Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
Phase: NA
Conditions: Lewy Body Disease, Parkinson Disease Dementia, Dementia With Lewy Bodies
Sponsor: Rush University Medical Center

 
 
 
[Year] 
Learning to PERSEVERE: 
Peer Mentor Support 
and Caregiver Education 
in Lewy Body Dementia 
NCT04649164 
Jori Fleisher; prepared 11/3/2022; protocol/analysis plan approved 6/5/2021 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
1 
 
Rush University Medical Center 
_____________________________________________________________________________________ 
 
Title: Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia 
 
 
Short Title: PERSEVERE 
Study #:  Study #: 20030604 
 
 
 
Principal Investigator:  
Jori Fleisher, MD MSCE 
Rush University Parkinson’s Disease and Movement Disorders Program 
Phone: 312-563-1603 
Jori_fleisher@rush.edu 
 
 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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ABBREVIATIONS 
AD 
Alzheimer’s Disease 
DAS 
Dementia Attitudes Scale 
GDS-SF 
Geriatric Depression Scale – Short Form 
HADS 
Hospital Anxiety and Depression Scale 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
Informed Consent Form 
LBD 
Lewy body dementia 
PD 
Parkinson’s Disease 
PDD 
Parkinson’s Disease Dementia 
PDQ-Carer 
Parkinson’s Disease Carer Questionnaire 
PERSEVERE 
Peer mentor support and caregiver education 
SCT 
Social Cognitive Theory 
ZBI-12 
Short Zarit Burden Interview 
 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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I. Project Rationale and Description 
I.a. Purpose of the Study 
Dementia is one of the most common and expensive conditions worldwide, with nearly 44 million people 
diagnosed, costing approximately $1 trillion worldwide1. Lewy body dementia (LBD) is the second most common 
major neurocognitive disorder, comprising Parkinson’s Disease (PD) dementia and Dementia with Lewy Bodies. 
LBD causes deterioration in multiple cognitive, motor, and neuropsychiatric domains, leading to heavy reliance on 
family caregivers2–6. As LBD progresses, patients are prone to complications resulting in emergency room visits, 
hospitalizations, and institutionalization7–9. Annual health care costs are nearly one third higher in LBD compared 
with Alzheimer’s Disease, driven primarily by hospitalizations for falls, neuropsychiatric symptoms, and infections, 
which are often preventable or treatable at home if recognized early8,10. LBD patients experience prolonged 
hospital stays, increased in-hospital mortality, and a fivefold higher risk of institutionalization, where they suffer 
suboptimal care and excess mortality9,11–17. Caregivers are uniquely positioned to identify and manage 
complications at home, preventing functional decline and emergencies. Yet simultaneously, caregiver strain is an 
independent risk factor for hospitalization and institutionalization in LBD8,9,18. Few interventions have addressed 
caregiver strain or mastery in this population3–6,8. 
 
In response to this knowledge gap, we piloted peer mentoring for caregivers of homebound patients with 
advanced PD, nested within a trial of interdisciplinary home visits (K23NS097615). This intervention included a five-
hour educational workshop among 34 mentors. We matched mentors with caregiver mentees for 16 weeks, and 
interim analyses of mentees completing the program indicate feasibility and acceptability.  
 
We now propose to adapt, improve, and implement a peer mentor support and caregiver education (PERSEVERE) 
intervention for LBD caregivers. We will conduct focus groups and interviews with pilot mentors, mentees, and 
current caregivers to generate feedback on the mentoring curriculum and handbook. We will focus on key areas of 
LBD caregiving mastery, including: fall prevention, detecting and managing infections, neuropsychiatric symptom 
management (particularly hallucinations, delusions, delirium, anxiety, and depression), and advance directives. 
Applying the stress process model of caregiver strain19, enhanced by feedback and behavior change theories20–23, 
we will revise the mentor training curriculum, conversation guides, and resource handbook to operationalize LBD 
caregiving mastery for the key areas above. We will recruit and train a cohort of approximately 30 LBD peer 
mentors using the revised curriculum, developing their capacity to serve as LBD caregiving mastery coaches. We 
will assess mentors’ caregiver mastery using Pearlin and Schooler’s scale pre- and post-training19. Finally, we will 
match each mentor with an active LBD caregiver for 16 weeks of peer mentoring using our revised conversation 
guides and handbook to assess the impact of mentoring on caregiver mastery, strain, anxiety, and depression.  
 
We will pursue the objectives above with the following specific aims:  
 
Aim 1: To operationalize caregiving mastery in LBD, focused on fall prevention, infection and neuropsychiatric 
symptom management, and advance directives.  
H1: By conducting focus groups and interviews with former and potential LBD mentors and mentees, we  
will refine a practical toolkit, including a training curriculum, resource handbook, and conversation guide.   
     
Aim 2: To test the impact of peer mentor training on LBD caregiver mastery. 
 
H2: Mentors will demonstrate greater caregiver mastery following training, as demonstrated by improved 
caregiver mastery and LBD knowledge scores compared to baseline.  
 
Aim 3: To assess the impact of peer mentoring on LBD caregiver mentees.  
H3: Family caregivers of patients with LBD will demonstrate increased caregiving mastery, LBD  
knowledge, and improved social support, after 16 weeks of structured peer mentoring. 
 
This work will identify key features of caregiving mastery and support in LBD, refine and validate a caregiver 
support toolkit, and test the impact of a theory-driven intervention to mitigate adverse caregiver outcomes. 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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I.b. Background 
PD affects nearly one million individuals in the US, with a 77% projected increase in prevalence by 203024. With 
increasing age and PD duration, the prevalence of PD Dementia (PDD) approaches 70%25,26. Conversely, 4.2 to 7.5% 
of all individuals with dementia will be diagnosed with DLB27. DLB and PDD differ in chronology but share similar 
underlying pathology and neuropsychiatric features—particularly, depression, anxiety, delusions, and 
hallucinations—hence the umbrella classification of LBD28. As LBD progresses, symptoms increase in number and 
severity, quality of life worsens, and hospitalizations and caregiver strain increase3,29,30.  
 
The leading causes of hospitalization in LBD are falls, urinary incontinence or infection, dehydration, and 
neuropsychiatric changes, many of which are preventable or treatable at home if recognized and addressed 
promptly12. An independent but related risk factor in both hospitalization and institutionalization in LBD is 
caregiver strain4,8,9. Once hospitalized or institutionalized, people with LBD suffer excessive iatrogenic morbidity 
and mortality12. Despite overwhelming evidence linking caregiver strain to both acute healthcare utilization and to 
adverse caregiver health consequences32, and despite unmet needs for prognostic counseling and education for 
LBD caregivers, few interventions have targeted caregiver strain in this population31–33.  
 
Early studies matched Alzheimer’s Disease (AD) caregivers with peer mentors—former informal AD caregivers—to 
bolster coping skills and social support34–36. Qualitative data showed benefits for caregivers and mentors, though 
some quantitative results are equivocal due to variable implementation34,37. There is a knowledge gap regarding 
the content, logistics, and implementation of peer mentorship, and LBD caregivers face different and greater 
challenges than their AD parallels38. While peer mentorship yields social support, this may be necessary but 
insufficient as it does not address other contributors to caregiver strain39.   
 
Caregiver strain and comorbidities have been conceptualized in the Stress Process Model such that background 
and context, primary stressors, role strain, and intrapsychic strains interact to yield outcomes of caregiver stress 
and strain, including depression, anxiety, and physical and psychological comorbidities39. Proposed mediators of 
these relationships are social support, coping, and mastery—both competence and confidence as a caregiver21. 
Indeed, Mausbach and colleagues have demonstrated that mastery attenuates the relationship between caregiver 
stress and depressive symptoms20,40. 
 
We have designed a theory-based intervention of targeted education on common causes of hospitalization in LBD 
patients, combined with social support from trained peer mentors, to enhance caregivers’ mastery and LBD 
knowledge. Social Cognitive Theory (SCT) proposes that behavior change is dynamic, affected by expectations, 
observational learning, and reciprocal influences from the environment23. Figure 1 shows how PERSEVERE applies 
SCT constructs to the revised Stress Process Model to improve caregiving mastery and ultimately, outcomes. 
PERSEVERE builds on our pilot framework, qualitative analysis of focus group feedback, and existing LBD and 
dementia caregiving educational materials. 
Preliminary data: The study team is currently completing a study of caregiver peer mentoring in caregivers of 
patients with PD (Rush IRB # 17080209, PI: J. Fleisher). During three five-hour sessions, our team trained 34 
caregiver peer mentors who were matched with caregivers of 65 homebound PD patients participating in an 
ongoing home visit trial. Caregivers were matched with a mentor at home visit 2 and consented to weekly 
mentoring calls between visits 2 and 3 (~16 weeks). This study has demonstrated the feasibility of this type of peer 
mentoring program: among 48 caregivers receiving mentoring, 35 have completed the program to date. Those 
completing the program had a median of 13 mentoring calls (IQR 7.5) with 98% of caregivers finding visits useful, 
99% getting along with their mentor, and a wide range of topics covered, from resources to coping strategies. The 
NIH K23 trial is ongoing. We will analyze change from baseline in caregiver strain, self-efficacy, anxiety, and 
depression upon study completion. We will also analyze secondary outcomes including changes within mentors 
themselves.  
 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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Figure 1. Conceptual Model of PERSEVERE Interaction and Social Cognitive Theory Constructs with Stress Process 
Model 
I.c. Study Design 
Overview: The aims of this study are to 1) operationalize caregiving mastery in LBD, focused in fall prevention, 
infection and neuropsychiatric symptom management, and advanced directives; 2) test the impact of peer mentor 
training on LBD caregiver mastery; and 3) assess the impact of peer mentoring on LBD caregiver mentees. We will 
address these goals by Aim 1: convening focus groups with stakeholders to obtain feedback on the existing 
mentoring curriculum and to reflect on key areas of LBD caregiving mastery for incorporation in the revised 
curriculum. We will then revise the PERSEVERE curriculum and handbook based on feedback and incorporation of 
LBD-specific and dementia-relevant educational materials for both social support and LBD mastery education. Aim 
2: To test the impact of the peer mentor training on LBD caregiver mastery, we will assess participating mentors’ 
caregiver mastery and LBD knowledge before and after participation in an 6-7 hour mentor training session.  Aim 
3: The trained mentors will be matched with family caregivers of patients with LBD and complete a 16-week, 
structured peer mentoring program.  We will compare change in caregiver mastery and LBD knowledge between 
baseline and 16 weeks of social support and education through mentoring calls. 
 
II. Characteristics of the Research Population 
II.a. Number of Subjects 
Total Number of Subjects: 896 total participants in four different categories: 30 focus group participants (across 
multiple focus groups, depending on scheduling needs), 800 participants in the online recruitment survey, 36 peer 
mentors, and 30 caregiver mentees 
Focus group participants: 30 participants who will each participate in one focus group of up to 10 participants   
Peer mentors: 36 non-professional current or former caregivers (allowing for the dropout of up to 6 mentors) 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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Caregiver mentees: 30 current non-professional caregivers 
Online Recruitment Survey Participants: 800 current caregivers 
Power Calculation: This is a pilot study, intended to generate data regarding effect sizes and to inform sample size 
calculations for a larger, multi-centered randomized controlled trial in the future. Thus, our sample size of 30 
mentees is based on historical recruitment to the preceding K23 and anticipated projections for recruitment within 
the time frame of this one-year grant. Working backwards from 30 mentees requiring a matched mentor and 
accounting for up to 15% dropout of mentors after training, we will enroll 36 mentors.  
II.b. Gender of Subjects 
There will be no exclusion of subjects based on gender. 
II.c. Age of Subjects 
Subjects will be 21-90 years old. 
II.d. Racial and Ethnic Origin 
There will be no exclusion of subjects based on racial or ethnic characteristics. Study demographics are expected to 
match those of the population from which it was drawn. However, subjects must be fluent in English to participate 
in the study due to the general lack of appropriately translated study assessments and to ensure clear 
communication between mentors and mentees participating in the mentor program. 
II.e. Inclusion Criteria 
1. Focus group participants 
a. Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and 
any ethnicity. 
b. Subjects must be either:  
i. Individuals who served as peer mentors in our previous study of caregiver peer 
mentoring and completed at least 16 weeks of mentoring. 
ii. Individuals who were caregiver mentees in our previous study of caregiver peer 
mentoring who completed 16 weeks of mentoring.  
iii. Current informal family caregivers of community-dwelling LBD patients in the Chicago 
area, recruited from Rush University System for Health and Advocate Aurora Health, 
who have not participated in mentoring.  
c. 
Each subject must be primarily English-speaking. 
d. Each subject must be willing and able to attend a virtual, online focus group via an internet- and 
video-camera-equipped computer, tablet, or smartphone.  
 
2. Peer mentors 
a. Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and 
any ethnicity. 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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b. Each subject must be a non-professional caregiver (defined as cohabitating with or spending >10 
hours weekly on unpaid caregiving duties) of LBD patients. Mentors may participate regardless of 
their loved one’s status (living at home, institutionalized, or deceased).  
i. If mentors also receive compensation for a portion of their time spent on caregiving 
duties through state or community programs, they may participate as long as they 
cohabitate or spend >10 hours providing unpaid care to their loved one.  
c. 
Each subject must have: 
• >2 years of LBD caregiving experience, or  
• >2 years of PD caregiving experience for an individual without cognitive impairment and 
professional or volunteer experience interacting with individuals with cognitive impairment or 
dementia, or their caregivers (e.g., support group leader, healthcare professional, counselor, 
social worker), or 
 
• >4 years of PD caregiving experience for an individual without cognitive impairment 
d. Each subject must be primarily English-speaking. 
e. Each subject must have a working email address and internet access. 
f. 
Each subject must have a working telephone number at which he or she can be reached and 
which he or she is willing to share with the matched mentee. 
g. 
Each subject who will attend an online peer mentor training session must have an internet- and 
video-camera-equipped computer, tablet, or smartphone. 
 
3. Caregiver mentees 
a. Each subject must be 21 years of age or older. A subject may identify as any sex, any race, and 
any ethnicity. 
b. Each subject must be a non-professional, unpaid caregiver, as defined above in II.e.2.b., of a 
community-dwelling LBD patient. 
c. 
Each subject must be interested in improving their caregiving mastery. 
d. Each subject must be primarily English-speaking. 
e. Each subject must have a working email address and internet access. 
f. 
Each subject must have a working telephone number at which he or she can be reached and 
which he or she is willing to share with the matched mentor. 
II.f. Exclusion Criteria for all Subjects 
1. Subjects exhibiting symptoms of a severe psychiatric disorder interfering with their ability to 
participate in the study, as determined by a study team member or the PI. 
2. Subjects who are primarily non-English-speaking. 
3. Terminal illness (life expectancy of < 12 months). 
II.g. Vulnerable Subjects 
This study will not include children, prisoners, and homeless persons.  Participants are not expected to have 
cognitive impairment, however as it is anticipated that many subjects may be elderly and at risk of age-related 
cognitive changes as well as neurodegenerative disease, all subjects will be assessed for capacity to consent (see 
Section V.b.). The consent form will state that participation in our study will not affect their loved one’s clinical 
care. 
II.h. Online Recruitment Survey Participants 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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These participants will include individuals who elect to complete an online survey in order to indicate their interest 
and eligibility to participate in a caregiver peer mentor program. 
 
III. Methods and Procedures 
III.a. Aim 1: Subject Identification, Recruitment, Consenting and Study Procedures  
Subjects participating in focus groups and interviews will be recruited from 3 different populations: 1) individuals 
who were caregiver mentees in our previous peer mentoring study, 2) individuals who served as peer mentors and 
completed 16 weeks of mentoring in our previous peer mentoring study, and 3) individuals who are current 
informal family caregivers of community-dwelling LBD patients in the Chicago area, recruited from Rush University 
and Advocate Aurora Health, who have not participated in mentoring.  A study team member will provide potential 
participants with information about the research study by reading from an IRB-approved recruitment script. Once 
they understand study requirements and the schedule of events, have expressed interest in participating and been 
screened for eligibility, their focus group or interview will be scheduled.   
If an individual does not meet eligibility criteria, the study team will maintain a list of screened and ineligible 
individuals containing only the individual’s sex, age, race, ethnicity, and responses to the eligibility criteria that 
rendered the individual ineligible for the purposes of ensuring adequate representation of minority populations in 
our recruitment and for documentation to the sponsor. Names or other identifiers will not be maintained on this 
list, and only aggregated, de-identified data will be shared with the sponsor in regards to screened and ineligible 
individuals. If an eligible individual chooses not to participate in the study between the time of the screening 
phone call and the initial study visit, that individual’s de-identified information will be stored as above, similar to 
screened and ineligible individuals 
Given the COVID-19 pandemic, we will conduct virtual focus groups/interviews using a password-protected 
videoconference platform such as Zoom. The informed consent process will take place online via REDCap prior to 
the focus group/interview date. In this way, participants can contact the study team with any questions or 
concerns prior to the start of the focus group/interview. After participants have read the online consent form and 
indicated they are willing to participate, they will complete capacity assessment questions (see Section V.b.) to 
ensure understanding of the consent process.   
Focus groups/interviews will be led by a qualified neuropsychologist and psychometrician (GS), using focus group 
manuals that include open-ended probes based on SCT constructs and the stress process model. The aim of these 
focus groups/interviews is to revise and improve upon our previous peer mentor program’s curriculum.  During the 
focus group or interview, participants will be presented with the previous program’s curriculum, including training 
slides and the mentor handbook.  We will also provide a variety of proposed educational resources for inclusion in 
the revised curriculum and obtain participants’ feedback.  We will also seek input from participants on the 
development of a mentoring preferences survey for both mentors and mentees to optimize mentor matching in 
Aim 3. These focus groups/interviews will be recorded and transcribed, with all identifying information stripped 
from the transcripts prior to analysis. 
III.b. Aim 2: Subject Identification, Recruitment, Consenting and Study Procedures 
We will recruit peer mentors by contacting facilitators of LBD support groups and asking them to distribute IRB-
approved recruitment fliers, placing recruitment fliers in the waiting area of Rush University’s Parkinson’s and 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
9 
 
Movement Disorders Program (including locations at Rush University Medical Center, Rush Copley, and Rush Oak 
Park, given the presence of movement disorders specialists at each location), distributing recruitment fliers at 
community events, asking national organizations such as the Parkinson’s Foundation and the Lewy Body Dementia 
Association to distribute recruitment fliers by mail, email or social media, asking national organizations such as the 
Parkinson’s Foundation and the Lewy Body Dementia Association to post a social media recruitment survey on 
social media platforms such as Facebook and Twitter that interested and eligible individuals can complete to 
indicate their potential interest in studies of caregiver peer mentoring, sending potential participants the 
recruitment flier via MyChart , contacting individuals referred to the program by providers at Rush or other 
institutions in the Chicago area, and contacting mentors and mentees who participated in the previous mentor 
program who might be interested in serving as a mentor in this program.  Interested participants will be given 
study information and screened for eligibility to exclude potential mentors who do not meet inclusion criteria, who 
express discomfort discussing sensitive topics with their potential mentee (including, but not limited to, challenges 
faced in their own caregiving journey, advance directives, or cultural differences between the mentor and 
mentee), or whose expressed belief systems would suggest inability to deliver the curriculum.  
Mentors will attend one 6-7 hour training session, either held in-person at Rush University or a via password-
protected videoconferencing application, such as Zoom.  Study expectations and logistics will be reviewed with 
each potential mentor prior to the training session via phone.  For all subjects, regardless of whether they attend 
an online or in-person training session, the informed consent process will take place online via REDCap prior to the 
training session date. In this way, participants can contact the study team with any questions or concerns prior to 
the training session. After participants have read the online consent form and indicated they are willing to 
participate, they will complete capacity assessment questions (see Section V.b.) to ensure understanding of the 
consent process. 
Individuals may refuse to participate in the study and leave the peer mentor training session at any time.  At the 
beginning of the training session, baseline data will be collected either via printed pen-and-paper assessments, or 
via online surveys (demographics, mentoring preferences, mastery scale, LBD knowledge test, Dementia Attitudes 
Scale (DAS); see Section III.d. for details). Next, mentors will receive training regarding topics including active 
listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on 
caregiver, practical approaches to symptom management, and caregiving issues. The study team will then present 
the new PERSEVERE curriculum and accompanying handbook.  The study team will solicit questions and lead role-
play conversations. Finally mentors will complete post-training assessments (mastery scale, LBD knowledge test, 
DAS) and will receive a training stipend (either directly from study team members if in-person, or mailed/emailed if 
completing training virtually). 
III.c. Aim 3: Subject Identification, Recruitment, Consenting and Study Procedures  
We will recruit caregiver mentees by contacting facilitators of LBD support groups and asking them to distribute 
IRB-approved recruitment fliers, placing recruitment fliers in the waiting area of Rush University’s Parkinson’s and 
Movement Disorders Program (including locations at Rush University Medical Center, Rush Copley, and Rush Oak 
Park, given the presence of movement disorders specialists at each location), distributing recruitment fliers at 
community events, asking national organizations such as the Parkinson’s Foundation and the Lewy Body Dementia 
Association to distribute recruitment fliers by mail, email or social media, asking national organizations such as the 
Parkinson’s Foundation and the Lewy Body Dementia Association to post a social media recruitment survey on 
social media platforms such as Facebook and Twitter that interested and eligible individuals can complete to 
indicate their potential interest in studies of caregiver peer mentoring, sending potential participants the 
recruitment flier via MyChart, and contacting individuals referred to the program by providers at Rush or other 
institutions in the Chicago area. A study team member will call interested caregivers to provide them with study 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
10 
 
information and logistics by reading from an IRB-approved recruitment script.  If interested, the team member will 
email the caregiver a link to the electronic informed consent and baseline survey in REDCap.  The components of 
the informed consent document will appear on the first page of the online survey.  Potential participants must 
read through the informed consent language on the first page and click a button agreeing to continue.  On the next 
page of the survey, we will incorporate capacity assessment questions to ensure understanding of the consent 
process.  Upon correct completion of these questions, the participants will be directed to begin the actual survey 
questions.  Participants will be asked to complete a demographics survey, a survey describing the characteristics of 
the LBD patient for whom they are caring, and a mentoring preferences survey to facilitate matching (see Section 
II.d. for details). As recruitment for mentees will be rolling and occurring during mentor recruitment and training, 
there may be lag time between ICF completion and mentoring intervention of weeks to months, and this will be 
clearly communicated to participants during the screening phone calls and reiterated in the ICF.  
 
Once Aim 2 (above) is complete and 36 mentors have been trained, caregiver mentees will be matched with 
mentors by relationship to LBD patient, then by sex and age, as much as possible. Mentor and mentee preferences 
expressed in the mentoring preferences survey will be honored to the extent that the study team is able given the 
available mentor and mentee participants. The study team will contact mentees once a match is available for 
them. First, the study team will direct the mentee to complete baseline primary and secondary outcome 
assessments online via REDCap, including: mastery scale19, LBD knowledge test, loneliness scale41, Short Zarit 
Burden Interview (ZBI-12)42, Hospital Anxiety and Depression Scale (HADS)43, Geriatric Depression Scale – Short 
Form (GDS-SF)44, and Dementia Attitudes Scale (DAS)45 in order to obtain their pre-intervention baseline. The study 
team will then provide the mentee with contact information for their mentor, and caregivers will be mailed the 
PERSEVERE handbook.   
Mentor-mentee pairs will then begin the 16-week peer mentor program. During this time, pairs will be expected to 
speak for >15-30 minutes weekly, and to review that week’s PERSEVERE topics in the handbook before or during 
each call to facilitate meaningful conversations. Discussions are not scripted and will not necessarily be limited to 
that week’s topics, at the discretion of the participants. Mentors and mentees will complete online study diaries 
every 2 weeks, assessing intervention fidelity. Up to 3 email reminders will be sent and/or up to 3 phone calls 
attempted to complete each study diary. Diary entries will include information such as call frequency, duration, 
topics discussed, and concerns. At the Week 8 or Week 10 survey, all mentees and those mentors who are still 
actively caregiving for a loved one with LBD will complete the Parkinson’s Disease Carer Questionnaire (PDQ-
Carer), a novel measure of PD-specific caregiver quality of life. Mentors will participate in 4 recorded monthly 
conference calls to share successes, challenges, and feedback, and to ask questions of and be supported by the 
study team. 
Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete post-
mentoring assessments online (mentors: mastery scale, LBD knowledge test, DAS, PDQ-Carer; mentees: mastery 
scale, LBD knowledge test, loneliness scale, ZBI-12, HADS, GDS-SF,  DAS, PDQ-Carer, and fall frequency and 
healthcare utilization of their loved one; see Figure 3). 
Figure 3. Outcomes, Fidelity Metrics, Covariates, and Confounders in Aims 2 & 3 
                                                   Aim 2 - Mentor Training                              Aim 3 – PERSEVERE Pilot 
Primary 
Outcomes 
• Mastery scale19 
• Multiple-choice LBD 
knowledge test 
• Mastery scale 
• LBD knowledge test 
• Loneliness scale41 
Secondary 
Outcomes 
• Mastery Scale (after 
mentoring) 
• Dementia Attitudes Scale 
(DAS)45  
• Parkinson’s Disease Carer 
Questionnaire (PDQ-Carer) 
• Short Zarit Burden Interview (ZBI-12)42 
• Hospital Anxiety and Depression Scale 
(HADS)43 
• Geriatric Depression Scale – Short Form (GDS-
SF)44 
• DAS 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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(only if actively caregiving for 
loved one with LBD) 
• Parkinson’s Disease Carer Questionnaire 
(PDQ-Carer) 
Fidelity Metrics 
 
• Frequency and duration of calls 
• Number of missed calls/weeks 
• Coverage of target topics; other topics 
discussed 
• Qualitative feedback in mentor conference 
calls 
• Dropout rate and reason  
Demographics, 
Confounders, 
Covariates 
Sex, age, race, ethnicity, education, comorbidities, caregiving relationship, duration of 
caregiving; patient’s disease duration, stage, ADLs46 and IADLs47 at baseline, and 
patient’s monthly frequency of falls and acute healthcare utilization (combined 
number of ER visits not yielding admission + hospital nights) in the months prior to and 
during the intervention. 
 
III.d. Assessments 
All participants who agree to be part of the study and sign the informed consent form will be asked to complete a 
series of surveys and assessments.  There is no known risk associated with completion of these assessments.  All or 
some of the following measures may be administered but are not limited to: 
• 
Mastery Scale: A 7-item scale measuring the extent to which a participant sees life as being under his/her 
personal control vs. something that is fatalistically ruled. Scores range from 7 to 28, with higher scores 
indicating greater levels of mastery.19 
 
• 
LBD Knowledge Test: A multiple-choice test created by the study team to assess participants’ level of 
knowledge of LBD.  Higher scores indicate a greater degree of knowledge of LBD and its effects. This 
assessment will be based on the revised PERSEVERE curriculum following the conclusion and analysis of 
data from focus groups.  
 
• 
Dementia Attitudes Scale (DAS): A validated, 20-item scale measuring participants’ attitudes toward 
dementia and individuals with dementia.  Scores can range from 7-140, with higher scores indicating more 
positive attitudes.45 
 
• 
Loneliness Scale: A 3-item, validated measurement of a participant’s feelings of isolation or 
disconnectedness. Scores can range from 3-9, with higher scores indicating greater loneliness.41 
 
• 
Short Zarit Burden Interview (ZBI-12): A 12-item, validated measurement of caregiver burden in older 
adults. Scores range from 0-48, with higher scores indicating greater caregiver burden.42 
 
• 
Hospital Anxiety and Depression Scale (HADS): Brief, 14-item highly validated scale for measuring anxiety 
(7 items) and depression (7 items), where scores of >8 for either anxiety or depression indicate probable 
symptoms.43 
 
• 
Geriatric Depression Scale – Short Form (GDS-SF): Brief, 15-item, highly validated scale for measuring 
depression in older adults, total possible range of 0-15, where a score >5 suggests depression44.   

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
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• 
Mentoring Preferences Survey: A survey designed by the study team, with input from focus group or 
interview participants (see Aim 1) that will allow for mentors and mentees to indicate matching 
preferences (e.g., matching with a person who likes to speak in the evenings vs. the morning, matching 
with someone of a specific gender, etc.) 
 
• 
Katz Index of Activities of Daily Living: A brief, 6-item assessment that indicates the level of assistance 
with ADLs needed by patients for whom mentees are caring46. 
 
• 
Lawton-Brody Instrumental Activities of Daily Living Scale: an 8-item assessment that indicates the level of 
assistance with IADLs needed by patients for whom mentees are caring47. 
 
• 
Parkinson’s Disease Carer Questionnaire: a 29-item, validated assessment measuring 4 domains of quality 
of life specific to unpaid/family caregivers of individuals with Parkinson’s Disease (Jenkinson et al 2012, 
Jenkinson et al 2013).  
III.e. Data Analysis and Data Monitoring 
I. 
Statistical analysis: The primary data will be entered into a HIPAA-compliant database (REDCap)48, with 
quarterly audits for fidelity.  Data will be exported to Stata 15 for analysis. Primary and secondary 
outcomes, covariates and confounders, and fidelity metrics are listed in Figure 2. 
 
II. 
Aim 1 (focus groups/interviews, PERSEVERE curriculum development): We will describe baseline 
demographics of focus group participants, transcribe recordings, and develop a theme codebook.  
Framework analysis49 will be used to guide the revision of the structured, 16-week mentoring curriculum, 
with provision of practical checklists, goal setting, and step-by-step guides for key areas of LBD caregiving 
mastery in addition to social support. Several topics in the revised curriculum will be repeated or given 
two weeks to allow for reiteration in the event of missed mentoring calls. 
 
III. 
Aim 2 (peer mentor training, LBD caregiver mastery): We will describe the demographics, baseline 
mastery, LBD knowledge, and dementia attitudes of mentors pre-training, assessing for normality and 
reporting means/standard deviation or medians/interquartile range. We will compare within-subject 
change in mastery, LBD knowledge, and DAS pre- and post-training (primary outcomes) and pre-training 
and post-mentoring (secondary outcomes) using paired t-tests or Wilcoxon sign rank test, as appropriate. 
 
IV. 
Aim 3 (caregiver peer mentoring): We will analyze data fidelity by summarizing categorical variables by 
frequencies and percentages and will assess continuous variables for normality, summarized by 
mean/standard deviation or median/interquartile range. We will describe the baseline demographics, 
patient characteristics (including fall frequency and acute healthcare utilization), mastery, LBD knowledge, 
loneliness, ZBI, HADS, GDS-SF, and DAS of caregivers. Bivariate analyses will compare change between 
baseline and 16 weeks of mentoring in each of the above, using paired t-test or Wilcoxon sign rank, as 
appropriate. We will also compare change in PDQ-Carer between mid-study and Week 16 as an 
exploratory outcome. To examine potential covariate effects, we will run a series of repeated measures 
ANCOVAs for pre- and post- primary and secondary outcome measures using demographic and 
confounder variables as nuisance variables.  These analyses will be considered exploratory due to the loss 
of degrees of freedom resulting from the covariates. Mentor program fidelity metrics including dropout 
rate and reasons, time spent on phone calls, number of phone calls, and topics discussed will be calculated 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
13 
 
based on responses obtained from biweekly online study diary entries. Qualitative data will be gathered 
from the monthly mentor conference calls via notes taken by the study team; framework analysis will be 
applied to identify key themes regarding successes, challenges, and recommendations for improving the 
program.  
 
V. 
Monitoring and Oversight: PERSEVERE will be maintained by the Principal Investigator. The Principal 
Investigator will review study procedures annually and report any concerns in the IRB continuing 
application. This is a Level I, Low, Minimal Risk study; therefore, there is minimal risk of unanticipated 
problems with the exception of breaches in confidentiality. The data for the study will be entered into a 
secured database using an electronic data capture program such as Research Electronic Data Capture 
(REDCap)48. The database will be stored on a secure password-protected server and not on individual 
desktop computers. The code sheet will be password protected and the password will be updated 
annually. Breaches of confidentiality will be reported to the IRB immediately with the “Reportable 
Event/Unanticipated Problem Form.” The PI, co-investigators, and/or study staff will review all data 
collection forms on an ongoing basis for data completeness and accuracy as well as protocol compliance. 
The data will be reviewed on a quarterly basis for: Subject accrual (including compliance with enrollment 
criteria); Status of all enrolled subjects; Adherence data regarding study activities and procedures. Any 
issues noted during the quarterly data and safety monitoring reviews will be submitted to the IRB 
annually. Safety data (AEs and SAEs) will be reported to the Principal Investigator and reviewed per 
occurrence and in accordance with the IRB’s regulations. Any significant findings (i.e. protocol deviations) 
will be reported to the IRB in accordance with requirements and will be documented accordingly. There 
are no predefined stopping rules for the overall study. 
III.f. Data Storage and Confidentiality 
All research data files will be stored at the Rush University Parkinson’s Disease and Movement Disorders Program 
in secured file cabinets, including case report forms, informed consent forms and informed consent 
documentation checklists, and de-identified notes taken by the study team during the focus groups and interviews, 
mentor training, or mentor program conference calls. Hard copies of case report forms and informed consent 
documentation checklists will be labeled with the study ID only and maintained in individual files by study ID 
number. Signed informed consent forms, containing subject names, will be stored separately in the regulatory 
binder, which will be stored in a locked file cabinet in the PI’s office. The notes taken by the study team will be 
reviewed for any errant identifying data on a monthly basis and censored, and the original hard copies of such 
notes will be stored in a locked file cabinet in the PI’s office.  
All subjects (focus group/interview participants, mentors and mentees) will be assigned unique ID numbers. 
Only the PI, Co-investigators and research staff will have access to the database. During the consent process, the 
potential participant will be informed that aspects of their PHI will be shared with collaborating researchers at 
Rush; however, they will have an opportunity to decline having their PHI shared and still participate. Data will be 
stored in a format suitable for research inquiries by the PI and Co-Investigators, who might make use of the data in 
a retrospective manner for other Rush-based research studies. The data collected from this study is restricted to 
access by the PI and direct study collaborators at Rush. No collaborator will be allowed to share the data outside 
the study team without the PI’s written approval. Collaborators interested in using the data outside of this study 
will be required to provide a written request to the PI noting the specific data fields of interest, a description of 
how the data will be used and who will have access/use the data. The PI reserves the right to grant/deny approval 
to any collaborator prior to the release of any study data. If a particular researcher/collaborator has an interest in a 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
Study #: 20030604 
14 
 
study population, then the PI will review the database to identify eligible subjects that meet the study inclusion 
criterion and the potential participant(s) will then be contacted by a member of this study team whom the subject 
has already met to see if they are interested in participating in the particular study. If a participant is interested, he 
or she will be referred to that Rush study team and will be scheduled for a separate consent procedure with the 
individual Rush researcher for that particular study and at that point the participant can choose whether to 
participate or not in that particular study. The results of this study may be published in a book, journal, and other 
media or used for teaching purposes. However, all published data will be made anonymous. 
 
IV. Risk/Benefit Assessment 
IV.a. Risk 
There are no known risks from the completing the surveys and assessments that we will use in this study. Subjects 
completing these types of surveys and assessments may experience mild boredom or cognitive fatigue. Subjects 
participating in the focus groups or training session may also experience mild boredom or cognitive fatigue.  There 
is a risk of loss of confidentiality by participating in this study, however the study team will take all reasonable 
precautions to secure the data and maintain confidentiality as described above. Due to the nature of focus groups 
and group training sessions, confidentiality of information shared cannot be guaranteed; however, the study team 
will emphasize to all participants that any information discussed should not be shared outside the group. Mentors 
will be instructed during mentor training about the importance of confidentiality of mentoring conversations, and 
this will be reiterated in the handbook for both the mentors and mentees. 
IV.b. Potential Benefit to Subjects 
Focus group or interview participants: The potential direct benefits to focus group participants include the 
satisfaction of having contributed to scientific knowledge about LBD and related disorders that may help to 
improve the quality of life for themselves and other subjects’ loved ones with movement disorders. For 
participants who were previously involved in other support groups or mentor programs, the focus groups may 
provide positive social interactions with other caregivers and feelings of validation. 
Caregiver peer mentors: The potential direct benefits to caregiver peer mentors include validation of their lived 
experiences and accumulated knowledge as caregivers to a loved one with LBD, providing some potential degree 
of closure or purpose. Caregiver peer mentors may have previously been involved with other caregivers but 
become disconnected if/when their loved one with LBD passed away, and by attending the mentor training 
session, establishing a mentoring relationship, and participating in  conference calls, may rejoin the caregiver 
community and derive benefits from social interactions and shared experiences. 
Caregiver mentees: The potential direct benefits to mentees include increased mastery due to the relationship and 
discussions held with their mentor, decreased depression, anxiety, and caregiver strain due to the positive 
relationship with emotional support from a caregiver peer mentor. 
All subjects: All subjects’ involvement will contribute to scientific knowledge determining whether a formal, 16-
week mentoring program can have an impact on caregiver mastery, strain, anxiety, and depression.  This study and 
future studies may provide a model of care to improve quality of life and caregiver strain for hundreds of 
thousands of individuals with LBD and related disorders. 
 

PI: Jori Fleisher, MD MSCE 
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V. Subject Consent 
V.a. Process of Consent 
All focus group and mentor program participants will complete the informed consent process online via REDCap 
after the study is explained to them and questions are answered by a member of the study team. Informed 
consent must be completed prior to any participant joining any portion of the study (focus groups, mentor 
training, or beginning the peer mentor relationship). Participants will be asked to give online consent for the study 
by trained study team members (PI or co-investigators, the latter of which will be trained by the PI in the process 
of assessing capacity and obtaining informed consent). Subjects completing the online recruitment survey will 
follow a link posted to social media by national organizations such as the Parkinson’s Foundation and the Lewy 
Body Dementia Association.  Before providing consent, online survey participants will be given the contact 
information of the study team and asked to contact the team if they have any questions before providing consent. 
Subjects are not expected to have cognitive impairment, however, subjects may be elderly and at risk of age-
related cognitive changes, so all subjects will be assessed for capacity to consent.  The study team has prior 
experience building capacity assessments into REDCap online surveys. 
V.b. Subject Capacity 
Capacity to consent will be assessed by a designated trained research staff member and/or the PI. Designated 
study staff will undergo individualized training with the PI in the process of capacity assessment and informed 
consent, in addition to all applicable research training in the capacity and consent processes available at Rush 
University. The study staff have experience building capacity assessments into REDCap online surveys, such that 
the potential participants will be prompted during the online consent process with questions to assess the 
participant’s comprehension by asking the participant to identify key elements of the consent form, particularly 
the sections of the consent form that explains what specifically they are being asked to do, how long they will be 
involved in the study, what risks and benefits are involved, how their confidentiality will be protected, and how 
their data will be stored for future use. 
V.c. Subject Comprehension 
The study team will assess comprehension during the capacity assessments and will be available by phone to 
answer any questions posed by the subject. Capacity assessments will be completed online for all participants. 
V.d. Debriefing Procedures 
Subjects will not be debriefed about the aims and study hypotheses following administration of all study 
procedures due to the nature of the study and the data collected. This study does not involve deception and the 
aims and hypotheses are explicitly described to participants, so further debriefing is not necessary 
 
V.e. Documentation of Consent 
The consent will always be completed online and consent process details (e.g., timing) will be recorded in REDCap 
after built-in capacity assessments. 
V.f. Costs to the Subject 
There will be no cost to subjects associated with participation in this study.   

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2021-June-05 
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V.g. Payment for Participation 
Participants who attend the peer mentor training in person will be provided with parking vouchers or 
reimbursement for their subway/taxi travel (up to $20). Participants who attend a focus group or interview will 
receive a $50 stipend. Mentors who complete the mentor training session will receive a $50 stipend. Finally, 
mentors and mentees will receive $75 upon completion of the 8-week online survey and an additional $75 upon 
completion of the 16-week final assessment online survey. 
 

PI: Jori Fleisher, MD MSCE 
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