Virtual Coaching to Maximize Dementia Caregivers' Respite Time-Use: A Stage 1 Pilot Test for Feasibility and Efficacy
Phase: NA
Conditions: Anxiety, Burden, Dependency, Caregiver
Sponsor: University of Utah

Virtual Coaching to Maximize Dementia Caregiver’s Respite Time Use 
NCT03689179 
Document Date: September 5, 2023 

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PUBLIC FACING TITLE:  Time for Living and Caring (TLC) 
Study: A Research Study to Learn How Dementia 
Caregivers Use Respite 
 
 
OFFICIAL TITLE:  Virtual Coaching to Maximize Dementia 
Caregivers’ Respite Time-Use: A Stage 1 Pilot Test for 
Feasibility and Efficacy 
 
Protocol Summary 
 
 
 
IRB Approval 
Date of 
Current 
Version: 
9/5/2023 
University of 
Utah IRB #: 
IRB_00120589 
Sponsor: NIH NATIONAL INSTITUTE ON AGING 
  
Principal 
Investigator: 
Rebecca Utz 
Internal Staff 
and  Sub-
Investigators: 
Site Name 
Staff Names 
University of Utah 
Rebecca Utz 
 
Anna Hsu 
 
Donald Godfrey 
 
Eli Iacob 
 
Bob Wong 
 
Max Coleman 
 
Michael Caserta 
 
Sarah Neller 
 
Jacqueline Eaton 
 
Alexandra Terrill 
 
Catharine Sparks 
 
AMBER THOMPSON 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

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Background and Introduction 
 
SIGNIFICANCE  
The challenge of providing care to a rapidly growing number of adults with Alzheimer’s 
Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD) has entered a crisis 
phase.1,23 There are presently 5.7 million Americans living with AD; these numbers are 
expected to grow to nearly 14 million by 2050.1 Currently, about 1 in 3 older adults die with 
AD/ADRD, and every 65 seconds someone develops the disease. Family members often 
provide significant amounts of care to these persons in their homes and community. Currently, 
there are over 42 million family caregivers in the U.S. caring for older adults in 
general,24 with 16.1 of these providing care for persons AD/ADRD.1 Dementia caregivers 
provide 18.4 billion hours of care annually, estimated at a value of $277 
billion.1 Family caregivers are generally unpaid and perform instrumental and technical care, 
often without adequate support or training.25,26 Due to various demographic trends, the 
number of available caregivers is not keeping pace with the increasing numbers of those who 
need care.2,16,27  Our population is rapidly aging, leading to a shrinking overall “caregiver 
support ratio.”2 The availability of family caregivers is also affected by couples having fewer 
children, increasing divorce rates among those age 50+, and more women and older persons 
who want or need to be in the workforce.28,29 On top of these demographic realities, 
the caregiving crisis is fueled by the physical and mental health declines, financial hardships, 
and personal sacrifices that caregivers experience after years of fulfilling the expectations 
associated with caregiving.2,30,31 In particular, those caring for someone 
with AD/ADRD have exceptionally high levels of daily stress,32-35 making our reliance on 
these particular caregivers to be even more tenable and unsustainable.36 Thus, establishing 
new ways to support dementia caregivers is critical for our nation’s public and economic 
health.  
Over the past couple of decades, the NIH funded two major caregiver intervention 
studies:37 REACH I (1996-2000),38 consisting of nine interventions to 
reduce AD/ADRD caregiver stress and the 5-site REACH II studies (2001-2006).39 These 
studies, as well as many others, have examined different types of caregiver interventions 
including self-care, safety, social support, emotional wellbeing, management of behavioral 
problems, skill training, telephone-based support, behavior modification, family therapy, 
computerized telephone communication, coping classes, and support 
groups.37,39 Most caregiver support programs, including those tested in the REACH 
studies, produce modest benefits for caregivers,40 but surprisingly, very few have examined 
the effectiveness of respite services.8,9,33,41,42 Respite is defined as formal services or 
informal arrangements that give caregivers time away from their caregiving duties.43 It has 
been identified as one of the most needed and desired services 6 and is thought to be one of the 
most promising ways to maintain and enhance caregiver wellbeing.13 Respite 
allows caregivers chances to maintain their health, social and family relationships, and other 
aspects of their daily lives that they neglected due to their overwhelming caregiving 
tasks.44 Several policy initiatives, including the 2018 Recognize, Assist, Include, Support, and 
Engage (RAISE) Family Caregivers Act, document that respite is critical to managing the 
caregiving crisis.16,45 However, past research on the effectiveness of respite finds only 
moderately positive, and often inconsistent or mixed results.11,13,43,46-48 No specific type 

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of respite activity is most effective, as time-use during respite needs to match the caregiver’s 
profile, culture, and caregiving circumstances.49,50 While skepticism about respite justifiably 
remains, we cannot afford to neglect its considerable promise, given that it is the most 
requested service from caregivers. From an intervention and policy standpoint, there is a need 
to deliver support that may make respite more effective for family caregivers, especially those 
AD/ADRD caregivers that are among the most burdened of all and could therefore benefit the 
most from effective use of respite.   
Scientific Premise - An important element missing from the research on respite’s 
effectiveness is how caregivers use their respite time. Congruence between desired and actual 
time use has been identified as a predictor of overall life satisfaction.51 Our previous research 
suggests that if caregivers are able to make respite more effective and have higher levels 
of respite time-use satisfaction, they will enhance their wellbeing and prevent further 
burnout, enabling them to continue in their role as caregivers for longer periods of 
time. An expert panel sponsored by ARCH (a federally-funded national respite network 
and resource center) recently summarized the state of research on respite and 
provided guidelines for future research;52 53 their recommendations included finding ways 
to make respite more effective. Any intervention designed to maximize the benefits of respite, 
or to support AD/ADRD caregivers in general, needs to be cost-effective, scalable, 
individually tailored to caregivers’ needs, and readily available no matter where caregivers 
reside, such as in rural areas.48,54,55 Consistent with a recommendation of the NIH AD 
Research Summit in 2015,56 these goals may be best achieved by delivering interventions 
using widely available mobile and internet technologies.  
The Phase 1 study was deemed Non Human Subjects Research. 
Phase 3 will not be conducted under this IRB application. 
 
 
 
Purpose and Objectives 
 
Respite, defined as time away from caregiving, has been identified as the most needed and 
desired service for family caregivers, especially the 16 million dementia caregivers who are 
faced with long term and demanding caregiving circumstances. Findings on the effectiveness 
of respite services have been mixed –how caregivers spend their respite time seems to be a key 
factor behind these inconsistent findings. We have developed a novel intervention called 
“Time for Living & Caring” (TLC) that shows promise in improving respite time-use and 
maintaining caregiver wellbeing.  However, it relied on trained facilitators and up to 15-20 
individual home visits or phone calls with each caregiver, limiting its scalability to real world 
practice. The purpose of this study is to redevelop the TLC intervention, in which AD/ADRD 
caregivers are taught strategies to assess and identify ways to spend upcoming periods of 
respite time, to a fully online, self-administered virtual coaching format, and then to pilot-test 
the new TLC intervention for feasibility and efficacy.  
Aim 1 is to modify, adapt, and refine the existing intervention modules. This phase of the 
project utilizes a community-engaged design process where stakeholders (i.e., current or 

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former caregivers, diverse community leaders, respite providers) will work alongside the 
research, technical, and creative teams to develop and provide feedback on the TLC design, 
features, and prototypes. 
Aim 2 is to conduct a pilot test with dementia caregivers who are currently using respite. This 
phase uses a full powered pilot sample (n=120) and a randomized waitlist control experimental 
design where participants are exposed to the redeveloped TLC intervention for 8 weeks and 
will provide assessments of daily respite use, respite time-use satisfaction, and wellbeing. 
These pilot data will be used to assess feasibility and to explore hypotheses regarding the 
potential efficacy of the intervention, as well as the mechanism (i.e., time-use satisfaction) 
underlying the intervention’s effect on wellbeing. Wellbeing is measured with two primary 
outcome of anxiety and caregiver burden, both thought to be closely related and responsive to 
intervention’s purpose.  
Aim 3 is intended to explore future implementation of the redeveloped TLC intervention with 
respite providers.  This provides yet another layer of the tool’s feasibility. We will host 
webinars to demonstrate the features and functionality of the TLC intervention as well as to 
preview pilot study results from Aim 2, then ask providers for feedback on their likelihood of 
implementation and barriers to using TLC with their clients. 
Together, these three aims represent a comprehensive approach to Stage 1 research activities, 
with the overall goal of developing an intervention that is scalable to real world applications. 
Throughout all stages of the proposed project, our team is committed to community-engaged 
research practices, where community partners will provide input and connect us with potential 
research participants. Given this pragmatic yet scientifically rigorous approach, the results 
have the potential to guide and accelerate the eventual implementation of the TLC intervention 
to community and health care practice.  
This application relates specifically to Phase 2 of the project, which specifically addresses Aim 
2 where human subjects will be recruited and enrolled.  
 
 
 
Study Population 
 
Age of Participants: Over 18 years of age 
 
Sample Size: 
At Utah: 
150  
All Centers: 
150 
 
Inclusion Criteria: 
Inclusion criteria: 
AD/ADRD caregivers who are currently using or interested in using respite, such as home-
care respite providers or adult daycare providers, or informally provided by family members 
or friends.   

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The caregiver must:  
1) be the primary caregiver, 
2) live in the same house with the care recipient, 
3) have access to and/or interest in using respite at least once a week for a minimum of 4 
hours, 
4) be providing care to a family member with Alzheimer's disease or dementia, 
5) be English speaking, and 
6) be age 18 or over.  
We will recruit a total of 150 caregivers with purposive selection of caregivers to ensure that 
we are getting a diverse sample of caregivers (i.e., males and females, racial and ethnic 
diversity, rural and urban residence, early and late-stage dementia caregivers).   
 
 
Exclusion Criteria: 
-   Not a primary caregiver 
-   Not living in the same house with the care recipient 
-   No access and/or interest in using respite at least once a week for a minimum of 4 hours 
- <18 years of age 
-   Non-English speaking 
-   Not providing care to a family member with Alzheimer's disease or dementia 
 
 
Design  
 
Randomized Trial 
 
 
Complete up to 140 brief daily time-use measures. 
 
Study Procedures 
 
Recruitment/Participant Identification Process: 
Recruitment will rely primarily on our team’s relationships with a number of community 
partnerships - for example, Community Faces of Utah, Utah Coalition of Caregiver Support, 
the Utah Telehealth Network, and the Alzheimer's Association (see letters of support) -- who 
will provide referrals to the TLC study team.  These organizations have agreed to collaborate 

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with the investigators, by passing along information and recruitment fliers about the TLC 
study. These groups will pass names of potentially eligible caregivers to the TLC research 
staff (if participant agrees to this transfer of information); or individuals identified by each 
community partner will reach out to the TLC research staff on their own after receiving a 
promotional flyer or business card. Potential participants will only be contacted by the TLC 
study team if they have given their permission to the community partner for their names and 
contact information to be given to the TLC study team for this contact.  Most eligible 
participants will contact the TLC study team on their own, after receiving a flyer and 
information about the study from a community partner. 
Other community-based recruitment strategies include: 
- Advertising in community-based senior-oriented publications, such as Simply Seniors.   
- Distribution of a promotional flyer or study information via websites, social media, 
newsletters, personal contacts, and other listservs that might reach ADRD caregivers in the 
community  (see updated flyer in attachments).  Potentially eligible participants who see the 
promotional flyer and are interested in participating will reach out to TLC study team to learn 
more about the study.  TLC project coordinator and RAs will respond to each inquiry within 
72 hours and begin the informed consent and enrollment process with each. 
We will also use the CHAAD database to identify potentially eligible participants for the TLC 
study (CHAAD database is formerly called the CACIR database, created and maintained by 
Dr. Norman Foster, Professor of Neurology & Director, Center for Alzheimer's Care and 
Imaging Research).  The CHAAD database contains information on up to 9,000 patients seen 
in the CACIR/Cognitive Disorders Clinic since 2008.  Dr. Foster and his team have agreed to 
identify a subset of caregivers (defined as the primary or lead care-partner of a patient seen in 
the CACIR clinic) from the CHAAD database.  All persons included in the database have 
agreed to be contacted for research purposes.  We will mail an initial "opt-out" letter to the 
identified care-partners describing the TLC study and giving them the option to 'opt out' of 
further contact from the TLC study (see 'opt-out' letter in attachments).  After waiting two-
weeks from the date of anticipated delivery of the 'opt out' letters, the TLC project coordinator 
or RA will initiate contact with any caregiver who did not opt-out to tell them more about the 
study and go through the informed consent process for those who are interested in 
participating.    
INFORMED CONSENT & ENROLLMENT:  Regardless of which method a potential 
participant is referred to the TLC study team, the Project Director and/or RA will conduct a 
call to screen eligibility and obtain verbal consent from any potentially eligible and 
interested caregiver.  A home visit and/or teleconference (video or audio) will then be set up to 
provide an initial orientation for the research participant, as well as to assess the capabilities of 
their personal technology and internet access.  Participants who consent to participate and who 
have the technological capabilities to participate will be enrolled in the study. 
To facilitate recruitment of the full sample, we will utilize all of these recruitment efforts until 
we meet our enrollment targets; not all participants have to start the study at the same time.  

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Informed Consent: 
Description of location(s) where consent will be obtained:  
Consent will be obtained verbally via home visit and/or teleconference (audio or video). 
Participants will therefore be in their homes and/or other location from which they can 
participate in a teleconference (audio or video). 
 
Description of the consent process(es), including the timing of consent:  
Once caregivers are identified to be potentially eligible for participation, (with their 
permission) they will be put in touch with project staff who will contact them to arrange 
informed consent and (if consented) enrollment into the study. During the consent process the 
potential participant will be informed of the overall purpose of the study, what participation 
would entail in terms of intervention participation and data collection, the randomization 
process (including they could be randomized into a wait-list control condition), potential risks, 
potential benefits (to self and society) and how they will be reimbursed for their time. They 
will also be informed that their participation would be entirely voluntary and that they could 
drop out at any time, and that their withdrawal or limited participation will not affect the 
respite services they are currently receiving or any services that they might be eligible for in 
the future. They will be informed that all their information will be confidential and secured. 
Participants will be given opportunity to ask questions about the study and participant 
expectations, and then asked to provide verbal consent during that teleconference call (video 
or audio). If the potential participant desires, they will be given additional time to decide if 
they want to participate and then contacted 2-3 days later to learn of their decision. All consent 
will be obtained verbally. Upon receiving verbal consent, Project Director and/or RA will send 
a copy of the formal consent document to the participant by email. The consent form contains 
24-hour phone numbers (including the Institutional Review Board) the participants may call if 
they have concerns or questions regarding their participation. A record of verbal consent and 
documentation of email delivery of the formal consent form will be recorded in REDCap.  
 
Procedures: 
Consenting and enrollment. During Phase 2, which is the only phase of the overall project 
that has been deemed human subjects research, caregivers will be recruited to participate 
with the assistance of the community partners (Community Faces of Utah, Utah Coalition of 
Caregiver Support, and the Utah Telehealth Network) who agreed to collaborate with 
the investigators. These groups will pass names of potentially eligible caregivers to the 
research staff. The Project Director and/or RA will then conduct a follow-up call (audio or 
video) to screen eligibility, describe the project, and obtain verbal consent. Upon receiving 
verbal consent, Project Director and/or RA will email the participant a full consent document 
for their records (see documents and attachments).   
A home visit and/or teleconference (audio or video) will subsequently be set up to provide an 
initial orientation for the research participant, as well as to assess the capabilities of their 
personal technology and internet access. Since this is a pilot test, we would like participants to 
use their own technology if possible, since it will provide us with information about the 
usability and feasibility of the intervention as accessed on a number of different types of 
devices, browsers, and networks. However, if needed, the project will provide a netbook 

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and/or high-speed internet service to those persons who do not have reliable access to these 
technologies.  
Intervention Description & Random assignment to group #1 or group #2 -  The TLC 
intervention is designed to be a fully self-administered 16-week program, where participants 
engage with online tools at least once a week.  The online TLC intervention will guide 
participants through goal setting and goal attainment processes to more effectively use their 
respite time.  They will use a digital calendar to schedule, plan, and review the respite time 
they had each week.  Throughout the intervention period, they will receive personalized 
weekly prompts (via email or text, based on their preferences) giving them instructions and 
reminders about how to schedule, plan, and review their respite needs.  There will be 
a hotline that caregivers can use to contact a project staff member should they encounter any 
unanticipated problems or new barriers. The TLC online intervention also includes resource 
pages to foster success as well as provide information useful to family caregivers 
Upon consent, participants will be randomly assigned to Group #1 or Group #2.  The study 
design is akin to a waitlist control design, with group #1 (treatment group) receiving 8 weeks 
of intervention followed by 8 weeks of continued use of TLC intervention tools, and group 
#2 (waitlist group) doing respite as usual for 8 weeks, followed by 8 weeks of more intensive 
coaching from the TLC intervention.  Both group #1 and #2 will fill out daily/weekly reviews 
of their respite use throughout the calendar functions of the TLC intervention tools during the 
16-week intervention period, as well as monthly questionnaires at baseline/enrollment, week 
4, week 8, week 12, week 16, and week 20.  
Note:  when we created the online, self-administered version of the TLC intervention, 
we merged all data collection instruments with intervention prompts into a single online 
delivery package, so both group #1 and group #2 receive access to the TLC study tools from 
day 1 and end their access at the end of week 20.  This has altered the traditional "waitlist" 
(i.e., no contact) condition associated with group #2.  Both group #1 and group #2 receive the 
same instructions and orientation to the study on day 1.  The groups differ only in the amount 
and type of "virtual coaching" (instructions and prompts from the TLC website) they receive at 
week 1 and week 9.  Group #1 receives more intensive coaching at week 1, with an 
encouragement to continue doing it on their own at week 9.  Group #2 receives less intensive 
coaching at week 1, with a more intensive coaching instructions presented to them at week 9.   
Self-administered questionnaires and daily ecological momentary assessments (EMAs). 
Participants in both conditions will complete self-administered questionnaires at baseline, 
and then every 4 weeks thereafter (for a total of 6 questionnaires, spread across 20 weeks). All 
questionnaires will be distributed electronically via email. Responses will automatically be 
recorded in a secure REDCap data base.  
Participants are also asked to complete daily ecological momentary assessments (EMAs), in 
which they indicate if they used respite that day, and if so, their experienced and 
evaluative satisfaction with respite time-use. The daily EMAs will take about 1-2 minutes to 
complete as they are only 3 items (respite used [yes/no], and two items each measuring 
experienced and evaluative time-use satisfaction). The caregivers will be prompted weekly to 
complete their EMAs.   Note:  as mentioned above, all EMA data collection has been 

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integrated into the online version of the TLC intervention tools through a digital calendar, 
combining the TLC intervention with the collection of daily EMA. 
Each questionnaire will take about 10-45 minutes to complete.  The baseline and final 
questionnaire are significantly longer than the monthly questionnaires (i.e., 10 minutes versus 
45 minutes).  Questionnaires will include standardized fixed-choice and open-ended survey 
questions related to : 
·         demographic indicators  
·         caregiving context, and  
·         caregiver health and well-being (i.e., burden, anxiety, positive affect, global health). 
The final questionnaire includes additional measures related to the participants' use of the TLC 
intervention tools. We will assess their perceptions of feasibility, usability, and acceptability of 
the online version of the TLC intervention.  Other feasibility indicators such as login behavior, 
intervention protocol completion, and dosage will be imported in real-time directly from 
google analytics into the secure REDCap data base.   
 
 
Procedures performed for research purposes only:  
 
 
Statistical Methods, Data Analysis and Interpretation 
 

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STATISTICAL DESIGN & POWER  
The overall project has three specific aims. This application relates to Aim 2, where 
which entails human subjects research.  
Aim 2: Conduct a hypothesis driven pilot test of the TLC intervention with dementia 
caregivers   
Statistical Design & Power - Aim 2  
 
The purpose of Phase 2 is to conduct a fully-powered pilot study to measure feasibility and 
efficacy of the TLC intervention with a sample of dementia caregivers (n=120).  This section 
describes the planned analyses to assess efficacy of the TLC intervention.       
  
Study Design  
Because this is part of early-stage intervention development activities (Stage 1), we have 
designed a clinical trial to pilot-test feasibility as well as efficacy of the redeveloped TLC 
intervention.  We propose to use a waitlist control cohort design, using a fully powered 
sample to provide the most rigorous analysis possible. The waitlist design allows all 
participants to receive the intervention. As shown here in the figure, partcipants will be 
randomized to one of two sequences. After baseline data collection and an initial 
orientation/control period for the first 4 weeks, Group A will have 8 weeks of TLC 
intervention, then 8 weeks of follow-up. Group B will have 8 weeks of waitlist control, 
and then TLC intervention for 8 weeks, beginning at week 12. We will use ecological 
momentary assessment (EMA) during the entire 20-week study period to capture daily time-
use trends for any respite periods received (n=140 daily reports, max). EMA aims to minimize 
recall bias and maximize ecological validity. Primary outcomes data will be collected via 
electroncially administered surveys at baseline (T0) and every 4 weeks thereafter (T4, T8, T12, 
T16, T20), for a total of 6 assessments.This randomized, prospective, and longitudinal design 

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allows each participant to serve as its own control and offers opportunities to assess both 
within- and between-group differences over time (Group A vs. B).   
Measures  
The primary outcome is wellbeing, measured with two standardized scales indicating 
“caregiver burden” and “anxiety.”  The mechanism driving the intervention effect is theorized 
to be related to respite time-use and time-use satisfaction.  This construct is measured 
with “experienced” and “evaluative” time-use measures.    
Analysis  
The analysis to test for efficacy will specifically look at treatment x time interaction that 
combines both vertical (between individuals at given timepoints) as well as horizontal 
(evolution within individual over time) comparisons. We will utilize a multilevel model that 
consists of level 1 (within person) and level 2 (between person). Thus, the overall composite 
two level Multi-Level Mixed effects Model (MLM) is defined as follows with the first set of 
brackets representing fixed effects and second set random effects:  
  
Yij = [β0 + β1Tj + β2Xij] + [ζ0i + ζ1iTij + εij]                                                   [equation 1]  
  
where Yij is the outcome measure (Caregiver Burden and Anxiety) for participant (i) at time 
(j) where j is an indicator for time (baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and 20 
weeks). β0 is the population mean level of the outcome measure prior to the TLC intervention, 
β1 fixed effect for time independent of intervention, Xij is the intervention status (pre-TLC or 
Post-TLC/Follow-up) at timepoint j, and β2 is the intervention treatment effect. Random 
effects include individual-level intercept (ζ0i), individual-level slope of change over time 
(ζ1iTij), and εij for residual error of each outcome measure.  Our hypotheses for Aim 2 are 
summarized here:  
  
  
  

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H1: Burden & anxiety will be lower among the treatment group compared to those in 
control/waitlist condition (direct effect)  
Our primary outcome will test the hypothesis that there will be significant change 
in “caregiver burden” or “anxiety” immediately post intervention. Figure 2 shows the 
anticipated results with no change during the run-in period, increase in wellbeing in Group A 
during the intervention but not WLC. Group B then shows increased wellbeing during 
TLC, with Group A maintaining or slight decrease in “caregiver burden” or “anxiety” over 
time. With the planned 120 participants (60 per group), we will be able to detect small to 
medium effect sizes on the two outcomes with greater than 90% Power (see below). Intent-to-
treat analyses (ITT) will be performed on non-completers using a terminal score for both 
“caregiver burden” and “anxiety” scores.       
H2: Time-use satisfaction will be higher among the treatment group compared to those in 
control/waitlist (direct effect)  
Time-use satisfaction data will be collected daily using EMA, of short questions.  First, did 
you have respite today?  Then, if yes, how satisfied are you with your respite time-use? (1-

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5)  Did the respite time make you feel more positive/negative about your role as a caregiver? 
(1-5). These two items measure “experienced” and “evaluative” time-use 
measures, respectively, which have been theorized to be associated with the wellbeing 
outcomes (anxiety & caregiver burden).  Aggregated averages of these two measures will be 
computed for specific time-periods (i.e., across the four-week interval spanning the primary 
data collection timepoints).  The same MLM will test significance of time x intervention 
interaction on mean Time-use satisfaction following TLC intervention compared to WLC.   
H3: Higher time-use satisfaction will be associated with lower burden & anxiety (direct 
effect)  
Using the same MLM framework, we will examine if aggregate Time-Use Satisfaction 
(predictor) is associated with lower “caregiver burden” and “anxiety.” As an exploratory aim 
we will examine Time (β1) immediately post intervention through follow up to determine 
maintenance, attenuation, or no change in Group A outcomes after TLC for wellbeing (anxiety 
& caregiver burden)  and time-use satisfaction (experienced & evaluative time-use).    
  
H4: Higher time-use satisfaction will mediate the effect of the intervention on burden and 
anxiety (direct & indirect effects)  
Figure 3 displays our overall mediation model, whereby TLC intervention improves wellbeing 
by increasing Respite Time-Use Satisfaction.  We hypothesize that “satisfaction with respite 
time-use” is the factor that links respite use with wellbeing outcomes such that TLC 
intervention leads to improvements in respite quality that in turn produces better outcomes 
over time.   

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Mediation analysis will be conducted as previously outlined for cross-sectional as longitudinal 
models.149, 138, 139 In its simplest form, mediation is represented by three linear equations  
Mediator (Time-Use) = i1 + aX + e1 (2)  
Y (Wellbeing) = i2 + cX + e2     [without mediator](3)  
Y (Wellbeing) = i3 + c’X + bM + e2     [with mediator]            (4)  
  
When substituting the Mediator M in equation 3 the indirect pathway by which the TLC 
intervention impacts wellbeing through time-use is represented by the product of 
coefficients a*b. If significant, then mediation is present. If the direct pathway c in 
equation 3 becomes non-significant in equation 4 (c’) when conditioning on the indirect 
pathway, then M is said to fully mediate the relationship between TLC and wellbeing. 
Importantly, in the models we will control for individual values of the wellbeing outcomes 
obtained before the start of the TLC intervention. The indirect pathway will be tested using the 
Sobel test that divides product-of-coefficients a*b by the first-order delta-method standard 
error of the indirect effect.  This value is compared against a standard normal distribution to 
test for significance.148 We will also consider additional statistical mediation tests that 
account for non-normality of the product of coefficients and/or bootstrapping methods for 
more accurate estimates.121   
  
Although not stated as distinct hypotheses, we will conduct additional exploratory analyses to 
further explain for whom and how the intervention achieves its effect. These analyses will 
be guided by the following questions: Do variations in the receipt of the intervention modify 
these relationships? For example, do participants that report higher 
intervention feasibility (i.e., higher satisfaction and usability of the tool) or higher dosage (i.e, 
they accessed more of the intervention’s features) show stronger treatment effects?  This will 
be assessed by replacing the dichotomous intervention variable X (TLC vs. WLC) in 
equation 1 with measures indicating dosage or perceived feasibility. Similarly, we will explore 
whether individual characteristics or circumstances modify the relationship between 
intervention, time-use satisfaction, and wellbeing over time. Here, we will 
use biologic variables of gender and age as well as measures that capture changes in the 
context of the caregiving relationship as both control variables and interaction. Finally, we will 
explore whether treatment effects maintain, attenuate, or no-change once the intervention 
period ends. This will be assessed using a repeated-measures design using Group A’s data 
from immediately post-intervention through the 8-week follow-up period.   
Power and Sample Size   
We assume clinically relevant small to medium effect sizes in the main outcomes of interest 
corresponding to 4-6.5 mean change on the total “caregiver burden” outcome and 1.0-1.4 mean 
change on the “anxiety” outcome. Power and sensitivity analysis were computed 
in GPower using RMANOVA finding a total sample of 116 would be sufficient to achieve 

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power of greater than 90% to detect these effect sizes. Therefore, we will aim to have a final 
sample size of 120 (60 in each sequence) with a 25% over-recruitment to account for study 
attrition providing a total sample size of 150.   
Sample size and sensitivity analyses for mediation analyses are based on empirical estimates 
conducted by Fritz and MacKinnon (2007).121 Assuming medium effects for each of the two 
parts of the indirect pathways (i.e. TLC->Time-use and Time-use->Wellbeing) in Figure 3, a 
sample size of 75-120 will provide greater than 80% Power (Sobel148 medium-medium 
effects) at p=0.05.  
  
Missing Data  
We will explore missing data patterns in SPSS using the Missing Value Analysis tool. We will 
specify the pattern fixed effects and interactions utilizing Little’s test for Missing Completely 
at Random. In keeping with an intent-to-treat standard and assuming maximum likelihood 
estimation, we will use all available data for analyses. It is not necessary to eliminate 
observations from participants who subsequently drop out, nor is it necessary to impute 
individual observations. Both practices can bias estimation and distort variability. The 
maximum likelihood estimates given the observed data points are the values most likely to 
have generated the complete ensemble of observed sample data under the assumed 
model. Systematic missingness (as determined by missing data patterns) may be included in 
our mixed effects model. Potentially non-ignorable missing data will be investigated using 
multiple imputation sensitivity analyses under a diverse set of covariate predictors. To 
minimize loss of scale scores due to missing items in a computed scale, we will prorate the 
respondent’s score based on available items.  If a respondent is missing more than 30% of the 
items in a computed score for the primary outcome variables, we will code the scale score as 
missing.  
  
Note:  feasibility is another primary outcome of the pilot test.  Feasibility-related analyses are 
discussed at the end of this document, since the focus on feasibility and the analytic 
strategies to measure feasibility are shared across Aims 1, 2, and 3.  
  
Feasibility  
All three aims of the overall project have a shared goal of evaluating some aspect of the 
intervention’s feasibility. This is not a hypothesis driven analysis, other than we expect that the 
TLC intervention to be feasible, from the perspective of both caregiver and provider. Our goal 
is to gather rich data to describe how the intervention is or is not feasible, and how it might be 
improved in later steps toward eventual implementation.   
To guide the feasibility-related analyses, we plan to use the five dimensions of the widely-
accepted and NIH-endorsed RE-AIM framework (Reach, Efficacy, Adoption, Implementation, 

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Maintenance).141-145  RE-AIM provides a systematic and standardized way to think about 
feasibility, and to improve the sustainable adoption and implementation of evidence-based 
interventions. To assess for overall feasibility, the Investigators (PI Utz & Co-I Caserta) will 
systematically archive whether the intervention achieves RE-AIM metrics during each phase 
of the project. Some of these measures are quantifiable and will be evaluated using statistics 
(primarily descriptive statistics); others will rely on qualitative metrics.  
First, we present an overview of the feasibility indicators we plan to use in the study, along 
with descriptive benchmarks that would indicate high levels of feasibility on any given 
item (Figure 4).  Second, we present an overview of the RE-AIM framework, noting which 
types of data and/or analyses from the proposed study will be used to illustrate each of the five 
dimensions of RE-AIM (Figure 5). These frameworks provide a structure and systematical 
methodology for us to consider as we explore and analyze the quantitative and qualitative 
measures of feasibility across the three phases of the study.   
  
Figure 4.  Quantifiable Feasibility Indicators and Benchmarks  
  
Research Feasibility  
Benchmark  
Length of time to identify potential participants (by recruitment sources)  12 months  
Consent/Enrollment Rate vs. those eligible  
≥ 50%  
Enrollment rate (participants/month)  
≥ 12/month  
Research design-related dropout rate  
≤ 10%  
Data collection completion rates (Primary data points and EMAs)  
≥ 80%  
  
Feasibility  
Benchmark  
Access to computer & internet  
≥ 90%  
Length of time to finalize web page design for testing  
24 months  
Length of time to hire and train hotline/chat line staff  
3 months  
System fail rate (e.g., system crashes, down server)  
≤ 5%  
Dosage (# of log-ins)  
At least 
1/week  
Completion of intervention protocol per log-in (assessment, goal-setting, 
action plan)  
≥ 90%  
Intervention-related drop-out rate  
≤ 10%  

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Acceptability  
Benchmark  
Caregiver positive or negative appraisal of intervention  
≥ 90% 
positive  
Caregiver confidence that tool will help make better use of respite time 
(1=low; 5=high)  
Mean ≥ 4  
Consider using tool in the future (yes/no)  
≥ 90% yes  
Would recommend to other respite users to help them plan their respite time 
(yes/no)  
≥ 90% yes  
  
Usability  
Benchmark  
On a scale of 1 to 5, how clear were the instructions on the introductory video?  Mean ≥ 4  
On a scale of 1 to 5, how easy was it to complete the time-use assessment?  
Mean ≥ 4  
On a scale of 1 to 5, how easy was it to go through the goal-setting steps?  
Mean ≥ 4  
On a scale of 1 to 5, how easy was it to complete an action plan to meet your 
goal(s)?  
Mean ≥ 4  
Overall, on a scale of 1 to 5 how easy was the virtual coach to use?  
Mean ≥ 4  
How easy was the layout on the screen to follow on a scale of 1 to 5?  
Mean ≥ 4  
To what extent was the information presented clear and concise on a scale of 1 
to 5  
Mean ≥ 4  
To what extent did having a chatline make the tool more useful on a scale of 1 
to 5?  
Mean ≥ 4  
To what extent was the chat line easy to use on a scale of 1 to 5?  
Mean ≥ 4  
How helpful was the information from the chat line staff on a scale of 1 to 5?  
Mean ≥ 4  
On a scale of 1-5, how useful were the links to other resources?  
Mean ≥ 4  
  
Implementation/Feasibility (from provider perspective)  
Benchmark  
On a scale of 1 to 5, how likely would you consider using this application as 
part of your service delivery?  
Mean ≥ 4  
On a scale of 1 to 5, to what extent do you believe your caregiving clients 
would be interested in using this virtual time-use coaching tool?   
Mean ≥ 4  

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What features of the virtual coach did you like most? Are there any features of 
the virtual coach you did not like? On a scale of 1-5, rank each feature of the 
intervention on its usefulness for your clients?  
Mean > 4  
In what ways would you incorporate it into how you deliver respite 
services? What would make you more likely to incorporate this application as 
part of your service package? What barriers do you believe exist that might 
make you less likely to incorporate this as part of your service package?  
Qualitative 
examples  
What do you think would make your clients more likely to use this tool?  
Qualitative 
examples  
  
Page Break  
Figure 5.  RE-AIM Dimensions, Suggested Questions for Evaluating Intervention, and 
Proposed Study  
  
  
Dimension  
Suggested Questions  
Proposed Study  
Reach   
What percent of potentially eligible 
participants a) were excluded, b) took 
part and c) how representative were 
they?  
  
Tracking and analysis of 
recruitment and eligibility data  
Efficacy or 
Effectiveness   
What impact did the intervention have 
on a) all participants who began the 
program; b) on process intermediate, 
and primary outcomes; and c) on both 
positive and negative (unintended), 
outcomes including quality of life?  
  
Hypothesis-driven statistical 
analyses identifying direct and 
indirect effects of the 
intervention’s efficacy (Aim 2)  
Adoption   
What percent of settings and 
intervention agents within these 
settings a) were excluded, b) 
participated and c) how representative 
were they?  
  
Comparison of provider sample 
characteristics (Aim 3) to 
population of respite providers  

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Implementation   
To what extent were the various 
intervention components delivered as 
intended, especially when conducted 
by different (nonresearch) staff 
members in applied settings?  
  
Qualitative themes describing 
provider comments about barriers 
and likelihood of implementation 
(Aim 3)  
Maintenance   
What were the long-term effects 
(minimum of 6-12 months following 
intervention)?   
  
  
  
  
What was the attrition rate; were drop-
outs representative; and how did 
attrition impact conclusions about 
effectiveness?   
  
  
To what extent were different 
intervention components continued or 
institutionalized? How was the 
original program modified?  
  
Initial maintenance or attenuation 
of intervention efficacy (after 2 
months) will be assessed by 
exploratory analysis comparing 
post-intervention wellbeing to 
follow-up wellbeing (Aim 2)  
  
Attrition rates will be calculated 
and described; missing data will 
be explored as a potential 
moderator of intervention efficacy 
(Aim 2)  
  
Stakeholders (Aim 1), caregivers 
(Aim 2), and providers (Aim 3) 
will all provide information on 
how the intervention might be 
further modified.  
  
 Table adapted from: www.re-aim.org  
Table 1: Amendments submitted and approved by IRB throughout study 
Amendments 
Date 
Description  
Adding RA 
9/2/2019 
Adding new study personnel   
Changing Staff on Project 
2/18/2019 
Adding new study personnel   

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Adding Study Personnel & 
Changes to Design/Procedures 
5/13/2020 
1. Adding new study personnel 
2. Inclusion/exclusion - wording change 
3. Screening eligibility - wording change 
4. Waiver of consent documentation - to 
accommodate verbal consent for phone-
based recruitment 
5. Participant compensation - adjusting 
amount paid for participation  
6. Updated survey documents - wording 
change 
7. Misc. updates to study protocols and 
descriptions to reflect how the 
intervention and data collection are 
integrated into a single online portal 
New URL for Study 
6/25/2020 
Created a study website - adding URL to 
promotional materials  
Adding Staff & Finalized Surveys 
9/4/2020 
Adding study personnel & uploading 
finalized t16 & t20 surveys 
Updating Recruitment Strategies 
12/18/2020 
Updated recruitment flyer & adding a 
new recruitment strategy - using an 
existing database from a cognitive 
disorders clinic 
Adding Study Personnel   
2/26/2021 
Adding new study personnel   
Adding Study Personnel 
5/29/2021 
Adding new study personnel   
Adding Study Personnel   
4/17/2023 
Adding new study personnel   
Adding Study Personnel   
8/30/2023 
Adding new study personnel