Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease
Phase: NA
Conditions: Alzheimer Disease, Cognitive Impairment
Sponsor: Northwestern University

 
 
STUDY PROTOCOL 
Version Date: 2/22/24 
NCT04837937 

1
STUDY TITLE: Negotiation Training to Optimize Caregiver Communication in Alzheimer's 
Disease
PRINCIPAL INVESTIGATOR:
Lee A. Lindquist, MD, MPH, MBA
Geriatrics
CO-INVESTIGATORS:
Kwang-Youn A. Kim, PhD
Preventive Medicine (Biostatistics)
Angela Pfammatter, PhD
Preventive Medicine (Behavioral Medicine)
VERSION DATE:
 02/22/24
RELATED STUDIES: 
N/A
IRB #: STU00212921-MOD0024 Approved by NU IRB for use on or after 3/12/2024

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Funding Agency: 
 National Institute on Aging (NIH/NIA)
Sponsored Research ID#: 
 5R01AG068421-03
Does the grant indicate that 
covered activities will include 
Human Research? 
(Yes / No / Unknown) 
Yes
 
Institution
Human Research Assessment 
***
(e.g., Non-Exempt Human 
Research, Exempt Human 
Research, Not Human 
Research, etc.)
Prime Award Recipient* 
Northwestern University 
Feinberg School of Medicine 
 Human Research
Sub-Award Recipients** 
 N/A
N/A
1.0
Purpose and rationale of the study:
The purpose of this study is to design a Negotiation and Dispute Resolution training 
intervention to improve communication and address resolution of conflicts that family 
caregivers of patients with Alzheimer’s Disease (AD) or memory loss frequently 
experience.
Specific aims:
Aim 1: Employ a caregiver (user)-centered design approach to modify and tailor 
negotiations and dispute resolution (NDR) training intervention to support 
communication skills of family caregivers of adults with AD. 
Aim 2: Utilizing Multiphase Optimization Strategy (MOST), conduct a randomized trial of 
the NDR intervention that targets better communication between caregivers and health 
teams, using a 2-3 full factorial design, to (2a) determine the feasibility of delivering the 
intervention, and (2b) derive estimates of the effect of 3 intervention components on 
changes in patient-centered outcomes at post-intervention and follow-up.
Exploratory Aim 3: Explore if intervention components (lectures/exercises) interact to 
change communication between caregivers and health care teams at post-intervention 
and follow-up. 
2.0
Enrollment Criteria (who can be in your study and who would not be eligible to 
participate in your study):
No subjects will be excluded on the basis of race or ethnicity.
IRB #: STU00212921-MOD0024 Approved by NU IRB for use on or after 3/12/2024

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In Aim 1, participants will be eligible if they:
1. Are age 21 or older;
2. Speak and read English (NDR is currently not available in other 
languages);
3. Provide caregiving support (e.g. emotional, social, physical, task-related) 
to an older adult (>age 65) at least one hour per week;
4. Older adult for whom they provide support to has cognitive loss based on 
the results of the informant AD8 screening tool (AD8 score >2 to have 
cognitive loss);
5. Are involved in decision-making related to the healthcare and support of 
the older adult with cognitive loss; and 
6. Have access and the ability to use a desktop or laptop computer with 
internet (the application is not currently mobile or tablet-friendly).
In Aim 2, participants will be eligible if they:
1. Are age 21 or older;
2. Speak and read English (NDR is currently not available in other
languages);
3. Provide caregiving support (e.g. emotional, social, physical, task-related)
to an older adult (>age 65) at least one hour per week;
4. Older adult for whom they provide support to has cognitive loss based on
the results of the informant AD8 screening tool (AD8 score >2 to have
cognitive loss);
5. Are involved in decision-making related to the healthcare and support of
the older adult with cognitive loss; 
6. Have access and the ability to use the internet to access the program 
(currently supported on mobile, tablet, laptop or desktop); and
7. Have a valid email address and/or willingness to create an email account for 
study purposes.
3.0
Sample Size:
Aim 1: We will recruit up to 15 family caregivers to participate in Aim 1. Data collected 
for Aim 1 will include both quantitative and qualitative data. Based on previous research 
it has been shown that 12-15 interviews are enough to reach thematic saturation in 
qualitative studies. Through our own experiences conducting qualitative studies, we 
anticipate reaching thematic saturation with this number. 
Aim 2: We will recruit up to 150 family caregivers to participate. We will keep recruiting 
until we reach the target of 120 family caregivers who complete all the aim 2 
activities, so we may recruit less than 150 participants. Proposed sample size is based 
off statistical power analysis which shows that n=120 will likely allow us to find 
IRB #: STU00212921-MOD0024 Approved by NU IRB for use on or after 3/12/2024

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statistical significance if the studied effect(s) exist in the full population.  
Recruitment and Screening Methods
Recruitment
Aim 1: We will recruit up to 15 family caregivers as study participants for Aim 1. We will 
recruit family caregivers through the Northwestern General Internal Medicine & 
Geriatrics Clinics as well as through our community partners. The study PI will present 
this study to healthcare providers at the Northwestern Medicine Geriatrics Clinic and 
ask them to pass along study information (recruitment flyer) to family caregivers that 
may be interested in the study. Potential subjects who are interested in learning more 
about the study will contact the Northwestern University research staff by phone or 
email. We will screen interested participants for eligibility over the telephone. 
We are also collaborating with three community-based family caregivers as consultants 
in Florida, New York, and suburban Illinois. These partners will comprise the study’s 
family caregiver advisory panel and will share this research study opportunity through 
word-of-mouth to family caregivers who may be interested in participating. They will 
distribute recruitment flyers containing study information. Potential subjects who are 
interested in learning more about the study will then contact the Northwestern 
University research staff by phone or email to learn more about the study and be 
screened for eligibility.
Aim 2: We will recruit up to 150 family caregivers as study participants for Aim 2. We 
will recruit family caregivers through the Northwestern General Internal Medicine & 
Geriatrics Clinics as well as through our community partners. The study PI will present 
this study to healthcare providers at the Northwestern Medicine Geriatrics Clinic and 
ask them to pass along study information (recruitment flyer) to family caregivers that 
may be interested in the study. Potential subjects who are interested in learning more 
about the study will contact the Northwestern University research staff by phone or 
email. We will screen interested participants for eligibility over the telephone. 
Additionally, we will be utilizing ResearchMatch as a study recruitment tool. 
ResearchMatch, is a national health volunteer registry that was created by several 
academic institutions and supported by the U.S. National Institutes of Health as part of 
the Clinical Translational Science Award (CTSA) program. ResearchMatch has a large 
population of volunteers who have consented to be contacted by researchers about 
health studies for which they may be eligible. 
We are also collaborating with three community-based family caregivers as consultants 
in Florida, New York, and suburban Illinois. These partners will comprise the study’s 
family caregiver advisory panel and will share this research study opportunity through 
word-of-mouth to family caregivers who may be interested in participating. They will 
IRB #: STU00212921-MOD0024 Approved by NU IRB for use on or after 3/12/2024

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distribute recruitment flyers containing study information. Social media will also be used 
to recruit potential subjects. Twitter and Facebook will be used to disperse study 
information to family caregivers nationally. Additionally, we are partnering with an Area 
Agency on Aging in Fort Wayne, IN which provides a variety of services to caregivers, 
and they will also help to recruit participants for Aim 2. 
Potential subjects who are interested in learning more about the study will then contact 
the Northwestern University research staff by phone or email to learn more about the 
study and be screened for eligibility.
Screening for Eligibility
Aim 1: Interested participants will contact the Northwestern University research team 
to be screened for eligibility over the phone using the Aim 1 study inclusion criteria. 
Data collected during the screening for eligibility for those study participants who are 
eligible and do participate in the study will be housed securely in the study screener 
data collection instrument on REDCap survey software. The questions asked during the 
study screener require no identifiers and will help us keep track of recruitment and 
screening status. We will discard screening data for people who are not eligible for the 
study or are eligible and decide not to participate, with the exception of demographic 
data we need to report for screening purposes. 
Eligible study participants for Aim 1 of the study will provide electronic consent (e-
consent) using REDCap to participate in the study. The Northwestern University 
research study coordinator will obtain e-consent for all enrolled study participants. 
Aim 2: Interested participants will contact the Northwestern University research time by 
either emailing, clicking the ResearchMatch link which will generate an email, or calling 
the phone number listed on recruitment materials. The study-specific email is 
monitored by research study coordinators and the research project manager. The phone 
number directs the participant to the primary research study coordinator. Study team 
staff will take the interested participant’s phone call and provide an overview of the 
study. If the participant reaches out via email, staff will send a message asking for a 
phone number to reach them to discuss the study. 
If the participant is interested, and meets eligibility criteria, study staff will collect 
contact information (phone number, email address, mailing address) and a phone call 
will be set up where research staff will further explain the study in more detail, sign the 
electronic Informed Consent Form (participant will view eConsent while on the call), and 
upon consent, complete a baseline survey using the online REDCap survey platform. 
NOTE: If participant has time to complete the e-consent after eligibility is determined, 
this can be done on the same day and does not necessitate a separate appointment. 
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Data collected during the screening for eligibility for those study participants who are 
eligible and do participate in the study will be housed securely in the study screener 
data collection instrument on REDCap survey software. The questions asked during the 
study screener require no identifiers and will help us keep track of recruitment and 
screening status.
4.0
Research Locations
Aim 1: The research will take place virtually, with study activities for Cycle 1 and Cycle 2 
completed online using the Zoom Cloud Meetings (Zoom) video teleconferencing 
software program; Cycle 3 will involve an electronic REDCap survey and a semi-
structured interview completed over the phone.  Data collection will entail using the 
online REDCap survey platform and Zoom. 
Aim 2: The research will take place virtually, with study screening taking place over the 
phone and study activities completed online via the study website, 
www.NegotiAge.com.  Data collection will entail participants answering survey 
questions using the online REDCap survey platform. 
We do not anticipate study participants being located outside of the United States for 
either study aim.
5.0
Multi-site Research (research that involves external collaborating institutions 
and individuals):  
This study is only taking place at one site, Northwestern University, however it involves 
various independent consultants. Some consultants are community-based stakeholders 
who are not affiliated with any institutions, while other consultants are from 
collaborating institutions (University of Southern California and University of Central 
Florida). Community-based caregiver consultants will assist with developing dialogue 
and content for the negotiation cases, provide feedback to the research team on 
proposed study protocols, educational materials, and surveys, and will help disseminate 
our participant recruitment information. Our academic collaborators will help tailor the 
online negotiation platform for our study using our content/dialogue, collaborate with 
our web developer to integrate the online platforms, and assist in analyzing de-
identified data.  None of the external collaborators, community-based or academic, will 
enroll or consent participants into this study nor will they participate in any other 
human research activities as defined by the IRB.
IRB #: STU00212921-MOD0024 Approved by NU IRB for use on or after 3/12/2024

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6.0
International Research (where data collection will occur outside the United 
States and U.S. territories, including online activities): N/A
7.0
P
roced
ures 
Involv
ed
Aim 1: 
Family 
caregi
ver 
partici
pants 
(n=15) 
will 
test 
and 
provid
e 
feedback on the web-based negotiation and dispute resolution (NDR) tool. The NDR tool 
is comprised of two main platforms: a research study website which hosts negotiation 
training educational materials (print and video), as well as the web-based negotiation 
activity platform, Interactive Arbitration Guide Online (IAGO). 
Since caregivers of older adults are often stretched for time (e.g. have full time jobs as 
well as that of caregiver, caring for children/older adults) and may find it difficult to 
attend in-person courses, we will offer the NDR training online using the Interactive 
Arbitration Guide Online (IAGO). IAGO is a platform for designing computer agents (AIs) 
that can negotiate with humans in a variety of game types.  Platforms such as IAGO are 
used by many business schools (e.g. Kellogg, Harvard, Wharton) to enable easy access to 
negotiation learning, activities, and remote negotiations between multiple parties or 
computer simulation. With this negotiation-specific platform, we are able to build new 
or adapt current cases, assign negotiator roles, make pairings, and integrate surveys and 
downloading of feedback. 
Caregiver feedback and usability testing will employ a user-centered design approach 
and inform refinements prior to the trial in Aim 2.
Usability Testing of NDR Tool (N=15)
Usability testing will occur across three cycles. Cycles 1 and 2 will be completed virtually 
with the study participant and the research study coordinator logged onto a Zoom 
Please check the boxes for all applicable data collection procedures you plan 
to use:
☒One-on-one interviews
☐Focus Groups
☒Questionnaires/surveys
☐Analysis of secondary data (medical record data, educational records, 
government or private sector datasets, etc.)
☐Ethnographic observation
☐Physiological measurements (e.g., EEG, EKG, MRI)
☐Biospecimen collection (saliva samples, blood draws, hair samples, etc.)
☐Mobile applications/data collection devices (e.g., Fitbits, actigraphs, etc.)
☒Behavioral decision-making tasks (e.g., puzzles, interactive games, etc.)
☐Physical activities such as walking and other forms of exercise
☐Other procedures (briefly list types of procedures here if not covered by the 
check-boxes above): ______________________________________________
IRB #: STU00212921-MOD0024 Approved by NU IRB for use on or after 3/12/2024

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virtual meeting. This modality will allow us to utilize the screen share feature and record 
the session. By recording the Zoom session, we will be able to better specify what parts 
of the NDR tool correspond with participant feedback. This will be useful especially if 
participants run into functionality problems on any of the web-based platforms since it 
will allow us to provide our software developers with specific screenshots/recordings 
they may need to make revisions. 
The research study coordinator will send a Zoom link to the research study participant’s 
email address prior to their scheduled session. Participants will log on to the Zoom 
session where the research study coordinator will introduce themselves and send them 
the link to the research study website via chat once in Zoom. Once participants have 
logged on, they will share their screen with the research study coordinator. Below is a 
sequence of the NDR tool components the study participants will review and provide 
feedback on in Aim 1. 
Usability testing is comprised of up to three cycles of study participant feedback. The 
first two cycles will include collection of qualitative and quantitative data. Participants 
will utilize the “think aloud” strategy to describe reactions while using the NDR tool and 
to help us identify any technical issues and/or glitches. The third, final cycle of feedback 
will involve the collection of quantitative data and a final qualitative assessment of the 
NDR tool with the study participants navigating through the entire tool on their own, 
completion of a brief online survey, and providing additional feedback via a semi-
structured phone interview.
Research study website
First, study participants will view and provide feedback on the research study website. 
The research coordinator will solicit feedback specifically regarding the website’s design, 
readability, functionality, and clarity of instructions.
(1) Interactive Arbitration Guide Online (IAGO)
Next, participants will access the IAGO platform utilizing the provided link embedded 
within the research study website. Participants will complete two negotiation activities 
and each activity session will take approximately 7-10 minutes. Below is an example of 
what the IAGO negotiation case interface will look like:
Figure 1. IAGO interface example
IRB #: STU00212921-MOD0024 Approved by NU IRB for use on or after 3/12/2024

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Study participants will complete both negotiation exercises in IAGO and the research 
coordinator will observe the interactions, paying particular attention to any technical 
problems and/or confusing elements to the study participant. Once the IAGO exercises 
are complete, study participants will provide feedback on the additional parts of IAGO: 
(1) tutorial, (2) content of the two* negotiation exercises, (3) individualized negotiation 
feedback generated by IAGO and (4) the overall usability of the IAGO platform and the 
negotiation exercises. 
*Note: The NDR tool will host four negotiation exercises. In order to ensure sufficient 
feedback for all of the exercises, while also not burdening the research study 
participants by asking them to complete all four exercises, participants will all review 
negotiation Exercise 1. The study coordinator will then assign an additional exercise to 
each participant for two exercises per participant. The exercises differ based on conflict 
topic and who the negotiation role-play scenario involves. The four negotiation 
exercises are as follows: Exercise 1: Caregiver vs. Older Adult Patient - Easy [Constant: 
All participants will view this]; Exercise 2: Caregiver vs. Caregiver; Exercise 3: Caregiver 
vs. Physician; and Exercise 4: Caregiver vs. Older Adult Patient [Advanced].
(2) Negotiation Learning Materials: Resources & Videos
Next, study participants will be re-directed from IAGO back to the research study 
website, which hosts negotiation learning materials and resources. Participants will 
review three documents hosted on the resources page: (1) High Performance 
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Negotiation Strategies checklist, (2) Interests-Rights-Power Negotiation Framework 
Summary and (3) Negotiation Planning template. 
Additionally, study participants will watch five videos hosted on the study website 
related to the negotiation content and strategies. The videos will cover the 
interests/right/power negotiation framework and negotiation tactics. Each video is 
approximately three minutes long; the longest video is about seven minutes. The total 
time needed to watch all five videos will be approximately 20 minutes. We will ask for 
feedback about the resources in general with a focus on clarity and perceived utility. 
Once all study participants complete Cycle 1, we will share the findings with the team 
and decide on modifications to the NDR tool based on the feedback/usability testing 
results. We will make user-driven refinements after each cycle of usability testing. We 
will repeat this process twice if needed. We anticipate it will take up to 3 months 
between the first and second cycles of feedback. Once we make changes to the NDR 
tool, we will repeat this process during Cycle 2 with the same set of study participants 
and repeat the procedures above, only if there are sections that were refined based on 
Cycle 1 feedback. We will again ask participants to interact with the NDR tool on Zoom 
and provide both qualitative and quantitative feedback. 
After Cycle 1 and Cycle 2, which will only occur if needed, of usability testing are 
complete, we will email all study participants a link to the final NDR tool. If Cycle 3 is 
needed, participants will run through the NDR tool independently and then fill out an 
online survey hosted on REDCap. This survey will include a modified version of the USE 
Scale (a measure of usefulness, satisfaction, ease of use, and ease of learning) to 
measure the participant’s final satisfaction with the tool. Additionally, we will ask 
participants to complete a brief, semi-structured interview over the phone to assess the 
overall NDR tool’s acceptability, satisfaction, and overall impressions. This semi-
structured interview will help enhance the quantitative data collected in Cycle 3.
Aim 2: All study timepoints will take place online (REDCap survey) with the exception of 
the study screener (phone) and e-CONSENT (participant will view online while research 
study coordinator is on the phone). 
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Baseline Survey 1: Participants who consent to participate in the study will be sent a link 
to the REDCap Baseline Survey 1 to their email address. The Research Study Coordinator 
will confirm that the Baseline Survey 1 link was received while they are still on the call 
with the participant after the e-Consent to ensure it was sent to the correct email 
address, was not in a Spam/Junk folder, etc. Participants will have 7 days to submit their 
completed Baseline Survey 1. 
Anticipated participant time required to complete Survey 1: 35 minutes
Study Intervention - Assigned NDR Exercises: Once the completed Baseline Survey 1 is 
received from the study participant, the Research Study Coordinator will send them a 
unique study link which includes their embedded randomization assignment (pre-
randomized) to their email. The link will give participants access to the study website, 
www.NegotiAge.com, as well as the negotiation platform where they will access their 
assigned NDR exercises, IAGO. Participants will have 14 days to complete their assigned 
exercises. 
Anticipated participant time required to complete Study Intervention – Assigned NDR 
Exercises*:  10-30 minutes
*Participants will be randomized to which/how many negotiation activities they are 
required to do so we are providing a range of time.
Post-Intervention Survey 2: Once a participant has completed all of their assigned NDR 
exercises, the research study team will be able to access their completion status via an 
automated report. Participants who have completed all of their assigned study activities 
will be emailed a link for them to complete the Post-Intervention Survey 2 on the 
REDCap survey platform. Participants are expected complete the Post-Intervention 
Survey 2 within 7 days of completing all of the Assigned NDR Exercises. 
Anticipated participant time required to complete Survey 2: 25 minutes
1-Month Post-Intervention Survey 3: Study participants will be emailed a link to Survey 
3 which will be hosted on REDCap and is to be completed online. Participants will be 
sent this survey for completion one-month after completion of Survey 2. Participants 
are expected to complete the 1-Month Post-Intervention Survey 3 within ±14 days of 
being sent the survey link. If a participant misses either of the follow-up surveys (Survey 
3 and/or Survey 4), they will continue to be enrolled in the study. 
Anticipated participant time required to complete Survey 3: 25 minutes
3-Month Post-Intervention Survey 4: Study participants will be emailed a link to Survey 
4 which will be hosted on REDCap and is to be completed online. This is the final study 
activity. Participants will be sent this survey for completion three-months after 
completion of Survey 2. Participants are expected to complete the 3-Month Post-
Intervention Survey 3 within ±14 days of being sent the survey link. 
Anticipated participant time required to complete Survey 4: 30 minutes
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Data collection instruments by time-point listed below: 
For the purposes of distributing and mailing study compensation, as well as collecting 
contact information necessary for data collection, the following identifiers will be 
collected in Aim 1 and Aim 2 of this study:

Participant name

Mailing address

Email address

Phone number
At the conclusion of the study, once final study analysis is complete, study participants 
will receive a summary of the findings in layman terms and next steps. In addition, upon 
request, study participants will receive a copy of this study’s primary findings 
manuscript once it has been published.
8.0
Research with Vulnerable Populations (if children are the ONLY vulnerable 
population you plan to enroll, do NOT complete this section -- instead fill out 
Appendix A): N/A
9.0
Incomplete Disclosure or Deception: N/A
10.0
Consent Process
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Aim 1: Informed consent (electronic) will be obtained by Northwestern research study 
coordinator using the REDCap e-consent application after the participant is deemed 
eligible to participate after completing the study screener. Informed consent will be 
viewed as a process, i.e., at several times during review of the IRB approved consent 
document, the participant will be asked to explain in his/her own words what his/her 
understanding of the consent. This will enable the research personnel to enter into a 
dialogue with the participant and ensure that the participants understands that he/she 
is free to withdraw at any time without penalty. We will provide information to the 
participants in terms that they can fully understand. There will be no exertion of any 
overt or covert coercion. The e-consent document is written in language that the 
potential participant can understand, and they will be encouraged to ask questions prior 
to giving consent.
A copy of the signed e-consent form will be downloaded from REDCap and uploaded 
into Study Tracker as well as saved on the FSMResFile shared project folder. All study 
participants will receive a copy of the signed e-consent form via email to their preferred 
email address. 
Aim 2: Research study coordinators using the REDCap electronic (e-consent) application 
will obtain informed consent. If the individual is eligible and is interested in 
participating, they will be sent a link to the electronic-consent form (e-consent) to their 
preferred email address. The Research Study Coordinator will explain the study to the 
participant over the phone, and both the participant and research coordinator will go 
through the e-consent together. 
If the participant does NOT have time to complete the e-consent after the screening 
assessment and/or does not have access to view/sign the e-consent that day, the 
Research Study Coordinator will schedule a day/time for completion of the e-consent 
with the participant. If the participant agrees to participate, they will sign the consent 
form electronically. The research staffer will also sign and date the form electronically. 
Informed consent will be viewed as a process, i.e., at several times during review of the 
IRB approved consent document, the participant will be asked to explain in his/her own 
words what his/her understanding of the consent. This will enable the research 
personnel to enter into a dialogue with the participant and ensure that the participants 
understands that he/she is free to withdraw at any time without penalty. We will 
provide information to the participants in terms that they can fully understand. There 
will be no exertion of any overt or covert coercion. The e-consent document is written in 
language that the potential participant can understand, and they will be encouraged to 
ask questions prior to giving consent.
A copy of the signed e-consent form will be downloaded from REDCap and uploaded 
into StudyTracker as well as saved on the project’s secured shared drive folder. All study 
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14
participants will receive a copy of the signed e-consent form to their preferred email 
address.
11.0
Waiver of Participant Signature on Consent Form: N/A
We are not requesting a waiver of participant signature on the consent form since 
signature will be obtained remotely using the REDCap platform for both study Aims 1 
and 2. 
12.0
Waivers and Alterations of Consent Information: N/A
13.0
Financial Compensation:
Aim 1: We will compensate study participants for their time and the amount of the 
compensation will depend on which study activities they complete. We anticipate that 
the study participants will spend up to 8 hours on the usability testing (approximately 2-
3 hours per each cycle). Subjects will be compensated only for the study activities they 
complete. Compensation was determined by using a rate of $50/hour for each activity.
Activity
Estimated 
Duration
Visa Gift Card 
Value
Cycle 1: Initial usability testing of NDR Tool
Up to 3 hours
$150
Cycle 2 (if needed): Usability testing of NDR 
Tool refinements
Up to 2 hours
$100
Cycle 3 (if needed): Final usability testing
Survey 3a. Final review & REDCap survey
Up to 2 hours
$100
Survey 3b. Semi-structured phone interview.
Up to 1 hour
$50
TOTAL
Up to 8 hours
Up to $400
We will compensate research study participants with Visa gift cards. They will receive 
compensation within 4 weeks of their completion of the study activities. Since the study 
activities are completed remotely, the Visa gift cards will be mailed to study participants 
at their specified mailing address. Participants will be compensated the full amount 
even if they do not spend the estimated duration period on the activity (e.g. if a 
participant only spends 2 hours on Cycle 1, they will be compensated $150, not $100).
We will not compensate study participants for study activities they do not complete. 
However, they will still be allowed to participate in Aim 1 of the study if they do not 
complete all three activity cycles (e.g. if they only complete Cycle 1 but not Cycle 2, they 
are still eligible to complete Cycle 3). Participants will not incur any costs in participating 
in this research study.  
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Aim 2: All enrolled participants will be compensated for their time and effort for the 
completion of each activity in Aim 2. Participants will receive up to $500 in virtual Visa 
gift cards.  Participants will only receive compensation for the activities that they 
complete. However, participants will still be allowed to continue their participation in 
the study even if they do not complete all the study activities. All activities will be 
completed online and the corresponding compensation upon completion is listed 
below:
*Includes completion of Study Intervention - Assigned NDR Exercises in addition to 
Survey 2
Virtual Visa gift cards will be emailed to study participants upon completion of each 
study activity no later than 5 days after each activity completion. The research study 
coordinator will call or email participation to confirm receipt of the virtual gift card and 
log all compensation mailings on the Aim 2 Participant Compensation Log. Participants 
will not incur any costs in participating in this research study. 
We are not able to receive a signed receipt from the study participants for either Aim 1 
or Aim 2 given that these study activities will take place virtually. The Research Study 
Coordinator will sign and date a receipt including the study participant ID and date of 
survey completion along with the compensation amount. This receipt will be kept 
electronically on the shared drive. In addition, a compensation tracking log will be 
tracked in Excel which will include the following fields: study ID, type of survey/activity 
completed, date survey/activity completed, Visa gift card number, ICN number, date gift 
card mailed, value of gift card, and the initials of the Research Study Coordinator who 
emailed the compensation.
14.0
Audio/Video Recording/Photography
Aim 1: Northwestern research staff will record the online Zoom sessions during Cycle 1 
and Cycle 2 of usability testing. Recordings will include audio of the Zoom sessions as 
well as video recordings of the screen share sessions. Recordings data will be used to aid 
in identifying any issues in usability/functionality across the NDR Tool web-based 
platforms. Recordings will also allow us to transcribe their responses to the feedback 
Activity, by time-point 
Estimated Duration
Virtual Visa 
Gift Card 
Compensation 
Amount
Baseline: Survey 1 
Up to 35 minutes
$25
Immediate-Post Intervention*: Survey 2 
Up to 60 minutes
$300
1-Month Post Intervention: Survey 3 
Up to 25 minutes
$75
3-Months Post Intervention: Survey 4 
Up to 30 minutes
$100
TOTAL
$500
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questions so that we capture data accurately. Agreeing to have the Zoom feedback 
sessions recorded in Cycle 1 and Cycle 2 is mandatory for study participation. 
Cycle 3, which includes a semi-structured survey over the phone, will not take place 
over Zoom however it will be audio recorded to allow us to transcribe their responses to 
the questions so that we capture their responses accurately. Agreeing to have the Cycle 
3 phone session recorded is not mandatory for study participation. If participants do 
not agree to be recorded, we will ask for additional time to allow us to capture their 
responses in real time. 
Zoom recordings will be directly saved to the desktop. Once the participant interview is 
complete, the recordings will be moved to the shared study folder on the Feinberg 
managed servers (FSM/NUCATS Managed storage), specifically on the GIM/GER shared 
research drive (specific project folder on the Research drive in GIM/GER) with no 
identifying information for the duration of the funded study, unless other arrangements 
are made. 
Audio from Cycle 3 will also be stored on the GIM/GER shared research drive (specific 
project folder on the Research drive in GIM/GER). The study PI and Northwestern 
research staff on the IRB of this study will have access to the files as needed. 
Participants may request that audio files be deleted before the end of the study, in 
which case we will comply. 
Aim 2: N/A
15.0
Potential Benefits of this Research: 
Aim 1 and Aim 2: Participants may experience a direct benefit from being a part of this 
research study since they will be exposed to negotiation and dispute resolution activities 
and may gain useful knowledge as a result. However, we cannot guarantee that they will 
directly benefit from being part of the study. They may however experience the indirect 
benefit of being involved in research that may lead to meaningful changes in how we 
can best support caregivers of people with Alzheimer’s disease/dementia. 
At a population level, the proposed study can lead to meaningful improvement in the 
lives of family caregivers and people with Alzheimer’s Disease and memory loss. 
Although benefits to individual participants may be minimal, the potential benefits of 
this study at a population level should greatly exceed the minimal risk to individual 
subjects. 
16.0
Potential Risks to Participants:
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Aim 1: There are minimal risks to participation. Potential risks to study participants 
include: potential loss of confidentiality and emotional discomfort in participating in 
potentially stressful scenarios and answering questions on surveys related to conflict.
Confidentiality may be broken by research staff to ensure the study participant’s safety 
if there is an imminent threat to self or others. All of these potential losses of 
confidentiality are disclosed in the consent documents.  All potential risks associated 
with participation in this study are disclosed in consent documents.  The procedures to 
protect against risks associated with potential loss of confidentiality include: keeping 
participant data strictly confidential, except as mandated by law (see section 18.0 where 
data security measures are described). 
Procedures to protect against risk associated with experiencing emotional discomfort in 
answering survey questions and/or completing conflict activities include information 
participants that they can decline to answer any questions they choose. Likewise, they 
will be informed that they do not have to complete any negotiation activities that they 
choose not to. Negotiation and dispute resolution training programs generally have not 
been shown to cause any harm. Participants can elect to stop the training activities at 
any time. Participants will give voluntary responses to interview questions; they are told 
that they can decline to answer any questions that they choose. 
We will inform participants that their involvement in the study is voluntary, and they 
may withdraw from the study at any time. We do not anticipate any circumstances 
where a participant would be withdrawn from the research without their consent.
Aim 2: There are minimal risks to participation. Potential risks to study participants 
include potential loss of confidentiality and emotional discomfort in participating in 
potentially stressful scenarios and answering questions on surveys related to conflict.
Confidentiality may be broken by research staff to ensure the study participant’s safety 
if there is an imminent threat to self or others. All these potential losses of 
confidentiality are disclosed in the consent documents.  All potential risks associated 
with participation in this study are disclosed in consent documents.  The procedures to 
protect against risks associated with potential loss of confidentiality include keeping 
participant data strictly confidential, except as mandated by law. 
Procedures to protect against risk associated with experiencing emotional discomfort in 
answering survey questions and/or completing conflict activities include information 
participants that they can decline to answer any questions they choose. Likewise, they 
will be informed that they do not have to complete any negotiation activities that they 
choose not to. Negotiation and dispute resolution training programs generally have not 
been shown to cause any harm. Participants can elect to stop the training activities at 
any time. Participants will give voluntary responses to survey questions; they can 
decline to answer any questions that they choose when they are completing the study 
surveys online. 
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We will inform participants that their involvement in the study is voluntary, and they 
may withdraw from the study at any time. We do not anticipate any circumstances 
where a participant would be withdrawn from the research without their consent.
17.0
Provisions to Protect Participant Privacy and Data Confidentiality:
Aim 1: 
Participant Privacy. In all research documentation, a unique identification number 
(“Study ID”) will identify participants, not by name, and any other identifying 
information (e.g. personal and/or contact information) will be kept separate from the 
other data; all information will be kept in secure, password protected files. This also 
includes Zoom video and audio files for those participants in Aim 1. We will ask 
participants to try and refrain from using any identifiers during recorded sessions. 
Further, unless required by law, only the study investigators, members of the research 
project staff, and representatives of the Northwestern University will have the authority 
to review any study records. In such case, they too will be required to maintain 
confidentiality.
Confidentiality of Data. Information from participants will not be linked to their name 
and will be assigned a unique identification number. The research database will be 
password protected and accessible only to the research team and the Institutional 
Review Board. Information linking participants with their unique identifier will be kept 
on a separate password-protected desktop computer in a locked office within an 
Administrative Suite in the Division of General Internal Medicine and Geriatrics, 
Northwestern University. Information linking subjects’ names and contact information 
with their unique identified will be kept in a separate password protected file. Copies of 
the signed, electronic consent forms will be kept in a locked cabinet only accessible by 
the research team and a copy will be either mailed to the study participant or emailed, 
depending on their preference. When demographic data is entered into the database, a 
de-identified subject number will be used to identify research subjects. No individuals 
will be identified in any presentations or publications resulting from this research.
Data Access. The Data Custodian is the Principal Investigator, Dr. Lee Lindquist. Only 
authorized personnel listed on in the IRB will have access to the data.  Any information 
that could allow identification of individual participants, including the master list, will be 
kept strictly confidential. 
Local Data Storage. Data will be stored in REDCap, a secure, web-based application, and 
on FSM/NUCATS Managed storage, specifically on the GIM/GER shared research drive 
(specific project folder on the Research drive in GIM/GER) for the length of the study. 
We will transcribe qualitative data as needed and save in Microsoft Excel for coding.  
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Quantitative data will be exported to data analysis software such as STATA or SAS. 
These data files will not contain any identifiable information, and will be identified by 
project staff with an assigned study ID. Upon completion of all study activities, we will 
create a final de-identified dataset an all-identifiable information will be deleted. This 
dataset will be stored indefinitely on the FSM/NUCATS managed storage, specifically the 
GIM shared research drive for secondary analyses. Only authorized personnel will have 
access to the dataset and study folder. We will delete identifiable information upon 
completion of the study. Zoom audio and video recordings three years after completion 
of the study per Northwestern University policy. 
Aim 2: 
Participant Privacy. In all research documentation, a unique identification number 
(“Study ID”) will identify participants, not by name, and any other identifying 
information (e.g. personal and/or contact information) will be kept separate from the 
other data; all information will be kept in secure, password protected files located on 
secure project folders on the shared drive. Further, unless required by law, only the 
study investigators, members of the research project staff, and representatives of the 
Northwestern University will have the authority to review any study records. In such 
case, they too will be required to maintain confidentiality.
Confidentiality of data. We will not include participant identifiers (e.g. contact 
information such as name, residential address, phone number, email address, etc.) 
together with the study data. We will have a separate database which is password 
protected and accessible only to the research team and IRB which will house the 
identifying information (REDCap). The study data from the REDCap surveys will be 
assigned a unique identification number and will not be linked to their name.  
Copies of the signed, electronic consent forms will be saved on the shared project drive 
and will also be uploaded into Study Tracker. When demographic data is entered into 
the database, a de-identified subject number will be used to identify research subjects. 
No individuals will be identified in any presentations or publications resulting from this 
research.
Data transmitted between web data collection and study servers for internal study 
purposes will be encrypted and password protected in transmission and will be housed 
securely on study servers. No identifiable information will be contained in the data 
transmitted between web data collection and the study servers.
Study research data, including consent forms, will be kept for a minimum of 3 years 
after the completion of the study on the password protected study folder located on the 
encrypted shared research drive.
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18.0
Data Monitoring Plan to Ensure the Safety of Participants:
This study did not meet the NIH/NIA requirements for a Data Safety and Monitoring 
Board (DSMB), but it does require a Safety Officer (SO). The SO is an independent 
individual who performs data and safety-monitoring activities in lower risk, but greater 
than minimal risk single-site clinical trials. The SO will advise the NIA Program staff and 
the Principal Investigator (PI) regarding participant safety, study risks and benefits, 
scientific integrity, participant recruitment, and ethical conduct of a study.
Our SO, Dr. Mara Schonberg has been approved by the NIA and has been added to the 
study IRB along with her human subjects training certificate. In Aim 2, the SO will 
receive the manual of operating procedures, which will contain the IRB-approved study 
protocol and data safety-monitoring plan, before study enrollment begins in Aim 2. The 
tasks of the SO will include reviewing the entire IRB-approved study protocol regarding 
subject safety and analysis, the informed consent document regarding applicability and 
readability, and participant recruitment and retention milestones.
Once we launch Aim 2 of the study, every six months the study team will prepare safety 
reports to be reviewed by the SO and NIA for recommendations for or against the trial's 
continuation, as well as any modification to the study. The SO is un-blinded to safety 
data, but not necessarily to outcome data. In addition to safety data, the SO will 
consider recruitment and retention rates. For instance, they will consider whether 
delayed recruitment raises concerns of futility and other ethical considerations.
19.0
Long-term Data and Specimen Storage and Sharing: 
Data will be stored on FSM/NUCATS Managed storage, specifically on the GIM/GER 
shared research drive (specific project folder on the Research drive in GIM/GER) and 
REDCap survey platform. Data collected on FSM department desktop and laptop 
computers is encrypted. Study data, which includes video and audio files, will not 
include identifiers. We will store data in the Feinberg Division of General Internal 
Medicine and Geriatrics for a minimum of three years after the project period has 
ended as per the Northwestern University Office of Sponsored Research. Destruction of 
research data will then follow applicable federal regulations, Northwestern policies on 
record retention and data disposal, sponsor requirements and other applicable 
guidelines.
20.0
Qualifications of Research Team to Conduct the Research:
This project is led by Dr. Lee A. Lindquist, along with Drs. Rogalski, Kim, and Pfammatter. 
Dr. Lee Lindquist is a geriatrician and Section Chief of Geriatrics at the Northwestern 
University Feinberg School of Medicine. Dr. Lindquist has extensive expertise in older 
adults, caregivers of seniors, caregiver support for patients with Alzheimer’s Disease and 
outpatient safety. She also has extensive experience collaborating in research with 
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community organizations and community members for recruitment, study 
implementation, data collection, and dissemination.
Dr. Kim is a biostatistician at the Northwestern University Feinberg School of Medicine 
and is very experiences in clinical trials, handling data transfer, harmonization, and 
workflow from REDCap. He has previously worked with Dr. Lindquist in submitting and 
implementing various studies. 
Dr. Pfammatter is a Clinical Health Psychologist with expertise in the development and 
testing of technology to influence health behaviors. Her research has focused on 
optimizing the efficiency, fidelity, and reach of interventions using technologies such as 
web, smartphone, and smartwatch applications and the Multiphase Optimization 
Strategy (MOST) and her clinical background has primarily been in a context of 
collaborating in a multidisciplinary team to approach patient care, which informs the 
interventions she has developed. Dr. Pfammatter will utilize her expertise in MOST to 
guide the design and implementation of this study with the goal of preparing and 
optimizing a scalable intervention to improve caregiver outcomes. 
Dr. Jonathan Mell is an Assistant Professor at the University of Central Florida and has a 
PhD in Computer Science (specifically in Human-Computer Interaction). His research 
centers on human-computer interaction with specific interests in emotion, automated 
negotiation, behavioral game theory, and artificial intelligence. He designs AIs that are 
capable of understanding human social interactions, and craft software and user 
experiences that allow the melding of technology and society. Dr. Mell is the creator 
and expert of the online negotiation software we will use, IAGO.
Dr. Lindquist, as the study PI, will personally train and supervise the Northwestern 
research staff in the day-to-day execution of the study details. Although Dr. Lindquist 
will have executive decision-making over all final research decisions, the research study 
coordinator will be the first point of contact “on the ground,” with close access to and 
constant communication with Dr. Lindquist. Any IRB revisions or updates will be 
submitted by the research manager or research coordinator, in addition to other 
administrative tasks (e.g. tracking of participant compensation, etc.). 
Team Meetings: The entire investigator team (Lindquist, Rogalski, Pfammatter, Kim), 
and research staff (research manager, research coordinator) will meet approximately 
once a month. The PI and research staff will meet weekly and meet with the consultants 
as needed. Dr. Lindquist and the research study coordinator will be responsible for 
presenting interim outcome data, including the number of participants screened, 
enrolled, refused, and any anticipated or unanticipated obstacles encountered. 
IRB #: STU00212921-MOD0024 Approved by NU IRB for use on or after 3/12/2024