Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
Phase: NA
Conditions: Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurocognitive Disorders, Neurodegenerative Diseases, Mental Disorders
Sponsor: UConn Health

Protocol Template, Version 5.0  
Pilot Pragmatic Clinical Trial to Embed 
Tele-Savvy into Health Care Systems 
 
 
 
NCT05080777 
 
 
April 12, 2021 
 
 
 
 
 
 
 
 

Protocol Template, Version 5.0 
 
PREFACE 
The Clinical Intervention Study Protocol Template is a suggested format for clinical trials 
sponsored by the National Institute on Aging (NIA). Investigators are encouraged to use this 
format, as appropriate, when developing protocols for their studies. Large multi-site 
observational studies will also benefit from this protocol template. 
Note that instructions and explanatory text are indicated by italics and should be replaced in 
your protocol with appropriate text.  Section headings and template text formatted in regular 
type should be included in your protocol document as provided in the template. 
The goal of this template is to provide a general format applicable to all single- and multicenter 
clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc).  
As you can see the version number and date are on the bottom of each page. When making 
changes to an approved and “final” protocol, please provide a summary of the changes, with the 
date, at the front of the protocol. 
 
 

Protocol Template, Version 5.0 
 
 
FULL PROTOCOL TITLE 
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy into Health Care Systems  
Study Chairman or Principal Investigator: 
Principal Investigator: Richard H. Fortinsky, PhD, Professor, UConn Center on Aging, 
University of Connecticut School of Medicine and UConn Health, Farmington, CT 06030-5215  
Supported by: 
The National Institute on Aging 
  
(FY20_Pilot2_Fortinsky) 
Study Intervention Provided by:  
Investigators  
Sponsor of IND/IDE:  
Not applicable 
 
 

Protocol Template, Version 3.0 
i 
TABLE OF CONTENTS 
Page 
PREFACE ....................................................................................................................................... i 
FULL PROTOCOL TITLE ......................................................................................................... ii 
TABLE OF CONTENTS .............................................................................................................. i 
PRÉCIS ......................................................................................................................................... iv 
Study Title .................................................................................................................................. iv 
Objectives .................................................................................................................................. iv 
Design and Outcomes ................................................................................................................ iv 
Interventions and Duration ......................................................................................................... v 
Sample Size and Population....................................................................................................... vi 
STUDY TEAM ROSTER............................................................................................................. 1 
Principal Investigator: Name .................................................................................................... 1 
Co-Investigators: Name............................................................................................................ 1 
PARTICIPATING STUDY SITES ............................................................................................. 2 
1 
Study objectives ..................................................................................................................... 3 
1.1 
Primary Objective ........................................................................................................... 3 
1.2 
Secondary Objectives...................................................................................................... 3 
2 
BACKGROUND AND RATIONALE ................................................................................ 3 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 3 
2.2 
Study Rationale ............................................................................................................... 4 
3 
STUDY DESIGN ................................................................................................................... 5 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................ 7 
4.1 
Inclusion Criteria ............................................................................................................ 7 
4.2 
Exclusion Criteria ........................................................................................................... 7 
4.3 
Study Enrollment Procedures ......................................................................................... 7 
5 
STUDY INTERVENTIONS ................................................................................................ 8 

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5.1 
Interventions, Administration, and Duration .................................................................. 8 
5.2 
Handling of Study Interventions ..................................................................................... 9 
5.3 
Concomitant Interventions .............................................................................................. 9 
5.3.1 Allowed Interventions ................................................................................................. 9 
5.3.2 Required Interventions ................................................................................................ 9 
5.3.3 Prohibited Interventions .............................................................................................. 9 
5.4 
Adherence Assessment ................................................................................................... 9 
6 
STUDY PROCEDURES ...................................................................................................... 9 
6.1 
Schedule of Evaluations ................................................................................................ 10 
6.2 
Description of Evaluations ............................................................................................ 11 
6.2.1 Screening Evaluation ................................................................................................ 11 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 12 
6.2.3 Follow-up Visits........................................................................................................ 13 
6.2.4 Completion/Final Evaluation .................................................................................... 13 
7 
SAFETY ASSESSMENTS ................................................................................................. 14 
7.1 
Specification of Safety Parameters ............................................................................... 14 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 14 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 14 
7.3.1 Reporting Procedures ................................................................................................ 15 
7.3.2 Follow-up for Adverse Events .................................................................................. 16 
7.4 
Safety Monitoring ......................................................................................................... 17 
8 
INTERVENTION DISCONTINUATION........................................................................ 17 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 17 
9.1 
General Design Issues ................................................................................................... 17 
9.2 
Sample Size and Randomization .................................................................................. 18 
9.2.1 Treatment Assignment Procedures ........................................................................... 18 
9.3 
Interim analyses and Stopping Rules ............................................................................ 18 
9.4 
Outcomes ...................................................................................................................... 18 
9.4.1 Primary outcome ....................................................................................................... 18 
9.4.2 Secondary outcomes ................................................................................................. 18 
9.5 
Data Analyses ............................................................................................................... 18 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 19 
10.1 
Data Collection Forms .................................................................................................. 19 

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10.2 
Data Management ......................................................................................................... 19 
10.3 
Quality Assurance ......................................................................................................... 20 
10.3.1 
Training ................................................................................................................. 20 
10.3.2 
Quality Control Committee................................................................................... 20 
10.3.3 
Metrics .................................................................................................................. 20 
10.3.4 
Protocol Deviations ............................................................................................... 20 
10.3.5 
Monitoring ............................................................................................................ 21 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 21 
11.1 
Institutional Review Board (IRB) Review .................................................................... 21 
11.2 
Informed Consent Forms .............................................................................................. 21 
11.3 
Participant Confidentiality ............................................................................................ 21 
11.4 
Study Discontinuation ................................................................................................... 22 
12 ETHICAL CONSIDERATIONS ....................................................................................... 22 
13 COMMITTEES................................................................................................................... 22 
14 PUBLICATION OF RESEARCH FINDINGS ................................................................ 22 
15 REFERENCES .................................................................................................................... 22 
16 SUPPLEMENTS/APPENDICES ...................................................................................... 27 
 
I. Procedures Schedule 
  
II. Other (add as many appendices as necessary) 
 
 

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PRÉCIS 
Study Title  
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy into Health Care Systems 
Objectives  
Objective 1: Evaluate effectiveness and implementation of the Tele-Savvy intervention, a group-
based, remotely delivered psychoeducational intervention for family and other informal 
caregivers of older adults with Alzheimer’s disease and related dementia (ADRD). In this pilot 
pragmatic clinical trial, we will introduce the Tele-Savvy intervention to ADRD caregivers at 
two health care system sites—UConn Health and Emory Healthcare—to determine feasibility 
and acceptability of offering Tele-Savvy as a routinely available caregiver program at both 
health care systems. To evaluate effectiveness, at each study site, we will conduct three 
sequential 7-week Tele-Savvy programs with 10 caregivers in each program. Caregivers will be 
randomly assigned to participate in either the Tele-Savvy Program or a self-guided Caregiving 
During Crisis program. To evaluate implementation, we will use Normalization Process Theory 
as a guide, with the goal of understanding staff acceptability and willingness to adopt Tele-Savvy 
as a routinely-offered caregiver psychoeducational program. 
 
Objective 2: Establish an identification and invitation strategy, embedded into the daily 
workflow of both study sites, enabling caregivers to be invited to participate in the Tele-Savvy 
program in a pragmatic fashion. We will use electronic health records (EHRs) to identify family 
members or significant others linked to patients with diagnoses of ADRD, and then verify the 
accuracy of these identified individuals by having clinicians confirm or disagree with these 
identified individuals.. These identified individuals will be invited to participate either via 
electronic means or by clinic staff members.  
 
Objective 3: Demonstrate viable routine collection of caregiver outcomes data into EHRs. 
Collaborating with information technology and clinical personnel at both health care systems, we 
will implement procedures enabling routine collection of these caregiver measures and inclusion 
of these measures into the EHRs at both health care systems.  
Design and Outcomes   
This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of 
embedding the Tele-Savvy intervention, a psychoeducational program for family and other 
informal caregivers of older adults living in the community with Alzheimer’s disease and related 
dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, 
Connecticut, and Emory Healthcare in Atlanta, Georgia. A total of 100 caregivers, 50 at each 
study site, will participate in this pilot study. At each site, 30 caregivers will be randomly 
assigned to receive the Tele-Savvy intervention, and 20 caregivers will be randomly assigned to 
receive the self-guided Caregiving During Crisis online program.   
 
All 100 caregivers will complete identical self-administered questionnaires to measure the 
caregiver-specific outcome measures in this pilot study. Outcome measures will include 
caregiver mastery (primary outcome), caregiver response to specific memory and behavioral 

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problems, and caregiver stress. Also, we will employ process measures of participation and 
engagement in the interventions for caregivers in both arms of the trial, as well as 
implementation outcomes via surveys with clinicians and Information Technology staff at each 
of the two clinical sites responsible for programming electronic medical records to enable 
capture and storage of caregiver outcomes. 
Interventions and Duration  
The Tele-Savvy intervention is grounded in social learning and stress process theory. Its main 
goal is to produce improved caregiver mastery over the symptom management skills commonly 
encountered when supervising and caring at home for an older adult living with ADRD. Over the 
7-week program, there are synchronous and asynchronous activities each week. The synchronous 
portion includes weekly scheduled videoconferences (60-80 min) that serve as an online 
classroom in which facilitators lead lectures and discussions and provide a venue for caregivers’ 
interactions and sharing of their experiences. The majority of Tele-Savvy is asynchronous. Daily, 
caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning 
objective. 
 
Tele-Savvy is a psychoeducation program designed to build not only knowledge and skill but 
also confidence.  The psychoeducation approach uses three main strategies to accomplish this 
goal.  The first strategy is instruction, providing information that helps caregivers increase their 
fund of knowledge for caregiving.  The second strategy involves active learning, accomplished 
by interactive exercises conducted during the course; for example, thinking about how, given 
what the caregiver now understands about the cognitive losses in dementia, to best convey 
information to the person living with dementia.  Active learning is also accomplished by asking 
course participants to try these strategies during the regular course of home caregiving -- this is 
what we refer to as "homework" -- the real life application of what is taught in class in the home 
setting. The third approach involves acknowledging caregiving success through a process of 
reporting back on caregiving activities during the week, particularly those that involved trying 
out the caregiving strategies taught in class.  Reporting success and observing the caregiving 
successes of other participants is an important means of building and reinforcing caregiver 
confidence and competence. 
 
The attention control group will receive the self-guided Caregiving During Crisis program. 
Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing 
education course aimed at developing the competency of informal caregivers of community-
dwelling persons living with dementia to ensure the safety of that person and themselves during 
this time of the COVID-19 pandemic.  The course, readily accessible by home computer or 
smartphone, describes methods of home infection control and prevention to create a Safe Home 
space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies 
for safely allowing service personnel (e.g., home health aides or electricians) and select family 
members to enter the Safe Home space, and risk management strategies to frame decisions 
when/if COVID restrictions are relaxed or revoked. 
 
Two-thirds of the 100 caregivers (the first 67 caregivers) enrolled in the study will be on study 
for 6 months, and one-third of the caregivers (the final 33 caregivers) will be on study for 3 
months.  

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Sample Size and Population  
We will enroll a total of 100 caregivers into this pilot study across the two clinical sites using a 
cluster randomized design. A total of 60 caregivers will be randomly assigned to receive the 
Tele-Savvy program in three sequential cohorts of 10 caregivers each at each site. A total of 40 
caregivers will be randomly assigned to receive the attention control condition in three sequential 
cohorts of 6-7 caregivers at each site. 
 

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STUDY TEAM ROSTER  
Principal Investigator: 
 
Richard H. Fortinsky, PhD 
UConn Center on Aging, University of Connecticut School of Medicine, 263 Farmington Ave., 
Farmington, Connecticut 06030-5215 
fortinsky@uchc.edu 
Main responsibilities/Key roles: responsible for successful conduct of all study tasks at both 
study sites, including direct supervision of study coordinator and research data base manager, 
and ensuring that personnel at both clinical sites perform their duties as required to successful 
conduct of the study. 
Co-Investigator:  
 
 
Karina Berg, MD 
UConn Center on Aging, University of Connecticut School of Medicine, 263 Farmington Ave., 
Farmington, Connecticut 06030-5215 
kberg@uchc.edu 
Main responsibilities/Key roles: Clinical lead at UConn Health site; responsible for facilitating 
use and modification of electronic health record system at this clinical site to enable recruitment 
of study participants (caregivers) and capture and storage of caregiver outcomes data in the 
electronic record system. 
 
Co-Investigator: 
Kenneth Hepburn, PhD  
Nell Hodgson Woodruff School of Nursing, Emory University, 1520 Clifton Rd., Atlanta, 
GA  30322 
khepbur@emory.edu 
Main responsibilities/Key roles: Scientific lead at Emory site, Dr. Hepburn will provide training 
of the Tele-Savvy facilitators at both the UConn Health (Geriatrics Associates) and Emory 
Healthcare (IMCC) sites, ensuring that they are certified to lead both synchronous and 
asynchronous components independently before the first caregiver cohort begins the program. 
Throughout the portion of the pilot study during which Tele-Savvy classes are held, he will 
provide guidance and oversight at both study sites to ensure that Tele-Savvy implementation 
there follows study protocol. 
 
Co-Investigator: 
Carolyn Clevenger, PhD 
carolyn.clevenger@emory.edu 
Main responsibilities/Key roles: Dr. Clevenger will be responsible for coordinating project 
activities at the Integrated Memory Care Clinic (IMCC) at the Emory site.  She will collaborate 
with her colleagues in identifying candidates for the Tele-Savvy trial and will oversee the work 
of clinic staff in facilitating the participation of selected caregivers into the trial, the gathering of 
caregiver outcomes data, and the transfer of caregiver data to Dr. Higgins for analysis. 
 
Co-Investigator: 
Melinda Higgins, PhD 
mkhiggi@emory.edu 
Main responsibilities/Key roles: Dr. Higgins, based at Emory University, will serve as the pilot 
project biostatistician.  She will work with the two project sites to ensure that caregiver data are 

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transferred securely to her and combine data into a single data base and then will take the lead in 
analyzing those data. She will participate in study team meetings and in manuscript writing. 
 
PARTICIPATING STUDY SITES  
List the name and address of each study site investigator, including telephone numbers and e-
mail address. Use the same format as used for the Study Team roster.  
 
Study Site #1: UConn Health (Dr. Fortinsky and Dr. Berg; please see email contact 
information above) 
 
Study Site #2: Emory Healthcare (Dr. Hepburn, Dr. Clevenger, and Dr. Higgins; please see 
email contact information above) 
 

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1 
STUDY OBJECTIVES 
This study consists of three objectives, all of which are of equal importance because this is a 
pilot study of a pragmatic clinical trial being tested at two health care systems, also referred to as 
clinical sites in this protocol.  
1.1 Primary Objective 
Evaluate effectiveness on caregivers and implementation of Tele-Savvy to determine feasibility 
and acceptability of offering Tele-Savvy as a routinely available caregiver program at both 
health care systems. We will test the hypothesis that caregivers receiving the Tele-Savvy 
intervention will experience a greater improvement in caregiver mastery than the attention 
control group. At each health care system, we will conduct three sequential 7-week Tele-Savvy 
programs. Caregivers will be randomly assigned to participate in either the Tele-Savvy Program 
or to receive the attention control condition, a self-guided Caregiving During Crisis program. We 
will use Normalization Process Theory to guide our implementation evaluation, with the goal of 
understanding staff acceptability and willingness to adopt Tele-Savvy as a routinely-offered 
caregiver psychoeducational program.  
 
1.2 Secondary Objectives 
Establish an identification and invitation strategy, embedded into the daily workflow of two 
health care systems, enabling caregivers to be invited to participate in the Tele-Savvy program. 
We will use electronic health records (EHRs) to identify family members or significant others 
linked to patients with diagnoses of ADRD, and then verify the accuracy of these identified 
individuals by having clinicians confirm or disagree with these identified individuals. These 
identified individuals will be invited to participate either via electronic means or by clinic staff 
members. 
 
Demonstrate viable routine collection of caregiver outcomes data into EHRs. 
Collaborating with clinicians and information technology personnel at both health care systems, 
we will implement procedures enabling routine collection of these caregiver measures and 
inclusion of these measures into the EHRs at both health care systems.  
 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Dementia, an umbrella term encompassing multiple causes of brain neurodegeneration that result 
in cognitive decline and development of behavioral and psychological symptoms, affected more 
than 50 million people worldwide in 2019; by 2050, this number will reach more than 150 million 
people.1 In 2020, an estimated 5.8 million Americans live with ADRD, and more than 16 million 
informal caregivers, mostly family members (hereafter, caregivers), provide unpaid care to 
them.2 The scope of caregiving activities varies widely, but for individual caregivers the 
activities often evolve in predictable fashion over the course of the dementia disease process. 
Caregivers must adjust to the realization that their relative or partner has a progressive 
neurodegenerative illness, witness cognitive and behavioral changes, gradually assume 
increasing responsibility for supervising and conducting instrumental and self-care related 

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activities of daily living, learn how to conduct medically complex tasks, coordinate services and 
communication with other family members, engage in advance care planning, and gatekeep the 
use of emergency and acute healthcare services. Caregivers of older adults with ADRD take on 
these responsibilities with little guidance, and many studies have shown that these caregivers 
provide more intense care and experience significant psychological and physical health-related 
consequences compared to caregivers of older adults without ADRD.2,3  
 
In the COVID-19 era, these caregiving challenges have become compounded. It is widely known 
that community-dwelling older adults are at highest risk for severe illness and death from 
COVID-19 and are also likely to face longer in-home restrictions than other segments of the 
population. Caregivers of older adults living at home with chronic illnesses and associated 
disabilities face serious challenges related to these COVID-19 restrictions, such as how to keep 
older adults and themselves occupied and socially engaged to avoid loneliness and social 
isolation, and how to manage older adults’ and their own health care needs by navigating the 
health care system. Caregivers of older adults with ADRD are at risk for increased physical and 
mental health problems due to loneliness and social isolation, especially if they experience 
unavailability of community-based services such as respite care and if they assume greater care 
responsibilities due to a shortage of in-home workers.4 The caregiver population is ethnically and 
racially diverse, so the social determinants of health associated health disparities likely add to the 
complexity of challenges faced in the COVID-19 era.5 Recent publications, principally 
commentaries and recommendations, have focused on the need to address caregivers of 
community-dwelling older adults, including those with ADRD, in the midst of the COVID-19 
pandemic. Recommendations have been offered regarding the potential benefits of health care 
providers using technology creatively to reach caregivers at home to train them about how to 
avoid unnecessary hospital visits and to address accumulating needs among caregivers of older 
adults at home in the COVID-19 pandemic, including remote assistance using technology.6-11   
2.2 Study Rationale 
In the absence of effective pharmacotherapy to treat ADRD or appreciably slow symptom 
progression, numerous non-pharmacologic interventions designed to help persons living with 
ADRD and caregivers have been implemented and evaluated. Recent meta-analyses and scoping 
reviews of systematic reviews of these interventions have found evidence of efficacious 
programs, particularly on improving skill-building and psychological outcomes of caregivers of 
persons living with ADRD.12-15 Tele-Savvy and its parent intervention Savvy Caregiver represent 
interventions designed to improve caregiver mastery through skill building, and to improve 
psychological outcomes such as burden.16,17 Attention in the field of caregiver interventions has 
turned to replicating or adapting efficacious interventions for persons living with ADRD and 
their caregivers in “real world” health care and social service systems and settings. Initially, these 
efforts were referred to as translational studies,18-20 whereas presently the field has moved toward 
efforts to implement efficacious interventions via embedded pragmatic trials.21,22 Recently 
published translational studies with pragmatic trial elements found that beneficial outcomes for 
persons living with ADRD and/or caregivers could be achieved when efficacious interventions 
are incorporated into community service settings.23,24   
 
Caregivers have long been recognized by researchers as critically important participants in 
medical visits with older adults generally, and for persons living with ADRD in particular.25-28 
Older adults report being more satisfied with outpatient medical visits when they are 

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accompanied by family members or other companions than when they are not. Older adults also 
report that physicians engage in more communication about their conditions when they are 
accompanied to medical visits, and these trends are strongest for older adults in the poorest 
health including those with cognitive impairment.29 The vast majority of primary care 
practitioners recognize the value of family caregivers as participants in older patients’ outpatient 
visits.30 This study also found that only 19% of practitioners referred their patients to the 
Alzheimer’s Association, compared to 30% in earlier studies.31,32 These results strongly suggest 
that efficacious interventions offering meaningful benefits that cannot be easily offered in the 
outpatient medical setting to caregivers of older adults would be attractive to physicians and 
other office-based practitioners, if the linkage could be made between interventions and these 
types of health care settings. This is precisely what the proposed pilot study is intended to 
accomplish—to offer Tele-Savvy, an efficacious caregiver intervention ideally suited to the 
COVID-19 era because it is an online program, to caregivers of older adults living with ADRD 
who accompany these older adults to medical encounters at geriatric and dementia care clinics, 
using pragmatic procedures to identify and invite caregivers to participate.  
 
Compilations of caregiver assessment tools have been developed and disseminated for use by 
health care practitioners,33 but evidence is lacking regarding the degree to which such tools have 
been adopted in outpatient medical care encounters with older adults. The greatest opportunity to 
embed caregiver assessment tools into EHRs lies in outpatient settings in which clinicians 
trained in geriatric medicine treat and manage older patients. The incorporation of caregivers into 
the coproduction of care for such patients is embodied in geriatric fellowship curricular 
milestones. Training includes managing psychosocial aspects of care including interpersonal and 
family relationships (Milestone 23) and assessing and incorporating caregiver needs and 
limitations, including caregiver stress, into care management plans (Milestone 24).34 As noted in 
Section C.3 below, the UConn Health site for the proposed pilot study is an outpatient setting in 
which geriatrics fellows receive training and, although fellows routinely meet with caregivers as 
part of their outpatient experiences, this pilot study would introduce the routine use of caregiver 
assessment tools already used as evaluation measures in the Tele-Savvy program.     
3 
STUDY DESIGN 
A total of 100 family or other informal caregivers of older adults living with Alzheimer's disease 
or other dementia (ADRD) will be enrolled in this study from the outpatient clinics at two health 
care systems—UConn Health and Emory Healthcare—that specialize in geriatric care and care 
of persons with ADRD and their families. Of these 100 caregivers, 60 will be randomly assigned 
to participate in a 7-week Tele-Savvy program, and 40 will be randomly assigned to an attention 
control group that will receive an online, self-guided program called Caregiving During Crisis.  
Pragmatic elements of this pilot clinical trial include use of electronic health record systems at 
each health care system site to identify and recruit caregivers, use of electronic patient portals to 
identify and invite caregivers to join the study, and the plan to incorporate caregiver-reported 
outcomes used in the study's outcome evaluation into the electronic health records of the persons 
living with ADRD/patients who receive care at the clinics. 
Three Tele-Savvy programs, with 10 caregivers in each Tele-Savvy program cohort, will be held 
sequentially at each health care system site, for a total of 60 caregivers in 6 Tele-Savvy cohorts. 
Recruitment will occur in three waves, whereby caregivers will be randomly assigned at a 3:2 
ratio to either Tele-Savvy or the attention control group until the first Tele-Savvy cohort is filled 

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(first wave), followed by the same randomization procedure until the second and third Tele-
Savvy cohorts are filled.   
The Tele-Savvy program, a low-risk, psychoeducational intervention, is grounded in social 
learning and stress process theory and its main goal is to produce improved caregiver mastery 
over the symptom management skills commonly encountered when supervising and caring at 
home for an older adult living with ADRD. Over the 7-week program, there are synchronous and 
asynchronous activities each week. The synchronous portion includes weekly scheduled 
videoconferences (60-80 min) that serve as an online classroom in which facilitators lead 
lectures and discussions and provide a venue for caregivers’ interactions and sharing of their 
experiences. The majority of Tele-Savvy is asynchronous. Daily, caregivers access online 6- to 
15-min prerecorded videos, each focused on one main learning objective. The lessons’ didactic 
messages are delivered through expert presentations that are usually augmented by vignettes 
enacted by amateur actors playing a “caregiving family” in various dementia-stage-specific 
caregiving situations and using caregiving strategies in familiar settings. Caregivers can watch 
the lessons whenever and as often as they wish. The Canvas platform at Emory University 
houses the Tele-Savvy software that includes analytics to monitor caregivers’ use of 
asynchronous material each week.” Topics of the synchronous sessions progress from cognitive 
losses through caregivers’ emotions, guiding behavior and decision-making skills, and family 
systems. Videos depicting caregiving situations follow a similar course as the more didactic 
videoconference topic presentations each week, ending with increasing caregiver mastery and the 
concept of caregiver village. 
The attention control group will receive the self-guided Caregiving During Crisis program. 
Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing 
education course aimed at developing the competency of informal caregivers of community-
dwelling persons living with dementia to ensure the safety of that person and themselves during 
this time of the COVID-19 pandemic. The course, readily accessible by home computer or 
smartphone, describes methods of home infection control and prevention to create a Safe Home 
space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies 
for safely allowing service personnel (e.g., home health aides or electricians) and select family 
members to enter the Safe Home space, and risk management strategies to frame decisions 
when/if COVID restrictions are relaxed or revoked.  
Evaluation of the Tele-Savvy program is based on three outcomes: caregiver mastery, perceived 
stress, and reactions to behavioral and psychological symptom expressed by the person living 
with ADRD. Identical outcomes will be measured in the attention control group as in the Tele-
Savvy program cohorts, at the same time points: pre-randomization; 3 months post-
randomization for all; and 6 months post-randomization for 40 of the 60 Tele-Savvy caregivers 
(those in the first two program cohorts at each site) and 26 of the 40 caregivers in the attention 
control group. Also, we will employ process measures of participation and engagement in the 
interventions for caregivers in both arms of the trial. 
We also will conduct an implementation evaluation guided by Normalization Process Theory to 
learn how well the Tele-Savvy intervention was accepted and perceived as a feasible ongoing 
caregiver educational program offered by the health care system clinics by caregivers and clinic 
staff, and to learn how successfully caregiver outcome data were embedded within the electronic 
health record system as planned. 

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4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria  
Participants must meet all of the inclusion criteria to participate in this study. Individuals will be 
eligible if they are: age 18 or older; identified by EHR systems and confirmed by a health care 
provider as a family member or unpaid significant other who provides care at home for an older 
adult (age 65 or older) living with ADRD; English speaking; able to understand study procedures 
and comply with them for the entire length of the study; and have access to appropriate video 
and audio technology to be able to participate in a Tele-Savvy program, or to be able to access 
the Caregiving During Crisis self-guided program.  
4.2 Exclusion Criteria  
All candidates meeting any of the exclusion criteria at baseline will be excluded from study 
participation. Exclusion criteria: unwilling to be randomized to receive either Tele-Savvy or 
Caregiving During Crisis; and plans to admit the person living with ADRD to a nursing home on 
a long-term basis within 6 months of randomization. 
4.3 Study Enrollment Procedures  
A total of 100 caregivers will be enrolled in this pilot study, 50 caregivers from the Integrated 
Memory Care Clinic at Emory Healthcare, and 50 caregivers from Geriatrics Associates, the 
outpatient geriatric care center at UConn Health. At both study sites, caregivers will be identified 
in Electronic Health Records (EHRs) of patients age 65 or older with a diagnosis of Alzheimer’s 
disease or other dementia (ADRD) as individuals to contact for patient care matters and who are 
known to clinicians and clinic staff to accompany patients to outpatient medical appointments. 
Caregivers of patients with ADRD identified through EHRs will be confirmed by clinicians as 
appropriate family/other informal caregivers, and after clinician confirmation caregivers will be 
provided information about an opportunity to opt-in or out to receive potentially one of two 
caregiver programs – Tele-Savvy or Caregiving During Crisis. This information will be provided 
either by telephone, email, or letter by clinic staff members or by an electronically-generated 
invitation from the EHR system. As a pragmatic approach, we will explain to caregivers that we 
are testing two programs we are considering making more generally available through the health 
care system, and that they will be assigned by chance to one or the other. Additionally, the 
information sheet will serve as the document to explain eligibility criteria so that caregivers can 
determine if they are eligible to participate. If caregivers have questions at this point, they will be 
instructed to contact an administrative staff member at each of the two participating study sites. 
 
A report will be generated in the EHR at each study site for review by the study team to 
document when caregivers choose to opt out of study participation upon receiving the invitation. 
Anonymity of caregivers who opt out will be maintained, and only a count of the number of opt 
outs will be reported in any dissemination of study results. 
 
   
Participation in the programs is completely voluntary.  Caregivers will be provided information 
and will have the opportunity to opt-in or out and cancel stop their participation at any time.  
Because of this, and the intention of this study to examine whether the Tele-Savvy program can 
effectively be rolled out in a real-world health care setting, we request a waiver of informed 

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consent for research purposes under the Revised Common Rule. We provide justifications for the 
request in section 6.2. 
 
Recruitment will proceed in 3 waves at each site, with caregivers in each wave randomly 
assigned either to a Tele-Savvy program or an attention control program called Caregiving 
During Crisis. The recruitment goal at each site in each wave is to enroll 10 caregivers for a 
Tele-Savvy program cohort and 6-7 caregivers to receive the Caregiving During Crisis self-
guided program. 
 
The study biostatistician will be responsible for generating randomization strings for each study 
site during each wave of recruitment, and for making the randomization strings available 
electronically in a secure location for access by the study coordinator.  
 
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
The Tele-Savvy program, a low-risk, psychoeducational, group-based intervention, is grounded 
in social learning and stress process theory and its main goal is to produce improved caregiver 
mastery over the symptom management skills commonly encountered when supervising and 
caring at home for an older adult living with ADRD. Over the 7-week program, there are 
synchronous and asynchronous activities each week. The synchronous portion includes weekly 
scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators 
lead lectures and discussions and provide a venue for caregivers’ interactions and sharing of their 
experiences. The majority of Tele-Savvy is asynchronous. Daily, caregivers access online 6- to 
15-min prerecorded videos, each focused on one main learning objective. The lessons’ didactic 
messages are delivered through expert presentations that are usually augmented by vignettes 
enacted by amateur actors playing a “caregiving family” in various dementia-stage-specific 
caregiving situations and using caregiving strategies in familiar settings. Caregivers can watch 
the lessons whenever and as often as they wish. The Canvas platform at Emory University 
houses the Tele-Savvy software that includes analytics to monitor caregivers’ use of 
asynchronous material each week. Topics of the synchronous sessions progress from cognitive 
losses through caregivers’ emotions, guiding behavior and decision-making skills, and family 
systems. Videos depicting caregiving situations follow a similar course as the more didactic 
videoconference topic presentations each week, ending with increasing caregiver mastery and the 
concept of caregiver village. 
The attention control group will receive the self-guided Caregiving During Crisis program. 
Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing 
education course aimed at developing the competency of informal caregivers of community-
dwelling persons living with dementia to ensure the safety of that person and themselves during 
this time of the COVID-19 pandemic. The course, readily accessible by home computer or 
smartphone, describes methods of home infection control and prevention to create a Safe Home 
space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies 
for safely allowing service personnel (e.g., home health aides or electricians) and select family 
members to enter the Safe Home space, and risk management strategies to frame decisions 
when/if COVID restrictions are relaxed or revoked.  

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5.2 Handling of Study Interventions  
Trained Tele-Savvy facilitators are used to lead all synchronous sessions, and an intervention 
manual is provided for both the facilitator and the caregivers participating in each program. 
Facilitators must complete a training program, and the facilitators for this pilot study at both sites 
program will have successfully completed the training before they begin leading the first 
program in this study. Facilitators also complete a checklist of objectives covered in each 
program session to help monitor treatment fidelity. 
The Tele-Savvy program will be offered on a secure Emory University School of Nursing 
Canvas platform.  The security of this platform has been demonstrated in a multi-site efficacy 
clinical trial, so there is little likelihood of its being penetrated in a way that might release 
individual’s private information. Results and publications that come from the evaluation of this 
project will not identify caregivers by name or other PHI identifiers. 
Caregivers assigned to the attention control condition, Caregiving During Crisis, will receive 
online instruction on how to use the self-guided intervention. This self-guided, online, 
asynchronous program will be accessible on the secure Emory University School of Nursing 
Canvas. Individual caregivers will access this program as often as they wish, using a secure 
password. Results and publications that come from the evaluation of this project will not identify 
caregivers by name or other PHI identifiers. 
Because this is a pragmatic clinical trial, no members of the study team will be masked.  
5.3 Concomitant Interventions 
Not applicable to this study. 
5.4 Adherence Assessment  
Tele-Savvy facilitators will be responsible for documenting attendance by caregivers at each 
synchronous session, which will be reviewed to determine caregiver adherence to the 
synchronous component of the intervention. The secure Tele-Savvy online platform located at 
Emory University will record each time a caregiver accesses educational and skill-building 
material for the asynchronous component of the intervention. Caregivers will be issued user 
identification numbers and passwords for both security purposes, and so that their adherence to 
the asynchronous material can be documented and retrieved by approved study staff to determine 
their adherence. Attendance in 4 or more of the 7 synchronous sessions will be operationally 
defined as adherent, and adherence to asynchronous components will be measured as high-
medium-low tertiles.  
 
6 
STUDY PROCEDURES 
 
 

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6.1 
Schedule of Evaluations 
 
 
Assessment 
Baseline, 
Enrollment,  
Randomization:  
3 months post-
randomization 
(+ 2 weeks) 
6 months post-
randomization 
(+ 2 weeks) 
Inclusion/Exclusion Criteria 
X  
  
  
Enrollment/Randomization 
X 
  
  
Demographics 
X 
 
  
Caregiver mastery 
X 
X 
X  
Reactions to behavioral 
and psychological 
symptoms 
X 
X 
X 
Caregiver stress 
X 
X 
 X 
Adverse Events  
X 
X 
X 
 
 
  
  
 
 
  
  
 
  
 
 
 
 
 
 
 
 
 
 

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6.2 Description of Evaluations  
Descriptions for the Schedule of Evaluations define what is to be done at each study 
period and include special considerations or instructions for evaluations.  
This section should include definitions of the row headings in the Schedule of Evaluations 
and any special instructions.  All of the items listed on the Schedule of Evaluations should 
be described in this section.   
6.2.1 Screening Evaluation 
Opt-in/Opt-out Procedure 
Participation in the programs (Tele-Savvy or the control program) is completely voluntary.  
Caregivers will be provided information and will have the opportunity to opt-in or opt-out.  
Because of this, and the intention of this study to examine whether it can be effectively be rolled 
out in a real-world health care setting, we request a waiver of informed consent for research 
purposes under the Revised Common Rule and provide the following justifications: 
 
 (i)  The research involves no more than minimal risk to the subjects: 
The research presents no more than minimal risk of harm or discomfort to subjects beyond those 
ordinarily encountered in daily life or during routine clinical exams or tests.  Participation in the 
programs (Tele-Savvy or the control program) is completely voluntary.  Caregivers will be 
provided information and will have the opportunity to opt-in or opt-out.   
Tele-Savvy is a low risk psychoeducational, group-based program, grounded in social learning 
and stress process theory and its main goal is to produce improved caregiver mastery over the 
symptom management skills commonly encountered when supervising and caring at home for an 
older adult living with ADRD. Offering the Tele-Savvy program as proposed in this pilot study 
is similar to standard approaches used by health systems to invite patients to participate in health 
education programs. Caregiving During Crisis program, used for the control group, is a fully 
online, asynchronous, professionally designed continuing education course aimed at developing 
the competency of informal caregivers of community-dwelling persons living with dementia to 
ensure the safety of that person and themselves during this time of the COVID-19 pandemic.  
Caregivers might experience distress while completing self-administered questionnaires, which 
ask about their experiences as caregivers and their emotional health and well-being. During the 
Tele-Savvy online classes, it is possible that caregivers will experience sadness, anxiety, anger, 
and other emotions during the process of sharing the ADRD journey that their spouses, parents, 
or other relatives/care recipients have traveled, as well as their own caregiving responsibilities. 
They also might become fatigued during the online classes as well as during the times between 
classes when they are viewing educational videos or doing their homework.  These are common 
stressors not outside of what they may ordinarily experience and they are free to stop 
participation in the programs at any time. 
 
 

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(ii)  The research could not practicably be carried out without the requested waiver or 
alteration: 
Inclusion of research informed consent would affect the scientific validity of studying a new 
process of implementing an efficacious intervention—the Tele-Savvy Program—for the 
underserved target population of family caregivers of older adults living with dementia in the 
two health systems participating in this pilot study.  Offering the Tele-Savvy program as 
proposed in this pilot study is similar to standard approaches used by health systems to invite 
patients to participate in health education programs.  One of the study sites, Emory, already 
offers the program as part of its standard practice. 
 
(iii)  The research involves using identifiable private information that could not practicably be 
carried out without using such information in an identifiable format: 
Identifiable private information is required in order to contact caregivers and follow them over 
time.  See section 11.3 below about how we will maintain participant confidentiality. 
Additionally a HIPAA waiver will be requested for the purpose of collecting PHI as it relates to 
the practicability of contacting caregivers and tracking them in the correct medical records of 
patients. Caregiver PHI will be collected for the sole purpose of ensuring that caregiver data are 
stored in the correct EMR record, that of the patient for whom they are a caregiver. 
 
(iv)  The waiver or alteration will not adversely affect the rights and welfare of the subjects: 
Caregivers will be provided with an information sheet that describes their participation in the 
research study and will have the option to Opt-in to participate or Opt-out.   If they choose to 
participate or not, it will not adversely affect the rights and welfare of either their loved ones care 
or their own.  
 
(v) Whenever appropriate, the subjects or legally authorized representatives will be provided 
with additional pertinent information after participation. 
As part of this pragmatic trial, we will share results of the pilot study with relevant clinicians and 
clinical service administrators at both the UConn Health and Emory Healthcare systems. We also 
will provide a brief synopsis of study results written in lay language that the health care systems 
will be able to share with caregivers who participate in the study.  
 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
Once caregiver eligibility has been established, a caregiver will be defined as enrolled in this 
study.  
Baseline Assessments 
All baseline assessments will be completed by caregivers. These self-administered assessment 
tools will be sent electronically to caregivers via secure email from each of the two participating 
clinical sites once they are enrolled in the study. Instructions will be provided to caregivers about 

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how to complete and return baseline assessments, either via return secure email or by uploading 
them to the secure EHR portal.  Baseline assessment tools will include: 
• Demographics: age, sex, race, ethnicity, relationship to older adult with ADRD (e.g., 
spouse, significant other, daughter), co-residence with older adult with ADRD, 
employment status, and number of hours per week providing care to person with ADRD  
• Caregiver mastery: measured using a 4-item self-perceived caregiving competence 
scale53 
• Caregiver reactions to memory and behavior problems: 24-item scale capturing caregiver 
reactions to 24 memory and behavior problems54 
• Perceived Stress Scale: 14-item measure of the degree to which situations in one's life are 
appraised as stressful55 
Randomization 
The administrative study coordinator will electronically access the appropriate study site’s 
randomization string (strings will be generated by the study biostatistician, see Section 4.3) after 
a caregiver returns completed baseline assessment forms. Randomization results will reveal 
whether the caregiver is assigned to the Tele-Savvy program or to the attention control group. 
Randomization will be performed within business 3 days of receipt of completed baseline 
assessment forms. The administrative study coordinator will then notify the Tele-Savvy 
facilitator at each study site of the randomization result, and the facilitator will notify caregivers 
about the treatment group to which they are assigned. The statistician will provide the 
randomization scheme (random sorting using 10% maximum allowable deviation using PASS 
2020 software56), which will be applied after the baseline assessment.  For the Tele-Savvy 
intervention, because 10 caregivers at each site must be assembled in order to convene a cohort, 
a window of up to 3 weeks will be allowed between randomization of a caregiver to that 
treatment group and initiation of the intervention. For the attention control group, caregivers will 
be permitted to access the Caregiving During Crisis program anytime beginning 3 days after 
randomization.   
6.2.3 Follow-up Visits 
Follow-up assessments will be sent electronically to caregivers for self-completion within the 
windows specified in the Table in Section 6.1. Identical assessments as completed at baseline 
(except Demographics) will be completed at the follow-up assessment points. 
6.2.4 Completion/Final Evaluation 
Potential reasons for early termination include unexpected serious illness or death of caregiver, 
voluntary withdrawal from the study by the caregiver, long-term nursing home admission of the 
older adults with ADRD, and death of the older adult with ADRD. Caregivers who terminate due 
to reasons other than death will be asked to complete follow-up assessments as appropriate to the 
time at which they terminate within their 6 months in the study.  This follow-up assessment 
request will be sent electronically by the administrative study coordinator.   
 

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7 
SAFETY ASSESSMENTS  
7.1 Specification of Safety Parameters 
Risks to study participants are primarily psychological in nature. They might experience distress 
while completing self-administered questionnaires, which ask about their experiences as 
caregivers and their emotional health and well-being. During the Tele-Savvy online classes, it is 
possible that caregivers will experience sadness, anxiety, anger, and other emotions during the 
process of sharing the ADRD journey that their spouses, parents, or other relatives/care 
recipients have traveled, as well as their own caregiving responsibilities. They also might 
become fatigued during the online classes as well as during the times between classes when they 
are viewing educational videos or doing their homework.  
 
Protection against risks from self-administered questionnaires: Caregivers will be instructed to 
contact the Tele-Savvy facilitator and/or the study site clinician (Co-investigator Dr. Berg at 
UConn Health and Co-investigator Dr. Clevenger at Emory Healthcare), if they have concerns 
about questionnaire items causing distress or other psychological reactions. The facilitator and/or 
study site clinician will send administrative study coordinator the follow-up outcome status of 
these contacts for recording for study regulatory and reporting purposes.   
 
Risks from participating in the Tele-Savvy program: The principal risk to participation is that the 
content and process may be emotionally-charged for participants and dealing with these 
materials may cause transient discomfort.  However, it is remotely possible that such discomfort 
might persist and be observed by the facilitators to be serious in nature. Both facilitators are 
Licensed Clinical Social Workers with extensive experience working with distressed caregivers 
and are capable of assessing the seriousness of participants’ discomfort. In such cases, 
facilitators will be instructed to note their observation to a participant and offer to refer him or 
her to the services of the clinicians on the study team if caregivers wish to speak with a clinician 
(Co-investigator Dr. Berg at UConn Health and Co-investigator Dr. Clevenger at Emory 
Healthcare). More generally, throughout the 7-week program, facilitators will introduce 
community-based resources and supports should caregivers feel distressed.  
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
All instances of psychological distress necessitating contact of clinicians on the study team will 
be recorded on case report forms by the study coordinator and will follow DSMB or Safety 
Officer and Institutional Review Board (IRB) of record guidelines for reporting.  
7.3 Adverse Events and Serious Adverse Events  
AE Definition: AE is any untoward or unfavorable medical occurrence in a human study 
participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with the participants’ involvement in the research, 
whether or not considered related to participation in the research.  
 
AEs for this study include:  As noted above, the only expected AEs with possibly deleterious 
outcomes for this study are risks of transient emotional upset experienced during completion of 
study questionnaires and/or in processing their caregiving situation during the course of 
participating in the group-based online course. 
 

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SAE Definition: SAEs consist of any adverse event that results in death; is life threatening or 
places the participant at immediate risk of death from the event as it occurred; requires or prolongs 
hospitalization; causes persistent or significant disability or incapacity; results in congenital 
anomalies or birth defects; is another condition which investigators judge to represent significant 
hazard 
 
SAEs for this pilot study include:   
 
No serious adverse events are expected. This is a very low risk study, principally involving 
participants being asked to complete an online program designed to enhance their caregiving 
self-efficacy and mastery when completing complex care tasks, and complete self-administered 
questionnaires. 
7.3.1 Reporting Procedures 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a daily 
basis. In addition, the NIA-appointed Safety Officer will oversee all data and safety monitoring 
activities for this study. The Safety Officer will act in an advisory capacity to the NIA Director to 
monitor participant safety, to evaluate the progress of the study, and to review procedures for 
maintaining the confidentiality of data, the quality of data collection, management, and analyses. 
Advarra IRB will conduct the ethical review required for the protection of human subjects.   
Severity of Event 
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant type 
causing no loss of time from normal activities. Symptoms do not require therapy or a medical 
evaluation; signs and symptoms are transient. 
Moderate: Events introduce a low level of inconvenience or concern to the participant and may 
interfere with daily activities, but are usually improved by simple therapeutic measures; 
moderate experiences may cause some interference with functioning 
Severe:  Events interrupt the participant’s normal daily activities and generally require systemic 
drug therapy or other treatment; they are usually incapacitating 
 
Expectedness  
• Unexpected - nature or severity of the event is not consistent with information about the 
condition under study or intervention in the protocol, consent form, product brochure, or 
investigator brochure. 
• Expected - event is known to be associated with the intervention or condition under 
study.  
Unexpected events will be subject to expedited reporting requirements as described in the NIA 
Guidance on Clinical Trials and in Section 1.2.3, below. 
  
Relatedness   
• Definitely Related:  The adverse event is clearly related to the investigational 
agent/procedure – i.e. an event that follows a reasonable temporal sequence from 
administration of the study intervention, follows a known or expected response pattern to 

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the suspected intervention, that is confirmed by improvement on stopping and 
reappearance of the event on repeated exposure and that could not be reasonably 
explained by the known characteristics of the subject’s clinical state. 
• Possibly Related:  An adverse event that follows a reasonable temporal sequence from 
administration of the study intervention follows a known or expected response pattern to 
the suspected intervention, but that could readily have been produced by a number of 
other factors. 
• Not Related:  The adverse event is clearly not related to the investigational 
agent/procedure - i.e. another cause of the event is most plausible; and/or a clinically 
plausible temporal sequence is inconsistent with the onset of the event and the study 
intervention and/or a causal relationship is considered biologically implausible.  
7.3.2 Follow-up for Adverse Events 
The study will adhere to the reporting requirements for AEs and SAEs stipulated in the NIA 
Adverse Event and Serious Adverse Event Guidelines as outlined below. 
 
Process for identifying AEs and SAEs:  
Facilitators of the Tele-Savvy programs in Connecticut and Georgia will receive training in AEs 
and SAEs and reporting procedures as part of their Tele-Savvy training. Within 24 hours of 
learning about any AEs or SAEs, facilitators will contact the study coordinator at UConn Health 
(Ms. Pascoe), who will complete a study form for collection of AE and SAE information. The 
study coordinator will report SAEs within 24 hours of learning about them to the PI (Dr. 
Fortinsky), will submit unexpected SAEs within 24 hours of learning about these events to the 
parties specified in the following section of this DSMP, and will submit all other SAEs to the 
parties noted in the following section on a quarterly basis, unless otherwise requested by the the 
NIA-appointed Safety Officer. All AEs and SAEs will be discussed during weekly study team 
meetings that will include key personnel from both sites and the study coordinator.    
Adverse event reporting schedule:  
 
Although no SAEs are expected due to the very low risk of the Tele-Savvy interventions, we will 
adhere to the following reporting schedule: 
 
• All adverse events that are both serious (SAE) and unexpected (i.e., have not been 
previously reported for the study’s intervention) will be reported to the IMPACT 
Collaboratory Regulatory and Data Team Leader (Julie Lima PhD), Advarra IRB, NIA 
IMPACT Collaboratory PO (Dr. Partha Bhattacharya), and the NIA-appointed Safety 
Officer of the study’s knowledge of SAE.  
• The summary of all other SAEs will be reported to IMPACT Collaboratory Regulatory 
and Data Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO 
(Dr. Partha Bhattacharya), and the  Safety Officer quarterly, unless otherwise requested 
by the Safety Officer.  

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• All deaths will be reported to IMPACT Collaboratory Regulatory and Data Team Leader 
(Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. Partha 
Bhattacharya), and the Safety Officer within 24 hours of study’s knowledge of death.  
• AEs will be reported per IRB policies and also to IMPACT Collaboratory Regulatory and 
Data Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. 
Partha Bhattacharya), and the Safety Officer at minimum every 6 months, or at a 
frequency requested by NIA and/or Safety Officer.  
7.4 Safety Monitoring 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a daily 
basis. In addition, the NIA-appointed Safety Officerwill oversee all data and safety monitoring 
activities for this study. The Safety Officer will act in an advisory capacity to the NIA Director to 
monitor participant safety, to evaluate the progress of the study, and to review procedures for 
maintaining the confidentiality of data, the quality of data collection, management, and analyses. 
Advarra IRB will conduct the ethical review required for the protection of human subjects.   
8 
INTERVENTION DISCONTINUATION  
We do not anticipate discontinuing this study because the intervention has been tested in an 
efficacy trial that was successfully completed. 
Caregivers may withdraw voluntarily from participation in the study at any time and for any 
reason. We will continuing to follow them, with their permission, even if the study intervention 
is discontinued. If modifications are required to the planned follow-up schedule due to temporary 
or permanent discontinuation of caregivers from the intervention, we will document accordingly 
and make every effort to complete one or both follow-up assessment points.   
Replacement of subjects who discontinue will not be done in this study. 
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
Statistical hypothesis: Caregivers who participate in the Tele-Savvy intervention will experience 
greater improvement in caregiver mastery between baseline and 3 month follow-up compared to 
caregivers who receive the self-guided, online Caregiving During Crisis program. 
Secondary hypotheses: Caregivers who participate in the Tele-Savvy intervention will 
experience greater improvement in reactions to behavioral and psychological symptoms of 
ADRD and in caregiver stress between baseline and 3 month follow-up compared to caregivers 
who receive the self-guided, online Caregiving During Crisis program. 
In this pilot pragmatic clinical trial, our primary goal is to successfully enroll caregivers invited 
to participate in this study by clinical sites in health care systems within the daily workflow of 
clinical activities. Within the one-year time frame allowed for this pilot study, we determined 
that we could enroll, at each of the two clinical sites, 3 sequential Tele-Savvy programs. We 
further determined that we could introduce an attention control condition and randomly assign 
caregivers to receive Tele-Savvy or the control condition in waves, each wave representing a 

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caregivers participating in a distinct Tele-Savvy program and a comparison group of caregivers 
receiving the Caregiving During Crisis program.     
9.2 Sample Size and Randomization 
9.2.1 Treatment Assignment Procedures 
Three Tele-Savvy programs, with 10 caregivers in each Tele-Savvy program cohort, will be held 
sequentially at each health care system site, for a total of 60 caregivers in 6 Tele-Savvy cohorts. 
Recruitment will occur in three waves, whereby caregivers will be randomly assigned at a 3:2 
ratio to either Tele-Savvy or the attention control group until the first Tele-Savvy cohort is filled 
(first wave), followed by the same randomization procedure until the second and third Tele-
Savvy cohorts are filled. 
9.3 Interim analyses and Stopping Rules 
No interim analyses are planned. 
9.4 Outcomes  
9.4.1 Primary outcome   
The primary outcome will be caregiver mastery of skills required to adequately fulfill 
the roles of being a dementia family caregiver. This primary outcome is consistent 
with the Social Learning theory42,43 underlying the Tele-Savvy intervention and with 
the content and learning dynamics of Tele Savvy sessions. Caregiver mastery will be 
measured using the mastery items from the measure developed by Pearlin and 
colleagues53; this measure was used as the primary outcome in the Tele-Savvy 
efficacy study.47 This outcome will be measured at study baseline for each caregiver 
(pre-randomization), 3 months post-randomization for all caregivers, and 6 months 
post-randomization for caregivers in the first and second waves. 
9.4.2 Secondary outcomes   
Secondary outcomes, also used in the Tele-Savvy efficacy study, will include 
caregiver reactions to behavioral and psychological symptoms expressed by persons 
living with dementia, using the Revised Memory and Behavior Problem Checklist, 
caregiver reactions scale,54 and perceived stress using the global measure of 
perceived stress measure.55   
9.5 Data Analyses 
The proposed sample size is for 60 caregivers randomized to a Tele-Savvy group and 40 
caregivers randomized to an attention control group with data collection at 2 primary time points 
(baseline and 3 months (post treatment)). This design is adequately powered at 80% power and 
5% level of significance to detect medium effect sizes for the group effect (Cohen’s f=0.285), 
within subject time effect (f=0.282) and group-by-time treatment effect (f=0.282) using repeated 
measures analysis of variance (RM-ANOVA).57,58 This expected effect size is supported by 
previously measured improvements in caregiver mastery from the “Testing Tele-Savvy” study, 
NIH R01AG054079. We also intend to collect an additional follow-up time point at 6 months as 
a measure of sustainability of the treatment for approximately 2/3 of the participants (40 in Tele-

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Savvy and 26 in attention control). For this smaller sample with a third time point we will be 
able to detect larger effects sizes (f=0.350 for group, f=0.388 for the time and group-by-time 
effects). In the “Testing Tele-Savvy” study, an effect size of f=0.46 was recorded for caregiver 
mastery improvements in active Tele-Savvy program participants. All data will be reviewed for 
completeness prior to analysis. All survey instruments will be scored and reliability computed 
prior to analysis. All measures will be assessed for normality and modeling assumptions with 
mathematical transformation applied as necessary prior to analysis. Multilevel mixed linear 
models (MLM) will be performed to utilize all data collected at each time point for all caregivers 
to assess changes in measures over time adjusting for attrition as needed. MLM will also adjust 
for the non-independence of the data collected across time nested within each subject. Post hoc 
pairwise comparisons between time points within subjects will be performed using Sidak error 
rate adjustments to control for multiple comparisons error rate inflation. Cohort number and 
clinical site will also be evaluated to see if any additional clustering effects are noted within each 
cohort or at each clinical site. Additionally, after performing an intent-to-treat (ITT) analysis, a 
follow-up analysis will also be conducted to see what if any additional effects were seen for 
subjects who were adherent versus those who weren’t, looking at the number of sessions 
attended for potential dose effect. The demographics of the subjects will also be evaluated as 
potential covariates for the statistical models. All statistical tests will be performed at 5% level of 
significance, with 95% confidence intervals reported for all effect sizes. 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
Self-Administered Questionnaires: These questionnaires are attached to the CIRBI application 
form. All study caregivers will be assigned ID numbers at enrollment, which will be used as 
identifiers on self-administered questionnaires. Caregivers will receive questionnaires via secure 
email and/or by password-protected portals at each site. Files linking study ID numbers to 
subjects’ identities will be kept in a separate password-protected file stored on a secure server, 
with access monitored by study personnel at the UConn Health site and the Emory Healthcare 
site.  
10.2 Data Management  
All quantitative data from self-administered caregiver questionnaires will be stored in a REDCap 
database at the UConn Health site, and in a TONIC database at the Emory Healthcare site. Data 
from individual caregivers will be de-identified and stored using ID numbers. Each site will be 
responsible for maintaining in a password-protected file and server the document linking subject 
names and de-identified ID numbers. The clinical data manager at the UConn Health site (Ms. 
Ohlheiser) and co-investigator Dr. Clevenger at the Emory Healthcare site will be responsible for 
the protection of their respective site’s data files. Transfer of de-identified study data files to the 
study Biostatistician at Emory School of Nursing (Dr. Higgins) will occur using secure file 
transfer software at each of the study sites. Dr. Higgins will be responsible for conducting all 
quantitative data analyses. 
Additionally, consistent with Objective 3 of this pragmatic clinical trial, we intend to implement 
procedures at both study sites whereby caregiver questionnaire results will be uploaded into 
electronic health record (EHR) systems. This is an innovative data management feature that has 

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the goal of enabling routine collection of these caregiver measures and inclusion of these 
measures into the EHRs at both health care systems. The clinical data manager at the UConn 
Health site (Ms. Ohlheiser) and co-investigator Dr. Clevenger at the Emory Healthcare site will 
be responsible for leading efforts to work with information technology staff at their sites to 
enable transfer of caregiver outcome measures to their respective EHR systems in such a way 
that these data are linked to the electronic records of the patients with ADRD who receive care 
by clinicians at these study sites.  
10.3 Quality Assurance  
10.3.1 
Training 
Dr. Fortinsky will be responsible for training the administrative study coordinator and the data 
management team based at UConn Health in all aspects of the study related to coordination and 
data-related tasks. Dr. Hepburn will be responsible for training facilitators to deliver the Tele-
Savvy intervention, for ensuring that the Caregiving During Crisis program is accessible to 
caregivers assigned to the attention control condition, and that the software for both interventions 
is working properly to monitor and document access to the software on the secure server at 
Emory University. Dr. Berg and Dr. Clevenger will be responsible for oversight of the clinical 
study sites at UConn Health and Emory Healthcare, respectively, to ensure that pragmatic trial 
processes implemented to identify and invite caregivers to join the study are operating smoothly 
and consistently throughout the study. 
10.3.2 Quality Control Committee  
Drs. Fortinsky, Hepburn, Berg, and Clevenger will form the quality control committee and will 
meet no less frequently than biweekly throughout the study period. They will be responsible for 
reviewing enrollment reports, adverse event reports, and protocol deviations at each meeting, and 
will work together to resolve potential problems related to recruitment and retention of 
caregivers at both study sites, as well as to patterns of adverse events requiring attention and 
resolution. The study coordinator will prepare enrollment, adverse event, and protocol deviation 
reports for each meeting of this committee.  This Committee also will be responsible for 
determining policies and procedures governing publication and other dissemination activities 
related to results from this study. 
10.3.3 Metrics 
Ms. Ohlheiser at the UConn Health site and Dr. Clevenger at the Emory Healthcare site will be 
responsible for monitoring the quality and completeness of self-administered questionnaires sent 
by study caregivers at each time point. Errors encountered will be forwarded to the study 
coordinator who will contact caregivers to resolve any data-related concerns regarding outcome 
measures. The study coordinator also will be available to answer questions from caregivers about 
the self-administered questionnaire items.  
10.3.4 Protocol Deviations 
Case report forms will be used to document protocol deviations. Tele-Savvy facilitators will be 
trained by Dr. Hepburn to document any protocol deviations related to the intervention, and the 
study coordinator will be trained to document any protocol deviations related to the study design. 
Protocol deviations will be reviewed at meetings of the quality control committee as noted in 
Section 10.3.2. 

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10.3.5 Monitoring 
Site monitoring will be conducted by the IMPACT Collaboratory as noted in Section 7.3.1.  
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol and any subsequent modifications will be reviewed and approved by the IRB or 
ethics committee responsible for oversight of the study.  
11.2 Informed Consent Forms 
Participation in the programs (Tele-Savvy or the control program) is completely voluntary.  
Caregivers will be provided with a study information sheet and will have the opportunity to opt-
in.  Because of this, and the intention of this study to examine whether it can be effectively be 
rolled out in a real-world health care setting, we request a waiver of informed consent for 
research purposes under the Revised Common Rule and provided justifications for our request in 
section 6.3. 
11.3 Participant Confidentiality  
Data safety and protection procedures and policies are in place at both study sites to ensure 
confidentiality of research data. All study participants’ names and locations will be coded and 
there will be no way to identify caregivers enrolled in the study in any published reports or data.  
 
Self-Administered Questionnaires: All study subjects will be assigned ID numbers at enrollment, 
which will be used as identifiers on self-administered questionnaires. Caregivers will receive 
questionnaires via secure email and/or by password-protected portals at each site. Files linking 
study ID numbers to subjects’ identities will be kept in a separate password-protected file stored 
on a secure server, with access monitored by the clinical data manager at the UConn Health site 
and co-investigator Dr. Clevenger at the Emory Healthcare site. All quantitative data from self-
administered caregiver questionnaires will be stored in a REDCap database at the UConn Health 
site, and in a TONIC database at the Emory Healthcare site. Data from individual caregivers will 
be de-identified and stored using ID numbers.  The clinical data manager at the UConn Health 
site and co-investigator Dr. Clevenger at the Emory Healthcare site also will be responsible for 
the protection of their respective site’s data files. Transfer of de-identified study data files to the 
study Biostatistician at Emory School of Nursing (Dr. Higgins) will occur using secure file 
transfer software at each of the sites. Dr. Higgins will be responsible for conducting all 
quantitative data analyses. 
 
Electronic Health Records (EHRs):  Internal policies and procedures governing data 
confidentiality and patient anonymity at both study sites will be followed to utilize EHRs for 
identifying potential study participants.  Also, as noted in Section 10.2, working with site 
information technology personnel at both health care systems, we will implement procedures 
enabling routine collection of these caregiver measures and inclusion of these measures into the 
EHRs at both health care systems. 
 

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At both study sites, all paper records will be kept in locked file cabinets in locked rooms.  All 
computer entry and networking programs will be done using de-identified IDs only. Information 
will not be released without written permission of the participant, except as necessary for 
monitoring by IRB and the NIA-appointed Safety Officer. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or other 
government agencies as part of their duties to ensure that research participants are protected.  
12 
ETHICAL CONSIDERATIONS 
Investigators and clinical trials staff involved in oversight, conduct, or management of this study 
have been trained in good clinical practice (GCP). 
13 
COMMITTEES 
Please see Section 10.3.2 for a description of the Quality Control Committee for this study. 
14 
PUBLICATION OF RESEARCH FINDINGS 
Publication and other dissemination activities related to results of this trial will be governed by 
the policies and procedures developed by the Quality Control Committee.  Any presentation, 
abstract, or manuscript will be made available for review by the sponsor and the NIA prior to 
submission. 
15 
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16 
SUPPLEMENTS/APPENDICES 
Not applicable.