 
and adjournment.  
 
Usual Care. Those randomized to this group will be encouraged to continue to receive care for the person 
living with dementia through whatever arrangement had been in place. Since this group will represent a sort of 
natural history of caregiving, we will not, with one exception, ask them to restrict any activity they might 
undertake to seek care for the person or information for themselves.  The exception we will request is that, 
during the 6-month period, they not enroll in an extended caregiver education program.  If, in the course of 
these 6 months, they participate in support groups, visit education web sites, attend informational seminars 
and/or consult with their health care providers, that will be fine.  These are all part of the natural history. 
 
Approximately four months after initial data collection, attention-control and usual care participants will be 
contacted to schedule their participation in Tele-Savvy which will begin 6 months after their baseline 
assessment.  Their Tele-Savvy experience will be exactly the same as that described above (Immediate 
Participation Group Procedures). These participants will be offered the opportunity of another practice 
session with Vidyo and Canvas prior to the beginning of Tele-Savvy.    
 
Category 
Instrument 
Instrument Description 
Psychometrics 
Baseline Only 
PLWA Cognitive 
Status 
Informant Questionnaire 
on Cognitive Decline in 
the Elderly (IQCODE),  
A 16-item rating scale (can be informant 
completed) not contaminated by education 
Correlates well with dementia 
diagnosis; predicts dementia dx as 
well or better than the MMSE. 109-110 
Demographic 
Information 
Demographic sheet 
Caregiving History 
SES, PLWA information, length of 
caregiving, co-residence with recipient. 
Study-developed form (Baseline 
only) 
 
PLWA ADLs 
Lawton ADL/IADL scale 
13-item scale elicits caregiver assessment 
of PLWA ADL and IADL functioning 
Interrater reliability between .87-
.91111  
[Caregiver Vars] 
Appraisal: Stress 
Perceived Stress  
Scale  
14-item Likert-type questionnaire; higher 
scores reflect higher perceived stress 
Internal consistency ranges 
reported  at 0.84 or higher.112 

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Data Collection.   Data will be collected at baseline and at four subsequent points (months 3, 6, 9, and 12). 
Each data collection event will follow the same procedure used with the baseline interviews.  The Navigator will 
establish the appointment for the Vidyo interview, and the research specialist, blinded to condition, will conduct 
the interview.  The data collection schedule allows for a direct comparison of outcome measures between 
groups (at 3 and 9 months); it allows for an examination of prolonged effects (at 9 and 12 months) in the 
immediate participation group; and it allows for pooling of data across both groups to examine the mediating 
effects of mastery on distal outcomes in caregivers and PLWD and to compare effects across racial/ethnic 
groups. Qualitative evaluation interviews will occur at T2 and T3 for a sub-sample of immediate and T4 and T5 
for a sub-sample of attention control subjects. 
 
III. G. Variables and Measures. The table above delineates the battery of standardized instruments we will 
employ; these have well-established psychometric properties (reliability, validity), are used extensively with 
dementia caregivers, and have been used previously in the Savvy Caregiver trials.  
 
As depicted in the figure below, there is a link between our theoretical model and the measures used to test it.  
Most data will be gathered through the regular interviews, some data will be obtained from self-reported 
evaluations that caregivers will complete through forms posted on the Canvas site (for example, through logs 
on the Canvas  site in which caregivers report caregiving behaviors they have enacted). After each program, 
caregivers will be asked, in phone or Vidyo interviews conducted by project investigators, to evaluate the 
program, indicating what they did/did not like, what did/did not work, how the intervention was helpful or not, 
and how they would change it. Blackboard will allow us to monitor adherence, dosage and intensity of the 
Depression 
Center for 
Epidemiological 
Studies-Depression  
A 20 item Likert scale scored 0-3 with 
somatic and psychological subscales 
Alpha=.85 for general population; 
validity well-established98 
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 .9499 
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 validity113 
Dyadic 
Relationship 
Dyadic Relationship 
Scale 
11-item scale assesses dyadic strain and 
dyadic interaction perceived by caregiver 
Caregiver alphas = .84 and .85114 
Coping 
Ways of Coping Scale  
A 42-item scale with 4-point Likert 
responses identifies emotion- and problem-
focused coping responses 
Used in multiple studies with well-
established validity115  
Caregiver Mastery 
Pearlin Mastery, Loss, 
and Competence  
6 brief (3-6 item) Likert scales assessing 
mastery and loss dimensions 
Alpha coefficients from .71-.92.100   
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 validity116 
Caregiver Reward 
Positive Appraisal of 
Care Scale: 
Consequential Gain 
6-item subscale providing caregiver self-
rating of benefits and positive experiences 
of caregiving 
Cronbach’s alpha 0.84 for the 
Consequential gain sub-scale. 
Established validity. Test-retest 
reliability 0.86 (p<0.01).117 
Caregiver Self-
Care 
Mindful Self-Care Scale 
Sub-scales 
Sub-scales related to supportive 
relationships (5 items); self-compassion 
and purpose (6); mindful relaxation (6); 
clinical (6); and general (3) [26 items total] 
Cronbach’s alpha 0.89 for the total 
33-item scale (excluding sub-
scales Clinical and General); 0.83 
for Self-Compassion and Purpose 
sub-scale; 0.77 for Mindful 
Relaxation sub-scale. Construct 
validity established preliminarily.118 
Caregiver Health 
Self-rated Health 
1-item questionnaire 
Test-retest reliability 0.92119 
[PLWA Variables] 
Quality of Life  
Quality of Life Scale in 
Alzheimer’s Disease  
Assesses QOL in 13 domains on a 1-4 
point Likert scale. Used as a self-report 
and surrogate-report instrument 
Good internal consistency (Cohen’s 
α=.86) and inter-rater reliability 
(Cohen’s Κ>.70).120  
Behavioral and 
Psychological 
Symptoms in 
Dementia 
Revised Memory and 
Behavior Problem 
Checklist 
A 22-item Likert scale instrument that 
assesses patient behaviors and caregiver 
responses to them 
Reliabilities of .84-.90 are reported 
for behavior and reaction.101 
Care Recipient 
Mood 
Neuropsychological 
Inventory Questionnaire 
12 item inventory assessing severity of 
mood states or behaviors reflecting mood 
Test-retest correlations between 
total symptom and distress scores 
in15 subjects were 0.80 and 0.94, 
respectively (P< 
0.0001 for both.121 

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intervention.  We will be able to track, for each participant, which daily videos were viewed, when they were 
viewed and in what pattern (e.g., daily or in a batch), and how often.  Attendance in the videoconferences will 
be recorded. We will also document any indications – through participant complaints or the Navigator’s log – of 
participant burden (e.g., complaints voiced during interviews or need to split interviews over multiple sessions) 
and reports of barriers to participation (e.g., CGs unable to join call, quality of audio/video).   
 
Data Management and Analysis Plan   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 into SPSS 
weekly and syntax run for cleaning, further data 
verification and file concatenation.  
 
Data integrity checks.  After each cohort data-
gathering point, all data will be merged in SPSS for 
scale computation, aggregation, and inferential 
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).  Formal test-retest/inter-rater reliability 
coefficients will be computed as data are concatenated.  
 
Analytic approach.  Preliminary analyses will examine baseline differences among completers and non-
completers and by study arm (immediate/attention control/usual care) as a randomization check using 
means/SDs/Inter-quartile range and t-tests for continuous variables and counts/percentages and N-Par/Chi-
Square tests for categorical variables. The association of predisposing factors (demographics, CG history, 
relationship and care recipient status at baseline) with baseline data as well as change in outcomes over time 
will be examined using goodness of fit, variance analysis, or correlational techniques depending upon 
measurement characteristics of variables involved.  Where significant baseline associations are detected, 
these potential confounders will be controlled in subsequent tests of major hypotheses through use of 
covariates/model adjustments.  
 
Aims 1, 2 and 3 (a). Our primary aims are concerned with assessing the effect of the Tele-Savvy program for 
reducing or retarding the burden, depression, and anxiety of Alzheimer’s family caregiving, promoting the 
quality of life of persons with Alzheimer’s (BPSD, agitation; Quality of Life; affect), and enhancing caregiver 
mastery. We will employ multi-level mixed effects models (MLM) with random (participant) and fixed (cohort) 
effects to test linear (and non-linear) trajectories of change for the intervention groups and model group X time 
and group*time interactions. To compare the Tele-Savvy intervention to the attention control and usual care 
groups, the first 3 time points will be used to test for differences between the 3 group longitudinal trajectories. 
Additionally, we will combine the intervention effects for the three groups across the main 3 time points from 
just before receipt of the intervention to immediately after the intervention to the 1st follow-up time point (T1-to-
T2-toT3 for the immediate group and T3-to-T4-to-T5 for the attention control and usual care groups 
respectively). These combined time points will be referred to as cT1, cT2, cT3. If there are significant 
differences between or among the 3 groups at the time point immediately prior to receipt of the intervention 
(cT1), these “baseline” effects will be included and adjusted for in the final model. Overall time effects will be 
assessed as well as planned post hoc comparisons for immediate effects (cT1 to cT2), longer term effect (cT1 
to cT3) and sustained effects (cT2 to cT3). Sidak Type-I error rate adjustment (which has higher power than 
Bonferroni) will be applied for the multiple pairwise time point comparisons.122 Additionally, longer term 
sustained effects will be captured for the immediate Tele-Savvy group using the additional follow-up times at 
T4 and T5 for this group. The proposed study design has the advantage of capturing 3 “baseline” time points 
for the wait-list attention control and usual care groups 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.123 These initial 

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data captured at T1-T2-T3 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 over time will be included to additionally adjust for these 
confounders124 To aid in final interpretation we will include the 95% confidence intervals around means by 
intervention group and time period. SPSS v.22 will be used for all analyses at the 5% significance level.122 
 
Aim 3(b). To test the mediating effect of mastery on Aim 1 & 2 outcomes, we will employ the PROCESS add-
on module for SPSS125 which includes performing the combined approaches of Baron and Kenney, the Sobel 
test, as well as semi-parametric estimation and testing of the Sobel test through bootstrapping. The focus will 
be on both the immediate (T2 for immediate Tele-Savvy group and T4 for attention control and usual care 
groups pooled together) and sustained (T3 for immediate Tele-Savvy group and T5 for attention control and 
usual care groups pooled together) effects of Tele-Savvy on the mediating measure of mastery on the Aim 1 
and Aim 2 outcomes of caregiver burden, depression, anxiety, and dyadic relationship and PLWD BPSD, 
agitation, mood, and quality of life. These indirect/mediation effects will also be tested and evaluated using 
structural equation modeling via AMOS v.22.126 
 
Exploratory Aim. All subjects will eventually participate in Tele-Savvy, and we will be able to assess program 
impact on the key caregiver and care recipient measures to test whether the program had similar or different 
effects across racial/ethnic groups (African American, Caucasian, and Latino/Hispanic).  We plan to use the 
ANCOVA technique to conduct this analysis, using race/ethnicity as the covariate of interest.  We expect to 
conduct a similar analysis to examine differences in impact on rural versus urban caregivers.  As our 
enrollment table indicates, we expect a 20:65:15 African American:Caucasian:Latino subject distribution. The 
qualitative interviews of participants will enable us to explore the extent to which Tele-Savvy meets caregivers’ 
needs, regardless of race/ethnicity and whether, and, if so, how, it might need to be adjusted to better address 
the caregiving situations of particular groups. 
 
We will use the technique of constant comparison127 to analyze the qualitative evaluation data gathered from 
Tele-Savvy participants (at a point four-months after participation).  Co-PI Hepburn and the project coordinator 
will independently read the transcripts from the first few cohorts, identifying codes that indicate unique 
observations expressed by participants as well as topics and broader themes around which various codes 
might cluster.  They will compare codes and themes to arrive at mutually agreed upon revisions/refinements in 
the developing coding scheme (Dr. Griffiths will adjudicate any unresolvable disagreements) and then apply 
the scheme to transcripts over the course of the project.  As significant new themes are identified, previously 
coded transcripts will be re-read, applying the revised scheme.  
 
Limitations and Challenges. Our decision to limit participation to caregivers with computers and internet 
access is based on our pilot experience. In the ADRC pilot, we required participants to have their own 
computers and internet connection; we encountered very few problems.  Access is not universal among 
caregivers, so results will not generalize to all caregivers, but, as noted, internet use in the target age groups 
(middle-aged and older) continues to rise.128 We will employ easy-to-use platforms (Vidyo and Canvas) for 
Tele-Savvy and attention control conditions; both platforms are accessed by a simple click on an email-
supplied link. Navigators can train caregivers to use Canvas and technical assistance of navigators will be 
provided (via phone and e-mail). A navigator will monitor all Tele-Savvy videoconferences to address any 
technical problems that might arise.  We plan to conduct the videoconferences during weekday working hours; 
this may be a barrier for some eligible caregivers.  To address this, we will schedule an occasional program on 
a weekend or in the evening. While recruitment is always a reasonable concern, our experience with the pilots 
provides confidence; operating with very little support, we were easily able to recruit 58 caregivers who 
completed the studies in the course of approximately 18 months.  All of the collaborating sites were chosen 
because their recruitment bases are at least as strong as that at Emory. There were very few dropouts in the 
pilots among those who actually began the program (<10%); we have used a 25% attrition rate to be 
conservative in our estimates for our recruitment target. 
 
 
 

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