An AI-Embedded Intervention to Promote Financial Wellbeing Among Latino Family Caregivers
Phase: NA
Conditions: Alzheimer Disease, Dementia, Caregiver Burden, Financial Stress
Sponsor: Case Western Reserve University

CONFIDENCE-AI Financial Education for 
Caregivers (CONFIDENCE-AI) 
Study Protocol and Statistical Analysis Plan 
NCT0613418
May 19, 2025 

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[USE THIS TEMPLATE IF YOUR PROJECT INCLUDES SURVEY, INTERVIEWS, FOCUS 
GROUPS OR EDUCATIONAL RESEARCH ACTIVITIES WITH NO BIOMEDICAL/CLINICAL 
COMPONENTS]
INSTRUCTIONS:

Use this template to prepare your IRB Protocol.

Depending on the nature of what you are doing, some sections may not be applicable to
your research. If so, please mark as N/A.

When you write a protocol, keep an electronic copy. You will need to modify this copy
when making changes.

Consider using a different color font for your answers.
PROTOCOL TITLE:
Include the full protocol title.
CONFIDENCE 2 Financial Education Program Evaluation.
PRINCIPAL INVESTIGATOR:
Name: Kylie Meyer
DATE:5/19/2025
Indicate the origin of this protocol (who conceived of and leads the development of the 
protocol regardless of funding):
☒
Investigator initiated (Investigator(s) developed protocol, regardless of funding)
☐
Industry (Pharmaceutical, Device, etc.) (Industry developed protocol)
☐
Federal (NIH, DOD, etc.)
☐
Cooperative Group (SWOG, GOG, etc.)
☐
Other - Please specify:  Click here to enter text.
Has this study been disapproved by or withdrawn from any other IRB?
☐  Yes☒  No
If so, please explain: .
Does this study involve cancer research or cancer-related issues?
☐  Yes☒  No
If yes, indicate the PRMC number: Click here to enter text.
Is this a student led study?
☐Yes☒  No
If yes, is the student: ☐ Undergrad
☐ Graduate Student  ☐Other Click here to enter text.
If yes, is the project:  ☐ Capstone
☐ Master’s thesis
☐ PhD dissertation
☐Other Click here to enter text.

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Is this work part of a larger collaborative research project where more than one institution is 
participating in the research?  (In collaborative projects, data/specimens/results are often shared 
between researchers at the participating institutions, and they will publish together.)
☐ No  ☒ Yes
If yes, please explain.
We are collaborating with the University of Southern California, where the intervention 
is being administered as a part of a social service program for caregivers (USC Family 
Caregiver Support Program). USC may participate in the publication of findings but is 
not involved in data collection procedures, other than registration data used as a part of 
regular programming. We are also working with Amicus Brain Innovations as a study 
partner. Amicus Brain Innovations is responsible for building out technology components 
of the CONFIDENCE program. They will store data such as utilization data (e.g., receipt 
of text messages) from caregivers in the NeuViCare app that we are integrating into the 
intervention.
1.0 Funding
If this study is grant funded, is the money coming directly to CWRU from the study sponsor?
☒  Yes☐  No ☐  N/A, not grant funded
2.0 Objectives
Directions: Describe the purpose, specific aims or objectives. Be sure to also include the 
hypothesis being tested. The overall objective of this project is to test the feasibility, acceptability, and preliminary 
efficacy on an AI-enhanced psychoeducational intervention to reduce financial strain among Latino/Hispanic family 
caregivers to people living with dementia (PLWD)  by supporting resource access called CONFIDENCE 2. The central 
hypothesis is that caregivers who participate in the CONFIDENCE intervention will report higher levels of 
resourcefulness and self-efficacy following participation in the CONFIDENCE intervention that will reduce financial strain 
among caregivers of PLWD.   
3.0 Background
Directions: Describe the relevant prior experience and gaps in current knowledge 
describing how this study will add to existing knowledge. Include any relevant preliminary 
data. Family caregivers to people living with dementia encounter financial strain, including material, 
psychological, and behavioral components. Caregivers to PLWD also spend an average of $8,978 per 
year out-of-pocket on caregiving expenses, which is around $1000 more than caregivers to persons 
without dementia. Research findings support that caregiving places individuals at increased risk of 
poverty, due to factors such as reduced ability to engage in employment and spending down one's own 
savings to cover costs. Financial strain is also a risk factor for caregiver depression and burden which 
affects 1 in 5 family caregivers to PLWD.  Financial strain disproportionately affects Latino/Hispanic 
family caregivers to PLWD. They spend 47%of their annual household income on out-of-pocket costs of 
caregiving, compared to 18% among non-Hispanic white, 34% among African American, and 22% 
among Asian American caregivers. These differences in out-of-pocket expenses are partially due to 
cultural preferences to provide care at home, such that Latino/Hispanic families provide more intensive 
care that is more likely to disrupt employment and increases out-of-pocket costs. Further, U.S. 
Latino/Hispanic households have a median net worth of $52,190 (four times lower than U.S non-

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Latino/Hispanic households), which makes it more difficult to absorb out-of-pocket costs when they 
occur. The impact of financial strain on Latino/Hispanic families is likely to grow substantially, given an 
anticipated 832% increase in the number of Latinos/Hispanics LWD in 2060. However in 2022 only two 
studies were found to examine intervention effects on financial strain of Latino/Hispanic caregivers.  
To address the need for programs to reduce financial strain among Latino caregivers, we developed the 
Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving 
(CONFIDENCE) program with support from AARP Foundation from 2020 to 2023. The original version 
of CONFIDENCE includes a 5-week, group-based psychoeducational intervention delivered by Zoom. 
Most data for the evaluation of the CONFIDENCE original program have been collected. Initial findings 
indicate high satisfaction with the program among participants (100% “Agree” or “Strongly Agree” they 
would recommend the program to other caregivers), but also lower-than-anticipated uptake and 
adherence. For example, only 51% of caregivers registering for CONFIDENCE at the USC Family 
Caregiver Support Center attended at least one session. Of those who attended at least one session, 
average attendance was 3.1 out of 5 sessions. These findings suggest high acceptability but limited 
feasibility. 
The second version of CONFIDENCE aims to build on lessons learned from the original CONFIDENCE 
program with the goal of improving program feasibility prior to testing the program’s efficacy. To 
improve uptake and adherence, we have shortened the number of group-based Zoom discussion sessions 
from 5 to 4 to reduce the time required to participate. Content covered in the sessions removed from the 
core program will be delivered by asynchronous, technology-driven means. Participating caregivers will 
have a chance to decide which topics to focus on based on their current needs and will receive 
informational text messages covering these topics. Caregivers will also have access to a conversational AI 
assistant (“Keiko”) that will draw from hand-picked and trusted resources to devise answers to questions 
caregivers may have about topics such as how to find reduced-cost home modifications, how to prepare 
for retirement, and how to prevent financial scams. To support learning between discussion sessions, 
NeuViCare also will host a moderated community forum where caregivers can connect with other 
participating caregivers .  
Please add relevant references at the end of the protocol, not at the end of this section.
4.0 Inclusion and Exclusion Criteria
Directions: Describe how individuals will be screened for eligibility. 
Participants will be asked to either complete an online self-administered survey 
to determine their eligibility, or to complete eligibility questions by telephone. 
Using the tables below, describe the inclusion and exclusion criteria that will define who 
will be included and excluded in your final study sample.
 
Inclusion
1.
Age range: from 18 to not upper limit
2.
Has been at least 6 months since the care recipient began to experience dementia 
symptoms
3.
Person living with dementia meets stage 4 to 6 criteria on Global Deterioration 
Scale according to family caregiver
4.
Latino/Hispanic ethnicity

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Exclusion
1.
Individuals who plan to place their family member in a nursing home in the next 3 
months
2.
Unreliable access to internet, tablet or smart phone, and email 
3. 
Does not agree to participate in at least 3 of the 4 group sessions and/or register for 
the NeuViCare app 
4.
Unable to read and speak in English or Spanish
5.0 Number of Research Participants
Directions: Indicate the target number of research participants to be accrued locally, and, 
if this is a multi-site study, indicate the total number of research participants to be accrued 
across all sites. 
Example language that can be used: We will enroll 25 subjects at CWRU and plan to enroll 
150 subjects study wide. We will recruit 42 family caregivers to account for the anticipated 20% 
attrition before and after participation in CONFIDENCE 2. Moreover, at least 12 participants 
will complete qualitative interviews.
6.0 Special/Vulnerable Populations
Indicate specifically if you will include each of the following special populations by checking 
the appropriate box: 
☐  
Adults unable to consent
☐  
Minors (infants, children, teenagers) 
☐  
Wards of the state (e.g. Foster Children)
☐  
Pregnant Women (only if targeted)
☐  
Neonates
☐  
Neonates of Uncertain Viability
☐  
Employees
☐  
Prisoners
☐  
Illiterate Individuals
☒  
Non-English Speaking
☐  
Students
☐  
None
1. If the research involves students or employees, describe how you will recruit so that: 
a) Employers or educators do not know if someone participated (until after grades have 
been assigned in the case of educators) 
b) Employers or educators do not directly recruit their own students or employees, and 
anything else to prevent feelings of coercion to those subordinate to their employer or 
educator. 
  

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2. If the research involves individuals that are included in a special/vulnerable population, 
describe the additional safeguards included to protect the rights and welfare of the 
individuals for each population indicated. Click here to enter text.
3. If excluding pregnant women, illiterate or non-English speaking individuals, provide a 
scientific rationale for the exclusion.  Inconvenience or cost is not an acceptable 
rationale. Persons who are illiterate are excluded from the study due to an inability to 
engage with the program materials, such as the written workbook and text materials.  
7.0 International information
☒  This is not an international study – please leave rest of this section blank.
☐  We will be conducting this research at the following international sites:
Click here to enter text.
☐  We are recruiting participants outside of the US from the following locations:
Click here to enter text.
☐  We are sending data outside of the US to the following locations:
Click here to enter text.
☐  We are receiving data from outside of the US from the following locations:
Click here to enter text.
8.0 Recruitment Methods
Note: Attach all applicable recruitment materials to the last section of the Smart form under 
“Recruitment Materials.”
1. Which of the following methods will be used to recruit research participants? – Select all 
that apply
☒  Email
☒  Phone call
☐  Letter
☒  Advertisement (e.g., poster, flyer, etc.)
☒  I attest that advertisements will only be placed with permission 
☒  Social media

Indicate the platform(s): Facebook
☒  I attest that recruitment information will only be posted with permission 
☐  Other. Please specify: Click here to enter text.
2. Describe when, where, how and by whom potential research participants will be 
recruited. Individuals involved in recruitment should be identified by role and not by 
name (e.g. study coordinator, co-investigator, research assistant).
Information about CONFIDENCE will be shared by email blast sent to caregivers in the 
USC FCSC mailing list. USC FCSC Family Consultants will also share information 
about the program with clients who may benefit (See Talking Points document.). 
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site. Participants who register on Eventbrite and indicate interest in learning more about 
the study will receive calls and emails from the study team with information about the 
study. If interested, eligibility screening will be conducted by phone and they will be sent 
an email with a REDCap consent form to review. Participants who complete the 
eligibility screening online will receive a link to the consent form and a telephone 
confirmation. Once enrolled, participants will receive a baseline survey up to 3 weeks 
before their first scheduled CONFIDENCE session. 
3. Describe the feasibility of recruiting the required number of suitable research participants 
within the agreed recruitment period. For example, how many potential research 
participants do you have access to? 
The anticipated recruitment period will begin in March 2024 to August 2025. We aim to 
enroll 5-6 caregivers per cohort. Each cohort will take 4-5 weeks to complete. We aim to 
use the same recruitment approach as was done in the original CONFIDENCE study, 
relying heavily on the USC FCSC client list. USC FCSC serves over 500 caregivers 
yearly, among whom 60% are Latino/Hispanic and 38% care for someone living with 
AD/ADRD. Although recruitment into the initial study was far lower than anticipated, 
multiple factors are expected to contribute to higher enrollment in this study, including 1) 
reduced burden of participation in the intervention (e.g., reduction of synchronous 
sessions from 5 to 4), 2) reduced burden of study participation (e.g., removal of daily 
spending diary component), and 3) expansion of age eligibility criteria from caregivers 
ages 50+ to 18+ in the current study. Further, we have expanded our recruitment 
approach during the initial CONFIDENCE study. 
9.0 Setting
Directions: Describe the sites and locations where your research team will conduct the 
research.
 All research will be conducted at Case Western Reserve University where the study team 
has lab space to collect data by telephone, REDCap, and Zoom in a private space. Some data 
on app utilization will be collected by Amicus Brain Innovations for use by Case Western 
Reserve University researchers. 
10.0 Consent Process
Indicate whether you will be obtaining consent:
☒  Yes
☐  No
If yes, answer the following questions:
1. Describe who will consent the subjects and where the consent process will take 
place: The consent process will be completed using an online consent 
form completed in REDCap, wherein participants will be asked to 
review a written consent form and answer 5 true or false questions 
about participation to check understanding. If these questions are 
not answered correctly, a study team member will contact the 
participant to clarify information and resend the consent form. If 

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answers are still incorrect, the participant will be deemed ineligible 
to participate and notified of their removal from the study.
  
2. The time that will be devoted to the consent discussion: The time to complete 
the online consent form will vary among participants, though we 
anticipate it will take no more than 1 hour and, for most 
participants, around 20 minutes.
3. Any waiting period available between informing the prospective subject and 
obtaining the consent: There is no required waiting period between 
informing the participant of their eligibility and the consenting 
process. However, participants may choose to delay consent 
following notification of eligibility, such as by taking additional time 
to complete the online consent form.
4. Steps that will be taken to ensure the research participants’ understanding: 
Participants will be asked to complete 5 questions about what is 
involved in the study to ensure understanding of the written consent 
form. They may also contact members of the study team with any 
questions they may have.
5. Any process to ensure ongoing consent: We will assume ongoing consent if 
the participant chooses to complete surveys. At the top of each 
survey, participants will be reminded that participation is voluntary
6. Steps that will be taken to minimize the possibility of coercion or undue influence 
to the subjects: While consenting participants, we will remind them 
that participation is voluntary and that they are welcome to 
participate in CONFIDENCE regardless of their choice to participate 
in the research study
For Adult Participants
Indicate if you will be asking for a waiver or alteration of consent process or 
documentation (consent will not be obtained, or written consent will not be documented)
☒  Yes
☐  No
If yes, explain how the research involves no more than minimal risk.  We are requesting a 
waiver of consent related to provision of a signature for a sub-study, wherein we will ask 
caregivers who are not in the parent study to participate in a qualitative interview. The 
interview content focuses on their experience in the CONFIDENCE program and is aligned 
with the goals of program evaluation/quality improvement. It is unlikely private or 
embarrassing information would be shared. 

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Indicate which part of the consent process you are requesting be waived or altered and 
the rationale for requesting the waiver or alteration:
☒  
I will obtain consent, but not participant’s signature.
1. Give the rationale for the request of a waiver of signed consent. Those 
individuals who did not enroll in the study are likely busier than those who 
are enrolled in the parent research study. Asking for a consent signature 
may add additional burden to a minimal-risk component of the study.
2. Please describe how you will be documenting that a participant has 
consented. The interviewer will ask the participant if they consent to 
participate at the beginning of the interview. They interview will not 
proceed unless consent is given 
3. Indicate if the subjects will be provided with written information about the 
study, and provide justification if you will not be providing a written 
explanation of the research. Caregivers will be sent a copy of the 
information sheet prior to the scheduled interview, if they agree to be 
interviewed. This will be reviewed at the beginning of the interview.
☐  
 I will obtain consent, but request a waiver of some of the elements of consent 
                      (e.g. use of deception).
☐  
 I will not obtain any consent, and I am requesting a full waiver of consent.
If you are requesting an alteration of consent, or a waiver of consent, please answer 
the following:
1. Give the rationale for the request of a waiver or alteration of the consent 
process. See above
2. Explain why the waiver or alteration of consent will not adversely affect 
the rights and welfare of the participants. The questions asked in the 
qualitative interview are unlikely to result in disclosure of sensitive 
information, and are more aligned with the goals of program evaluation or 
quality improvement than research. 
3. Explain why the research could not practicably be carried out without the 
waiver or alteration of consent. Requiring a signature would put additional 
burden on caregivers without necessarily reducing already minimal risks.
4. Indicate if the subjects will be provided with additional information about 
the study after participation. Caregivers will be provided additional 

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information at the end of the study, including a written summary and 
invitation to view a presentation about results 
*Be sure to upload a consent script or information sheet with your study protocol
Additional Considerations for Consent Process with Adults
Non English Speakers (Please select one)
☐  I am not enrolling non-English speaking individuals in this research study. The following is 
justification for why non-English speaking individuals cannot be enrolled: Click here to enter 
text.
☒  I will be targeting non-English speaking adults
1. Describe the process to ensure that the oral and written information provided to those 
research participants will be in that language during initial consent as well as throughout 
the study. Study, intervention, and communicative documents have been translated from 
the English version to Spanish by a professional translation service and checked by 
research assistants that are fluent/native in both English and Spanish languages. When 
available, we use validated translations of scales; for those scales that are not validated, 
we use forward and back translation with at least two study team members fluent in 
Spanish. Qualitative interviews will also be translated by a professional translation team 
(ASTA USA). Interventionists responsible for delivering the Spanish version of 
CONFIDENCE at the USC Family Caregiver Support Center are fluent in Spanish. Study 
team members who conduct enrollment of participants and review the consent process 
will also be native Spanish speakers. Three RAs have been hired to ensure sufficient 
coverage for this,
2. List the language(s) other than English that will be targeted: Spanish  
☐  I am not targeting non-English speaking individuals. If a non-English speaking individual is 
eligible for the study, we will use the following procedures to enroll: 
1. Describe the process to ensure that the oral and written information provided to those 
research participants will be in that language during initial consent as well as throughout 
the study. Click here to enter text.
2. List the language(s) other than English that will be targeted: Click here to enter text.
Adults Unable to Consent
☒  I am not enrolling adults unable to consent in this research study – please leave the rest of 
this section blank.
☐  There is an anticipated direct benefit to the subject. Explain: Click here to enter text.

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☐  There is NOT an anticipated direct benefit to the subject. Explain: Click here to enter 
text.
1. Describe the process to determine whether an individual is capable of consent. Click here 
to enter text.
2. List the individuals from whom permission will be obtained in order of priority (e.g. 
durable power of attorney for health care, court appointed guardian for health care 
decisions, spouse, and adult child). Click here to enter text.
3. For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective 
subject to their participation in the procedure(s) involved in the research. Click here to 
enter text.
☐ N/A  
4. Describe the process for assent of the research participants. Indicate:

Which subjects that are unable to consent will be required to give assent? If not all, 
explain why. Click here to enter text.

Describe whether assent of the research participants will be documented and the 
process to document assent. Click here to enter text.
☐  The subject will be informed about the research to the extent compatible with the 
subject’s understanding.
☐   Subjects will be closely monitored.
☐  The subject will be withdrawn if they appear unduly distressed.
Research Participants Who Are Not Yet Adults (infants, children, teenagers)
☒  I am not enrolling participants who are not yet adults in this research study. – please leave the 
rest of this section blank
1. Will parental permission be obtained from:
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child
☐  Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the 
care and custody of the child
☐  Requesting a waiver of parental permission
If you are getting parental/guardian permission:
a.
Indicate how you will be documenting the permission:
☐  Signed consent form

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☐  Requesting a waiver of documentation of parental permission
b. Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission. Describe the 
process used to determine these individuals’ authority to consent to each child’s 
participation in research. Click here to enter text.
If a waiver of parental permission is being requested:
a.
Describe how the study is designed for a subject population for which 
parental/guardian permission is not a reasonable requirement to protect the 
subjects, if applicable. Click here to enter text.
b. Describe how the research could not practicably be carried out without the 
waiver of parental permission. Click here to enter text.
c.
Indicate if the subjects will be provided with additional information about the 
study after participation. Click here to enter text.
2.   Will assent be obtained from:
☐  all of the children
☐  some of the children
☐  none of the children
If assent will be obtained from some children, indicate which children will be 
required to assent. Click here to enter text.
If assent will be obtained from none of the children, indicate the rationale. Click here 
to enter text.
When assent of children is obtained, describe how it will be documented. Click here 
to enter text.
3. For children who are pregnant, describe how assent and permission are obtained. Click 
here to enter text.
☐ N/A 
11.0 Sharing of Results with Research Participants
Individual test or research results will be shared with research participants (this is not referring to 
sharing through standard academic channels, e.g., publishing, presentation, etc.):
☐ Yes
☒ No
If yes, describe how the results will be shared. Click here to enter text.
Individual test results will be shared with others (e.g., lab results given to a primary care 
physician):

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☐ Yes
☒ No
If yes, describe with whom and how the results will be shared. Click here to enter text.
12.0 Study Design/Procedures
Directions: 
1) Describe the overall study design (e.g.: single visit, single-blind, double-blind, 
non-randomized, randomized, blood draw, investigational drug, device etc.).
2) Provide a description of all study-related research procedures being performed, 
including the length of time involved. 
3) Include procedures being performed to monitor research participants for safety 
or minimize risks. 
4) Describe the source records including medical or educational records, which will 
be used to collect data about subjects.
5) Include a description of any device being used to collect data (e.g., eye tracker, 
step counter).  If the device itself is being studied, include additional information in 
Section 29.
Overall design. A single-arm pre- and post-test clinical trial of the CONFIDENCE 
intervention will be conducted. This study builds on the original CONFIDENCE study 
(STUDY20221010), but with a modified version of the intervention and minor updates in 
data collection protocols to reduce participant burden. Participation will be offered to any 
caregiver of persons living with dementia nationally who register for the program via the 
USC Family Caregiver Support Center (USC FCSC) Eventbrite. Study participation is 
optional. CONFIDENCE will be delivered in English and Spanish, and participants may 
participate in the study in either language.
Intervention The intervention includes participation in four, 1.5 hour group discussion 
sessions delivered by Family Consultants from the USC Family Caregiver Support 
Center. Zoom sessions will be attended by other caregivers and will feature vignette-style 
videos featuring family caregivers as well as peer-learning activities. Between the 
sessions, caregivers will receive text messages from NeuViCareTM with informational 
tips and reminders to complete practice exercises. They may also choose to interact with 
Keiko, the apps conversational AI assistant that generates responses to questions based 
on sources selected or created by the study team. Caregivers can also participant in a 
monitored community forum, wherein they will be able to communicate with other 
caregivers in the program. Participants will be sent instructions on how to register for the 
NeuViCare App, and will have a dedicated “NeuViCare champion” at the USC FCSC 
who they can turn to if they need additionals support. Total time for intervention 
participation in 8 to 10 hours over 4 weeks.
Recruitment strategy. Caregivers will primarily be recruited from the USC FCSC by 
sending information about CONFIDENCE via email blast, as well as individual email 
invitations and follow-up calls sent to participants who are likely to be eligible for the 
study. The USC FCSC may also advertise this program via social media channels and 
with community partners, as they would any program they offer to the community. 
Caregivers may also learn about the study on the Alzheimer’s Association TrialMatch 

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site.
Enrollment and consenting. Participants who register on Eventbrite and are interested in 
learning about the study will receive up to four calls and emails by a study team member 
to learn more about the study. If interested in participating, eligibility screening and a 
review of the study consent information will be conducted by phone with the PI or a 
trained study team member. (Participants may complete the screening process online, but 
are asked to complete a telephone follow up where they will be asked the screening item 
about the Global Deterioration Scale and other questions they did not respond to.) 
Participants will then be sent an email with a REDCap consent form to review and 
signature. Total enrollment and consenting time is estimated to take up to 1 hour.
Survey administration. Once enrolled, participants will receive the baseline survey up 
to 3 weeks before their first CONFIDENCE session by email, which includes questions 
about spending on out-of-pocket care costs, financial strain, resourcefulness, self-
efficacy, and information about the caregiving context and use of supports. The first 
follow-up survey will be sent mediately post-intervention (i.e., within 1 week). A second 
follow-up survey will be sent two months following intervention completion to 
understand the maintenance of outcomes. We estimate follow up surveys take about 30 to 
45 minutes to complete.
Qualitative interviews. In-depth, open-ended, semi-structured qualitative interviews will 
be conducted with at least 12 participants by phone and/or Zoom, both in Spanish and 
English. Questions will be based on caregiver’s experiences and opinions about their 
participation in CONFIDENCE 2. The interview guide will be based on the seven 
components of the Theoretical Framework of Acceptability. This guide will be previously 
reviewed by an advisory council. Questions about the theory of resourcefulness will be 
also included to better understand its application. Depending on how much participants 
would like to share, we estimate interviews will last 15 minutes to 1 hour. Update 
9/2/2024: The research team may also follow up with caregivers who participated in 
CONFIDENCE but did not enroll in the research study to conduct qualitative interviews. 
The process for these interviews are consistent with those used for caregivers enrolled in 
the parent study. We will use purposeful sampling according to engagement int the 
program (e.g., attended all four sessions). 
NeuViCare Utilization data. Data on app utilization will be available on a dashboard 
viewable to the study team and facilitator on the NeuViCare App. They PI will be able to 
view and record data stored in the secure NeuViCare Google Cloud on a secure 
dashboard using a unique login. Aggregated information on Care Advisory search subject 
will be shared by email; that is, we will not see questions individuals submitted to Keiko. 
Payment. Participants will receive up to $160 for their participation using emailed 
Amazon Gift Cards. They will receive $50 for the baseline survey completion and $50 
and $60 for the first and second follow-up survey, respectively. 

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Fidelity monitoring. Fidelity will be monitored using a form developed for the initial 
CONFIDENCE intervention with additional refinements from talking to interventionists. 
This form will be completed by an observer who views a video recording of selected 
sessions. Questions will be based on adherence to the session agenda, timing, participant 
experience, and quality of delivery. One session per cohort will be randomly selected for 
fidelity monitoring.
Attendance. Attendance to each session will be recorded by facilitators and shared with 
Case Western using a Box folder. The average number of sessions attended by 
participants and the standard deviation will be reported and compared between the 
English and the Spanish sessions. Another comparison, in the form of percentage based 
on the different number of possible sessions to attend, will be made on attendance 
between CONFIDENCE vs CONFIDENCE.
Participant safety monitoring. Confidentiality. All survey data will be de-identified and 
only the PI will have access to the identifier information. NeuViCare user data will be 
tracked using an email address and phone number. Only the PI will have access to the 
study key that will allow link study data to contact information, and will not share this 
with other study team members to prevent breach of privacy. Transient emotional 
distress. If caregivers experience emotional distress while interacting with a study team 
member, they will be referred to resources of self-care, community support and the 
Alzheimer’s Association 24/7 Helpline. Adverse events. All suspected study adverse 
events will be reported using a standardized form in REDCap. These will be tracked and 
monitored by the PI. All study team members will be trained to identify on risk 
management protocols, such as when to immediately contact the PI about a suspected 
adverse event. See the Adverse Event Form.  
13.0 Study Timeline (optional)
14.0 ClinicalTrials.gov Information
Pre-
Screening
Visit 1
Visit 
2
Visit 
3
Six week Follow 
up
Estimated time 
requirement of visit
Data Collection
Study Procedure 1
Study Procedure 2
Study Procedure 3
Phone Call 
Questionnaire

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Directions: If this study has been registered on ClinicalTrials.gov, provide the 
ClinicalTrials.gov identifier and the investigator/sponsor responsible for registering. If this 
study has not been registered on ClinicalTrials.gov, provide the rationale as to why and 
if/when it will be. If it does not meet the requirement for being registered on 
ClinicalTrials.gov, please state that.
 Unique Protocol ID: STUDY20230876. 
15.0 List of Data to be Collected
1. Indicate what identifiers you will collect
☒
Name
☒
Address (e.g., Zip code, other geographical designation, etc.)
☐
Dates related to an individual (e.g., Date of admission, birth, surgery, etc.)
☒
Telephone number
☐
Fax number
☒
Email address
☐
Social security number
☐
Medical record number
☐
Health plan beneficiary number
☐
Account number
☐
Certificate/license number
☐
Any vehicle or other device serial
☐
Device identifiers or serial numbers
☐
Web URL
☐
Internet protocol (IP) address
☒
Finger or voice prints (includes audio recordings)
☒
Photographic images (includes video recordings)
☐
Other: Any characteristic that would uniquely identify the individual
If other, please explain: Click here to enter text.
2. List all other data to be collected for the research study. Attach all data collection tools on 
the Local Site Documents page of the SpartaIRB smart form (Other Attachments). 
Baseline, Follow Up 1, and Follow Up 2 Surveys; Qualitative interviews (recordings 
and transcripts); Utilization of NeuViCare App including logins, completion of 
activities, receipt of text messages, community forum posts, and AI prompts (de-
identified; includes non-study participants); Intervention fidelity, including selected 
CONFIDENCE session recordings; Characteristics of study participants and non-
study participants (USC FCSC Eventbrite registration); intervention attendance; 
Study adverse events; Study retention
16.0 Online Data Collection
☐
We will not collect data through an online platform.

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1.  List the online platform to be used.  The preferred platforms are REDCap and Qualtrics, 
as these provide good data security and have options for collecting data without 
individually identifiable information.
All survey data will be collected through REDCap. Qualitative interview data will be 
collected on an institutional Zoom account and recorded. Eventbrite data will also 
be downloaded on registrants, regardless of study participation. Eventbrite data, 
also collected in the previous CONFIDENCE study, includes information such as 
demographics information to help us understand the characteristics of those who 
participate in the CONFIDENCE program when delivered in a community setting. 
Finally, app utilization data in the NeuViCare program will be stored in a dashboard 
and made accessible to the study team by individual password protected accounts. 
2. If your intent is to collect the data without identifiers linked to an individual (including IP 
addresses), describe how you will ensure that no identifiable information will be 
associated with the data.  
☐ Qualtrics:  enable Anonymize Responses setting (removes IP addresses and 
location data) 
☐ REDCap:  use of the Public Survey Link
☐ REDCap:  use of a Participant List without a Participant Identifier field 
(Note: this does maintain a connection between the data and the individual, but it is only 
accessible to REDCap support personnel and not the researchers.  Data collected in this manner 
should not be referred to as anonymous, but rather as data that is deidentified to the researchers).
☐ Other: Click here to enter text.
17.0 Data Analysis Plan
Directions: Describe the data analysis plan, including any statistical procedures. If 
applicable, provide a power analysis, and study/safety endpoints. 
Outcome measures. Resourcefulness (primary outcome). Resourcefulness skills help family 
caregivers lower material out-of-pocket costs through identification of community resources and 
alternative ways of managing costs. This will be measured using Resourcefulness Scale, a 28-
item scale used to measure potential and social resourcefulness (alpha=0.83; range: 0 to 140). 
Self-efficacy (second primary outcome) is measured using the Caregiver Self-Efficacy Scale. 
This 8-item scale combines domains of self-efficacy (e.g., managing behavioral symptoms, 
accessing respite, and controlling upsetting thoughts. It demonstrates high reliability 
(alpha=0.89) and good test-retest reliability (0.73). Scores range from 8 (lowest) to 80 (highest). 
Financial strain (secondary outcome). Interventions to reduce caregiver financial strain are 
needed across multiple levels, individual-level behavioral interventions are needed given the 
slow pace of policy change to promote caregiver’s financial security. This will be primarily 
measured using the 11-item Comprehensive Score for Financial Toxicity (COST) Scale, which 
has been modified from the cancer field, which demonstrates validity and reliability (a=0.91; 
range: 0 to 44). We will also use a secondary measure of psychological financial strain that was 
used in the initial CONFIDENCE study. (See NCT05292248 for details on this measure.) 
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access to community resources that may reduce the costs of caregiving. We will assess whether 
or not caregiver accessed 1 or more new community resources since beginning CONFIDENCE. 
Outcome Analysis. Scores for resourcefulness, self-efficacy, and financial strain will be 
analyzed using t-test analyses, where we will compare baseline scores to scores from each 
follow-up survey. If there is a p-value <0.05, this indicates that there was a statistically 
significant difference between scores. Mean scores and standard deviation for all scores on each 
scale will be also examined. (We will use descriptive statistics alone to assess whether or not a 
caregiver accessed new resources following program participation.) 
Satisfaction surveys. To analyze Likert responses to satisfaction surveys, a percentage for each 
response will be provided. Each item will be compared to items collected for the initial 
CONFIDENCE study, as well as scores for items of CONFIDENCE between Spanish and 
English intervention.
Attendance. We will report the average number of sessions attended (range 0 to 4) and the 
standard deviation. Comparison on the number of sessions attended will be compared between 
the English and the Spanish sessions as well as between the earlier and current version of 
CONFIDENCE in the form of percentages to allow us to draw preliminary comparisons, given 
the different number of possible sessions to attend (3 vs. 5). The average number of sessions will 
be calculated both with and without accounting for make-up sessions. (i.e., giving credit for 
attendance in Session 1 if the caregiver attended the makeup session for this lesson.)
App Utilization. Usage data from NeuViCareTM Care and Resources Advisors will be reported 
in aggregate Individual-level data will be collected on the average number of text received, 
average interactions on the Community Hub, and average number of practice activities 
completed on NeuViCare.
Fidelity. Fidelity reports will be evaluated using total scores averaged across all CONFIDENCE  
sessions observed. Sub scores will be reported for adherence to the facilitator guide, participant 
experience, and quality of delivery. These will be reported separately for English and Spanish 
participants by using a percentage, as well as means and standards of deviation, to examine 
variability. 
Qualitative interviews. Qualitative interviews will be transcribed verbatim, and for the ones 
conducted in Spanish, they will be previously translated. Transcription and translation of 
interviews conducted in Spanish will be by ASTA-USA. English Transcriptions will be done by 
GMR. A preliminary code book will be developed by at least two research members and will be 
refined prior to applying codes to the remaining interviews. At least two coders will analyze each 
transcript independently and will meet to compare the codes. The second round of coding will be 
conducted to integrate new codes if needed.
18.0 Confidentiality of Data

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1. To maintain the confidentiality of the data:
☒
I will use a unique study identifier to code individuals’ identifiable data and will 
store the master list separate from the study data.
☐
 I will use a unique study identifier to code individuals’ data, but it will never be 
linked to a master list.
☒
Other- please explain: Utilization data collected from the NeuViCare app will be 
manually entered into study survey linked with individual contact information. The PI 
will, using the study key, merge data on app utilization with study data to examine 
“exposure” to the intervention prior to analysis. Aggregate deidentified data about 
questions asked to the conversational AI assistant will be shared by Amicus Brain by 
email. By limiting who has access to utilization data from NeuViCare, reporting 
questions to NeuViCare in aggregate, and storing data in secure locations, we will protect 
participant confidentiality. Caregivers who participate in the CONFIDENCE will be 
notified that their app utilization data will be recorded.
Provide a plan to maintain or destroy identifiers once analysis of identifiable information 
is complete.    All identifiers will be removed by the PI from study data prior to long-term 
storage in an encrypted Box folder. For survey data, this will be done first by 
downloading data in REDCap using the “Remove Identifiers” function, followed by 
visual examination to confirm all variables with identifying information is removed. 
Columns in Eventbrite (e.g., email addresses) will be manually deleted prior to saving. 
The electronic study key will be deleted.
☒  I attest that any recordings (audio or video) saved to a portable device will be 
deleted by formatting the device’s storage memory.
How are you storing your electronic data?
☒CWRU Redcap 
☐CWRU Secure Research Environment (SRE)
☒CWRU Box
☐OnCore
☐CWRU Secure Network Drive
☐Zoom Cloud
☒  Portable device (must be encrypted, not just password protected)
☒Other - List storage method and provide justification: Downloaded data is stored in Box 
on portable devices, rather than in less secure locations (e.g., Documents or Desktop). 
Eventbrite information on program registrations is maintained by USC; USC will share login 
information with the PI so she can manually download data on registrants for analysis to 
reduce the need for data transferring by email. Intervention recordings will be temporarily 
stored in a Case Western’s Box drive with limited access while the study team checks for 
fidelity, and then deleted at the end of this research study. Electronic data on caregiver 
utilization of the NeuViCare app is maintained by Amicus Brain in a HIPAA compliant 
Google Drive Folder. The PI will have access to user data via a dashboard with a unique 

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login. See attached NeuViCare s security information. 
Please note: if you’re storing or entering your electronic data in any system other than an 
approved system listed above, please contact the CWRU IRB (cwru-irb@case.edu).
2.
☐ I acknowledge that paper research data and documents will be stored in a double-
locked secure environment in the following location: Click here to enter text. 
 ☒ We will not have paper research documents.
3. Will data be shared?
☒ Yes 

List the exact data elements that will be shared: De-identified survey data from 
the surveys will be shared, as well as de-identified qualitative interview 
transcripts with investigators at the University of Southern California, led by 
Donna Benton, PhD, who co-developed CONFIDENCE with the PI. The Case 
Western study team will also provide “over the shoulder” (i.e., Zoom share 
screen) access to review de-identified data to other investigators to support 
analyses. Further, screening and enrollment data will be shared with the 
National Institute on Aging, the study’s funder, which requires these data to 
be uploaded as a part of their CROMS requirements on a monthly basis: 
https://www.nia.nih.gov/research/grants-funding/nias-clinical-research-
operations-management-system-croms 
Data sharing with NeuViCare: Identifiable information about participants will 
be shared with the NeuViCare app to administer the CONFIDENCE study. 
With the participant’s consent, we will add their email and phone number to 
register them for the CONFIDENCE app. We will also add their preferred 
topics on financial well-being in order to send tailored text messages. This 
information will be drawn from the baseline survey and Eventbrite 
registration, and will be entered directly into the NeuViCare app. The 
research team will also be able to view the app participant’s completion of 
activities.
Data sharing with USC Family Consultants: In order to administer the 
CONFIDENCE program to caregivers, we will share the names, email 
addresses, and phone numbers of eligible caregivers with the USC Family 
Consultants. Family consultants will receive an affiliate ID at Case Western to 
receive emails about participant information, and to deliver sessions using at 
Case Western HIPAA-compliant Zoom account. Recordings for fidelity 
monitoring and attendance reports will be stored in a Case Western Box 
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
Describe how data will be sent: De-identified data will be shared by email
Contact information to use the app will be entered directly into the 
app
Affiliate accounts will be set up for USC Family Consultants to 
receive names by email, and for them to store recordings and 
attendance information in Boxl
☐ No
☐ N/A  
 If sharing data, please complete a request to ensure the proper contracts/agreements are in 
place:  https://case.edu/research/faculty-staff/technology-transfer/material-transfer-data-use-
agreements
18.0 HIPAA Authorization 
Does this study collect, access, use, or distribute any Protected Health Information (PHI)?  
Protected Health Information (PHI) is (1) any individually identifiable health information transmitted or maintained 
in a medical record, paper or electronic, or (2) designated data set that was created, disclosed, or used in the 
course of providing a health care service such as diagnosis, payment or treatment.
☐  Yes
☒ No
If yes, indicate how HIPAA authorization will be obtained (check all that apply):
☐  HIPAA authorization is in the consent form
☐  I am receiving a Limited Data Set under a Data Use Agreement (DUA)
☐  Requesting a full or partial waiver of HIPAA for prescreening
☐  I will complete the Request for Waiver of HIPAA Authorization form.  See 
SpartaIRB Library
☐  Requesting a full or partial waiver of HIPAA
☐  I will complete the Request for Waiver of HIPAA Authorization form.  See 
SpartaIRB Library
19.0 FERPA Authorization 
Does this study collect, access, use, or distribute any personally identifiable information from 
student records or personal education information from an education program (defined as: any 
program principally engaged in the provision of education, including, but not limited to, early 
childhood education, elementary and secondary education, postsecondary education, special 
education, job training, career and technical education, and adult education)? This includes, but 
is not limited to, classroom assignments and course evaluations.
☐  Yes
☒ No
If yes, how do you plan to get written authorization from the student (or parent if the student is a 
minor)?

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☐  I will incorporate FERPA language* into the consent and obtain written and dated 
signature or authorized electronic signature using REDCap
☐  I will incorporate FERPA language* into a separate form and obtain written and dated 
signature or authorized electronic signature using REDCap
20.0 Risks to Research Participants
1. List the reasonably foreseeable risks such as breach of confidentiality, discomforts, 
hazards, or inconveniences to the research participants related to their participation in the 
research. Include a description of the probability, magnitude, duration, and reversibility 
of the risks. Include the physical psychological, social, legal, and economic risks.
 Breach of confidentiality. This is unlikely to occur, as all the research data collected will 
de de-identified and each participant will be assigned a different ID that only the PI will 
have access to. Emotional distress, such as finding intervention activities and survey 
questions uncomfortable or upsetting is also unlikely but possible. Participants will be 
reminded that participation is voluntary in each moment, and survey questions can be 
chosen to be skipped. Finally, there is a slight possibility that participants would receive 
information that is incorrect for their individual situations while using the NeuViCare 
app. The most likely outcome, if this occurs, is inconvenience, such as applying for a 
financial aid program that is not relevant to the caregiver. It would be unlikely that a 
caregiver would receive information that would harm them financially, given that all 
sources from which the AI responses will be drawn are either hand-picked (e.g., 
Department of Labor’s information on Family Medical Leave) or developed by the 
research team. Further, multiple elder law professionals were involved in generating or 
reviewing intervention materials. However, we include language in the consent form 
notifying participants of this possibility. 
2. If applicable, indicate which experimental procedures may have risks to the research 
participants that are currently unforeseeable. We cannot identify any 
unforeseeable risks to participation
☐ N/A  
3. If applicable, describe the risks to others who are not research participants. Click here to 
enter text.
☒ N/A  
4. Describe the availability of medical or psychological resources that research participants 
might need.  As a part of the CONFIDENCE intervention, participants are 
provided with multiple resources to help with caregiving, including 
information about how to access counseling, support groups, and respite 
care for caregiver stress
☐ N/A  
21.0 Provisions to Protect the Privacy Interests of Research Participants
* FERPA language: 1. Specify the educational records that may be both accessed and used in the research. 2. State 
the purpose of the access and use of records. 3. Identify to whom the records disclosure may be made. 

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Directions: Indicate the measures that will be taken to protect research participants’ 
privacy interests.  Select all that apply:
☐  In person interactions will be conducted in a private space where conversations would not be 
overheard by others -- this could be at a specific location determined by the research team 
or at a location that the participant chooses.
☒  For online/remote data collection, participants will be advised to choose a location that would 
be private.
☐  Researchers will only contact participants if permission has been given to do so.
☒ Other: Participants will be notified both during an initial telephone call, in the consent form, 
and when registering for the NeuViCare app that their information, including inquiries 
submitted to “Keiko” will be stored for the purpose of evaluation. These reminders are 
intended to prevent caregivers from providing personal information they would not wish to 
share when communicating with the AI assistant. Even if this does occur, these entries will be 
reported in aggregate and will not be linked to individual participants. 
22.0 Potential Benefit to Research Participants
☒ There is potential benefit to research participants.
Describe the potential benefits that individual research participants may experience from 
taking part in the research. Include the probability, magnitude, and duration of the 
potential benefits. Do not list compensation. Participants will learn about resources on 
how to reduce caregiving costs (e.g., reduced cost home modifications) and they may 
discuss challenges experienced with other caregivers, which could be therapeutic. 
☐ There is no direct benefit to research participants.
If no direct benefit, state the potential benefit to society or others. Do not list 
compensation. Click here to enter text.
23.0 Withdrawal of Research Participants
Directions: Describe the anticipated circumstances under which research participants will 
be withdrawn from the research without their consent. Also include the procedures that 
will be followed when a research participant withdraws or are withdrawn from the 
research, including partial withdrawal from procedures with continued data collection. 
Participants will be removed from the study if the study team believes the participant is 
fraudulent (e.g., inconsistencies in study information provided), submits surveys that are 
excessively incomplete (e.g., more than 50% of responses are missing), or is no 
longer eligible (e.g., care recipient passes away). Participants will be notified by email if 
they are removed from the study. Participants may continue to participate in the study to 
complete the second follow up survey, even if the first follow up survey is not complete. 
The research team will retain study data for participants who are withdrawn or lost to 
follow up, unless it is specifically requested by the participant that data be removed prior 
to de-identification.
☐ N/A

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24.0 Alternatives to Participation
Directions: List other options to participation.  If subjects will be compensated with extra 
course credit, the course instructor offering extra course credit must provide alternatives 
to earn extra course credit.  The alternative assignment must require equal or less time and 
effort for the same amount of earned extra credit that you can earn through participation 
in research.  If there are other available clinical treatments, what would be included if a 
subject continued on standard of care therapy. If there is a viable alternative you must list 
it in the consent.
 Participants may still participate in the CONFIDENCE program, regardless of 
study participation. 
☐   The alternative is for research subjects not to participate.
25.0 Costs to Research Participants
☐  There are no costs to research participants or their insurance companies (there are no clinical 
visits or billable procedures.) – please leave rest of this section blank 
1. Describe what costs research participants will be responsible for as a result of their 
participation in the research, including but not limited to: clinical services required by the 
protocol deemed billable to insurance, transportation to study visits, parking, costs of drugs, 
cost of therapy, lost broken or stolen devices, etc. Participants, if they choose to receive 
text messages, will be responsible for costs based on applicable charges from their 
carrier. Participants may choose to end text messages at any time.
2. Explain who will be responsible for payment of provided services in the event of insurance 
denials. Not applicable
3. List what procedures, drugs, devices, supplies will be paid by the study sponsor or covered by 
other funding. List the other funding source. None
26.0 Research Participant Compensation
☐  There is no compensation or reimbursement for research participants – please leave rest of 
this section blank
☒  There is compensation for research participants. 
Describe the schedule, payment method, and payment total of any incentives or 
compensation that research participants will receive for participation in the research (e.g., gift 
cards or cash with amount, t-shirts, devices, bags, swag, etc.) Amazon gift cards will be sent to participants by 
email for each study activity (surveys and interviews). We will pay participants for the baseline survey within a week of completion ($50). A second 
payment will be administered within a week of the first follow up survey being completed ($50), and a third payment 1 week after the third follow up 
is complete ($60). Payment for interviews will be sent within 1 week of completing the interview ($25). Participants may earn up to $160 for 
participating, or $185 if they complete the qualitative interview. .
☐  There will be reimbursement for research participants. 
Describe the schedule, payment method, and payment total of any reimbursement that 
research participants will receive for participation in the research (e.g., gift cards or cash with 
amount, etc.) Click here to enter text.

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27.0 Compensation for Research Related Injury
Describe who will pay for the costs of medical treatment and/or compensation in the event of a 
research related injury:
☐  
Funding agency is providing some/all payment for injury
☐  
Funding agency is providing no payment for injury
☒  
N/A 
28.0 Provisions to Monitor the Data to Ensure the Safety of Research 
Participants
1. Describe how often the data will be monitored for completeness, accuracy and adherence 
to the protocol. All baseline and follow up surveys will be visually assessed 
for completeness and unusual responses (e.g., “straight line” 
responses) within 1 week of completion. In addition, the investigator team 
will complete a Data Safety Monitoring Report every 6 months of the study. 
The Data Safety Monitoring Report will include the following core 
elements: a) Progress towards enrollment and participant retention; 2) 
Participant characteristics for enrolled and retained participants (e.g., age, 
race, ethnicity, gender, aspects of the caregiving situation) according to 
intervention status; and 3) Documentation of adverse events, serious 
adverse events, and unanticipated problems, as defined below, including 
resolution of these events and study protocol modifications. Weekly team 
meetings will also provide a time and space to identify and discuss non-
adherence to study protocols. Further, all study incidents will be reported. 
If there is any observation of harm to a participant, this will be reported to 
the IRB and study funder by the PI as soon as possible for serious adverse 
events or within 48 hours, whichever is sooner,
2. Indicate if there will be a Data and Safety Monitoring Board or Committee:
☒
There will not be a formal Data and Safety Monitoring Board/Committee.
☐
There will be a formal Data and Safety Monitoring Board/Committee. 
Provide information about the DSMB/C including the contact information of the committee 
member(s) (as applicable); whether it is independent from the study sponsor; how often it 
meets; the type of data that will be used; written reports, etc. Click here to enter text.
29.0 Additional Information
If you have any additional information regarding your study not covered in the template, please 
include it here. .
30.0 Devices
Does the study include the use of a device that is integral to the study question?

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☐  Yes – Answer the questions below.
☒  No – Leave the rest of this section blank.
☐  There is an active IDE (Investigational Device Exemption) for the proposed study.
Attach an official letter of support or proof of approval which identifies the IDE holder and 
IDE number to the SpartaIRB smartform.
List devices:  Click here to enter text.
☐  The device has obtained a 501k clearance.
Attach 501k documentation to the SpartaIRB smartform.
List devices:  Click here to enter text.
☐  The device meets the criteria for an IDE Exemption.
Download the IDE Exemption Form from the SpartaIRB library (HRP-580) and attach to 
the SpartaIRB smartform.
List devices:  Click here to enter text.
☐  The device (and its use) is a non-significant risk device for the proposed study design.
List devices here and provide the PI’s rationale for the non-significant risk device 
determination. Click here to enter text.
If the research involves device(s), describe your plans to use, store, handle, administer and 
track those device(s) to ensure that they will be used only on research participants and be used 
only by authorized investigators. Click here to enter text.
31.0 Community-Based Participatory Research
☒  
This is not a community-based participatory research project – please leave the rest of 
this section blank
☐
This is a community-based participatory research project
Describe the involvement of the community in the design and conduct of the research. 
Click here to enter text.
 
Note: Community based research is research that is conducted as an equal partnership between 
academic investigators and members of a community. In Community Based Participatory 
Research (CBPR) projects, the community participates fully in all aspects of the research 
process.  
32.0 MULTI-SITE RESEARCH (when CWRU is the IRB of Record)
Does this project have multiple sites?

HRP-
503SBER
TEMPLATE: CWRU SBER Protocol
Approved:
09/2021
Prior Version: 
05/2021
Additional information can be provided in section 29, or added as a comment.
Page 26 of 27
☐  
Yes
☒  
No – please leave the rest of this section blank
Non-Local Site Information for Multi-Site Studies
If this is a multi-site study where you are the lead investigator, list the following information for 
each relying site:
1. Name of site: Click here to enter text.
2. PI of relying site: Click here to enter text.
3. Name of IRB contact: Click here to enter text.
4. Phone number of IRB contact: Click here to enter text.
5. Email address of IRB contact: Click here to enter text.
Non-Local Recruitment Methods for Multi-Site Studies
If this is a multi-site study and research participants will be recruited by methods not under the 
control of the local site (e.g. call centers, national advertisements) describe those methods. 
Local recruitment methods are described above. 
1. Describe when, where, and how potential research participants will be recruited. Click 
here to enter text.
2. Describe the methods that will be used to identify potential research participants. Click 
here to enter text.
3. Describe the materials that will be used to recruit research participants. Click here to 
enter text.
Multi-Site Research Communication Plan (when you are the lead investigator)
If this is a multi-site study where you are the lead investigator, describe the processes to ensure 
communication among sites including:
☐  
All sites will have the most current version of the protocol, consent document, and 
HIPAA authorization     
☐
All required approvals (initial, continuing review and modifications) have been obtained 
at each site (including approval by the site’s IRB of record)    
☐
All modifications have been communicated to sites, and approved (including approval of 
the site’s IRB of record) before the modification is implemented    
☐
All engaged participating sites will safeguard data, including secure transmission of 
data, as required by local information security policies
☐
All engaged participating sites will safeguard data, including secure transmission of 
data, as required by local information security policies     
☐
All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws     
☐
All non-compliance with the study protocol or applicable requirements will be reported 
in accordance with local policy     
If this is a multi-site study where you are the lead investigator, describe the method for 
communicating to engaged participant sites the following: 
1.   Problems: Click here to enter text.     

HRP-
503SBER
TEMPLATE: CWRU SBER Protocol
Approved:
09/2021
Prior Version: 
05/2021
Additional information can be provided in section 29, or added as a comment.
Page 27 of 27
2.   Interim results: Click here to enter text.     
3.   The closure of the study: Click here to enter text.    
33.0 References
Click here to enter text.