Improving Care Partner Outcomes Through Positive Connections
Phase: NA
Conditions: Social Connectedness
Sponsor: University of Rochester

 
 
Version 9.0,  
January 31 2023 
 
1
 
Title: Social-LEAF Life Enhancing Activities for Caregivers 
IRB Approved Protocol 
 
NCT05274074 
Date of last Modification: 1.31.23  
 
 

 
 
Version 9.0,  
January 31 2023 
 
2
 
 
Improving Dementia with Lewy Bodies Care Partner Outcomes through Positive 
Connections  
 
• Principal Investigator:   
Benzi Kluger, MD, MS 
• Co-Investigators: 
 
Sue Ouellette, PhD  
   
Judith Moskowitz, PhD 
Sandhya Seshadri, PhD, MS, MA 
• Sub-Investigator: 
 
Kathi Heffner, PhD 
 
Sally Norton, PhD 
Benjamin Chapman, PhD, MPH 
Sarah Kluger, LMHC, MA 
Judy Long, MDiv, BCC 
• Research Coordinators:  
Ellen Beckwith, BS 
Kelly Bellenger-Fedele, MS 
Jeffrey Swan, MA 
 
1. PURPOSE OF STUDY  
Family care partners of persons with Lewy Body Dementia (also known as Dementia 
with Lewy Bodies, DLB) face numerous challenges to their wellbeing including social 
isolation, changes in close relationships, difficult emotions, high burden of caregiving 
tasks and burnout. Many interventions focus on education around dementia caregiving, 
dementia symptom management, and dealing with negative consequences of caregiving. 
More recently, interest has arisen in developing strength-based interventions that seek to 
support family care partners discover positive emotions, self-efficacy, and meaning in 
caregiving.  
 
The purpose of this study is to further this work using the Life Enhancing Activities for 
Family Caregivers (LEAF) intervention by adapting it to a group setting and by tying 
LEAF skills to social connections (Social-LEAF). We hope to display that social 
networks’ can be used as a means of reinforcing the positive life skills of the 
intervention; and that these same skills will enhance social networks, increase mutual 
satisfaction in social interactions, and boost motivation to reach out to others, thus 
combatting social isolation.  
 
In this 18-month long pilot study we hope to create a foundation for future clinical trials to 
test the effectiveness and mechanisms of Social-LEAF through the two main aims that will 
be displayed and utilized throughout the duration of this study.  
 
Aim 1) To understand care partner needs, preferences, concerns and optimal 
communication strategies to adapt the LEAF intervention to a group with social 
components; and Aim 2) To determine the feasibility and acceptability of the LEAF 
intervention as a source of pilot data for future grants, and to assess for signs of efficacy 
and to identify areas where further optimization may be needed. 
 

 
 
Version 9.0,  
January 31 2023 
 
3
 
2. BACKGROUND AND RATIONALE  
With the aging of the US and global population, the number of persons living with, and 
dying from, dementia is predicted to increase with an estimated 1/3 of older adults dying 
with dementia1 DLB is the second most common Alzheimer's disease and related 
dementias, and, despite increased motor symptoms and behavioral complications, is 
relatively understudied2 DLB has direct impacts on individuals, society, and our elder-
care infrastructure; what tends to be less discussed is the impact of the growing number 
of family care partners who do the vast majority of caregiving. This impact includes lost 
financial opportunities, adverse effects on mental and physical health and social isolation3  
 
Interference from direct caregiving hours, changing priorities, and loss of supportive 
from their spouse all contribute to social isolation in DLB care partners4. Social isolation 
in turn contributes to worsening of care partner outcomes, including increased caregiving 
stressors, poor psychological outcomes, and increased susceptibility to stress-related 
illnesses5. 
 
The majority of interventions for dementia care partners utilize psychoeducational 
approaches to target care partner burden, manage symptoms and address negative affect6 
While these interventions are reflective in achieving their aims, they neglect many 
significant opportunities to improve the care partner experience, particularly 
opportunities for joy, meaning and connection. 
 
To optimally promote wellbeing, we need to go beyond merely treating diseases and 
eliminating suffering, to also actively promoting health and positive emotions7 Notably 
positive interventions, such as the Life Enhancing Activities for Family care partners 
(LEAF) intervention, have been shown to increase positive outcomes (e.g. positive affect, 
physical health) while still addressing important negative outcomes (e.g. depression, 
anxiety)8 
 
While positive interventions have been linked in general to prosocial behaviors and 
improved relationships9 this has not been studied in the context of dementia care partner. 
Given the promise of positive interventions for this purpose and the pressing need for 
improved social support for family care partner, we see this as a critical gap with a high 
potential for addressing this need, impacting research in this field, and changing the 
clinical care landscape. 
 
3. ADMINISTRATIVE ORGANIZATION   
This study will be conducted and have the majority of its operations held at the 
University of Rochester Medical Center. This will include faculty in the Department of 
Neurology and the Center for Health and Technology (CHeT). We will also be 
collaborating with the Rochester Roybal STAR Center, a professor and Co-Investigator 
on the study at Northwestern University, the Alzheimer's Association and the Parkinson’s 
Foundation. Dr. Moskowitz's key roles will be to offer templates for the individual 
interviews and pilot testing and assist in the adaptation of the intervention for Aim 1 and 
2, verifying that study procedures are adequately being conducted, and help interpret the 
findings during data analysis and manuscript preparation. 

 
 
Version 9.0,  
January 31 2023 
 
4
 
 
 
Study Overview 
We seek to adapt the LEAF intervention to a group setting and by tying LEAF skills to 
social connections (Social-LEAF). We hypothesize that social networks can reinforce the 
positive life skills of the intervention; and that these same skills will enhance social 
networks. In this 18-month pilot study we will create a foundation for future clinical trials 
to test the effectiveness and mechanisms of Social-LEAF. 
 
4. STUDY DESIGN 
This will be a completely virtual 18-month long pilot randomized control study. The 
initial month will be dedicated to start-up activities including IRB submission, training, 
database set-up and initial meetings with our internal team to review the intervention. 
Following this, 3 months will be towards executing the activities related to Aim 1 of the 
study. This will include individual interviews with up to 20 people, iterative optimization 
and ongoing analyses, and piloting of the Social-LEAF procedures. We will be assessing 
the efficacy of the Social-Leaf procedures before finalizing the intervention to implement 
these changes for Aim 2. Aim 1 is mainly about the interview and gaining feedback on 
what individuals would like to see and what they would change about the intervention. At 
the end of Aim 1, our team members will meet to review the transcripts and suggestions 
we’ve received.  The feedback we get from Aim 1 will facilitate the study materials and 
final intervention for Aim 2.  
Moreover, the next 12 months of the study will be focused on the execution and 
completion of Aim 2. This will include the implementation of the Social-LEAF 
interventions. Beginning with the 1:1 randomization of subjects to the intervention and 
waitlist control arms of the study. The intervention group starts study procedures soon 
after they are consented, while the waitlist control group begins study procedures 6 weeks 
after. Our biostatistician has provided us with a randomization program that will be 
downloaded into Redcap. This will allow subjects who have consented to study and 
entered into Redcap to be randomly assigned to the group that they will be in (waitlist 
control or intervention). The Social-LEAF course consists of 6 skills delivered online, 
through video-conferencing (“video sessions”) with a trained facilitator, to help manage 
subject’s mood and cope with the stressors of caregiving. Aim 2 subjects will complete 
the finalized 6-week program from the feedback we receive from Aim 1. Eligible subjects 
will be asked to take part in an end of study interview. The last 2 months of the proposal 
will be dedicated to completing data analyses/quality assurance, planning future studies, 
and the writing of grants, manuscripts, etc. Below, Table 1 depicts an expected timeline 
for the study procedures.  
 
Table 1: 
Study Procedure 
Timeline 
Study start up 
0-1 Month 
Aim 1 
3 Months  
Aim 2 
12 Months 

 
 
Version 9.0,  
January 31 2023 
 
5
 
Analyses, extensions, etc.  
2 Months 
 
 
CHARACTERISTICS OF THE RESEARCH STUDY POPULATION 
 
Subjects: 
Overall, they must be a primary care partner of a person with DLB, have had direct 
contact with the care recipient at least 3 days per week (bereaved care partners can be 
included for this aim), be able to speak English, and be willing to participate. Subjects 
will be excluded if they lack the capacity to consent for themselves or have urgent 
supportive care needs. We are looking for up to 20 subjects for Aim 1 and 60 subjects for 
Aim 2.  
 
Gender, Age, Racial, and Ethnic Origin of Subjects: 
Gender and Age of Subjects:  
There will be no gender-based restrictions. There will be no maximum age restriction. 
 
Racial and Ethnic Origin: There will be no enrollment restrictions based upon race or 
ethnic origin. The study will include enrollment of persons of diverse racial/ethnic 
backgrounds to ensure that the benefits and burdens of research participation are 
distributed in an equitable manner. 
 
Vulnerable Subjects 
Caretaking for individuals with conditions like Dementia with Lewy Bodies (DLB) can 
be a strenuous task. Individuals identified by the study coordinator and/or investigator to 
be exhibiting characteristics of poor mental health will be addressed as soon as possible. 
This includes extreme responses to the questionnaires, tearfulness, signs of self-injury, 
etc. The coordinator will adapt ways in which to identify and approach these situations. 
In a more serious case, the subject will be referred to the chaplain and/or the mental 
health counselor on the study. Their needs and concerns are crucial to the implementation 
of this project.  
 
5. INCLUSION AND EXCLUSION CRITERIA 
SUBJECTS  
Aim 1 
• CARE PARTNER INCLUSION CRITERIA: Must be a primary care partner of a person 
that has been clinically diagnosed with Dementia with Lewy Bodies (DLB) or 
Parkinson’s Disease Dementia, and has access to high-speed internet connection at home 
or in a location where they can speak privately with a facilitator. iPads and a hotspot will 
be given to those who lack internet and a sufficient mobile device but show willingness 
to participate. The iPads and hotspot will be returned to the study team once study 
procedures have concluded.  
 
• CARE PARTNER EXCLUSION CRITERIA: Not a primary care partner of a person 
with DLB. Is a primary care partner of someone who has not been clinically diagnosed 
with DLB. Cannot provide clear and concise consent to the project.  

 
 
Version 9.0,  
January 31 2023 
 
6
 
 
 
Aim 2 
• CARE PARTNER INCLUSION CRITERIA: Must be a primary care partner of a person 
that has been clinically diagnosed with Dementia with Lewy Bodies (DLB) or 
Parkinson’s Disease Dementia, and has access to high-speed internet connection at home 
or in a location where they can speak privately with a facilitator. iPads and a hotspot will 
be given to those who lack internet and a sufficient mobile device but show willingness 
to participate. The iPads and hotspot will be returned to the study team once study 
procedures have concluded. Must be willing and ready to begin the intervention either 
immediately or in 6 weeks depending on which group they are randomly selected to be 
in.  
 
o CARE PARTNER EXCLUSION CRITERIA: Not a primary care partner of a 
person with DLB. Is a primary care partner of someone who has not been 
clinically diagnosed with DLB. Cannot speak English or provide clear and 
concise consent to the project.  
 
o INTERVENTION INCLUSION CRITERIA: Must begin LEAF procedures as 
soon as consented to the study. Has not taken part in Aim 1 of the study.  
 
o INTERVENTION EXCLUSION CRITERIA: Has not started LEAF procedures 
at the beginning and has taken part in Aim 1 of the study. 
 
o  CONTROL INCLUSION CRITERIA: Will have waited the 6-week period 
before starting LEAF procedures after consenting and has not taken part in Aim 1 
of the study.  
 
o CONTROL EXCLUSION CRITERIA: Has started/taken part in the LEAF 
procedures at the beginning and also has taken part in Aim 1 of the study.  
 
6. RECRUITMENT METHODS 
 
Aim 1 Recruitment Plan:  
Leaders of Lewy Body Dementia support groups identified by the Parkinson Foundation or 
Alzheimer's Association will be contacted to assess their interest in participating in this research. 
We will provide information on the study goals by way of the flyers/information sheets. Interest 
by the group will lead to the study coordinator contacting them to schedule them for an individual 
interview.  
 
Aim 2 Recruitment Plan:  
Subjects will be recruited using recruitment strategies that have been successful for our ongoing 
studies of care partners of a family member with DLB. Including: 
• Flyers to family members of patients with DLB receiving care at UR Memory Care and 
clinics participating in the UR Provider-Based Research Network 

 
 
Version 9.0,  
January 31 2023 
 
7
 
• Lifespan and Alzheimer’s Association staff who have direct contact with older care 
partners in the community seeking services and interventions (who provide referrals) 
• Existing research registries held by our investigators (which afford direct contact with 
older care partners who have previously agreed to be contacted for future research study 
participation).  
• ResearchMatch- Potential volunteers will be sent out a contact message with a brief 
overview of our study which is in our IRB approved ResearchMatch form. Potential 
volunteers will then have an option to complete a brief pre-screening survey via a 
REDCap survey link and provide their contact information if they would like to be 
contacted about the study. The prescreening survey will screen potential subjects for age 
and care partner of LBD or PDD eligibility criteria. 
• The Roybal STAR Center 
• Foxtrialfinder (research matching service maintained by Michael J. Fox flyer on the 
website and interested individuals will contact the study personnel directly.  
• Alzheimer’s Association TrialMatch website (connects individuals living with 
Alzheimer’s caregivers and healthy volunteers to clinical trials). 
https://www.alz.org/alzheimers-dementia/research_progress/clinical-trials/trialmatch  
• LBDA Research Study page (Lewy Body Dementia Association website’s research study 
page). https://www.lbda.org/research/clinical-trials/ 
• We will also use strategies specific to recruiting care partners for individuals with 
Dementia with Lewy Bodies (DLB):  mailing the flyer to researchers in the Lewy Body 
Dementia Research Network (national network of which URMC is a Center of 
Excellence); newsletters and mailings through the Parkinson Foundation (international 
network of which URMC is a Center of Excellence); recruitment at UR Memory Care, 
movement disorders center and neuropalliative care clinics by clinicians. In working with 
UR Memory Care and Movement Disorders clinics, study coordinators may review charts 
for upcoming clinics and ask clinicians to provide approved study flyers to introduce the 
study if they feel it would be helpful and appropriate for DLB caregivers of their patients. 
• In addition, we may also reach out to Recruitment Consultation, a service core of UR 
Clinical and Translational Science Institute (CTSI) for consultation and recruitment 
strategy planning to promote inclusion of racial and ethnic minority subjects.  
 
 
Staff-level strategies (continuous quality monitoring and refresher trainings targeting the 
 
following): 
1. Establish rapport. 
2. Know the subject. 
3. Guide subject with sensitivity. 
4. Ongoing communications 
5. Accommodations for subject needs and safety, such as transportation, safety 
protocols (i.e., in response to suicidal ideation, for example). 
6. Focus on achievement and progress. 
 
7. CONSENT PROCESS 
Aim 1:  

 
 
Version 9.0,  
January 31 2023 
 
8
 
Potential subjects will have prior information about the study via the P.I., referrals, 
information sheet, flyers, and their support group leaders, etc. Once interested they will 
be in contact with the project study coordinator. We are requesting a waiver of 
documentation of consent because the research is no greater than minimal risk and the 
interview will be addressing a topic where written consent is not normally required. The 
waiver won’t affect the rights and welfare of the subjects. The Roybal center will play an 
integral part in the determination of subject eligibility (I.e. the screening process). They 
will use our inclusion/exclusion criteria to view potential subjects, and if seen to be 
eligible by them and our criteria, they will send these subjects to the study coordinator. 
The coordinator will then verify their interest and eligibility by contacting them either via 
phone or email using the verbal script. If interest is presented and eligibility is met, the 
study coordinator will move forward with acquiring the subject's consent to participate. 
Once they have consented to participate, the project study coordinator will proceed to 
schedule them for an interview session.  
 
Aim 2: 
All subjects will receive some information with regard to the study via our different 
recruitment methods (i.e. Researchmatch), help from the Roybal Center, etc. Once they 
have expressed their interest about participating in the study coordinator will begin the 
screening process of checking their eligibility for the study. This will include verifying 
that they are a primary care partner of someone with DLB or PDD, did not participate in 
Aim 1, are willing and able to provide clear and concise consent, etc. In addition, the 
screening will also utilize the already established inclusion/exclusion criterions. After the 
eligibility criteria is met and their consent has been obtained, all subjects will be asked to 
provide contact/demographic information about themselves and begin the study 
procedures.   
 
The project study coordinator will complete a thorough review of the study procedures 
and information with potential study subjects prior to obtaining consent. Potential study 
subjects will have an opportunity to ask questions and have their questions answered to 
their satisfaction prior to giving consent. The process of reviewing the study information 
will be conducted in a manner to facilitate questions from potential study subjects. If the 
project study coordinator is unable to answer a question, an investigator will be 
contacted. All questions from potential subjects will be answered prior to the project 
study coordinator obtaining consent. They will be reminded of the voluntary nature of 
study participation and the project study coordinator will explain the study, the voluntary 
nature of participation, the study’s potential benefits and risks, and alternatives as needed 
for the subject. The study coordinator will also explain to the potential subject that even if 
they decide to drop out of the study, we will still use any data that we previously 
gathered, up to the point in which they decide to discontinue. An explanation of risks will 
include information that questions asked may cause subjects to feel uncomfortable or 
upset. They will be informed that they may withdraw from the study at any time for any 
reason without negative consequences to them. They will also be notified that all of their 
rights will be protected.  
 

 
 
Version 9.0,  
January 31 2023 
 
9
 
We plan to obtain documentation of consent for this Aim via e-consenting. Subjects will 
receive the form via email as a survey through REDCap. As a result of this, the 
mechanism of authorization will be via the electronic device they decide to use to fill out 
the e-consent form. To verify that the individual signing the consent form is the subject, 
there will be a verification code. This verification code will be the last 4 digits of the 
phone number they provide us with.  Once received they can either go over the form on 
their own, over the phone with the help of the study coordinator, or over zoom with the 
study coordinator (if requested by the subject). A confirmation email is supposed to be 
sent to all respondents that have completed the survey, but because your email address is 
not on file, the confirmation email cannot be sent automatically. If you wish to receive it, 
you must provide your email address to the study coordinator. There will be a signature 
section at the end of the document which will confirm the subject's participation in the 
study. This will be an e-signature which will document that the subject understands the 
study, their procedures for the study, and that they consent to participate in it. Moreover, 
once the first 20 individuals have expressed interest and are consented into the study then 
they will be randomized as 10 intervention, 10 waitlist control. This will continue to be 
the recruitment/consent process until our recruitment goal of 60 subjects is met. We plan 
to administer this consent process via e-consent.  
 
 
8. STUDY PROCEDURES (AIM 1) 
 
Aim 1: Adapt the Life Enhancing Activities for Family Caregivers intervention to an 
online group intervention integrating social skills and connections. We will conduct these 
individual interviews with up to 20 care partners to adapt the LEAF course materials to a 
group setting. Also, we plan to incorporate social connections and skills (Social-LEAF) 
with these materials. We are looking for a max of 20 subjects to take part in this. We will 
be scheduling these potential subjects in a 6 week window based on their availability. 
Depending on the timing, there may be multiple individual interviews conducted in one 
day. Once they agree to take part in this portion of the study, subjects will join the 
interview and be exposed to the intervention (this will be completely virtual, and 
interviews will take place via the Zoom application). We will provide them the main 
basis of each element of the intervention during the interview, then go through the guide 
to see what kind of feedback we receive, Landmark Associates will be utilized to 
transcribe these interviews to help the study team further develop the intervention for 
Aim 2.  Those who have participated in Aim 1 and aid in the adaptation of this 
intervention will be automatically ineligible for Aim 2.  
 
- 
Aim 1 Procedures: The adaptation and tailoring process will consist of individual 
interviews, feedback, and consultation with the study team which some members 
have experience with supporting individuals who are dementia care partners. 
Explanation of the implementation of these interviews is above, and will be further 
outlined in sections below. As a first step, our core team will review the LEAF 
intervention, the LEAF-2 modifications (study in progress: R01AG058613) and the 
Positive Emotion Orientation for Nurturing Your Relationships intervention 
(PEONY: R01AA024065) to create the first draft of the Social-LEAF training manual 

 
 
Version 9.0,  
January 31 2023 
 
10
 
and guide. We will draw on these other interventions to deliver the CORE aspects of 
LEAF in a group context and to integrate social examples, skills, and positive social 
outcomes. We will then begin recruitment/enrollment for individuals who are 
interested, mainly through support groups and the Parkinson’s Foundation. 
Individuals who enroll will be asked to provide basic contact information as part of 
their enrollment into the study, so that we are able to schedule them for the interview. 
During the interview subjects will receive a brief introduction to the intervention and 
its core components by the interviewer, who is a part of the study. The interviewer 
will then go through the interview guide and ask subjects questions about the 
intervention and acquire feedback from them. The interview will be recorded and 
later transcribed by Landmark Associates for our study team to review. Notably, Co-
investigator Dr. Moskowitz (consultant and originator of LEAF, LEAF-2, and 
PEONY) has adapted her interventions to multiple populations and contexts using the 
procedures described below, including to a group intervention for men infected with 
HIV (PEONY). Dr. Moskowitz’s main role within this study is to provide her own 
feedback and consultation on how the intervention should be provided to subjects. 
She has years of experience with these interventions and modifying them, so she will 
play an integral role in the finalization of the intervention for Aim 2. She will have 
access to the de-identified data of the subjects but she will not be directly interacting 
with them. Moreover, she will also play a part in quality assurance and making sure 
study procedures are being conducted properly for Aim 2. Additionally, Table 2 
outlines the core components of the virtual 6-week LEAF intervention and how they 
may be adapted to social skills and content. Group adaptations would include the use 
of facilitated group discussions, role play, dyad exercises, and encouragement to 
connect between facilitated sessions.  
- 
Outcomes will be the data/feedback we receive from the individual interviews (the 
materials for the adapted LEAF program, see Study Procedures below). Subsequent 
to this, after all the interviews have been conducted the main study team will get 
together to review and finalize the intervention in preparation for Aim 2. The research 
study coordinator will submit any RSRB modifications needed if anything within the 
intervention is changed subsequent to study approval.  
 
Table 2. Current LEAF Content and Potential Adaptations for Social-LEAF 
 
Weekly Focus 
Potential Adaptations  
Week 1 
Noticing Positive 
Events  
Noticing the positive impact of social events both large 
(family visit) and small (email or card); Develop plans to 
build on social intentions 
Week 2 
Mindfulness 
Learn to balance self-awareness and self-compassion with 
attentive listening and mindful connection 
Week 3 
Positive 
Reappraisals  
Recognize role of negative attributions in disrupting social 
connections; Consider ways to share positive reappraisals of 
stressful events 
Week 4 
Strength and 
Goals  
Recognizing social strengths (e.g., good listener) and positive 
attributes (e.g., sense of humor) 
Week 5 
Acts of Kindness  
Appreciate the personal and relational benefits of both 
performing small acts of kindness and in receiving them 

 
 
Version 9.0,  
January 31 2023 
 
11
 
Week 6 
Sustainment 
Subjects develop concrete plans to continue to practice 
Social-LEAF skills including with members of their social 
network 
 
 
9. STUDY PROCEDURES (AIM 2) 
 
Aim 2: The goal of this aim is to assess the acceptability, appropriateness, feasibility, and 
efficacy of Social-LEAF. We will conduct a pilot randomized controlled trial of the 
Social-LEAF intervention in 60 subjects (30 intervention; 30 waitlist control) and use 
mixed methods to assess feasibility, acceptability and efficacy. 
- 
Aim 2 Procedures: Subjects will complete six, weekly, 90 minute group sessions of 
the Social-LEAF intervention. Subjects enrolled in the study will be randomly 
assigned into either an immediate intervention group or a waitlist control (receives 
intervention after 6 weeks) by a computer program. Subjects will know which arm 
they will be in after enrollment in the study. The intervention will be delivered 
completely online. We ask that subjects find a nice and quiet area in which there is 
minimal distractions to conduct these visits. Subject privacy is very important to us. 
Subjects will be asked to complete a daily emotion check-in (5 minutes) during the 6-
week course period. This will be delivered to them via Redcap as a survey as well. 
Prior to beginning the Social-LEAF course, they will receive a computer tablet to use 
for the study, if they express the need for it. Subjects will also be asked to complete 
our online outcome measures at each data collection point (3 total) approximately 
every 6 weeks (baseline, week 6, and week 12) after you are officially enrolled in the 
study. The total time to complete these activities in one day is approximately 2 hours 
and 15 minutes. Please refer to Table 4 for a list of these measures. Furthermore, if 
the study research coordinator sees anything concerning (I.e., signs of abuse, self-
harm, etc.) during the duration of a research visit, then there are measures in place to 
address this. These measures include contacting the PI and chaplain immediately, 
relaying these concerns, and gathering as much information as possible before taking 
action towards this concern. There will be 3 groups of 10 (on average; this number 
may range from 5-15 depending on randomization, recruitment and retention)  that 
will be in each group (intervention or control). Each group of subjects will go through 
the study procedure together. Data from subjects in all groups will be collected at 
baseline, week 6, and week 12. Data collection will happen via zoom/via Redcap 
survey sent to them by the email subjects initially provide the coordinator with. The 
waitlist control subjects will start the intervention at week 6 but still complete the 
measures for data collection at baseline, week 6 and week 12. Table 3 displays the 
timeline in which the study procedures for Aim 2 will take place. Planned 
deliverables from this aim will include a final intervention manual, a manuscript on 
the pilot intervention, and pilot data suitable to pursuing future grant opportunities.  
- 
Quantitative Survey Outcome Measures: Our primary outcome measure is the 
PROMIS Positive Affect Scale. We will also be assessing the Positive Aspects of 
Caregiving scale (positive consequences of caregiving)10   and other measures of 
caregiver distress and wellbeing (see Table 4). These measures will be administered 
at each data collection point mainly via Redcap as a survey, and/or via the study 

 
 
Version 9.0,  
January 31 2023 
 
12
 
coordinator administering it as required by the scale. The health history data will be 
collected when the subject initially consents, and updated as the study progresses. 
Altogether, the duration to complete these measures altogether is roughly 2 hours and 
15 minutes.  
Table 3. Aim 2 Procedures Timeline 
 
Intervention 
Waitlist Control 
Baseline 
Data collection point, Start 
online LEAF procedures 
Data collection point 
Week 6 
Data collection point 
Data collection point, Start 
online LEAF procedures 
Week 12 
Data collection point 
(maintenance) 
Data collection point 
 
Table 4. Outcome measures 
Demographics (Baseline) 
UCLA Loneliness, short form 
Modified Barthel Index (Baseline) 
Perceived Stress Scale (PSS-10) 
FAST (Baseline) 
Positive Aspects of Caregiver scale 
PROMIS social isolation  
Berkman-Syme Social network 
PROMIS satisfaction w/ roles and activities  
Modified Caregiver Strain Index  
PROMIS depression  
SF-14 
PROMIS anxiety  
Montgomery Borgata Caregiver Burden Scale  
PROMIS Positive Affect Scale 
UCLA Loneliness, version 3  
NPI-Q 
Differential emotions scale  
 
- 
Aim 2 Feasibility and Efficacy Outcomes: We will utilize the RE-AIM framework to 
assess feasibility including: % of subjects approached who join the study (Reach); 
change in survey results (Efficacy); % of subjects who complete all intervention 
activities (Adoption); fidelity of facilitators to the manual as written 
(Implementation); and % of subjects who continue to engage in these skills 6-weeks 
following the intervention (Maintenance).  
- 
Aim 2 Interviews and Value Proposition Design: We will conduct a semi-structured 
end of study interview with select subjects at the completion of the study to 
understand their perspectives on whether the intervention was beneficial, how it 
impacted their personal and social lives, and how it was received by others in their 
social network. Additionally, we would like to receive feedback on what specifically 
worked for them and what areas they would personally modify. To understand 
opportunities for any further improvements we will follow customer discovery and 
value proposition design guidance and materials from Osterwalder et al.11 This 
framework allows us to gain greater depth into the perceived “jobs, pains, and gains, 
of daily care partner and features of the intervention and related social support that 
serve as “gain creators and pain relievers.” Care partners will undergo a single, brief 
and focused interview at the end of the study to see whether and where they noticed 
any changes in social interactions with the primary subject and whether they have 
suggestions for further improvement.   
- 
Analysis: Our primary analyses of surveys and data will be descriptive with particular 
attention paid to feasibility and to which scales appear most and least responsive to 

 
 
Version 9.0,  
January 31 2023 
 
13
 
the intervention. Secondary quantitative analyses will explore mechanisms and 
qualitative analyses will be used to gain further insights into how Social-Leaf benefits 
care partners, what outcomes are most meaningful and whether further adaptations 
are needed. 
 
Demographic data will be obtained by the URMC project study coordinator after study 
subjects have provided their consent to participate. The information will be provided by 
subjects via Zoom and/or REDCap survey sent to their email. The demographic 
information will be documented in the University of Rochester’s REDCap system.  
 
End of study interview will be conducted by the URMC project study coordinator who 
is trained in interview techniques. Subjects will be scheduled for a video interview via 
Zoom based on their choice and convenience. Interviews will be conducted at a time 
convenient to the subject, will be audio-recorded using Zoom connected to a URMC-
approved HIPPA-compliant account. Interviews with the research coordinator will 
typically last approximately 30-45 minutes.  
 
Interview questions will focus on recognizing that people have the capacity to experience 
positive emotion even in the midst of distressing circumstances, identifying recent 
positive events and things to be grateful for, having a basic understanding of gratitude 
and the potential benefits it might have, etc.  
 
The interview will be audio recorded so that the full conversation can be transcribed for 
later analysis, and subjects will be informed of this before the discussion begins. No 
identifying information (for example, subject names, or other personal details shared 
during the discussion) will be included in the transcript.  
 
Return of Research Results  
As part of this study, we may learn information relevant to subject. If this happens, we 
 
will provide them information that would be relevant once the study is complete. Subjects 
 
will be given the option at the end of this consent to decide if they would like to receive 
 
these relevant results. For the interpretation of these results, we strongly recommend 
 
subjects contact their primary care physician.  
 Some things subjects should know about results:  
• Sometimes the meaning of the results will be uncertain. It is important to know 
that our understanding of health is changing quickly, and in many cases, we may 
not know for sure what the results mean for a subject’s future health. 
• Any results we return to subjects will first be verified by the PI. 
 
10. AUDIO/VIDEO RECORDINGS  
A URMC-approved HIPPA-compliant zoom account will be used to conduct the 
recording of the interviews. Recordings of interviews will be deleted from the recording 

 
 
Version 9.0,  
January 31 2023 
 
14
 
devices once the recordings are transferred from the recording devices to Landmark 
Associates for transcription. All recordings will be transcribed and the transcription will 
be kept for three years following the completion of the study and then destroyed. Subjects 
can request to have these recordings destroyed at any time. Interview recordings will be 
transcribed by Landmark Associates, a transcription company that has been approved and 
vetted by the University of Rochester IT Security. All files transmitted or stored in their 
system are protected by multiple layers of encryption through Amazon’s S3-managed 
encryption keys (SSE-S3). With SSE, every file is encrypted with a unique key, which is 
also encrypted by a separate master key which rotates regularly. The encrypted data, 
encryption keys and master keys are stored and secured on separate hosts for additional 
layers of protection. In addition, Landmark internally implements two-factor 
authentication for administrative users, which adds an additional safeguard in the login 
process. Login attempts that do not have the valid credentials from both sources are not 
granted access to the system. In addition, Landmark implements IP restrictions, 
preventing those who try to login to their system outside the designated IP address to gain 
access. Each employee, executive staff member and contractor of Landmark is required 
to sign a non-disclosure and confidentiality agreement, and follow Landmark’s security 
policies.  
10. RISKS TO SUBJECTS 
For the majority of study activities (which include the qualitative/quantitative measures, the 
intervention, and the interview) the primary risk is mild reactions of distress or fatigue or is 
invasion of privacy, and/or breach of confidentiality (if safety issues are detected). It is 
possible that conversations around certain conditions, telehealth, or support needs could 
cause distress or anxiety. The URMC project study coordinator is trained to recognize 
potential signs of fatigue and distress among subjects and is experienced in coordinating the 
interviews. During the course of the semi-structured interviews, the researcher will listen for 
signs of fatigue and will offer subjects a break from the interview, or provide them with the 
option to complete the interview over several sessions if needed. If subjects express or 
demonstrate signs of distress, they will have the option to decline answering a question. 
There is the possible risk of unauthorized release of interviews that could result in release of 
private information. All and every effort will be made to minimize any breach of data and 
ensure that all data are de-identified.  There is potential risk of signs of depression and 
suicidal ideation. If the study team finds a subject exhibiting these characteristics, they will 
address this immediately by contacting the chaplain. The research study coordinator will 
ascertain their risk by their responses to questionnaires and their overall discretion on how 
the subject is interacting with them. They will contact the PI and /or chaplain for immediate 
assistance/guidance to develop a plan to address the issue. Lastly, if the study team learns 
that you or someone with whom you are involved is in danger or potential harm, such as 
elder abuse they will need to inform, as required by New York State law, the appropriate 
agencies. 
 
11. POTENTIAL RISK TO SUBJECTS 
Fatigue, stress, topics that may be saddening, conversation about these topics, invasion of 
 
 privacy, etc.  
12. POTENTIAL BENEFITS TO SUBJECTS 

 
 
Version 9.0,  
January 31 2023 
 
15
 
There are no anticipated benefits. 
 
13. COSTS FOR PARTICIPATION 
None anticipated 
 
14. PAYMENT FOR PARTICIPATION  
Subjects will receive $25 for successfully completing the individual interview for Aim 1. 
For Aim 2, they will receive $25 for the completion of each data collection point 
associated with the study. This includes baseline, week 6, and week 12, for a total of $75. 
Individuals who express interest and are chosen to do the post-intervention interview will 
receive $25 as well, which can will total their compensation to $100.  
15. SUBJECT WITHDRAWALS 
Subjects are free to withdraw at any time without negative consequences. Subjects may 
also refuse to answer any individual questions. If a subject voluntarily withdraws from 
the study, we will attempt to the note the reason if provided by the subject. We will use 
the data already collected up until the point in which the subject decides to voluntarily 
withdraw from the study. In the event of the latter, subjects who withdraw from the study 
will be replaced. 
 
16. PRIVACY AND CONFIDENTIALITY OF SUBJECTS AND RESEARCH DATA 
We are requesting altering HIPAA authorization so as to obtain permission during the 
verbal consent process to gather subjects’ demographic data.  
 
• Elements of authorization are being altered  
• Without subjects’ phone, email, and home address the study data collection 
and the mailed check for participation cannot be completed. Other 
demographic data such as race/ethnicity are important to answering the study 
research questions as they will facilitate an understanding of the challenges, 
barriers, and supports experienced by different subjects. 
• The demographic data being gathered are no more than minimal risk to the 
privacy of the individuals 
• All identifying information will be maintained on the REDCap system at the 
University of Rochester and printed copies of subject’s names, email, and 
home addresses will be held by the URMC project study coordinator in a 
locked cabinet in her office at the University of Rochester and on an 
encrypted University of Rochester computer. All identifying information will 
be destroyed three years after the completion of the study.  
•  PHI will not be reused or disclosed to any other person or entity except (i) as 
required by law, (ii) for authorized oversight of the research study, or (iii) for 
other research for which the use or disclosure of PHI would be permitted by 
the HIPAA Privacy Rule. 
 
 
In order to protect the confidentiality of subject information, we will take a number of 
precautions. All data will be securely stored and maintained according to the regulations 
of privacy stipulated by the University of Rochester. All data will be held by the URMC 

 
 
Version 9.0,  
January 31 2023 
 
16
 
project study coordinator in a locked cabinet in her office at the University of Rochester 
and on an encrypted University of Rochester computer. Audio recordings of semi-
structured interviews will be transcribed and then kept three years following the 
completion of the study. Demographic information and de-identified transcripts will be 
stored on an encrypted, password protected computer and will be accessible only to the 
study PI and study team members. Back-ups of all study files will be made daily to allow 
for recovery of data due to disk failure. Confidentiality will be further maintained by the 
storage of "hard copy" data in locked files in a locked office. Only the research team and 
approved study personnel will have access to the data. All data reported in presentations 
or publications will be de-identified and will report only cumulative data or descriptions 
certain to maintain subjects' anonymity.  
 
15. DATA / SAMPLE STORAGE FOR FUTURE USE 
N/A 
 
16. DATA AND SAFETY MONITORING PLAN 
N/A 
 
17. DATA ANALYSIS PLAN 
Qualitative analyses (Aim 1) will use Atlas.ti software for coding and an inductive approach.11 
We will iteratively modify materials alongside interviews and will plan to pilot our group 
approach in single sessions of several modules to troubleshoot materials before finalizing pilot 
materials for Aim 2. For qualitative analyses in Aim 2, to understand opportunities for any 
further improvements we will follow customer discovery and value proposition design guidance 
and materials from Osterwalder et al.12 
  
For Quantitative analyses (Aim 2), our primary analyses of surveys and data will be primarily 
descriptive with particular attention paid to feasibility and to which scales appear most and least 
responsive to the intervention. Secondary quantitative analyses will explore mechanisms and 
qualitative analyses will be used to gain further insights into how Social-Leaf benefits care 
partners, what outcomes are most meaningful and whether further adaptations are needed. With 
60 subjects we will be able to detect large between-group differences (0.7 SD/mean) and modest 
pre/post differences (0.5 SD/mean), which fall within the range of the original LEAF results.8  
 
18. REFERENCES 
1) Creutzfeldt CJ, Kluger B, Kelly AG, et al. Neuropalliative care: Priorities to move the 
field forward. Neurology 2018;91:217-226 
2) Boersma I, Jones J, Carter J, et al. Parkinson disease patients' perspectives on palliative 
care needs: What are they telling us? Neurol Clin Pract 2016;6:209-219. 
3) Boersma I, Jones J, Coughlan C, et al. Palliative Care and Parkinson's Disease: 
Caregiver Perspectives. J Palliat Med 2017;20:930-938. 

 
 
Version 9.0,  
January 31 2023 
 
17
 
4) Kluger BM, Shattuck J, Berk J, et al. Defining Palliative Care Needs in Parkinson's 
Disease. Mov Disord Clin Pract 2019;6:125-131. 
5) Kluger BM, Miyasaki J, Katz M, et al. Comparison of Integrated Outpatient Palliative 
Care With Standard Care in Patients With Parkinson Disease and Related Disorders: A 
Randomized Clinical Trial. JAMA Neurol 2020. 
6) Kluger BM, Vaughan CL, Robinson MT, Creutzfeldt C, Subramanian I, Holloway RG. 
Neuropalliative care essentials for the COVID-19 crisis. Neurology 2020. 
7) Beebe, J. Rapid Qualitative Inquiry: A Field Guide to Team-Based Assessment. 
Second Edition. Rowman & Littlefield, Lanham, Maryland. 2014 
8) Neal JW, Neal ZP, VanDyke E, Kornbluh M. Expediting the analysis of qualitative 
data in evaluation: A procedure for the rapid identification of themes from audio 
recordings (RITA). American Journal of Evaluation. 2015;36:118-132. 
9) Norton SA, Ladwig S, Caprio TV, Quill TE, Temkin-Greener H. Staff Experiences 
Forming and Sustaining Palliative Care Teams in Nursing Homes. Gerontologist. 
2018;58(4):e218-e225. 
10) Boerner K, Schulz R, Horowitz A. Positive aspects of caregiving and adaptation to 
bereavement. Psychol Aging. 2004;19(4):668-675. 
11) Osterwalder A, Pigneur Y, Bernarda G, Smith A. Value proposition design: How to 
create products and services customers want. John Wiley & Sons; 2014