Care to Plan: Preliminary Efficacy of a Tailored Resource for Family Members of Persons With Dementia
Phase: NA
Conditions: Dementia, Alzheimer Disease, Memory Loss
Sponsor: University of Minnesota

 
 
Title: Care to Plan: Preliminary Efficacy of a Tailored Resource for 
FamilyMembers of Persons with Dementia; NCT03901456 
[Document title] 
This page is a cover page for upload to ClinicalTrials only. This version of 
theprotocol (V16; 4/28/23) was IRB approved on 5/1/23. 
 

PROTOCOL TITLE: Care to Plan: Preliminary Efficacy of a Tailored Resource for 
Family Members of Persons with Dementia 
 
 
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PROTOCOL COVER PAGE 
 
 
Protocol Title 
Care to Plan: Preliminary Efficacy of a Tailored Resource for 
Family Members of Persons with Dementia; ClinicalTrials.gov 
Identifier: NCT03901456 
Principal 
Investigator/Faculty 
Advisor 
Name: Joseph E. Gaugler, PhD 
Department: Division of Health Policy Management, School of 
Public Health 
Telephone Number: 612-626-2485 
Email Address: gaug0015@umn.edu 
Student 
Investigator 
Name: 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific 
Assessment 
Nationally-based, federal funding organizations 
Version 
Number/Date: 
Version 16.0, 4.28.2023 
 

PROTOCOL TITLE: Care to Plan: Preliminary Efficacy of a Tailored Resource for 
Family Members of Persons with Dementia 
 
 
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REVISION HISTORY 
 
MOD # 
Protoco
l 
Revisio
n # 
Version/SubmissionDa
te 
Summary of Changes 
Consent 
Change? 
#1: 12876 
X 
8/22/19 
 
Add Katie Louwagie to 
study 
X 
#2: 12990 
X 
8/28/19 
 
Added Zach Baker to 
study 
X 
#3: Discarded 
- 
- 
- 
- 
#4: 14377 
X 
11/11/19 
 
Updated CtP Flyer made 
by Riverside Health for 
recruitment 
 
X 
#5: 14878: 
X 
12/9/19 
 
Added Ashley Millenbah 
to project 
 
X 
#6: 15818 
X 
2/3/20 
 
Added Elizabeth Albers 
to project 
 
X 
#7: Discarded 
- 
- 
- 
- 
#8:  
16213 
 
1 (V2) 
2/26/20 
1. Update of eligibility 
criteria, 2. Update to 
reflect overall 
intervention 
development (CtP 
interventionists will 
assist caregivers in CtP 
assessment/navigation; 
provided with online tool 
for use following 
navigation with RHS 
staff), 3. Detailing 
timeline for completion 
of CtP and follow up 
procedures, 4. Update to 
consent form and survey 
processes (phone-
based), 5. Information 
about 
building/management of 
CtP tool by UMN HST 
and use of the Secure 
Computing Environment 
portal, 6. Update 
recruitment methods, 7. 
Addition of permission to 
share contact 
information form (to be 
completed 
electronically by 
Riverside Health) 
Yes 

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Family Members of Persons with Dementia 
 
 
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MOD # 
Protoco
l 
Revisio
n # 
Version/SubmissionDa
te 
Summary of Changes 
Consent 
Change? 
 
#9:  
16662 
 
X 
3/19/20 
 
Modification of 
telephone-based 
consent form to include 
additional information 
(i.e. mandated reporting 
of vulnerable adult 
abuse, ClinicalTrials 
information, & data 
storage information) 
 
Yes 
#10, 11, 12: 
Discarded 
- 
- 
- 
- 
#13:  
17283 
 
2 (V3) 
4/15/2020 
1. Update to reflect hard 
copy form availability if 
needed, 2. Change of 
study end-point to reflect 
use of CtP services (not 
frequency of use), 3. As 
desired/needed, 
participant may review 
online tool 
simultaneously with care 
navigator, 4. Ensure 
accurate terminology 
regarding the RHS 
contact referral 
process/outreach, 5. 
Update incentive 
payment process in 
regards to the semi-
structured interview; 6. 
Uploaded Riverside staff 
training certificates to 
IRB/Ethos 
Yes 
#14:  
17595 
 
X 
5/3/20 
Update to permission to 
contact form to allow for 
inputting both name of 
person obtaining 
permission for contact 
and name of person 
completing the form. 
 
X 
#15:  
18063 
 
X 
6/3/2020 
Add Ayush Shah, 
research assistant, to 
project 
X 
#16:  
18430 
 
3 (V4) 
6/25/2020 
Uploading of Phase II 
consent form (designed 
to mimic the phase I 
consent form, with 
Yes 

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MOD # 
Protoco
l 
Revisio
n # 
Version/SubmissionDa
te 
Summary of Changes 
Consent 
Change? 
updates to study 
delivery), surveys, and 
recruitment ads. 
Protocol update clarifies 
screening process for 
contacts who reach out 
to UMN directly and 
recruitment section 
updated to include 
Riverside Intranet. 
#17:  
5971 
 
4 (V5) 
8.24.2020 
Modification to adverse 
event section to create a 
more robust Data Safety 
Monitoring Plan; 
clarification of processes 
for “usual care” control 
group for Phase II; 
clarification of process 
for selection of Phase II 
final phone 
interviews/process for 
analysis; minor updates 
to surveys; removal of 6 
month CtP checklist; 
addition of disposition 
surveys for Phase II; 
submission of phase II 
advertisements and 
cover letters (minor edits 
ongoing as needed); 
removal of coaching 
manual on ethos 
(integrated into online 
tool); adding online URL 
for CtP tool to protocol 
and screen shots of 
tool/recommendations to 
Ethos; clarification of 
study 
withdrawal/termination 
by PI. 
Yes 
#18: 
Discarded 
- 
- 
- 
- 
#19:  
19666 
 
X 
9/3/2020 
CtP tool 
recommendations 
updated 9/2/2020; list of 
updated resources 
uploaded to Ethos for 
record; CtP tool 
navigator tip added to 
X 

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MOD # 
Protoco
l 
Revisio
n # 
Version/SubmissionDa
te 
Summary of Changes 
Consent 
Change? 
consider nearby zip 
code regions for 
participants on edge of 
region; Space to 
document participant 
questions added to 
consent form for phase 
II; Edit to screener for 
phase II to include 
gender tracking per 
protocol; Minor 
screener/survey edits to 
facilitate electronic data 
entry/management via 
Qualtrics, and ensure 
that the Qualtrics 
versions used by study 
staff match the Ethos 
forms 
 
#20: 19978 
X 
9/22/2020 
Updates to the semi-
structured interview to 
reflect language 
adaptations for those 
who do not view the CtP 
tool online; Uploading of 
phase I general cover 
letter; Uploading of final 
Phase I consent form 
[see Ethos for details]  
Yes 
#21:  
20523 
 
5 (V6) 
10.26.2020 
Addition of newspaper 
advertisement and 
recruitment via 
registration/presentation
s; Clarification of window 
for staff to send/receive 
surveys and request 
final interview; 
Clarification of Riverside 
staff EMR use outside of 
study context - UMN 
study staff do not have 
access to Riverside 
EMR; Clarification of 
process for phone 
consent when 
participant requests form 
via mail  
X 
#22: 20684 
X 
10/30/2020 
Approval of grayscale 
newspaper ad 
X 

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MOD # 
Protoco
l 
Revisio
n # 
Version/SubmissionDa
te 
Summary of Changes 
Consent 
Change? 
 
#23: 20859 
6 (V7) – 
not 
uploade
d 
properly 
11/11/2020 
Adding staff (Jinhee Cha 
and Colleen Peterson); 
addition of all 
modifications to revision 
history in protocol; 
allowing for e-mail 
delivery of consent form 
for review prior to phone 
consent (on request) 
X 
#24 
6 (V7) 
11/13/2020 
Uploading V7 of protocol 
that was not approved 
with MOD 20859 as 
intended; Update to 
registration form 
permission to contact 
 
#25 
6 (V7)  
11/25/2020 
no changes to protocol 
text; Ethos document 
upload of Caregiver 
Coalition newsletter; 
template for sharing CtP 
link if needed; prior 
participant quotes (for 
use in presentations, 
etc.); FLTC project 
webpage text and 
Clinicaltrials.gov URL 
X 
#26: 
MOD0002157
2 
6 (V7) 
12.23.2020 
No changes to protocol 
text. Upload of Riverside 
website, email 
templates, new CtP 
resource, and direct 
permission to contact 
form. 
No 
#27: 
MOD0002205
0 
7 (V8) 
1.27.2021 
Clarification of 
recruitment methods 
and procedures, addition 
of TV ad and letters to 
providers, upload of new 
recruitment text 
No 
#28:  
8 (V9) 
2.23.2021 
Clarification of CtP tool 
data capture; 
clarification regarding 
use of CtP tool with 
senior care 
navigation/staff; 
clarification regarding 
qualitative data 
analysis/processes, 
meeting frequencies, 
 

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MOD # 
Protoco
l 
Revisio
n # 
Version/SubmissionDa
te 
Summary of Changes 
Consent 
Change? 
and site visits to 
Riverside; clarification 
regarding recruitment; 
clarification regarding 
remote phone calling 
practices 
#29 
9 (V10) 
4.30.21 
1) Creation of hard copy 
permission to contact 
forms; 2) Creation of 
language for permission 
to contact via webinar 
“poll”; 3) Addition of 
email abilities for 
consent copy, sending 
recommendations 
generated by the CtP 
tool, etc; 4) Addition of 
procedures for a post-
phase II waitlist control 
(with corresponding 
screening forms and 
cover letters as needed); 
5) Updates to the 
Riverside website; 6) 
Update to original study 
consent form to alert 
participants that we will 
contact those in the 
control group to offer 
access to the tool 
following the study 
period (either via 
enrolling in the study 
extension or by sending 
the URL); 7) Updated 
version of ClinCard’s 
FAQ document 
Yes – 
update to 
original 
consent & 
new 
permission 
form 
#30 
10 (V11) 
5.19.21 
1) Addition of participant 
name field to permission 
form for waitlist control; 
2) Clarification regarding 
eligibility criteria (MCI 
and vulnerable 
populations); 3) 
Clarification that any 
templates/corresponden
ce may be sent via 
email; 4) Clarification 
regarding administration 
of checklist for waitlist 
 

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MOD # 
Protoco
l 
Revisio
n # 
Version/SubmissionDa
te 
Summary of Changes 
Consent 
Change? 
control group; 5) 
Clarification of phone 
templates 
#31 
11 (V12) 
6.21.21 
1) Update to semi-
structured interview 
selection/procedure; 2) 
Added ClinicalTrials 
identifier on Ethos 3) 
Update to CtP resource 
contact 
information/process 
Yes 
(permissio
n for 
waitlist 
control 
only) 
#32 
12 (V13) 
9.22.21 
Update staff member to 
coordinator status and 
update procedures with 
goal to reduce loss to 
follow up. Also included 
clarification regarding 
internal procedures for 
partially completed 
surveys. 
No 
#33 
X 
10.26.21 
1) Add Joana Lopez, 
research assistant, to 
project 
2) Remove Colleen 
Peterson, research 
assistant, from project 
X 
 
#34 
13 (V14) 
12.8.2021 
1) Changed study 
enrollment status to 
permanently closed for 
enrollment 
2) Added semi 
structured interviews for 
SCN and Riverside 
collaborators as a part of 
Phase II. 3) Updated 
Semi-Structured 
Interviews document to 
include a script for 
interviewing Riverside 
collaborators, and made 
small changes to SCN 
interview appropriate for 
Phase II.  
X 
#35 
X 
1.6.2022 
No changes to protocol 
text. Updated Semi-
Structured interviews 
document to include a 
COVID-19 question for 
the Senior Care 
X 

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MOD # 
Protoco
l 
Revisio
n # 
Version/SubmissionDa
te 
Summary of Changes 
Consent 
Change? 
Navigators and 
Riverside Collaborators.  
#36 
14 (V15) 
1.12.22 
Removal of 2 study staff 
no longer working on 
project; protocol update 
to reflect current 
processes and addition 
of ClinicalTrials number. 
X 
#37 
X 
5/11/22 
Removed 
undergraduate research 
assistant from project as 
appointment is finished 
 
X 
#38 
X 
7/22/22 
Removed 2 external 
team members; 
Uploaded phase one 
summary of results and 
cover letter for 
participants 
X 
#39 
x 
8/17/22 
Add new GRA to project 
X 
#40 
x 
10/18/22 
Add new GRA to project 
X 
#41 
x 
4/14/23 
Staff change (add 3 new 
staff; remove 3 staff no 
longer working on 
project) 
X 
#42 
15 (V16) 
4/28/23 
Remove burden and 
community-
based/Health service 
use as secondary 
outcomes; add Loss of 
Intimate exchange 
X 
 
 

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Table of Contents 
 
1.0 
Objectives............................................................................................................... 12 
2.0 
Background ............................................................................................................ 12 
3.0 
Study Endpoints/Events/Outcomes ....................................................................... 13 
4.0 
Study Intervention(s)/Interaction(s) ...................................................................... 13 
5.0 
Procedures Involved .............................................................................................. 14 
6.0 
Data Banking .......................................................................................................... 21 
7.0 
Sharing of Results with Participants ...................................................................... 22 
8.0 
Study Duration ....................................................................................................... 22 
9.0 
Study Population .................................................................................................... 22 
10.0 Vulnerable Populations .......................................................................................... 23 
11.0 Number of Participants .......................................................................................... 23 
12.0 Recruitment Methods ............................................................................................ 24 
13.0 Withdrawal of Participants .................................................................................... 25 
14.0 Risks to Participants ............................................................................................... 26 
15.0 Incomplete Disclosure or Deception ..................................................................... 28 
16.0 Potential Benefits to Participants .......................................................................... 28 
17.0 Data Management ................................................................................................. 28 
18.0 Confidentiality ........................................................................................................ 28 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants ................... 30 
20.0 Provisions to Protect the Privacy Interests of Participants ................................... 42 
21.0 Compensation for Research-Related Injury ........................................................... 42 
22.0 Consent Process ..................................................................................................... 42 
23.0 Setting .................................................................................................................... 43 
24.0 Multi-Site Research ................................................................................................ 44 
25.0 Resources Available ............................................................................................... 44 
26.0 References ............................................................................................................. 44 
 

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ABBREVIATIONS/DEFINITIONS 
 
ADRD: Alzheimer’s disease and related dementias 
 
RHS: Riverside Health Service 
 
CtP: Care to Plan 
 
UMN: University of Minnesota 
 
 

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1.0 
Objectives 
Specific Aim 1. Implement CtP for 20 family members of persons with ADRD in four 
RHS regions (Phase I). A convergent parallel mixed methods design (quan + QUAL] will 
be implemented to examine the feasibility, acceptability, and utility of CtP over a 1-
month period. Twenty caregivers from four RHS regions who use CtP will be interviewed 
at 1-month to obtain information and guidance on how CtP is best administered in this 
service context. Three RHS interventionists will also be interviewed after phase I 
participants complete CtP. The combination of quantitative and qualitative data from 
Phase I will offer robust data to refine and further prepare CtP for subsequent 
evaluation in Phase II. 
 
Specific Aim 2. Evaluate the preliminary efficacy and implementation of CtP (Phase II). 
By utilizing an embedded randomized controlled evaluation, the second phase of this 
project will implement the findings of Aim 1 to evaluate CtP. A newly enrolled sample of 
100 ADRD caregivers will be randomly assigned to one of two groups: one that receives 
the CtP with guidance from caregiver support staff and a usual care control. Three- and 
six-month outcomes will include caregiver self-efficacy and distress; caregiver use of 
recommended support; and service utilization on the part of persons with ADRD. These 
findings will provide initial insights into efficacy of CtP as well as the acceptability and 
utility of CtP over time. The results will also serve as a source of empirical estimates to 
inform subsequent larger-scale evaluation and translation efforts.  
 
2.0 
Background 
Approximately 5.7 million persons in the U.S. had Alzheimer’s disease in 2018, and these 
individuals relied on 16.1 million family members for necessary care and support.1 
Family members are the backbone of the long-term care system of the U.S.; 83% of 
older adults rely on relatives for the help needed to manage Alzheimer’s disease or 
other chronic conditions.2 Given the well-documented health implications of dementia 
family caregiving, existing interventions are designed to modify the more challenging 
aspects of care for a relative with Alzheimer’s disease or a related dementia (ADRD) in 
order to improve key outcomes. Multiple meta-analyses of these interventions exist,3-5 
and several programs are in translation throughout the U.S.6-8 However, current 
research has yet to discern which caregivers are most likely to benefit from different 
types of interventions. A consistent unmet need indicated by many family members of 
persons with dementia is a lack of quality information about support strategies or 
services that can help ease the challenges of their specific caregiving situations,9,10 and 
tailored solutions that can directly meet the diverse needs of caregivers or their 
relatives with ADRD remain unrealized.11 
 
The proposed Stage I R21 project will advance scientific knowledge, technical capability, 
and clinical practice as they pertain to ADRD management and caregiver support.12 
Although research on family caregiving has served as a platform for multidisciplinary 
research, a critical gap is the relative absence of rigorous inquiry as to whether the 

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personalization of services for dementia family caregivers can enhance the effectiveness 
of these programs. This project serves as an innovative effort to directly test this 
premise in actual community contexts. The research team has established the feasibility 
and utility of an online care planning tool prototype (called Care to Plan, or CtP) that 
provides a succinct and clear overview of various types of ADRD caregiver intervention 
types, administers a brief validated assessment of risk,13 and generates individualized 
recommendations for ADRD caregivers as well as resources that link users to a selected 
recommendation. The goal of CtP is to offer a more efficient, user-centered process to 
connect ADRD caregivers to the services that may be most appropriate for them given 
their needs, the needs of their relatives, and other contextual characteristics.14  
 
The proposed project will build on the CtP prototype to further refine the tool and 
ascertain the preliminary efficacy of CtP in preparation for a larger-scale, randomized 
controlled evaluation and translation effort. We will deploy and evaluate CtP for  
caregivers of persons with ADRD who seek services in a diverse healthcare system 
(Riverside Health System, or RHS) in the state of Virginia.  
 
Although the evidence base of dementia caregiver intervention efficacy has expanded,3-
5 research that ascertains the potential of easy-to-use, acceptable technologies that can 
generate personalized recommendations to family caregivers in need remains 
underdeveloped. The proposed project aims to fill this gap in scientific inquiry by 
evaluating an online care planning tool that has the potential to personalize dementia 
caregiver service recommendations. We anticipate that the CtP will serve as an 
innovative, low-cost tool that both families and long-term service and support providers 
can utilize to meet the diverse needs of caregivers of persons with ADRD in various 
community and clinical contexts. In this regard, the proposed R21 project is responsive 
to the National Plan to Address Alzheimer’s Disease’s scientific and clinical priorities and 
the recently released recommendations of the 1st National Research Summit on Care, 
Services, and Supports for Persons with Dementia and Their Caregivers.15   
 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: Caregiver self-efficacy 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): Caregiver distress (role 
captivity, role overload, loss of intimate exchange, depressive symptoms); 
Use of CtP-recommended services 
4.0 
Study Intervention(s)/Interaction(s) 
Care to Plan (CtP) is an online care planning tool that provides a succinct and clear 
overview of various types of ADRD caregiver interventions, administers a brief validated 
assessment of risk, and generates individualized service recommendations for 
Alzheimer's disease and related dementia (ADRD) caregivers as well as resources that 
link users to a selected recommendation. Caregivers will complete the tool with the 
guidance of a CtP interventionist (Senior Care Navigator/Riverside Health System staff).  

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The interventionist will discuss CtP recommendations with caregivers and help 
caregivers enroll in a recommended support service if so desired. The online tool is 
located at: https://caretoplan.ahc.umn.edu/. Following completion of CtP assessment 
and consultation, participants would receive a mailing (or e-mailing) including the 
recommendations generated by the tool.   
 
5.0 
Procedures Involved 
5.1 Study Design, Procedures, and Follow-Up:  
Phase I Procedure  
6.0 
A mixed methods design [quan+QUAL] will be used to generate qualitative and 
quantitative data on the feasibility and utility of CtP across four RHS regions. 
Following screening procedures to determine eligibility, a telephone-based 
consent process will be administered using Qualtrics.  If requested, a copy of the 
consent form script can be sent (via mail/email) for the participant’s review 
during/prior to providing verbal permission via telephone.  Following consent, 
the research coordinator or research assistant will administer a baseline survey 
to the enrolled caregiver. Following completion of the telephone-based baseline 
survey via Qualtrics, the CtP interventionist will re-contact the participant to 
complete CtP. As applicable, the interventionist will provide guidance to 
dementia caregivers, facilitate CtP use, review recommendations, and help 
caregivers enroll in a recommended support services if desired.  If desired, 
interventionists may have participants review the CtP tool simultaneously during 
their consultation. If CtP users identify barriers, the interventionist will make 
other recommendations and these barriers will be identified at follow-up. The 
interventionist can bridge the structured options generated by the tool with 
dementia caregivers’ preferences so that the overall usage experience results in 
feasible, tailored support. As part of the feasibility testing procedures, the time 
spent using CtP will be tracked, along with any notes regarding the review of the 
tool/completion. A summary-sheet of assessment responses and zip 
code/region-specific resources generated by Care to Plan may be saved to Box 
and/or printed to give to the participant as needed. The participant may use the 
online CtP tool again on their own following review of the tool with the 
navigator.  
 
The research team will utilize multiple approaches to assess the feasibility of CtP 
implementation in the four RHS regions.  A CtP coach guide is integrated into the 
CtP tool to provide prompts/guidance to interventionists to facilitate the 
interaction and tool use. Dr. Gaugler and the research coordinator will train 
three CtP interventionists at RHS based on the guidance integrated into the tool. 
Ongoing monitoring of CtP’s performance, acceptability, and utility will ensure its 
feasibility. The CtP tool, built by the University of Minnesota Health Sciences 
Technology, will track assessment responses and recommendations generated 

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for the region. The time spent using the tool will also be recorded. Note: For 
resources in the tool that are IRB approved, a new modifications will be 
submitted only if information other than contact information/directions for 
existing resources are changed. 
 
The research coordinator or research assistant will administer a 21-item checklist 
to the caregiver via telephone at 1 month following completion of the baseline 
survey. This checklist will include Likert items designed to measure dementia 
caregivers’ perception of the performance of CtP.   
 
Note: If desired, the telephone-based surveys may be administered in hard copy. For 
Phase I, staff will call participants 1 month (+/- 7 days) following baseline 
completion to complete their follow-up survey, or mail their follow up survey at that time 
if requested. Several telephone reminders will be provided as needed to facilitate 
completion. Completion of this follow-up may occur outside of the timeframe for initial 
contact. Phase II follow-up will include a disposition form as well, and follow these same 
procedures, with staff attempting to contact participants via phone or mailing surveys 3 
and 6 months (+/- 7 days) from completion of the baseline survey. For those opting for 
mail survey completion, staff may obtain the disposition status prior to mailing the 
appropriate survey within 7 days of obtaining this information. Staff may send a hard 
copy survey (omitting the disposition form as needed) if unable to reach them via phone, 
in an attempt to reduce loss to follow up. Those selected for the final telephone interview 
in Phase II will be contacted within 3 months of completion of their final 6 month survey 
(however, completion of the interview may occur outside of this timeframe based on 
participant scheduling needs). Three or 6 month follow-up surveys conducted via phone 
are conducted by a blinded staff member. 
 
The UMN team will also determine the degree to which participants use and 
apply CtP recommendations. The research assistant or research coordinator will 
conduct a brief semi-structured telephone interview 1 month following baseline. 
If the participant has not completed CtP by the 1 month time-point, the 
participant will be considered lost to follow up, and the checklist and interview 
will not be administered. The research assistant or coordinator will also 
administer semi-structured interviews to the three CtP interventionists to obtain 
their perceptions when administering the tool to ADRD caregivers. These 
interviews will be conducted after the Phase I participants have completed CtP. 
The open-ended responses will provide in-depth information on facilitators to 
use and barriers to refine prior to Phase II. Recorded interviews will be 
transcribed (by Production Transcripts) for data analysis. 
 
Phase II Procedure  
The qualitative and quantitative data available from Phase I will be employed to 
refine the content and delivery of CtP prior to phase II. In phase II, 100 caregivers 
of persons with ADRD will be enrolled. Similar to phase I, after receiving a new 

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contact, the UMN team will conduct a telephone-based screening for eligibility, 
complete consent, and administer the baseline survey. Participants will be 
randomly assigned in a 1:1 ratio to receive either the CtP intervention or a usual 
care control condition. The UMN team will generate a random assignment 
schedule using http://randomizer.org. The research staff who will have 
responsibility for all follow-up data collection will not have access to the random 
assignment schedule, nor will they be able to determine the next treatment 
assignment in the sequence. The randomization procedures will ensure both 
random assignment as well as treatment concealment during data collection and 
are consistent with CONSORT recommendations. Participants in both groups will 
be followed for six months with data collection at baseline, three months, and 
six months. For Phase II, a brief disposition survey to determine the participant’s 
caregiving status, as well as the status of the person they provide care for, will be 
administered (at 3 and 6 month follow up) prior to administering the appropriate 
survey. An embedded experimental mixed methods design will be utilized 
([QUAN+qual]qual) that will incorporate various qualitative data collection 
elements within and following the 6-month randomized controlled evaluation of 
CtP.  
 
As of February 2021, only those with an ID number (i.e. those reviewing the tool with 
study interventionists) will have their CaretoPlan responses tracked. Thus, others using 
the tool for personal use within or outside of the context of the study will no longer 
have responses tracked.  Note: If it is learned that someone enrolled in the study 
reviewed the tool on their own prior to reviewing it with a study interventionist, this 
information will be tracked internally. 
 
As with phase I, surveys will be administered via telephone or in hard-copy 
surveys. 
 
Inclusion criteria will remain the same as detailed in Phase I. Enrollment and 
recruitment procedures will also largely mirror those of Phase I. As a secondary 
analytic objective is to examine gender differences in CtP effects (see below), a 
stratified enrollment process will take place to ensure that at least 1/3 of the 
Phase II sample are male caregivers. CtP interventionists will be made aware of 
the recruitment goal of 33 male caregivers and will reach out to them to 
encourage their participation. If necessary, the study team and RHS will directly 
engage male caregivers during recruitment and enrollment to further ensure 
gender representation. Following completion of baseline interviews, caregivers 
will be randomly assigned to the CtP condition as detailed in Phase I or a usual 
care control group. The refined CtP with an integrated guide for the 
coach/navigator will be used to facilitate the use of CtP.   
 

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Caregivers of persons with memory loss who contact RHS Senior Care Navigation 
or other RHS services will likely seek information and support. Senior Care 
Navigators, social workers, or similar staff will deliver routine care and services 
to caregivers regardless of: a) whether they decide to enroll in the CtP project; or 
b) if they are randomly assigned to the control condition. Participants assigned 
to the usual care control group will be provided with the contact information for 
Senior Care Navigation. These participants may contact Senior Care Navigation 
for information and support as desired. Care to Plan enhances standard RHS care 
by creating a more structured assessment process along with individually 
tailored recommendations, thus resulting in a more efficient referral process. 
The time spent using the electronic CtP tool will be tracked. Given the size of the 
proposed Phase II sample and the number of Care to Plan (CtP) interventionists 
(n = 3), a cluster randomization approach is not feasible. Based on Riverside 
Health standard practices, individuals may contact Riverside’s SCN program for 
consultation as needed. SCNs will document contact with study participants in 
both the treatment and usual care groups. Comparisons across treatment and 
control conditions in the number of interactions with the interventionists (i.e., 
RHS Senior Care Navigators) will determine if alternative randomization 
approaches in subsequent, larger-scale evaluations of CtP are necessary. 
 
As indicated in Phase I, a number of approaches will be adopted to examine the 
degree to which caregivers of persons with ADRD utilize CtP as well as their 
perceptions of acceptability of the online care planning tool. The time spent 
using CtP will be tracked, allowing for an analysis of practicality (i.e., how long 
caregivers actually utilize CtP). Those randomized to receive CtP will also be 
provided with access to the online tool following review of the tool with a 
Riverside Health care navigator.  
 
For those completing CtP, the 21-item system review checklist will be 
administered at 3 to determine how well ADRD caregivers in the treatment 
group perceive CtP’s performance, acceptability, and utility. For those in the 
treatment group who have not completed CtP by the 3 month time point, follow-
up surveys will occur without administration of the review checklist. 
 
Phase II will feature 20 telephone-based semi-structured interviews with 
purposively sampled caregivers who are randomly assigned to receive the CtP. 
These interviews will take place following completion of the final 6-month 
follow-up survey. A sequential mixed methods sampling approach will be utilized 
where the results of the first methodological strand will inform the selection of 
participants in this second methodological strand. Specifically, research staff will 
purposively select 20 caregivers who report higher and lower average system 
review checklist scores (indicating how well CtP met or did not meet their 
needs). A stratified purposive sampling approach will be applied: caregivers of 

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different kin relationship, caregiver gender, and racial or ethnic background of 
caregivers will be identified and asked to participate. Note: Those without 
checklist scores may also be interviewed as needed. Additionally, participants 
may be selected from the waitlist control group. Again, recorded interviews will 
be transcribed (by Production Transcripts) for data analysis.  
 
Surveys are sent within 7 days of their due date, and participants are given several 
reminders to facilitate survey completion as needed. If any survey is not returned, 
participants are still provided subsequent surveys, unless they withdraw from the study. 
Those selected for a final phone interview will be contacted within 2 months of 
completion of their final survey.  
 
As with Phase I, the research assistant or coordinator will administer semi-structured 
interviews to the three CtP interventionists to obtain their perceptions when 
administering the tool to ADRD caregivers. In addition, semi-structured interviews will 
be conducted with Riverside Health collaborators to obtain their perceptions on the 
benefits and hindrances of implementing CtP in their healthcare system. These 
interviews will be conducted after the Phase II recruitment ends on 12/1/2021, and 
participants have completed CtP. With permission, these interviews will be recorded 
and professionally transcribed (by Production Transcripts) for data analysis.  The open-
ended responses will provide in-depth information on facilitators to use and barriers 
to inform future implementation possibilities of CtP.  
 
Waitlist Control 
 
Following Phase II of the Care to Plan study, participants in the control group will be 
asked if they are interested in enrolling in a similar, additional feature of the study to test 
the Care to Plan tool.  
 
The purpose of this waitlist control is to provide an opportunity for those participants 
who were originally randomly assigned to the control group during Phase II an 
opportunity to test the Care to Plan intervention tool. This also provides the research team 
with additional information testing the efficacy and implementation of the Care to Plan 
tool, in alignment with Aim 2. We do not anticipate any change in risk to participants, as 
the same intervention and similar surveys are being offered, following the original Phase 
II 6 month study period. Thus, participants opting to enroll in this would participate in the 
study for an additional 6 months. 
 
The only eligibility criteria for these individuals to continue project participation would 
be that 1) the caregiver was enrolled in the control group and will complete their 6 month 
survey by December 1, 2021; 2) the caregiver is still providing care to the care recipient; 
and 3) the caregiver is willing to review the Care to Plan tool with Riverside. Telephone 
based screening will be completed via Qualtrics. If it is known a participant is not eligible 
(i.e. caregiver is bereaved, etc.), the caregiver will not receive a formal invitation for the 
extended study, but will be provided with the URL for the online care planning tool. 

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Interested participants would: 
 Verbalize meeting the eligibility criteria via phone with study staff 
 Provide permission for additional surveys and testing of the tool [Based on 
participant preference: Permission form is reviewed by the participant via 
email/mail or the form script is read by study staff via telephone as desired; study 
staff then document the permission obtained following review of the form; copy of 
permission form and original consent form will be given to participant]. 
 Review the Care to Plan tool with Senior Care Navigation 
 Complete the disposition and follow up surveys 3 months and 6 months following 
the original study’s 6-month survey [9 and 12 months following the original 
Phase II baseline; no blinding for this portion] 
o Note: This post-phase II 3 month survey (the survey 9 months following 
the original Phase II baseline survey) would include the treatment 
checklist (for those able to complete use of the tool); the post-phase II 6 
month survey (12 months following the original Phase II baseline survey) 
would not include the additional treatment checklist (mimicking the 
structure of the original Phase II program). Modified bereavement surveys 
will be administered as needed. 
o If selected, be contacted for a telephone interview within 2 months 
following completion of their final survey (6 month survey - occurring 12 
months following the original Phase II baseline survey) [Note: For those 
enrolling in the waitlist control prior to the permission form updates 
including information about the phone interview, the updated permission 
form would be administered only if and prior to one of these participants 
being administered a phone interview.] 
o During the follow up, SCNs would continue to monitor the calls from 
these participants as able 
o Adverse events would be tracked during this timeframe as study team is 
aware of them 
 Be compensated for these 2 additional surveys ($25 each) using either the same or 
a new ClinCard. Note: If the individual is selected for a final interview, they 
would be offered an additional $25 compensation via their ClinCard. 
Please note: No consents for the subsequent evaluation would be completed following 
12/1/2021. Individuals completing 6-month phase II surveys following that time period 
would be offered the Care to Plan tool URL to use as they desire. Additionally, unless a 
participant declines, those declining or ineligible to participate in the additional surveys 
following their experience as a participant in the control group of Phase II would be 
offered the Care to Plan URL (via phone/mail/email) to use on their own as they wish. 
 
Please note: A copy of the routine templates used for written correspondence with 
participants is included on Ethos. Minor edits/modifications are performed as needed to 
meet participant needs. As able, these templates may be used via hard copy mail or via 

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email. Additionally, phone templates that are included are used for staff training and as 
guidance for Riverside. Once familiar with the content, staff are not required to read 
from these scripts (except for in the case of consent). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The below diagram shows general Phase II study flow: 

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6.1 
Individually Identifiable Health Information: The HIPCO Survey was 
completed and uploaded to ETHOS. 

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7.0 
Data Banking 
N/A 
8.0 
Sharing of Results with Participants 
8.1 Results are shared with participants after the conclusion of the study and 
once they are published prior to de-identification of our tracking files. 
9.0 
Study Duration 
9.1  
 
In Phase I, caregivers of persons with ADRD will participate for about 
1 month.  In Phase II, caregivers of persons with ADRD will participate 
for about 6 months.  
 
We anticipate it will take 3 months to enroll 20 caregivers in Phase I, 
and approximately 8-10 months in Phase II.  
 
We anticipate completing all study procedures and data analysis in 24 
months.  
10.0 Study Population 
10.1 Inclusion Criteria:  
The care recipient has received a provider diagnosis of Alzheimer's disease 
or a related dementia (ADRD); and 2) the caregiver is 21 years of age or 
older; 3) English-speaking; 4) self-identifies as someone who provides help 
to the person with ADRD because of their cognitive impairments; 5) the 
caregiver indicates a willingness to use Care to Plan (CtP); and 6) caregiver 
resides in one of 4 Riverside Health regions (based on zip code). Note: For 
study purposes, a diagnosis of mild cognitive impairment is considered 
along with related dementia diagnoses for study inclusion. 
10.2 Exclusion Criteria: Those who do not meet the inclusion criteria above are 
not eligible. Additionally, those who endorse a history of a serious mental 
health disorder whose: a) symptoms have exacerbated in the last six 
months, and b) are not receiving steady, ongoing pharmacological or other 
treatment for these symptoms, will be excluded from the project. 
10.3 Screening:  
To facilitate recruitment and enrollment in both phases of the project, RHS 
staff (e.g., RHS clinic management, social worker, Senior Care Navigator, or 
other staff) will present details about the CtP R21 study over the 
telephone. Those caregivers that express interest and agree to be 
contacted about the study are referred to the Riverside Senior Care 
Navigation project team, who securely share their contact information with 
the UMN research team (Dr. Gaugler, the UMN research coordinator, and 
the research assistant). The inclusion criteria listed above will then be 

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applied via a telephone-screening procedure by the UMN research 
coordinator or research assistant. Interested contacts that contact UMN 
staff directly will have the same screening and eligibility procedures 
applied.  If eligible, the UMN research coordinator or research assistant will 
then describe the study process to an eligible caregiver, and proceed to the 
consent procedures. 
11.0 Vulnerable Populations 
11.1 Vulnerable Populations:  
☐ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 
☐ 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 
☐ Approached for participation in research during a stressful situation such 
as emergency room setting, childbirth (labor), etc. 
☒ Disadvantaged in the distribution of social goods and services such as 
income, housing, or healthcare 
☒ Serious health condition for which there are no satisfactory standard 
treatments 
☐ Fear of negative consequences for not participating in the research (e.g. 
institutionalization, deportation, disclosure of stigmatizing behavior) 
☐ Any other circumstance/dynamic that could increase vulnerability to 
coercion or exploitation that might influence consent to research or 
decision to continue in research 
☒ Undervalued or disenfranchised social group 
☒ Members of the military 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
☐ None of the above 
Additional Safeguards:  
Though not specifically targeted for inclusion, participants from some of the 
above groups may be allowed to participate. Due to the nature of the project and its 
risk, a specific capacity to consent assessment is not included. Participants will be 
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, 

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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). 
Additionally, those who have had a serious mental health disorder whose: a) symptoms 
have exacerbated in the last six months, and b) are not receiving steady, ongoing 
pharmacological or other treatment for these symptoms, will be excluded from study 
participation. 
12.0 Number of Participants 
12.1 Number of Participants to be consented: In Phase I we plan to enroll 20 
caregivers of persons with ADRD; for Phase II, we plan to enroll 100 
caregivers of persons with ADRD. These numbers are the lowest that will 
allow for data analysis; it is possible that up to 25 caregivers in Phase I and 
125 caregivers in Phase II may agree and consent to participant at most.  
13.0 Recruitment Methods 
13.1 Recruitment Process:   
Riverside Health System (RHS) was selected as a site for the proposed R21 due to 
the ethnically, racially, and geographically diverse population of older adults 
served. The Senior Care Navigation case management program; a geriatric 
assessment clinic; a memory café program, an evidence based caregiver 
intervention program; and other RHS services will serve as sources of 
recruitment. Riverside staff (within and outside the project staff) may call/share 
information about the project via phone to their clients as desired (i.e. when 
waiting for appointments, etc.). Interested contacts will have their contact 
information securely transferred to study staff. Other sources of recruitment 
may include Riverside Center for Excellence in Aging and Lifelong Health 
outreach; radio interviews; community organizations and events; Riverside or 
community leadership; letters to providers to share information about the study; 
the Riverside Intranet; newspaper advertisements; and other IRB-approved 
flyers (electronic/hard copy), print ads, e-mail, newsletters, and social media (i.e. 
Instagram, Facebook, Twitter, LinkedIn, etc.) ads. Registration forms for 
educational presentations (by study staff or other agencies) may include an 
opportunity for individuals interested to provide their permission for the 
research team to contact them to share additional information about the study. 
[Thus, by nature of this, UMN staff or other agency staff involved in planning, 
hosting, or post-webinar certificates will have access to the names/contact 
information of those indicating interest in receiving more information about the 
study]. Presentation “polls” may offer an additional opportunity for presentation 
attendees to provide permission for contact. Presentation slides may also be 
used during these community presentations to increase outreach. Hard copy 
permission forms may also be presented at in-person presentations. 
Ads/approved presentation slides may also be displayed online/electronically via 

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television in clinics/waiting rooms throughout Riverside or other organizations, 
or as visual television ad in community. IRB approved recruitment ads/text may 
be used for recruitment via other protocol-approved modalities (i.e. approved 
newspaper ad used within emails, etc.). Note: General promotional 
materials/text (emails/newsletters/flyers/etc) are shared in the context of 
general promotional recruitment efforts. However, study staff do not pursue 
individualized study-related contact with potential participants until contact is 
made by an interested individual or a permission form/request for information is 
obtained.  
 
From January 2017 to May 2018 a total of 2,123 individuals were served. 
Approximately 63% (n = 1,330) were women. Close to 70% (n = 1,430) had 
cognitive impairment. Twenty percent of clients served were from rural areas (n 
= 425) and over 30% were African-American (n = 658). A little over 5% of all 
clients served over the 17 month period were Hispanic/Latino (n =116).  
 
To facilitate recruitment and enrollment in both phases of the project, RHS staff 
(e.g., RHS clinic management, social worker, Senior Care Navigator, or other 
staff) will present details about the CtP R21 study over the telephone. Those 
caregivers that express interest and agree to be contacted about the study are 
referred to Riverside Senior Care Navigation project team, who securely share 
their contact information with the UMN research team (Dr. Gaugler, the UMN 
research coordinator, and research assistant). For interested individuals that 
may contact the UMN team directly, the same screening and eligibility 
procedures will be applied. 
 
13.2 Recruitment Materials:  
 
To facilitate CtP recruitment, a flyer will be utilized and developed.  Prior to use, 
all flyers and ads will be IRB-approved. 
13.3 Payment:  
All caregivers in the proposed project will also be provided with up to $100 
incentive upon study completion. Greenphire ClinCard will be used for 
compensation; we include the template language in the consent form. 
For phase I, participants must complete the initial survey, review the Care to 
Plan tool during the month after enrollment, and complete the one month 
follow up survey and interview via phone with the University of Minnesota 
research team in order to receive this $100 compensation. A prorated payment 
of $75 will be given to those who wish to opt out of the semi-structured 
interview. 
For phase II, participants are eligible to receive the study compensation based on 
completion of the initial survey, 3 and 6 month follow up, as well as the 

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telephone interview with the University of Minnesota research team (if 
selected).  Participants will be paid $25 for each survey time-point (up to $75), 
and an additional $25 (for a total up to $100) if selected for a final telephone 
interview. When necessary or unable to complete a survey in full, participants 
will be fully compensated for partially completed surveys.  
13.4 Withdrawal Circumstances:  
We do not anticipate encountering circumstances under which participants will 
be withdrawn from the research without their consent. The only instance is if the 
caregiver reports they have engaged in self-harm or have harmed the care 
recipient with dementia; in such instances, the appropriate authority in Virginia 
(Adult Protective Services in Virginia; (888) 832-3858; see 
http://www.dss.virginia.gov/family/as/aps.cgi) will be notified. Additionally, if 
the study staff have reason to believe that the intervention is causing the 
participant harm, or the participant is deliberately jeopardizing the integrity of 
the study, the participant may be withdrawn at the PI’s discretion.  
During phase I, participants who do not complete Care to Plan in the 1-month 
timeframe following their baseline survey will be considered lost to follow up, 
and the 1 month checklist and interview will not be administered.  During phase 
II, participants that do not complete Care to Plan within the first 3 months 
following their baseline survey will continue follow up surveys at 3 and 6-month 
time-points, but would not be administered a 21-item checklist or telephone 
interview. 
13.5 Withdrawal Procedures: If caregivers withdraw 
from the study, we will not conduct additional data from 
them.  
13.6 Termination Procedures: Data prior to 
termination/withdrawal will be utilized in subsequent 
analyses. 
14.0 Risks to Participants 
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 

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the past 12 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, RHS, 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, Virginia 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.  
 
The CtP tool will be created by the University of Minnesota Health Sciences Technology 
and hosted on a secure PHR/PHI-compliant server; data can be accessed by the study 
team via the Secure Computing Environment portal (for those that complete CtP with a 
provider/care navigator as a part of the study). Note: While the CtP tool used to capture 
data inputted, as of February 2021, the data inputted will only be captured and saved to 
the secure environment for those who complete with an guide/input an ID number. A 
summary-sheet of assessment responses and zip code/region-specific resources 
generated by Care to Plan may be saved to Box (from a Riverside Health password-
protected computer) and/or printed to give to the participant as needed. Other 
resources or recommendations may be provided by the Senior Care Navigators as a part 
of the routine Riverside Health consultation process.  The UMN study team would not 
have access to Riverside Health medical records.  
 
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 

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and all research papers or presentations from these data. Similarly, paper forms of the 
data will be 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. 
 
15.0 Incomplete Disclosure or Deception 
Not applicable 
 
16.0 Potential Benefits to Participants 
16.1 Potential Benefits 
We believe participation in both Phase I and Phase II will yield benefits for 
participants. Utilization of CtP will provide dementia caregivers with improved 
ability to identify supportive services that are tailored to their needs. Caregivers 
will be paid up to $100 following their participation in the study. See above for 
details related to compensation. 
 
17.0 Data Management 
17.1 Data Analysis Plan:  
Phase I quantitative analyses: Specific Aim 1. As the Phase I aim is to examine the 
feasibility, acceptablity, and utility of CtP within the partnering RHS sties, the 
quantitative analyses of the R21 phase will largely rely on descriptive statistics. 
Specifcally, Phase I quantitative analyses will utilize frequency tables and means 
to examine sample characteristics and item-level responses to the CtP review 
checklist.  
 
Phase II quantitative analyses: Specific Aim 2. Logistic regression analyses will 
determine whether participation in the CtP treatment group results in utilization 
of caregiver support programs over the 6-month evaluation period when 
compared to ADRD caregivers in the control group. Care to Plan treatment vs. 
control group membership will be the independent variable of interest; caregiver 
use of CtP recommended services will serve as the dependent variables. 
Additional variables will serve as covariates, including time-invariant and time-
varying measurements of stress process covariates. Odds ratios will be examined 
in order to determine the degree to which these variables explain the observed 
effects of CtP on dependent variable occurrence. Data available at baseline, 3 
months, and 6 months will allow for descriptive and growth curve analyses of 
rate of change in key outcomes: caregiver efficacy and caregiver distress.16,17 The 
individual growth curve model conceives of development, or change, as the 
function of an individual growth curve plus random error. In our outcome 
evaluations, the baseline value will be included as a covariate and time will be 
“centered” at 6-months post-baseline. We will specifically examine whether 
individual growth parameter estimates have significant variance around the 

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mean trajectories of change in key dependent variables, and then determine 
whether treatment group assignment influences outcome change parameters in 
these models. IBM SPSS 21 will be utilized to conduct the within-subject growth 
curves; the PI has extensive experience conducting growth curve/trajectory 
analyses.18-24 An additional advantage of this approach is its ability to incorporate 
missing longitudinal data points, given assumptions of missing at random.25 
 
Variations in CtP use and sex as a biological variable. Empirical utility/feasibility 
data and context of care measures that assess heterogeneity in the use of CtP 
within the treatment condition (e.g., frequency and duration of CtP use) as well 
as degree of contact with CtP interventionists across treatment and control 
groups will explore the effects of these variations on key study outcomes. 
Caregiver gender will also be included to examine whether women or men 
caregivers are more likely to indicate acceptability of CtP and report significant 
increases or decreases in the hypothesized outcomes following CtP use over a 6-
month period. 
 
Phase I and Phase II qualitative analyses. Analyses of acceptability and feasibility 
across Phases I and II will focus on thematic content analysis of open-ended data 
to examine CtP utility and mechanisms of benefit. Qualitative analytic techniques 
described by Morse and others26,27 will be used. These approaches allow 
participants to construct meanings, perceptions, and behaviors from their own 
vantage points. All open-ended data collected will be read by study’s 
dissemination team 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 
11 analytic software). These themes will provide insights as to CtP’s 
implementation as well as use and mechanisms of benefit in both Phases I and II. 
During weekly meetings Dr. Gaugler, the research coordinator, and the research 
assistant will discuss their own identified codes to reach a consensus.  
 
Phase II mixed methods analysis. Additional mixed methods analyses28,29 will 
take place during Phase II. The thematic codes and categories of 
implementation/use and mechanisms of benefit will be cross-tabulated with the 
empirical data from the randomized controlled evaluation to determine whether 
the findings diverge, converge, or highlight pathways toward additional 
questions and analysis.28 This comparative, mixed method analysis approach will 
inform why or why caregivers do not experience benefit when using CtP. 
17.2 Power Analysis 
Longitudinal analysis procedures (growth curve modeling) will be utilized to 
capitalize on the randomized design and the multiple waves of data that will be 
collected. The objective of the Phase II analyses is to generate power estimates 
for a subsequent, larger scale evaluation of CtP. However, a sample size of 100, 

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factoring in a conservative 10% attrition rate at 6 months, would have sufficient 
power to detect a medium/large effect size).30,31 As noted in various 
recommendations, a sample of 20 is considered adequate for semi-structured 
interview protocols to ensure the richness of open-ended data collected.32,33 
17.3 Data Integrity 
Regular Zoom conference meetings that include Dr. Gaugler, Dr. Jensen and the 
RHS and UMN teams will take place to ensure study rigor/integrity and progress. 
Dr. Gaugler is currently utilizing a similar strategy on a national translational 
project where he and the other PI are located at different institutions (R01 
AG049692). Combined with annual in-person meetings (as COVID-19 safety 
restrictions allow) between Dr. Gaugler and Dr. Jensen at the Gerontological 
Society of America and in Williamsburg, VA, the project management plan will 
facilitate coordination between the University of Minnesota and RHS. 
 
18.0 Confidentiality 
18.1 Data Security: Please see above. No consent form will be placed in 
participants’ medical, employment, or educational records.  
Please note: [If there is interest in Care to Plan, the Riverside staff would 
complete the permission for contact form and securely share the contact 
information with the UMN research team]. Riverside Senior Care 
Navigators or other RHS staff may communicate/document about referrals 
made to Riverside Senior Care Navigation for consultation, 
interest/involvement in the Care to Plan study, and other referrals provided 
to individuals who may be enrolled in the Care to Plan study. This 
communication/documentation occurs outside of the study context (as a 
part of their routine roles in care consultation with Riverside Health 
System), and UMN study staff do not have access to the Riverside Epic 
electronic health record or to the staff's internal time tracking system 
where staff reference this information (SalesForce/Livwell).  
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
 
18.1 PARTICPANTS SAFETY 
18.1.1 Potential Risks and Benefits for Participants 
Potential 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 

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only to possible violations of confidentiality. Given the procedures outlined below, such 
risks are highly unlikely. 
 
Potential Benefits: We believe participation in both Phase I and Phase II will yield 
benefits for participants. Utilization of CtP will provide dementia caregivers with 
improved ability to identify supportive services that are tailored to their needs. 
Caregivers will be paid up to $100 following their participation in the study.  
18.1.2 Adverse Event and Serious Adverse Event Collection and Reporting 
In addition to ongoing monitoring of protocol and human subjects compliance, Dr. 
Gaugler and research team will generate safety reports annually 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 they occur. If the research team becomes aware of an adverse event or 
unanticipated problem occurring while a participant is enrolled in the study (consent 
through the participant’s final data collection), the event will be documented and/or 
reported per the protocol below. 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. 
 
Taken directly from the NIA Adverse Event and Serious Adverse Event Guidelines, the 
definition of each event is as follows: 
Adverse event (AE). Any untoward or unfavorable medical occurrence in a 
human study participant, including any abnormal sign (e.g. abnormal physical 
exam or laboratory finding), symptom, or disease, temporally associated with 
the participants’ involvement in the research, whether or not considered related 
to participation in the research.  
Serious adverse event (SAE). Any adverse event that results in death; is life 
threatening, or places the participant at immediate risk of death from the event 
as it occurred; requires or prolongs hospitalization; causes persistent or 
significant disability or incapacity; results in congenital anomalies or birth 
defects; and/or is another condition which investigators judge to represent 
significant hazards.  
Unanticipated problem (UP). any incident, experience, or outcome that meets all 
of the following criteria: unexpected, in terms of nature, severity, or frequency, 
given (a) the research procedures that are described in the protocol-related 
documents, such as the IRB-approved research protocol and informed consent 
document; and (b) the characteristics of the study population; related or possibly 
related to participation in the research (in this guidance document, possibly 
related means there is a reasonable possibility that the incident, experience, or 
outcome may have been caused by the procedures involved in the research); 

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and suggests that the research places participants or others at a greater risk of 
harm (including physical, psychological, economic, or social harm) than was 
previously known or recognized. 
 
Phase II participants will be asked at 3 and 6 month follow up: “In the last three months, 
since your last survey, was there any new or worsening health problem that caused you 
to be unable to perform your daily routine (i.e. not go to work or volunteer), seek 
medical care (i.e. go see your doctor, go to the ER or hospital), or take a new 
medication?” Those medical events will be documented as adverse events. Other events 
that will also be considered adverse events are included below.  
 
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) 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 in data 
monitoring reports.  
 
AE 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 documented via the team’s electronic AE form and included in the 
annual report (to be shared with IRB, Safety Officer, and NIA Program Officer). 
 
SAEs occur that are unanticipated (i.e. not listed in the Data and Safety 
Monitoring Plan) and related to the intervention will be reported to the IRB, NIA 
Program Officer, and to the Safety Officer 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, Safety Officer, 
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 Safety Officer. 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. 
 

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Due to the nature of our study population, the following scenarios may be encountered 
during project enrollment, and will be handled per the below protocol.  
 
 Considered adverse events: 
 
- 
Medical events or emergencies: Research staff will call 911 as needed for 
emergencies (if during study procedure) or provide psychological support 
and encourage the participant to follow-up with their medical provider as 
needed (if occurred outside of study procedures).  These medical issues 
(unrelated to study involvement) are considered expected, due to the nature 
of our study population. These events will be documented/reported as 
adverse events per above protocol if they meet one of the following criteria: 
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. [Note: Medical events or emergencies of a non-participant will 
not be considered/documented as adverse events]. 
 
- 
Death of participant is reported promptly to the University of Minnesota IRB 
per above procedures (and is also reported to the Safety Officer and NIA 
within 24 hours of the team’s knowledge if determined potentially related to 
study involvement; otherwise is included on routine annual reports shared 
with Safety Officer and NIA). Deaths in our study population (unrelated to 
study involvement), are considered expected. [Note: Deaths of a non-
participant will not be considered/documented as adverse events]. 
 
- 
Suicidal ideation of participant: If participant informs study staff of thoughts 
of suicide, staff will discuss the concern with the participant and offer 
resources (i.e. 1-800-SUICIDE line, healthcare provider, etc.).  Staff will ask 
them to provide verbal agreement not to harm themselves, and alert PI 
immediately.  If necessary, staff will call 911. This will be 
documented/reported as serious adverse event.  
 
- 
Abuse/Neglect of participant: Document as adverse event per above 
protocol. If indicated, make vulnerable adult report to adult protective 
services.  
 
- 
Other events that in the discretion of the PI should be reported as adverse 
events. 
 
 Not considered adverse events: 
 

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- 
If a participant scores 16 or higher on the CES-D [risk for depression], study 
staff will provide resources as needed (i.e. https://www.samhsa.gov/, 
healthcare provider, and Riverside/Senior Care Navigation). Mental health 
concerns are common in our study population and fluctuation of assessment 
scores is expected. Unless participant indicates a concern regarding self-harm 
or that the health issue has caused them to: be unable to perform their daily 
routine, seek medical care, or take a new medication, it will not be 
documented as an adverse event.  
 
- 
Survey responses indicating changes in sleep, stress/anxiety, activities of 
daily living, or general well-being alone will not trigger an adverse event 
report. These concerns are common in our study population and fluctuation 
of assessment scores is expected. Unless participant indicates a concern 
regarding self-harm or that the health issue has caused them to: be unable to 
perform their daily routine, seek medical care, or take a new medication, it 
will not be documented as an adverse event.  
 
- 
Routine or planned medical encounters for symptoms or conditions that are 
not new, worsened, or changed since enrollment, as well as those events 
that have not caused the participant to: be unable to perform their daily 
routine, seek medical care, or take a new medication, will not be 
documented as an adverse event. 
 
- 
A physical attack or injury to participant by a non-participant (i.e. care 
recipient) would be documented/reported as an adverse event if the 
participant requires medical care. [Note: Other potential dementia related 
behaviors that do not result in participant injury are not considered adverse 
events.] 
 
- 
Participant reports that non-participant (i.e. care recipient or person with 
memory impairment) displays risk-behavior (i.e. aggression/threats, 
comments about death or self-harm): This will not be documented as 
adverse event, as individual is not enrolled in the study. If participant reports 
concern to study staff, study staff will encourage them to follow up with 
healthcare provider or Riverside/Senior Care Navigation for resources.  
 
- 
Suicidal ideation of non-participant (care recipient): If participant shares 
concern about care recipient (non-participant) suicidal ideation, study staff 
will talk about the concern and provide resources as requested (i.e. 1-800-
SUICIDE line, healthcare provider, etc.). This is not documented as an adverse 
event, as individual is not enrolled in the study. 
 

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- 
Abuse/Neglect of non-participant: Document and report as an adverse event 
only if study participant is involved. Make vulnerable adult report to adult 
protective services as indicated. 
 
- 
Driving with dementia/cognitive impairment (participant or non-participant): 
Provide resources as needed (i.e. https://alz.org/help-
support/caregiving/safety/dementia-driving, 
https://www.thehartford.com/resources/mature-market-
excellence/dementia-driving, etc.), encourage family involvement with 
medical provider, and adhere to local laws. This is not 
considered/documented as an adverse event.  
 
- 
Unlicensed driving (participant or non-participant): If study staff are informed 
that an individual is driving without a license, staff will encourage driving in 
accordance with local laws and explain potential consequences. This is not 
considered/documented as an adverse event. 
 
- 
Environmental/home hazards (i.e. unlocked/loaded weapons, other safety 
concerns): Encourage remedying this situation for safety; recommend in-
home safety assessment as needed. This is not considered/documented as 
an adverse event unless immediate risk of harm is identified (i.e. 
abuse/neglect).  
 
As taken directly from the NIA Adverse Event and Serious Adverse Event Guidelines, the 
severity, expectedness, and relatedness of each AE and serious adverse event (SAE) will 
be graded as follows: 
 
Severity 
 
 Mild: Awareness of signs or symptoms, but easily tolerated and are of 
minor irritant type causing no loss of time from normal activities. 
Symptoms do not require therapy or a medical evaluation; signs and 
symptoms are transient. 
 Moderate: Events introduce a low level of inconvenience or concern to 
the participant and may interfere with daily activities, but are usually 
improved by simple therapeutic measures; moderate experiences may 
cause some interference with functioning 
 Severe: Events interrupt the participant’s normal daily activities and 
generally require systemic drug therapy or other treatment; they are 
usually incapacitating 
Expectedness 

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 Unexpected - nature or severity of the event is not consistent with 
information about the condition under study or intervention in the 
protocol, consent form, product brochure, or investigator brochure. 
 
 Expected - event is known to be associated with the intervention or 
condition under study. 
Relatedness 
The potential event relationship to the study intervention and/or participation is 
assessed by the site investigator. A comprehensive scale in common use to categorize 
an event is: 
 Definitely Related: The adverse event is clearly related to the 
investigational agent/procedure – i.e. an event that follows a reasonable 
temporal sequence from administration of the study intervention, follows 
a known or expected response pattern to the suspected intervention, 
that is confirmed by improvement on stopping and reappearance of the 
event on repeated exposure and that could not be reasonably explained 
by the known characteristics of the subject’s clinical state. 
 Possibly Related: An adverse event that follows a reasonable temporal 
sequence from administration of the study intervention follows a 
known or expected response pattern to the suspected intervention, 
but that could readily have been produced by a number of other 
factors. 
 Not Related: The adverse event is clearly not related to the 
investigational agent/procedure - i.e. another cause of the event is most 
plausible; and/or a clinically plausible temporal sequence is inconsistent 
with the onset of the event and the study intervention and/or a causal 
relationship is considered biologically implausible. 
 
18.1.3 Protection Against Study Risks 
Informed consent process. In creating our research design and sampling procedures, an 
important objective was to preserve the privacy, confidentiality, and autonomy of all 
participants. Following discussion of the Phase I or Phase II components to potential 
caregivers, the research coordinator or research assistant will reach out to the caregiver.  
Inclusion criteria are as follows: 1) The care recipient has a physician diagnosis of 
Alzheimer's disease or a related dementia (ADRD); and 2) the caregiver is 21 years of 
age or older; 3) English-speaking 4) self-identifies as someone who provides help to the 
person with ADRD because of their cognitive impairments, 5) indicates a willingness to 

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use Care to Plan (CtP), and 6) caregiver resides in one of 4 Riverside Health regions 
(based on zip code). 
During the informed consent process, the research coordinator or research assistant will 
explain the project in detail to each potential participant, including a description of the 
types of assessments to be obtained and the time required. The UMN study coordinator 
or research assistant will read the telephone-based consent form and the caregiver will 
have the opportunity to ask questions. If the consent form is mailed in hard copy or e-
mailed on request: the study staff provide a project overview, the individual has the 
ability to review the consent form via mail/email, and then the study staff provide the 
opportunity to ask any questions prior to obtaining/completing the verbal telephone 
consent to complete the final pages of the form (note: in cases of participants 
requesting a hard copy/e-mail copy of the consent form prior/during, the consent script 
is not read verbatim by study staff unless a participant were to request this.) The 
electronic version of the consent form will be signed by the member of the study team 
reviewing consent with the participant (Dr. Gaugler, research coordinator, or research 
assistant). Participants will be mailed/emailed a copy of the completed consent form for 
their records. Please note: An additional permission form will be required for those 
opting to enroll in the post-Phase II waitlist control. 
 
Additional protection against risks. Those who endorse a history of a serious mental 
health disorder whose: a) symptoms have exacerbated in the last six months, and b) are 
not receiving steady, ongoing pharmacological or other treatment for these symptoms, 
will be excluded from our project.  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.  
 
18.2.0 INTERIM ANALYSIS 
Interim analyses are not planned because this is an R21 project that is largely designed 
to establish the feasibility and potential efficacy of CtP to inform a larger, subsequent 
randomized controlled trial. 
 
18.3.0 DATA AND SAFETY MONITORING  
18.3.1 Frequency of Data and Safety Monitoring  
In addition to ongoing review of the protocol and human subjects research compliance 
during weekly project meetings with staff, the PI (Dr. Gaugler) will generate annual 
reports to ensure that each case complies with Institutional Review Board (IRB) 
requirements, including use of IRB-approved forms (particularly the consent form), and 
that each staff person on the proposed project adheres to the study protocol. In both 
weekly meetings and audit reports, Dr. Gaugler will actively work with project staff to 
minimize research-associated risk and protect confidentiality of participant data (see 

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Protection of Human Research Subjects section). The research staff 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, RHS or 
other entities. . The Safety Officer will act in an advisory capacity to the NIA PO to 
monitor participant safety, evaluate the progress of the study, to review procedures for 
maintaining the confidentiality of data, the quality of data collection, management, and 
analyses. 
 
 
In the event a caregiver does become upset during the interview process, the research 
staff 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 
refer the participant to 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, 
the Virginia 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 on the secure Academic Health Center project folder, 
the Secure Computing Environment, as well as within the secure Box and Qualtrics 
applications. 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. The 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 
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. 
Staff working remotely will continue use of these secure environment’s as needed. 
Note: University staff calling from personal lines outside of the University will block their 
personal numbers when able, note they are calling from a personal line to reduce and 
request a callback to a work-based telephone number, or use a google voice account. 
Riverside staff will adhere to their internal agency policies. 
 
Annual reports. The responsibility of Dr. Gaugler (who has oversight for the data 
management and analysis of the project), along with study staff, will include the 

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production of an annual report that will highlight the results of the audit analysis, as 
well as study progress. In addition, Dr. Gaugler and study staff 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 Safety Officer will review the annual report to ensure ongoing quality control, and 
will work with Dr. Gaugler and the study staff, if needed, to ascertain if audited cases 
deviate from the approved study protocol.In instances of adverse events occurring, the 
procedures in the protocol will be followed.  
 
The Safety Officer will review study progress, data quality, and participants safety at a 
predetermined intervals (e.g. annually) and make recommendations to the NIA for or 
against the trial's continuation, as well as any modification to the study. Safety reports 
will be distributed to the Safety Officer annually and will include a detailed analysis of 
study progress, data and safety issues. 
 
Data will be complied by the graduate research assistant or other study staff, and if 
greater expertise is required, by a statistician (Sue Duval, PhD) in the University of 
Minnesota Medical School. All data will be directly available to the Safety Officer and 
the NIA Program Officer on request.  
 
When final research results are generated, the research team may share any 
publications derived directly with research participants. 
 
18.3.2 Content of Data and Safety Monitoring Report  
The annual report will include the following: 
1. Title Page 
2. Table of contents 
3. Report summary 
a. Protocol synopsis 
b. Discussion of issues or problems 
c. Report preparation procedures 
4. Study description 
a. Project organizational chart, personnel  
b. Brief statement of purpose of trial  
c. Projected timetable and schedule 
d. Overall study status 
5. Study recruitment and administration 
a. Reasons for screen failures 
b. Enrollment by year or month of study 
c. Comparison of target to actual enrollment by month 
d. Demographic and key baseline characteristics 
e. Withdrawals 
f. Forms status 

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i. Status of forms (e.g., consent, completing of screener, baseline 
assessment, etc.) 
g. Summary of protocol changes 
h. Summary of reportable information/adverse events [safety assessment] 
i. Adverse events 
ii. Serious Adverse Events 
iii. Deaths 
iv. Protocol deviations 
6. Action items (as needed) 
18.3.3 DSMB Membership and Affiliation 
Phase I: The Independent Study Monitor (ISM), Dr. Timothy Beebe, is Mayo Professor 
and Division Head of Health Policy and Management in the School of Public Health. As 
this protocol is: a) not a Phase III Clinical Trial; b) does not include multiple field sites; c) 
is not at an increased risk of adverse events;  and d) will not result in more effective way 
to monitor study safety and progress as there is not a large sample to be enrolled, a 
DSMB was deemed not appropriate for this R21 project. 
Phase II: Cynthia Boyd, MPH, MD, is a Professor of Medicine in the Division of Geriatric 
Medicine and Gerontology, Johns Hopkins University School of Medicine, the Center on 
Aging and Health, and the Department of Health Policy and Management and 
Epidemiology. Her research career has focused on the optimal management of people 
with multiple chronic conditions, including geriatric conditions and frailty. Her research 
has addressed barriers to developing and applying guidelines in patients with multiple 
chronic conditions and the implications for performance measurement and 
improvement. 
18.3.4 Protection of Confidentiality  
Data will be presented in a blinded manner in ISM reports. All data and discussions are 
confidential in reports for the ISM or Safety Officer (Phase II). Participant identities will 
not be known to the ISM (Phase I) or Safety Officer (Phase II). 
18.3.5 ISM Responsibilities 
ISM responsibilities are as follows: 
 Review the research protocol, informed consent documents and plans for 
data safety and monitoring; 
 Recommend subject recruitment be initiated after receipt of a satisfactory 
protocol; 
 Evaluate the progress of the trial, including periodic assessments of data 
quality and timeliness, recruitment, accrual and retention, participant risk 

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versus benefit, performance of the trial sites, and other factors that can 
affect study outcome; 
 Consider factors external to the study when relevant information becomes 
available, such as scientific or therapeutic developments that may have an 
impact on the safety of the participants or the ethics of the trial; 
 Review study performance, make recommendations and assist in the 
resolution of problems reported by the Principal Investigator; 
 Protect the safety of the study participants; 
 Report to NIA on the safety and progress of the trial; 
 Make recommendations to the NIA and the Principal Investigator concerning 
continuation, termination or other modifications of the trial based on the 
observed beneficial or adverse effects of the treatment under study; 
 Ensure the confidentiality of the study data and the results of monitoring; 
and, 
 Assist the NIA by commenting on any problems with study conduct, 
enrollment, sample size, and/or data collection. 
Phase II:  
The Safety Officer responsibilities are to:  
 review the entire IRB-approved research protocol, informed consent documents and 
plans for data safety and monitoring;  
 advise the NIA on the readiness of the study staff to initiate recruitment; 
 evaluate the progress of the trial, including periodic assessments of data quality and 
timeliness, recruitment, accrual and retention, participant risk versus benefit, 
performance of the trial sites, and other factors that can affect study outcome; 
 consider factors external to the study when relevant information becomes available, 
such as scientific or therapeutic developments that may have an impact on the 
safety of the participants or the ethics of the trial; 
 review study performance, make recommendations and assist in the resolution of 
problems reported by the Principal Investigator;  
 protect the safety of the study participants; 
 report to NIA on the safety and  progress of the trial;  
 make recommendations to the NIA, the Principal Investigator, and, if required, to 
the Food and Drug Administration (FDA) concerning continuation, termination or 
other modifications of the trial based on the observed beneficial or adverse effects 
of the treatment under study; 

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 if appropriate, review interim analyses in accordance with stopping rules, which are 
clearly defined in advance of data analysis; 
 ensure the confidentiality of the study data and the results of monitoring; and,  
 assist the NIA by commenting on any problems with study conduct, enrollment, 
sample size and/or data collection. 
 
20.0 Provisions to Protect the Privacy Interests of Participants 
20.1 Protecting Privacy: Please see above; participants will be identified on a 
voluntary basis; no contact information will be shared with the UMN 
research coordinator and team unless the participant verbally agrees or 
contacts the UMN team directly.  
20.2 Access to Participants: The research team will have no access to medical 
records or other sources of private information.  
21.0 Compensation for Research-Related Injury 
Not applicable 
 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained):  
In creating our research design and sampling procedures, an important objective was to 
preserve the privacy, confidentiality, and autonomy of all participants. Following senior 
care navigators’ discussion of Phase I or Phase II components with caregivers, the 
potential participant provides verbal permission to allow Riverside to share the 
caregiver’s contact information with the UMN team.  If interested, the research 
coordinator or research assistant will reach out to caregiver for screening procedures. 
For interested individuals that may contact the UMN team directly, the same screening 
and eligibility procedures will be applied.  Inclusion criteria are as follows: 1) The care 
recipient has a physician diagnosis of Alzheimer's disease or a related dementia (ADRD); 
and 2) the caregiver is 21 years of age or older; 3) English-speaking 4) self-identifies as 
someone who provides help to the person with ADRD because of their cognitive 
impairments, 5) indicates a willingness to use Care to Plan (CtP), and 6) resides in one of 
4 Riverside Health regions (based on zip code). 
During the informed consent process, the research coordinator or research assistant will 
explain the project in detail to each potential participant, including a description of the 
types of assessments to be obtained and the time required. The UMN research staff will 
read the participant the telephone-based consent form (or mail/e-mail the script if 
requested in lieu of reading the full script via phone), and will provide an opportunity for 
the potential participant to ask questions prior to consenting to participate. The name 
of the participant providing verbal consent is documented and the consent form will be 
signed by the member of the UMN team administering consent procedures (research 

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coordinator, research assistant, or Dr. Gaugler). Participants will be provided (via 
mail/email) a copy of the completed consent form for their records. 
 
Surveys will be administered by either the research coordinator or research assistant, 
and these surveys will take place at baseline and 1 month in Phase I and at baseline, 3 
months, and 6 months in Phase II. The research coordinator and research assistant will 
also conduct semi-structured interviews with participants following the 1-month 
evaluation period in Phase I (n = 20) and three CtP interventionists and the 6-month 
evaluation period in Phase II (n = 20 purposively sampled Phase II ADRD caregivers) and 
three CtP interventionists. The interviews and surveys will continue to be administered 
whether the person with ADRD is at home or enters a residential long-term care setting. 
Specifically modified surveys that collect appropriate post-bereavement data will occur 
for caregivers of persons with ADRD who die during the course of the study.  
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):  
Since participants are located out of state, UMN staff will administer a 
telephone-based consent using the Qualtrics consent script uploaded to ethos. 
As the script states, participants will be asked if they have any questions 
regarding the study prior to asking for their consent to participate. The UMN 
staff will document the caregiver’s verbal consent by signing the form. This 
consent form will be completed by the UMN team electronically via Qualtrics.  
The consent form/script was developed using an IRB-template, the study 
procedures (review of online CtP tool, surveys, and interviews) do not routinely 
require written consent outside of the research context, and the study does not 
involve newborn dried blood spots. If a participant enrolls, a copy of the 
completed consent form, signed by the UMN team, will be mailed to the 
participant for their records.  
 
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: N/A 
22.7 Adults Unable to Consent: N/A 
23.0 Setting 

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23.1 Research Sites:  
Riverside Health System was selected as a site for the proposed R21 due to the 
ethnically, racially, and geographically diverse population of older adults served. 
Eligibility will be based on zip-code based region per eligibility criteria (See 
Section 10 Study Population). See section 13.0 Recruitment Methods for details 
regarding recruitment strategies. From January 2017 to May 2018 a total of 
2,123 individuals were served. Approximately 63% (n = 1,330) were women. 
Close to 70% (n = 1,430) had cognitive impairment. Twenty percent of clients 
served were from rural areas (n = 425) and over 30% were African-American (n = 
658). A little over 5% of all clients served over the 17 month period were 
Hispanic/Latino (n =116). 
 
The University of Minnesota will oversee all consent, data collection, data 
management, and analysis of this project.  
23.2 International Research: N/A 
23.3 Community Based Participatory Research: N/A  
24.0 Multi-Site Research: N/A 
 
25.0 Resources Available 
25.1 Resources Available: N/A  
26.0 References 
 
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