Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement With People Living With Dementia and Their Care Partners
Phase: NA
Conditions: Dementia, Cognitive Impairment
Sponsor: Benjamin Rose Institute on Aging

 
 
 
 
 
MANUAL OF OPERATIONS  
AND PROCEDURES 
Prepared by the Benjamin Rose Institute on Aging, Center for Research and Education. 
 
Principal Investigator: Lisbeth Sanders 
Co-Investigator: Silvia Orsulic-Jeras 
Development of a Reminiscence Therapy Online Platform with Machine Learning to Increase 
Engagement with People Living with Dementia and Their Care Partners 

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Development of a Reminiscence Therapy 
Online Platform with Machine Learning to 
Increase Engagement with People Living with 
Dementia and Their Care Partners 
 
Protocol Number: 1908-216  
National Clinical Trial (NCT) Identified Number: NCT04769466 
Principal Investigator: Beth Sanders 
Sub-Award Principal Investigator: Silvia Orsulic-Jeras 
Sponsor: LifeBio Inc. 
Grant Title: Development of a Reminiscence Therapy Online Platform 
with Machine Learning to Increase Engagement with People Living with 
Dementia and Their Care Partners 
Grant Number: 5R44AG069566-02 
Funded by: National Institute on Aging (NIA) 
Version Number:  v.1.0  
26 May 2021  
 

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Table of Contents 
Study Protocol....................................................................................................................................... 3 
Rationale: .............................................................................................................................................. 3 
Study Organization and Responsibilities .......................................................................................... 4 
Training Plan ......................................................................................................................................... 7 
Communications Plan .......................................................................................................................... 7 
Project Overview .................................................................................................................................. 8 
Study Flow ............................................................................................................................................. 9 
Recruitment Procedures ................................................................................................................... 11 
Screening ............................................................................................................................................ 12 
Eligibility ............................................................................................................................................... 12 
Informed Consent ............................................................................................................................... 13 
Participant Retention ......................................................................................................................... 14 
Study Measurements and Procedures............................................................................................ 15 
Specific Aim 1: ................................................................................................................................ 15 
Specific Aim 2 ................................................................................................................................. 15 
Specific Aim 3: ................................................................................................................................ 16 
Safety Reporting ................................................................................................................................. 19 
Protection Against Risks ............................................................................................................... 19 
Adverse Event Collection and Reporting .................................................................................... 20 
Potential Benefits for Participants ................................................................................................ 20 
Data Flow ............................................................................................................................................ 21 
Retention of Study Documentation .................................................................................................. 21 
Data Management .............................................................................................................................. 22 
Quality Control Procedures ............................................................................................................... 22 
Reports ................................................................................................................................................ 23 
Data and Safety Monitoring Activities ............................................................................................. 23 
Study Completion Procedures ......................................................................................................... 24 
Dissemination ..................................................................................................................................... 24 
References .......................................................................................................................................... 24 
Appendix .............................................................................................................................................. 25 
Aim 1 Flowcharts ............................................................................................................................ 25 
Aim 1 Recruitment Flyer ................................................................................................................ 27 
Aim 1 Recruitment Script for Stakeholders ................................................................................ 28 
Video Recording Consent ............................................................................................................. 30 
Focus Group Enrollment Letter .................................................................................................... 31 

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tMMSE ............................................................................................................................................. 33 
Verbal Consent Form ..................................................................................................................... 35 
 
Study Protocol 
Rationale: 
Almost 6 million Americans are currently living with Alzheimer’s disease (AD) or AD-
related dementias (ADRD), and the number of affected individuals is rapidly growing. 
Symptoms include impaired cognition, resulting in difficulty in performing daily 
activities and consequent functional dependence on others. The progressive nature 
of AD and ADRD can result in increasing degrees of care required from professional 
and family caregivers. Non-pharmacologic interventions positively influence 
cognition, mood, and other behavioral and psychological symptoms of dementia, and 
one well-established intervention, life story work (the use of written and oral life 
histories), serves as an effective technique that can elicit conversation and memories 
in those living with AD and ADRD. However, generating useful life story materials is 
a time-consuming task for caregivers. To overcome this barrier, LifeBio Inc. 
proposed to develop a reminiscence therapy platform, LifeBio MemoryTM, with a 
novel machine-learning-based application that converts speech to text and 
generates life stories to serve as an interactive tool to cultivate communication 
between people living with dementia and their family and caregivers. 
Funding: 
 
 
The LifeBio MemoryTM Project is funded by the National Institute on Aging (NIA) and 
is a collaboration with investigators from LifeBio Inc. and Benjamin Rose Institute on 
Aging (BRIA). 
IRB Approval: 
Benjamin Rose Institute on Aging (BRIA) serves as the single IRB (sIRB) of record 
given the relevant expertise in human research protections to review the study. The 
other identified participating sites, i.e., LifeBio, also rely on the BRIA sIRB. Other 
agreements and reporting responsibilities are determined, as necessary. Sites can 
communicate via email or phone with the IRB Coordinator at BRIA: Ms. Miriam Rose 
(mrose@benrose.org; 216-373-1674) regarding any questions and concerns related 
to the IRB. This study was approved by the Benjamin Rose IRB on 6/25/2020. 
 
 

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Study Organization and Responsibilities 
Primary Awardee Site: LifeBio Inc., founded in 2012 as a privately held corporation, 
is an online storytelling platform company that currently resides in Marysville, Ohio. 
The initial idea for LifeBio began years ago when Beth Sanders, the Founder & CEO, 
interviewed her own grandmother on an old tape recorder. That day, she watched as 
her grandmother “lit up” as she shared priceless memories. Since then, LifeBio helps 
people ask the right questions to bring out the best memories and stories with the 
goal of engaging more effectively and creating a lasting and priceless legacy. LifeBio 
works with thousands of people in the U.S. and around the world to help them 
capture their life stories and publish biographies. LifeBio also offers tools and 
reminiscence methods used in senior living and healthcare settings.  
Staff Contact Information: 
Lisabeth (Beth) Sanders, B.A. 
                        Primary Principal Investigator 
                        LifeBio Inc. 
                        232 North Main Street, Suite 2J 
                        Marysville, OH 43040 
                        Office: 937-303-4574 
                        bsanders@lifebio.com 
Jeff Sanders, M.S. 
            Chief Technical Officer 
            LifeBio Inc. 
            232 North Main Street, Suite 2J 
            Marysville, OH 43040 
            Office: 937-303-4574 
            jsanders@lifebio.com 
Rebecca Williams, B.S. 
            Project Manager 
            LifeBio Inc. 
            232 North Main Street, Suite 2J 
            Marysville, OH 43040 
            Office: 937-303-4574 
            becky@lifebio.com 
Sub-Awardee Site: Benjamin Rose Institute on Aging (BRIA), founded in 1908, is an 
over 110-year-old Cleveland-based non-profit organization whose mission is to 
support caregivers and empower all people to age well through research, consumer-
responsive services, and client advocacy. The organization’s work is accomplished 
by deepening the understanding of older adults and their caregivers in a changing 
society; developing and delivering innovative, high-quality solutions; and promoting 
effective public policies. BRIA’s Center for Research and Education, established in 
1961, is one of the nation’s premier and longest-standing Centers for applied aging 
research located in a non-university setting. The Center conducts state-of-the-art 
research using various methodologies to enhance the lives of older adults, their 
families, and the service providers who care for them. Specialty areas include family 

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caregiving; services, interventions, and evidence-based programs; long-term care; 
active aging; and program evaluation. Because it is part of a service and advocacy 
organization, the Center is uniquely qualified to collaborate with health and social 
service providers in translating research findings into evidence-based programs and 
other useful products and resources. Innovative programs and services are 
developed by the Center and implemented by service organizations across the 
country.  
Silvia Orsulic-Jeras, M.A. 
            Subaward Principal Investigator  
            Benjamin Rose Institute on Aging 
            11890 Fairhill Road 
            Cleveland, OH 44120 
            Office: 216-373-1625 
            sjeras@benrose.org  
Ashlee Cordell, M.G.S. 
            Project Coordinator 
            Benjamin Rose Institute on Aging 
            11890 Fairhill Road 
            Cleveland, OH 44120 
            Office: 216-373-1722 
            acordell@benrose.org 
Sara Powers, Ph.D. 
            Co-Investigator 
            Benjamin Rose Institute on Aging 
            11890 Fairhill Road 
            Cleveland, OH 44120 
            Office: 216-282-3164 
            spowers@benrose.org 
Farida Ejaz, Ph.D. 
            Co-Investigator 
            Benjamin Rose Institute on Aging  
            11890 Fairhill Road 
            Cleveland, OH 44120 
            Office: 216-373-1660 
            fejaz@benrose.org 
Christa Wilk, B.S., B.A. 
            Research Assistant 
            Benjamin Rose Institute on Aging 
            11890 Fairhill Road 
            Cleveland, OH 44120 
            Office: 216-373-1665 
            cwilk@benrose.org 
 

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Safety Officer: The safety officer (SO) must maintain independence from the study. 
Accordingly, the SO will not be directly involved in the design and conduct of the 
study, and will not have scientific, proprietary, financial, or other interests that may 
affect independent decision-making. The following SO was reviewed and approved 
by the NIA. Should there be any questions regarding the independence of the SO, it 
will be addressed and corrected as necessary. 
Neelum T. Aggarwal, MD 
Associate Professor: Department of Neurological Sciences  
Rush Alzheimer’s Disease Center 
Research Director: Rush Heart Center for Women 
Rush University Medical Center 
Office: 312-942-3333 
Neelum_T_Aggarwal@rush.edu  
 
Program Officer: The program officer (PO) reviews and approves data and safety 
monitoring plans, reviews safety reports, reviews proposed protocol changes and 
new protocols, and reviews Research Performance Progress Report (RPPR). 
Elizabeth A. Necka, Ph.D.  
Program Director 
Individual Behavioral Processes (IBP) Branch 
Division of Behavioral and Social Research (DBSR) 
National Institute on Aging (NIA) 
7201 Wisconsin Ave, Bethesda, MD 20892 
Office: 301-480-6947  
Liz.Necka@nih.gov 
Study-Related Questions: Please direct any development-related questions to Beth 
Sanders (Primary Principal Investigator) and research-related questions to Silvia 
Orsulic-Jeras (Subaward Principal investigator). 
 
 

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Training Plan 
Research Staff:  
Prior to beginning tasks on the project, research staff are required to obtain human 
subject training (or show proper verification of having recently completed such 
training). Research Assistants receive on-going supervision from the Principal 
Investigator on a weekly basis, or additional as needed. All BRIA research staff have 
completed NIH-approved human subjects training.  
Residential Care Professionals:  
During the full-scale fidelity trial, residential care professionals will be trained in the 
use of the revised LifeBio MemoryTM product using the associated training modules. 
Enrolled staff will have varying levels of prior training, background in gerontology, 
and/or experience working directly with older adults. Preloaded tablets with LifeBio 
MemoryTM will be distributed in a staggered manner for self-paced, online instruction. 
Each staff member is required to complete the training within one week of 
assignment, as well as a pre-training, baseline survey that collects demographic 
information, job history, previous experience with life story work, and attitudes 
towards person-centered care and older adults living with dementia. Other support 
materials, like frequently asked questions (FAQs), will also be provided for viewing. 
Staff members also complete a checklist and post-training survey on the tablets that 
gathers their opinion on 1) the length of time spent on training, 2) whether they had 
difficulty particular sections/content/materials, 3) whether they felt prepared to 
conduct life story interviews with older adults living with dementia. 4) whether they 
felt comfortable with the basic functionality of LifeBio MemoryTM, 5) whether they felt 
confident the technology would accurately convey the story of the resident living with 
dementia, and 6) whether they had specific questions not covered by the FAQs or 
training. They also have the opportunity to provide comments on their overall 
experience via open-ended questions. 
Communications Plan 
The project team at BRIA meets internally on a weekly basis to discuss project tasks 
and the study at large. The entire project team, including BRIA and LifeBio staff, 
meets on a weekly basis to provide updates on project tasks and discuss the 
progression of the study overall. 
 
 

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Project Overview 
Narrative: 
Non-pharmacological interventions and person-centered care strategies are 
important elements of care for people with AD and ADRD. Life story work, which 
uses written and oral life histories to elicit conversation and memories, is an effective 
intervention for individuals living with dementia; however, because of the time-
consuming nature of generating useful life story materials, has not been widely 
implemented in nursing homes and other care environments. The development of an 
easy-to-use reminiscence therapy platform, LifeBio MemoryTM, with a novel machine-
learning-based application that converts speech to text and generates life stories to 
serve as an interactive tool to cultivate communication between individuals living with 
dementia and their family and caregivers. The LifeBio MemoryTM platorm application 
will elicit and store individuals’ stories and photos, and ultimately deliver 
personalized, point-of-care reminiscence therapy exercises to program users.  
Goals and Objectives: 
• Develop prototype enhancements of the existing LifeBio program and conduct 
focus group evaluations of these prototypes with existing or former LifeBio 
users, dementia care professional familiar with LifeBio, and older adults living 
with early-stage dementia to help maintain person-centered practices 
throughout the research process. 
• Finalize the LifeBio MemoryTM product, which will include the development of 
a system to automatically record and process individuals’ life stories. 
Conduct a full-scale fidelity trial of the complete package with care professionals and 
dementia care dyads within assisted living and nursing home settings. 
 
 

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Study Flow 
The table shows the work plan and specific milestones to be reached. 
 
Specific Aim 1: The first Aim of the study takes place during the first 6 months of the 
24-month project period.  
Month 1: The project PIs from LifeBio Inc. and BRIA hold a kick-off meeting to 
orient the project teams. LifeBio staff reach out to partnering sites to identify 
current or former users of LifeBio and staff members who are familiar with LifeBio 
to invite them to participate in the focus group evaluation. At the same time, two 
Northeast Ohio Alzheimer’s Association Chapters identify individuals living with 
early-stage dementia who are interested in participating in the focus group 
evaluation. The design team, led by the LifeBio PI, begins prototyping 
development for two key features of the LifeBio MemoryTM tablet app – automatic 
speech-to-text voice recording and automatic uploading – for use in the focus 
group evaluation. The research team, led by the BRIA PI, obtains IRB approval. 
Month 2: The research team begin participant recruitment for existing user, staff 
member, and individuals living with dementia focus groups. The design team 
improve and further develop final prototypes.  
Month 3: The research team finalize all focus group evaluation protocols, 
materials, and questions, and completed the enrolment process, including 
obtaining consent, for all focus groups.  
Month 4: The research team conduct 7 focus groups - 2 groups of existing users, 
4 groups of staff members, and 1 group of individuals living with dementia as 
stakeholders. Subject payments are also processed. 
Month 5: The research team, including the Project Coordinator and Research 
Assistant, transcribe all the focus group sessions. The research team PI and Co-
Investigators, along with the qualitative data analysis expert consultant (Dr. Ruth 
Walker) lead focus group analysis. 

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Month 6: The research team prepare reports of focus group evaluation findings 
and provided recommendations to the design team based on the focus group 
evaluation findings. The design team revise Aim 2 goals based on significant 
findings from the research team’s report. 
Specific Aim 2: The second Aim of the study largely takes place during months 7-12 
of the 24-month project period. 
Months 7-12: The LifeBio design team setup new data storage for AI/machine 
learning, design and implement Microsoft Azure Cognitive Services for speech-to-
text and other AI services, develop and test a machine learning module and 
tagging feature, automate search services, develop a text summarization feature, 
and create an accessible Android and iOS tablet apps and accompanying training 
materials. 
Specific Aim 3: The third Aim of the study takes place during the last 11 months of 
the 24-month project period, beginning in month 13. 
Month 13: The LifeBio design team demoes the new LifeBio MemoryTM product 
features and materials with the BRIA research team. 
Months 14-15: The design team conducts final debugging of the app to deploy to 
Android and Apple tablets. The research team begins preparing to reconvene Aim 
1’s focus groups and develop new focus group materials and questions based on 
the completed LifeBio MemoryTM program.  
Month 15: The research team conducts a second round of focus groups with Aim 
1 participants and begins recruiting and enrolling staff and resident participants for 
the fidelity trial. 
Months 16-21: The research team begins baseline data collection (Time 1) for 
staff and resident participants. Time 1 interviews continue until month 19 as fidelity 
trial sites are brought on using a staggered design (3 sites at a time). Staff also 
complete the LifeBio Memory™ training immediately after their Time 1 Interview. 
Staff then conduct life story interviews with their assigned residents. Follow-up 
interviews (Time 2) with staff begin within 2 weeks of completing life story 
interviews. The design team is on-call for technical assistance as needed 
throughout the training and life story interview period, and up until the final LifeBio 
Memory™ product pieces (Life Story Book, Snapshot, Action Plan) are delivered 
to the sites. Final follow-up interviews (Time 3) with staff and residents begin in 
month 19 and continue through the end of month 21 when the fidelity trial 
concludes. 
Months 21-22: The research team conducts data analysis. The design team 
makes final improvements to the product. 
Months 23-24: The research and design teams prepare the final report and 
collaborate on a marketing study to prepare for the commercialization of LifeBio 
MemoryTM. 
 
 

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Recruitment Procedures 
Recruitment for Aim 1 focus group participants occurs during the first three months 
of the study, from August 2020 through October 2020. 
Existing LifeBio Users and Staff Focus Groups: Existing user and staff focus group 
participants were recruited directly from LifeBio Inc.’s pre-existing user base and 
sites which have already implemented the program. LifeBio distributed flyers to the 
identified sites and developed a list of interested participants in both populations. 
The cover letter, consent form, and flyer included phone numbers, mailing 
addresses, and email addresses for the PIs and designated IRB. Participants were 
recruited by LifeBio over the phone and were asked to provide contact information 
and consent for sharing their contact information with BRIA research staff. Referral 
forms collected from LifeBio were then shared with the BRIA PI and Project 
Coordinator using encryption security. 
Stakeholder Focus Group: Stakeholders (individuals living with dementia) were 
recruited through two Northeast Ohio Alzheimer’s Association Chapters - Greater 
East and Cleveland. Recruitment packets were mailed to the individuals living with 
dementia as well as any persons responsible for the medical decisions of the 
individuals living with dementia. Items sent in the recruitment packet included: a 
cover letter, a study flyer, two copies of the consent form (one copy signed and 
returned, and one copy retained for the person’s records), and a self-
addressed/postage-paid envelope. Contact information for the research team was 
also provided with the materials, and individuals were invited to contact researchers 
with any questions. The consent forms included detailed information about what 
participation in the study entailed. It also listed all the potential risks of the study, 
ways in which researchers will protect against the risks, and the likely benefits of the 
study. In all recruitment materials, it was also made clear that participation in the 
stakeholder group is voluntary, and that participants can stop participating at any 
time. Recruitment for the Aim 3 clinical trial is scheduled during months 13-14 of the 
study, from August 2021 through September 2021. 
Staff Participant Recruitment: Staff participants are recruited with assistance from 
the residential care facility site liaison. Site liaisons assist with distributing flyers to all 
staff members related to the program, describing study requirements, incentives and 
the overall goals of the program. Staff are instructed to refer to the flyers with 
research team contact information if interested.  
Residents Living with Dementia Participant Recruitment: Recruitment packets are 
mailed to persons responsible for the medical decisions of all participants living with 
dementia. Items sent in the recruitment packet include: a cover letter, a study flyer, 
two copies of the consent form (one copy signed and returned, and one copy 
retained for the person’s records), and a self-addressed/postage-paid envelope. The 
cover letter, consent form, and flyer included phone numbers, mailing addresses, 
and email addresses for the PIs and designated IRB. Individuals are invited to 
contact researchers with any questions. The consent forms include detailed 
information about what participation in the study entails. It also lists all the potential 
risks of the study, ways in which researchers will protect against the risks, and the 
likely benefits of the study. In all recruitment materials, it is also made clear that 

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participation in the stakeholder group is voluntary, and that participants can stop 
participating at any time. 
Screening 
Focus Groups: Researchers provide a verbal summary of the study of the phone. If 
the person seems interested in participating based upon the verbal summary, a 
consent form providing detailed information about the study is provided to the 
person, including what taking part in the study entails, risks, protection against risks, 
and potential benefits. Potential participants are encouraged to speak to researchers 
with questions. If the person decides to enroll, he/she signs the form and returns it to 
researchers.  
Clinical Trial: Researchers screen the potential staff person for fit prior to enrolment 
in the study. Enrolled staff participants assist with retaining participants and are 
asked to take part in bi-weekly calls with project staff. 
Eligibility 
Focus Groups: Focus group participants are required to be at least 18 years old, 
have previous experience with the LifeBio intervention, speak and read English, and 
be able to virtually attend the focus group on their own. Existing user and staff 
member focus group participants are excluded from the study if they were diagnosed 
with MCI or dementia. Stakeholder focus group members (persons living with 
dementia) are required to reside in the community, be at least 55 years old, speak 
and read English, and be diagnosed with dementia. Persons living with dementia are 
excluded from the study if they show signs of rapid cognitive decline or physical 
deterioration over the last 6 months, as evidenced by information gained during 
screening. 
Clinical Trial: Staff participants are required to be at least 18 years old, work within a 
residential care facility participating in the study, speak and read English, and be 
able to provide or arrange their own transportation to complete research interviews. 
Residents living with dementia are required to reside with a participating residential 
care facility, be at least 55 years old, speak and read English, be diagnosed with 
dementia, and score at least a 15 on the MMSE. Persons living with dementia are 
excluded from the study if they show signs of rapid cognitive decline or physical 
deterioration over the last 6 months, as evidenced by information gained during 
screening. 
 
 

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Informed Consent 
Focus Groups: The verbal consent form is read aloud, and verbal consent is 
established. Those who are interested after hearing an overview of the study, are 
screened to determine if they meet study criteria, and agree to participate. A copy of 
the verbal consent form that provides detailed information about the study, including 
what taking part in the study entails, possible risks, protection against risks, and 
potential benefits is also provided to the person by mail. Participants are also 
encouraged to speak to researchers with questions.  
Clinical Trial: In all recruitment materials, it is made clear that participation in this 
study is voluntary, and that participants can stop participating at any time. For those 
who did not wish to take part in the study, it is made clear that their currently 
provided services will continue to be made available. It is also 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 provided consent for the study, the resident himself/herself can 
still decide whether or not he or she wanted to take part in the study (through the 
assent process, described next).  Research staff speak with the participant about the 
study and provide the person with an assent form. The assent form is a simpler and 
shorter version of the consent form, with large, easy to read font. The researcher 
answers any questions that the resident has, and then asks the resident if he or she 
is interested in participating in the study. If so, the resident signed the assent form. A 
copy of the full consent form is also made available to the resident in case he or she 
wants to review the full document. 
 
 

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Participant Retention 
Focus Groups: As these participants from Aim 1 are planned to return for Aim 3, we 
maintain regular contact with focus group participants and provide updates on the 
project. A follow-up date for the Specific Aim 3 focus groups investigating the 
prototype is planned following the initial meetings, contact information is gathered, 
and the groups are notified at regular intervals leading in to the second round – and 
up to several months out, the groups are notified at one month, two weeks, and one 
week prior to the second round. A second round of incentives are also handed out to 
all participants upon completion of the second focus group ($25 for existing LifeBio 
users and staff members; $50 for stakeholders). 
Clinical Trial: In order to maximize participation, research staff are very clear when 
talking with residents and staff that their participation will include follow-up interviews 
(one follow-up interview for residents approximately 1-month post baseline; two 
follow-ups for staff participants, within 1-month of life story interview, and 1-month 
after delivery of full LifeBio MemoryTM product). Because of the short time frame 
between data collection points, we plan for an attrition rate of approximately 10% 
from T1 through T3 to ensure that our recruitment and retention goals are met. To 
address potential attrition over the 3-month participation period, we follow sample 
retention strategies that have yielded low levels of attrition (approximately 10-13%) in 
our previous intervention programs: 
1) Onboarding meetings with the residential care facility sites, with project staff 
and site. Onboarding meetings describe the protocols and procedures of 
Specific Aim 3 and clinical trial. 
2) Site liaisons identified within each site assist with the study’s recruitment and 
LifeBio MemoryTM implementation, as well as reaching resident and staff 
participants to complete their research interviews. 
3) Research staff hold bi-weekly calls with each site to provide updates on 
participant recruitment, program implementation, and identify areas where 
support is needed. 
4) Staff compensation of $15/interview for each timewave (Times 1-3) and site 
honorariums of $500/site are processed upon completion of study 
requirements.  
5) We oversampled to accommodate a reasonable level of attrition. 
 
 

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Study Measurements and Procedures 
Main Research Question: Does the LifeBio concept, technology, and training offer a 
viable model for effectively delivering a person-centered life story intervention across 
residential care settings by utilizing professionals to deliver the program? 
Specific Aim 1: 
Develop prototype enhancements of the existing LifeBio program and conduct focus 
group evaluations (n=38) of these prototypes with existing or former LifeBio users 
(n=12) and dementia care professionals (n=20) familiar with LifeBio. Convene 
stakeholder focus group with older adults living with early-stage dementia (n=6) to 
help maintain person-centered practices throughout the research process.  
A tablet-app-based prototype is designed based on features of the current LifeBio 
intervention to automate tasks that are manually performed at present. The three 
novel features included voice recording of life story information, automated uploading 
of voice files to LifeBio cloud storage, and initial enhancements to training materials. 
Recommendations of Krueger (2002) are followed in selecting the size and number 
of groups. Focus group methodology explores participants’ and staff members’ 
experience with and need for the LifeBio program and assesses their reaction to the 
LifeBio MemoryTM prototype.  
The first set of focus groups consists of individuals who were currently participating or 
had already participated in the LifeBio intervention. The groups last approximately 90 
minutes and provide feedback on the prototype in a semi-structured way. The 
participants use the prototype with guidance from facilitators in a manner similar to 
that in the program. They are allowed to manipulate the prototype’s tools and offer 
their opinions about the features that are either present or missing from the prototype 
and intervention materials. 
The second set convenes 4 groups of professionals familiar with the original LifeBio 
program. The groups reacted to the prototype and discussed whether the prototype 
and materials met their expectations and needs for training. The group is asked 
questions about whether the proposed LifeBio MemoryTM prototype will produce high 
levels of acceptability for participants and of treatment fidelity, and if not, what type of 
modifications would increase acceptability and fidelity. Finally, they discuss whether 
the enhanced LifeBio MemoryTM product could be feasibly implemented within their 
organizations and the potential hurdles to implementation. The group sessions last 
approximately 90 minutes. 
The third set consisted of stakeholders, or persons living with early-stage dementia. 
Topics of discussion include: A description of the original LifeBio program and its 
intended target market (i.e., residential care facilities, families of persons with 
dementia living at home). The needs of persons living with dementia and how LifeBio 
can improve to meet these needs. How the LifeBio team can continue to involve 
persons living with dementia in the development and improvement of the next version, 
LifeBio MemoryTM.  
Specific Aim 2 
Develop LifeBio Memory™, incorporating a system to automatically record and 
process individuals’ life stories.  

16 
 
LifeBio will build the capability to audio record interviews and convert speech to text 
on web, Android, and iOS-based platforms. They will also use machine 
learning/artificial intelligence (AI) and tagging to automatically build Snapshot and 
Action Plan summaries so that they are quickly and easily available to health care 
providers and caregivers. 
A series of key performance indicators (KPIs) are measured throughout 
development: 
• The average time to create the end products (Snapshots, Action Plans, and Life 
Story Books) and, where applicable, the difference between the current process 
and the AI-based process. 
• The increase/decrease in time to create the end products measured week over 
week. 
• The difference between the amount of data collected via the mobile app and 
the amount of supplemental data from search services and data tagging. This 
is also tracked on a weekly basis to obtain the trend over time. 
• The total count of the number of distinct data sources that searched and the 
difference week over week (trending over time). 
• The number of aggregated transactions performed against AI services, number 
of end products created, and cost of the technology to run, all of which is 
aggregated across daily/weekly/monthly situations.  
The success of the LifeBio MemoryTM product for the end users. 
Specific Aim 3: 
Conduct a second round of focus groups with Aim 1 existing or former LifeBio users, 
dementia care professionals, and stakeholders. Conduct a full-scale fidelity trial of 
the enhanced LifeBio MemoryTM product with staff (n=60) who work within residential 
care settings (independent, assisted living, and/or nursing home settings) that serve 
persons living with dementia (n=242).  
Focus group participants are reconvened to provide feedback on the revised LifeBio 
MemoryTM software application. Questions focus around improvements made to the 
prototype and training materials based on the previous suggestions made by the 
groups. The full functionality of the application is displayed, and additional 
recommendations and feedback are elicited. Particular attention is paid to training 
materials for each group (older adults with dementia and staff), with 
recommendations and fixes addressed prior to implementation in the fidelity trial. 
The groups are walked through a hands-on demonstration of their respective user 
experiences, including the training materials, guided interview process, text-to-
speech function, multimedia upload function, and the automated production of life 
story materials, including the Life Story Book, Snapshot, and Action Plan, using 
machine learning/AI. Following qualitative, open-ended data collection from the focus 
group sessions, participants are also asked to complete short user-acceptance 
testing surveys to validate the design and the overall functionality of the application, 
as well as the changes based on the recommendations suggested in Aim 1. 
Care professionals are trained to implement the revised version of LifeBio Memory™ 
in their organizations. Staff training is scheduled using a staggered protocol, and 
tablets preloaded with LifeBio Memory™ are the main medium of self-paced, online 

17 
 
instruction. Each trainee is asked to complete the training within one week of 
assignment, as well as complete a pre-training, baseline survey that collected 
demographic information, job history, previous experience with life story work, and 
attitudes towards person-centered care and older adults with dementia. The app also 
tracks whether trainees view other support materials from the LifeBio MemoryTM 
application, namely, the Frequently Asked Questions (FAQs). After training, the staff 
trainees complete a checklist and a post-training survey on the tablet that gathers 
their opinion on: 
• The length of time spent on training. 
• Whether they had difficulty with particular sections/content/materials. 
• Whether they feel prepared to conduct life story interviews with older adults with 
dementia 
• Whether they feel comfortable with the basic functionality of LifeBio MemoryTM 
• Whether they feel confident the technology would accurately convey the story 
of the resident with dementia. 
• Whether they have specific questions not covered by the FAQs or the training.  
• They also have the opportunity to provide comments on their overall experience 
via open-ended questions adapted from our previous evaluation questionnaires 
used in the pilot program. 
Time 1 baseline interviews are conducted with residents living with dementia and 
staff members. Separate baseline research interviews (developed from earlier work) 
are conducted by researcher interviewers with each resident and staff trainee.   
Time 1 resident interviews include: 
• demographic information 
• depression, anxiety, agitation, and loneliness 
• perception of whether staff have adequate knowledge of their care preferences 
and interests  
• quality of communication/interactions between the resident and staff 
• whether staff have an understanding of the resident’s life story 
• level of tension and frustration with staff 
• general well-being and quality of life.  
Interviews with staff are conducted on each of their assigned residents (2-6 residents 
per time wave) and include:  
• resident depression, anxiety, agitation, loneliness, and incidence of memory 
and behavior problems  
• their current knowledge of resident care preferences and interests 
• utilization of person-centered care practices 
• quality of communication between the resident and themselves and other staff 
• their current understanding of that resident’s life history 
• level of tension and frustration with the resident 
• perception of the resident’s overall well-being and quality of life, as well as their 
self-efficacy related to providing care. 
Life story interviews are completed between trained staff and their assigned residents 
using the LifeBio MemoryTM tablet app. 

18 
 
After the research interview is completed, a trained staff member conducts a life story 
interview with a resident within a two-week period. Treatment fidelity is monitored 
through oversight of the staff administering the life story interviews. LifeBio MemoryTM 
sessions with residents are audiotaped with the permission of the resident or his/her 
legal guardian. Trained raters monitor treatment fidelity by rating staff on whether they 
followed protocols included in their training and used appropriate techniques to elicit 
life story information from residents. Ratings for each strategy follow a 6-point scale 
indicating the frequency with which each suggested strategy and/or protocol was used, 
with scores ranging from 0 (not at all) to 5 (a great deal). Higher scores indicate that 
the specific strategy was used to a great extent during the interview. Raters begin 
coding recordings once they reach a threshold reliability greater than an Intraclass 
Correlation Coefficient (ICC) of .80. Staff participants conducting the resident 
interviews are prompted to complete a brief electronic survey on the tablet immediately 
after each of their assigned LifeBio MemoryTM interviews with residents.  
The survey questions gather information on satisfaction with: 
• interviewing the resident/quality of interaction with the resident 
• positive experiences and difficulties encountered using the LifeBio MemoryTM 
tablet app 
• perceived advantages of the program 
• perception of meeting the program goals 
• Staff also have an opportunity to provide feedback in open-ended note fields 
and will give their perceptions of the importance and usefulness of life story 
work, whether it is likely to improve resident-staff interactions, and the feasibility 
and acceptability of the program in their facility.  
Time 2 research interviews are conducted with staff members within two weeks of 
completing life story interviews with residents.  
Research interviewers conduct post-life-story-interview assessments with staff 
regarding each of their assigned residents. This shorter survey examines the 
experience of participating in LifeBio MemoryTM’s life story interview. Time 2 interviews 
mirror those of Time 1, except for demographic information. A series of satisfaction 
items related to the LifeBio MemoryTM training and experience administering the life 
story interview are also included in the Time 2 interview. 
Final LifeBio MemoryTM materials are delivered, and a complete evaluation of the 
program is completed. Within 4 weeks of baseline (Time 1), final LifeBio MemoryTM 
materials are delivered and implemented. A Life Story Book, Snapshot Summary, and 
Action Plan are delivered in a digital or printed format according to the needs of the 
care environment. Time 3 resident and staff interviews mirror Time 1, except for 
demographic information, and also include satisfaction measures directly related to 
the use of the complete LifeBio MemoryTM  product, with specific items related to use 
of the Life Story Book, Snapshot Summary, and Action Plan. The data collected 
through Time 3 staff interviews informs the commercialization plan, specifically 
regarding staff perceptions of the acceptability and feasibility of automated processes 
in the LifeBio MemoryTM app, potential reasons why residents decline participation or 
and/or do not complete the LifeBio MemoryTM protocol at various steps of the 
recruitment process, challenges and opportunities in delivering LifeBio MemoryTM, and 
modifications needed to sustain the program in different communities.    
 
 

19 
 
Safety Reporting 
Potential Risks for Participants: loss of confidentiality, overtaxing or overburdening 
respondents with dementia, adverse reaction. 
Protection Against Risks 
Loss of Confidentiality: To protect against the loss of confidentiality, a variety of 
safeguards are in place. First, all data obtained in research interviews is kept on 
secure servers and in locked cabinets at Benjamin Rose. Second, all participants are 
given an Identification (ID) Number; the master code sheet is kept only by the 
Subaward Principal Investigator (Ms. Orsulic-Jeras) and the Research Project 
Coordinator (Ms. Cordell). Therefore, only the PI and Project Coordinator have 
access to individually private information about human subjects. All data collection 
forms use only the ID numbers. Any electronic protected health information (ePHI) 
collected on human subjects is 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 is 
certified as HIPAA-compliant has 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. Third, the hard copy data forms are transported from sites to 
Benjamin Rose in a locked briefcase or laptop case. Fourth, regarding security on 
the individual single board computers, all of the machines are password-protected. 
Antivirus, firewall, and security software are installed and regularly updated. The 
machines are also housed within a locking plastic case that protects them from 
physical attack. 
Overtaxing or Overburdening Respondents with Dementia: Research interviewers 
are trained to use techniques and clinical procedures to avoid overtaxing or 
burdening respondents and to enhance communication. In past studies, we have 
implemented interviewing procedures specifically designed for aged and/or impaired 
persons. Examples include giving visual cues (choice cards), scheduling interviews 
at times when fatigue is less likely, and being sensitive to respondents’ emotions 
(e.g., allowing for pauses in the interview process or taking a break so they can 
regain composure). Instruction in these techniques are an important part of the 
project’s interviewer training. In addition, at the start of each interview, respondents 
are reminded that they are free to decline to answer any question and can end the 
interview whenever they choose. 
Adverse Reaction: In the unlikely event that a respondent has an adverse reaction, 
two safeguards are in place to resolve the situation. First, the researchers involved in 
the study are experienced in working with this population and are prepared for 
coping with a respondent’s emotional reactions. Ms. Orsulic-Jeras has over 20 years 
of experience working directly with individuals living with dementia, as well as 
residential care facility staff. Second, respondents have access to the services of 
their referring community service agency, including experienced social workers, and 
are also able to receive referrals to appropriate regular communication with sites and 

20 
 
referring organizations to identify any problems that might arise. These procedures 
have been used extensively in past research. 
Adverse Event Collection and Reporting 
Ms. Orsulic-Jeras and Ms. Sanders will be informed of any serious adverse events 
as soon as they occur and notify the Data and Safety Monitoring Team within 24 
hours of notification.  
In the event of an adverse event, the following information will be reviewed: 
• Participant’s study status. 
• How the participant was recruited into the study and the efforts that took place 
to retain him/her. 
• The nature of the adverse event and a determination of how the participant’s 
safety has been threatened as a result. 
In most mild cases (i.e., increased stress), a recommendation will be made to 
discontinue the individual’s participation in the intervention and/or to withdraw the 
participant from the study. In moderate cases (i.e., unable to cope), the participant 
will be referred to an identified expert (the Alzheimer’s Association, a geriatric care 
manager, or licensed clinical social worker, etc.). If the adverse event is deemed to 
be very serious (i.e., suicidal risk or the health/well-being of the participant is in 
jeopardy), the case will be reported to the appropriate authorities to intervene on the 
situation immediately. 
Any significant adverse events will be reported to the IRB, the NIA Program Officer, 
and the Safety Officer within 48 hours of knowledge of occurring. A summary of all 
other adverse events will be reported to the NIA Program Officer and Safety Officer 
quarterly, unless otherwise requested. 
Potential Benefits for Participants 
Increase knowledge and understanding of life story work, dementia and its 
consequences, and about services that might be useful now or in the future.  
Enjoyment of sharing information about both positive and negative feelings related to 
their work, especially related to their own needs.  
Enhance knowledge and theory about training residential care facility staff to 
implement cutting-edge life story work.  
Alleviate staff burden, enhance person-centered care practices, and improve 
resident well-being, health and quality of life.  
Data will provide both an empirical basis and practical foundation for professionals to 
use when working with residents with dementia from a variety of backgrounds 
throughout their professional caregiving career. 
 
 

21 
 
Data Flow 
Attrition:  
Recommendations of Krueger were followed in selecting the size and number of 
groups. No difficulties are expected in recruiting participants to participate in the 
focus groups given the positive reactions and exceptionally low attrition rate of our 
LifeBio pilot that used a longitudinal design using three waves of data collection with 
75% completing in the first wave, 92% completing in the second, and 99% 
completing in the third. In addition, ten percent attrition or less was estimated 
between project enrollment and completion of the life story interviews in the clinical 
trial.  
Data Analysis and Coordination: 
The research team and technology consultants conduct a review and thematic 
analysis of the data. Broadly, the analysis focuses on the feasibility of the modified 
LifeBio intervention as a viable solution for implementing person-centered care in 
residential care facilities.  
In addition to monitoring fidelity, the effectiveness of the training in relation the 
professional staff’s ability to conduct the intervention in a manner that maintains the 
high levels of acceptability and feasibility found in the pilot study is determined. 
Analysis of variance will be used to analyze responses to evaluation questions by 
groups (staff and residents) with respect to the program’s importance and usefulness 
and their satisfaction. Investigators also examine whether resident outcomes (e.g., 
depression, anxiety, and loneliness) changed as a result of the participating in the 
program. 
Retention of Study Documentation 
Per Benjamin Rose institute on Aging Policies and Procedure 800A: Client Record System, 
disposal of the records following a minimum of seven (7) years shall be done to ensure the 
confidentiality of the client and administrative records. Client and administrative records shall 
be burned or shredded depending on accessibility and cost of these procedures. The Sr. 
Vice President & COO or his/her designee is responsible for supervision of the disposal of all 
records. 
 
 

22 
 
Data Management 
NVivo: Focus group transcripts are loaded into NVivo, a mixed-method qualitative 
analysis software, for ease of analysis. A variety of tools, such as word frequency 
queries, text search, sentiment analysis, and coding matrices were used to validate 
constructs and themes that formed basis of the thematic coding structure. Them, the 
codes and themes from the open, inductive, and axial reads of the research team’s 
initial readings of the project are loaded into the software and tagged line by line in a 
deductive approach. After transcripts are coded, the coder’s project files are merged, 
and the team utilizes the coding comparison tool within NVivo to calculate a Cohen’s 
Kappa Score to determine inter-rater reliability. In the event of disagreements or 
discrepancies between coders, the sections identified by the software are brought to 
the larger research group and discussed until a consensus is reached and a high 
level of inter-rater reliability of .85 is reached. NVivo also allows for the opinions and 
design preferences of existing LifeBio users, staff members, and persons living with 
dementia to be compared in coding matrices. The reporting of these coding matrices 
allows for the identification of proposed changes or recommendations for 
improvement.  
Access Database: A database was created in access to store all project-specific 
documentation including referral logs, participant mailing addresses, completed 
screens, communication logs, survey responses. 
 
Quality Control Procedures 
Standard Operating Procedures. The study’s standardized operating procedures 
(SOP) document is located in the study’s electronic record on BRIA’s secure network 
with appropriate backup systems (filename: LifeBIO_SBIR_SOP.docx). [Document 
still in progress]. 
 
 

23 
 
Reports 
A report was submitted to NIA on March 13, 2021 after the completion of Aim 1 
A final report will be submitted upon the completion of Aim 3. 
Data and Safety Monitoring Activities 
The Principal Investigators (PIs), Ms. Orsulic-Jeras and Ms. Sanders, hold 
responsibility for ensuring participants’ safety on a daily basis during their 
participation. Data and safety monitoring is assured by the study’s research team 
senior key personnel: The subaward PI (Ms. Orsulic-Jeras) and Project Evaluators 
(Dr. Powers and Dr. Ejaz). Dr. Ejaz is a licensed independent social worker (LISW), 
while other senior key personnel are experts in the field of dementia and comprised 
the study’s Data and Safety Monitoring Team. This team, joined by an independent 
Safety Officer (SO), acts to monitor participant safety, evaluate the progress of the 
study, review procedures for maintaining the confidentiality of data, the quality of 
data collection, management, and analyses. 
The PIs meet weekly with members of the research team either in-person or by 
teleconference to review the study’s progress, review data quality, and participants’ 
safety. At these meetings, an evaluation of the progress of the study is reviewed, 
including periodic assessments of data quality, timeliness of recruitment, the 
appropriateness of the strategies for recruiting participants into the study, assessing 
the participants’ risk in using the LifeBio MemoryTM materials, and other factors that 
might have affected the study’s outcomes. In addition, safety reports are sent to the 
SO at least twice a year and include a detailed analysis of study progress, data and 
safety issues. 
 
 

24 
 
Study Completion Procedures 
Successful completion of this study delivers a final LifeBio MemoryTM product that 
was tested by its potential customers, aimed at facilitating and enhancing 
communication between people living with dementia and their family and caregivers. 
Dissemination 
ClinicalTrials.gov 
The Subaward Principal Investigator (Ms. Orsulic-Jeras) ensures that processes are 
in place to achieve and maintain compliance with the following policy requirements 
for all clinical trials proposed in this application: 
Clinical trial registration information is submitted to ClinicalTrials.gov no later than 21 
calendar days following the study start date. Clinical trials registration initially took 
place for this study on 9/28/2020. The Subaward PI maintains the accuracy of the 
record content, resolves problems, and leads all content update and modifications 
within the record. Clinical trial summary results information is submitted to 
ClinicalTrials.gov no later than 1 year following the study completion date.  
Clinical trial information submitted to ClinicalTrials.gov is verified, updated and 
corrected in accordance with all applicable deadlines established in the Final Rule 
for Clinical Trials Registration and Results Information Submission (42 CFR 11.64). 
Publications 
Basic results of the Aim 3 clinical trial will be reported in the ClinicalTrials.gov record 
within 12 months of trial completion. Research manuscripts and other publications 
will be submitted according to the research team’s publication plan. All publications 
will be tracked throughout the project period and reported accordingly in annual and 
final project reports. 
References 
Krueger, R. A. Designing and Conducting Focus Group Interviews. (2002). 

25 
 
Appendix 
Aim 1 Flowcharts 
 

26 
 
Aim 1 Focus Group Study Procedures 
 
 
 
 
 

27 
 
Aim 1 Recruitment Flyer  
 
 

28 
 
Aim 1 Recruitment Script for Stakeholders 
 
 

29 
 
 
 

30 
 
Video Recording Consent 
 
 

31 
 
Focus Group Enrollment Letter  
 

32 
 
 
 
 

33 
 
tMMSE 
 
Cognitive Screen (T-MMSE) 
Now I’d like to ask you a few questions and give you some problems to solve. Please try to answer 
as best as you can. 
1. What     (5) 
  
WRITE DOWN RESPONSE 
        Incorrect         Correct 
year is this? 
  
            0☐                  1☐ 
season is this? 
  
            0☐                  1☐ 
month of the year is this? 
  
            0☐                  1☐ 
is today’s date? 
  
            0☐                  1☐ 
day of the week is this? 
  
            0☐                  1☐ 
  
2. What     (4) 
  
    WRITE DOWN RESPONSE 
        Incorrect         Correct 
county are you in? 
  
            0☐                  1☐ 
state are we in? 
  
            0☐                  1☐ 
city/town are you in? 
  
            0☐                  1☐ 
is the name of the 
place/room you are in? 
  
            0☐                  1☐ 
  
3. I am going to name three objects. After I have said all three objects, I want you to repeat 
them. Remember what they are because I am going to ask you to name them again in a few 
minutes.     (3)     “ball”   “car”   “man”   Please repeat the three items for me. 
RECORD EXACT 
RESPONSE 
  
0☐        1☐          2☐          3☐ 
          
  
  
NUMBER OF TRIALS 
  
SCORE ONE POINT FOR EACH CORRECT ANSWER. IF RESP DOES NOT REPEAT ALL 
THREE, REPEAT UNTIL THEY HAVE LEARNED ALL THREE, OR UP TO A MAXIMUM OF 
5 TIMES. ALLOW 20 SECONDS FOR REPLY. SCORE FIRST RESPONSE ONLY. 
  
4. Spell the word WORLD. Now would you spell WORLD backwards?     (5) 
D  L  R  O  W 
RECORD 
EXACT 
RESPONSE 
  
0☐    1☐    2☐    3☐    4☐    5☐  
SCORE ONE POINT FOR EACH LETTER IN THE CORRECT ORDER. ALLOW 30 SECONDS. 
  
5. Now what were the names of the three objects that I asked you to remember?     (3) 
RECORD EXACT 
RESPONSE 
  
0☐        1☐          2☐          3☐ 
  
  
SCORE ONE POINT FOR EACH CORRECT ANSWER: BALL  CAR  MAN. ALLOW 10 
SECONDS. 
  
6. Could you please tell me what the object is you are speaking into? (TELEPHONE)     (1) 

34 
 
RECORD EXACT 
RESPONSE 
  
                0 ☐                1 ☐ 
ALLOW 10 SECONDS. 
  
7. I’d like you to repeat the following phrase after me: “No ifs, ands, or buts.”     (1) 
RECORD EXACT 
RESPONSE 
  
                0☐                 1☐  
ALLOW 10 SECONDS. 
  
8. I’d like you to “say hello, tap the mouthpiece of the phone 3 times, then say I’m back.”     
(3) 
FIRST COMMAND 
                         0☐                         1☐ 
SECOND COMMAND 
                         0☐                         1☐ 
THIRD COMMAND 
                         0☐                         1☐ 
SCORE ONE POINT FOR EACH CORRECTLY PERFORMED COMMAND. ALLOW 30 
SECONDS. 
  
9. Could you please give a phone number where you could be reached?     (1) 
RECORD EXACT 
RESPONSE 
  
                0☐                 1☐  
SCORE ONE POINT FOR A COMPLETE PHONE NUMBER REGARDLESS OF ACCURACY. 
  
TOTAL NUMBER CORRECT OUT OF 26:     ___ / 26 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

35 
 
Verbal Consent Form 
Purpose/Introduction 
Hello, this is (NAME) from the Benjamin Rose Institute on Aging. The reason for my call is 
to invite you to participate in a research study that will develop and evaluate training 
materials and electronic applications for the LifeBio Memory program. These materials will 
be designed to help individuals with dementia document their life stories in the form of life 
story booklets and summaries about their lives. We believe that when staff know more about 
their residents, they can provide more personalized and higher quality of care to them.  
Study Procedures 
Your participation in the project will include participation in one of the following focus 
groups at the beginning of the study, then once again approximately 9 months later. The 
group you will participate in is checked below: 
☐1) STAFF FOCUS GROUP: 120-minute focus group with 5-6 other professionals who are 
familiar with and have participated in the LifeBio program; or 
☐2) LIFEBIO USER GROUP: 90-minute focus group with 5-6 other individuals who have 
used LifeBio to capture their own or a family member’s life story. 
☐3) STAKEHOLDER GROUP: 60-minute focus group with 4-5 other individuals with a 
diagnosis of dementia who have not participated in the LifeBio.  
Focus groups will be led by Benjamin Rose project staff who will ask participants questions 
designed to gain feedback and recommendations for: 1) revising, as necessary, existing 
LifeBio intervention materials, 2) designing the new electronic applications, and 3) 
enhancing the prototype features and associated training materials.  For research purposes, 
the group discussion will be digitally recorded.  These recordings will be destroyed once they 
have been used to document the responses given by the group. 
Groups will be held at a central location as convenient to you as possible.  You may 
voluntarily end your participation in the focus group and/or refuse to respond to specific 
questions at any time. 
Risks 
There are a few possible risks of participating in this program.  The potential risks to you 
from participating in the program include the possibility of an adverse emotional or 
psychological reaction to questions that will be discussed in each focus group.  The focus 
group leaders you will be working with have been trained to recognize and address any signs 
of distress that you may have during your group. If at any point during the focus group you 
become upset or agitated, the leader may suggest that you end your participation.  If a major 
issue arises that our group leaders are unable to handle, you may wish to seek professional 
assistance through a social service agency that we can refer you to.  Again, if you do not wish 
to answer a question, you can choose not to participate in that specific discussion. 
Benefits 
Participation in this program may aid in improving information and services for persons with 
memory challenges and their families. 

36 
 
Alternatives to Participation 
Because of the nature of this research, the only alternative is not to participate in this study. 
Financial Information 
There is no cost to you for participation in this study. 
Confidentiality 
All information you give is confidential, unless you or your loved one is being abused, 
neglected, or exploited by another person.  Our staff are required by law (Ohio Revised Code 
5101.60) to report such concerns to the Adult Protective Services unit of the County 
Department of Job and Family Services. All data collected from this study will be de-
identified to protect your privacy.   
Compensation/Cost 
Stakeholder focus group participants will receive a total of one hundred dollars ($100) for 
participation in each of the two rounds of focus groups. One check (of $50) will be mailed to 
you from Benjamin Rose to your home within two weeks after you have attended your first 
focus group. The second check of $50 will be mailed to you two weeks upon completion of 
the second round of focus groups. Community service organizations will be compensated for 
their staff’s time as part of their contractual arrangement with the Principal Investigators.   
Summary of Your Rights as a Participant in a Research Study 
Your participation in this research study is voluntary.  If you decide to join the study, you 
may withdraw at any time and for any reason, without penalty or loss of benefits.  If 
information from this study is published or presented, your identity will not be revealed.  If 
new information becomes available that changes the risks or benefits of this study, you will 
be notified.  Once notified, you may decide whether or not to continue participating.  
Contact Information 
________________________________________ has described to you what is going to be 
done, the risks, hazards, and benefits involved. Silvia Orsulic-Jeras (Principal Investigator) 
can also be contacted at (216) 373-1625.  
Signature 
Providing verbal consent indicates that you have been informed about the research study in 
which you voluntarily agree to participate; that you have asked any questions about the study 
that you may have; and that the information given to you has permitted you to make a fully 
informed and free decision about your participation in the study.  By providing consent, you 
do not waive any legal rights, and the investigator(s) or sponsor(s) are not relieved of any 
liability they may have.  A copy of this consent form was provided to you. 
 
 
 

37 
 
 
 
The person listed below gave verbal consent to participate in this study. 
 
_________________________________ Date________   
Printed Name of Participant                                                         
  
_________________________________ Date________     
Signature of Person Obtaining Consent   
             
         
_________________________________ Date________   
Signature of Principal Investigator (Affirming subject eligibility  
for the study and that informed consent has been obtained.) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1 
 
Statistical Analysis Plan (SAP) 
LifeBio Memory Digital Reminiscence Platform 
 
 
 
 
Study Title: Development of a Reminiscence Therapy Online Platform 
With Machine Learning to Increase Engagement With 
People Living With Dementia and Their Care Partners 
Study Registration Number NCT04769466 
Sponsor Benjamin Rose Institute on Aging 
11890 Fairhill Rd 
 
Cleveland, OH, 44120 USA 
Collaborator: National Institute on Aging (NIA) 
 
Protocol Number: 1908-216 
 
Phase: Phase 2 
 
Statistical Analysis Plan Version Version 1.0 
 
Statistical Analysis Plan Date September 8, 2025 
 
Sub-Principal Investigator: Silvia Orsulic-Jeras, MA 
 
Benjamin Rose Institute on Aging 
11890 Fairhill Rd 
Cleveland, OH, 44120 USA 

2 
 
 
 
 
 
 
 
 Primary Author: Name: Sara Powers, PhD 
Position/Title: Senior Research Scientist 
September 8, 2025 
Signature Date 
 
SAP Contributor: Name: Lacey DiFranco, MA 
 Position/Title: Research Analyst 
 September 8, 2025 
 Signature Date  
  
Approved By: Name: Silvia Orsulic-Jeras, MA 
Position/Title: Senior Research Associate 
September 8, 2025 
Signature Date 
  
  
  
  

3 
 
Abbreviations:  
AE  
Adverse Event 
CES-D 
Change in Center for Epidemiological Studies Depression Scale 
CI 
Confidence Interval 
CMAI 
Change in Cohen-Mansfield Agitation Inventory 
GCDMP 
Good Clinical Data Management Practices  
ICI 
Change in Individualized Care Instrument 
IRB 
Institutional review board  
ITT 
Intent to Treat 
MMSE 
Mini Mental Status Examination 
PCCAT 
Person-Centered Care Assessment Tool 
PLWD 
People (or Persons) Living with Dementia 
PP 
Per Protocol 
SAP 
Statistical Analysis Plan 
SCIDS 
Sense of Competence in Dementia Care Staff  
SD 
Standard Deviation 
SPSS 
Statistical Package for the Social Sciences 
QoL-AD 
Change in Quality of Life Alzheimer's Disease  
 
 
 

4 
 
Table of Contents 
Abbreviations: ........................................................................................................... 3 
1. Administrative Information ...................................................................................... 6 
1.1 Approvals and Oversight .................................................................................... 6 
1.2 Version Control and Updates ............................................................................. 6 
1.3 Deviations from SAP .......................................................................................... 6 
1.4 Compliance with Regulatory and Institutional Policies ......................................... 6 
2. Introduction ........................................................................................................... 7 
2.1 Study Background ............................................................................................. 7 
2.2 Study Objectives ............................................................................................... 7 
2.3 Purpose of the SAP ............................................................................................ 7 
2.4 Scope of the SAP ............................................................................................... 8 
3. Study Design .......................................................................................................... 8 
3.1 Sample Size & Power ......................................................................................... 8 
3.2 Actual Analyzed Sample ..................................................................................... 8 
3.3 Randomization / Masking ................................................................................... 9 
3.4 Analysis Populations ......................................................................................... 9 
4. Outcomes .............................................................................................................. 9 
4.1 Primary outcome (Residents & Staff) ................................................................... 9 
4.2 Secondary outcomes (Residents & Staff) ........................................................... 11 
4.3 Other Prespecified (Staff) ................................................................................. 11 
5. Statistical Considerations ..................................................................................... 12 
5.1 General Principles ........................................................................................... 13 
5.2 Missing Data ................................................................................................... 14 
5.3 Descriptive Statistics ....................................................................................... 15 
5.4 Primary Analyses ............................................................................................. 15 
5.5 Secondary Analyses ........................................................................................ 16 
5.6 Multiplicity ...................................................................................................... 16 
5.7 Subgroup Analyses .......................................................................................... 16 

5 
 
6. Data Management ................................................................................................ 17 
6.1 Data Capture .................................................................................................. 17 
6.2 Data Entry and Verification ............................................................................... 17 
6.3 Data Cleaning and Quality Control .................................................................... 17 
6.4 Confidentiality and De-Identification ................................................................ 17 
6.5 Data Retention and Archiving ........................................................................... 17 
6.6 Data Access and Oversight .............................................................................. 18 
7. Quality Control ..................................................................................................... 18 
8. Reporting ............................................................................................................. 18 
8.1 Reporting Standards ........................................................................................ 18 
8.2 Planned Tables, Figures, and Listings (TFLs) ...................................................... 19 
8.3 Statistical Summaries ...................................................................................... 19 
8.4 ClinicalTrials.gov Reporting .............................................................................. 19 
8.5 Transparency and Deviations ........................................................................... 19 
8.6 Dissemination ................................................................................................. 20 
Appendix Reporting ........................................................... Error! Bookmark not defined. 
8.2 Planned Tables, Figures, and Listings (TFLs) ............ Error! Bookmark not defined. 
 
 
 
 
 
 
 

6 
 
1. Administrative Information 
The primary objective of this study is to assess the efficacy and safety of LifeBio Memory to 
increase engagement with people living with dementia and their care partners.  
 
This document outlines the statistical methods to be implemented during the analyses of data 
collected within the scope of Benjamin Rose’s Protocol “1908-216”. 
 
This Statistical Analysis Plan (SAP) has been developed in accordance with NIH guidance for 
clinical trial and behavioral research SAPs, ensuring transparency, reproducibility, and alignment 
with the study protocol. 
1.1 Approvals and Oversight 
• 
The SAP must be reviewed and approved by the following individuals prior to database lock 
and initiation of any analysis: 
• 
Principal Investigator (PI) – ensures alignment with study objectives and protocol. 
• 
Sponsor/Study Funder – ensures compliance with funding requirements and reporting 
standards. 
• 
Lead Statistician – ensures that planned analyses are appropriate, reproducible, and 
methodologically sound. 
1.2 Version Control and Updates 
• 
Any revisions to the SAP after initial approval must be documented with rationale, date, and 
approvers. 
• 
Updated versions will be clearly labeled (e.g., v1.1, v2.0) and stored securely alongside 
previous versions. 
1.3 Deviations from SAP 
• 
Any deviations from the prespecified analyses outlined in this SAP (e.g., due to unexpected 
missing data patterns, assumption violations, or post hoc exploratory analyses) will be 
documented in the final study report, including: 
o Description of the deviation 
o Reason for the deviation 
o Date and personnel responsible for the decision 
• 
Deviations will be reported transparently in any manuscripts or regulatory submissions to 
maintain integrity of the study findings. 
1.4 Compliance with Regulatory and Institutional Policies 
• 
This SAP, along with all associated datasets and outputs, will adhere to: 
o Institutional review board (IRB) requirements 
o NIH/NIA policies on data management and reporting 
o Good Clinical Data Management Practices (GCDMP) 
 

7 
 
2. Introduction 
2.1 Study Background 
The LifeBio Memory project is a behavioral intervention designed to enhance the well-being of 
residents living with dementia and to support staff in delivering person-centered care. The program 
uses structured life-story interviews, while providing staff with training and tools to better 
understand residents’ preferences and histories. Previous research indicates that life-story 
interventions may improve quality of life, reduce depressive symptoms, and increase social 
engagement among persons living with dementia, while also enhancing staff competence and job 
satisfaction. 
The current study is a non-randomized, pre-post evaluation designed to assess changes in resident 
and staff outcomes following participation in the LifeBio Memory program over a 4-week period. 
The study includes two primary participant groups: residents living with dementia and staff who 
facilitate/support the intervention. 
2.2 Study Objectives 
• 
Primary Objectives:  
o To evaluate the effect of the LifeBio Memory program on resident outcomes, 
including depressive symptoms (CES-D), quality of life (QoL-AD), agitation (CMAI), 
loneliness, and satisfaction with care. 
o To evaluate the effect on staff outcomes, including attitudes toward persons living 
with dementia, dementia care competence, job satisfaction, and person-centered 
care practices (PCCAT and ICI subscales). 
• 
Secondary Objectives: 
o To examine changes in residents’ cognitive status (MMSE) and staff knowledge of 
resident life stories/preferences. 
o To assess program feasibility, training effectiveness, and satisfaction among both 
residents and staff. 
• 
Exploratory Objectives: 
o To explore any potential sub-group differences (e.g., staff role, site-level 
differences) and consistency of outcomes across measures. 
2.3 Purpose of the SAP 
This Statistical Analysis Plan (SAP) specifies all planned analyses for the LifeBio Memory project 
prior to database lock and unblinding of outcome data. The SAP ensures that analyses are: 
• 
Prespecified and reproducible, minimizing risk of bias; 
• 
Transparent, with detailed plans for handling missing data, quality control, and statistical 
testing; 
• 
Aligned with study objectives, allowing clear interpretation of primary, secondary, and 
exploratory outcomes. 

8 
 
2.4 Scope of the SAP 
This SAP covers: 
• 
Definition of analysis populations (residents and staff, ITT and complete-case). 
• 
Data cleaning, missing data handling, and quality control procedures. 
• 
Descriptive statistics, primary and secondary analyses, and effect size reporting. 
• 
Subgroup and sensitivity analyses, as well as approach to multiplicity. 
• 
Reporting conventions, including tables, figures, and adherence to the CONSORT extension 
for non-randomized trials. 
3. Study Design  
The LifeBio Memory project is an interventional, parallel assignment, non-randomized, open-label 
study evaluating the effects of a structured life-story intervention on residents living with dementia 
and the staff who facilitate their life story interviews. 
• 
Participant Groups: Two primary groups will be assessed: 
1. Residents living with dementia participating in LifeBio Memory intervention. 
2. Staff who facilitate or support the intervention. 
• 
Data Collection: Outcomes will be assessed at baseline (Time 1) and 4 weeks post-
intervention (Time 2). Training outcomes will be assessed immediately following the 
completion of intervention training videos. 
3.1 Sample Size & Power  
• 
Planned Enrollment: Based on the study proposal and prior pilot data, at least 20 residents 
per site across eight sites (n=160 residents) were planned for recruitment. Staff 
participants were included according to the number of residents assigned to them (2–6 
residents per staff participant). 
• 
Power Analysis: The study was powered to detect small-to-moderate effect sizes (Cohen’s 
d = 0.35–0.40) for paired t-tests on primary outcomes with 80% power and a two-sided α = 
0.05, assuming 20–25% attrition. 
• 
Baseline Assessments: Demographic variables and cognitive status (MMSE) were collected 
at baseline. Descriptive analyses will summarize these characteristics for residents and 
staff. 
3.2 Actual Analyzed Sample 
• 
Residents: 107 participants included in final analyses. 
• 
Staff: 53 participants included in final analyses. 

9 
 
3.3 Randomization / Masking 
• 
The study did not include randomization or blinding due to feasibility and practical 
considerations. 
3.4 Analysis Populations 
• 
Intention-to-Treat (ITT): All participants with baseline and at least one post-intervention 
measure. ITT analyses will use mean substitution for missing items within allowable 
thresholds (≤50% missing per scale). 
• 
Per-Protocol (PP): Participants completing baseline and 4-week follow-up without major 
protocol deviations. Analyses restricted to this population will serve as sensitivity analyses. 
4. Outcomes  
4.1 Primary outcome (Residents & Staff)  
 
Title  
Description of Primary Outcome Measures 
1 
 
Change in Center for 
Epidemiological 
Studies Depression 
Scale (CES-D) 
10-item Measure of depressive symptomatology; Scale: 0 (rarely 
or none of the time) to 3 (most or almost all of the time); 
Possible scores range from 0 (minimum) to 30 (maximum). 
Higher scores indicate higher frequency of reported depressive 
symptomology. 
2 
Change in Satisfaction 
With Care in the 
Nursing Home Scale 
Measurement of resident satisfaction with care in a long-term 
care facility; 8-items measured on a scale of 1 = generally yes 
and 0 = generally no; Possible scores range from 0 (minimum) to 
8 (maximum). Higher scores indicate higher satisfaction with 
care at the resident's facility. 
3 
Change in Quality of 
Life Alzheimer's 
Disease (QoL-AD) 
13-item Quality of life scale for an individual living with 
Alzheimer's Disease: rated on a scale of 1 (poor) to 4 (excellent); 
Possible scores range from 13 (minimum) to 52 (maximum). 
Higher scores indicate higher quality of life. 
4 
Change in Cohen-
Mansfield Agitation 
Inventory (CMAI) - Short 
Form From Baseline 
14-item Measurement of agitation that was completed by the 
staff for each resident they were assigned to conduct a life story 
interview with at baseline and post-intervention (proxy 
completed by staff on behalf of each resident) rated on a scale: 
1 (never) to 5 (several times an hour) scores can range from 14-
70, with higher scores indicating higher frequency of agitated 
behaviors of persons living with dementia as reported by those 
staff conducting their life story interviews. 
5 
Change in Staff 
Attitudes Towards 
Residents Scale From 
Baseline 
Measurement of the attitudes of long-term care staff towards 
the residents under their care includes 4-items on a 5-pt scale 
of 1= never to 5=always, scores ranging from 4 to 20, higher 
scores indicate more positive attitudes toward residents. 
6 
Change in 
Individualized Care 
Instrument (ICI) 
13-item subscale of the ICI scale "knowing the person"; rated on 
a scale from 1 (strongly disagree) to 4 (strongly agree); Possible 
scores range from 13 (minimum) to 52 (maximum). Higher 
scores indicate staff feel they know the resident(s) more. 

10 
 
Subscale - Knowing the 
Person - From Baseline 
7 
Change in The UCLA 3-
Item Loneliness Scale 
From Baseline 
3-item Measurement of feelings of loneliness; rated on a scale: 
1 (hardly ever) to 3 (often), ranging from 3 to 9, higher scores 
indicate higher feelings of loneliness. 
8 
Resident Satisfaction 
With the LifeBio 
Memory Program 
A total of 9-items were developed from the pilot and current 
study to understand residents’ acceptance and satisfaction 
with the LifeBio Memory program. Participants answered either 
"no" (0) or "yes" (1) to each item, with total scores ranging from 0 
to 9 (higher scores indicating high satisfaction with the LifeBio 
Memory program). 
9 
Change in Perceived 
Importance of Life 
Story Work Among Staff 
A 3-item measure related to the importance of life story work 
with residents; items are rated on a scale from 1 = strongly 
disagree to 5 = strongly agree, scores ranging from 3 to 15, with 
higher scores indicating staff feeling life story work is more 
important. 
10 
Staff Satisfaction With 
LifeBio Memory 
Program 
On the follow-up post-evaluations, staff were asked to rate their 
overall satisfaction with the LifeBio Memory program. A total of 
8-items developed from the pilot and current study were rated 
on a 1 (strongly disagree) to 5 (strongly agree) scale. Possible 
scores range from 8 (minimum) to 40 (maximum). Higher scores 
indicate higher satisfaction with the program. 
11 
Change in Sense of 
Competence in 
Dementia Care Staff 
(SCIDS) Scale From 
Baseline 
17-item measurement of staffs' overall sense of dementia care 
competence; rated on a scale: 1 (not at all) to 4 (very much) with 
scores potentially ranging from 17-68, higher scores indicating 
higher sense of competence in dementia care among staff. 
12 
Change in Person-
Centered Care 
Assessment Tool [Sub-
Scales I and II] From 
Baseline 
10-item measurement of staff experience with person-centered 
care in their current care community; rated on a scale: 1 
(strongly disagree) to 5 (strongly agree), scores ranging from 10-
50, higher scores indicating higher agreement with experience 
providing person-centered care. 
13 
Change in Direct Care 
Worker Job Satisfaction 
Scale From Baseline 
9-item measurement of staff satisfaction with different aspects 
of their job; rated on a Scale: 1 (very dissatisfied) to 4 (very 
satisfied), potential scores ranging from 9-36, higher scores 
indicating higher satisfaction with their job. 
14 
Change in 
Individualized Care 
Instrument (ICI) 
Subscale - Resident 
Autonomy Subscale - 
From Baseline 
15-item Measurement of staff perceptions about resident's 
autonomy; rated on a Scale: 1 (never) to 5 (very frequently), 
potential scores ranging from 15-75, higher scores indicating 
staff perceiving residents having more frequent autonomy. 
15 
Change in 
Individualized Care 
Instrument (ICI) 
Subscale - Staff and 
Resident 
7-item measurement of staff perceptions of their 
communication with residents; rated on a Scale: 1 (never) to 4 
(always), scores ranging from 7-28. higher scores indicating 
higher frequency of staff to resident communication about their 
care. 

11 
 
Communication 
Subscale - From 
Baseline 
16 
Change in 
Individualized Care 
Instrument (ICI) 
Subscale - Staff to Staff 
Communication 
Subscale - From 
Baseline 
10-item measurement of staff perceptions of staff to staff level 
communication, rated on a scale from 1 (never) to 4 (always), 
scores ranging from 10-40, higher scores indicating more 
frequent staff to staff communication. 
17 
Staff Perceptions About 
the Feasibility of the 
LifeBio Memory 
Program Protocol 
7-items were developed (rated on a 1 = strongly disagree to 5 = 
strongly agree response scale) and administered on the follow-
up post-evaluation to understand staff's perceptions about the 
feasibility of the program protocol once interviews were 
complete and materials (i.e., Action Plans, Life Story books, 
Snapshots) were delivered (e.g., Within the first 2-weeks of 
delivery, I was able to present the residents' Action Plans during 
a team meeting"). Possible scores range from 7 (minimum) to 35 
(maximum). Higher scores indicate higher feasibility with the 
implementation of program materials. 
 
4.2 Secondary outcomes (Residents & Staff) 
• 
MMSE, Staff knowledge of resident life stories and care preferences. 
 
Title  
Description of Secondary Outcome Measures 
18 
 
Change in Mini Mental 
Status Examination 
(MMSE) From Baseline 
Screening for resident cognitive status, scores can range from 0-
30, lower scores indicate more cognitive impairment (higher 
scores indicate less cognitive impairment). 
19 
Change in Staff 
Adequate Knowledge of 
Residents' Care 
Preferences From 
Baseline 
1-item asked of staff for each resident they interviewed on a 
scale of 1 = not at all well, to 5 = extremely well ("How well do 
you know the resident's care preferences?") 
20 
Change in Staff 
Adequate Knowledge of 
Residents' Life Stories 
From Baseline 
1-item asked of staff for each resident they interviewed on a 
scale of 1 = not at all well, to 5 = extremely well ("How well do 
you know the resident's life story?") 
 
4.3 Other Prespecified (Staff) 
 
Title  
Description of Other Pre-specified Outcome Measures 
21 
 
Length of Time Staff 
Spent on LifeBio 
Memory Training 
Item related to staff time spent on LifeBio Memory training 

12 
 
22 
Preparedness Of Staff 
Conducting Life Story 
Interviews 
Staff self-rated preparedness to conduct life story interviews 
with residents and set up their accounts following training; two 
1-item survey questions rated on a scale from 1 = strongly 
disagree to 6 = strongly agree. Higher score on each item means 
stronger agreement towards feelings of being prepared to 
conduct a life story interview with a person living with dementia 
using the LifeBio Memory app and setting up their account using 
the LifeBio Memory app. 
 
23 
Staff Training Needs 
Being Met With LifeBio 
Memory Training 
Staff overall feelings of needs being met with the LifeBio Memory 
Training Program. Staff were asked, "Overall, how well does the 
LifeBio Memory App training meet your needs?" On a scale from 
1 = not well at all to 5 = extremely well. 
24 
Staff Objective 
Knowledge of LifeBio 
Memory Training 
Content 
Staff completed an 11-item quiz post-training (tested on content 
detailed in the training videos). It was a multiple choice type 
quiz, and average score represents total number of correct 
items on the quiz. Scores could range from 0 to 11, with the staff 
ranging from 5-items correct to 11-items answered correctly. 
Higher scores indicate higher number of quiz items answered 
correctly. 
 
5. Statistical Considerations  
All analyses will follow a prespecified Statistical Analysis Plan and adhere to best practices for 
exploratory behavioral and clinical research. Analyses will be conducted in SPSS (Version 
28.0.1.1), with syntax retained to ensure reproducibility. Statistical tests will be two-sided at α = 
0.05, with 95% confidence intervals reported alongside p-values. Given the exploratory nature of 
the study and multiple outcomes, effect sizes (Cohen’s d for t-tests, partial η² for ANOVA, 
Pearson’s r for correlations) will be emphasized in interpretation. 
Primary analyses will focus on pre - post changes within residents and staff, with paired-samples t-
tests used for continuous outcomes and descriptive summaries for program-specific measures. 
Secondary and exploratory analyses will include additional intervention specific and knowledge 
outcomes, as well as subgroup analyses when applicable. For all parametric tests, assumptions of 
normality, homogeneity of variance, and linearity will be assessed, and nonparametric alternatives 
will be applied if assumptions are violated. 
Finally, due to the exploratory study design, no formal multiplicity correction will be applied. 
However, results will be interpreted with caution, emphasizing consistency across outcomes and 
practical/clinical significance. Transparency will be maintained by reporting all prespecified 
outcomes, documenting handling of missing data, and providing effect sizes alongside inferential 
statistics. 

13 
 
5.1 General Principles 
All statistical analyses will adhere to standard practices for clinical and behavioral research and 
will be conducted in a reproducible and transparent manner. 
 
5.1.1 Analysis Software 
• 
All analyses will be performed using IBM SPSS Statistics Version 28.0.1.1. 
• 
Syntax will be retained to ensure reproducibility. 
5.1.2 Significance Level and Confidence Intervals 
• 
All hypothesis tests will be two-sided with a significance threshold of α = 0.05, unless 
otherwise justified (e.g., exploratory analyses). 
• 
95% confidence intervals (CIs) will accompany point estimates for all primary and 
secondary outcomes to convey precision. 
5.1.3 Effect Sizes 
• 
Effect sizes will be reported for all inferential analyses to complement p-values and provide 
practical significance: 
o 
Cohen’s d for paired or independent-samples t-tests 
o 
Partial η² for ANOVA or repeated measures designs 
o 
Pearson’s r for correlations 
• 
Effect size interpretation will follow conventional thresholds (small, medium, large) and be 
considered in context of the exploratory nature of the study. 
5.1.4 Analysis Populations 
• 
Complete-case: Analyses restricted to participants with no missing data on the outcome of 
interest. 
5.1.5 Assumptions and Model Checks 
• 
For parametric tests (t-tests, ANOVA, Pearson correlations), assumptions of normality, 
homogeneity of variance, and linearity will be evaluated using: 
o 
Shapiro–Wilk test and Q–Q plots (normality) 
o 
Levene’s test (homogeneity of variance) 
o 
Scatterplots (linearity for correlations) 
• 
If assumptions are not met, appropriate nonparametric alternatives will be considered 
(e.g., Wilcoxon signed-rank test, Spearman correlations). 
5.1.6 Interim Analyses 
• 
No interim analyses are planned due to the exploratory and short-duration nature of the 
LifeBio Memory project. 
5.1.7 Reporting Conventions 
• 
All results will include sample sizes (n), descriptive statistics (mean, SD, median, IQR as 
appropriate), p-values, 95% CIs, and effect sizes. 
• 
Any deviations from the pre-specified analyses will be documented and justified. 
 

14 
 
5.2 Missing Data 
Procedures for handling missing data will follow published guidelines for patient-reported outcome 
(PRO) measures and psychometric scales. 
• 
Item-level missingness for composite scales: 
o 
If a participant is missing more than 50% of the items on a given measure, no total 
score will be calculated and the case will be excluded from that outcome analysis. 
o 
If less than 50% of items are missing, the participant’s total score will be calculated 
using mean substitution at the item level. Specifically, the individual’s mean score 
across available items will be imputed for missing items, and the total score will be 
computed based on the expected number of items in the scale. 
o 
This approach is consistent with recommendations for handling missing items in 
multi-item questionnaires where internal consistency is expected (Enders, 2010; 
Fayers & Machin, 2016). 
• 
Examples of application in this study: 
o 
UCLA Loneliness Scale (3-item short form): If 2 or more items are missing, no total 
score will be calculated. If 1 item is missing, the mean of the two available items 
will be substituted. 
o 
Resident Satisfaction with Care Scale (8 items): If ≤3 items are missing, the 
individual mean will be substituted for missing items; otherwise, the score will not 
be calculated. 
o 
Quality of Life–AD Scale (13 items): If ≤6 items are missing, mean substitution will 
be applied; otherwise, the score will not be calculated. 
o 
CES-D 10-item form: If ≤5 items are missing, mean substitution will be applied; 
otherwise, the score will not be calculated. 
• 
Dataset-level handling: 
o 
No advanced imputation methods (e.g., multiple imputation, maximum likelihood) 
are planned due to the modest sample size and exploratory nature of the project. 
• 
Documentation: 
o 
All imputation procedures will be implemented in SPSS using standard syntax with 
explicit commands. 
o 
All decisions about missing data will be logged, and final datasets will be archived 
with accompanying metadata to preserve transparency. 
Citations  
• 
Enders, C. K. (2010). Applied Missing Data Analysis. New York: Guilford Press. 
• 
Fayers, P. M., & Machin, D. (2016). Quality of Life: The Assessment, Analysis and 
Interpretation of Patient-Reported Outcomes (3rd ed.). Wiley. 

15 
 
• 
Little, R. J. A., & Rubin, D. B. (2019). Statistical Analysis with Missing Data (3rd ed.). Wiley. 
5.3 Descriptive Statistics 
• 
All study variables will first be summarized descriptively to characterize the sample and 
provide context for subsequent analyses. 
• 
Continuous variables (e.g., age, MMSE scores, CES-D, QoL-AD) will be summarized using 
means, standard deviations (SDs), medians, interquartile ranges (IQRs), and ranges, as 
appropriate. Normality assumptions will be assessed visually (histograms, Q–Q plots) and 
statistically (Shapiro–Wilk test). 
• 
Categorical variables (e.g., gender, education) will be reported as counts and percentages. 
• 
Baseline characteristics will be summarized separately by participant type (resident, staff), 
and group-level comparisons will be presented descriptively only (i.e., no inferential tests 
for baseline balance given the non-randomized design). 
5.4 Primary Analyses 
• 
The primary analyses will evaluate pre–post changes within residents and staff across the 
outcomes of interest. 
o 
Residents: Paired-samples t-tests will be conducted comparing baseline (T1) and 4-
week (T2) scores for: 
 
Center for Epidemiologic Studies Depression Scale (CES-D) 
 
Quality of Life in Alzheimer’s Disease (QoL-AD) 
 
Cohen-Mansfield Agitation Inventory (CMAI) 
 
Loneliness scale 
 
Satisfaction with Care measure 
o 
Staff: Paired-samples t-tests will be conducted comparing baseline and 4-week 
scores for: 
 
Staff attitudes toward persons living with dementia 
 
Dementia care competence 
 
Job satisfaction 
 
Individualized Care Inventory (ICI) subscales 
 
Person-Centered Care Assessment Tool (PCCAT) 
o 
Program-specific outcomes: Descriptive statistics and paired-samples t-tests will 
summarize outcomes related to satisfaction with the LifeBio program, feasibility of 
implementation, and training outcomes (e.g., perceived preparedness, confidence 
in using LifeBio). 
o 
For all paired t-tests: 
 
Results will be reported as mean differences with standard deviations, t-
statistics, degrees of freedom, p-values, and 95% confidence intervals. 
 
Effect sizes (Cohen’s d) will also be reported. 
o 
In cases where normality assumptions are substantially violated, nonparametric 
alternatives (Wilcoxon signed-rank test) may be considered and reported as 
sensitivity analyses. 
 

16 
 
5.5 Secondary Analyses 
• 
Secondary analyses will explore additional outcomes not designated as primary but still 
relevant to the LifeBio Memory project. 
o 
Residents: Mini-Mental State Examination (MMSE) scores will be analyzed using 
paired-samples t-tests (baseline vs. 4 weeks). 
o 
Staff: Knowledge of resident life stories and personal preferences will be analyzed 
using paired-samples t-tests. 
o 
Exploratory analyses: Where appropriate, subgroup analyses (e.g., stratification by 
site) will be conducted to explore heterogeneity of effects. These analyses will be 
treated as exploratory and interpreted with caution. 
• 
Results will be reported consistently with the primary analyses, including p-values, 95% 
confidence intervals, and effect sizes. 
5.6 Multiplicity 
• 
Given the exploratory nature of this project and the inclusion of multiple outcomes, formal 
adjustment for multiplicity (e.g., Bonferroni or Holm corrections) will not be applied. 
Instead, the following principles will guide interpretation: 
o Primary vs. Secondary Outcomes: If designated, primary outcomes will be the main 
focus of interpretation. Secondary outcomes and subgroup analyses will be 
considered hypothesis-generating. 
o Subgroup and Sensitivity Analyses: Comparisons across subgroups (e.g., 
completers versus non-completers, site-level differences) will be viewed as 
exploratory and interpreted cautiously. 
o Interpretation Strategy: Results will be evaluated in terms of effect sizes, 95% 
confidence intervals, and the consistency of findings across related measures, with 
attention to clinical and practical significance. 
o Transparency: All pre-specified outcomes will be reported regardless of statistical 
significance to minimize selective outcome reporting. 
5.7 Subgroup Analyses 
• 
Baseline Comparisons Between Groups 
o To assess whether participants who completed the study protocol differ from those 
who did not at baseline, independent samples t-tests will be conducted for all 
continuous baseline outcome variables (e.g., MMSE, agitation, quality of life, 
depression, loneliness, satisfaction with care).  
o Assumptions: Levene’s Test for Equality of Variances will be used to assess 
homogeneity of variance. If assumptions are violated, the t-test results under 
“equal variances not assumed” will be reported. 
o Effect Sizes: Cohen’s d will be calculated to estimate the standardized mean 
difference between groups. Effect sizes will be interpreted as small (~0.20), 
medium (~0.50), and large (~0.80).  
o Significance Threshold: All tests will use two-tailed significance testing with α = .05. 

17 
 
6. Data Management 
All study data will be managed to ensure accuracy, integrity, and confidentiality, in compliance 
with institutional policies, NIH/NIA guidelines, and Good Clinical Data Management Practices 
(GCDMP). 
 
[All study data will be captured in a secure electronic format at the Benjamin Rose Institute. To 
ensure accuracy, double-entry verification will be performed, and any data queries will be 
documented and resolved prior to analysis. Before analysis begins, all datasets will be de-
identified to protect participant confidentiality.]  
 
6.1 Data Capture 
• 
Data will be collected in a secure electronic format using the Benjamin Rose Institute on 
Aging’s approved data systems, with access restricted to authorized study personnel only. 
• 
Where paper case report forms (CRFs) or checklists are used in the field, data will be 
entered electronically by trained study staff within 5 business days of collection. 
6.2 Data Entry and Verification 
• 
A double-entry process will be used for quantitative data to minimize transcription errors. 
• 
Automated range checks and logic checks (e.g., impossible dates, out-of-range scores) will 
be built into the data entry system to prevent invalid entries. 
• 
Data queries will be generated automatically or manually by the data management team 
and documented in a query log. Queries will be reviewed and resolved by the study 
coordinator or PI prior to database lock. 
6.3 Data Cleaning and Quality Control 
• 
Regular data quality checks will be conducted (e.g., completeness, consistency across 
timepoints, adherence to allowable ranges). 
• 
Any modifications to the dataset (e.g., corrections, imputations) and collected surveys will 
be documented with date, rationale, and responsible staff initials to maintain a full audit 
trail. 
• 
Interim datasets may be produced for monitoring, but final analyses will only be performed 
after database lock. 
6.4 Confidentiality and De-Identification 
• 
All datasets used for analysis will be de-identified by removing direct identifiers and 
replacing participant IDs with unique study codes. 
• 
A master linking file will be stored separately on a secure, access-restricted server and 
accessible only to the PI and designated data manager. 
• 
All electronic data will be stored on encrypted, password-protected servers that comply 
with institutional IT security standards. 
6.5 Data Retention and Archiving 
• 
Study data will be retained for at least 7 years after completion of the study, consistent with 
institutional policy and NIH requirements. 

18 
 
• 
At study closeout, data will be archived in a secure format, with clear documentation of file 
structures, variable definitions, and metadata to support future re-use if permitted. 
• 
If applicable, de-identified datasets may be shared with NIH data repositories (e.g., NIA-
approved archives) following sponsor and IRB approval. 
6.6 Data Access and Oversight 
• 
Access to the data will be role-based, with permissions granted according to study 
responsibilities. 
• 
A data manager will oversee ongoing data integrity, maintain audit trails, and ensure 
compliance with this SAP. 
• 
Any breaches or irregularities will be reported to the PI and IRB per institutional policy. 
 
7. Quality Control 
Quality control procedures will be applied throughout the study to ensure accuracy, reliability, and 
adherence to protocol. 
• 
Training and Standardization: All staff involved in data collection and entry will receive 
standardized training, with refresher training provided as needed. 
• 
Ongoing Monitoring: The data manager will conduct routine checks for completeness, 
timeliness, and consistency. Discrepancies will be logged, investigated, and resolved in 
collaboration with the PI. 
• 
Audit Trail: All data modifications will be documented with date, rationale, and staff initials. 
• 
Pre-analysis Review: Prior to database lock, a final quality review will be conducted, 
including verification of key variables against source documents, reconciliation of missing 
data, and confirmation of resolution of all outstanding queries. 
• 
Documentation: A QC log will be maintained to document all procedures performed, issues 
identified, and corrective actions taken. 
These measures ensure that all analyses conducted under this SAP are based on high-quality, 
reliable data. 
 
8. Reporting 
• 
Results reported according to CONSORT extension for non-randomized trial 
• 
Tables/Figures will include: 
o Participant flow (CONSORT diagram) 
o Baseline characteristics (by staff/resident) 
o Pre-post outcome tables (means, SDs, p-values, effect sizes) 
o Subgroup analyses where applicable. 
 
8.1 Reporting Standards 
• Results will be reported in accordance with the CONSORT 2017 extension for non-
randomized trials and best practices for transparent reporting of clinical and 
implementation studies. Reporting will also comply with ClinicalTrials.gov 

19 
 
requirements, including timely submission of summary-level results within 12 
months of study completion. 
8.2 Planned Tables, Figures, and Listings (TFLs) 
The following tables and figures will be included in study reports and publications: 
• Participant Flow: A CONSORT-style diagram summarizing enrollment, 
exclusions, intervention completion, and analysis populations (staff and 
residents). 
• Baseline Characteristics: Tables summarizing demographics, 
cognitive/functional characteristics, and relevant staff/resident attributes by 
study group. 
• Pre–Post Outcomes: Summary tables of primary and secondary outcomes, 
reporting means, standard deviations, sample sizes, p-values, and effect 
sizes (Cohen’s d). 
• Subgroup Analyses: Where applicable, outcomes stratified by relevant 
subgroups (e.g., completers of the intervention versus non-completers). 
• Supplementary Figures: Graphical displays of key outcomes over time (e.g., 
line graphs, bar charts). 
8.3 Statistical Summaries 
• 
Continuous variables will be reported using means and standard deviations (or medians 
and interquartile ranges, as appropriate). 
• 
Categorical variables will be reported as counts and percentages. 
• 
All hypothesis tests will be reported with p-values and 95% confidence intervals. 
• 
Effect sizes will be presented for primary and secondary outcomes. 
• 
Missing data will be summarized by frequency and percentage. 
8.4 ClinicalTrials.gov Reporting 
• 
Results will be uploaded to ClinicalTrials.gov following registry requirements. 
• 
Only summary-level data will be reported (no individual-level data). 
• 
Pre-specified outcomes from the protocol and SAP will be included to ensure consistency 
and transparency. 
• 
Adherence to reporting timelines will be maintained in compliance with NIH/NIA 
expectations. 
8.5 Transparency and Deviations 
• 
Any deviations from the pre-specified analysis plan will be documented, justified, and 
reported in both the ClinicalTrials.gov results submission and any manuscripts. 

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• 
Protocol deviations (e.g., exclusion due to missing >50% of composite variables) will be 
summarized in tabular form. 
• 
Harms/adverse events (if applicable) will be reported descriptively. 
8.6 Dissemination 
• 
Findings will be disseminated in peer-reviewed publications, presentations at national 
conferences, and summary reports for participating sites and stakeholders. 
• 
Supplementary materials (e.g., detailed statistical outputs, additional tables/figures) may 
be provided in online appendices. 
• 
No individual participant data (IPD) will be shared outside the study team unless required 
by the sponsor or IRB.