SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons With Dementia
Phase: NA
Conditions: Alzheimer Disease, Dementia, Dementia, Vascular, Dementia, Mixed
Sponsor: Hopeful Aging

 
 
 
 
 
 
 
 
SAFE at Home: A Service to Provide 
Social Engagement to Community-
Dwelling Persons With Dementia 
Study Protocol 
NCT05516147  
12/1/23 
 
 

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1.0 STUDY OVERVIEW 
 
Study Title:  
SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons with 
Dementia 
 
The proposed Phase 1 study will involve initial development and evaluation of a new service called 
Social Activities For Engagement at Home or SAFE at Home (SaH). SaH will enable PWD to 
participate in videoconference-based group activities with their peers—i.e., other PWD. 
 
The SAFE at Home app will consist of five main components:  
(1) Get to Know You Portal 
(2) Social Engagement Portal 
(3) Peer-to-Peer Interaction Portal (To Be Developed in Future Phase II Study) 
(4) Self-Study Portal (To Be Developed in Future Phase II Study) 
(5) Staff Training Portal 
(6) Scheduling Portal (To Be Developed in Future Phase II Study) 
 
The study will be conducted by two teams over the course of 12 months. The Development Team 
(DT) will be responsible for providing the overall vision for the app, as well as website / app 
development, training creation, and content creation. The Experimental Team (ET) will be tasked 
with all investigatory work on the project. 
 
Participants 
A total of 12 PWD living at home are expected to complete the quasi-experiment. We plan to 
oversample by 25% to accommodate attrition.  
 
Inclusion / Exclusion Criteria  
PWD must be at least 65 years old, speak and read conversational English, and be diagnosed with 
dementia (any type). PWD will be excluded from the study if they show signs of rapid cognitive 
decline or physical deterioration over the last six months, as evidenced by medical records. 
 
Baseline Period/Measures 
During the 4-week baseline period, the ET will collect the following data. PWD Demographics, 
medications, diagnoses, and type of dementia will be collected via proxy (family member) 
interview. The following assessments will be administered directly: The Short Portable Mental 
Status Questionnaire (SPMSQ-T; Roccaforte et al., 1994), the Dementia Quality of Life Scale 
(DEMQOL; Smith et al., 2005), the Geriatric Depression Scale-Short Form (GDS-SF; Yesavage 
& Sheikh, 1986; Yesavage et al., 1983), and the UCLA Loneliness Scale (ULS; Wongpakaran 
et al, 2020). Researchers will interview family members (FMs) using the Neuropsychiatric 
Inventory-Nursing Home (NPI-NH; Cummings, 1997; Wood et al., 2001). Using the Menorah 
Park Engagement Scale (MPES; Camp, Skrajner, & Gorzelle, 2015), researchers will observe 
PWD engagement and affect via videoconference on four days. 
 
Intervention Period/Measures 

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During the 8-week intervention period, PWD will participate in SaH sessions through the Social 
Engagement Portal.  Data on engagement and affect will be collected during SAFE at Home 
sessions using the MPES. In addition, PWD will answer questions related to satisfaction at the 
end of each session.  
 
Post-Treatment/Distal Measures:  
The DEMQOL, GDS-SF, ULS, and NPI-NH will be re-administered at Post-Intervention, 
allowing us to investigate possible long-term effects. Changes on these longer-term measures are 
not expected in this Phase 1 study.  
 
This App will be considered successful if (1) At least 85% of PWD agree to take part in 80% of 
the sessions; (2) mean session length is at least 25 minutes; (3) PWD exhibit higher levels of 
positive engagement/affect and lower levels of negative engagement during SaH sessions, as 
compared to baseline (based upon the MPES); and (4) PWD report high satisfaction with the app, 
defined as 85% being satisfied or very satisfied. 
 
 
 
 
 

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2.0 STUDY ORGANIZATION AND RESPONSIBILITIES 
 
REDACTED FOR PRIVACY 
 

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3.0 STUDY FLOW  
 
Study Flow Diagram  
 
 
 
 
 
 
 
 
Staff Member Confirms Eligibility Via Family 
Member Interview and/or Chart Review 
PWD Entered into Screening Log 
 
Baseline Assessment / Observations / 
Caregiver Interviews 
Indicate Reason 
on Screening 
Log 
STOP 
Intervention Period Data Collection 
 (Two Months Participating in SAFE at Home) 
Post-Treatment Assessments /  
Caregiver Interviews 
NO 
YES 
PWD 
Eligible 
for Study? 
Legally Authorized Representative (or PWD) 
Signs Informed Consent Form  
& PWD Signs Assent Form 

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4.0 RECRUITMENT AND RETENTION 
ED CONSENT  
PWD 
Please note: The approaches used for recruitment have been approved by an external Institutional 
Review Board (Heartland Institutional Review Board-- IORG0006400) prior to the 
commencement of the study.  
 
Community-dwelling PWD will be recruited by contacting one or more of the Recruitment Sites 
listed in the grant proposal all of which have senior independent living apartments and/or 
housing: 
 
After contacting each site, Mr. Skrajner will conduct an in-person and/or videoconference-based 
presentation about the project. A separate, personalized presentation will be used for each site. 
The presentation will be delivered to PWD themselves (in cases where PWD still provide their 
own consent) and/or family members of PWD (in cases where PWD who no longer provide their 
own consent). At the end of the presentation, Mr. Skrajner will hand out flyers (an aesthetically-
pleasing summary of the key aspects of the project) and consent forms (if the presentation is 
done in person) and/or recommend that persons interested in enrolling in the study go to the 
study website. The study flyer and consent form will be included on the study website in PDF 
format. Interested PWD and/or family members will be able to sign up for the study by digitally 
signing the consent form on any device by using Adobe Sign, which is HIPAA compliant. Or 
they will be able to download and print the consent form, sign the hard copy, and mail it to 
Hearthstone. 
 
In addition, after conducting each recruitment presentation, Mr. Skrajner will ask the 
organization to send a (a) recruitment email and/or (b) hard copy recruitment packet to PWD (in 
cases where PWD still provide their own consent) and/or family members of PWD (in cases 
where PWD who no longer provide their own consent).  
 
(a) The Recruitment Email will include a cover letter (in the body of the email), an attached 
study flyer (in PDF format), and an attached consent form (in PDF format). 
• The PWD and/or family member will be encouraged to contact Hearthstone and/or 
the IRB to discuss any questions about the study.  
• PWD and/or family members will be able to enroll their loved on in the study by 
signing the consent form digitally on any device (by using Adobe Sign) or by 
signing a hard copy and sending to Hearthstone.  
(b) The Hard Copy Recruitment Packet will include a cover letter, study flyer, two copies of 
the consent form (one to sign and send back to Hearthstone and one to keep for their 
records), and a postage-paid, pre-addressed return envelope (for sending the signed consent 
form to Hearthstone). 
• The PWD and/or family member will be encouraged to contact Hearthstone and/or 
the IRB to discuss any questions about the study.  
• PWD and/or family members will be able to enroll their loved on in the study by 
going to the study website and digitally signing the consent form on any device (by 
using Adobe Sign) or by signing a hard copy and sending to Hearthstone.  
 
YES 

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The cover letter, consent form, and flyer will have phone numbers, addresses, and email 
addresses for the PIs and Heartland IRB. The person will be encouraged to contact the PI or IRB 
if he/she has any questions. The consent form will include detailed information about what 
participation in the study entails. 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 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 PWD 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 PWD to participate in the study, the PWD 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, an ID number will be assigned to the participant. 
They will then speak with the PWD 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 PWD might have and then ask the PWD if 
he or she is interested in participating in the study. If so, the PWD will sign the assent form. Note: 
a copy of the full consent form will also be available to the PWD, in case he or she would like to 
review the full consent form. 
 
 
4.1 Retention 
 
In terms of retention, study staff will be in regular contact with all participants. Researchers will 
assist them 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 PIs at any point. Please also note that we will oversample to 
accommodate a reasonable level of attrition. 
 
4.2 HIPAA Authorization 
PWD 
Included with the consent packet will be a HIPAA authorization form, which will inform the 
legally authorized representative (LAR) that researchers will collect the PWD's protected health 
information (PHI) for use in this study, as specified in the consent form. The researcher will ask 
the LAR to please review and sign the HIPAA authorization form to allow the study team to access 
the PWD’s PHI. Participant information will only be accessed as needed to collect study-relevant 
data, including the following: diagnoses, medications, psychological test results, medical history, 
and demographics such as age, race/ethnicity, date of birth, sex, and education level. 
 
Any electronic protected health information (ePHI) collected on human subjects will be 
transmitted to, stored by, and accessed, via a HIPAA-compliant secure cloud provider. Such 
services secure the data while in transmission from the local machine to the servers and have high-
level encryption in place to secure the data once it has arrived. The system ultimately chosen will 

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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. 
 
5.0 SCREENING AND ELIGIBILITY CRITERIA  
 
5.1 Screening  
The following screening procedures will be used for each type of participant: 
 
A researcher will confirm that the participant meets the following inclusion/exclusion criteria by 
interviewing a family member or obtaining medical records for the person:  
 
Inclusion: PWD must be at least 65 years old, speak and read conversational English, and be 
diagnosed with dementia (any type).  
 
Exclusion: PWD will be excluded from the study if they show signs of rapid cognitive decline or 
physical deterioration over the last six months, as evidenced by medical records. 
.  
 
5.2 Screening Log 
After completing the screening process, the researcher will enter data into the Screening Log. The 
Screening Log will be digital in nature (a spreadsheet) and include all relevant screening data (as 
listed above).  
 
5.3 Eligibility Criteria 
 
Inclusion: PWD must be at least 65 years old, speak and read conversational English, and be 
diagnosed with dementia (any type).  
 
Exclusion: PWD will be excluded from the study if they show signs of rapid cognitive decline or 
physical deterioration over the last six months, as evidenced by medical records. 
 
 
6.0 STUDY INTERVENTION  
 
Description of SAFE at Home 
The SaH Service will be made available to consumers via the SaH Member Website (for computers) and 
the SaH App (for tablets). The same content and functionality will exist on the website and the app. The 
tablet-based app will be offered to ensure a high-quality experience on tablets. The Member website/app 
will consist of six different components. There will be four user types: Members (PWD/Family Members), 
Engagement Professionals (staff who facilitate SaH sessions), and Engagement Coaches (staff who are 
more extensively trained). Users will access the website by entering a username/ password. After logging 
in, they will be directed to the SaH Dashboard, which will be dynamic based on user type.  
(1) Get to Know You Portal (For All User Types) [Phases 1 & 2] Engagement Coaches will access 
this portion of the app to conduct the Get to Know You Session with the PWD and family member. The 
Get to Know You Session will last approximately 45 minutes and be split into three main parts: (1) the 
Cognitive/Communication Assessment, (2) the Full Interest Inventory, and (3) Account Creation / 

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Orientation. The first two parts of the session will be facilitated one-on-one with the PWD; however, the 
family member should be nearby to help with any technical issues that the PWD may experience. The final 
part of the session will be conducted privately with the family member. The purpose of the 
Cognitive/Communication assessment will be to determine whether the PWD is appropriate for a high 
cognitive / communication ability group or a middle cognitive / communication ability group. Persons who 
have low cognitive / communication abilities will have been be previously deemed ineligible for SaH 
(during the Trial Session). The assessment will use Hearthstone’s I’m Still Here Skills Inventory (ISH-SI). 
The ISH-SI has been successfully used with for over 10 years to place people in appropriate activity 
programming for their particular ability level. This 5-10 minute assessment is an adapted version of the 
MMP/MAS, which was developed and tested in an NIH-funded study (R01AG021508). The ISH-SI 
assesses cognitive/communication skills by inviting the PWD to participate in three brief activities 
(Hearthside Book Club, Sort It Out, and Critic’s Corner). These activities determine the extent to which the 
person can read, look at pictures/videos, and engage in conversation. Participants who score similarly on 
the ISH-SI will be identified as potential group peers. Further determination as to whether they show be 
assigned  to the same group will be based upon their specific background / interests. Engagement 
Professionals will access this component to learn about PWD who will be taking part in sessions that they 
will be facilitating. To maintain privacy, they will only have access to information for PWD assigned to 
their groups. Members (PWD and family members) will have access to this portal to confirm/adjust 
information gathered about his/her interests and background. It should be noted that members do not need 
to access this portion of the app/website during the Get to Know You Session. In fact, we do not expect 
members to access this part of the app/website very often (it is possible that they will never do so). However, 
since information about the PWD will be saved here (in way that is HIPAA-compliant), it is important for 
us to provide access to this information, so that we are transparent about the data we collect. 
(2) Social Engagement Portal (For All User Types) [Phases 1 and 2] This will allow for Engagement 
Professional-led social engagement of multiple Members simultaneously and is the central component of 
the product. Members (PWD, likely with the help of a family member) will access this portion of the app 
to participate in social engagement sessions. A list of upcoming sessions will be shown when accessing this 
portion of the website. To join a session, they will simply click “Start Now” to be connected via 
videoconference to an Engagement Professional and up to five other PWD. Members will be able to go to 
the Social Engagement Portal to start each session or they will be able to click on a link included in the 
reminder email that will be sent. Engagement Professionals will facilitate a session by interacting with 
participants via the webcam but will also share their screen with participants to show the activity content. 
As mentioned earlier, activities that have been shown to be effective in prior research will be used. 
Everything an Engagement Professional needs to facilitate a session will be included in the Social 
Engagement Portal, including access to the activities. Engagement Coaches will also have access to the 
Social Engagement Portal. They will drop in unannounced to audit sessions, but not appear on video. The 
goal is for the Engagement Coach to make certain that high quality sessions are being offered to members 
and that fidelity to the procedures is being maintained in order to ensure a high quality intervention. Please 
note: Mr. Skrajner [PI] conducted six proof of concept activity sessions with 18 PWD via videoconference 
to determine whether conducting sessions using this methodology would be successful. In all cases, PWD 
were able to engage in the activities and generally seemed to enjoy participating. In a few cases, PWD 
spoke very quietly, which made it hard for Mr. Skrajner to hear their responses. But this was due to the fact 
that they were too far away from their tablet. So, we will instruct family members to place the device very 
close to their loved one for sessions, and to encourage PWD use headsets with mics, to avoid such issues 
in the future.  
(3) Peer-to-Peer Interaction Portal (For Members) [Phase 2] In order to maximize the potential for 
social engagement, Members (PWD) will be encouraged to participate in “breakout sessions” with 1-2 
other PWD when they are not participating in staff-facilitated Social Engagement Sessions. To do so, they 
would log in to the Peer-to-Peer Study Portal at the same time as others. It is likely that family members 
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would have options to engage with each other in meaningful ways ranging from simply chatting informally 
to having access to small group assignments / conversation starters that they can work on or discuss together 
(e.g., “talk about what it was like to go to the movies years ago”) 
(4) Self-Study Portal (For Members) [Phase 2] Members (PWD) will also be encouraged to participate 
in Self-Study when they are not participating in the Social Engagement or Peer-to-Peer Study Portals. 
Distinct versions of Hearthstone’s proprietary, evidence-based activities formatted and structured for 
private use will be available in this portal.  
(5) Staff Training Portal (For Engagement Professionals and Engagement Coaches) [Phases 1 and 
2] Engagement Professionals will access this portion to take video-based, SCORM-compliant training 
modules. In order to be eligible to be an Engagement Professional, the person must have experience in 
recreation therapy, life enrichment, physical therapy, occupational therapy, speech therapy, or a related 
field. The person must have at least one year of experience working with PWD. So, we expect our 
engagement professionals to have most of the basic qualifications needed to work effectively with PWD. 
That being said, our training will be designed to ensure that the person has the appropriate knowledge and 
skills to facilitate a videoconference-based session with PWD. More specifically, there will be five main 
training modules. (1) Video Conferencing Best Practices, (2) Overview of the 10 SaH Activities, (3) 
Communicating with PWD, (4) Tips for Facilitating Activities with PWD via Videoconference, and (5) 
Using the SaH Website and App. After completing the self-study online training courses and taking a test 
that shows that he/she has acquired the necessary knowledge to implement SaH sessions, each Engagement 
Professional will schedule a Mock Session with an Engagement Coach. The Mock Session will be 
scheduled within the Staff Training Portal. During the Mock Session, the Engagement Professional will 
connect with two Engagement Coaches, who will participate in a simulated SaH session, which will be led 
by the trainee. If the Engagement Professional shows competence at facilitating the mock session (based 
upon a 20-item checklist of key processes for leading SaH), he/she will become a certified SaH Engagement 
Professional. He/she will then be able to facilitate sessions as they are needed. Engagement Coaches will 
also have access to this portion of the app, so they can check progress trainees have made on the self-study 
online courses, review test results, and also start the Mock Sessions. Please note that Engagement Coaches 
will be trained initially by taking the Online Training courses and then doing the Mock Session (like 
Engagement Professionals). However, in addition, in order to become a certified Engagement Coach, the 
person will need to facilitate 30 SaH sessions (receiving good reviews from Members), pass a knowledge 
test, and receive further individualized training. 
(6) Scheduling Portal (For All User Types) [Phase 2] Members (Family Members) will access this 
component to schedule sessions. They will be asked to indicate all available time slots, as well as the number 
of sessions they wish to participate in per week. Once a session is scheduled, based upon availability of all 
PWD, they will be able to approve/deny the session request. If an insufficient number of PWD approve a 
requested session day/time, a new session time will be proposed (Please note: in order to achieve the goal 
of social engagement, sessions will only occur if at least three PWD can participate.) However, even if a 
session is unavailable, family members can opt to log their loved one in for a Self-Study session, allowing 
them to benefit from being personally engaged even if social engagement isn’t available at that time. 
Engagement Professionals will access this component of the app to see all requests for engagement 
sessions. They can then accept or reject such requests. A calendar showing all requests and future 
engagements will be available. They will only be invited to facilitate a session if the calendar determines 
that they are available. Engagement Coaches will access this component to determine which sessions 
he/she might view for auditing purposes.  
 

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7.0 STUDY MEASUREMENTS AND PROCEDURES  
 
 
PWD 
 
Baseline Assessments / Observations 
1. Chart Review Form 
a. A researcher will conduct a CHART REVIEW to collect the following data: 
i. 
Demographics (race/ethnicity, education level, marital status, and number 
of years living in LTC) 
ii. 
Diagnoses 
iii. 
Type of dementia 
iv. 
Medications 
2. Short Portable Mental Status Questionnaire (SPMSQ-T) 
a. A researcher will conduct a direct interview with the PWD to administer the 
DEMQOL  
b. The Short Portable Mental Status Questionnaire (SPMSQ-T) by Roccaforte et al. 
(1994) is a brief, validated tool used to screen for cognitive impairment in older 
adults. It consists of 10 simple questions assessing orientation, memory, and basic 
arithmetic, providing a quick evaluation of mental functioning in clinical and 
research settings. 
3. Dementia Quality of Life (DEMQOL) 
a. A researcher will conduct a direct interview with the PWD to administer the 
DEMQOL. However, if the PWD is unable to respond to questions on the 
DEMQOL, this measure will be administered via proxy interview (with a staff 
member who is familiar with the PWD). 
b. The DEMQOL is a 28-item self-reported measure related to health-related quality-
of-life (HRQL) in residents with dementia. The DEMQOL takes cognition, 
negative emotion, positive emotion, social relationships, and loneliness into 
consideration. The DEMQOL-Proxy is a 31-item measure administered to the 
staff/caregiver and focuses on cognition, negative emotion, positive emotion, daily 
activities, and appearance. 
i. 
Each item on the DEMQOL (and DEMQOL-Proxy) has four response-
options: 
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: 

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Not at all = 1 
A Little = 2 
Quite a Bit = 3 
A Lot = 4 
iv. 
The total possible score on the DEMQOL ranges from 28 – 112, with lower 
scores indicating a lower quality of life. The total possible score on the 
DEMQOL-Proxy ranges from 30 to 120. If a DEMQOL-Proxy is 
administered, the total score is calculated and scaled to fit the same scoring 
range as the DEMQOL. If DEMQOL-Proxy total score = X, then (X/30) x 28 
= DEMQOL (summary/scaled) total score. 
v. 
The final item on the DEMQOL (and DEMQOL-Proxy), asks how the PWD 
would rate his/her overall quality of life. This item has the following options 
and coding: 
Poor = 1 
Fair = 2 
Good = 3 
Very Good = 4 
vi. 
This final item is not included in the total score on the DEMQOL (nor on 
the DEMQOL-Proxy) 
4. Geriatric Depression Scale – Short Form (GDS-SF) 
a. A researcher will conduct a direct interview with the PWD to administer the 
GDS-SF.  
b. The Geriatric Depression Scale-Short Form (GDS-SF) is a 15-item screening tool 
designed to assess depressive symptoms in older adults. It uses a simple yes/no 
format to evaluate mood, energy, and outlook, making it quick and easy to 
administer in clinical and community settings. 
5. UCLA Loneliness Scale (ULS) 
a. A researcher will conduct a direct interview with the PWD to administer the ULS. 
b. The UCLA Loneliness Scale is a widely used instrument designed to measure 
subjective feelings of loneliness and social isolation. It consists of 20 items that 
assess the frequency of loneliness-related thoughts and feelings, providing insight 
into an individual’s perceived social connectedness. 
6. Neuropsychiatric Inventory-Nursing Home (NPI-NH) 
a. A researcher will administer the NPI-NH by interviewing a proxy (staff/caregiver) 
who is familiar with the PWD. 
b. The NPI-NH is a comprehensive assessment of psychopathology in PWD, focused 
on people residing in nursing homes. The NPI-NH evaluates 12 neuropsychiatric 
symptoms in dementia patients in the nursing home setting, including the 
following: Delusions, Hallucinations, Agitation, Depression / Dysphoria, Anxiety, 
Apathy, Irritability, Euphoria, Disinhibition, Aberrant Motor Behavior, Nighttime 
Behavior, and Appetite / Eating Changes.  
i. 
Each item is initially rated as present or absent. 
ii. 
If the symptom is present, the interviewee is asked to rate the frequency (1 
to 4) and severity (1 to 3) of the symptom for the PWD 
iii. 
A frequency x severity score is then calculated for each item; if a symptom 
is absent, the frequency x severity score is 0. As such, the total possible 

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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. 
7. Baseline Comparison for Engagement 
a. This study will use the MPES in this study to examine engagement and affect of 
PWD. 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.  
b. For the Phase I study, we will use a large database of participants engaging in 
activities as the baseline MPES scores. An independent samples t-test will be 
conducted to examine differences.   
0. If a person has not been seen in group activities after three visits and/or if 
a staff member has told us the person does not attend group activities, we 
will consider the person a “chronic non-activity attender.” 
1. We will then target this person in particular in future visits. 
2. We will ask staff to invite up to three non-attenders per activity. 
3. If the person attends, we will observe them in the activity. 
4. If they do not attend, we will go to the person’s room during the session 
and find out if they are awake or asleep (knock on the door). 
0. If they are awake, it will be coded as DID OTHER for more than 
half. 
1. If they are asleep, it will be coded as SLEPT/CLOSE EYES for 
more than half.  
c. Please note: all MPES observations will be conducted via a HIPAA compliant 
Google Form. Submitted responses will automatically be sent to a database. As 
such, there will be no need to save a corresponding PDF file in each participant’s 
digital binder for each MPES observation. To prevent changing of data in the 
database, there will be a lock on the database preventing changing of data, except 
by the PI or Experimental Team Leader. Although each MPES observation will not 
have a corresponding PDF file in the participant’s digital binder, a PDF will be 
generated for each observation for auditing purposes. The PDFs will be placed in a 
single folder. MPES observations will be spot checked for accuracy by comparing 
database data to PDF form data.  
 
Intervention Period Data Collection 
 
PWD will participate in SAFE at Home for two months during the Intervention Period of the Study.  
A variety of data will be collected during and/or after the session.   
 
1. Ease of Use and Satisfaction Measure 
After each session, the PWDs will be asked simple questions related to ease of use and 

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satisfaction (e.g., Did you find the activity easy to use? Did you enjoy the activity? Would you 
recommend it to others?) 
 
2. Observations of PWD in SAFE AT HOME Sessions w/ MPES 
a. Researchers will observe PWD’s engagement and affect during SAFE AT HOME 
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 SAFE AT HOME 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 
 
The following measures will be collected again at post-treatment: 
1. DEMQOL 
2. GDS-SF 
3. ULS 
4. NPI-NH 
 
 
 
 

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8.0 TIMELINE AND VISIT SCHEDULE 
 
Assessment / Interview / Data 
to Collect 
Screening 
Baseline  
Intervention 
Period 
Post-Treatment  
 
Informed Consent Form 
(Legally Authorized 
Representative or PWD) 
X 
 
  
  
Assent (PWD) 
X 
 
 
 
Confirm That the PWD Meets 
Eligibility Criteria 
X 
 
 
 
Enrollment (if person meets 
basic eligibility criteria) 
X 
 
 
 
SPMSQ (Baseline) 
 
X 
 
 
DEMQOL (Baseline) 
 
X 
 
 
GDS-SF (Baseline) 
 
X 
 
 
ULS (Baseline) 
 
X 
 
 
NPI-NH (Baseline) 
 
X 
 
 
MPES (Baseline Database of 
Existing Means / SD) 
 
X 
 
 
MPES (Intervention Period) 
 
 
X 
 
Satisfaction / Ease of Use 
Questions 
 
 
X 
 
DEMQOL (Post-Treatment) 
  
 
 
X  
GDS-SF (Post-Treatment) 
 
 
 
X 
ULS (Post-Treatment) 
 
 
 
X 
NPI-NH (Post-Treatment) 
 
 
 
 
DEMQOL (Post-Treatment) 
   
 
 
X  
NPI-NH (Post-Treatment) 
 
 
 
X 
 
 

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9.0 VISIT PROCEDURES 
 
PWD 
 
Screening Procedures 
 
A researcher will confirm that the participant meets the following inclusion/exclusion criteria by 
interviewing a family member or obtaining medical records for the person:  
 
Inclusion: PWD must be at least 65 years old, speak and read conversational English, and be 
diagnosed with dementia (any type).  
 
Exclusion: PWD will be excluded from the study if they show signs of rapid cognitive decline or 
physical deterioration over the last six months, as evidenced by medical records. 
 
Baseline Procedures 
 
Chart Review/Interview with Staff 
Researchers will collect the following data from each PWD’s chart: 
• Demographics (race/ethnicity, education level, marital status, and number of years living 
in LTC) 
• All diagnoses 
• Type of dementia 
• All meds 
 
Baseline Assessment  
A researcher will schedule a time to work with the PWD and conduct a direct interview with him/her 
to administer the SPMSQ, DEMQOL, GDS-SF, and ULS.  
 
Caregiver Interview 
Researchers will interview a caregiver to collect data related to neuropsychiatric symptoms (based 
upon the NPI-NH) and agitation (based upon the CMAI) exhibited by the PWD. In addition, if needed 
(i.e., if the PWD was unable to respond to the DEMQOL and/or GDS-SF questions), a researcher will 
interview the caregiver to administer the proxy version of the DEMQOL and/or GDS-SF.  
 
Observations of Standard Activities 
For the Phase I study, we will use a large database of participants engaging in activities as the 
baseline MPES scores. An independent samples t-test will be conducted to examine differences.   
 
Intervention Period Procedures 
 
PWD will be invited to participate in SAFE at Home sessions via videoconference twice per week for 
two months. The sessions will led by a Life Enrichment Professional.  
 
Observations of SAFE AT HOME Sessions 

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Researchers will observe the PWD taking part in SAFE at Home sessions using the MPES. We will 
aim to conduct multiple observations for each activity type, so that an average score can be calculated 
for SAFE AT HOME activity programming. Researchers will follow the standard protocols for using 
the MPES and be extensively trained on how to properly use these measures.  
 
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.  
 
 
Post-Treatment Procedures 
 
Post-Treatment Assessment  
A researcher will schedule a time to work with the PWD and conduct a direct interview with him/her 
to administer the DEMQOL, GDS-SF, and ULS.  
 
Caregiver Interview 
Researchers will interview a caregiver to collect data related to neuropsychiatric symptoms (based 
upon the NPI-NH) and agitation (based upon the CMAI) exhibited by PWD. In addition, if needed 
(i.e., if the PWD was unable to respond to the DEMQOL and/or questions), a researcher will interview 
the caregiver to administer the proxy version of the DEMQOL and/or GDS-SF. 
 
10.0 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.  
 
11.0 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.  
 
12.0 SAFETY REPORTING 
 
For the purposes of this study, a participant is considered enrolled if they have successfully completed 
the screening procedure outlined above. The appointed Safety Officer provides safety oversight of the 
trial.   
 
After being enrolled in the study, participant safety will be monitored regularly by the PI and reported 
as needed to the Safety Officer. 
 
All adverse events that are both serious (SAE) and unexpected (i.e., have not been previously reported 
for the study's intervention), they should be reported to IRB, NIA PO and to the NIA-appointed Safety 
Officer (SO), within 48 hours of the study's knowledge of SAE. 
 
The summary of all other SAEs should be reported to NIA Program Officer and to the DSMB (or a 
Safety Officer) quarterly (or biannually), unless otherwise requested by the DSMB or a Safety Officer. 

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Reports of death should be submitted to NIA Program Officer and to the Safety Officer within 24 
hours of study’s knowledge of death. AEs should be reported per IRB policies. They should also be 
reported the NIA Program Officer and the SO, at frequency requested by NIA and/or by the SO. At 
minimum, annual reports are required. 
 
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 
• 
Persistent or significant disability/incapacity 
 
As this is a minimal risk psychosocial activity intervention, no AEs or SAEs are expected per NIH 
definitions, as none of the risks of the study will affect medical outcomes or occurrences.  
• The PI will review study conduct in real time. 
• The PI will review accrual, drop-outs, and protocol deviations on an annual basis.  
• The PI will review AEs individually in real-time, and in aggregate on an annual basis.   
• The PI will review serious SAEs in real-time, and in aggregate on an annual basis.  
• SAEs and specific procedure-associated AEs will be reported to the Heartland IRB when 
the yearly IRB report is due, unless the SAE or AE is “possibly related” or “related” to 
the study procedures.  
o If the SAE or AE is “possibly related” or “related” to the study procedures, the 
SAE or AE will be reported to the IRB within 24 hours of determination of AE/SAE. 
o If any SAEs occur, the PI will, with the assistance of the IRB, determine if any 
modifications need to be made to the study protocol and procedures. As this is a 
minimal risk study, this is highly unlikely. 
 
12.1 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 their participation in the programming 
will stop for that session. If this occurs at a clinical level that then results in an AE, it will be reported 
to the IRB when the yearly IRB report is due. 
 
12.2 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. 
 
 

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12.3 Reporting Procedures 
 
SAEs and AEs are reported to the Heartland IRB when the yearly IRB report is due, unless the 
SAE or AE is “possibly related” or “related” to the study procedures. If the SAE or AE possibly 
related” or “related” to the study procedures, the SAE or AE will be reported to the IRB within 24 
hours. 
12.4 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 
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. 
12.5 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.  
12.6 Follow-up for Adverse Events 
Expected AEs 
Expected AEs associated with the study procedures include:   
• Extreme Feelings of Frustration/Embarrassment during the Assessments / 
Intervention 
 
AE Management 
• Only staff with proper experience in working with vulnerable populations will be 
permitted to take part in primary data collection. This will increase the chances that 
they know how to reduce such feelings in participants 
• All SPs will receive training on how to recognize signs of frustration and 
embarrassment and what to do in such situations. 
• SPs will be instructed that, if such signs are present, the assessment or activity will be 
discontinued and/or the participant will be given an alternative activity. 

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12.7 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. 
 
13.0 STUDY COMPLIANCE  
 
The PI will maintain a Protocol Deviation / Violation Log, in which he will report of all protocol 
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 
 
 
14.0 DATA COLLECTION AND STUDY FORMS 
 
The following documents are used in this study. Descriptions of measures are included above.  
 
PWD 
 
Screening Documents  
1. PWD Initial Screening / Inclusion Form 
 
Baseline Assessments / Observations Documents   
1. Chart Review Form 
2. SPMSQ 
3. DEMQOL 
4. GDS-SF 
5. ULS  
6. NPI-NH 
 
Intervention Period Data Collection  
1. Satisfaction Question Form 
2. MPES  
  
Post-Treatment Assessment Documents 
1. DEMQOL 
2. GDS-SF 
3. ULS  
4. NPI-NH 

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15.1 Source Documentation 
 
This section describes how participant data are maintained in the study. 
 
Definitions: A source document is any document on which study data are initially recorded. Source 
documents for this study include demographics forms, medical records, standardized test forms, 
satisfaction questionnaires, and engagement forms, etc. Most source documents are electronic in 
nature and will also serve as electronic Case Report Forms (eCRFs) to document study-specific data 
requirements. This method reduces the likelihood of transcription errors. All data will be checked and 
cleaned during a QA process to ensure data integrity.  
 
All essential study documents will be retained by the investigator in an electronic Participant Binder 
and include:  
• Source documents  
• Measures administered to the participant 
• Measures administered to the proxy interviews 
• eCRFs 
• Applicable Notes to File (including Notes to File that indicate errors in forms) 
 
Note: The only exception to this is that Resident Consent Documents are kept in an 
electronic folder named “Participants and Consents.” This keeps the participant name 
separate from de-identified data. 
 
At the conclusion of the study, all source documents, eCRFs, and other required documentation will 
be kept with study records as required by protocol and IRB guidelines. 
 
Please note: all MPES observations will be conducted via a HIPAA compliant Google Form. 
Submitted responses will automatically be sent to a database. As such, there will be no need to 
save a corresponding PDF file in each participant’s digital binder for each MPES observation. To 
prevent changing of data in the database, there will be a lock on the database preventing changing 
of data, except by the PI or Experimental Team Leader. Although each MPES observation will not 
have a corresponding PDF file in the participant’s digital binder, a PDF will be generated for each 
observation for auditing purposes. The PDFs will be placed in a single folder. MPES observations 
will be spot checked for accuracy by comparing database data to PDF form data.  
 
 
15.2 Forms Maintenance 
 
All forms will be stored in electronic participant “binders.” Forms which are collected digitally will 
automatically be saved to a secure, HIPAA-compliant database and then manually distributed to the 
correct participant binder. Hard copy forms will be scanned and placed into the proper digital binder.  
 
Please note: all MPES observations will be conducted via a HIPAA compliant Google Form. Submitted 
responses will automatically be sent to a database. As such, there will be no need to save a 

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corresponding PDF file in each participant’s digital binder for each MPES observation. To prevent 
changing of data in the database, there will be a lock on the database preventing changing of data, 
except by the PI or Experimental Team Leader. Although each MPES observation will not have a 
corresponding PDF file in the participant’s digital binder, a PDF will be generated for each observation 
for auditing purposes. The PDFs will be placed in a single folder. MPES observations will be spot 
checked for accuracy by comparing database data to PDF form data.  
 
 
15.3 General Instructions for Completing Forms 
 
For All forms: 
• All forms should be filled out electronically. 
• Any hard-copy forms will be scanned as soon as feasible and become the source document.   
• Completed forms should be saved in the participant's digital binder (file folder with their ID 
number) 
• To ensure the best possible level of confidentiality, after scanning hard copy forms, these forms 
will be stored in a secure area. After data from hard copy forms have been entered / double 
checked, such forms will be shredded.  
• The Experimental Team Leader and/or PI will spot check a subset of forms before they are 
entered into SPSS to ensure that proper protocols are being adhered to and data is appropriately 
cleaned. 
• After data on digital forms are confirmed to be accurate, researchers will flatten the digital 
form (to prevent accidental changes to the file) and save it to the participant’s digital binder.  
o The file name will have descriptive details about what is included in the file (e.g., 
Resident Assessment, HBC Session Observation / Evaluation Form, etc.) 
o In addition, the researcher will end the file name with his/her initials and the date (e.g., 
dw_2022_01_01) 
• The Experimental Team Leader is responsible for updating forms, as needed. 
• The PI will review and approve all changes to forms. 
• During weekly meeting, issues with data collection, including possible problems with forms 
should be discussed by study team members. 
• Researchers should be sure to completely fill out all forms. 
• 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. 

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• Comments written extraneously on forms cannot be captured in the database; thus, write only 
in the spaces indicated.   
• If an error has been made on the study forms, place a single line through the erroneous entry 
and record the date and your initials. Indicate the correct response. 
• Do not skip any items. Some items may carry "Unknown" or "Not Applicable" response 
choices which should be checked when necessary.  
• Data may not be available to complete the form for various reasons. Circle the item for which 
data is not available and indicate the reason near the appropriate field: 
• If an evaluation was not done, write ND and provide a reason. 
• If the information is not available, but the evaluation was done, write NAV.   
o Only in rare circumstances, as in the case of lost documentation, should NAV be 
recorded on the form. Every effort should be made to obtain the information requested. 
• If an evaluation is not applicable, write NA. 
• Incomplete or Illegible forms: Incomplete forms that do not have adequate explanation (as 
described above) compromise the integrity of the entire study. 
• If/when site-staff share a document with a participant’s name on it, the name of the person will 
be digitally redacted, and the ID number of the person put in place of the name 
o To preserve privacy, the document with the name of the person will be deleted 
o The version with the ID number will be place in the appropriate digital file folder.  
 
For Digital Forms: 
When a form is completed, it should be placed in the digital binder (file folder) for the individual 
participant. 
 
For Hard Copy Forms: 
Hard copy forms should only be used when a tablet and/or internet is unavailable. If used, hard copy 
forms must be scanned immediately after collection and uploaded to the participant binder. The 
scanned version will then be considered the source document. Hard copy will then be stored in a 
secured area. When completing hard copy study forms, print using dark ink. 
 
15.4 Data Flow  
Completed forms (whether electronic or hard copy) will be reviewed by a researcher to ensure 
completeness and accuracy. Any errors will be crossed out, corrected, and then initialed. After data on 
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 Retention of Study Documentation  

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After the study ends, research staff shall maintain participant forms in Hearthstone’s HIPAA-
compliant database for three years or as indicated by the protocol, federal regulations, and IRB 
guidance.  
 
 
16.0 DATA MANAGEMENT 
 
Data Tracking will be conducted in the following way: 
• A data tracking spreadsheet will be used. Each row will contain a participant ID and each 
column will contain a piece of data required for the study (e.g., NPI-NH or DEMQOL). 
This will allow him to track which data has been and which data will need to be collected 
(and by when). Once data is collected, he will note the person who collected the data and 
on what date (e.g., Collected by XX on 7/30/21). It should be noted that separate data 
tracking spreadsheets will be maintained for each type of participant (PWD, SPs, and 
Family Members). 
 
Study Form Review will be conducted in the following way: 
• After data on digital forms are confirmed to be accurate, researchers will flatten the digital 
form (to prevent accidental changes to the file) and save it to the participant’s digital binder.  
a. The file name will have descriptive details about what is included in the file (e.g., 
Resident Assessment, HBC Session Observation / Evaluation Form, etc.) 
b. In addition, the researcher will end the file name with his/her initials and the date 
(e.g., dw_2022_01_01) 
 
Data Entry will be conducted in the following way: 
• The Research Assistant will enter data directly into SPSS by reviewing the forms. Data 
will be double-checked for accuracy.  
 
Data Analyses will be conducted in the following way: 
• The PI will conduct data analyses using SPSS. 
 
 
16.1 Quality Control Procedures 
All research staff responsible for data collection and management will have received human subjects 
and, as applicable, 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 the separate Data and Safety and Monitoring Plan. 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. 

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• 
The PI will notify participants of the study completion. 
 
 
17.3 Confidentiality Procedures 
The following confidentiality safeguards will be used: 
• 
Electronic files – Data identifying participants that are stored electronically will be 
maintained in a separate file that is saved on a secure, HIPAA-compliant server. 
• 
Forms – Forms or pages containing personal identifying information will be separated 
from other pages of the data forms and be retained in a secure location.  
• 
Data listings – Participant name, name code, long-term care chart, record number, and 
other unique identifiers will not be included in any published data listing. 
• 
Data distribution – Data listings that contain participant name, name code, or other 
identifiers easily associated with a specific participant will not be distributed. 
• 
Data disposal – Computer listings that contain participant-identifying information will 
be disposed of in an appropriate manner. 
• 
Access – Participant records will not be accessible to persons outside the site without the 
express written consent of the participant. 
• 
Storage – Study forms and related documents will be retained both during and after study 
completion and will be stored in a secure location 
• 
Passwords – Passwords will be used to provide limitations on general access to computer 
systems and to the functions that individuals can use. Passwords will be changed on a 
regular basis. 
• 
User Training – Research staff with access to computer systems will be trained in their 
use and in related security measures. Training will include explanations of how to access 
the system and a discussion of the need for, and importance of, system security.  
• 
System Testing – Prior to the use of a new computer system, and after any modifications, 
the system will be tested to verify that it performs as expected. Testing will verify that 
the password-activated access system performs as intended. 
• 
System Backups – Backup copies of electronic data will be made on a regular basis. 
 
17.4 Publications 
Study results will be made available to the public as soon as possible. Publication of the results of 
this trial will be governed by the policies and procedures of Hearthstone, NIH guidelines, and 
standard industry practice. Any presentation, abstract, or manuscript will be made available for 
review by the sponsor and the NIA prior to submission. 
 
18.0 MOP MAINTENANCE 
 
The MOP will be updated on an as needed basis. When a new revision is made, the following 
procedure will be followed: 
 
1. The version date on the cover page and footer will be updated with the latest date. 
2. A list of key changes will be listed on the cover pages. All changes will tracked.   
3. Previous versions of the MOP will be maintained and saved.