The Residential Care Transition Module
Phase: NA
Conditions: Alzheimer Disease, Dementia
Sponsor: University of Minnesota

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ANCILLARY REVIEWS 
DO NOT DELETE.  Submit the completed checklist below with your protocol. 
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PROTOCOL COVER PAGE 
Protocol Title 
The Residential Care Transition Module; NCT02915939 
Principal 
Investigator/Faculty 
Advisor 
Name: Joseph Gaugler, PhD 
Department: School of Public Health 
Telephone Number: 
Email Address: gaug0015@umn.edu 
Student Investigator 
Name: N/A 
Current Academic Status (Student, Fellow, Resident): N/A 
Department: N/A 
Telephone Number: N/A 
Institutional Email Address: N/A 
Scientific Assessment 
I believe Scientific Assessment is not required. 
Version 
Number/Date: 
76, 2/10/2022 
 
 

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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
62 
11.09.20 
Added detail about procedures for 
sending Thank You Letters to 
participants at the end of their study 
completion. Also, we clarified the 
consent procedures so that each 
section of the consent form will be 
briefly reviewed with each potential 
participant to ensure comprehension.   
Yes 
63-64 
N/A 
Discarded 
N/A 
65 
12.15.2020 
Revised adverse event plan to 
enhance clarity. Added clarity to 
survey timing procedures. Edited typo 
on follow-up survey. 
No 
66 
1.8.2021 
Added a script for reaching out to 
participants in the COVID-19 
supplement to participate in the semi-
structured interviews. 
No 
67 
2.10.2021 
Revised email and cover letter 
language for the follow-up surveys for 
Groups B and C to clarify what the 
additional surveys are for. Added 
questions to the follow-up surveys 
about the COVID-19 vaccine. Added 
procedure, with UBACC and phone 
script, to screen participants who staff 
identify as having potential memory 
concerns (in response to 
RNI00005994).  
No 
68 
3.05.2021 
A semi-structured interview script 
was created for bereaved participants 
so that the interview script was more 
sensitive and applicable to 
participants whose care recipient has 
passed away. If a participant’s care 
recipient is still living, the original 
script will still be used. Also, updated 
procedures for working remotely. 
No 
70 
9.2.21 
Added final newsletter along with 
COVID supplement results page and 
No 

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cover letter to Ethos. No changes to 
protocol.  
74 
12.21.21 
Continuing Review and Modification. 
A former employee (Ann Emery, 
carl0219@umn.edu) is receiving IRB-
related updates about this project 
from ethos, please remove her. 
No 
75 
1.11.22 
Staff update; no protocol changes 
 
76 
2.10.2022 
Updated protocol to newest UMN IRB 
Social template, retaining all 
information included in old format.  
Updated study staff not at UMN per 
IRB guidance. 
No 
 
 
 
 

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Table of Contents 
1.0 
Objectives ............................................................................................................................................ 8 
2.0 
Background ......................................................................................................................................... 9 
3.0 
Study Endpoints/Events/Outcomes ............................................................................................. 15 
4.0 
Study Intervention(s)/Interaction(s) ............................................................................................ 15 
5.0 
Procedures Involved ........................................................................................................................ 17 
6.0 
Data Banking .................................................................................................................................... 25 
7.0 
Sharing of Results with Participants ............................................................................................ 25 
8.0 
Study Duration .................................................................................................................................. 26 
9.0 
Study Population .............................................................................................................................. 26 
10.0 
Vulnerable Populations .................................................................................................................. 27 
11.0 
Number of Participants ................................................................................................................... 29 
12.0 
Recruitment Methods ..................................................................................................................... 29 
13.0 
Withdrawal of Participants ............................................................................................................ 31 
14.0 
Risks to Participants ........................................................................................................................ 32 
15.0 
Incomplete Disclosure or Deception ............................................................................................. 33 
16.0 
Potential Benefits to Participants ................................................................................................. 33 
17.0 
Statistical Considerations ............................................................................................................... 33 
18.0 
Health Information and Privacy Compliance ............................................................................. 38 
19.0 
Confidentiality .................................................................................................................................. 41 
20.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ................................... 41 
21.0 
Compensation for Research-Related Injury ................................................................................ 45 
22.0 
Consent Process ................................................................................................................................ 45 
23.0 
Setting ................................................................................................................................................ 48 
24.0 
Multi-Site Research: N/A ................................................................................................................ 49 
25.0 
Coordinating Center Research N/A .............................................................................................. 49 
26.0 
Resources Available ......................................................................................................................... 49 
27.0 
References ......................................................................................................................................... 49 
 

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ABBREVIATIONS/DEFINITIONS 
● 
ADRD: Alzheimer’s disease or a related dementia 
● 
DMO: Data Monitoring Officer  
● 
DSMP: Data and safety monitoring plan 
● 
IRB: Institutional review board 
● 
NH: Nursing home 
● 
NIA: National Institute on Aging 
● 
RCT: Randomized controlled trial 
● 
RC: Research coordinator 
● 
RCTM: Residential Care Transition Module 
● 
RLTC: Residential long-term care 
● 
SPM: Stress Process Model 
● 
SPM-RC: Stress Process Model for Residential Care 
● 
TC: Transition counselor 
● 
UMN: University of Minnesota 
 
 
 
 
 

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1.0 
Objectives 
1.1 
Purpose: This 5-year project will utilize a randomized controlled trial (RCT) to evaluate an 
intervention designed to help families successfully adapt to the admission of a cognitively 
impaired relative to a RLTC facility. The Residential Care Transition Module (RCTM) provides 
6 individualized formal sessions of consultation (one-to-one and family sessions) over a 4-
month period to those who have admitted a relative to a RLTC setting. The RCTM will 
identify individual placement stressors and enhance family caregivers’ strategies for coping 
with them. In this RCT, family members who have admitted a cognitively impaired relative 
to a RLTC setting will be randomly assigned to the RCTM [(n  = 120)] or a usual care control 
condition [(n = 120)]. A mixed methods analysis62 will be used to pursue the following aims: 
 
Specific Aim 1. Assess whether the RCTM yields statistically significant reductions in family 
members’ primary subjective stress (e.g., burden) and negative mental health outcomes 
(depressive symptoms) in the 12 months following enrollment when compared to controls; 
o Secondary Aim 1a. Determine whether the RCTM results in greater increases in caregiver 
competence and self-efficacy when compared to controls; 
o Secondary Aim 1b. Ascertain whether those who receive the RCTM report greater family 
involvement and visits to relatives in RLTC when compared to usual care controls; 
 
Specific Aim 2. Determine whether family members who receive the RCTM indicate 
statistically significant decreases in secondary role strains (perceived adjustment of the 
relative and the caregiver to RLTC placement) over a 12-month period when compared to 
control family members;  
 
Specific Aim 3. Determine whether RCTM family members report statistically significant 
decreases in residential care stress (e.g., improved perceptions of staff communication or staff 
support; reduced upset at having a relative in residential care; reduced negative interactions 
with relatives or staff in the facility) when compared to family members in the usual care 
control group; and  
 
Specific Aim 4. Delineate the mechanism of action of RCTM under conditions of high and low 
success by embedding qualitative components (up to 30 semi-structured interviews) at the 
conclusion of the 12-month evaluation. 
 
The RCTM will fill an important clinical and research gap by evaluating a multidimensional 
intervention designed specifically for families following RLTC entry to determine whether and how 
this approach can help families better navigate residential care transitions of cognitively impaired 
relatives.64,67-70   
 
Many RCTM caregivers have been caring for a relative in RLTC since the onset of the COVID-19 
pandemic, and are currently reporting to us new stressors associated with COVID-19. We will 
systematically assess caregivers’ COVID-19-related experiences and extend the originally planned 
collection of caregiver stress and mental health data for an additional 4-months beyond the 
current study period to capture changes in caregiver mental health and well-being following the 
onset of the pandemic.  The following aims have been identified for the supplement focused on 
caregivers' coping with COVID-19: 
 
Specific Aim 1. Examine COVID-19-specific experiences among RCTM participants with a 
care recipient currently in residential care. We will gather quantitative and qualitative data on 
caregivers’ current COVID-19-specific experiences, including preventive practices implemented by 

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facilities, effects of the pandemic on communication and visiting, and concerns about the care 
recipient’s health and well-being. We will use a parallel-convergent mixed methods design and 
analytic strategy, with data collected via a supplemental quantitative survey delivered at 0-, 1-, 
and 4- months post-pandemic-onset, as well as semi-structured interviews with 20 participants. 
We will also gather insights from RCTM case notes, as recent sessions with currently-enrolled 
participants have focused on addressing caregivers’ challenges in adapting to COVID-19. 
Specific Aim 2. Evaluate the influence of COVID-19 on caregiver stress and mental health 
trajectories for AD/ADRD caregivers. We propose to extend the currently-administered surveys of 
caregiver stress and mental health to collect additional assessments at 0-, 1- and 4-months. This 
will provide a total of up to seven waves of data per participant, with multiple assessments before 
and after the onset of the COVID-19 pandemic. These data will allow us to estimate nonlinear 
longitudinal models examining how caregiver stress and mental health have changed after the 
onset of the pandemic, and how specific COVID-19-related experiences intensify or buffer against 
changes in caregiver stress and well-being. 
Specific Aim 3. Determine whether RCTM treatment group participants are more 
resilient to negative psychosocial effects of COVID-19. There is a need to identify supports and 
services to help RLTC residents and their families adapt to the novel stressors introduced by the 
COVID-19 pandemic. The RCTM intervention is designed to provide caregivers with coping skills 
that may translate to other stressful experiences and potentially protect against negative 
consequences of COVID-19. We will compare trajectories of caregiver stress and well-being across 
the treatment and control groups to determine whether the RCTM provides benefits in the 
context of COVID-19. 
 
2.0 
Background 
2.1 
Significance of Research Question/Purpose:  
Emerging research on family caregiving and institutionalization has found that families do 
not disengage from care responsibilities following relatives’ admissions to residential long-
term care settings. Families instead remain involved in a spectrum of care activities ranging 
from instrumental activities of daily living to emotional support. Perhaps for these reasons, 
a number of studies have noted that caregiving stress, depression, or other key outcomes 
remain stable or sometimes increase following residential long-term care (RLTC) entry for 
certain types of caregivers. A few interventions have attempted to increase family 
involvement after institutionalization, but no rigorous studies have demonstrated that these 
interventions are effective in helping families navigate transitions to RLTC environments. 
Persons with dementia rely heavily on informal (i.e., unpaid) sources of care, and this has a 
staggering effect on families. Currently 85% of the 5.3 million persons with Alzheimer’s 
disease or a related dementia (ADRD) in the United States are cared for by one or more 
family members, and 15 million individuals provide unpaid care to persons with ADRD.1 
There is no one consistent definition of caregiving, but in its most global sense caregiving 
refers to attending to an individual’s health and daily care needs.2,3 Dementia caregiving can 
extend to managing the consequences of specific symptoms, such as behavioral disruptions. 
A well-established literature demonstrates the adverse effects of dementia care on family 
members, including impaired physical health,4-6 financial strain,7 degradation in social well-
being, and increased prevalence of depression, anxiety, or other psychological symptoms.8,9   
 

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2.2 
Preliminary Data:  
R21 AG026525/RCTM Feasibility and Pilot Evaluation. The research team has collaborated to 
establish a strong base of preliminary research to support the evaluation of the RCTM. 
Specifically, preliminary work on this project was supported by R21 AG026525 to Dr. 
Gaugler (PI), Dr. Mittelman (Co-I), and Dr. Hepburn (Co-I);4-6 the R21 also supported 
formative research to develop and test the feasibility of the RCTM. Dr. Gaugler’s research 
team first conducted focus groups at two local RLTC facilities with families and staff (N = 48) 
to determine the need for a psychosocial program for families who have admitted their 
relative to RLTC and to review an outline of potential content for the RCTM intervention. 
The focus groups lasted approximately 2 hours each and posed 4-5 questions with follow-up 
probes. Each facility hosted two focus groups (one consisting of family members and 
another consisting of professional nursing staff). Participants were identified through flyers. 
These focus groups were conducted via the phone to ease participant burden.  Each group 
of 6-10 participants was audiotaped and results were transcribed. A content analysis was 
conducted, and a range of themes emerged that highlighted how family needs could be 
addressed through consultation following RLTC placement, including family members’ stress 
and feelings of guilt, managing the administrative paperwork related to admission, fostering 
positive staff relationships to advocate for a relative’s needs, managing the impact of staff 
turnover on family involvement with and quality of care for the relative, and managing 
family conflict related to the placement transition. Families also indicated the need for a 
“go-to” person to provide psychosocial consultation, support, and education about/referral 
to key resources that could meet their relatives’ care needs (this was a theme that also 
emerged in the staff focus groups, along with the difficulties of establishing positive 
relationships with family due to distrust, negative stereotypes regarding RLTC, and similar 
issues). This focus group information, along with a systematic review of existing protocols 
involving family member support during and after the placement transition,42,43,46-48,75 led to 
the development of the RCTM intervention model and a preliminary treatment manual.  
 
A feasibility study of the RCTM using the draft treatment manual as the principal guide to 
implementation was also conducted by the PI and Mr. Reese. Fifteen Caucasian family 
members (N = 13 daughters; age M = 54.53 years, SD = 5.29; duration of care M = 5.11 
years, SD = 2.56) of cognitively impaired relatives who had placed their relatives in nursing 
homes or memory care units of assisted living facilities approximately a year prior to 
enrollment completed the RCTM intervention. Baseline/pre-RCTM and post-RCTM (4-
months later) interview assessments were also completed. The small sample size precluded 
extensive empirical analysis. Several measures (such as perceived stress, guilt, and distress 
related to care recipient neuropsychiatric problems) trended downward. A content analysis 
of the open-ended data collected from participants as well as the TC notes revealed several 
mechanisms of benefit including the formation of a therapeutic relationship, provision of 
psycho-education related to dementia and its progression, and explorations of guilt and 
stigma. The results made it clear that the initial session held particular importance in that it 
allowed caregivers to fashion their own narrative related to the RLTC transition; repeatedly 
caregivers stated how surprised they were at the positive effects of telling their story in a 
linear and sequential manner. The TC suggested that the act of narrating the event helps to 
remove the sense of immediacy and allows caregivers to build up tolerance and coping skills 
related to RLTC. 
 

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Following feasibility testing and refinement of the treatment manual, a pilot efficacy 
evaluation of the RCTM intervention was conducted.91 A randomized controlled design was 
used (N = 36; n = 19 in usual care control condition; n = 17 in the RCTM treatment 
condition); participants were administered a pre-RCTM baseline survey along with 4- and 8-
month follow-up interviews. Participants had admitted their relatives to a RLTC an average 
of 141 days prior to the baseline interview. Twenty-nine caregivers were women and 17 
were spousal caregivers; all were Caucasian. On average, caregivers were 62.67 years of age 
and had provided care an average of 51.79 months. All RCTM counseling sessions provided 
emotional support to participating caregivers. Twenty-six (29.6%) individual and three 
(33.3%) family counseling sessions addressed relatives’ behaviors. Approximately 40% of all 
individual sessions addressed caregivers’ issues with the relative’s facility compared with 
only one family session. Bivariate analyses of sociodemographic characteristics, caregiving 
duration, and other context of care indices found no statistically significant differences 
between the RCTM treatment and control conditions. Seven care recipients had died during 
the 8-month follow-up; 5 prior to the 4-month interview and 2 prior to the 8-month 
interview. Analyses of variance found that caregivers in the RCTM treatment group 
indicated significantly less distress on the Neuropsychiatric Inventory-Questionnaire92 at 4-
month follow up compared to caregivers in the control group (p< 0.05). Caregivers in the 
RCTM treatment group reported less role overload at 8 months compared to usual care 
controls (p< 0.05). Due to the small pilot sample, a number of findings did not achieve 
statistical significance below the p< 0.05 threshold but trended in the expected clinical 
direction (p ≤ 0.10; role overload at 4 months; Perceived Stress Scale at 4 months;93 and 
Zarit Burden Inventory94 at 8 months). Focus groups conducted following the RCTM 
indicated that caregivers highly valued the readily available psychosocial support following 
RLTC placement. Combined, the preliminary quantitative and qualitative data emphasize 
that the provision of skilled psychosocial support can potentially help families navigate the 
emotional distress and crises in the months following a cognitively impaired relative's 
admission to RLTC.91  
 
Our prior work22-24 established a profile of caregivers most at-risk for persistent negative 
outcomes in the 6 and 12 months after nursing home admission. Wives, daughters, 
caregivers who have challenges meeting the needs of care recipients, and caregivers with 
their own health needs appeared particularly susceptible to high levels of burden in the 6 
months following residential long-term care (RLTC) placement. Husbands and caregivers 
with their own prior health impairments and emotional stressors were most likely to suffer 
from depression in the 12 months after a relative’s RLTC entry.23 Our research leads us to 
hypothesize that psychosocial interventions – particularly in the months immediately 
following admission – can ease the RLTC transition for caregivers and alleviate its adverse 
outcomes such as burden and depression. 
 
2.3 
Existing Literature: Longitudinal analyses of dementia caregiving make it clear that 
caregiving does not “end” with the institutionalization of a cognitively impaired relative.10 
The high prevalence of dementia among NH residents (64% of Medicare beneficiaries in NHs 
have ADRD and 47% of all NH residents have a formally recorded dementia diagnosis)11 
likely influences the need for ongoing family care. Family members thus remain engaged in 
the lives of institutionalized relatives.12,13 While “hands-on” technical care for ambulation 
and transferring is often assumed by direct care workers in a NH or other types of 

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residential memory care settings (e.g., assisted living memory care units), family 
involvement continues and ranges from regular visits, to ongoing provision of more 
instrumental forms of direct care (such as transportation and financial management), to 
interaction with staff to ensure proper care delivery.12-16 Multiple studies have found that 
high levels of caregiving stress or depressive symptoms continue or, in some cases, increase 
with institutionalization.17-21 
Facilitating family caregivers’ RLTC transition is important, because family caregiver well-
being may influence their relative’s quality of life once in a residential setting. Various 
studies have emphasized that while NHs are oriented to delivering the necessary physical 
care, these facilities often fall short of providing hospitable environments or encouraging 
individual residents to pursue the goal of a ‘life worth living.’25-29 Several studies imply that 
social engagement, family visits, and other types of involvement can potentially improve life 
satisfaction and health outcomes for NH or assisted living residents.30-35 These findings 
emphasize that reducing emotional distress and negative mental health outcomes and 
enhancing families’ overall perceptions of and relationships with staff can have positive 
effects on residents’ outcomes.  
 
Innovation 
The RCTM is different from existing evidence-based caregiver intervention models in that it 
is transition-specific; unlike most other interventions the RCTM targets a key transition in 
the dementia caregiving trajectory and as a result is a more focused and compact protocol 
than other multi-component, efficacious dementia caregiver interventions. The RCTM’s 
clinical content is specific to the needs of families attempting to adapt to the residential 
long-term care (RLTC) admission transition. The RCTM is further positioned as an innovative 
intervention when considering the state-of-the-art in transitional care management for 
older adults. Family caregivers often experience significant stress and upheaval when in the 
midst of care transitions for older relatives in need, often because of the lack of 
coordination between care settings.56 Randomized controlled evaluations of transitional 
care support for older persons have demonstrated considerable success,56-60 but these 
protocols have not been explicit about how family caregivers are included.61 Given the 
approach of the RCTM, it is anticipated that this protocol will be among the first clinical 
interventions that adopt a family caregiver focus to facilitate successful residential 
transitions for older persons with cognitive impairment. The RCTM has undergone multiple 
phases of testing to develop a protocol that is clinically and conceptually tailored to 
facilitate families’ management of the RLTC transition for cognitively impaired relatives. 
 
Another innovative aspect of this proposal is the use of mixed methods to evaluate the 
RCTM. Specifically, we propose to use an embedded experimental mixed methods design.62 
Mixed methods is generally defined as the collection and analysis of both quantitative and 
qualitative data that link these two forms of data concurrently or sequentially.63 Data 
integration can occur within the design of a single study or across multiple studies.64 Mixed 
methods research is generally used: a) to better understand a research problem by 
converging numeric trends from quantitative data and specific details from qualitative data; 
and b) to obtain statistical, quantitative data from a sample and identify individuals who 
may expand on the empirical results through qualitative findings.65 The proposed design 
combines the collection and analysis of qualitative data within a traditional randomized 
controlled trial design; the collection of “embedded” qualitative data in the proposed study 

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will occur after the randomized controlled trial.64, p. 90 The analysis of qualitative data will 
enhance interpretation of empirical outcomes and will assist us in examining why and how 
the RCTM worked or did not for ADRD caregivers. This strategy will allow for a more in-
depth exploration of the mechanisms of benefit than existing family caregiver interventions, 
most of which do not adopt qualitative methods to explore processes of intervention 
efficacy.66 Specifically, qualitative components will provide more comprehensive 
information on the mechanisms and pathways that lead to benefit for family caregivers who 
are struggling to navigate the RLTC transition.64,67-70  
 
An additional innovation in the current proposal is the utilization of a conceptual framework 
that is applicable to the RLTC placement transition for families. The conceptual model 
underlying the proposed study is the Stress Process Model for Residential Care (SPM-RC), 
developed by Whitlatch and colleagues20 and based on the widely used Stress Process 
Model (SPM) for dementia caregiving (Pearlin et al.).71 The SPM offers a multidimensional, 
theoretical framework for analyzing the occurrence of stress and outcomes in the caregiving 
career.71,72 The model incorporates an appreciation for the sociodemographic context of 
care (e.g., background characteristics of the caregiver and care recipient), care demands 
(functional, cognitive, and behavioral severity of dementia), subjective stress (caregivers’ 
emotional appraisals of and reactions to care demands), resources (formal and informal 
support), and caregiver well-being (physical and psychological indicators of caregivers’ 
global well-being). The major mechanism that helps to explain exacerbated stress is 
proliferation:72 as stress accumulates in primary stressor domains, this stress then “spreads” 
to life domains outside of the primary caregiving situation (i.e., secondary stressors) which 
then negatively influences global dimensions of dementia caregivers’ mental or physical 
health. In the SPM, psychosocial or formal resources are hypothesized to stem the 
proliferation of stress, thereby limiting or preventing negative health outcomes. 
 
The SPM-RC adds and refines several interconnected domains of Pearlin’s SPM to result in a 
model that is directly pertinent to RLTC. The SPM-RC captures the possible changes in 
relationship processes and structures in areas such as the emotional closeness of the 
relative and family member and family members’ perceptions of difficulty when managing 
relatives’ emotional and mental status (an appraisal that may change and expand once a 
relative is admitted to a RLTC setting; primary subjective stressors). Family members’ 
perceptions of their relative’s adjustment to the RLTC setting can produce “secondary” role 
strains, particularly if the family member feels guilt or believes the placement decision is 
contrary to the wishes of the relative. With RLTC admission, an array of placement-related 
stressors may emerge (residential care stress). These range from establishing effective roles 
and relationships with direct care workers or other facility staff, attempting to remain 
involved in the life of the relative in order to maintain or improve quality of life, and 
advocating for more appropriate care should families perceive that institutional care is of 
deficient quality.73,74 Personal and organizational stressors frequently interact. If family 
members perceive that their relative is not doing well, they may increase their engagement 
in advocacy, hands-on care, or other types of involvement in order to improve their 
relative’s overall sense of well-being (family involvement and visits).35,46,73,74 Similarly, family 
members’ own perceptions of how they have adjusted to a relative’s placement and the 
potentially new roles they have assumed may contribute to their stress. Finally, the model 
includes contextual indices related to family caregivers’ interactions with and perceptions of 

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the RLTC setting itself. Family members’ appraisals of their involvement with and the quality 
of interactions with staff may reflect how well family members’ perceive their own – as well 
as their relative’s – overall adjustment to the residential care setting. In this manner, the 
SPM-RC model incorporates placement-specific stressors to better capture the experience 
of RLTC for family members, including its impact on key emotional and mental health 
outcomes.  
 
Prior efforts have successfully analyzed and tested the SPM-RC model (and several 
hypothesized relationships within it) that informs the RCTM.20 We predict that the RCTM will 
act as a psychosocial resource for family members, operating on and producing beneficial 
outcomes in the key outcome domains identified by the SPM-RC. The RCTM topic areas are 
linked to stressors identified in the model, and its psychoeducational approach is designed 
to strengthen family caregiver self-efficacy in these same domains. As such, we hypothesize 
reductions in primary subjective stress and negative mental health outcomes on the part of 
family caregivers (Specific Aim 1); reductions in secondary role strains (Specific Aim 2); and 
reductions in residential care stress (Specific Aim 3). Related to the predicted outcomes, we 
have – innovatively, we believe – tailored our measurement strategy to capture outcomes 
most closely associated with RLTC placement alongside more general measures of stress and 
mental health. Prior research focusing on RLTC entry for dementia caregivers employ 
measures designed for at-home care situations (e.g., the Zarit Burden Interview).22,23,75 
Similarly, many studies of caregiver stress following RLTC placement include pre- and post-
placement measurements that often do not capture challenges specific to residential care 
admission for caregiving families (e.g., perceptions of staff support; perceived adjustment to 
the RTLC transition). The inclusion of such measures in the proposed study will help to 
advance understanding of how individualized psychoeducational and psychosocial support 
can enhance family caregivers adaptation to a relative’s RLTC admission. Our embedded 
evaluation strategy described earlier likewise addresses this gap.  
 
Clinical framework of the Residential Care Transition Module. There is a demonstrable need 
for supporting family members following RLTC placement. Scholars emphasize the 
importance of incorporating families in the provision of services and care to cognitively 
impaired older adults in residential care settings.36  However, most services for families are 
designed for at-home caregivers,37 and in prior intervention studies RLTC placement has 
been conceptualized as an outcome to be prevented or delayed. Earlier RLTC transition 
intervention protocols that sought to increase the frequency and quality of family 
involvement (e.g., reduce staff-family conflict) can be categorized into three models: group 
protocols that include peer-led support,38-42 limited telephone-based counseling support to 
families,43 and staff-family partnerships that attempt to clarify the family and staff roles and 
responsibilities in RLTC.44-47 These various approaches have modest to weak effects in 
increasing family involvement, enhancing staff satisfaction, and improving resident well-
being.48 Although several pilot studies and a recently published randomized controlled trial 
(RCT) report on providing support to families of institutionalized relatives, these protocols 
either lack sufficient rigor to support their implementation or, in the case of the RCT, did not 
result in positive outcomes for family caregivers due in part to the clinical content, delivery, 
and measurement approach selected.49,50 
 

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3.0 
Study Endpoints/Events/Outcomes 
3.1 
Primary Endpoint/Event/Outcome:  
● 
The parent study’s primary outcomes include reductions in family members’ primary 
subjective stress and negative mental health outcomes. 
● 
The administrative supplement’s primary outcomes include changes in caregivers’ 
mental health and caregiving stress before and during the COVID-19 pandemic. 
3.2 
Secondary Endpoint(s)/Event(s)/Outcome(s): 
● 
Parent study’s secondary outcomes include secondary role stressors, and residential 
care stress. Other variables include context of care, caregiver depressive symptoms, 
primary objective stressors and resources.  
● 
The administrative supplement’s secondary outcomes include AD/ADRD caregivers’ 
and care recipients’ COVID-19 related experiences and resilience during COVID-19 
pandemic. 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 
Description:  
Residential Care Transition Module (RCTM) clinical sessions are designed to be delivered 
during the timeframe (i.e., the months following RLTC entry) when family caregivers are 
most at-risk for psychosocial distress. The RCTM incorporates psychosocial and 
psychoeducational approaches, focusing on the identification of potential stressors 
associated with RLTC placement and the development of more effective individual coping 
strategies and enhanced caregiving self-efficacy within this new environment. As critical 
reviews of caregiver interventions suggest, multi-component programs that provide some 
combination of therapeutic/social support along with training and skills-based modules 
appear most likely to improve caregiving outcomes.51,52 The RCTM is structured in similar 
fashion to provide individual and family counseling as well as ad hoc support in addition to 
knowledge and skill transfer to assist families adapt to RLTC.48   
     
The RCTM includes six consultation sessions over a 4-month period conducted by a trained 
Transition Counselor (TC) with a primary family caregiver (self-identified as the person most 
responsible for providing on-going assistance to the care recipient in RLTC).2 Other family 
members may also be included in the counseling sessions based on the needs expressed by 
and at the discretion of the primary caregiver. Typically, these additional participants would 
be identified before the enrollment of the primary caregiver and thus, participate in the 
initial screening and consent process, often completing the study surveys as well. The first 3 
sessions are held weekly and the final 3 sessions are held monthly [subject to 
scheduling/availability]. RCTM sessions take place either via telephone or video-based 
conference. The sessions focus on the experiences of the caregiver, the care recipient, and 
(potentially) other family members following RLTC admission. Among the objectives for 
each session are the caregiver’s acquisition of information and strategies designed to deal 
with unique issues, including distance caregiving. The sessions are designed to establish a 
therapeutic rapport with the caregiver and the family; provide a safe environment to 
explore stressors; examine family relational dynamics as they relate to the RLTC placement 
decision itself as well as the roles different family members play in the life of the caregiver 
and relative in RLTC; identify new modes of communication to facilitate more effective 

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interactions with other family members and care staff; and identify effective ways to 
advocate for improved quality of care for and quality of life of their relatives in RLTC. 
Throughout the RCTM counseling process/relationship, caregivers receive constructive 
feedback to help achieve their goals stated at the outset of the RCTM intervention. The 
duration of each session is about 45 to 150 minutes each. 
 
The following summarizes the clinical content of the semi-structured RCTM, delivered 
across six sessions, each of which is prioritized and tailored according to the needs 
expressed by the caregiver. Each component is designed to positively influence key outcome 
domains of RLTC admission for family caregivers: primary subjective stress; secondary role 
strain; care-related distress; and depressive symptoms (see below): 
 
Information about core questions is provided and information is tailored to respond to the 
needs of the caregiver and family and woven across the sessions. Among the questions 
often addressed include: How does RLTC placement affect the caregiver or other family 
members participating in the counseling session?; What are the constraints and reasons for 
the way dementia care is provided in RLTCs?; How can this care be optimized?; and How can 
the family caregiver’s voice be heard when expressing the long-term care goals of the 
relative? Critical stressors identified during the intake interview, crisis situations, and 
adaptation issues are taken into account when individualizing a “curriculum” that uses 
conversation, presentations and online information and support. 
 
Psycho-education: Education on how dementia affects the brain and behavior, 
personality, and cognition is provided to explain the changes the relative is currently 
experiencing and may experience in the future. There is a focus on the biological 
basis for why these changes occur, emphasizing that they are not under the 
relative’s control. 
 
Promotion of communication: The objective is to strengthen family members’ skills 
in understanding other family members’ perspectives and to establish positive and 
collaborative relationships with RLTC staff.48 The Four Steps of Conflict Resolution 
and dementia-friendly activities designed to engage the PWML are included. 
 
Problem solving: Individual and family counseling sessions help caregivers divide 
potentially overwhelming problems into manageable components and direct the 
caregiver or other family members to formal/informal services available within the 
facility and in the outlying community (e.g., ombudsman).  
 
Patient behavior management strategies: Instruction and practice focuses on 
acquisition of skills and strategies to manage reactions to unpredictable behavior [as 
utilized in evidence-based interventions for dementia family caregivers such as the 
Savvy Caregiver Program as well as strategies provided by the Alzheimer’s 
Association].53-55  
 
Concrete planning: Goals for care to optimize personal and socioemotional care 
assistance for relatives in RLTC are explored and strategies are developed to secure 
support for them from other family members and facility staff. These goals can also 
be made concrete in the facility’s care plan for the relative in RLTC.67 Follow-up 
allows for refinement of the care plan.  
 
Making families aware: Caregivers acquire knowledge about the rehabilitative 
treatments used in RLTCs to effectively manage dementia symptoms (e.g., 
depression, agitation, etc.) and to determine whether such treatment approaches 

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are available and delivered in the relatives’ RLTC setting. Caregivers also learn about 
differences in the levels and types of care within different care settings (for example 
assisted living versus memory care).  
 
Ad hoc counseling is provided throughout the RCTM, which consists of ongoing, 
informal counseling on the telephone, or via email with the TC at the request of the 
family caregiver. This makes it possible for the TC to respond to the effects of the 
changing nature of the disease; changes in the RLTC environment, services, and 
policies; and crises as they occur. As needed, information/resources are provided to 
participants. 
 
5.0 
Procedures Involved 
 
5.1 
Study Design:  
We propose to use an embedded experimental mixed methods design.62 Mixed methods is 
generally defined as the collection and analysis of both quantitative and qualitative data 
that link these two forms of data concurrently or sequentially.63 Data integration can occur 
within the design of a single study or across multiple studies.64 Mixed methods research is 
generally used: a) to better understand a research problem by converging numeric trends 
from quantitative data and specific details from qualitative data; and b) to obtain 
statistical, quantitative data from a sample and identify individuals who may expand on the 
empirical results through qualitative findings.65 The proposed design combines the 
collection and analysis of qualitative data within a traditional randomized controlled trial 
design; the collection of “embedded” qualitative data in the proposed study will occur after 
the randomized controlled trial.64, p. 90 The analysis of qualitative data will enhance 
interpretation of empirical outcomes and will assist us in examining why and how the 
RCTM worked or did not for ADRD caregivers. This strategy will allow for a more in-depth 
exploration of the mechanisms of benefit than existing family caregiver interventions, most 
of which do not adopt qualitative methods to explore processes of intervention efficacy.66 
Specifically, qualitative components will provide more comprehensive information on the 
mechanisms and pathways that lead to benefit for family caregivers who are struggling to 
navigate the RLTC transition.64,67-70  
 
5.2 
Study Procedures:  
Recruitment.  At various outreach events, a Documentation of Permission form will be 
utilized to provide the PI and research team the ability to reach out to the potential 
participant about the project. Following completion of this form, a research coordinator will 
initiate email, telephone, or mail contact with family caregivers. Alternatively, interested 
research participants can reach out to the study team directly to initiate contact. During 
initial contacts with potential participants, the coordinator will describe the RCTM 
intervention, explain study procedures such as voluntary participation, randomization, and 
what the usual care control condition includes. A telephone and email script will be utilized. 
More information about recruitment can be found under section 12.0 “Recruitment 
Methods”. 
 

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-Study schedule: Months 3-44 (see Timeline below) 
 
Eligibility screening.  If caregivers are interested in participating, the RC will conduct a brief 
screening procedure using the RCTM Screening Form, developed based on the above 
eligibility criteria.  
 
-Study schedule: Months 3-44 (see Timeline below) 
-Time for participants: 10-15 minutes 
 
Enrollment/Consent. Following eligibility screening, the consent process will take place. 
Going forward, our consent process will specifically entail: study staff reviewing highlights 
of each section of the consent form with the potential participant, then study staff will ask 
each potential participant whether they have any questions about the consent form or 
study details. Since we are improving our procedures, this more detailed consent process 
will begin after approval of the protocol (v 11.09.2020). During the parent study and the 
supplement, we provided potential participants an overview of the project prior to 
initiating the consent process, which we will continue to do.  
 
After an overview of the project has been described, highlights of the consent form will be 
described and any questions from the potential participant will be answered, then a signed 
informed consent will be obtained from the eligible family caregiver. This consent will be 
offered electronically, over the phone or via mail. Online consent forms will be 
administered via the secure University of Minnesota Qualtrics survey application. 
Participants will be provided with a copy of their completed consent form. See more details 
on the consent process in section 22.1 “Consent process”. 
 
-Study schedule: Months 3-44 (see Figure below) 
-Time for participants: 30-45 minutes 
 
Baseline. Following the completion of consent, the baseline survey will be administered.  
The survey will ask the family caregiver to complete a survey that will ask questions about 
the family caregiver, the person with ADRD, and the person with ADRD’s and family 
caregiver’s memory loss’ emotional, psychological, physical health, the caregiver’s 
confidence about their care situation.  The survey will also ask the family caregiver about 
various health events that the person with ADRD may have experienced. The baseline 
survey can be completed via mail, telephone interview, or online (with minor verbiage 
edits to instructions made to facilitate online completion/tracking via Qualtrics).   
 
-Study schedule: Months 3-44 (see Timeline below) 
-Time for participants: approximately 45 minutes 
 
Treatment/Intervention Period. Participants will be randomly assigned in a 1:1 ratio to 
receive either the RCTM intervention or a usual care control condition. The project 
biostatistician (Dr. Roth) will generate a random assignment schedule using a random 
number generator provided by the SAS analysis system. Treatment condition assignments 
generated by this program will be printed and individual caregiver assignment slips will be 
placed in sequentially numbered, sealed opaque envelopes. The next sealed envelope in 

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the sequence will be opened at the time each individual participant is randomly assigned to 
his or her condition. The randomization schedule will be stratified by family member 
relationship (spouse vs. non-spouse) and time since the relative’s admission (3 months or 
less vs. over three months) to ensure balance on these important predictors of caregiver 
outcomes. Cases will be randomized within variable-sized blocks that range from 6 to 10 
participants. No research staff or investigator interacting with potential participants will 
have access to the random assignment schedule, and, because of the variable block sizes 
and the sealed assignment envelopes, no person with participant contact will be able to 
determine the next treatment assignment in the sequence. These procedures accomplish 
both random treatment assignment and treatment allocation concealment throughout the 
trial, and are consistent with the recommendations of the CONSORT statement (see 
http://www.consort-statement.org/). The RC will inform the ADRD caregiver of their 
randomization status as soon as possible following completion of the baseline interviews.   
 
-Study schedule: Months 3-44 (see Figure below) 
-Time for participants: approximately 10 minutes 
 
Usual Care. The usual care control group proposed here is similar to those we have used in 
our prior studies91,95-97 to adjust for the social engagement provided to the RCTM treatment 
condition. As summarized above, the TC will provide quarterly contact calls. If caregivers in 
the control group initiate contact with the TC for care needs, the TC will provide 
information and referral support. Based on our prior experience, ADRD caregivers in an 
attention control group will often seek information and psychosocial support during 
quarterly contact calls; in order to balance ethics with the integrity of the randomized 
control design, the TC will provide information and referral (e.g., local phone numbers of 
the Alzheimer’s Association or an Area Agency on Aging). The TC will collect data on the 
duration, frequency, and content of each quarterly contact call.  
 
-Study schedule: Months 3-56 (see Figure below) 
-Time for participants: approximately 15 minutes for each follow-up contact call 
 
For those ADRD caregivers who are assigned to the RCTM treatment condition, the semi-
structured RCTM intervention (described above) will be administered.  
 
-Study schedule: Months 4-55 (see Figure and Timeline below) 
-Time for participants: from 45-150 minutes per session 
 
 
5.3 
Follow-Up:  
Follow-up for the parent was planned through Month 55, resulting in about a 53-month 
data collection period.  Following the completion of the RCTM disposition form, blinded 
research assistants will administer follow-up surveys to enrolled caregivers at 4 months, 8 
months, and 12-month time-points. Unless the research team is aware that the participant 
is bereaved, staff send (or call in attempt to complete) the disposition survey 7 days (+/- 7 
days) prior to the date the next follow-up survey is scheduled to be sent. If no response is 
received, staff send reminders (or call) as needed. As needed, the disposition and follow-up 

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survey may be sent together per study procedures. The follow-up survey is scheduled to be 
sent 4 months (+/- 7 days) following the receipt of the previous survey or within 7 days of 
receiving the disposition status. If the date a survey is scheduled to be sent falls on a 
weekend/holiday, the survey send date is moved to the next business day (and the survey is 
sent +/- 7 days from that date). Participants are given several reminders to facilitate survey 
completion. [Please note: Survey time-points are calculated following the date of receipt of 
the previous survey (or if the previous survey was not returned, surveys time-points are 
calculated using the appropriate time interval following the receipt date of the prior survey). 
Based on this, if participants are not prompt in survey completion, subsequent surveys are 
pushed back accordingly.] In addition to the 4, 8, and 12-month surveys, additional surveys 
may be sent if the participant is participating in surveys related to the COVID supplement. 
These supplemental survey time points are calculated according to the protocol-based 
survey schedule (i.e. 1, 3 months) following the sent or receipt date of the previous survey 
as described above. Data will be collected regarding any caregiver status changes or 
bereavements. Surveys will continue to be administered whether the person with ADRD 
moves to another setting or passes away. A modified survey will be administered if the 
person with ADRD passes away during the course of the study. For participants still enrolled 
in the RCTM study in May 2020, additional COVID-19 related questions will be included in 
follow-up surveys. 
 
Note: Depending on the survey type and time-point, the due date for surveys administered to 
primary caregivers that enrolled with other family members is either calculated separately or 
is dependent upon the receipt of the other family members’ surveys. Specifically, due dates 
for treatment fidelity surveys and routine 4-month surveys are calculated based upon the 
receipt of the previous survey time-point by all family members; other surveys are calculated 
based upon the receipt of that individual’s survey only. 
 
We will take several steps to address attrition bias. If ADRD caregivers wish to withdraw 
from the RCTM treatment group, but agree to continue with follow-up interviews/surveys, 
we will continue routine data collection without counseling. 
 
Several steps will enhance study retention. Baseline and follow-up surveys are administered 
in a format that is convenient to ADRD caregivers (online, telephone, or mail 
survey/questionnaire formats). Baseline interviews are anticipated to take no more than 60 
minutes; follow-up interviews are expected to take approximately 45 minutes. Quarterly 
follow-up calls by the TC to all participants will ask “how things are going” and will offer the 
opportunity for controls to feel connected to the overall study. Following completion of the 
final 12-month assessment, participants receive a call from one of the TCs. A handwritten 
note from the study team to thank each participant for their study participation will be sent 
out to enrolled participants after their last survey or semi-structured interview. These thank 
you letters will not be sent if a participant withdraws from the study. If a participant did not 
return all surveys as scheduled, a thank you card will be sent near the projected date of 
their last study survey. If a participant is enrolled in the study supplement, a thank you letter 
will be sent after their last survey or interview is completed. Bi-annual project newsletter 
will be sent to all participants. We will also pay participants $25 following the completion of 
each baseline, 4-, 8-, and 12-month and final qualitative interview (if selected). Payments 
will be made using a pre-paid debit card, using the Greenphire ClinCard system.  

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-Study schedule: Months 3-56 (see Timeline below for general guide) 
-Time for participants: 45 minutes 
 
Treatment fidelity. To guarantee accuracy of treatment delivery, Mr. Reese and Dr. Gaugler 
developed a detailed RCTM treatment manual based on the extensive preliminary work 
detailed above. The treatment manual will ensure consistent implementation of the RCTM 
in the proposed project. The manual is an ongoing reference that provides a step-by-step 
timeframe of delivery activities. The manual will eventually serve as a training tool for future 
TCs and help enhance the consistency of RCTM clinical approach and strategy. 
 
Throughout delivery of the RCTM, the TC will maintain a detailed contact log and notes to 
document the frequency, duration, and clinical content of each RCTM session; this will serve 
as a means to assess treatment receipt as recommended by Burgio et al.98  and others and 
will allow the research team to track administration of the RCTM. This will also assist in 
documenting any deviations from the multi-session protocol of the RCTM and the reasons 
for them. Also, as recommended by investigators of other evidence-based, ADRD caregiver 
interventions (e.g., REACH),98 feedback from caregivers themselves in the RCTM treatment 
condition can further ascertain treatment receipt. Specifically, caregivers’ perceptions of the 
RCTM will be assessed using close-ended items from a 22-item online or mail survey that 
will ask caregivers to rate their experiences with various facets of the TC’s psychosocial 
counseling. This checklist will be administered at each follow-up to caregivers who are 
randomly assigned to receive the RCTM intervention. 
 
Strategies to assess treatment enactment will determine how participants apply the 
counseling content to their everyday care situations. Multiple open-ended questions will be 
included on the 22-item checklist described above to all caregivers in the RCTM treatment 
condition at the 4-, 8-, and 12-month interview intervals. Surveys are sent within 7 days of 
their scheduled send date (send dates falling on a weekend/holiday are moved to the next 
business day and administered +/- 7 days from that time). Participants are given several 
reminders to facilitate survey completion as needed. [Note: Survey time-points are 
calculated 4 months following receipt of previous treatment fidelity survey (or 4 months 
following the sent date of the previous survey, if the previous survey was not returned). 
Based on this, if participants are not prompt in survey completion, subsequent surveys are 
pushed back accordingly. In order to maintain blinding of staff involved in administering the 
routine follow-up surveys, the treatment fidelity surveys are administered separately from 
the routine follow up surveys and thus the timing of these surveys are calculated without 
regard to receipt of the routine follow up survey.] 
 
The open-ended responses will provide qualitative data as to the reasons why family 
caregivers felt the counseling recommendations of the RCTM were or were not appropriate, 
whether the recommendations were helpful, which elements of the RCTM caregivers used 
and how effective they found them, and what barriers or facilitators exist when 
implementing the TC’s recommendations.  
 
Post-evaluation semi-structured interviews.  Up to 30 semi-structured interviews with 
ADRD caregivers receiving the RCTM treatment condition will take place. The interviews will 

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occur within a 3-month period following the completion of the caregiver’s final 12-month 
follow-up survey. Caregivers are selected for an interview based on their RCTM Review 
Checklist (i.e. treatment receipt perception) scores.  The research coordinator calculates the 
treatment fidelity scores for those that have completed their 4, 8, and 12-month Checklist.  
The TCs and PI will select a sample of participants with average Checklist scores between 4 
and 5 (i.e. RCTM met their needs) and those with average Checklist scores 4 and below. In 
addition to the selection of higher and lower average Checklist scores, a stratified purposive 
sampling approach will be applied.  As applicable, the PI and TCs will purposively identify 
caregivers of varying kin relationship (spouse vs. adult child), length of stay in the residential 
care setting, caregiver gender, and racial or ethnic background. The open-ended responses 
of the semi-structured interviews will provide in-depth information on the reasons why and 
how dementia caregivers felt the RCTM counseling sessions reduced or exacerbated ADRD 
caregivers’ strain and facilitated or hindered adaptation to the residential care transition. 
Interviews will be conducted via telephone and digitally recorded. Audio recordings will be 
transcribed by a professional transcription service into a Microsoft Word file which will then 
be uploaded to nVivo10 for subsequent analysis. If the participant does not give permission 
for interview to be recorded, interviewer will ask permission to take notes. If permission is 
granted, interviewer will proceed with the interview taking notes only. If participant does 
not grant permission for interviewer to record or take notes but still wants to be 
interviewed, interviewer will proceed with interview but data from interview will not be 
analyzed.   
 
5.4 
Study Procedures for COVID-19 Administrative Supplement:  
 
The four key components of the additional data collection (depicted in Figure 1) are:  
1. 
additional follow-up surveys that will assess caregivers’ COVID-19-related experiences 
and track their stress and mental health after the onset of the pandemic;  
2. 
the addition of supplemental COVID-19-related questions to planned surveys for 
participants still currently enrolled in the RCTM study;  
3. 
20 additional semi-structured interviews to investigate caregivers' COVID-19 related 
experiences and challenges; and  
4. 
extraction of relevant qualitative data regarding participants’ COVID-19 responses 
from RCTM case notes and open-ended surveys, as currently-enrolled participants 
have spontaneously begun discussing pandemic-related concerns in the context of 
these ongoing components of the parent study. 
 
 

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Figure 1. Data collection schedule for planed parent study and proposed supplemental study.  
The sample for this supplement will be drawn from participants in the original RCTM parent study. 
Because participants are at varying stages of completing the parent study, we have devised a data 
collection schedule that accommodates participants’ heterogeneous starting points (see Figure 1). 
This schedule integrates the proposed additional surveys into the ongoing data collection schedule 
for the parent study, aligning the supplemental surveys with currently-planned measurement 
occasions to the extent possible. The proposed schedule allows for at least three assessments of 
caregivers’ stress, well-being, and COVID-19-specific experiences after the onset of the pandemic, 
which will facilitate the planned longitudinal modeling. For post-COVID-19-onset survey 
assessments, we propose measurement intervals of 0, 1, and 4 months in order to capture 
caregivers’ responses to the rapidly-changing conditions that are occurring early in the pandemic 
period, as well as longer-term adjustment across several months. 
 
We will aim for a total of at least 100 participants to complete the post-COVID-19-onset 
assessments. This sample size will allow for robust longitudinal modeling. We anticipate the 
sample will include the participants who remain currently enrolled in the study, plus eligible 
caregivers who had previously completed the full parent RCTM study. The recruitment and 
retention procedures used in the parent study have been highly successful, with survey 
completion rates of over 98% at each wave. We anticipate that the strong rapport built through 
previous engagement with the RCTM study will help us to re-engage a substantial portion of the 
original sample and maintain strong retention among the currently-enrolled participants. 
 
Caregivers who are eligible to take part in the supplemental assessments will receive an invitation 
to complete additional surveys, which will provide information about the supplemental study aims 
and procedures. Those who are interested in participating will then provide informed consent to 
participate in the additional data collection efforts. The surveys will be administered according to 

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the same procedures that were used in the parent study. As in the parent RCTM study, 
participants may choose to complete the supplemental surveys either online, by mail, or by 
phone. We will offer caregivers $25 to thank them for participating in each survey. 
 
We will also select a purposive sample of approximately 20 participants (split evenly among the 
treatment and control group) to invite for a semi-structured interview to investigate their COVID-
19 and long-term care related experiences in-depth. Participants will be selected based on their 
responses to the COVID-19 specific items in the survey, aiming for diversity in terms of 
experiences navigating pandemic-related changes. For example, we will seek to recruit 
participants who have reported a high degree and a low degree of perceived preparedness from 
their care recipient's RLTC, participants who have chosen to remove their care recipient from RLTC 
as well as those whose care recipient has remained in RLTC, and participants living in areas with 
higher and lower disease exposure. Semi-structured interviews will be conducted by phone, audio-
recorded, and transcribed for analysis. Participants will also receive $25 for taking part in the 
semi-structured interview. 
 
Administrative Supplement Data & Measures 
The supplemental surveys administered after the onset of the COVID-19 pandemic will include 
two main sections. The first section will consist of the same measures of caregiver stress and well-
being that are included in the main RCTM follow-up surveys. These assessments will allow us to 
model trajectories of change in caregiver stress and well-being before and after the onset of the 
pandemic. 
 
The second section of the supplemental surveys will consist of a questionnaire focused specifically 
on AD/ADRD caregivers’ and care recipients’ COVID-19 related experiences. We developed items 
for the COVID-19 questionnaire through discussion with the RCTM research team, review of 
emerging literature on COVID-19 and long-term care, and recent counseling session notes with 
currently-enrolled RCTM participants. The following measures assess key contextual factors and 
decisions related to COVID-19 that may affect caregivers’ and care recipients’ experiences. 
● 
Care recipient’s residential status. The questionnaire will assess whether the care recipient 
is still living in an RLTC facility, the approximate capacity of the RLTC, and whether the 
care recipient has roommates.  
● 
RLTC measures to mitigate COVID-19. Participants will complete a checklist of possible 
measures that their care recipient’s RLTC facility may have taken to prevent the spread of 
COVID-19 or mitigate its effects on residents (e.g., limiting visitors, canceling group 
activities, facilitating video or phone contact with family members).   
● 
Care recipient’s health status. Participants will report whether their care recipient has a 
known COVID-19 diagnosis, has experienced symptoms of COVID-19, and has any pre-
existing health conditions that may contribute to heightened risk of serious infection. 
● 
RLTC COVID-19 status. Items will assess whether the RLTC facility has known positive 
COVID-19 cases and the facility’s plans for management of COVID-19 cases. 
● 
Caregiver’s health, employment, and family status. Caregivers will be asked whether they 
have been diagnosed with COVID-19, or are experiencing symptoms. They will also be 
asked about their employment status, and responsibilities for caring for other family 
members aside from the care recipient. 
● 
Perceptions of RLTC crisis management. This portion of the questionnaire will ask 
caregivers to evaluate the RLTC facility’s handling of the situation, in terms of 

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preparedness, communication, effectiveness of preventive measures, and efforts to help 
residents remain engaged. 
● 
Caregiver-Care recipient communication. Participants will report the methods they have 
used to remain in contact with their care recipient, the frequency of contact, and the 
effects of any changes in contact on the caregiving relationship. 
● 
Staying or leaving RLTC. Caregivers will be asked if they have decided to move their care 
recipient out of RLTC and the reasons for their decision. 
 
We developed a semi-structured interview protocol for in-depth evaluation of participants’ 
experiences related to COVID-19 and long-term care. The semi-structured interview protocol will 
ask participants first about their overall experience of the COVID-19 pandemic as it relates to their 
caregiving role, starting with the onset of the pandemic and describing up to the present. 
Participants will then be asked a series of probing questions to explore the challenges that have 
emerged and the coping strategies caregivers have used. Interview questions will prompt 
participants to discuss any COVID-19-specific practices that their care recipient’s RLTC has 
implemented and how these practices have affected the caregiver and care recipient. Participants 
who received support from the RCTM Transition Counselor through the pandemic period will also 
be asked how the RCTM was or was not helpful in coping with COVID-19. Interview questions will 
be modified by caregiver bereavement status to be conscientious of more difficult topics for 
participants whose care recipient has passed away. 
Relevant qualitative data will also be extracted from counseling case notes and open-ended 
survey questions. 
5.5 
Individually Identifiable Health Information: A HIPAA waiver was requested for participants’ 
study involvement with study approval. 
6.0 
Data Banking 
6.1 
Storage and Access:  Any datasets generated and/or analyzed S:\Public_Health_Center-on-
Aging_Gaugler\Smartwatch Memory Aid\Protocol & MOP\current protocol and published or 
placed in a data repository will be de-identified.  
6.2 
Data: See 6.1.  
6.3 
Release/Sharing: All information obtained from the participants will remain strictly 
confidential and will not be released except at the express written request of the study 
participant [unless permitted by law or regulatory oversight]. 
7.0 
Sharing of Results with Participants 
7.1 
When manuscripts are published, the findings will be distributed to all research 
participants. Main outcome papers that address the study aims will not be disseminated 
until all data collection procedures are completed. However, analyses of treatment receipt, 
perceived utility, important aspects of intervention delivery, and other descriptive analyses 
have and will be disseminated prior to the main outcome papers. The project team aims to 
minimize the length of time between final data collection procedures and dissemination of 
final outcome papers to appropriate peer-reviewed journals. We anticipate a timeframe of 6 
months between final data collection and peer-reviewed article submissions of RCTM 
outcomes.  
 

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8.0 
Study Duration 
8.1 
ADRD caregivers will participate in the parent study for about 12-months; the total project 
duration is 5 years (06/01/2016 - 05/31/2021).  This will be extended for the COVID-19 
administrative supplement for one year beyond the originally planned timeline.  A project 
timeline is below: 
 
Project Timeline 
 
Months 
1-3 
Months 
4-12 
Months 
13-55 
Months 
56-60 
Months 
60-62 
Data management processes 
● 
○ 
○ 
○ 
○ 
Hiring and training of research coordinator and 2 research 
assistants 
● 
○ 
○ 
○ 
○ 
Monthly research team meetings/Project management 
● 
● 
● 
● 
● 
Recruitment of ADRD caregivers [(n = 240)] 
● 
● 
● 
 
 
Re-enrollment of previous RCTM participants (up to N = 113) 
to take part in supplemental COVID-19 surveys 
 
 
 
 
● 
Administration of Residential Care Transition Module 
counseling sessions 
 
● 
● 
○ 
 
Baseline, 4-, 8-, and 12-month data collection 
 
● 
● 
○ 
 
Treatment fidelity/process evaluation 
 
● 
● 
● 
 
Embedded semi-structured interviews, post evaluation 
 
 
● 
● 
● 
RCT longitudinal analysis; Analysis of post-RCT embedded 
component 
 
 
● 
● 
 
Dissemination 
 
 
○ 
● 
● 
NOTE: ADRD = Alzheimer’s disease or a related dementia; RCT = randomized controlled trial;  
LEGEND: ● = primary focus; ○ = ongoing but less intensive 
9.0 
Study Population 
9.1 
Inclusion Criteria: Eligibility criteria include family caregivers who consider themselves the 
most involved in visiting and providing assistance to the person with memory loss (or who 
share the primary caregiving role equally). For the caregiver to participate, the care 
recipient must be residing in a RLTC setting (e.g. assisted living, nursing home, memory care, 
or other residential long-term care setting) and have received a physician’s diagnosis of 
ADRD. Family caregivers must be English speaking, 21 years of age or older, and not 
participating in any other one-to-one psychosocial consultation specifically for caregiving 
(support group participation is not a deterrent to enrollment, nor is general counseling not 
specific to caregiving). Family caregivers on psychotropic medications, such as anti-
depressants or anti-psychotics, will be eligible if they have remained on a stable dosage for 
the last 3 months.  
The sample for the administrative supplement focused on COVID-19 will be drawn from 
participants in the original RCTM parent study. Caregivers who have already completed the 
study and who have not previously reported bereavement, as well as those caregivers who 
remain currently enrolled in the parent study, will be invited to take part in the proposed 
supplemental assessments. Among previously-completed participants, those whose care 
recipient is still alive will be eligible to re-enroll.  Among currently-enrolled participants, any 
who are not bereaved, or who are bereaved but have been continuing to participate in 

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bereavement-modified surveys, will be eligible to participate in supplemental surveys.  Both 
control and treatment group participants will be eligible. Previously-completed caregivers 
whose care recipient has already passed away will not be eligible to enroll in the 
supplement. 
9.2 
Exclusion Criteria: Caregivers are not eligible to participate if they do not meet the inclusion 
criteria above.  
9.3 
Screening: If caregivers are interested in participating, the RC will conduct a brief screening 
procedure using the RCTM Screening Form, developed on the above eligibility criteria.  
Previously completed participants who are interested in participating in the additional 
survey(s) for the COVID-focused supplement will complete a brief screening survey prior to 
re-enrollment, including items assessing bereavement 
10.0 Vulnerable Populations 
10.1 
Vulnerable Populations:  
Population / Group 
Identify whether any of the following 
populations will be primary focus of 
the research (targeted), included but 
not the focus of the research or 
excluded from participation in the 
study.  
Children 
Excluded 
Pregnant women/fetuses/neonates 
included but not the focus 
Prisoners 
Excluded 
Adults lacking capacity to consent 
and/or adults with diminished capacity 
to consent, including, but not limited 
to, those with acute medical conditions, 
psychiatric disorders, neurologic 
disorders, developmental disorders, 
and behavioral disorders 
 included but not the focus; see 
Sections 10.2 and 22.6 for 
descriptions and safeguards 
Non-English speakers 
Excluded 
Those unable to read (illiterate) 
Excluded 
Employees of the researcher 
Excluded 
Students of the researcher 
Excluded 

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Undervalued or disenfranchised social 
group 
included but not the focus 
Active members of the military (service 
members), DoD personnel (including 
civilian employees) 
included but not the focus 
Individual or group that is approached 
for participation in research during a 
stressful situation such as emergency 
room setting, childbirth (labor), etc. 
Excluded 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
included but not the focus 
Individual or group with a serious 
health condition for which there are no 
satisfactory standard treatments. 
included but not the focus 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Excluded 
Any other circumstance/dynamic that 
could increase vulnerability to coercion 
or exploitation that might influence 
consent to research or decision to 
continue in research. 
Excluded 
 
10.2 
Additional Safeguards: N/A 
All participants in the above table that are listed as “included but not the focus” could be 
included in the study by chance. However, these vulnerable groups are not sought out 
during recruitment and we do not ask potential participants if they belong to one of the 
above groups or not. Thus, extra safeguards are not put in place to protect these groups 
since we would not know if they were included in the research or not. Given our study 
population of interest, it is unlikely for participants to be a part of the groups listed as 
“included but not the focus,” besides adults lacking the capacity to consent or have a 
diminished capacity to consent which is addressed below.  

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Due to the nature of the project and its risk, a specific capacity to consent assessment is 
not included with consent. Participants are reminded that all study procedures are 
voluntary and they can withdraw at any time. We do not anticipate any individuals from 
the above noted groups to have increased risk from participating in the proposed research, 
such as an increased risk of coercion, etc. Thus, our standard protocol practices (i.e. data 
security, confidentiality procedures, etc.) provide reasonable protections to these 
potentially vulnerable participants (including those listed above and any others who may 
meet inclusion criteria to enroll). For specific procedures for those with potential memory 
impairment noted during the study, see section 22.6. 
 
10.3 
If research includes potential for direct benefit to participant, provide rationale for any 
exclusions indicated in the table above:  
 
Some individuals in the above vulnerable groups are excluded because they are not our 
population of interest or because participating in such research would potentially be risky 
for them.  
 
11.0 Number of Participants 
11.1 Number of Participants to be Consented:  
● 
Parent study: 240 primary caregivers 
● 
Administrative supplement: 100 caregivers 
12.0 Recruitment Methods 
12.1 Recruitment Process: At various outreach events, a Documentation of Permission form will 
be utilized to provide the PI and research team the ability to reach out to the potential 
participant about the project. Following completion of this form, a research coordinator will 
initiate email, telephone, or mail contact with family caregivers.  
Alternatively, interested research participants can reach out to the study team directly to 
initiate contact. During initial contacts with potential participants, the coordinator will 
describe the RCTM intervention, explain study procedures such as voluntary participation, 
randomization, and what the usual care control condition includes. A telephone and email 
script will be utilized. 
Participants for the supplement will be drawn from participants in the original RCTM parent 
study. Caregivers who are eligible to take part in the supplemental assessments will receive 
an invitation to complete additional surveys, which will provide information about the 
supplemental study aims and procedures.  
12.2 Source of Participants: Dr. Gaugler has created a University of Minnesota Caregiver Registry 
that includes family and professional caregivers who have participated in his free annual 
community education conference, “Caring for a Person with Memory Loss” (CPWML). 
Approximately 200-350 persons attend each CPWML conference. Attendees are invited to 
complete a brief form which enrolls them in the Registry and gives Dr. Gaugler and his 
research staff permission to contact and invite them to participate in his studies. We will 
periodically send project recruitment materials to members of the caregiver registry. 
Specifically, a research coordinator will initiate email, telephone, or mail contact with family 

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caregivers on the University of Minnesota Caregiver Registry or with others recruited by the 
PI or the TC. Professional care providers on the Registry will also be asked to identify 
potential ADRD family caregivers for recruitment purposes. During initial contacts with 
potential participants, the coordinator will describe the RCTM intervention, explain study 
procedures such as voluntary participation, randomization, and what the usual care control 
condition includes. If caregivers are interested in participating, the research coordinator will 
initiate a brief screening procedure applying the inclusion criteria above. Caregivers will be 
offered the opportunity to ask questions about the study procedures, and informed consent 
will be obtained.  
 
Dr. Gaugler is a member of the Minnesota Care Options Network. To supplement Registry-
based recruitment efforts, we will ask ‘facility liaisons’ (e.g., administrator, director of 
nursing, or director of social services) to assist with recruitment efforts. Initially, facility 
liaisons will be asked to advertise monthly presentations that will be conducted by the 
University of Minnesota evaluation team (Dr. Gaugler, the TC, or research coordinators). 
These presentations will introduce the RCTM to interested family members. Following each 
presentation, the evaluation team will circulate a sign-up sheet for those interested in 
participating in the project. In addition, facility liaisons can post flyers in select areas of 
facilities that are frequented by residents and family members and/or distribute 
announcements in the facility newsletter and web page. Finally, facility liaisons will be asked 
to contact eligible family members to share information about the RCTM and ask family 
members’ permission for Dr. Gaugler, the TC, or research coordinators to contact them to 
discuss participation in the project.  
 
We will also ask direct care providers in the Registry to identify ADRD caregivers of diverse 
ethnic or racial origin and geographic location who are not in the Registry. These 
recruitment efforts will be facilitated by the Minnesota Board on Aging (MBA) and the 
Minnesota-North Dakota Alzheimer’s Association regional office (see Letters of Support). 
The MBA will help us promote this study through Area Agencies on Aging, many of which 
serve ethnic and racially diverse older adults as well rural ADRD caregivers. To further 
facilitate these efforts, the PI will conduct a number of free, community presentations about 
the RCTM throughout the Minneapolis/St. Paul and outlying rural areas seeking to recruit 
underrepresented ADRD caregivers. 
 
IRB-approved information sheets, flyers, and study materials will be shared at various 
community events, including events such as Minnesota’s Farm Fest and the Minnesota State 
Fair. 
 
In addition to the above methods of recruitment, we will also recruit in such a way where 
interested parties can reach out to our research team directly, such as e-letters sent out by 
the Alzheimer’s Disease Education and Referral program of the National Institute on Aging. 
Additional recruitment is conducted through the following IRB-approved advertisements: a 
radio announcement, periodic newspaper advertisements in local circulars in various states; 
project listings on CTSI StudyFinder and Clinicaltrials.gov; the University of Minnesota School 
of Public Health website; Banner Health’s Alzheimer’s Prevention Registry (including a study 
listing, geotargeted e-mails, Facebook posts), and via Facebook advertisements. A Families 
and LTC Facebook business page has been created and will be used to manage the ad 

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placement. The goal of recruiting via these various recruitment modalities is to broaden our 
study population. 
 
For the COVID-19 administrative supplement, participants will be recruited from among 
current and previous participants in the parent RCTM study. 
12.3 Identification of Potential Participants: Please see above.   
12.4 Recruitment Materials: Please see above. 
12.5 Payment:  
Participants will be paid $25 following the completion of each baseline, 4-, 8-, and 12-month 
and final qualitative interview (if selected). These same payments are provided for the 
administrative supplement. Payments will be made using a pre-paid debit card, using the 
Greenphire Clincard system.  
13.0 Withdrawal of Participants 
13.1 
Withdrawal Circumstances:  
Staff may become aware of participants who have potential memory concerns through 
study interactions, such as phone calls by the interventionist or research coordinator. 
When this type of participant is identified, the research coordinator will call the 
participant and determine if they are able to consent to participation. To do so, a brief 
summary of the consent form will be read to the participant, then the research 
coordinator will administer the UBACC (UCSD Brief Assessment of Capacity to Consent). 
Please see details in section 22.6- “Cognitively Impaired Adults, or adults with 
fluctuating or diminished capacity to consent” for more information on administering the 
UBACC. If the participant scores under 14.5, then we will withdraw them from the study 
and therefore not ask them to complete any additional surveys. Participants in the 
treatment group who do not pass the capacity to consent screener will be offered the 
opportunity to continue contact with the study interventionist, if they desire, even if they 
are withdrawn from the study. This will ensure continued support for any participants 
who had planned to continue their contact with the counselor, but are no longer eligible 
to participate in surveys. We will report participants who are withdrawn for this reason 
along with their UBACC scores to the IRB as an RNI within 5 business days of the capacity 
to consent call with the participant. This data will also be reported in the annual data 
reports on participant safety as part of the data safety monitoring plan (see plan below).  
13.2 
Withdrawal Procedures:  
In instances where ADRD caregivers wish to withdraw from the study, we will attempt to 
determine the reason for study withdrawal and conduct necessary documentation (RNI, 
tracking forms, etc.). Withdrawn participants will not be contacted for further data 
collection. 
 
13.3 
Termination Procedures: 
There is no intention to terminate any participant’s participation in the research study, 
however if this were to occur, the procedures that would be carried out would be similar 
to those if the participant requested to withdraw, or was lost to follow up. Data from 
participants who were terminated would be used up until the point of their termination.  

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14.0 Risks to Participants 
14.1 Foreseeable Risks:  
Since the study involves no invasive procedures, there will be no physical risks to study 
participants. The consideration of need is potentially stressful, and thus there are possible 
psychological risks for the caregiver. However, the research team has considerable 
experience providing psychosocial support to dementia caregivers on various protocols and 
serious psychological risks are unlikely to occur based on this experience. The potential 
social or legal risks for the participants relate only to possible violations of confidentiality. 
Given the procedures outlined below, such risks are highly unlikely. 
 
The experience of the research team and the exclusion of caregivers with serious psychiatric 
illness will minimize the possibility of psychological risks. The unlikelihood of such problems 
is evident from the absence of any clinically significant problems during the past 13 years 
that the research team has operated various protocols related to dementia caregiving 
intervention research. The research coordinator and research assistant will be trained to 
interview in ways that are non-threatening, friendly, and respectful. We will emphasize to 
all participants that they do not have to complete any question they do not want to answer, 
and that the interview may be terminated at any time according to their wishes. We will 
stress to ADRD caregivers that their decision to discontinue the study will in no way affect 
the services they are receiving from the University of Minnesota, long-term care facility, or 
other entities. 
 
In the event a caregiver does become upset during the interview process, the research 
coordinator or research assistant will contact Dr. Gaugler, who will be available for 
consultation. If a caregiver is in crisis because of their care situation or some other reason, 
research staff will be instructed to consult with Dr. Gaugler. With the caregiver’s permission, 
we will then contact the appropriate resource person in an external agency (e.g., the 
Alzheimer’s Association). Based on the research team’s experience working with their 
caregiving families, we expect very few or no such instances to occur. If a member of the 
research team does identify neglect or other potentially inappropriate care practices, Adult 
Protective Services will be notified to protect the rights of persons with dementia and their 
families. 
 
All information obtained from the participants will remain strictly confidential and will not 
be released except at the express written request of the study participant. All electronic 
data will be maintained in Qualtrics, the Secure Computing Environment, secure Academic 
Health Center project folder, and in Box. All data on Dr. Gaugler’s computer in D351 Mayo 
Building and the research staff’s computers (also located in D351 Mayo Building) are 
encrypted and protected by strong passwords only accessible to Dr. Gaugler and the 
research team. 
 
Research data will be maintained on the Academic Health Center secure project folder for 
approximately 2-3 years which is the time anticipated it will take to disseminate any and all 
research papers or presentations from these data. Similarly, paper forms of the data will be 

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located in a locked file cabinet in D351 Mayo Building only accessible to the research team. 
Unless the data are being filed or accessed, these cabinets will remain locked. 
 
14.2 Reproduction Risks: N/A 
14.3 Risks to Others: N/A 
15.0 Incomplete Disclosure or Deception 
15.1 Incomplete Disclosure or Deception: N/A 
16.0 Potential Benefits to Participants 
16.1 Potential Benefits:  
There are no expected benefits from participation, but participants who receive the 
intervention may feel better about navigating the transition of your loved one into 
residential care. See above for details related to compensation. 
17.0 Statistical Considerations 
17.1 Data Analysis Plan:  
Analysis of Specific Aims 1-3   
Data available at baseline, 4 months, 8 months, and 12 months will allow for individual 
growth curve models that examine change in ADRD caregiver outcomes.103,104 Multilevel 
analysis approaches are available that support growth curve modeling. In this context, 
growth curve modeling is an example of a 2-stage modeling process consisting of 1) a 
within-subjects model across time, and 2) a between-subjects model that incorporates 
caregiver and person with ADRD covariates.105,106 The primary independent variable in the 
proposed investigation consists of an indicator variable for random assignment into the 
RCTM treatment condition or the attention care control. [SAS (version 9.4) Proc Mixed107] 
will be used to conduct these analyses, as it supports multilevel and growth curve modeling 
procedures.  
 
Our proposed analyses will provide in-depth tests of Specific Aims 1 to 3 (i.e., rates of 
change in primary subjective stress, secondary role strains, residential care stress, and 
caregiver depressive symptoms) over a 12-month period. In one set of outcome evaluations, 
the baseline value will be included as a covariate, and time will be “centered” at 4-months 
post-baseline. This scales the intercept effect to be a main effect of RCTM group assignment 
and allows the RCTM treatment and the attention control groups to have different 4-, 8-, 
and 12-month change trajectories, or an RCTM treatment*time interaction effect. After 
establishing that the individual growth parameter estimates have significant variance 
around the mean trajectories of change in key dependent variables, an RCTM treatment vs. 
control group indicator will be added as the key independent variable to predict intercepts 
and rates of change in outcomes. Additional analyses will determine if covariates (e.g., 
context of care indicators, primary objective stressors, and resources) significantly vary 
across the RCTM treatment and control groups at baseline and over time via growth curve 
modeling procedures. If statistically significant variations between the RCTM treatment and 
control groups are found, initial status and rate of change parameters for these covariates 
will be included in all tests to provide further statistical control.  
 

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Secondary Analyses 
In addition to analyses of secondary Aims 1a and 1b (which will mirror the Specific Aims 1-3 
analyses described above), empirical treatment fidelity data on variations in use of RCTM 
(e.g., frequency and duration of counseling sessions) will be included in growth curve 
models as a series of post-hoc Specific Aims 1, 2, and 3 analyses. These analyses will explore 
the effects of variations in RCTM utilization on the outcomes hypothesized above. [A series 
of mediational models will also be tested examining some of the hypothesized pathways of 
the SPM-RC as described in the conceptualization of the proposed project (e.g., whether 
RCTM assignment mediates the empirical relationships between care-related stressors and 
more global psychological and emotional outcomes on the part of family caregivers). As 
detailed by Selig and Preacher and other methodologists, mediational models appropriate 
for longitudinal data will be utilized.108 These analyses will explore the empirical 
mechanisms that explain RCTM’s efficacy or lack thereof.] 
 
Specific Aim 4 Analyses 
Specific Aim 4 analyses will primarily focus on thematic content analysis of open-ended data 
to examine RCTM utility and mechanisms of benefit. Systematic reading and rereading of 
qualitative content and hand coding of a significant proportion of this content is necessary 
in order to develop an understanding of meanings in their conversational or observational 
contexts.109,110 Specifically, the PI, Dr. Garcia (Co-Investigator) and the research assistants 
will independently develop coding categories together with descriptors (via hand-coding 
and NVivo) and will develop a shared coding scheme that will reflect the primary categories 
of the transcription. Through repetition of this procedure, a consensus perspective on 
appropriate coding categories and themes will be modified and developed. These themes 
will provide insights as to the RCTM’s implementation and use (i.e., treatment 
fidelity/process evaluation) and mechanisms of benefit (i.e., semi-structured interview 
embedded component). 
 
Grounded theory techniques described by Morse111 and Strauss and Corbin109 will guide the 
analyses of qualitative data in the treatment fidelity/process evaluation procedures and 
Specific Aim 4. These approaches allow participants to construct meanings, perceptions, and 
behaviors from their own vantage points. All open-ended data collected will be first read by 
the PI, Dr. Garcia, and the research assistants to identify textual elements that emerge 
repeatedly (i.e., codes); these codes will then be clustered into larger categories that are 
later used to construct major thematic elements from the text (with the use of nVivo 10112 
analytic software).  
 
During weekly meetings in the analysis phase of the proposed project, the PI, Dr. Garcia, and 
the research assistants will discuss their own identified codes to reach a consensus about 
specific codes, categories, and themes that emerge from the qualitative data (these 
decisions will be noted in an audit trail). In addition, patterns that link particular themes will 
be identified and discussed in successive meetings between the PI, Dr. Garcia, and the 
research assistants to identify more complex processes of RCTM use or RCTM’s pathways to 
benefit. During monthly team meetings, the development of codes, categories, and themes 
will be reviewed with the other Co-Investigators to yield any additional input into these 
project components. The multiple team meetings and discussions will allow for an 
exploration of alternative interpretations of the qualitative data and will also provide a 

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check regarding the quality and richness of the data collected during the embedded mixed 
methods components. [Moreover, member checking113,114 will take place where transcripts 
in addition to emergent thematic findings from the qualitative data are presented to 
participants themselves to ensure that we interpret open-ended responses and the 
meanings derived from these data appropriately.]  
 
Additional mixed methods analyses63,64 will take place to complete Specific Aim 4. The 
thematic codes and categories of the post-RCT embedded component will be cross-
tabulated with the empirical data from the RCT to determine whether the findings diverge, 
converge, or highlight pathways toward additional questions and analysis.64 Findings that 
diverge will be treated as “interpretive opportunities” to either demonstrate that no true 
discrepancy in efficacy exists or to propose the phenomenon that explains the apparent 
discrepancy.115  Specifically, empirical outcome data of the RCT will be sorted according to 
the qualitative themes that emerge across the two subgroups of the embedded semi-
structured interview component (e.g., increased or decreased rates of change in care-
related strain). This integration will provide empirical context for ADRD caregivers’ 
statements regarding why the RCTM is perceived to work or not, respectively.64,116 The 
comparative, mixed method analysis approach may also suggest that those who reported 
greater increases in subjective stress during RCTM use may indicate certain themes more 
often or may use RCTM differently than ADRD caregivers who report greater decreases in 
care-related strain. 
 
The post-intervention interviews will help explain mechanisms of benefit based on the 
questions of “why” and “how” that are implicit in qualitative data. While empirical analyses 
such as mediational models might provide some suggestion as to why the RCTM exerts 
benefits, utilizing qualitative data is a more comprehensive approach by allowing 
intervention participants to describe, in their own words and experiences with the RCTM, 
why the psychosocial support provided helped families adapt to the RLTC transition. Such an 
approach may also identify domains untapped in empirical measurement. This certainly 
occurred in the pilot evaluation of RCTM efficacy,117 and is largely why a mixed methods 
design for this larger-scale evaluation was selected. Also, the qualitative data that emerge 
from the post-RCTM interviews may suggest additional secondary analyses of the empirical 
data that could test possible mediators or path analyses (see above). In this regard, the 
mixed methods approach is advantageous for the proposed project. 
 
Planned Interim Analyses 
Not applicable; if these are done, they will be conducted at the 4-, 8-, and 12-month 
intervals; given how the qualitative data component of the mixed methods research design 
is structured, these findings will not be fully available until the final months of the 5-year 
project. 
 
Analysis Plan for COVID-19 Administrative Supplement 
 
We will aim for a total of at least 100 participants to complete the post-COVID-19-onset 
assessments. This sample size will allow for robust longitudinal modeling. A sample size of 
20 is appropriate for exploratory semi-structured interviews to examine the potential 
effects of COVID-19 on caregivers with a relative in long-term care. 

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For our first aim (examining COVID-19-related experiences among caregivers with a care 
recipient in RLTC), we will use a parallel-convergent mixed methods design to integrate 
qualitative and quantitative data about participants' COVID-19-specific experiences. We will 
calculate descriptive statistics for the measures of COVID-19-specific experiences, and use 
appropriate correlational methods to examine the relationship between key COVID-19 
experiences (e.g., having a confirmed positive case in the relative's RLTC facility; removing a 
relative from the RLTC facility; perceptions of the RLTC's crisis response effectiveness) and 
caregivers' stress and mental health. In addition, we will use thematic analysis techniques 
developed by Braun and Clarke to investigate themes from semi-structured interviews and 
open-ended survey responses relating to caregivers' challenges and coping responses to 
COVID-19. These open-ended responses will provide insights regarding novel challenges that 
are currently emerging for caregivers, and reveal which issues are perceived as most 
important and urgent from caregivers' perspectives. All open-ended data will be read by the 
PI and the coding team to identify preliminary patterns within the text (i.e., codes). These 
codes will be refined through an iterative process of weekly discussion and adjustment of 
the coding scheme. Decisions will be noted in an audit trail to enhance transparency of the 
coding process. Codes will be clustered into broader overarching themes that reflect key 
insights. Additional mixed methods analyses will involve cross-tabulating the thematic codes 
with the quantitative data on caregivers' COVID-19 experiences, RCTM treatment group 
assignment, and caregiving stress to determine whether the findings diverge, converge, or 
highlight additional directions to explore. This comparative, mixed methods analysis 
approach may suggest how and why caregivers are able to cope with COVID-19 related 
challenges. 
 
For our second aim (evaluating the effects of COVID-19 on caregiver stress), we will use 
latent growth curve modeling to estimate trajectories of change in caregiver stress over 
time. Latent growth curve modeling is a structural modeling approach to longitudinal 
analysis that can accommodate individually-varying measurement occasions. With up to 
seven waves of data per participant, we will be able to estimate nonlinear growth 
trajectories. We will examine change in caregivers' primary subjective stress, residential care 
stress, and depressive symptoms, and will center our longitudinal analyses around March 
13, 2020, the date when COVID-19 was declared a national emergency in the United States.  
 
For our third aim (determining whether RCTM treatment group participants are more 
resilient to negative psychosocial effects of COVID-19), we will incorporate a time-invariant 
covariate reflecting treatment or control group membership into the latent growth curve 
models for caregiver outcomes. This will allow us to compare the trajectories for the 
treatment and control groups to determine whether the RCTM intervention affected change 
in caregiver stress and mental health before and after the onset of the pandemic. We will 
also conduct sensitivity analyses that incorporate measures of treatment group participants’ 
contact with the RCTM counselor after the onset of the COVID-19 pandemic, to distinguish 
the effects of current support via RCTM from the potential protective effects of having 
completed the intervention prior to the pandemic. 
 
Statistical analyses used will include calculation of frequencies, bivariate correlations, t-
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Latent growth curve modeling will be used to estimate trajectories of caregiver mental 
health and well-being before and after the onset of the pandemic.   
 
17.2 Power Analysis:  
Determination of Sample Size   
Intensive longitudinal analysis procedures (multilevel regression analyses of outcome and 
growth curve modeling) will be utilized to capitalize on the randomized controlled design 
and the multiple waves of data to be collected. The number of ADRD caregivers to be 
enrolled to address study hypotheses was determined using power analysis procedures that 
take into account the hierarchical analytic design of the study.99 In this framework, the 
researcher identifies the Type I error rate (e.g., p < .05) to differentiate between a null and 
alternative test hypothesis, a suitable level of statistical power (.80 is considered an 
excellent power value), and the expected difference between the two study groups in order 
to determine the number of ADRD caregivers to enroll into the project. [We sought a sample 
size that would be sufficient to detect a group difference of 0.50 standard deviation units 
and modest effect sizes that we identified in our preliminary efficacy trial. This is considered 
to be a “medium” effect size100 and is a reasonable benchmark to evaluate the efficacy of a 
behavioral intervention in comparison to a usual care control condition. We also used a 
Bonferroni adjusted Type I error rate of .0125 (.05/4) to accommodate up to 4 primary 
outcome variables (primary subjective stress; secondary role strain; residential care stress; 
caregiver depressive symptoms), and we allowed for a conservative 10% loss to follow-up. 
With these specifications, an enrolled sample size of 240 ADRD caregivers (120 in each 
group) was sufficient to provide adequate statistical power. After attrition, this sample size 
will give us .87 power to detect a 0.50 effect size and .80 power to detect a slightly smaller 
effect size of 0.46 standard deviation units. This effect size could apply to covariate-adjusted 
mean differences at a particular follow-up point, or two linear slope differences of change 
across time between the intervention and control conditions.]    
 
As noted in various recommendations for mixed methods sampling, 30-40 participants is 
considered an adequate sample size for semi-structured interview protocols as proposed 
here.101,102 As “sample size“ in qualitative research is based more on the richness and depth 
of open-ended data collected, it is possible to achieve the goals of the post-randomized 
controlled evaluation embedded component with a smaller number of semi-structured 
interviews. Given the expected number of ADRD caregivers in the RCTM treatment 
condition, we decided on 30 semi-structured interviews to ensure the richness of the 
qualitative data collected. 
 
17.3 Statistical Analysis: Please see data analysis plan. 
17.4 Data Integrity: Several steps will be taken to ensure data quality. The psychometric 
properties of the study measures are generally well-established; however, additional steps 
will be taken to ensure the reliability and validity of the study measures. For example, 
internal reliability will be established with Cronbach's alpha (α) estimates for each measure 
and subscale. These procedures will help to establish the psychometric qualities of each tool 
beyond their utilization in prior study. Each outcome variable will be examined to determine 
if skewness exists or outliers are present. Normal probability plots and histograms of each 

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dependent variable will be analyzed; this step is necessary because individual outcome 
variables must have near-normal distributions in order to be included in subsequent models. 
If the outcome variables are not normally distributed, the original variables can be subjected 
to algebraic transformations or other standard transformation techniques to meet model 
assumptions. 
18.0 Health Information and Privacy Compliance 
18.1 
Select which of the following is applicable to your research: 
X My research does not require access to individual health information and therefore 
assert HIPAA does not apply.   
☐ I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone form or 
the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research participant 
authorization to participate in the research. 
Appropriate Use for Research: 
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U of M 
stand-alone HIPAA Authorization.  Note: External IRB must be serving as the privacy 
board for this option. 
 
18.2 
Identify the source of Private Health Information you will be using for your research 
(Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also referred 
to as the University's Information Exchange (IE) or data shelter) to pull records for me 
X I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone Marrow 
Transplant (BMPT) database, also known as the HSCT (Hematopoietic Stem Cell 
Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe:  
18.3 
Explain how you will ensure that only records of patients who have agreed to have their 
information used for research will be reviewed. N/A 
18.4 
Approximate number of records required for review: N/A 

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18.5 
Please describe how you will communicate with research participants during the course of 
this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication with 
research participants. 
☐ Communication with research participants will take place in the course of treatment, 
through MyChart, or other similar forms of communication used with patients 
receiving treatment.  
X Communication with research participants will take place outside of treatment settings. 
If this box is selected, please describe the type of communication and how it will be 
received by participants. When participants consent to participating in the research, 
they are asked whether or not they agree to communicate with the research team via 
unencrypted email. If a participant does not agree to communicate this way, the team 
can send encrypted emails to participants. Participants also agree to telephone-based 
counseling, depending on randomization, and completing surveys either via hard copy 
or via secure Qualtrics survey platform.  
Access to participants 
Our research team is not permitted to access medical records. Any private information 
that the research team is allowed to have access to will need to be provided by the 
participant. This includes, but is not limited to, survey responses, semi-structured 
interview responses, and contact information.  
18.6 Location(s) of storage, sharing and analysis of research data, including any links to research 
data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store ☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT (Hematopoietic 
Stem Cell Transplant) Database  
 ☐ Store ☐ Analyze 
☐ Share 
☐ In REDCap (recap.ahc.umn.edu)  
 ☐ Store ☐ Analyze 
☐ Share 
X  In Qualtrics (qualtrics.umn.edu) 
 X Store ☐ Analyze 
X Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store ☐ Analyze 
☐ Share 
X In the University’s Box Secure Storage (box.umn.edu) 
 X Store ☐ Analyze 
X Share 
X In an AHC-IS supported server. Provide folder path, location of server and IT Support 
Contact: 
S:\Public_Health_Center-on-Aging_Gaugler\The Residential Care Transition Module 

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IT Support Contact: Troy Karkula, karku003@umn.edu 
 X Store X Analyze 
X Share 
 ☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 
☐ Store ☐ Analyze 
☐ Share 
☐ Other.  
Indicate if  data will be collected, downloaded, accessed, shared or stored using a server, 
desktop, laptop, external drive or mobile device (including a tablet computer such as an iPad 
or a smartform (iPhone or Android devices) that you have not already identified in the 
preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not previously 
listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
 
18.7 Consultants. Vendors. Third Parties.  
John Hopkins University will have responsibility for data analysis. Additionally, Production 
Transcripts is a professional transcription service that will be used to transcribe audio 
recordings of qualitative interviews. Audio recordings will be securely uploaded to their 
secure website and the transcripts will be securely shared with the research team once 
completed.   
18.8 Links to identifiable data:  
Individualized links are generated via Qualtrics and saved on the server. Links are destroyed 
at the end of data collection. 
 
18.9 
Sharing of Data with Research Team Members. Data will be shared via Box, Qualtrics and 
the secure server. See 19.1 “Data Security”. 
 
18.10 Storage of Documents: All electronic data will be maintained on a University of Minnesota 
secure server folder and a Box folder. Paper forms of the data will be located in a locked 
file cabinet in D351 Mayo Memorial Building (Dr. Gaugler’s research office) only accessible 
to the research team. The office containing the files is also locked.  Unless the data are 
being filed or accessed, these cabinets will remain locked. 
 
18.11 Disposal of Documents: Per University of Minnesota and the School of Public Health 
security guidelines, participant data will be maintained on the secure project folder for 
approximately 2-3 years which is the time anticipated it will take to disseminate any and all 
research papers or presentations from these data. Baseline, follow-up, or disposition 
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for tracking will be de-identified upon study completion. De-identified records will be kept 
indefinitely, in order to encourage data sharing submitted to the National Institute on 
Aging. 
 
19.0 Confidentiality 
19.1 Data Security:  
Who Will Manage the Study Data 
Dr. Gaugler (the PI), Dr. Mitchell (the administrative supplement PI), the TCs, the research 
coordinators, and graduate research assistants will have primary responsibility for managing 
all study data.  Research assistants who work under the supervision of Dr. Gaugler in the 
Families and LTC Projects at the University of Minnesota may also enter, clean, and assist 
the PI and other RCTM team members to manage data as appropriate during the course of 
the project.  
 
Dr. Gaugler’s team uses VPN and Remote Desktop Connection to access study data.  They 
are not to download, view, or save any project-related data on their personal laptops or any 
mobile data storage device. Staff working remotely will continue use of these secure 
environments as needed. Note: University staff calling from personal lines outside of the 
University will block their personal numbers when able, and note they are calling from a 
personal line and request a callback to a work-based telephone number, or alternatively use 
a google voice account.  
 
Confidentiality Assurance and Data Management 
Names and contact information are included in study tracking documents for the purposes 
of interview reminders and completion of the various data collection procedures.  However, 
data used for analysis will be de-identified according to standard procedures. Procedures for 
data collection and storage are described above. 
 
As mentioned above, baseline, follow-up, or disposition surveys inputted into Qualtrics 
databases that contained a participant’s identifier (name) for tracking will be de-identified 
upon study completion. De-identified records will be kept indefinitely, in order to encourage 
data sharing submitted to the National Institute on Aging. 
 
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
20.1 Data Integrity Monitoring.  
Dr. Gaugler (the PI) and the research coordinators will have primary responsibility for 
managing all study data. Research assistants who work under the supervision of Dr. Gaugler 
in the Families and LTC Projects at the University of Minnesota may also enter, clean, and 
assist the PI and research coordinators manage data as appropriate during the course of the 
project. 
Prior to University of Minnesota Institutional Review Board (IRB) submission, Dr. Gaugler 
will identify a Data Monitoring Officer (DMO) at the University of Minnesota. The DMO will 
be a senior faculty member with experience conducting clinical trials. 

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Review process. Dr. Gaugler and the DMO will review data monitoring and safety activities 
annually during the 5-year project period. The responsibility of Dr. Gaugler (who also has 
oversight for the data management and analysis of the project) will include the production 
of an administrative report that will highlight study accrual. In addition, Dr. Gaugler will 
provide information on any deviations from the approved protocol (e.g., deviations in 
adhering to study eligibility criteria), error rates, and any other issues related to the progress 
of the study. The DMO will review the administrative report to ensure ongoing quality 
control, and will work with Dr. Gaugler if necessary to identify individual cases to ascertain 
any deviations in the approved study protocol. Following this review, the administrative 
report will be presented to the National Institute on Aging (NIA). In instances of adverse 
events (see Data Safety Monitoring Plan), the DMO, the NIA project officer, and the 
University of Minnesota IRB will be notified per below specifications. 
 
The administrative reports will include the following: 
1. Table of contents 
2. Narrative/trial summary 
a. Summary of main findings 
b. Discussion of issues or problems 
c. Report preparation procedures 
3. Study description 
a. Project organizational chart, personnel 
b. Brief statement of purpose of trial 
c. Projected timetable and schedule 
4. Study administration 
a. Recruitment and participant status 
i. Table 1: Enrollment by year or month of study 
ii. Figure 1: Comparison of target to actual enrollment by month 
b. Forms status 
i. Status of forms (e.g., consent, completing of screener, baseline 
assessment battery, etc.) 
 
Data Report. 
Dr. Gaugler will also prepare interim analysis reports for review with the DMO. These 
interim analysis reports will include the following: 
1. Recruitment and participant status 
a. Table 2: Targeted/Planned Enrollment Table 
b. Table 3: Demographic and key baseline characteristics by group 
2. Safety assessment for all participants 
a. Table 4: Treatment duration for all participants 
b. Table 5: Adverse events by participant 
c. Table 6: Serious adverse events by participant 
d. Table 7: Participant deaths 
e. Table 8: Participants without capacity to consent during follow-up 
 
Reports from the DMO (largely taken from National Institute of Allergy and Infectious 
Diseases guidelines). 

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At the conclusion of each annual review, the DMO will discuss her/his recommendations 
and findings with Dr. Gaugler. If necessary, the DMO will also issue a written summary 
report that identifies key issues in the administrative, safety, and data reports and 
provides overall safety assessment and recommendations. Any rationale for 
recommendations will be included where appropriate. The report will not include 
confidential information. Following dissemination of this report to Dr. Gaugler, Dr. Gaugler 
will provide the report to NIA and the Co-Investigators for review. 
 
The DMO will notify Dr. Gaugler of any findings of a serious nature or recommendations to 
discontinue all or part of the intervention. Dr. Gaugler will then immediately inform the 
project officer at NIA of this recommendation. 
 
20.2 Data Safety Monitoring.  
A data monitoring safety plan (DMSP) that includes a data safety and monitoring officer is 
proposed to provide additional oversight of the research protocol and adverse event reporting, if 
necessary. 
 
The main activities of the DMSP will be as follows (taken from National Institute of Allergy and 
Infectious Diseases guidelines): 
1. Review of interim and cumulative data for any evidence of study-related adverse events 
(AEs); 
2. Review of interim/cumulative data for evidence of efficacy of the intervention; 
3. Review of data quality, completeness, and timeliness; 
4. Review the adequacy of compliance with goals for recruitment and retention, including 
those related to the participation of women and minorities; 
5. Review adherence to the protocol; 
6. Review factors that might affect the study outcome or compromise the confidentiality of 
the data (such as protocol violations, unmasking, etc.); and 
7. Identification of factors external to the study such as scientific or therapeutic 
developments that may impact participant safety or the ethics of the study. 
 
Safety reports. In addition to producing administrative reports on an annual basis to the DMO, Dr. 
Gaugler will generate annual safety reports that will list adverse events, serious events, 
unexpected events, events related to or associated with the intervention, and the potential 
causality of the intervention to the event for each participant. If the research team becomes 
aware of an adverse event or unanticipated problem occurring while a participant is enrolled in 
the study (from consent through the participant’s final data collection), the event will be 
documented and/or reported per the protocol below. Events will be documented/reported as 
adverse events per the protocol if they meet one of the following criteria: a participant alerts 
study staff of a new or worsening health problem that causes the participant to 1) be unable to 
perform their daily routine, 2) seek medical care (provider visit, hospitalization, residential care 
placement, etc.), or 3) take a new medication. Conditions existing prior to study enrollment that 
have not worsened/changed will not be considered adverse events and will not be 
documented/reported. Per the University of Minnesota IRB guidelines, all events or information 
that indicates a new or increased risk, or a safety issue, will be promptly reported. 

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Taken from earlier National Institutes of Mental Health policy on Data and Safety Monitoring in 
Clinical Trials, the definition of each event is as follows: 
Adverse event. Any untoward medical occurrence in a patient or clinical investigation 
participant which does not necessarily have to have a causal relationship with the 
treatment. An adverse event can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding, for example), symptom, or disease temporally 
associated with the participants’ involvement in research, whether or not considered 
related to participation in the research. 
Serious adverse event. Any adverse experience that results in any of the following 
outcomes: death, a life threatening experience, inpatient hospitalization, a persistent or 
significant disability/incapacity, or a congenital anomaly/birth defect. Important medical 
events that may not result in death, be life threatening, or require hospitalization may be 
considered a serious adverse experience when based upon appropriate medical judgment, 
and they may require medical or surgical intervention to prevent one of the outcomes 
listed in this definition. 
Unexpected. Any adverse experience, the specificity or severity of which is not consistent 
with the risk information described in the [protocol or consent documents]. 
Related to (or associated with) the intervention. There is a reasonable possibility that the 
experience may have been caused by the intervention. 
Causality. A reasonable possibility that the product is etiologically related to the adverse 
event. Causality assessment includes, for example, assessment of temporal relationships, 
dechallenge/rechallenge information, association with (or lack of association with) 
underlying disease, presence (or absence) of a more likely cause, plausibility, etc. 
 
Survey responses regarding health information will not be considered adverse events, unless 
otherwise communicated to the study staff. [Note: Medical events or emergencies of a non-
participant will not be considered/documented as adverse events].  Regardless of the 
classification of an event (adverse event versus serious adverse event), only those events 
determined to be potentially related to the participant’s involvement in research will be reported 
to IRB promptly. All other adverse events reported to study staff by participants will be recorded 
and reported annually via routine reports. Any participant deaths will also be promptly reported, 
regardless of the cause.  
 
In the instance of an adverse event, Dr. Gaugler and/or the study team will classify whether the 
event is unexpected, adverse, or seriously adverse, whether the event is unexpected or related to 
the intervention, and what potentially caused the event. Per the protocol, Dr. Gaugler will review 
the data routinely and will alert both the DMO as well as NIA as needed if these events occur.  
 
All AEs (following consent) will be collected on an adverse event form, in electronic format. AEs 
experienced by a participant during a study procedure (i.e. intervention/survey) and are 
considered potentially related to the participant’s involvement in research will be reported within 
5 days of discovery to the University of Minnesota IRB (per the University’s IRB procedures) and 
annually to the NIA, DMO, and IRB in data monitoring reports.  
 
AEs that occur outside of the context of a study procedure (i.e. intervention/survey), as well as 
those that are determined to be not related to the participant’s involvement in the study, will be 

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documented via the team’s electronic AE form and included in the annual report (to be shared 
with IRB, DMO, and NIA Program Officer). 
 
SAEs that are unanticipated and related to the intervention will be reported to the IRB, NIA 
Program Officer, and to the DMO within 48 hours of our team’s knowledge of SAE. The summary 
of all other SAEs (i.e. those determined not related to study involvement) will be included in the 
annual report (to be shared with IRB, DMO, and NIA Program Officer). 
 
Deaths determined not-related to the study will be reported to the IRB within 5 days of the team’s 
knowledge of the participant’s death, and reported to the Safety Officer and NIA Program Officer 
via routine annual reports. Though unlikely, if a participant’s death during the project enrollment 
has a possible relationship to the study, it will be reported in expedited fashion (within 24 hours of 
the team’s knowledge of a participant’s death) to the University of Minnesota IRB, the NIA 
Program Officer, and to the DMO. A written SAE report will be submitted soon thereafter.  
 
No adverse events are expected to be related to study involvement. However, due to the nature 
of our study population, possible adverse events (i.e. general medical events and/or emergencies) 
may occur during the time a participant is enrolled in the study. These events will be documented 
and/or reported according to the protocol. 
 
Dr. Gaugler will present the safety report to the DMO to ensure that there are no negative effects 
of the treatment. The DMO will review the safety reports annually to ensure that the proper 
procedure was followed and to identify any potential trends in the data. Dr. Gaugler will present 
the safety reports to NIA if adverse events occur. 
 
Relationships between the Proposed Data Monitoring and Safety Plan and the IRB 
We will notify the University of Minnesota IRB of our data monitoring and safety plan. If the 
University of Minnesota IRB requests it, we will provide feedback to the IRB of these data 
monitoring activities on an annual basis (in addition to the annual progress reported required by 
the University of Minnesota IRB). A brief summary report will be sent to the IRB documenting that 
a review of the data took place on a given date and will outline the DMO’s review of any adverse 
or unanticipated events. Any requests for modification in the protocol will also be forwarded to 
the University of Minnesota’s IRB. 
 
21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury: N/A 
21.2 Contract Language: N/A 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained):  
Following eligibility screening, the consent process will take place. Going forward, our 
consent process will specifically entail: study staff reviewing highlights of each section of the 
consent form with the potential participant, then study staff will ask each potential 
participant whether they have any questions about the consent form or study details. Since 
we are improving our procedures, this more detailed consent process will begin after 

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approval of the protocol (v 11.09.2020). During the parent study and the supplement, we 
provided potential participants an overview of the project prior to initiating the consent 
process, which we will continue to do.  
 
After an overview of the project has been described, highlights of the consent form will be 
described and any questions from the potential participant will be answered, then a signed 
informed consent will be obtained from the eligible family caregiver. This consent will be 
offered electronically, over the phone or via mail. Online consent forms will be 
administered via the secure University of Minnesota Qualtrics survey application. 
Participants will be provided with a copy of their completed consent form. 
 
Due to the COVID-19 pandemic, hard copy records of signed consent forms will not be 
maintained at D351 Mayo. However, records of signed consent forms will be saved on the 
University of Minnesota secure server. For this reason, staff are unable to sign online 
consent forms.  
The modality of consent will determine who signs the consent form, as detailed below:  
 
Online consent form: only the participant signs 
 
Phone (verbal) consent form: only the staff member signs 
 
Mail consent form: both the participant and the staff member sign 
The online and verbal consent forms in Qualtrics will only display the appropriate signature 
blocks according to the modality. As before, once consent is obtained, participants will be 
emailed or mailed a copy of their completed consent form.  
 
For the COVID-19 administrative supplement, participants will be recruited from among 
current and previous participants in the parent RCTM study. 
 
Previously-enrolled participants: For caregivers who have previously completed the 12-
month parent RCTM survey, research staff will reach out by phone, email, or mail to invite 
caregivers to re-enroll in the study to complete three additional surveys.  We will describe 
the contents and timing of these additional surveys, and invite caregivers to participate.  
Previously completed participants who are interested in participating in the additional 
survey(s) for the COVID-focused supplement will complete a brief screening survey prior to 
re-enrollment, including items assessing bereavement.  Caregivers who are eligible and 
agree to re-enroll will provide informed consent, and will receive the additional surveys 
according to the same procedures used for the parent study surveys. 
 
Semi-structured interviews: We will select a purposive sample of approximately 20 
participants (split evenly among the treatment and control group) to invite for a semi-
structured interview to investigate their COVID-19 and long-term care related experiences 
in-depth. Participants will be selected based on their responses to the COVID-19 specific 
items in the survey, aiming for diversity in terms of experiences navigating pandemic-related 
changes. For example, we will seek to recruit participants who have reported a high degree 
and a low degree of perceived preparedness from their care recipient's RLTC, participants 
who have chosen to remove their care recipient from RLTC as well as those whose care 
recipient has remained in RLTC, and participants living in areas with higher and lower 
disease exposure.  We will reach out to the selected participants to provide information 
about the interview and invite them to participate.  Those who are interested will provide 

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informed consent for the interview and will be scheduled for the interview at a time 
convenient to them. 
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, required 
information will not be disclosed, or the research involves deception): N/A 
22.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent will not 
be obtained):  
As mentioned, for the COVID-19 administrative supplement, participants will be recruited 
from among current and previous participants in the parent RCTM study. 
Currently-enrolled participants: We will invite caregivers who remain currently-enrolled in 
the parent study to extend their participation with additional surveys.  Research staff will 
reach out by phone, email, or mail to describe the contents of the additional surveys and 
the timing of these additional assessments, and to invite participants to participate.  
Caregivers will receive an information sheet describing the additional surveys, as well as 
the original RCTM consent form if they have questions.  Those who agree to take part in 
the additional surveys will then receive the additional surveys according to the same 
procedures used for the parent study surveys. We request a waiver of documentation of 
consent for these participants, as they are still currently enrolled in the parent RCTM study, 
and the additional surveys they will be invited to complete present no more than minimal 
risk. 
22.4 Non-English Speaking Participants: N/A 
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of age): 
N/A 
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to consent:  
Although we do not purposively recruit cognitively impaired adults, due to the longevity of 
the study, staff may become aware of participants who have potential memory concerns 
through study interactions such as phone calls by the interventionist or research 
coordinator. When this type of participant is identified, the research coordinator will call the 
participant and determine if they are able to consent to participation. To do so, a brief 
summary of the consent form will be read to the participant, then the research coordinator 
will administer the UBACC (UCSD Brief Assessment of Capacity to Consent). In accordance 
with the UBACC administration instructions, if a participant does not correctly answer an 
item, the interventionist or research coordinator may repeat and discuss information from 
the consent form relevant to that item, and then repeat the item for up to three trials.  A 
score of 14.5 or higher indicates the participant has the capacity to consent. If a participant 
scores 14.5 or higher, they will be eligible to continue on with the study as planned. If the 
participant scores under 14.5, then we will withdraw them from the study and therefore not 
ask them to complete any additional surveys. Participants in the treatment group who do 
not pass the capacity to consent screener will be offered the opportunity 
to continue contact with the study interventionist, if they desire, even if they are withdrawn 
from the study. This will ensure continued support for any participants who had planned to 
continue their contact with the counselor, but are no longer eligible to participate in 
surveys. We will report participants who are withdrawn for this reason along with their 
UBACC scores to the IRB as an RNI within 5 business days of the capacity to consent call with 
the participant. This data will also be reported in the annual data reports on participant 

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safety as part of the data safety monitoring plan (see plan below). We will only assess 
participants with possible memory problems since the study was determined by the IRB to 
pose no greater than minimal risk to the participants, and though capacity was not formally 
assessed at initial consent, all participants were assumed to have the capacity to consent at 
study onset. 
22.7 Adults Unable to Consent: N/A 
23.0 Setting 
23.1 Research Sites:  
Our research will be conducted at the University of Minnesota, School of Public Health, 
Division of Health Policy and Management, D351 Mayo Memorial Building, 420 Delaware 
Street S.E. Minneapolis, MN 55455. Please refer to section 12.2 “Source of Participants” for 
information on recruitment sources.   
Collaborating Sites 
Johns Hopkins University, New York University Langone Medical Center, Emory University, 
and the Benjamin Rose Institute on Aging are all collaborating sites; while Johns Hopkins will 
have responsibility for data analysis, the University of Minnesota site will oversee all study 
procedures, data collection, and management. 
 
The PI (Dr. Gaugler), the Co-Is (Drs. Mittelman, Hepburn, Whitlatch, and [Roth]) and the TC 
(Mark Reese, MA, PC, LMFT) have extensive experience developing, implementing, and 
evaluating interventions for family caregivers of persons with ADRD. Dr. Mittelman is the PI 
of the NYUCI76-81 and Dr. Hepburn is the PI of the Savvy Caregiver.53-55,82,83 
 
Both the NYUCI and Savvy Caregiver are recognized as evidence-based, high quality 
psychosocial and psychoeducational programs (respectively) and are in widespread 
translation across the United States. Dr. Whitlatch also has considerable expertise designing 
and evaluating interventions for dementia family caregivers; she also developed the SPM-RC 
which is the conceptual basis of the proposed evaluation.20,84,85 [Dr. Roth is a noted expert in 
applied research methods and longitudinal analyses of family caregiving.]86-88 
Dr. Gaugler, Dr. Mittelman, [and Dr. Roth] implemented and evaluated outcome trajectories 
prior to and following RLTC in an analysis of Dr. Mittelman’s long-running, randomized 
controlled evaluation of the NYUCI.75,89,90 The results offered some of the first high quality 
evidence of the benefits of enhanced counseling in the years prior to and following 
institutionalization for caregivers of people with AD. The RCTM is designed to build on these 
earlier randomized controlled trials with a focus on adaptation to the RLTC placement 
transition.  
 
[The Co-Is will provide guidance to the PI as to the utility and implementation of RCTM; 
offer their expertise regarding data collection; assist in interpretation of quantitative and 
qualitative data; and collaborate on all dissemination efforts. Specifically, the Co-Is will 
evaluate the TC contact logs as well as qualitative data collection during and following the 
RCTM evaluation to develop codes/themes that characterize TC’s processes; to achieve the 
mixed methods goals of the proposed evaluation, these insights could later be used to 
investigate whether certain types of counseling contact influences the various outcomes to 
be analyzed in the randomized controlled evaluation. The Co-Is will also take the lead in 

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preparing a “final” dissemination product of the RCTM to facilitate potential 
implementation and translation of the RCTM. Finally, the Co-Is will review protocol 
adherence, participant enrollment and attrition patterns, and any adverse events that might 
occur as part of the data monitoring and safety plan. The Co-Is will meet via tele- or web 
conference to discuss the project at periodic enrollment milestones.]  
23.2 International Research: N/A 
23.3 Community Based Participatory Research: N/A 
24.0 Multi-Site Research: N/A 
25.0 Coordinating Center Research: N/A 
26.0 Resources Available 
26.1 Resources Available:  
As part of his academic appointment in The School of Public Health, Dr. Gaugler will have 
the necessary time to devote to the proposed project. The teaching load is flexible and 
based on external support for Dr. Gaugler’s research time. Service expectations include 
standard membership on School of Public Health and university committees. Due to the 
advantageous research environment provided by The School of Public Health, Dr. Gaugler 
can devote a majority of his time to research projects.  
 
Dr. Gaugler’s secure suite in the Mayo Building includes his own office, three other 
connected office spaces, a meeting room, and a file area. Dr. Gaugler’s office suites are 
equipped with secure computers (including the necessary statistical software), printers 
(including one color), web cameras, telephone access, and ample secure file space to 
conduct the proposed study. The computers have LAN access. Dr. Gaugler’s suite is a private 
location to conduct research participant interviews when needed as well as collect and 
manage any related human subjects research data. 
  
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