LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
Phase: NA
Conditions: Dementia, Vascular, Alzheimer Disease, Dementia, Mixed
Sponsor: Hopeful Aging

 
 
 
 
 
 
 
 
 
 
LEAD IT!  
An App to Enable Persons With Early Stage Dementia 
to Lead Group Activities for Their Peers 
Project Also Known As: 
PEER: Purposeful Engagement for Every Resident 
NCT05516342 
Study Protocol 
 
 

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1.0 STUDY OVERVIEW 
 
Study Title:  
LEAD IT! An App to Enable Persons with Early-Stage Dementia to Lead Group Activities for 
Their Peers 
(Also Known As "PEER: Purposeful Engagement for Every Resident") 
 
The purpose of this study is to develop and evaluate a tablet-based app called PEER that will 
enable persons with dementia (PWD) to lead group activities for their peers (i.e., other PWD). This 
Phase 2 Small Business Innovation Research (SBIR) grant is focused on evaluation of the PEER 
app and its impacts on users. 
 
A quasi-experiment will be conducted. It will be a cluster randomized trial (CRT), consisting of 
pre- and post-intervention measurements of two nonequivalent groups: a Treatment Group (TG)—
i.e. 48 PWD who receive the intervention – and a Control Group (CG)– i.e., 48 PWD receiving 
standard programming / care. Since this experiment will occur after all enhancements to the PEER 
App are complete, it will represent the definitive trial of PEER’s proximal and distal effects.  
 
The Phase 2 study will be conducted by two teams. The Development Team (DT) will be 
responsible for content and software development for the PEER app. The team will consist of Mr. 
Skrajner (PI and Team Leader), John Zeisel (Content Development Expert), Mr. Knapp (Software 
Engineer), and Mr. Lombardo (Graphic Designer). This team has previously worked together on 
SBIR projects. As was the case for Phase 1, Mr. Skrajner will storyboard the app and create all 
activity content; Dr. Zeisel (Content Development Expert) will assist with this process, as well. 
The structure, storyboard, and logic for the app will be communicated to Mr. Knapp and Mr. 
Lombardo using Pencil (pencil.evolus.vn) and Behavior Driven Development (BDD) 
methodology (Solis & Wang, 2011). Mr. Knapp will again develop the app using Adobe PhoneGap 
and a separate Ruby on Rails application. Mr. Lombardo will work on the graphic design of the 
app. The goal will be to create a clean, simple, and aesthetically pleasing design that reduces 
distractions (which could confuse PWD) and is age-appropriate (e.g., cartoonish design elements 
will not be used). As discussed below, we will elicit feedback from PWD and staff on the design 
of the app, by providing various options to them. The Experimental Team (ET) will be tasked 
with all investigatory work for both PWD and Staff Participants (SPs). This team will be led by 
Mr. Gorzelle, who has served as a PI on several SBIR studies, as well as two RA’s. 
 
The final sample size will consist of 96 PWD—i.e., at each of 8 sites, there will be 10 Resident 
Players (RPs) and 2 Resident Leaders (RLs) who complete all study procedures. To accommodate 
for attrition of up to 25%, we will initially enroll 120 PWD—i.e., 12 RPs and 3 RLs at each site. 
The experiment will also include 24 Staff Participants (SPs). PWD will be 55+ years old, 
diagnosed with any type of dementia, speak and read English, and must reside in an ALF or NH. 
RPs must score at least five on the Mini-Mental State Examination (MMSE) -OR- score at least 
one (1) on the I’m Still Here Skills Inventory – PEER Version (ISH-SI-PV); RLs must score at 
least 13. In addition, RLs must perform adequately on the PEER leader assessment. PWD will be 
excluded from the study if they show signs of rapid cognitive decline or physical deterioration 

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over the last six months, as reported by staff (this last exclusion criteria is defined more specifically 
below). SPs must be at least 18 years old and speak English. 
 
Randomization: Sites will be randomized with respect to condition (Control or Experimental) at 
the beginning of the experiment. Individual random assignment is not feasible, because a single 
site cannot practically serve as both a control and treatment site. That is, if a single site had some 
control participants and some treatment participants, control participants may still find their way 
into PEER sessions, which would cause contamination of the control group and, in turn, be a threat 
to validity. 
 
PWD will take part in the study for about 6.5 months.  During a one-month Baseline Period, PWD 
will take part in baseline assessments, during which time researchers directly interview PWD to 
assess cognition, depression, and quality of life. Researchers will also observe PWD participating 
in standard activities and interview caregivers to obtain data related to agitation and 
neuropsychiatric symptoms exhibited by PWD. 
 
PWD will then enter the Intervention Period. For PWD at Experimental Sites, PWD will be invited 
to participate in PEER sessions twice per week for 4.5 months; 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. For PWD at Experimental Sites, PWD 
will participate in standard care for 4.5 months. 
 
After the Intervention Period, researchers will directly interview PWD to reassess depression and 
quality life, as well as interview caregivers to obtain data related to agitation and neuropsychiatric 
symptoms exhibited by PWD. 
 
SPs will only be enrolled at Experimental Sites since their only involvement will be related to 
providing feedback about the PEER training and intervention. SPs will participate in the study for 
about 6.5 months. Their 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 staff after taking the training. Staff will then enter the 
Intervention Period. Staff will be invited to participate in PEER sessions twice per week for 4.5 
months; each PEER session is expected last about 45 minutes. 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. 
 
 
 
 

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2.0 STUDY ORGANIZATION AND RESPONSIBILITIES 
Table 1: Staff Roster 
 
 
 
 
 
 
 
 
 
 
 
•  
 
 
 
 
 
•  
 
 
 
 
 
•  
 
 
 
 
 
•  
 
 
 
 
 
•  
 
 
 
 
 
•  
 
 

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3.0 STUDY FLOW 
An overview of the study processes, presented in a flow diagram in Figure 1, describes each of 
the study's major steps.  
 
Figure 1: Study Flow Diagram for PWD 
 
 
 
 
Legally Authorized Representative Signs 
Informed Consent Form 
Initial Screening Via Staff-Confirmation of 
Eligibility Criteria and/or Chart Review 
PWD Signs Assent Form  
& Researcher Conducts MMSE (and ISH-SI-PV, 
if needed) 
PWD Entered into Screening Log 
 
Baseline Assessment / Observations / 
Caregiver Interviews 
Indicate Reason 
on Screening 
Log 
STOP 
Intervention Period Data Collection  
Control: Standard Care for 4.5 months 
Experimental: PEER Sessions 2x /week for 4.5 months 
Post-Treatment Assessments /  
Caregiver Interviews 
NO 
YES 
PWD 
Eligible 
for Study? 

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Figure 2: Study Flow Diagram for Staff Members (Experimental Sites Only) 
 
 
 
 
 
YES 
Staff Member Signs Informed Consent Form 
 Staff Member Entered into Screening Log 
 Screening Via Staff Screening / 
Demographics Form 
 
Training, Training Satisfaction Questions,  
and Quiz 
Indicate Reason 
on Screening 
Log 
STOP 
Intervention Period Data Collection  
PEER Sessions 2x /week for 4.5 months) 
Final Satisfaction Questions 
NO 
Staff 
Member 
Eligible 
for Study? 

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4.0 INFORMED CONSENT  
 
PWD 
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 to persons responsible for the 
medical decisions of potential participants that their loved ones will still have a choice as to 
whether they want to take part in the study. That is, even if a family member provides consent for 
the study, the resident himself/herself can still decide whether or not he or 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 (i.e., the person is at least age 
55, able to read/speak English, diagnosed with dementia, and does not show signs of rapid 
cognitive decline or physical deterioration over the past 6 months (this final item 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 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 or 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 conduct 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 
LAR and resident, in case they would like to review the full consent form. Copies of signed consent 
and assent forms will be provided to participants and placed in their digital file folders. 
 
Copies of the study flyer, legally authorized representative consent form, and PWD assent form 
are included in the Appendix. 
 
Staff Members 
Researchers will initially provide a verbal summary of the study (either in person or via telephone). 
If the person 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 staff participants will be encouraged to speak to researchers with questions. If the person 
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 

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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. Copies of signed consent forms will be provided to staff participants 
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, 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). 
 
Staff Members 
HIPAA authorization will not be required for staff members, 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 nursing home and assisted living facility 
and ask that they send recruitment packets to the legally authorized representatives 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 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’s. It will also list all 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 

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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 persons responsible for the medical decisions of potential participants that their loved ones will 
still have a choice as to whether they want to take part in the study. That is, even if a family member 
provides consent for the study, the resident himself/herself can still decide whether or not he or 
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 (i.e., 
the person is at least age 55, able to read/speak English, diagnosed with dementia, and does not 
show signs of rapid cognitive decline or physical deterioration over the past 6 months (this final 
item 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 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 or 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 conduct 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 or she would like to review the full consent form. Copies of 
signed consent and assent forms will be provided to participants and placed in their digital file 
folders. 
 
Staff Members 
Researchers will initially provide a verbal summary of the study (either in person or via telephone). 
If the person 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 staff participants will be encouraged to speak to researchers with questions. If the person 
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 staff participants and placed in their files. 
 
5.2 Participant Retention  
Study staff will be in regular contact with staff members 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 also note that 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 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: 
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 actively dying.  
v. 
His/her health is 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 via a table that will be sent to staff (see screenshot of this table in the 
Appendix). Information from this table will be de-identified (names redacted) and data will be 
saved in a folder called “Raw DataàBulk DataàSite Name.” Data from the form will then be 
entered individually for each PWD into the PWD Initial Screening / Inclusion Form.  
 
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 below) and, if needed, the ISH-
SI-PV (described in detail below). 
• 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 conduct 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 conducting the PEER Leader Assessment. In order to be eligible to 
be a RL, the person must perform adequately on the PEER Leader Assessment. 
 
 
Staff Members 

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A researcher will ask the staff member to complete a form to determine whether the staff 
member 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 only 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) 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). 
 
Staff Members 
Staff will be eligible if they meet the criteria listed in section 6.1 (see Staff Member 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), (6) Would You Rather, and (7) DiscussIT. 
 
The PEER App will have three modes. Each mode will be used by different people and serve a 
different purpose. 
 
(1) Admin Mode will be used exclusively by staff. The purpose of this mode will be to provide 

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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. Would You Rather gives participants a chance to choose between two different concepts or 
ideas. For instance, they might be asked, "Would you rather be able to fly or be able to become 
invisible." Residents cast a vote for their person choice and then a discussion occurs related to that 
topic. 
 
7. 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 Experiment 
 
Sites will be randomized with respect to condition (Control or Experimental) at the beginning of 
the experiment.  
 
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 4.5 
months (36 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 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 required for successfully implementing each activity and the 
degree of staff assistance required. 
 
For PWD at Experimental Sites, PWD will participate in standard care for 4.5 months. 
 
SPs 
 

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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 staff after taking the training.  
 
In addition, researchers will implement two PEER sessions with residents while site staff observe 
and assist, so site staff will become familiar with the app in a real-life setting. 
 
The knowledge and experience that staff gain from the training will prepare them to properly 
implement the PEER intervention. To help remind staff members of the key aspects of the training, 
two quick-reference sheets will also be available in the app to staff 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 staff member and Resident Leader through each activity 
step by step, so an implementation manual is essentially be embedded within the app. Second, in 
past studies, we had given staff members extensive implementation manuals, but the manuals were 
typically ignored by staff. This is not surprising, since staff are very busy with main caregiving 
and other responsibilities. If they need to refer to a long reference manual, it would be nearly 
impossible for them to have time to implement an intervention. In addition, some staff have low 
literacy (especially caregivers) and/or speak English as a second language. For such staff, it may 
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 such as 
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 staff 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, 
staff will then enter the Intervention Period. Staff will be invited to participate in PEER sessions 
twice per week for 4.5 months; each PEER session is expected last about 45 minutes. Activity staff 
will oversee programming. Other staff (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 

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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 
2. Mini Mental Status Exam (MMSE) 
      A researcher will conduct a direct interview with the PWD to complete 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 

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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 
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 

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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: 
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 complete the 
DEMQOL. However, if the PWD is unable to respond to questions on the 
DEMQOL, this measure will be collected 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-

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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 completed by 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: 
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 
conducted, 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 complete the GDS-
SF. 
b. The GDS-SF is a 15-item self-reported measure of depression in older adults that 
is conducted 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 

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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 
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 conduct 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 conduct 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 conduct 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 

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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 
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 taken on 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 
 
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 4.5 
months. 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 are preceded with 
RPs* 
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 

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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 thre 
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 forms 
themselves 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 
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) 

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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 
/ 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 complete the 
DEMQOL. However, if the PWD is unable to respond to questions on the 

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DEMQOL, this measure will be collected 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 complete the GDS-
SF. The GDS-SF is described above. 
3. NPI-NH 
a. The NPI-NH will be conducted by a researcher by interviewing a staff member who 
is familiar with the PWD. The NPI-NH is described above. 
4. CMAI 
a. The CMAI will be conducted by a researcher by interviewing a staff member who 
is familiar with the PWD. The CMAI is described above. 
 
 
Staff Members 
 
 
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? 
 
 
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-M  
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 staff before and after the training to examine 
knowledge transfer 
3. Satisfaction Questions for PEER Training 
a. Satisfaction questions will be posed to staff after they take the PEER training 
4. Treatment Fidelity / Process Measures 

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b. The Staff Member will be invited to oversee two PEER sessions per week for 4.5 
months (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 Staff Members are preceded with 
SM* 
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. SM* Staff ID (site staff member) 
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 thre 
options : YES, MORE THAN ½ OF THE TIME; 
YES, UP TO ½ OF THE TIME; and NO. 
b. SM* 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 forms 
themselves in the Appendix.  

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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. SM* 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. SM* 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, 
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. SM* STAFF 1. Did STAFF successfully and appropriately 
set up the tablets? (YES / NO / N/A) 
q. SM* STAFF 2. Did STAFF have any difficulty using the 
special table (if applicable)? (YES / NO / N/A) 
r. SM* STAFF 3. Did the STAFF member attach the button to 

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the RL tablet? (YES / NO / N/A) 
s. SM* STAFF 4. Did the STAFF member attach the button to 
the RP tablets? (YES / NO / N/A) 
t. SM* STAFF 5. Did you enjoy this activity? (YES / NO / 
N/A) 
u. SM* STAFF 6. Do you think the residents enjoyed it? (YES 
/ NO / N/A) 
v. SM* STAFF 7. Would you do it again sometime? (YES / 
NO / N/A) 
w. SM* 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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Staff Participants 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 conduct 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 conducting 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 complete the MMSE, ISH-SI-PV (if needed), GDS-SF, and DEMQOL. The researcher will follow 
standard protocol for conducting 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 obtain 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 questions), a researcher will 
interview the caregiver to conduct the proxy version of the DEMQOL and/or GDS.  
 
Observations of Standard Activities 
Researchers will observe the PWD taking part in standard activities using the MPES. Multiple 
observations will be taken with 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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The PWD will be invited to participate in two PEER sessions per week for 4.5 months. The sessions 
will be overseen by a staff member at the nursing home or assisted living facility. The staff member 
will be trained on how to conduct PEER Sessions, as described earlier. 
 
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 
complete 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 complete the DEMQOL and GDS-SF.  
 
Caregiver Interview 
Researchers will interview a caregiver to obtain 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 conduct the proxy version of the DEMQOL and/or GDS. 
 
Staff Members 
 
Please note: staff members will only be enrolled at Experimental Sites.   
 
Screening Procedures 
 
Direct Interview for Eligibility Criteria 
After consent is obtained from the staff member, a researcher will ask a staff member to fill out a form 
that confirms that he/she meets the following criteria: 
a. The Staff Member is age 18+ 
b. The Staff Member is able to read and speak English 
c. The Staff Member does not only work third shift 
 
Intervention Period Procedures 
 
Take Training Course 

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Staff will take part in a live training session. 
 
Pre-Post Training Quiz for Training Modules 
Before and after taking the PEER training, the Staff Member will be presented with a 15-item quiz. 
 
Treatment Fidelity / Process Measures  
At Experimental Sites, Staff Members will be invited to oversee two PEER sessions per week for 4.5 
months. At Control Sites, staff will provide standard activities / care for 4.5 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 staff member to pose final satisfaction questions to 
the staff member 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 staff members 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 
• Life-threatening  
• Event requiring inpatient hospitalization or prolongation of existing hospitalization 

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• 
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.  
• 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. 
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 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 the programming will stop. 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 specific procedure-associated 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 
transient laboratory test alterations. 
Moderate:  An experience that is alleviated with simple therapeutic treatments.  The 

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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 members who have prior experience 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 staff members will receive training on how to recognize signs of frustration and 
embarrassment and what to do in such situations. 
• Staff members 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. The 
measures themselves are 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. HBC Session Observation / Evaluation Form [Experimental Only] 
2. LB Session Observation / Evaluation Form [Experimental Only] 
3. SIO Session Observation / Evaluation Form [Experimental Only] 
4. CC Session Observation / Evaluation Form [Experimental Only] 
5. QV Session Observation / Evaluation Form [Experimental Only] 
6. Would You Rather Session Observation / Evaluation Form [Experimental Only] 
7. DiscussIT Session Observation / Evaluation Form [Experimental Only] 
8. MPES  
  
Post-Treatment Assessment Documents 
1. DEMQOL  
2. GDS-SF 
3. CMAI 
4. NPI-NH  
 

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Staff Members 
 
Screening Documents  
1. Staff Screening and Demographics Form 
 
Intervention Period Data Collection 
1. Pre-Post-Training Quizzes for Training Modules  
2. HBC Session Observation / Evaluation Form [Experimental Only] 
3. LB Session Observation / Evaluation Form [Experimental Only] 
4. SIO Session Observation / Evaluation Form [Experimental Only] 
5. CC Session Observation / Evaluation Form [Experimental Only] 
6. QV Session Observation / Evaluation Form [Experimental Only] 
7. Would You Rather Session Observation / Evaluation Form [Experimental Only] 
8. 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 completed by the participant 
• Measures completed by 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. 
 

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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.  
 
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. 
• 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.   

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• 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 members 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 
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  

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After the study ends, study 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, Staff Members, 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. 
 
 
16.1 Quality Control Procedures 
All study 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  
 

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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 
 
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. 

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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 – Study 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. 
 
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.   

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3. Previous versions of the MOP will be maintained and saved.