All About Me: An Intervention to Ease the Transition to Long-term Care, Build Community, and Improve Quality of Care for Persons With Dementia
Phase: NA
Conditions: Dementia, Alzheimer Disease, Dementia, Vascular, Dementia, Mixed, Dementia of Alzheimer Type
Sponsor: Hopeful Aging

 
 
 
 
 
 
All About Me: An Intervention to Ease the 
Transition to Long-term Care, Build Community, 
and Improve Quality of Care for Persons with 
Dementia 
NCT05516134 
Protocol 
7/27/22 
 
 
 

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1.0 STUDY OVERVIEW 
 
Study Title:  
All About Me: An Intervention to Ease the Transition to Long-term Care, Build Community, and 
Improve Quality of Care for Persons with Dementia 
 
The purpose of this study is to develop and test the All About Me (AAM) app, which aims to 
simultaneously assist staff with providing person-centered care and enable persons with dementia 
(PWD) living in long-term care (LTC) to improve relationships with one another and with staff. 
This Phase 1 Small Business Innovation Research (SBIR) grant is focused on proof of concept and 
feasibility of the AAM app.  
 
The AAM app will consist of five main components:  
(1) Fun Facts About Me (FFAM) game, which will provide an enjoyable way for family 
members and LTC residents to provide information about the PWD's personal background, 
interests/hobbies, and care preferences.  
(2) The Resident Game Bundle (RGB), which will consist of games that allow residents to 
learn about one another in an enjoyable way. In the current study, one game—the Survey 
Says Game (similar to Family Feud)—will be developed and tested. 
(3) The My Residents Module (MRM) will provide CGs with a simple way to obtain 
information about PWD with whom they work. 
(4) The AAM Training Modules will consist of two video-based and SCORM compliant 
training modules—one for staff and one for family members. The staff training will cover 
two topics: (1) How to use the AAM App, which will discuss the “nuts and bolts” of using 
all app components; and (2) How to use the MRM info to provide high quality care. The 
family training will be brief and simply explain how to play the FFAM Game. 
(5) The Meet the Staff Module (MSM) will consist of games that allow residents to learn about 
the staff members who work at the community. Please note: this module will be developed 
and tested in a future Phase II project. 
 
The study will be implemented by three teams. The Content Team (CT) will be responsible for 
storyboarding all components of the AAM and creating all activity content. The Software Team 
(ST) will be responsible for software development and graphic design for the AAM App. The 
Experimental Team (ET) will be tasked with all investigatory work. 
 
Focus Groups 
During Stage 1 of the study [Months 1-7], the ET will assemble three Advisory Panels, each of 
which will participate in focus groups to help guide design and development of the AAM app.  
• Advisory Panel #1 will consist of six staff from Hearthstone's Centers of Excellence 
(COEs), including two activity / life enrichment professionals, two nurses, and two CGs. 
• Advisory Panel #2 will consist of six family members of residents at Hearthstone's COEs. 
• Advisory Panel #3 will consist of six LTC residents living with mild dementia. 
 
Inclusion / Exclusion Criteria (For Focus Groups)  
PWD must reside in an ALF or NH, be 60+ years old, speak and read English, be diagnosed with 
dementia (of any type), and score 18+ on the MMSE. Family Members, LTC Staff Members, and 

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Focus Group Staff Members must be 18+ years old and speak and read English. 
 
Quasi-Experiment 
Participants 
During Stage 2 of the study [Months 8-12], the ET will conduct a quasi-experiment, which will 
involve 24 PWD, 24 Family Members (FMs), and 12 staff members. The study will be conducted 
at one Assisted Living Facility (ALF) and one Nursing Home (NH). As such, 12 PWD will reside 
at the ALF and 12 PWD will reside at the NH. Half of the FM (n=12) will be associated with 
residents at the ALF and the other half (n=12) with residents at the NH. Finally, half of the staff 
(n=6) will work at the ALF and the other half (n=6) at the NH. Staff members will not have 
previously participated in the focus groups. However, some of the PWD participating in the quasi-
experiment may have previously participated in the focus groups.  
 
Inclusion / Exclusion Criteria (For Quasi-Experiment)  
PWD must reside in an ALF or NH, be 60+ years old, speak and read English, be diagnosed with 
dementia (of any type), and score at least eight on the MMSE. Family Members, LTC Staff 
Members, and Focus Group Staff Members must be 18+ years old and speak and read English. 
 
Baseline Period/Measures 
PWD: The following data will be collected via chart review: demographics, medications, 
diagnoses (including type of dementia), and primary language. In addition, the MMSE48 and 
the Dementia Quality of Life Scale (DEMQOL)50 will be administered via direct interview. 
The Neuropsychiatric Inventory-Nursing Home (NPI-NH),51,52 done via staff interview, will 
be used to collect data on challenging behaviors. PWD will also be observed taking part in 
standard activities using the Menorah Park Engagement Scale (MPES).53 MPES data for 
standard activities will allow us to conduct a robust comparison to the RGB/Survey Says Game. 
Family Members and LTC Staff Members: researchers will interview family members to 
obtain demographics.  
 
Intervention Period/Measures 
During the first month of the intervention period, family members will play the FFAM Game with 
their loved one on an Android tablet. We expect the game to take 60 minutes to complete, but we 
will encourage family members to split up the game into two 30-minute sessions. The app will 
automatically capture data about how many questions/items were completed and the length of 
time to complete the game. In addition, after playing the FFAM Game, family members and PWD 
will be asked questions related to ease of use and satisfaction.  
 
During the second month of the intervention period, PWD will play the GB/Survey Says Game twice 
per week for four weeks. The game will be played on an Android tablet, which will be connected 
to a large screen TV. After each Survey Says Game session, PWD and Staff Members will be 
asked questions related to ease of use and satisfaction. During this same time period, LTC staff 
members will use the MRM daily when working with PWD. Each staff member will be given an 
Android smartphone and they will be encouraged to briefly review information about PWD 
before interacting with and/or providing care to them. At the end of this time period, staff will be 
asked questions related to ease of use and satisfaction for the MRM (e.g., Did you find it easy to 
use? Would you recommend it to others? Did it help you provide better care? 

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Treatment Fidelity/Process Measures 
In the backend of the app, a variety of treatment fidelity/process measures will automatically be 
collected by the app, including dates/times each participant used the app, length of time for each 
session; number of buttons pressed in each activity, and dates/times of any crashes. 
 
Post-Treatment/Distal Measures:  
PWD: The DEMQOL and NPI-NH will be re-administered. Family Members: No post-treatment 
measures will be taken. LTC Staff Members: No post-treatment measures will be taken. 
 
Please note that, since the purpose of a Phase I SBIR is to demonstrate proof of concept and 
feasibility, and since the intervention period will be relatively brief, changes are not expected 
from baseline to post-treatment on longer-term measures (i.e., the  DEMQOL and NPI-NH). 
These measures are being used in Phase I exclusively to obtain means and standard deviations to 
conduct a power analysis to ensure that a sufficiently sized sample is used in Phase II SBIR. 
 
Statistical Analyses:  
The AAM App will be considered successful if the following results are found: (1) at least 85% 
of participants complete 85% of the FFAM Game; (2) mean completion time for the FFAM Game 
is 45-75 minutes; (3) at least 85% of family members and PWD are satisfied with the FFAM 
Game and find it easy to use; (4) for PWD, levels of positive engagement/affect are higher, and 
levels of negative engagement are lower, during the Survey Says Game, as compared to standard 
programming (based upon a paired sample t-test); with the proposed sample size, and using 
means and standard deviations from the previous studies by the PI, we will have a power of 93% 
to detect effects (alpha = .05; one-tailed test). (5) at least 85% of PWD and LTC staff members 
are satisfied with the Survey Says Game and find it easy to use; and (6) at least 85% of LTC staff 
members are satisfied with the My Resident Module and find it easy to use. 
 
 
 

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2.0 STUDY ORGANIZATION AND RESPONSIBILITIES 
 
REDACTED FOR PRIVACY 
 

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3.0 STUDY FLOW  
 
Figure 1a: Study Flow Diagram for PWD Participating in Focus Groups 
 
 
 
 
Legally Authorized Representative or PWD 
Signs Informed Consent Form 
Initial Screening Via Staff-Confirmation of 
Eligibility Criteria and/or Chart Review 
PWD Signs Assent Form  
& Researcher Conducts MMSE  
PWD Entered into Screening Log 
 
Indicate Reason 
on Screening 
Log 
STOP 
Focus Group Participation 
(3 sessions over the course of six months) 
NO 
Eligible 
for Study? 
YES 

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Figure 1b: Study Flow Diagram for Staff Members and Family Members Participating in 
Focus Groups 
 
 
 
Staff Member / Family Member  
Signs Informed Consent Form 
Screening Via Direct Interview 
 
Indicate Reason 
on Screening 
Log 
STOP 
Focus Group Participation 
(3 sessions over the course of six months) 
NO 
YES 
Eligible 
for Study? 
NO 
YES 

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Figure 2a: Study Flow Diagram for PWD Enrolled in Quasi-Experiment 
 
 
 
 
Legally Authorized Representative or PWD 
Signs Informed Consent Form 
Initial Screening Via Staff-Confirmation of 
Eligibility Criteria and/or Chart Review 
PWD Signs Assent Form  
& Researcher Conducts MMSE  
PWD Entered into Screening Log 
 
Baseline Assessment / Observations / 
Caregiver Interviews 
Indicate Reason 
on Screening 
Log 
STOP 
Intervention Period Data Collection 
Month 1: Play FFAM with FM 
Month 2: Play RGB / Survey Says twice per week 
Post-Treatment Assessments /  
Caregiver Interviews 
NO 
YES 
PWD 
Eligible 
for Study? 

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Figure 2b: Study Flow Diagram for Family Members Enrolled in Quasi-Experiment 
 
 
 
 
Staff Member / Family Member  
Signs Informed Consent Form 
Screening Via Direct Interview 
 
Indicate Reason 
on Screening 
Log 
STOP 
Baseline Data Collection 
(Demographics) 
Eligible 
for Study? 
NO 
YES 
Intervention Period Data Collection 
Month 1: Play FFAM with Loved One (PWD) 

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Figure 2b: Study Flow Diagram for Staff Members Enrolled in Quasi-Experiment 
 
 
 
 
Staff Member / Family Member  
Signs Informed Consent Form 
Screening Via Direct Interview 
 
Indicate Reason 
on Screening 
Log 
STOP 
Baseline Data Collection 
(Demographics) 
Eligible 
for Study? 
NO 
YES 
Intervention Period Data Collection 
Month 1: Hiatus 
Month 2: Observe RGB Sessions & Use MRM / 
(Provide Feedback) 

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4.0 INFORMED CONSENT  
 
PWD 
Prior to recruitment of PWD, staff at the ALF / NH participating in the study will inform us 
whether any PWD at their community provide consent form their own medical decisions. The staff 
will make this determination by reviewing documentation PWD records. If any PWD do provide 
their own consent, then we will obtain consent directly from the PWD by speaking to him/her 
directly and reviewing the full consent form. For other PWD (usually the majority of PWD living 
in LTC), we will follow our standard protocol of contacting legally authorized representatives. 
That is, recruitment packets will be mailed to persons responsible for the medical decisions of all 
PWD. Included in the recruitment packet will be a cover letter, a study flyer, two copies of the 
consent form (one copy to be signed and returned, and one copy to be retained for the person’s 
records), and a self-addressed/postage-paid envelope. The cover letter, consent form, and flyer will 
have phone numbers, addresses, and email addresses for the PI and the designated IRB. The person 
will be invited to contact any of these individuals if he/she has any questions. The consent form 
will include detailed information about what participation in the study entails for PWD. It will also 
list all of the potential risks of the study and ways in which researchers will be protecting against 
the risks. Potential benefits will also be described. In all recruitment materials, it will be made 
clear that participation in this study is voluntary, and that participants can stop participating at any 
time, for any reason. For those who do not wish to take part in the study, currently provided 
services will continue to be made available. Also, it will be made clear that even if a Legally 
Authorized Representative (LAR) provides consent for the study, the resident himself/herself can 
still decide whether or not he/she wants to take part in the study (through the assent process, 
described next). Once a consent form is received by researchers via mail or electronically, an ID 
number will be assigned to the participant. Researchers will determine whether the participant 
meets basic eligibility criteria (which is defined in more detail below). If the PWD meets the basic 
eligibility criteria, a researcher will speak with the participant about the study and provide the 
person with an assent form. The assent form will be a simpler and shorter version of the consent 
form, with large, easy to read font. The researcher will answer any questions that the resident might 
have, and then ask the resident if he/she is interested in participating in the study. If so, the resident 
will sign the assent form (or verbally indicate that he/she is willing to participate, if he/she cannot 
sign his/her name). The researcher will then administer the MMSE and to determine final 
eligibility for the study. Copies of signed consent and assent forms will be placed in their digital 
file folders. 
 
LEFT OFF HERE 
 
Copies of the study flyer, Family Member/LAR consent form, and assent form are included in the 
Appendix. 
 
SPs 
Researchers will initially provide a verbal summary of the study (either in person or via telephone). 
If the staff member seems interested in participating based upon the verbal summary, a consent 
form will be provided to the person. The consent form will provide detailed information about the 
study, including what taking part in the study entails, risks, protection against risks, and potential 
benefits. The SPs will be encouraged to speak to researchers with questions. If the staff member 
YES 

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decides to enroll, he/she will sign the form and return it to researchers. Please note: staff members 
will be invited to participate in the study by researchers, not by their supervisors or other staff at 
the facility. This should help to prevent staff members from feeling that they are expected—and/or 
are being coerced—to participate in the study. Furthermore, the consent form will clearly state that 
a staff member’s decision to participate or not participate in the study will in no way affect their 
employment at the facility. After an SP provides their signed consent form to a researcher, an ID 
number will be assigned to the SP. Copies of signed consent forms will be provided to SPs and 
placed in their digital file folders. 
 
A copy of the Staff Member consent form is included in the Appendix. 
 
4.1 HIPAA Authorization 
PWD 
Included with the consent packet will be a HIPAA authorization form, which will inform the LAR 
that researchers will collect the PWD's protected health information (PHI) for use in this study, as 
specified in the consent form. The researcher will ask the LAR to please review and sign the 
HIPAA authorization form to allow the study team to access the PWD’s PHI. Participant 
information will only be accessed as needed to collect study-relevant data, including the following: 
diagnoses, medications, psychological test results, medical history, and demographics such as age, 
race/ethnicity, date of birth, sex, and education level. 
 
Any electronic protected health information (ePHI) collected on human subjects will be 
transmitted to, stored by, and accessed, via a HIPAA-compliant secure cloud provider. Such 
services secure the data while in transmission from the local machine to the servers and have high-
level encryption in place to secure the data once it has arrived. The system ultimately chosen will 
have been certified as HIPAA-compliant and have all possible modern safeguards, including but 
not limited to encryption, high-strength passwords, firewalls, intrusion detection, virus protection, 
audit trails, provision of a Business Associate Agreement (BAA), and secure off-site backup. 
 
A copy of the HIPAA authorization form is included in the Appendix (it is part of the overall 
consent form). 
 
SPs 
HIPAA authorization will not be required for SPs, as PHI will not be collected. 
 
5.0 RECRUITMENT AND RETENTION 
 
5.1 Participant Recruitment 
PWD 
The PI will speak to the administrator or other staff at the NH or ALF and ask that they send 
recruitment packets to the legally authorized representatives (LARs) of all residents who have a 
dementia diagnosis. Included in the recruitment packet will be a cover letter, a study flyer, two 
copies of the consent form (one copy to be signed and returned, and one copy to be retained for 
the person’s records), and a self-addressed/postage-paid envelope. The cover letter, consent form, 
and flyer will have phone numbers, addresses, and email addresses for the PI and the designated 
IRB. The LAR will be invited to contact any of these individuals if he/she has any questions. The 

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consent form will include detailed information about what participation in the study entails for 
PWDs. It will also list all the potential risks of the study and ways in which researchers will be 
protecting against the risks. Potential benefits of the study will also be described. In all recruitment 
materials, it will be made clear that participation in this study is voluntary, and that participants 
can stop participating at any time, for any reason. For those who do not wish to take part in the 
study, currently provided services will continue to be made available. Also, it will be made clear 
to LARs of potential participants that residents will still have a choice as to whether they want to 
take part in the study. That is, even if a LAR provides consent for the study, the resident 
himself/herself can still decide whether or not he/she wants to take part in the study (through the 
assent process, described next). Once a consent form is received by researchers via mail or 
electronically, an ID number will be assigned to the participant. Researchers will determine 
whether the participant meets basic eligibility criteria (which is defined in more detail below) by 
contacting site-staff and/or conducting a chart review. If the PWD meets the basic eligibility 
criteria, a researcher will then speak with the participant about the study and provide the resident 
with an assent form. The assent form will be a simpler and shorter version of the consent form, 
with large, easy to read font. The researcher will answer any questions that the resident might have, 
and then ask the resident if he/she is interested in participating in the study. If so, the resident will 
sign the assent form (or verbally indicate that he/she is willing to participate, if he/she cannot sign 
his/her name). The researcher will then administer the MMSE and, if needed, the ISH-SI-PV to 
determine final eligibility for the study (details about how these measures determine eligibility are 
included below.) Note: a copy of the full consent form will also be available to the resident in case 
he/she would like to review the full consent form. Copies of signed consent and assent forms will 
be placed in their digital file folders. 
 
SPs 
Researchers will initially provide a verbal summary of the study (either in person or via telephone). 
If the staff member seems interested in participating based upon the verbal summary, a consent 
form will be provided to them. The consent form will provide detailed information about the study, 
including what taking part in the study entails, risks, protection against risks, and potential benefits. 
The staff will be encouraged to speak to researchers with questions. If the staff member decides to 
enroll, he/she will sign the form and return it to researchers. Please note: Nursing Assistants, 
Activity Staff, and other staff members will be invited to participate in the study by researchers, 
not by their supervisors or other staff at the facility. This should help to prevent staff from feeling 
that they are expected—and/or are being coerced—to participate in the study. Furthermore, the 
consent form will clearly state that a staff member’s decision to participate or not participate in the 
study will in no way affect their employment at the facility. Copies of signed consent forms will 
be provided to SPs and placed in their files. 
 
5.2 Participant Retention  
Research staff will be in regular contact with SPs and PWD to assist in any way possible to lessen 
burden and make the experience of participating in the study as easy as possible. We will also 
provide contact information to participants so that they can discuss any issues with the PI at any 
point. Please note: we will oversample to accommodate a reasonable level of attrition. In the event 
that a participant is unavailable or refuses to participate in portions of the study, the PI and/or 
Experimental Team Leader will speak to the participant.  
 

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6.0 SCREENING AND ELIGIBILITY CRITERIA  
 
6.1 Screening  
The following screening procedures will be used for each type of participant: 
 
PWD 
 
INITIAL ELIGIBILITY 
A researcher will confirm the following information with staff at the community and/or conduct a 
chart review to determine initial eligibility (i.e. the PWD meets the following inclusion / exclusion 
criteria): 
a. He/she is age 55+ 
b. He/she is able to read and speak English 
c. He/she is diagnosed with dementia (of any type) 
d. He/she does NOT show signs of rapid cognitive decline or physical deterioration 
over the last 6 months 
i. 
He/she is NOT bed confined. 
ii. 
He/she is NOT completely unable to communicate verbally. 
iii. 
He/she is NOT cognitively and/or physically impaired to such a point that 
they are unable to participate in group activities.  
iv. 
He/she is NOT actively dying.  
v. 
His/her health is NOT declining so rapidly that they are going to be unable 
participate in group activities in next week. 
 
For efficiency, in most cases, confirmation of eligibility will be obtained for all residents at a given 
site at the same time collected via a table that will be sent to site-staff (see screenshot of this table 
in the Appendix). Data from the form will then be entered individually for each PWD into the PWD 
Initial Screening / Inclusion Form. Information from this table will be de-identified (names 
redacted, ID#s inserted) and data will be saved in a folder called “Raw DataàBulk Dataà[Site 
Name].” Data from the table will then be entered individually for each PWD into the PWD Initial 
Screening / Inclusion Form.  
 
FINAL ELIGIBILITY 
If the PWD meets the initial inclusion criteria, a researcher will meet directly with the PWD and 
ask him/her to sign the assent form. If the PWD signs the assent form, the researcher will continue 
to interview him/her and determine final eligibility by administering the MMSE (described in 
detail below) and, if needed, the ISH-SI-PV (described in detail below). 
• If the PWD scores at least 5 on the MMSE, he/she is eligible to be an RP in the study. 
• If the PWD scores below 5 on the MMSE, the researcher will administer the ISH-SI-PV 
o If the PWD scores at least 1 on the ISH-SI-PV, he/she is eligible for the study 
• If the PWD scores at least 13 on the MMSE, he/she is eligible to be an RL in the study.  
o Final determination as to whether the PWD is appropriate to be an RL will be 
determined by administering the PEER Leader Assessment. In order to be eligible 
to be an RL, the PWD must perform adequately on the PEER Leader Assessment. 
 
 

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SPs 
 
A researcher will ask the SP to complete a form to determine whether the SP meets the 
following criteria: 
a. He/she is age 18+ 
b. He/she is able to read and speak English 
c. He/she does not solely work third-shift 
 
6.2 Screening Log 
After completing the screening process, the researcher will enter data into the Screening Log. The 
Screening Log will be digital in nature (a spreadsheet) and include all relevant screening data (as 
listed above).  
 
A screenshot of the study’s Screening Log with sample data entered is included in the Appendix.  
 
6.3 Eligibility Criteria 
 
Inclusion Criteria 
 
PWD 
PWD will be eligible if they meet the criteria listed in section 6.1 (see PWD subsection). 
 
SPs 
Staff will be eligible if they meet the criteria listed in section 6.1 (see SPs subsection). 
 
 
7.0 STUDY INTERVENTION  
 
Description of the PEER App 
 
PEER will be the first product and app that will enable persons with early stage dementia (PESD) 
to lead seven different types of Montessori activities for other PWD. While leaders and participants 
will ostensibly view PEER as a set of enjoyable activities, it will actually be an evidence-based 
intervention aimed at reducing responsive behaviors in PWD and enabling PESD to fill meaningful 
social roles. As an innovative peer support intervention, PEER aims to maximize the abilities of 
PWD and give meaning to their lives. The primary user of the app will be PWD in LTC, so the 
primary purchaser will be activity professionals and other LTC staff. A secondary target will be 
PWD attending adult day centers (ADCs). 
 
The seven types of PEER activities that will be included in the market-ready version of the product 
are (1) Hearthside Book Club® (HBC), (2) Lingo Bingo (LB), (3) Sort It Out (SIO), (4) Critic’s 
Corner (CC), (5) Quote Vote (QV), and (6) DiscussIT. 
 
The PEER App will have three modes. Each mode will be used by different people and serve a 
different purpose. 
 

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(1) Admin Mode will be used exclusively by staff. The purpose of this mode will be to provide 
staff with tools for successfully selecting RLs and Resident-Players (RPs) and training RLs. The 
Admin Mode will consist of the PEER Leader Assessment and PEER Training Resources. The 
PEER Leader Assessment will be used to determine the extent to which a PWD would be a 
successful leader. PEER Training Resources will consist of PDF versions of training materials. 
 
(2) Leader Mode will be used exclusively by RLs and provide them with all instructions and leader 
versions of activities needed to facilitate activities. Details are provided below. Safeguards in the 
app will prevent RPs from entering this mode. 
 
(3) Player Mode will be used exclusively by RPs; the purpose of this mode is to provide the activity 
materials needed for RPs to take part in activities led by a PESD. Details are provided below.  
 
Leader Selection. In past research, we found that selecting an appropriate leader is an important 
component of successfully implementing resident-led programming. The PEER training will 
describe the key characteristics of a successful leader and also teach staff members how to 
implement the PEER Leader Assessment. After completing the training, staff will have the 
knowledge needed to identify appropriate RLs.  
 

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PEER Activity Setup. The activity is set up with five RPs and one RL seated around a table. This 
setup was successfully used in Phase 1 and is 
rooted in Montessori Activity Programming. 
Groups of different sizes can certainly be used, 
but past research this size is optimal. Staff 
members prepare the tablets prior to the 
beginning of PEER sessions by opening the 
PEER app on each tablet, selecting leader mode 
on one tablet and player mode on the others, 
selecting the activity type for that day (e.g., 
“Hearthside Book Club®”), and placing the 
tablets on the table. Ideally, each tablet will be 
placed on a tablet stand, to ensure that the tablet 
is at an appropriate viewing angle. In addition, if 
the staff member overseeing PEER knows that 
residents at his/her community have difficulty 
tapping the screen of the tablet, an adaptive 
switch is also be placed in front of the tablets. We 
found that an adaptive switch is helpful for 
participants who are frail, in the advanced stages 
of dementia, and/or having trouble pressing the 
tablet’s screen with the fleshy part of their finger. 
While we purposefully limit the number of times 
RPs need to press a button on the screen, the 
switch was a very helpful for those limited times 
when they were asked to press the screen. 
 
Starting a PEER Activity. Since a staff member 
prepares the tablets ahead of time, when the 
residents arrive, the activity type for that day has 
already been chosen. As shown in Figures 1a-1d, 
the four starting screens on all activities are 
basically the same. As shown in Figure 1a, the 
first screen on the RL’s tablet reads, “Say, 
‘Welcome to [insert name of activity],’” while 
the RPs’ tablets read, “Welcome to [insert name 
of activity.]” (Please note: italicized text, which 
is also yellow in the app, represents instructions 
for the RL, while all other text, which is white, 
represents words that should actually be read 
aloud.) As shown in Figure 1b, the second screen on the RL’s tablet reads, “Say, ‘My name is 
[insert name of leader]. What is your name?’ Give everyone a chance to say their name,” while 
the RPs’ tablets say, “Say your name out loud when asked.” As shown in Figure 1c, the third screen 
on the RL’s tablet reads, “Say, ‘Please tap the topic you would like to discuss today.’ Give everyone 
a chance to vote.’ While the RPs’ tablets read, “Please tap the topic you would like to discuss 
today.’ The RPs’ screens also display two large buttons with the topics for that day. These two 
 
Figures 1a-1d. First four screens for RL & RPs 

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topics are either randomly chosen by the app (in which case the app excludes recently-used topics) 
or pre-chosen by the staff member (an option that is helpful when the activity staff member is 
facilitating theme-based programming). RPs cast their votes by pressing the on-screen button with 
the topic of their choice. Alternatively, if adaptive switches are being used, RPs can press a color-
coded adaptive button—i.e., they can choose the topic on the left side (with a white border) by 
pressing the left/white button, or they can choose the topic on the right side (with a yellow border) 
by pressing the right/yellow button. As shown in Figure 1d, once an RP has chosen his/her 
preferred topic, the tablet proceeds to a fourth screen that reads, “Thank you for voting!” After 
RPs cast their votes, results are sent to the RL’s tablet. As shown in Figure 1d, the RL’s screen 
automatically proceeds to a screen that reads, “Say, ‘Most people chose [insert topic with most 
votes.] Let’s begin!’” The RL then presses the NEXT button and the activity with the most votes 
begins. (Please note: if an RP fails to vote, results are presented to the RL after a predetermined 
length of time.) 
 
Please note: in most cases, the RL is the only person who needs to tap the screen to proceed from 
one screen to the next. That is, when the RL presses the NEXT button to get to a new screen, the 
RPs’ tablets automatically proceed to the next screen. One exception to this general rule is when 
the RPs’ are asked to vote for a topic. In this case, RPs are, in fact, expected to tap the screen (or 
adaptive switch). However, it is important to note that, even in cases where RPs are asked to tap 
the screen, if an RP fails to do so, he/she is still able to proceed with the activity, as the app 
automatically moves them along to the next step at the right time. This functionality is made 
possible through the use of WebSockets.  
 
In the next section, descriptions of the seven PEER activities are provided. For HBC and LB, we 
provide very detailed descriptions of exactly how the PEER version of the activity is implemented. 
These detailed descriptions are provided to demonstrate how carefully we have considered and 
created every single aspect of the app to ensure that RLs and RPs have a successful experience. 
Brief descriptions of the five remaining activities will be provided. Similar approaches (task 
breakdown, leader notes, etc.) are used in all of the PEER activities.  
 
1. Hearthside Book Club® (HBC) is a reading and discussion activity developed and tested by 
Mr. Skrajner [PI] in a Phase 2 SBIR study [5R44AG039907]. Participants take turns reading a 
story that has interesting facts about topics likely to be of interest to older adults. Large (40pt) bold 
font is used to accommodate for vision issues. In addition, the content of each page stands on its 
own, so there is no need to remember information on previous pages. Half of the pages include 
narrative with interesting information. On 25% of the pages, discussion questions that are 
appropriate for PWD are included. The remaining 25% of the pages contain an image along with 
a caption that contains a discussion question.  

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As shown in Figure 2a, in the PEER version, the first HBC-specific screen displays the title page 
for the activity. On the RP’s version of the title page screen, only the title page itself appears. The 
RP’s screen is purposefully very 
simple, as we wish to refrain from 
including extra information, which 
could be distracting to RPs. On the 
RL’s version of the title page screen, 
there are three parts. First, at the top, 
there is a leader prompt (≈10% of the 
screen vertically), which says, “Say, 
‘The title of this story is [insert title of 
HBC story].’” Second, the title page 
itself appears in the middle of the 
screen (≈ 70% of the screen). Third, 
there is a leader prompt at the bottom 
of the screen (≈20% of the screen), 
with a custom discussion question 
related to the title page. For instance, 
for the National Parks story, the 
bottom prompt says, “Say, ‘What do 
you like to do at a park? Enjoy the 
scenery? Walk? People-watch? Other 
things?’” When being trained, the RL 
is encouraged always to begin at the 
top of the screen and proceed 
downward, reading the prompts and 
instructions. So, the RL reads the top 
prompt, looks at the title page, and 
finally reads the bottom prompt. The 
RL then engages the participants in 
discussion about the question. When 
discussion ends, the RL presses the 
NEXT button to continue. As seen in 
Figure 2b, at this point, the second 
HBC-specific screen is displayed, 
which is actually Page 1 of the story. 
The 
RPs’ 
tablets 
automatically 
proceed to the next screen—i.e., they 
do not need to press anything. As was 
the case for the title page, the RPs’ version of this screen simply displays Page 1. The RL’s version 
of this screen again consists of three sections: a top prompt, Page 1 itself, and a bottom prompt. 
As shown in Figure 2c, from this point forward, the top prompt is always “Say, ‘We are on Page 
[insert page number]. Would someone like to read this page?’” If the page simply includes 
narrative, the bottom prompt includes a discussion question—e.g., “Say, ‘Do you think that it was 
a ‘great idea’ to create the National Park system?’” If the page already includes a discussion 
question, the bottom prompt is “Say, ‘Thank you for discussing this with me. We will now go to 
 
Figures 2a-2c. PEER version of HBC for RLs and RPs 

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the next page.’” The same approach is used all remaining pages.  
 
2. Lingo Bingo (LB) is a combination of bingo and trivia. This activity has been developed and 
tested in several NIH-funded studies [R21MH063395, 1R34MH075799, and 5R44AG049579]. 
The PEER version, which is shown in Figures 3a-3d, is facilitated in the following way. After the 
group chooses a topic, each RP is randomly assigned a game board. As shown in Figure 3a, the 
game board fills the bottom 80% of 
each RP’s screen, and consists of a 3 x 
3 matrix, with 9 total squares. The 
middle square is a FREE SPACE; each 
of the other eight squares contain a 
single word. The goal of LB is to 
cover—or more precisely, fill in—all 
of the squares (“blackout bingo”). A 
square is “filled in” when it turns green. 
So, the first person to turn all of the 
squares green is considered the 
“winner.” However, the game is played 
until all RPs have bingo. As shown in 
Figure 3a, when the game boards 
appear on RPs’ screens, the RL’s tablet 
displays the following message, “Say, 
‘Please tap your FREE SPACE’” Give 
everyone a chance to do this.” 
Meanwhile, the RPs screen shows the 
game board, along with the phrase 
“Tap the FREE SPACE” at the top of 
the screen. The RPs tap the FREE 
SPACE on the board, at which time the 
square will be “filled in” (it will turn 
green). If an adaptive switch is being 
used, either button can be pressed to fill 
the FREE SPACE. After the RL gives 
participants time to fill the FREE 
SPACE, he/she presses the NEXT 
button. (Please note: if the RPs fail to fill the FREE SPACE, it is automatically filled when the RL 
advances the game.) 
 
As shown in Figure 3b, after the RL presses the NEXT button, the RP’s screen displays the first 
LB clue in the top 20% of the screen. Each LB clue is a well-known phrase with the final word 
missing (e.g., As cool as a…). Meanwhile, on the RL’s tablet, the following information appears, 
“Say, ‘How would you finish this phrase?’ As cool as a…” The answer does not initially appear 
on the RL’s screen. However, after five seconds—a length of time shown to be appropriate in 
Phase 1— the following phrase appears, “CUCUMBER. Say, “If you have the word CUCUMBER, 
tap it.” RPs are given time to tap the square that contains that word, if it appears on their board. To 
make it easier, RPs can actually press anywhere on the game board to fill the square. If an adaptive 
switch is being used, either button can be pressed to fill the square with the word. If the RP does 
 
Figures 3a-3d. PEER version of LB for RLs and RPs. 

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not have the word that has been called on their game board, but they tap a square, the square briefly 
turns light green and returns to being white after about one second. This gives a dynamic feel to 
the app and was used in Phase 1 with great success. After the RL gives RPs time to press the square 
on their board, the RL presses the NEXT button. At this point, the same basic process occurs for 
the second clue. The game continues in this way until all RPs get bingo. 
 
Once all RPs have covered all their squares, the RL presses the NEXT button. As shown in Figure 
3c, at this point, a transitional statement appears, marking a change in the focus on the activity: 
“Say, ‘Now let’s talk about these sayings.’” While the first half of LB focuses on playing a bingo-
style game, the second half focuses on reminiscence and discussion related to the sayings used in 
the game. After the leader says, “Now let’s talk about these sayings,” he/she presses the NEXT 
button and the first discussion question appears. As shown in Figure 3d, on the RP’s tablets, only 
the discussion question appears—e.g., the screen simply displays the statement, “Do you consider 
yourself ‘as cool as a cucumber?’ Why or why not?” The RL’s tablet displays additional leader 
instructions—e.g., the RL tablet displays: “Say, ‘Do you consider yourself “as cool as a 
cucumber?” Why or why not?’ Give everyone a chance to respond.” After the RL engages the RPs 
in discussion, he/she taps the NEXT button. Then, the next discussion question appears. This basic 
process continues for all remaining discussion questions.  
 
The decision to split the activity into two parts—i.e., the game of bingo first, and then discussion 
and reminiscence—was made after extensive testing in Phase 1. Initially, discussion about each 
clue came immediately after the clue appeared. However, RPs had difficulty alternating between 
playing the game and engaging in discussion—i.e., they got confused about which statements 
made by the RL were clues and which ones were “merely” discussion questions. For this reason, 
the discussion and reminiscence part of the activity was split into a separate, later part of the 
activity.  
 
3. Sort It Out (SIO) is an 
activity in which RPs sort 
words or photos into one of 
two categories. For example, 
as shown in Figure 4, for the 
topic “Pets,” a photo of an 
alligator, along with the 
caption “Alligator” beneath 
the image, might appear. 
Above the image is a prompt 
question that asks: “Would 
this make a good pet?” 
Below 
the 
image, 
two 
choices appear as large buttons—e.g., “No” and “Yes.” SIO was developed and tested in three 
NIH-funded studies. 
 
4. Critic’s Corner (CC) allows participants to discuss famous works of art. It is inspired by more 
than 15 years of experience providing specialized art museum tours to PWD by Dr. Zeisel [Senior 
Research Collaborator], as part of the ARTZ program. In addition, Critic’s Corner was developed 
 
Figure 4. PEER version of SIO for RLs and RPs 

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and tested in Mr. Gorzelle’s [Experimental Team Leader] HOME 4 CARE® study 
[5R44AG049579, Gorzelle PI]. 
 
5. Quote Vote (QV) presents RPs with brief, dementia-appropriate quotes about love, nature, 
family, beauty, etc. RPs vote on whether they like the quote and then discuss it. QV was developed 
and tested in an NIH-funded study. 
 
6. DiscussIT presents participants with an interesting fact, such as “Baseball player Wade Boggs 
ate only chicken on the day of a game.” Participants are then presented with a discussion question 
related to that fact, such as “Could you eat only chicken for an entire day?” 
 
Ending the Activities. In an effort to capitalize on procedural memory (Squire, 2004), all 
activities end the same way. The following message appears on all screens: “Thank you for doing 
this with me. Would you like to do it again some time?”  
 
Description of the Intervention Period in the PEER Study 
 
Sites will be randomized with respect to condition (Control or Experimental) at the beginning of 
the study.  
 
PWD 
 
For PWD at Experimental Sites, at the beginning of the Intervention Period, PEER groups will be 
formed. Each group will consist of one Resident Leader (RL) and five Resident Players (RPs). 
Each RL will serve as a facilitator for a consistent group of RPs. There will be two groups per 
Experimental Site. PWD will be invited to participate in PEER sessions twice per week for 3.5 
months (28 total sessions); each PEER session is expected last about 45 minutes. If PWD or staff 
are unable to attend (e.g., due to illness or a doctor’s appointment), researchers will simply note 
their absence. MPES data will be collected during PEER sessions, as well as Treatment Fidelity / 
Process measures—i.e., Session Observation / Evaluation Forms (described below). Observations 
of the PEER groups will be conducted in person, or via live web-stream as an infection control 
protocol to limit exposure of participants to additional staff. For RLs, we will track the extent to 
which he/she follows each of the key steps needed to implement each activity and the degree of 
SP assistance required. 
 
For PWD at Control Sites, PWD will participate in standard care for 3.5 months. 
 
SPs 
 
SPs’ participation will begin by attending an in-person training on PEER. Prior to and after the 
training, SPs will take a quiz (to examine knowledge transfer). In addition, satisfaction questions 
will be posed to SPs after taking the training.  
 
In addition, researchers will implement the first two PEER sessions with residents while SPs 
observe and assist, allowing site-staff to become more familiar with the app in a real-life setting. 
 

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The knowledge and experience that SPs gain from the training will prepare them to properly 
implement the PEER intervention. To help remind SPs of the key aspects of the training, two 
quick-reference sheets will also be available in the app at the completion of the training modules: 
one quick-reference sheet for the “Setting Up PEER Activity Session” and one quick-reference 
sheet for “10 Tips for ‘Training’ a Resident to Lead PEER Activities.” These quick-reference 
sheets (each of which will be one page) will include key information from the training, stated as 
succinctly and clearly as possible.  
 
We have purposefully decided not to use a long and detailed implementation manual for two main 
reasons. First, the PEER app will guide the SP and RL through each activity step by step, so an 
implementation manual is essentially embedded within the app. Second, in past studies for which 
extensive implementation manuals were given, the manuals were typically ignored by staff. This 
is not surprising, since staff are very busy with primary caregiving and other responsibilities. If 
they need to refer to a lengthy manual, it would be nearly impossible for them to have time to 
implement an intervention. In addition, some staff may have low literacy (especially caregivers) 
and/or speak English as a second language. For such staff, it would likely be difficult to 
comprehend and remember all of the information included in such a detailed manual. 
 
As such, we have found that the best way to ensure staff properly follow an intervention like the 
PEER app is to (a) embed the steps required to implement the intervention into the app itself, (b) 
provide high-quality, interactive training on how to use the intervention, (c) provide an opportunity 
for SPs to observe researchers implementing PEER with residents, and (d) provide quick-reference 
sheets (in this case, one quick-reference sheet for each of the two training modules). 
 
After taking the PEER training and observing researchers facilitating at least two PEER sessions, 
SPs will then enter the Intervention Period. SPs will be invited to participate in PEER sessions 
twice per week for  months (28 total sessions); each PEER session is expected last about 45 
minutes. Activity staff will oversee programming. Other SPs (CNAs, managers, etc.) will observe 
programming so feedback can be elicited. Each activity type will be used at least six times by each 
PEER group. Satisfaction questions will be posed to SPs at the end of each PEER session. After 
the Intervention Period has ended, SPs will also be posed final satisfaction questions. 
 
8.0 STUDY MEASUREMENTS AND PROCEDURES  
 
All measures are included in the Appendix 
 
PWD 
 
Baseline Assessments / Observations 
1. Chart Review Form 
a. A researcher will conduct a CHART REVIEW to collect the following data: 
i. 
Demographics (race/ethnicity, education level, marital status, and number 
of years living in LTC) 
ii. 
All diagnoses 
iii. 
Type of dementia 
iv. 
All meds 

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2. Mini Mental Status Exam (MMSE) 
      A researcher will conduct a direct interview with the PWD to administer the MMSE. 
a. The MMSE is a structured evaluation aimed at evaluating aspects of cognition in 
elderly residents. The MMSE assesses patient attention, level of orientation, and 
ability to recall information. These are the sections of the MMSE assessment:  
i. 
Orientation to Time: temporal orientation is evaluated by asking the 
resident to recall temporary coordinates (current year, season, month, day 
of the week, and date). These are to be asked in separate questions and about 
30 seconds are to be given for response. [TOTAL POSSIBLE POINTS: 5] 
ii. 
Orientation to Place: the resident is asked details of their current location 
(name of the state, county, city, building, and floor of the building). These 
are to be asked in separate questions and about 30 seconds are to be given 
for response. [TOTAL POSSIBLE POINTS: 5] 
iii. 
Registration: the resident is asked to repeat three words that are to be given 
by the assessor. The accuracy of their word reproduction is assessed. Also, 
the resident is informed that they will need to remember the words at a later 
moment during the evaluation. [TOTAL POSSIBLE POINTS: 3] 
iv. 
Attention and Calculation: the resident is asked to subtract 7 from 100, 
and then continue to subtract 7 from each answer (in a series of 5: 93–86–
79–72–65). The accuracy of their calculations is assessed. If the resident 
refuses to perform the series of calculations, the assessor will ask the 
resident to spell the word “WORLD” forward, then backward. Only the 
accuracy of the backward-spelling (per-letter) is assessed. [TOTAL 
POSSIBLE POINTS: 5] 
v. 
Recall: the resident is asked to recall the three words given in the 
Registration stage of the assessment. The accuracy of their recollection of 
all three words is assessed. [TOTAL POSSIBLE POINTS: 3] 
vi. 
Naming: the resident is asked to name two separate items that the assessor 
points to, typically starting with the assessor’s writing implement (assessor 
points to pencil or pen). The second item is typically a wristwatch, but this 
can be substituted if the assessor isn’t wearing a common wristwatch. 
Substituted items must be visually recognizable/familiar, such as a pair of 
eyeglasses, a standard key (to a door), or a simple water bottle. The accuracy 
of the terms/names given to both items by the resident is assessed. [TOTAL 
POSSIBLE POINTS: 2] 
vii. 
Repetition: the resident is asked to repeat an entire phrase to be stated by 
the assessor (“No ifs, ands, or buts.”) The accuracy of the resident’s 
reproduction of the phrase is assessed, with one point given only if each 
word (including pluralization) in the phrase is repeated correctly. [TOTAL 
POSSIBLE POINTS: 1] 
viii. 
Comprehension: the resident is asked to carry out three short tasks within 
a one-sentence instruction: “Take this paper in your right hand, fold it in 
half, and put it on the table (or hand it back to me).” The assessor pauses 
briefly between each task when giving the instruction before handing the 
resident a blank piece of paper. The assessor does not repeat instructions 
once the resident begins the tasks. The resident’s ability to accurately recall 

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and perform each of the three tasks is assessed. [TOTAL POSSIBLE 
POINTS: 3] 
ix. 
Reading: the assessor holds up a piece of paper with the words “CLOSE 
YOUR EYES” largely typed in the center and asks the resident to “Please 
read this and do what it says.” The resident can read the words aloud or to 
themselves, but the point is only given if the resident successfully completes 
the instructed task by closing their eyes. [TOTAL POSSIBLE POINTS: 1] 
x. 
Writing: the resident is provided a pen or pencil and asked to write a 
sentence on a blank piece of paper (the same/unfolded blank paper used in 
the Comprehension stage of the assessment) provided by the assessor. If the 
resident is confused or overwhelmed with the broad instruction, the assessor 
rephrases the instruction with more specificity: “Write a sentence about the 
weather.” Errors in spelling or grammar are ignored, but a point is given 
only if the resident’s written sentence is comprehensible and contains a 
subject and a verb. [TOTAL POSSIBLE POINTS: 1] 
xi. 
Drawing: the resident (still provided with a pen or pencil) is provided with 
a paper showing two intersecting pentagons and asked to reproduce/copy 
the design anywhere on the page’s available space remaining. A point is 
given based on the geometric accuracy of the design (if the resident’s 
drawing consists of two 5-sided figures that intersect to form a 4-sided 
figure). [TOTAL POSSIBLE POINTS: 1] 
b. Each stage of the MMSE consists of one to five separately scored items, with each 
item awarded 1 or 0 points, and a total of 30 items. The higher the score, the lower 
the impairment to the cognitive response. Scores closer to 0 indicate severe 
cognitive impact whilst scores closer to 30 indicate an intact cognitive response. 
i. 
Score Interpretation 
0 – 9 
Severe cognitive impact 
10 – 16 
Moderate impairment 
17 – 30 
Intact cognitive response 
3. I’m Still Here Skills Inventory – PEER Version (ISH-SI-PV)  
a. Please note: the ISH-SI-PV is only administered if the PWD scores below 5 on the 
MMSE) 
b. This assessment asks the participant to read / respond to three pages of information. 
i. 
On the first page, the PWD is asked to read the following aloud: “Today we 
take the telephone for granted. We can pick up the phone and call anywhere 
in the world. This would have seemed like magic to people who lived before 
1876.” 
1. Scoring: 
0 – Unable to Read Aloud 
1 – Able to Read 1 – 3 words aloud (out of 31) 
2 – Able to Read 4 – 25 words aloud (out of 31)  
3 – Able to Read 26 – 31 words aloud (out of 1) 
ii. 
On the second page, there is a photo of an old telephone, along with the 
following text, which the PWD is asked to read aloud: “This is an early 
phone from Sweden. Do you think it would be easy to use?” 
1. Scoring: 

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a. Reading Ability 
0 – Unable to Read Aloud 
1 – Able to Read 1 – 3 words aloud (out of 16) 
2 – Able to Read 4 – 11 words aloud (out of 16)  
3 – Able to Read 12 – 16 words aloud (out of 16) 
b. Ability to Answer Question 
0 – No Response 
1 – Unintelligible Response 
2 – Simple Response (e.g., “yes” or “no” or “not sure” or 
“hard to say”) 
3 – Response with additional details (e.g., “No. I would 
have no idea how to use it…”) 
iii. 
On the final page, there is the question “Do you like this food?” along 
with a photo of Brussel sprouts (with a caption beneath it that reads 
“Brussel Sprouts”) and buttons that say YES and NO. 
1. Scoring: 
a. Reading Ability 
0 – Unable to Read Aloud 
1 – Able to Read 1 – 2 words aloud (out of 5) 
2 – Able to Read 3 – 5 words aloud (out of 5)  
b. Ability to Answer Question 
0 – No Response 
1 – Unintelligible Response 
2 – Simple Response (e.g., “yes” or “no” or “not sure” or 
“hard to say”) 
3 – Response with additional details (e.g., “No. That looks 
gross!”) 
 
iv. 
All items are added together to calculate the Total Score 
1. The score can be interpreted as follows: 
0            = INAPPROPRIATE for PEER Activities (ineligible) 
           
               1 – 3      = POTENTIALLY appropriate for PEER Activities (eligible) 
                                                       4 – 10    = LIKELY to be appropriate for PEER Activities (eligible)  
                                                       11 – 14  = DEFINITELY appropriate for PEER activities (eligible) 
4. Dementia Quality of Life (DEMQOL) 
a. A researcher will conduct a direct interview with the PWD to administer the 
DEMQOL. However, if the PWD is unable to respond to questions on the 
DEMQOL, this measure will be administered via proxy interview (with a staff 
member who is familiar with the PWD). 
b. The DEMQOL is a 28-item self-reported measure related to health-related quality-
of-life (HRQL) in residents with dementia. The DEMQOL takes cognition, 
negative emotion, positive emotion, social relationships, and loneliness into 
consideration. The DEMQOL-Proxy is a 31-item measure administered to the 
staff/caregiver and focuses on cognition, negative emotion, positive emotion, daily 
activities, and appearance. 
i. 
Each item on the DEMQOL (and DEMQOL-Proxy) has four response-
options: 

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Not at all 
A Little 
Quite a Bit 
A Lot 
ii. 
Most items are scored as follows 
Not at all = 4 
A Little = 3 
Quite a Bit = 2 
A Lot = 1 
iii. 
However, since some questions are worded differently, they are reverse 
coded in the following manner: 
Not at all = 1 
A Little = 2 
Quite a Bit = 3 
A Lot = 4 
iv. 
The total possible score on the DEMQOL ranges from 28 – 112, with lower 
scores indicating a lower quality of life. The total possible score on the 
DEMQOL-Proxy ranges from 30 to 120. If a DEMQOL-Proxy is 
administered, the total score is calculated and scaled to fit the same scoring 
range as the DEMQOL. If DEMQOL-Proxy total score = X, then (X/30) x 28 
= DEMQOL (summary/scaled) total score. 
v. 
The final item on the DEMQOL (and DEMQOL-Proxy), asks how the PWD 
would rate his/her overall quality of life. This item has the following options 
and coding: 
Poor = 1 
Fair = 2 
Good = 3 
Very Good = 4 
vi. 
This final item is not included in the total score on the DEMQOL (nor on 
the DEMQOL-Proxy) 
5. Geriatric Depression-Short Form (GDS-SF) 
a. A researcher will conduct a direct interview with the PWD to administer the GDS-
SF. 
b. The GDS-SF is a 15-item self-reported measure of depression in older adults that 
is administered via direct interview. 
i. 
Each item on the GDS-SF has two options: 
YES 
NO 
ii. 
Each YES/NO item is coded with a one or zero depending on the question’s 
positive or negative assumed premises, scoring points for responses 
symptomatic of depression. 
1. Scoring example: Item 1 
a. Are you basically satisfied with your life? 
YES = 0 
NO = 1 
2. Scoring example: Item 4 

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a. Do you often get bored? 
YES = 1 
NO = 0 
iii. 
The total possible score on the GDS-SF ranges from 0 – 15, with higher 
scores indicating signs of depression. 
6. PEER Leader Assessment 
a. A researcher will administer the Leader Assessment by interviewing a resident 
using the assessment form.  
b. The assessment uses various portions of multiple PEER activities to determine the 
ability of a resident to lead an activity. 
7. Neuropsychiatric Inventory-Nursing Home (NPI-NH) 
a. A researcher will administer the NPI-NH by interviewing a proxy (staff/caregiver) 
who is familiar with the PWD. 
b. The NPI-NH is a comprehensive assessment of psychopathology in PWD, focused 
on people residing in nursing homes. The NPI-NH evaluates 12 neuropsychiatric 
symptoms in dementia patients in the nursing home setting, including the 
following: Delusions, Hallucinations, Agitation, Depression / Dysphoria, Anxiety, 
Apathy, Irritability, Euphoria, Disinhibition, Aberrant Motor Behavior, Nighttime 
Behavior, and Appetite / Eating Changes.  
i. 
Each item is initially rated as present or absent. 
ii. 
If the symptom is present, the interviewee is asked to rate the frequency (1 
to 4) and severity (1 to 3) of the symptom for the PWD 
iii. 
A frequency x severity score is then calculated for each item; if a symptom 
is absent, the frequency x severity score is 0. As such, the total possible 
score for each of the twelve symptoms ranges from 0 to 12. 
c. A total score is then calculated across all twelve items 
i. 
The total possible score on the NPI-NH ranges from 0 to 144. 
8. Cohen Mansfield Agitation Inventory (CMAI) 
a. A researcher will administer the CMAI by interviewing a proxy (staff/caregiver) 
who is familiar with the PWD. 
b. The CMAI is a scale intended to systematically assess agitation in long-term care 
residents, including those with dementia. The CMAI consists of 14 items that are 
posed to a proxy (staff/caregiver) pertaining to the PWD based on observed 
behaviors over the past two weeks; for example: “During the past two weeks, did 
the resident display cursing or verbal aggression?” and “Did the resident display 
constant request for attention for help.”  
c. The frequency of each item is rated on a scale of one (behavior never occurs) to 
five (behavior occurs a few times an hour or continuous for a half an hour or more). 
Therefore, total scores on the CMAI can range from 14 to 70, with higher scores 
indicating higher levels of agitation. 
9. Observations of PWD in Standard Activities w/ MPES 
a. Researchers will observe PWD’s engagement and affect during standard, staff-led 
activities using the MPES (Camp, Skrajner, & Gorzelle, 2015). The MPES is an 
observational scale that measures four types of engagement: Constructive 
Engagement: motor/verbal behavior exhibited clearly in response to the target 
activity; Passive Engagement: listening/watching a target activity; Distracted 

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Engagement: motor/verbal behavior exhibited in response to something other than 
the target activity; and Non-Engagement / Apathy: outward signs/indicators of 
apathy, such as sleeping, closing one’s eyes, and staring into space. The MPES also 
measures Pleasure, defined as clearly observable smiling or laughing. Each 
observation period lasts five minutes, with multiple observations conducted for 
each participant. To ensure MPES data provides a robust comparison for treatment 
programming, each participant will be observed multiple times, so that averages 
can be calculated for each type of engagement/affect. 
a. Some residents never attend group activities. As such, obtaining MPES activity 
observations on these participants can be challenging. As such, we will use the 
following policy. 
0. If a person has not been seen in group activities after three visits and/or if 
a staff member has told us the person does not attend group activities, we 
will consider the person a “chronic non-activity attender.” 
1. We will then target this person in particular in future visits. 
2. We will ask staff to invite up to three non-attenders per activity. 
3. If the person attends, we will observe them in the activity. 
4. If they do not attend, we will go to the person’s room during the session 
and find out if they are awake or asleep (knock on the door). 
0. If they are awake, it will be coded as DID OTHER for more than 
half. 
1. If they are asleep, it will be coded as SLEPT/CLOSE EYES for 
more than half.  
b. Please note: all MPES observations will be conducted via a HIPAA compliant 
Google Form. Submitted responses will automatically be sent to a database. As 
such, there will be no need to save a corresponding PDF file in each participant’s 
digital binder for each MPES observation. To prevent changing of data in the 
database, there will be a lock on the database preventing changing of data, except 
by the PI or Experimental Team Leader. Although each MPES observation will not 
have a corresponding PDF file in the participant’s digital binder, a PDF will be 
generated for each observation for auditing purposes. The PDFs will be placed in a 
single folder. MPES observations will be spot checked for accuracy by comparing 
database data to PDF form data.  
 
Intervention Period Data Collection 
1. Treatment Fidelity / Process and Satisfaction Measures  
a. The PWD will be invited to participate in two PEER sessions per week for 3.5 
months (28 total sessions). For each session, a Session Observation / Evaluation 
Form will be completed.  
Session Observation / Evaluation Form 
i. 
The following is a full description of the Session Observation / Evaluation 
Form.  
1. Items that specifically apply to Resident-Leaders (RLs) are preceded 
with RL* 
2. Items that specifically apply to Resident-Players (RPs) are preceded 
with RPs* 

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ii. 
During each session, a two-page Session Observation / Evaluation Form 
will be completed. Since the steps required to lead each activity type differ, 
distinct Session Observation / Evaluation Forms have been created for each 
activity type (e.g., there is a Hearthside Book Club Session Observation / 
Evaluation Form, a Lingo Bingo Session Observation / Evaluation Form, 
etc.) However, certain parts of the form remain the same for all activities, 
as described next.  
1. On the top of PAGE 1 of ALL Session Observation / Evaluation 
Forms, the following data is collected (i.e., these data are 
consistently collected across all activity types): 
a. Date of session 
b. Person filling out form (researcher) 
c. Site 
d. # of Leader Form for the Day 
e. RL*/RPs* # of Residents Attended the Activity (for that 
session) 
f. Topic (or HBC Story) 
g. Session Start Time 
h. Session End Time 
i. Length of Session 
j. Staff ID (site-staff member) 
k. RL* Resident Leader (RL) ID 
l. RPs* Resident Player (RP) IDs (all who attended) 
2. The remainder of PAGE 1 includes items that are unique to each 
activity type; these items track…  
a. RL* the extent to which the Resident Leader (RL) 
completed each step required to facilitate that particular 
activity’ 
i. 
For steps that only occur once (e.g., say your name 
out loud), there are two options: YES and NO. 
ii. 
For steps that occur more than once (e.g., ask 
someone to read the page aloud), there are three 
options : YES, MORE THAN ½ OF THE TIME; 
YES, UP TO ½ OF THE TIME; and NO. 
b. RL*the amount of staff help needed for that step. 
i. 
There are three options: NOT AT ALL, A LITTLE, 
AND A LOT. 
c. To see the exact steps tracked for each activity, see the 
individual forms in the Appendix.  
3. On PAGE 2 of ALL Session Observation / Evaluation Forms, the 
following data is collected (i.e., these data are consistently collected 
across all activity types): 
a. RL* Did the RL use the physical button? (YES / NO / N/A) 
b. RL* If NO TO 16, why not? 
c. RL* How often did the NEXT button work successfully for 
the RL, even if he/she had to try more than once? (whether 

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using the on-screen button or physical button) (NOT AT 
ALL / UP TO ½ / MORE THAN ½ / N/A)  
d. RL* How often did RL have to press more than once to get 
the NEXT button to work? (whether using the on-screen 
button or physical button) (NOT AT ALL / UP TO ½ / 
MORE THAN ½ / N/A) 
e. RL* How often did the STAFF member press the NEXT 
button for the RL? (whether using the on-screen button or 
physical button) (NOT AT ALL / UP TO ½ / MORE THAN 
½ / N/A) 
f. RL* In the researcher’s opinion, did the STAFF member 
assist the RL more than necessary? (Could the staff member 
allow the resident-leader more autonomy/independence in 
leading activity?) (YES / NO / N/A) 
g. RL* How often did the RL have difficulty pressing the 
NEXT button? (whether using the on-screen button or 
physical button) (NOT AT ALL / UP TO ½ / MORE THAN 
½ / N/A) 
h. RL*/RPs* Would you do this again sometime? (tally all 
participants, even if not study) 
i. RL*/RPs* Did you like the activity? (tally all participants, 
even if not study) 
j. RL*/RPs* Would you recommend it to others? (tally all 
participants, even if not study) 
k. RL* How often did the RL read a prompt too soon? (NOT 
AT ALL / UP TO ½ / MORE THAN ½ / N/A) 
l. RL* How often did the RL read a prompt too quickly for 
participants to understand/hear? (NOT AT ALL / UP TO ½ 
/ MORE THAN ½ / N/A) 
m. RL* How often did the RL read a prompt unnecessarily? 
(NOT AT ALL / UP TO ½ / MORE THAN ½ / N/A) 
n. RL* How often did the RL press the next button too soon? 
(NOT AT ALL / UP TO ½ / MORE THAN ½ / N/A) 
o. RL* How often did the RL seem quite confused about what 
to do next? (NOT AT ALL / UP TO ½ / MORE THAN ½ / 
N/A) 
p. STAFF 1. Did STAFF successfully and appropriately set up 
the tablets? (YES / NO / N/A) 
q. STAFF 2. Did STAFF have any difficulty using the special 
table (if applicable)? (YES / NO / N/A) 
r. STAFF 3. Did the STAFF member attach the button to the 
RL tablet? (YES / NO / N/A) 
s. STAFF 4. Did the STAFF member attach the button to the 
RP tablets? (YES / NO / N/A) 
t. STAFF 5. Did you enjoy this activity? (YES / NO / N/A) 
u. STAFF 6. Do you think the residents enjoyed it? (YES / NO 

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/ N/A) 
v. STAFF 7. Would you do it again sometime? (YES / NO / 
N/A) 
w. STAFF 8. Would you recommend it to colleagues? (YES / 
NO / N/A) 
 
2. Observations of PWD in PEER Sessions w/ MPES 
a. Researchers will observe PWD’s engagement and affect during PEER sessions 
using the MPES (Camp, Skrajner, & Gorzelle, 2015). The MPES is described 
above. There are six different types of activities, and each activity type will be used 
at least six times by each PEER group. Each participant will be observed multiple  
times during the intervention period, so that averages can be calculated for each 
type of engagement/affect. 
 
Post-Treatment Assessments 
1. DEMQOL 
a. A researcher will conduct a direct interview with the PWD to administer the 
DEMQOL. However, if the PWD is unable to respond to questions on the 
DEMQOL, this measure will be administered via proxy interview (with a staff 
member who is familiar with the PWD). The DEMQOL is described above. 
2. GDS-SF 
a. A researcher will conduct a direct interview with the PWD to administer the GDS-
SF. The GDS-SF is described above. 
3. NPI-NH 
a. The NPI-NH will be administered by interviewing a staff member who is familiar 
with the PWD. The NPI-NH is described above. 
4. CMAI 
a. The CMAI will be administered by interviewing a staff member who is familiar 
with the PWD. The CMAI is described above. 
 
 
SPs 
 
 
Baseline Assessments 
1. Only the following demographic data will be collected: 
a. Type of community  
b. Age 
c. Gender 
d. Race/ethnicity 
e. Education level 
f. Primary language 
g. Job title 
h. How long at current job 
i. How long worked in elder care / long-term care 
j. How many residents do you work with? 

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Intervention Period Data Collection 
1. PEER Training 
a. The PEER training will be done in person and the topics to be covered include:  
i. 
What is PEER?  
ii. 
Characteristics of a Successful Leader 
iii. 
Using the ISH-SI-PV  
iv. 
Preparing the Environment  
v. 
Preparing the Tablets  
vi. 
Steps to Training a Resident to Lead Activities 
vii. 
Tips for PEER Training and PEER Programming 
2. Pre-Post Quiz for Training 
a. A 15-item quiz will be presented to SPs before and after the training to examine 
knowledge transfer 
3. Satisfaction Questions for PEER Training 
a. Satisfaction questions will be posed to SPs after they take the PEER training 
4. Treatment Fidelity / Process Measures 
b. The SP will be invited to oversee two PEER sessions per week for 3.5 months (28 
total sessions; enough for PWD PEER participants to attend at least six PEER 
sessions for each of the six activity types featured on the PEER app). For each 
session, a Session Observation / Evaluation Form will be completed.  
Session Observation / Evaluation Form 
i. 
The following is a full description of the Session Observation / Evaluation 
Form.  
1. Items that specifically apply to SPs are preceded with SP* 
ii. 
During each session, a two-page Session Observation / Evaluation Form 
will be completed. Since the steps required to lead each activity type differ, 
distinct Session Observation / Evaluation Forms have been created for each 
activity type (e.g., there is a Hearthside Book Club Session Observation / 
Evaluation Form, a Lingo Bingo Session Observation / Evaluation Form, 
etc.) However, certain parts of the form remain the same for all activities, 
as described next.  
1. On the top of PAGE 1 of ALL Session Observation / Evaluation 
Forms, the following data is collected (i.e., these data are 
consistently collected across all activity types): 
a. Date of session 
b. Person filling out form (researcher) 
c. Site 
d. # of Leader Form for the Day 
e. # of Residents Attended the Activity (for that session) 
f. Topic (or HBC Story) 
g. Session Start Time 
h. Session End Time 
i. Length of Session 
j. SP* STAFF ID (site-staff member) 

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k. Resident Leader (RL) ID 
l. Resident Player (RP) IDs (all who attended) 
2. The remainder of PAGE 1 includes items that are unique to each 
activity type; these items track…  
a. the extent to which the Resident Leader (RL) completed each 
step required to facilitate that particular activity’ 
i. 
For steps that only occur once (e.g., say your name 
out loud), there are two options: YES and NO. 
ii. 
For steps that occur more than once (e.g., ask 
someone to read the page aloud), there are three 
options : YES, MORE THAN ½ OF THE TIME; 
YES, UP TO ½ OF THE TIME; and NO. 
b. SP* the amount of staff help needed for that step. 
i. 
There are three options: NOT AT ALL, A LITTLE, 
AND A LOT. 
c. To see the exact steps tracked for each activity, see the 
individual forms in the Appendix.  
3. On PAGE 2 of ALL Session Observation / Evaluation Forms, the 
following data is collected (i.e., these data are consistently collected 
across all activity types): 
a. Did the RL use the physical button? (YES / NO / N/A) 
b. If NO TO 16, why not? 
c. How often did the NEXT button work successfully for the 
RL, even if he/she had to try more than once? (whether using 
the on-screen button or physical button) (NOT AT ALL / UP 
TO ½ / MORE THAN ½ / N/A)  
d. How often did RL have to press more than once to get the 
NEXT button to work? (whether using the on-screen button 
or physical button) (NOT AT ALL / UP TO ½ / MORE 
THAN ½ / N/A) 
e. SP* How often did the STAFF member press the NEXT 
button for the RL? (whether using the on-screen button or 
physical button) (NOT AT ALL / UP TO ½ / MORE THAN 
½ / N/A) 
f. SP* In the researcher’s opinion, did the STAFF member 
assist the RL more than necessary? (Could the staff member 
allow the resident-leader more autonomy/independence in 
leading activity?) (YES / NO / N/A) 
g. How often did the RL have difficulty pressing the NEXT 
button? (whether using the on-screen button or physical 
button) (NOT AT ALL / UP TO ½ / MORE THAN ½ / N/A) 
h. Would you do this again sometime? (tally all participants, 
even if not study) 
i. Did you like the activity? (tally all participants, even if not 
study) 
j. Would you recommend it to others? (tally all participants, 

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even if not study) 
k. How often did the RL read a prompt too soon? (NOT AT 
ALL / UP TO ½ / MORE THAN ½ / N/A) 
l. How often did the RL read a prompt too quickly for 
participants to understand/hear? (NOT AT ALL / UP TO ½ 
/ MORE THAN ½ / N/A) 
m. How often did the RL read a prompt unnecessarily? (NOT 
AT ALL / UP TO ½ / MORE THAN ½ / N/A) 
n. How often did the RL press the next button too soon? (NOT 
AT ALL / UP TO ½ / MORE THAN ½ / N/A) 
o. How often did the RL seem quite confused about what to do 
next? (NOT AT ALL / UP TO ½ / MORE THAN ½ / N/A) 
p. SP* STAFF 1. Did STAFF successfully and appropriately 
set up the tablets? (YES / NO / N/A) 
q. SP* STAFF 2. Did STAFF have any difficulty using the 
special table (if applicable)? (YES / NO / N/A) 
r. SP* STAFF 3. Did the STAFF member attach the button to 
the RL tablet? (YES / NO / N/A) 
s. SP* STAFF 4. Did the STAFF member attach the button to 
the RP tablets? (YES / NO / N/A) 
t. SP* STAFF 5. Did you enjoy this activity? (YES / NO / 
N/A) 
u. SP* STAFF 6. Do you think the residents enjoyed it? (YES 
/ NO / N/A) 
v. SP* STAFF 7. Would you do it again sometime? (YES / NO 
/ N/A) 
w. SP* STAFF 8. Would you recommend it to colleagues? 
(YES / NO / N/A) 
 
 

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9.0 TIMELINE AND VISIT SCHEDULE 
 
PWD Timeline and Visit Schedule 
Assessment / Interview / Data to Collect 
Screening 
Baseline  
Intervention 
Period 
Post-Treatment  
 
Informed Consent Form (Legally Authorized 
Representative) 
X 
 
  
  
Initial Screening (for Basic Criteria) Via Staff Report 
and/or Chart Review (PWD Initial Screening Form)  
X 
 
  
  
Document / Confirm All Diagnoses, Type of 
Dementia, Meds, Demographics (Chart Review Form) 
X 
 
 
 
Initial Enrollment (if person meets basic eligibility 
criteria) 
X 
 
 
 
Assent (Person with Dementia) 
X 
 
 
 
Mini-Mental Status Exam (MMSE) 
X 
 
 
 
I’m Still Here Skills Inventory – PEER Version (ISH-
SI-PV) [if person scores below 5 on MMSE] 
X 
 
 
 
Final Enrollment 
X 
 
  
  
Dementia Quality of Life (DEMQOL)Geriatric 
Depression Scale-Short Form (GDS-SF) 
 
X 
 
 
PEER Leader Assessment (if potential RL) 
 
X 
 
 
Neuropsychiatric Inventory-Nursing Home (NPI-NH) 
 
X 
 
 
Cohen-Mansfield Agitation Inventory (CMAI) 
 
X 
 
 
Observations of PWD in Standard Activities w/ 
Menorah Park Engagement Scale (MPES) 
 
X 
 
 
Session Observation / Evaluation Form (Experimental 
Only) Observations of PWD during PEER activities 
(Experimental) and Standard Activities (Control) 
using the MPES 
  
 
X* 
  
DEMQOL 
   
 
 
X  
GDS-SF 
  
 
 
X 
NPI-NH 
 
 
 
X 
CMAI 
 
 
 
X 
*As noted in the first column of this table, some Intervention Period measures differ between 
Experimental and Control. 
 
 

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SPs Timeline and Visit Schedule 
Assessment / Interview / Data to Collect 
Screening/ 
Baseline 
Intervention Period 
 
Post-Treatment  
 
Informed Consent Form 
X 
  
  
Demographics 
X 
  
  
Enrollment (if eligible) 
X 
 
 
PEER Training Pre-Quiz  
 
X 
 
Take PEER Training Course 
   
X 
 
PEER Training Post-Quiz 
 
X 
 
PEER Training Satisfaction Questions 
 
X 
 
Observe/Assist with PEER Session led by 
Researcher 
 
X 
 
Session Observation / Evaluation Form 
 
X 
 
Final Satisfaction / Focus Group Questions 
 
 
X 
 
 
10.0 VISIT PROCEDURES 
 
PWD 
 
Screening Procedures 
 
INITIAL ELIGIBILITY 
A researcher will confirm the following with staff at the community and/or conduct a chart review 
to determine initial eligibility by determining whether the PWD meets the following inclusion / 
exclusion criteria: 
e. He/she is age 55+ 
f. He/she is able to read and speak English 
g. He/she is diagnosed with dementia (of any type) 
h. He/she does NOT show signs of rapid cognitive decline or physical deterioration 
over the last 6 months 
i. 
He/she is NOT bed confined. 
ii. 
He/she is NOT completely unable to communicate verbally. 
iii. 
He/she is NOT cognitively and/or physically impaired to such a point that 
they are unable to participate in group activities.  
iv. 
He/she is actively dying.  
v. 
His/her health is declining so rapidly that they are going to be unable 

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participate in group activities in next week. 
 
FINAL ELIGIBILITY 
If the person meets the initial inclusion / exclusion criteria, a researcher will meet directly with the 
person with dementia and ask him/her to sign the assent form. If the resident signs the assent form, 
the researcher will continue to interview him/her and determine final eligibility by administering 
the Mini-Mental Status Examination (MMSE—described in detail above) and, if needed, the ISH-
SI-PV (described in detail above). 
• If the person scores at least 5 on the MMSE, he/she is eligible to be a RP in the study. 
• If the person scores below 5 on the MMSE, the researcher will administer the ISH-SI-PV 
o If the person scores at least 1 on the ISH-SI-PV, he/she is eligible for the study 
• If the person scores at least 13 on the MMSE, he/she is eligible to be a RL in the study.  
o Final determination as to whether the PWD is appropriate to be a RL will be 
determined by administering the PEER Leader Assessment. In order to be eligible 
to be a RL, the person must perform adequately on the PEER Leader Assessment. 
 
Baseline Procedures 
 
Chart Review/Interview with Staff 
Researchers will collect the following data from each PWD’s chart: 
• Demographics (race/ethnicity, education level, marital status, and number of years living 
in LTC) 
• All diagnoses 
• Type of dementia 
• All meds 
 
Baseline Assessment  
A researcher will schedule a time to work with the PWD and conduct a direct interview with him/her 
to administer the MMSE, ISH-SI-PV (if needed), GDS-SF, and DEMQOL. The researcher will follow 
standard protocol for administering these measures and be extensively trained on how to properly use 
these measures. Please note that the MMSE is not an outcome measure.  
 
Caregiver Interview 
Researchers will interview a caregiver to collect data related to neuropsychiatric symptoms (based 
upon the NPI-NH) and agitation (based upon the CMAI) exhibited by the PWD. In addition, if needed 
(i.e., if the PWD was unable to respond to the DEMQOL and/or GDS-SF questions), a researcher will 
interview the caregiver to administer the proxy version of the DEMQOL and/or GDS-SF.  
 
Observations of Standard Activities 
Researchers will observe the PWD taking part in standard activities using the MPES. Multiple 
observations will be conducted so that an average score can be calculated for baseline, standard activity 
programming. Researchers will follow the standard protocols for using the MPES and be extensively 
trained on how to properly use these measures.  
 
Intervention Period Procedures 
 

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For Experimental participants, PWD will be invited to participate in two PEER sessions per week for 
3.5 months (28 total sessions). The sessions will be overseen by a SP at the nursing home or assisted 
living facility. The SP will be trained on how to administer PEER Sessions, as described earlier. 
 
For Control Participants, PWD will participate in standard activities for 3.5 months.  
 
Treatment Fidelity / Process / Satisfaction Measures 
Researchers will complete a Session Observation / Evaluation Form for each scheduled session, even 
if the session does not actually occur due to the PWD’s unavailability or refusal to participate. Data 
collected on the Session Observation / Evaluation Form is detailed above.  
 
There will be no Treatment Fidelity / Process Measures for Control Participants. 
 
Observations of PEER Sessions 
Researchers will observe the PWD taking part in PEER sessions using the MPES. We will aim to 
conduct multiple observations for each activity type, so that an average score can be calculated for 
PEER activity programming. Researchers will follow the standard protocols for using the MPES and 
be extensively trained on how to properly use these measures.  
 
 
Post-Treatment Procedures 
 
Post-Treatment Assessment  
A researcher will schedule a time to work with the PWD and conduct a direct interview with him/her 
to administer the DEMQOL and GDS-SF.  
 
Caregiver Interview 
Researchers will interview a caregiver to collect data related to neuropsychiatric symptoms (based 
upon the NPI-NH) and agitation (based upon the CMAI) exhibited by PWD. In addition, if needed 
(i.e., if the PWD was unable to respond to the DEMQOL and/or questions), a researcher will interview 
the caregiver to administer the proxy version of the DEMQOL and/or GDS-SF. 
 
SPs 
 
Please note: SPs will only be enrolled at Experimental Sites.   
 
Screening Procedures 
 
Direct Interview for Eligibility Criteria 
After consent is obtained from the SP, a researcher will ask a SP to fill out a form that confirms that 
he/she meets the following criteria: 
a. The SP is age 18+ 
b. The SP is able to read and speak English 
c. The SP does not only work third shift 
 
Intervention Period Procedures 

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Take Training Course 
SPs will take part in a live training session. 
 
Pre-Post Training Quiz for Training Modules 
Before and after taking the PEER training, the SP will be presented with a 15-item quiz. 
 
Treatment Fidelity / Process Measures  
At Experimental Sites, SPs will be invited to oversee two PEER sessions per week for 3.5 months (28 
total sessions). At Control Sites, staff will provide standard activities / care for 3.5 months. 
 
A Session Observation / Evaluation Form will be completed for each scheduled session, even if the 
session does not actually occur due to the PWD’s unavailability or refusal to participate. Data collected 
on the Session Observation / Evaluation Form is detailed above.  
 
 
Final Satisfaction Questions 
 
Final Satisfaction Questions 
A researcher will schedule a time to work with the SP to pose final satisfaction questions to the SP 
regarding the PEER training and app. The questions will consist of a combination of closed- and open-
ended questions.  
 
11.0 FOLLOW-UP 
This is a low-risk study of a non-pharmacological intervention. As such, follow up is not required. 
The final point of contact for PWD will be the post-treatment assessment. The final point of contact 
for SPs will be the final satisfaction interview.  
 
12.0 EARLY DISCONTINUATION  
Participants are free to withdraw from participation in the study at any time and for any reason. If they 
do withdraw, we will no longer collect data on the person.  
 
13.0 SAFETY REPORTING 
 
For the purposes of this study, a participant is considered enrolled if they have successfully completed 
the screening procedure outlined above. Safety oversight of the trial is provided by the Principal 
Investigator (PI), Mr. Skrajner. 
 
After being enrolled in the study, participant safety will be monitored regularly by the PI.  
 
Adverse Event (AE):  Any unfavorable and unintended sign, symptom, or disease 
temporally associated with the use of a medical treatment or procedure, regardless of whether 
it is considered related to the medical treatment or procedure. 
 
Serious Adverse Event (SAE):  Any AE that results in any of the following outcomes: 
• Death 

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• Life-threatening  
• Event requiring inpatient hospitalization or prolongation of existing hospitalization 
• 
Persistent or significant disability/incapacity 
 
As this is a minimal risk psychosocial activity intervention, no AEs or SAEs are expected per NIH 
definitions, as none of the risks of the study will affect medical outcomes or occurrences.  
• The PI will review study conduct in real time. 
• The PI will review accrual, drop-outs, and protocol deviations on an annual basis.  
• The PI will review AEs individually in real-time, and in aggregate on an annual basis.   
• The PI will review serious SAEs in real-time, and in aggregate on an annual basis.  
• SAEs and specific procedure-associated AEs will be reported to the Heartland IRB when 
the yearly IRB report is due, unless the SAE or AE is “possibly related” or “related” to 
the study procedures.  
o If the SAE or AE is “possibly related” or “related” to the study procedures, the 
SAE or AE will be reported to the IRB within 24 hours of determination of AE/SAE. 
o If any SAEs occur, the PI will, with the assistance of the IRB, determine if any 
modifications need to be made to the study protocol and procedures. As this is a 
minimal risk study, this is highly unlikely. 
 
13.1 Specification of Safety Parameters 
As this is a non-medical, short duration pre-post design trial with no interim measures (pre-post 
design), there are no lab values or test scores that fill this role. If a participant becomes extremely 
embarrassed or agitated during an assessment or activity, they will be redirected, and their participation 
in the programming will stop for that session. If this occurs at a clinical level that then results in an 
AE, it will be reported to the IRB when the yearly IRB report is due. 
 
13.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
The risk profile for this study is low as it is a minimal risk, nonpharmacologic intervention. As such, 
assessing and recording of the parameters will be done by the PI with the end goal of informing the 
IRB when the yearly IRB report is due. Since the PI and Experimental Team Lead will be intimately 
involved in all aspects of the trial, all subject data will be regularly reviewed by them and all staff will 
report to them on an ongoing basis. 
 
A screenshot of the “Adverse Event and Serious AE Log” with sample data is included in the 
Appendix 
 
13.3 Reporting Procedures 
 
SAEs and AEs are reported to the Heartland IRB when the yearly IRB report is due, unless the 
SAE or AE is “possibly related” or “related” to the study procedures. If the SAE or AE possibly 
related” or “related” to the study procedures, the SAE or AE will be reported to the IRB within 24 
hours. 
13.4 Severity of Event 
AEs will be graded according to the following scale: 
Mild:  An experience that is transient, and requires no special treatment or intervention.  
The experience does not generally interfere with usual daily activities.  This includes 

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transient laboratory test alterations. 
Moderate:  An experience that is alleviated with simple therapeutic treatments.  The 
experience impacts usual daily activities.  Includes laboratory test alterations indicating 
injury, but without long-term risk. 
Severe:  An experience that requires therapeutic intervention.  The experience interrupts 
usual daily activities. If hospitalization (or prolongation of hospitalization) is required for 
treatment it becomes an SAE. 
13.5 Relationship To Study Intervention 
All AEs will have their relationship to study participation assessed with a level of specificity 
appropriate to the non-pharmacological study design. The study uses the following AE attribution 
scale: 
Not related:  The AE is clearly not related to the study procedures (i.e., another cause of 
the event is most plausible and/or a clinically plausible temporal sequence is inconsistent 
with the onset of the event).   
Potentially related:  An event that follows a reasonable temporal sequence from the 
initiation of study procedures, but that could readily have been produced by a number of 
other factors. 
Related:  The AE is clearly related to the study procedures.  
13.6 Follow-up for Adverse Events 
Expected AEs 
Expected AEs associated with the study procedures include:   
• Extreme Feelings of Frustration/Embarrassment during the Assessments / 
Intervention 
 
AE Management 
• Only staff with proper experience in working with vulnerable populations will be 
permitted to take part in primary data collection. This will increase the chances that 
they know how to reduce such feelings in participants 
• All SPs will receive training on how to recognize signs of frustration and 
embarrassment and what to do in such situations. 
• SPs will be instructed that, if such signs are present, the assessment or activity will be 
discontinued and/or the participant will be given an alternative activity. 
13.7 Unanticipated Problems 
Upon notification of an Unanticipated Problem, the Experimental Team Leader or PI will notify all 
appropriate parties as described in the protocol: 
1. The Experimental Team Leader will immediately notify the PI. 
2. The PI will send a notification email to the IRB.  
3. The PI will advise the Study Team regarding screening, enrollment, and ongoing participation. 
4. Upon advisement by the IRB, the PI will determine the study’s status and notify the Study 
Team. 
 
14.0 STUDY COMPLIANCE  
 
The PI will maintain a Protocol Deviation / Violation Log, in which he will report of all protocol 

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deviations/violations, including but not limited to the following:  
• 
Enrollment of an ineligible participant 
• 
Failure to obtain Informed Consent 
• 
Failure to keep IRB approval up-to-date 
• 
Wrong treatment administered to participant 
• 
Follow-up visit at a time point different from that specified in the protocol 
 
A screenshot of the Protocol Deviation / Violation Log is included in the Appendix. 
 
15.0 DATA COLLECTION AND STUDY FORMS 
 
The following documents are used in this study. Descriptions of measures are included above. Each 
measure listed is also included in the Appendix.  
 
PWD 
 
Screening Documents  
1. PWD Initial Screening / Inclusion Form 
 
Baseline Assessments / Observations Documents   
1. Chart Review Form 
2. MMSE 
3. ISH-SI-PV (if needed) 
4. DEMQOL  
5. GDS-SF 
6. NPI-NH 
7. CMAI 
8. PEER Leader Assessment (Tablet-Based) 
9. MPES  
 
Intervention Period Data Collection  
1. Hearthside Book Club Session Observation / Evaluation Form [Experimental Only] 
2. Lingo Bingo Session Observation / Evaluation Form [Experimental Only] 
3. Sort it Out Session Observation / Evaluation Form [Experimental Only] 
4. Critics Corner Session Observation / Evaluation Form [Experimental Only] 
5. Quote Vote Session Observation / Evaluation Form [Experimental Only] 
6. DiscussIT Session Observation / Evaluation Form [Experimental Only] 
7. MPES  
  
Post-Treatment Assessment Documents 
1. DEMQOL  
2. GDS-SF 
3. CMAI 
4. NPI-NH  
 
SPs 

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Screening Documents  
1. Staff Screening and Demographics Form 
 
Intervention Period Data Collection 
1. Pre-Post-Training Quizzes for Training Modules  
2. Hearthside Book Club Session Observation / Evaluation Form [Experimental Only] 
3. Lingo Bingo Session Observation / Evaluation Form [Experimental Only] 
4. Sort it Out Session Observation / Evaluation Form [Experimental Only] 
5. Critics Corner Session Observation / Evaluation Form [Experimental Only] 
6. Quote Vote Session Observation / Evaluation Form [Experimental Only] 
7. DiscussIT Session Observation / Evaluation Form [Experimental Only] 
 
Final Satisfaction Questions 
1. Final Satisfaction Questions / Focus Group Questions for Staff   
 
15.1 Source Documentation 
 
This section describes how participant data are maintained in the study. 
 
Definitions: A source document is any document on which study data are initially recorded. Source 
documents for this study include demographics forms, medical records, standardized test forms, 
satisfaction questionnaires, and engagement forms, etc. Most source documents are electronic in 
nature and will also serve as electronic Case Report Forms (eCRFs) to document study-specific data 
requirements. This method reduces the likelihood of transcription errors. All data will be checked and 
cleaned during a QA process to ensure data integrity.  
 
All essential study documents will be retained by the investigator in an electronic Participant Binder 
and include:  
• Source documents  
• Measures administered to the participant 
• Measures administered to the proxy interviews 
• eCRFs 
• Applicable Notes to File (including Notes to File that indicate errors in forms) 
 
Note: The only exception to this is that Resident Consent Documents are kept in an 
electronic folder named “Participants and Consents.” This keeps the participant name 
separate from de-identified data. 
 
At the conclusion of the study, all source documents, eCRFs, and other required documentation will 
be kept with study records as required by protocol and IRB guidelines. 
 
Please note: all MPES observations will be conducted via a HIPAA compliant Google Form. 
Submitted responses will automatically be sent to a database. As such, there will be no need to 
save a corresponding PDF file in each participant’s digital binder for each MPES observation. To 
prevent changing of data in the database, there will be a lock on the database preventing changing 

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of data, except by the PI or Experimental Team Leader. Although each MPES observation will not 
have a corresponding PDF file in the participant’s digital binder, a PDF will be generated for each 
observation for auditing purposes. The PDFs will be placed in a single folder. MPES observations 
will be spot checked for accuracy by comparing database data to PDF form data.  
 
 
15.2 Forms Maintenance 
 
All forms will be stored in electronic participant “binders.” Forms which are collected digitally will 
automatically be saved to a secure, HIPAA-compliant database and then manually distributed to the 
correct participant binder. Hard copy forms will be scanned and placed into the proper digital binder.  
 
Please note: all MPES observations will be conducted via a HIPAA compliant Google Form. Submitted 
responses will automatically be sent to a database. As such, there will be no need to save a 
corresponding PDF file in each participant’s digital binder for each MPES observation. To prevent 
changing of data in the database, there will be a lock on the database preventing changing of data, 
except by the PI or Experimental Team Leader. Although each MPES observation will not have a 
corresponding PDF file in the participant’s digital binder, a PDF will be generated for each observation 
for auditing purposes. The PDFs will be placed in a single folder. MPES observations will be spot 
checked for accuracy by comparing database data to PDF form data.  
 
 
15.3 General Instructions for Completing Forms 
 
For All forms: 
• All forms should be filled out electronically. 
• Any hard-copy forms will be scanned as soon as feasible and become the source document.   
• Completed forms should be saved in the participant's digital binder (file folder with their ID 
number) 
• To ensure the best possible level of confidentiality, after scanning hard copy forms, these forms 
will be stored in a secure area. After data from hard copy forms have been entered / double 
checked, such forms will be shredded.  
• The Experimental Team Leader and/or PI will spot check a subset of forms before they are 
entered into SPSS to ensure that proper protocols are being adhered to and data is appropriately 
cleaned. 
• After data on digital forms are confirmed to be accurate, researchers will flatten the digital 
form (to prevent accidental changes to the file) and save it to the participant’s digital binder.  
o The file name will have descriptive details about what is included in the file (e.g., 
Resident Assessment, HBC Session Observation / Evaluation Form, etc.) 
o In addition, the researcher will end the file name with his/her initials and the date (e.g., 
dw_2022_01_01) 
• The Experimental Team Leader is responsible for updating forms, as needed. 
• The PI will review and approve all changes to forms. 
• During weekly meeting, issues with data collection, including possible problems with forms 
should be discussed by study team members. 
• Researchers should be sure to completely fill out all forms. 

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• Participants must not be identified by name on any study document submitted with the forms. 
If research sites provide forms with the participants name on them, researchers will redact the 
participant’s name and replace with his/her identification (ID) number.  
• Researchers should complete the header information on EVERY page, including pages for 
which no study data are recorded.  
• The participant ID must be recorded on EVERY page, including pages for which no study data 
are recorded. 
• Time: Use a 24-hour clock (e.g., 14:00 to indicate 2:00 p.m.) unless otherwise specified. 
• All dates must be verifiable by source documents. Historical dates are sometimes not known 
(e.g., date of first symptom); therefore, conventions for missing days and/or months should be 
described (e.g., UNK or 99). 
• Use of abbreviations not specifically noted in the instructions for completing the forms can be 
problematic and should be held to a minimum. 
• Comments written extraneously on forms cannot be captured in the database; thus, write only 
in the spaces indicated.   
• If an error has been made on the study forms, place a single line through the erroneous entry 
and record the date and your initials. Indicate the correct response. 
• Do not skip any items. Some items may carry "Unknown" or "Not Applicable" response 
choices which should be checked when necessary.  
• Data may not be available to complete the form for various reasons. Circle the item for which 
data is not available and indicate the reason near the appropriate field: 
• If an evaluation was not done, write ND and provide a reason. 
• If the information is not available, but the evaluation was done, write NAV.   
o Only in rare circumstances, as in the case of lost documentation, should NAV be 
recorded on the form. Every effort should be made to obtain the information requested. 
• If an evaluation is not applicable, write NA. 
• Incomplete or Illegible forms: Incomplete forms that do not have adequate explanation (as 
described above) compromise the integrity of the entire study. 
• If/when site-staff share a document with a participant’s name on it, the name of the person will 
be digitally redacted, and the ID number of the person put in place of the name 
o To preserve privacy, the document with the name of the person will be deleted 
o The version with the ID number will be place in the appropriate digital file folder.  
 
For Digital Forms: 
When a form is completed, it should be placed in the digital binder (file folder) for the individual 
participant. 
 
For Hard Copy Forms: 
Hard copy forms should only be used when a tablet and/or internet is unavailable. If used, hard copy 
forms must be scanned immediately after collection and uploaded to the participant binder. The 
scanned version will then be considered the source document. Hard copy will then be stored in a 
secured area. When completing hard copy study forms, print using dark ink. 
 
15.4 Data Flow  
Completed forms (whether electronic or hard copy) will be reviewed by a researcher to ensure 
completeness and accuracy. Any errors will be crossed out, corrected, and then initialed. After data on 

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digital forms are confirmed to be accurate, researchers will flatten the digital form (to prevent 
accidental changes to the file) and save it to the participant’s digital binder.  
o The file name will have descriptive details about what is included in the file (e.g., 
Resident Assessment, HBC Session Observation / Evaluation Form, etc.) 
o In addition, the researcher will end the file name with his/her initials and the date (e.g., 
dw_2022_01_01) 
If any accidental references to the person by name is included on the data form, such references 
will be redacted and initialed by reviewer. Data from the form will then be entered into the study's 
master database by the research assistant.  
 
15.5 Administrative Forms 
 
A Staff Training Log will be used. A screenshots of this log is included in the Appendix. 
 
15.6 Retention of Study Documentation  
After the study ends, research staff shall maintain participant forms in Hearthstone’s HIPAA 
compliant database for three years or as indicated by the protocol, federal regulations, and IRB 
guidance.  
 
 
16.0 DATA MANAGEMENT 
 
Data Tracking will be conducted in the following way: 
• The Experimental Team Leader will manage a data tracking spreadsheet. Each row will 
contain a participant ID and each column will contain a piece of data required for the study 
(e.g., NPI-NH or DEMQOL). This will allow him to track which data has been and which 
data will need to be collected (and by when). Once data is collected, he will note the person 
who collected the data and on what date (e.g., Collected by XX on 7/30/21). It should be 
noted that separate data tracking spreadsheets will be maintained for each type of 
participant (PWD, SPs, and Family Members). 
 
Study Form Review will be conducted in the following way: 
• After data on digital forms are confirmed to be accurate, researchers will flatten the digital 
form (to prevent accidental changes to the file) and save it to the participant’s digital binder.  
a. The file name will have descriptive details about what is included in the file (e.g., 
Resident Assessment, HBC Session Observation / Evaluation Form, etc.) 
b. In addition, the researcher will end the file name with his/her initials and the date 
(e.g., dw_2022_01_01) 
 
Data Entry will be conducted in the following way: 
• The Research Assistant will enter data directly into SPSS by reviewing the forms. Data 
will be double-checked for accuracy.  
 
Data Analyses will be conducted in the following way: 
• The PI will conduct data analyses using SPSS. 
 
 

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16.1 Quality Control Procedures 
All research staff responsible for data collection and management will have received human subjects 
and good clinical practice training/certification. In terms of training for collection of other measures 
and adherence to other study protocols, all staff will be trained via standard, in-person training 
protocols on all measures and will achieve a minimum inter-rater reliability rating of 90% on the 
primary outcome measures. 
 
16.2 Data and Form Checks 
Before data is entered into SPSS, a researcher will check the forms for the following possible issues: 
• 
Missing data or forms  
• 
Out-of-range or erroneous data 
• 
Inconsistent and illogical dates over time  
• 
Data inconsistency across forms and visits 
• 
Not completing all fields of a "completed form" or no reason for missing data is provided  
 
16.3 Site Monitoring 
This is a single-site clinical trial since there is one investigational site (Hearthstone) conducting and 
coordinating the study protocol. As such, the PI and Experimental Team Leader will be jointly 
responsible for the following monitoring activities: 
• Ensuring the rights and safety of participants 
• Confirming that the study is conducted in accordance with GCP guidelines 
• Ensuring maintenance of required documents 
 
• Verifying adherence to the protocol 
• Monitoring the quality of data collected 
• Ensuring accurate reporting and documentation of all AEs and unanticipated problems 
 
The study team will meet weekly about the project and each of the above items will be part of the 
meeting agenda each week. Researchers will voice any concerns or issues related to the above areas 
during the meeting.  
 
17.0 DATA AND SAFETY MONITORING ACTIVITIES 
The roles and responsibilities of the entities monitoring participant safety and study quality are 
described in this section. All clinical trials supported by NIA must have a data and safety monitoring 
plan. This single-site, minimal risk study will be overseen by the PI. 
 
17.1 Reports 
 
The following reports will be produced for this study: 
 
Safety Reports  
• Delivered to the IRB as needed and will include a detailed analysis of study progress, AEs, 
and SAEs.   
• Produced by the Experimental Team Leader 
Final Report 
• Delivered to NIH and IRB no more than 120 days after the completion of the project.  
• Produced by the PI and Experimental Team Leader 

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17.2 Study Completion and Close-Out Procedures  
The following study completion and close-out procedures will be used: 
• 
The PI and/or Experimental Team Leader will verify that study procedures have been 
completed, data have been collected, and study intervention(s) and supplies are returned 
to the responsible party or prepared for destruction.  
• 
The PI will ensure that all data queries have been completed. 
• 
The PI will ensure that correspondence and study files are accessible for external audits. 
• 
The PI will ensure that the study records are maintained and any relevant study 
information reported to the NIA.  
• 
The PI will notify the IRB of the study’s completion and store a copy of the notification. 
• 
The PI will prepare a report summarizing the study’s conduct. 
• 
The PI will notify participants of the study completion. 
 
17.3 Participant Notification 
A close out letter will be sent to participants, with a summary of key results. The letter will also thank 
them for participating in the study. The PI will have lead responsibility for creating the letter and 
making sure it is sent to all participants.  
 
17.4 Confidentiality Procedures 
The following confidentiality safeguards will be used: 
• 
Electronic files – Data identifying participants that are stored electronically will be 
maintained in a separate file that is saved on a secure, HIPAA-compliant server. 
• 
Forms – Forms or pages containing personal identifying information will be separated 
from other pages of the data forms and be retained in a secure location.  
• 
Data listings – Participant name, name code, long-term care chart, record number, and 
other unique identifiers will not be included in any published data listing. 
• 
Data distribution – Data listings that contain participant name, name code, or other 
identifiers easily associated with a specific participant will not be distributed. 
• 
Data disposal – Computer listings that contain participant-identifying information will 
be disposed of in an appropriate manner. 
• 
Access – Participant records will not be accessible to persons outside the site without the 
express written consent of the participant. 
• 
Storage – Study forms and related documents will be retained both during and after study 
completion and will be stored in a secure location 
• 
Passwords – Passwords will be used to provide limitations on general access to computer 
systems and to the functions that individuals can use. Passwords will be changed on a 
regular basis. 
• 
User Training – Research staff with access to computer systems will be trained in their 
use and in related security measures. Training will include explanations of how to access 
the system and a discussion of the need for, and importance of, system security.  
• 
System Testing – Prior to the use of a new computer system, and after any modifications, 
the system will be tested to verify that it performs as expected. Testing will verify that 
the password-activated access system performs as intended. 
• 
System Backups – Backup copies of electronic data will be made on a regular basis. 

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17.5 Publications 
Study results will be made available to the public as soon as possible. Publication of the results of 
this trial will be governed by the policies and procedures of Hearthstone, NIH guidelines, and 
standard industry practice. Any presentation, abstract, or manuscript will be made available for 
review by the sponsor and the NIA prior to submission. 
 
18.0 MOP MAINTENANCE 
 
The MOP will be updated on an as needed basis. When a new revision is made, the following 
procedure will be followed: 
 
1. The version date on the cover page and footer will be updated with the latest date. 
2. A list of key changes will be listed on the cover pages. All changes will tracked.   
3. Previous versions of the MOP will be maintained and saved.