Support Via Technology: Living and Learning With Advancing FTD
Phase: NA
Conditions: Caregivers Burnout, Frontotemporal Dementia
Sponsor: Oregon Health and Science University

 
                        Page 1 of 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Support via technology: Living and learning with advancing 
Frontotemporal Degeneration (STELLA-FTD): Phase 2 
 
NCT # 05338710 
 
03/07/2022 
 
 

 
                        Page 2 of 16 
Minimal Risk Protocol Template 
 
1) 
Protocol Title 
Support via technology: Living and learning with advancing Frontotemporal Degeneration 
(STELLA-FTD): Phase 2 
 
2) 
Objectives 
The purpose of this study is to test the STELLA-FTD intervention that we designed from end-user 
feedback in Phase 1.  The STELLA (Support via Telehealth: Living and Learning with Advancing 
Alzheimer’s Disease) intervention to specifically address the needs of family Care Partners of persons 
with frontotemporal degeneration (FTD).  STELLA-FTD is a multicomponent video-conference based 
intervention designed to facilitate effective use of community and peer resources to foster effective 
management of behavioral and psychological symptoms of dementia. In the STELLA-FTD intervention, 
professionals ("Guides") meet with family members ("Care Partners") caring for persons with FTD 
conditions. Working together, the Care Partners and Guides identify strategies to address upsetting 
behaviors. The goal of this intervention is to reduce upsetting behaviors and thus Care Partner burden.  
STELLA-FTD has not been tested with families living with FTD and thus, it is not known if it will be 
helpful to them.  In this study, we will test the new version, STELLA-FTD, to specifically address 
the needs of family Care Partners for persons with frontotemporal degeneration. 
 
Aim 1 (Phase 1). Adapt STELLA to the needs of Care Partners for those with FTD 
a. Gather FTD Care Partner feedback on STELLA and suggestions for tailoring STELLA for 
FTD 
b. Adapt STELLA for FTD Care Partners based on end-user feedback 
 
Aim 2 (Phase 2). Assess the feasibility and acceptability of STELLA-FTD with FTD Care Partners 
Aim 3. Assess the preliminary efficacy of STELLA-FTD on the primary outcomes: reducing the 
frequency of behavioral symptoms and Care Partner reactivity to the symptoms as measured on the 
Revised Memory and Behavior Problems Checklist (RMBPC).1  
 
3) 
Background 
Frontotemporal degenerative diseases, such as behavioral variant FTD, primary progressive aphasia 
and progressive supranuclear palsy (referred to in this proposal as “FTD”) place a heavy toll on 
families.2  FTD tends to occur in individuals younger than 65, impacting family income and well-being to 
a greater extent than later-onset dementias.3,4 Affecting about 60,000 people in the US, FTD often 
presents with pronounced behavioral symptoms that lead to family Care Partner burden, depression, 
financial strain, reduced quality of life, and grief.5,6 Research indicates that Care Partners for persons 
with FTD experience higher levels of burden and worse sleep quality than Care Partners of persons 
with ADRD.7,8 Like Care Partners of persons with other forms of dementia, FTD Care Partners may 
experience pre-death grief in addition to burden as they perceive their family members changing into 
“well-known strangers.”9  
 
The psychological impact of FTD on families has been established, but only a few psychoeducational 
interventions have been developed to support FTD Care Partners. FTD-focused interventions, such as 
the Primary Progressive Aphasia education and support group,10 the telehealth intervention for 
spouses,11 the positive affect intervention,12 and the tailored activity program13 have shown promising 
results. These programs are acceptable to Care Partners and have demonstrated efficacy for reducing 
Care Partner burden. However, most of these interventions were developed for families outside the US, 
or are limited to specific FTD sub-groups, making them inaccessible to the many Care Partners who 
need them. 
 

 
                        Page 3 of 16 
FTD Care Partners have access to support options, including the Alzheimer’s Association support 
groups, but FTD Care Partners often feel these programs are not a good fit for them, as this one noted, 
“I felt like a zebra in a room of horses.” To address this gap, the Association for Frontotemporal 
Degeneration (AFTD) sponsors support groups, including telephone-based programs.14 To date, only 
seven leaders provide these groups across the nation. In-person groups are also available, but there 
are only five in Oregon and Washington (combined), and none in Idaho and Wyoming. This is 
concerning, considering that almost 20% of Besser and Galvin’s large sample lived in rural areas. 3 For 
many family Care Partners across the US, distance, care demands, cost, stigma, and depression limit 
engagement in support and education programs.  
 
Taken together, the literature indicates there are few accessible psychoeducational programs tailored 
for the unique needs of Care Partners for family members with FTD. Programs that do exist tend to be 
in the formative stages, require in-person engagement, or are sparsely available, especially in the 
northwestern part of the US. This proposed study addresses these gaps by tailoring the STELLA 
telehealth intervention specifically for FTD Care Partners.  
 
STELLA was adapted for the well-known STAR-C program.15 Pilot testing of STELLA prototypes 
informed revisions, and now STELLA is a telehealth-based, multi-component intervention designed for 
ADRD Care Partners. STELLA is now being tested on a larger scale, with NIA funding with ADRD Care 
Partners (R01AG067546)). In two pilot studies the STELLA prototype reduced burden in ADRD Care 
Partners.16,17  The qualitative and quantitative data from these studies revealed that the Care Partners 
felt that it was feasible, acceptable and private. This foundational work indicates that STELLA is primed 
for modification to meet the unique needs of Care Partners for those with FTD. 
 
4) 
Study Design  
 
STELLA-FTD is a prospective, mixed methods clinical trial and will occur in two phases. In Phase 1, we 
gathered FTD Care Partner feedback on STELLA and suggestions for tailoring STELLA for FTD 
(completed in Fall 2021).  We have adapted STELLA for FTD Care Partners based on this feedback. In 
Phase 2, we will assess feasibility, acceptability and preliminary efficacy of the modified intervention. 
 
STELLA-FTD components and study activities.  STELLA-FTD will be adapted from the current 
STELLA version. Like all STELLA versions, the STELLA-FTD intervention will be provided via 
videoconferencing and email. There are no in-person activities.  
 
Phase 1.  
 
This study employed a convergent mixed-methods design18 to address 
the aims. We gathered FTD Care Partner feedback on STELLA and 
suggestions for tailoring STELLA for FTD through focus groups facilitated 
by trained STELLA Guides, and elicited written commentary on printed 
STELLA interventional materials and surveys. We sought Care Partner 
suggestions for modifications to the intervention so that it meets the 
unique needs and challenges posed by FTD. The groups were held via 
videoconferencing. Phase 1 was completed in Fall of 2021.  
 
The focus groups were conducted with 15 Care Partners (Table 1).  The 
adaptation and revision suggestions from the participants are nested in 
the intense caregiving experience of living with complex behavioral 
symptoms, feeling burdened, isolated, and “living in darkness.”  Focus 
group participants offered practical suggestions to create a revised 
STELLA intervention to address the needs of families living with FTD. 
Three common themes emerged that will frame Phase 2:  FTD and 

 
                        Page 4 of 16 
accompanying behaviors lead to burden; it is difficult to get a diagnosis, and finally, there are barriers to 
participation in caregiver support programs. Care Partners recommended Phase 2 include a roadmap 
for navigating FTD.  
 
Phase 2 
 
The Revised Intervention. STELLA-FTD will focus on improving participants’ ability to a) identify 
family stressors and b) subsequently use the ABC approach to address the stressors. Identified 
stressors may include behavioral, cognitive or language symptoms, but could also involve the need for 
external services (i.e.: speech and language pathology, social work). STELLA FTD will be entirely 
group-based, without one-to-one sessions. 
 
All meetings will be via telehealth videoconferencing, phone or chat.   
 
 
5) 
Study Population 
a) Number of Subjects 
 
Phase 2. We will conduct STELLA-FTD with up to 20 FTD family Care Partners.  
 
b) Inclusion and Exclusion Criteria 
 
Inclusion criteria, Phase 2. The Phase 2 sample will be made up of participants who self -identify as a 
Care Partner for family member, close friend or kin with FTD, primary progressive aphasia, progressive 
supranuclear palsy or other frontotemporal degenerative dementia. They must speak English and be 
able to see and hear the videoconference-based interactions. The Care Partner must provide care for 
the person with FTD. Participants from Phase 1 may choose to enroll in Phase 2, but they are not 
obligated to do so. 
 
 
Table 2. Inclusion/Exclusion Criteria, STELLA-FTD Phase 2 
Participants  
Inclusion  
Exclusion  
Care Recipient  
• 
Diagnosis of FTD or FTD-like 
dementia.  
• 
Family member of Care Partner 
(this can be a relative, spouse, or 
close kin that is considered family).  
• 
Live in OR, WA, CA, ID, MT, TX 
and WY. 
• 
No Frontotemporal Degeneration 
diagnosis.  
• 
Unable to leave Care Partner during 
STELLA-FTD sessions.  
Care Partner  
• 
Adult caring for family member 
with FTD-like dementia.  
• 
Active or retired family Care 
Partner (Age 18 years or older).  
• 
Speaks and understands English 
to be able to participate in 
intervention.  
• 
Owns a telephone (smartphone, 
cell phone or landline).  
• 
Has email and mailing address to 
receive computer, study materials and 
surveys.  
• 
Provides informed consent to 
participate in the research.  
• 
Unable to find activity for care recipient 
during STELLA-FTD sessions to allow Care 
Partner to work privately with Guide and other 
Care Partners.  
Hearing and/or vision problems severe enough 
to prevent participation.  
• 
Refuses to be video-recorded during 
STELLA-FTD sessions.  
• 
Unwilling or unable to adequately follow 
study instructions and participate in study 
procedures.  

 
                        Page 5 of 16 
Care Partners need to provide care for their family member with FTD. Due to COVID and other 
unforeseen conditions, this care does not need to be in-person. Care Partners experience burden 
regardless of the location of the person with dementia, thus they do not have to live with them (Table 
2).  
 
Care Partners who attend an external support group can participate.  
 
Exclusion Criteria, Phase 2. See Table 2 for detailed Inclusion/Exclusion Criteria. It should be noted that this 
study includes Care Partners for those with advanced dementia. Thus, it is possible, but not likely, that the care 
recipient with FTD will die of natural causes while in STELLA-FTD. If this occurs, the Care Partner can remain 
in the study if he or she chooses to do so. 
 
Care Partners must consent to be video-recorded while in STELLA-FTD sessions. They may turn off 
their cameras if they prefer. 
 
Once identified, the recruitment team will complete the full screen with potential participants, and if eligible, 
proceed with the consent procedures (below) with the eligible Care Partners. Screening will be completed 
using paper or electronic (Qualtrics or REDCap) forms.   
 
In the event of a screen failure, data collected during screening will be destroyed at the end of the study. The 
recruitment team will track the number of Care Partners screened for the study, the number consented, the 
number of those that dropped out, the number who completed some of the intervention, and the number of 
those that completed the entire intervention. 
 
c) Vulnerable Populations 
 
The primary focus of this study is to assess the acceptability, feasibility and efficacy of the STELLA-
FTD intervention. Therefore, in order for this study to be successful, Care Partners of care recipients 
with FTD will be recruited.  
 
There is a risk of loss of confidentiality if the persons with FTD come into view of the Care Partner’s 
computer screen or if they are overheard on the audio during the STELLA-FTD sessions. Care Partners 
may discuss their family member with behaviors with other study participants. It may be distressing for 
the person with FTD if they overhear their Care Partner discussing their family’s situation.  
 
To minimize these risks, we will ask Care Partners to identify an activity that will keep the person with 
FTD (and anyone else) occupied and out of computer range during the weekly, hour-long STELLA-FTD 
visits.   
 
d) Setting 
 
This study will occur at OHSU. All study activities (screening, consent, intervention, surveys, etc.) will 
be conducted by the OHSU team.  
 
All study activities will occur via phone, videoconferencing, mail, email and/or text. No in-person visits 
are required. 
 
e) Recruitment Methods 
 
We will take a multi-pronged approach to subject identification and recruitment which includes working 
with the Association for Frontal Temporal Degeneration to identify participants. Care Partners may be 
recruited from clinic sites, ADRC research cohorts, electronic registries, community advisory 

 
                        Page 6 of 16 
committees, faith communities and the community at large. We will reach out to families from We will 
reach out to families in Oregon, California, Washington, Idaho, Montana, Texas and Wyoming.  
 
Up to 10 of the 20 FTD families enrolled in STELLA-FTD will be recruited from UCSF’s ALLFTD study. 
The ALLFTD team has given our team permission to recruit from this cohort. 
 
Respondents to the media or other contact (e.g., clinic patients or calls from the AFTD) will fill out a 
electronic screening survey, providing their names and contact information, the family member’s 
diagnosis (see Screening Survey in IRB Documents). If the potential participant is eligible, they will be 
automatically connected to the eConsent.   
 
This data may be stored on Excel files on the OHSU OneDrive, the H or X drives and/or the Qualtrics 
and REDCap databases.   
 
Advocacy organizations, such as the Association for Frontal Temporal Degeneration, the Alzheimer’s 
Association and CurePSP may be asked to promote STELLA-FTD in their community events. We may 
present information about STELLA-FTD for these organizations and other community groups.   
 
f) Consent Process 
 
Phase 2. After completing the on-line screen, eligible participants will be given a copy of the Information 
Sheet. The Information Sheet describes the study in detail.  We will ask the Care Partner to confirm that 
they have received and reviewed the Information Sheet. They may do this electronically via survey 
questions, in writing (by initialing their own copy of the Information Sheet) or verbally, by informing the 
STELLA-FTD staff that they agree to be in the study. The participant will retain a copy of the eConsent; 
the STELLA-FTD study will not retain copies of the individual Information sheets. At the first STELLA-
FTD session, the PI will review the key points of the consent with the participants.  
 
Participants will be advised that the study team is obliged to report any elder abuse. Participation in this 
research is not meant in any way to replace regular care. 
 
6) 
Procedures 
  
STELLA-FTD Intervention. Up to 20 Care Partners for family members with FTD will meet with up to 5 
faculty members (called “Guides”) and guest speakers on a weekly basis to discuss the strategies to 
facilitate effective coping with FTD diagnoses across the disease trajectory (Table 4). The lessons will 
include information on behavioral management and how to access services. We will encourage peer 
support by including activities that foster conversation.  
 
The STELLA-FTD ABC approach will use the traditional ABC approach, but in the context of living with 
FTD.  We will teach participants how to identify the activators of a behavior, describe the behavior in 
detail, and discuss the consequences of the behavior. In STELLA-FTD, the “behavior” can be any 
action that causes distress in the family. With a deeper understanding of the behavior, Care Partners 
can develop strategies to prevent or modify it. Once the behavioral is described, Care Partners are 
instructed on how to develop a plan to address the behavior (Box 1).  
 
Each STELLA-FTD videoconference session will begin with a brief didactic lesson presented by the 
faculty (the “hub”) for the Care Partners (the “spokes”). Following the lesson, the faculty and guest 
speakers will encourage Care Partners will share their questions and stories about their families’ 
experiences with FTD.  
 
The faculty hub team is responsible for ensuring respectful exchange and closes with positive feedback 
for the Care Partners. Should Care Partners be reluctant to share their experiences, the faculty will 

 
                        Page 7 of 16 
have example stories to discuss. Adult learning is most effective when learners share their knowledge 
with each other.  
 
 
Care Partners who are unable to complete all STELLA-FTD components will remain in the study and 
we may collect the data noted in Table 5. Care Partners who do not complete any trainings, or are 
unwilling or unable to adequately follow study instructions and participate in study procedures, may be 
withdrawn from the study. We will retain and analyze any data from their participation. They may also 
be asked to complete the surveys, despite not completing all of the trainings.  
 
We will record the faculty and guest speakers’ sessions. The recordings will not have any participants in 
them, nor identifying information.  We will share the recordings with participants who request this.  
 
Focus groups. We may have one focus group of up to 20 participants after the intervention is 
completed. The format may be the same as the Phase 1 focus group. Any Care Partner who signed a 
consent, whether or not they participated in the intervention, can participate in this focus group. Focus 
group leaders will use a semi-structured interview guide to facilitate discussion about the Care Partners’ 
experiences with STELLA-FTD. The focus groups will be video-recorded and transcribed. Transcripts 
will be analyzed for themes of acceptability.  
Implementation. The Care Partners (up to 20) will receive the intervention as described above. 
Feasibility will be assessed by tracking recruitment patterns, enrollment and retention rates. 
Acceptability will be assessed in one focus group with Care Partners via videoconferencing. 
 
 
 
 
Table 3. Example of STELLA-FTD Schedule 
Week  
Topic 
Notes 
1 
Lindauer 
Introduction/ 
Orientation 
• 
Review program, ground rules, plan for next seven weeks 
• 
Participants introduce themselves, discuss challenges, may break into small 
groups 
2 
Lindauer 
Using the 
ABCs 
• 
Instruction on how to use the ABC method to identify and address 
challenging behaviors for all family members.  
• 
Discuss how to make an ABC plan  
3 
Mooney 
 
 
 
Communication 
Challenges  
• 
Using ABC to identify challenging communication issues and emotional 
responses to the communication issues.  
• 
Discuss how speech therapy (SLP) can help with communication  
• 
Outline how to request a referral to SLP 
4 
Foidel* 
OT 
• 
Use ABC to identify stressors related to function 
• 
Discuss the benefits of working an Occupational Therapist (OT) 
• 
Outline steps request a referral to OT 
5 
Wilhelm* 
PT 
• 
Use ABC to identify challenging mobility issues.  
• 
Discuss the benefits of working with a physical therapist (PT) 
• 
Outline how to request a referral to PT 
6 
McGuire* 
Dietician 
• 
Nutrition and Eating Challenges 
7 
TBA* 
 
Elder Law 
Attorney 
• 
Use ABC to identify concerns about long-term care planning 
• 
Discuss the benefits of working an elder law specialist 
• 
Outline steps to identifying a legal specialist 
8 
Willis* 
Care Partner 
Self-Care 
• 
Use ABC to identify emotional challenges and caregiving  
• 
Discuss the benefits of working a social worker 
• 
Outline steps request a referral to Social Work 
*Guest speakers will not partake in the research, they will only present their information and entertain questions and answer s. 
 

 
                        Page 8 of 16 
 
 
 
Measures. Please see Table 5 for descriptions 
and Table 4 (Care Partner Activities) for timing 
of (1)distribution to the Care Partners. 
Demographic information (such as address, age, 
gender, race / ethnicity, urban / rural status, 
gender), and information about care tasks 
performed by Care Partners, and the frequency 
and duration of providing care may be collected 
upon enrollment. Care-recipient dementia 
diagnosis and diagnosis year will be 
documented. Diagnosis will be identified by Care 
Partner  
 
The primary outcome, the burden of behavioral 
symptoms, will be assessed with the 24-item 
RMBPC, which measures the frequency of 
BPSD and caregivers’ reactions to these 
behaviors. The RMBPC is among the most 
commonly-used measures of burden in ADRD 
caregiver research and has strong internal 
consistency (α=.86).1 
 
Care Partners may fill out weekly “Orbit” surveys 
that were developed by the Oregon Roybal 
Center for CAre Support Translational Research 
Advantaged by Integrating Technology 
(ORCASTRAIT), housed at the Oregon Alzheimer’s Disease Research Center. The survey includes the 
“ORCASTRAIT Care Partner Weekly Survey,” which measures Care Partner emotional and physical 
strain, The 4-item ZBI, a brief measure of burden (α=.78),31 medication use, likelihood of placing their 
care recipient into long term care (e.g., assisted living, memory care), and frequency of contact with 
both their and their family member with dementia’s clinical providers. Also included in the Orbit survey 
is the “ORCASTRAIT Caregiver Cost Survey,” which measures out-of- pocket costs. The two surveys 
will take approximately 1-15 minutes (total) to fill out and will be emailed to the Care Partners weekly. 
 
If the Care Partners drop out of the study, we will ask them to complete the Exit Survey so we can get 
their feedback. 
 
 
Table 4: STELLA-FTD Care Partner Activities, Phase 2  
Activity 
Description 
Due 
Consent 
Care Partner and care recipient consent 
Prior to any study activities 
Preliminary session(s) 
Collect enrollment information 
Set up and test videoconferencing link 
After consent completed 
STELLA-FTD (8 weeks) 
Mecury Survey (Survey 1) 
Baseline surveys (Table 5) 
Prior to intervention start 
Intervention 
Meet with Faculty and Guest Speakers for 
7 weekly, 1-hour, sessions 
After Baseline Survey completed 
Venus Survey (Survey 2) 
See Table 5 
Within one week of completion of STELLA-FTD 
Optional Focus Group 
 
About 1 month after completion of STELLA-FTD 
Weekly Orbit Surveys: Distributed weekly (Table 6) 
Orbit surveys start after enrollment and continue until all surveys are completed  
Box 1. Example of using ABC’s in STELLA-FTD 
 
Activator:   
Care Partner asks family member with FTD: “What do you want to 
do this weekend? Should we visit the kids? Go out for dinner?  
See a movie?” 
 
Behavior: 
Family member with FTD Behavior:  Stares, stammers, says, 
“Don’t know.” 
 
Care Partner raises voice, asks more questions, and tells family 
member “You’re just not trying.” 
 
Consequence:   
Person with FTD feels shamed and undervalued, Care Partner 
feels frustrated, sad. 
 
Identify solutions:  
The family, with the help of the STELLA-FTD team, discuss 
options to improve communication.  In the STELLA-FTD session, 
they learn how to optimize communication in FTD. 
 
Make a plan:  
Care Partner writes down a plan in her handbook: 
1. 
Limit questions 
2. 
Use simple statements 
3. 
Ask PCP for referral to Speech Therapist in order to 
learn strategies that can help with expressive and 
receptive communication challenges. 

 
                        Page 9 of 16 
 
 
We will implement the above measures using Qualtrics or REDCap Survey Platforms The surveys will 
be emailed to the Care Partners. Auto-reminders will be sent to the Care Partners until they complete 
the surveys. If they do not complete the surveys within 5 working days, the STELLA-FTD coordinator 
may call them to identify barriers to completing the surveys. The electronic functionality allows Care 
Partners to complete surveys in the privacy of their homes, at a time that works for them. The Qualtrics 
and REDCap platforms are HIPAA compliant and secure. We will assess completion rates and internal 
consistency of the online platform surveys. Focus group participants will be queried about their 
experience with the platform. 
 
Technology. All contacts, surveys and interventions may be completed by phone, email, texting, 
videoconferencing and/or electronically-administered assessments.  
 
This study will be using interactive, real-time delivery of telehealth care over distance using video-
conferencing equipment. The basic mode of connectivity between the study subjects and the research 
team will be via OHSU’s Webex system. This platform is secure as independently validated by OHSU’s 
IT and legal department.  
 
Table 5. STELLA-FTD Survey Descriptions 
Enrollment:  Demographics etc 
Baseline (complete within one week of orientation) 
Revised Memory & Behavioral Problems 
Checklist (RMBPC)1 
Measure of frequency and reactivity to behavioral and psychological 
symptoms of dementia 
Center for Epidemiologic Studies Depression 
Scale (CESD-10)26 
10-item depressive symptoms measure 
Marwit Meuser Caregiver Grief Index-Short 
Form (MMCGI-SF) 25 
Care Partner pre-death grief 
Quality of life survey(1) 
QOL for person with FTD and care Partner 
Self-efficacy for symptom management(2) 
5-item scale to determine how certain Care Partners are in their ability 
to manage FTD symptoms 
Self-efficacy for community support service 
use(3) 
 
5-item scale to determine how certain Care Partners’ are in their ability 
to access services. 
Ten Item Personality Inventory 
Measures intro- and extraversion 
Computer self-efficacy scale 
Measures comfort with computer use 
Computer anxiety scale 
Measures anxiety with computer use 
Venus-FTD Survey 
RMBPC 
(see Baseline for descriptions) 
CESD-10 
MMCGI-SF 
QoL (person with FTD and CP; filled out by 
CP) 
Self-efficacy for symptom management 
5-item scale to determine how certain Care Partners are in their ability 
to manage FTD symptoms 
Self-efficacy for community support service 
use 
 
5-item scale to determine how certain Care Partners’ are in their ability 
to access services. 
Sleep Health Survey 
Assesses quality of sleep 
Service Use Survey 
Assesses use of services, such as rehab 
STELLA-FTD contact 
STELLA-FTD Care Partner contact post intervention 
STELLA-FTD Experience Survey 
16-item + comments on satisfaction, privacy, ease of use 
Weekly Orbit Survey: Distributed weekly during full intervention 
Measures Care Partner emotional and physical strain and frequency of contact with both their and their family member 
with dementia’s clinical providers.  It measures the frequency of as-needed medication use for behavioral symptoms; 
measures out-of- pocket costs; and contains the 4-item ZBI. 

 
                        Page 10 of 16 
The Webex recording system will be used to record the telehealth visits. This service can securely record all 
visits as needed. There is no limit as to how many visits can be recorded concurrently. Visit recordings will be 
managed through the Webex secure web portal requiring OHSU credentials and multi-factor authentication. 
OHSU Security Engineering department has agreed to ensure that this study’s policies and procedures meet 
strict Information Security Directives (ISDs).  
 
The Faculty and guest speakers will meet with Care Partners via videoconferencing using either an OHSU 
computer or their own computer and an OHSU, HIPAA-secure link. Faculty and speakers may complete the 
STELLA-FTD sessions from their homes, OHSU office or other convenient private location. They may use 
headphones and a privacy screen so that participants will not see their home or office environments. During 
the STELLA-FTD sessions, Care Partners can connect to the videoconference-based sessions from their 
home or another private location. 
 
Care Partners may use their own computers, tablet or smartphones for this study. We will provide them 
with a secure OHSU-generated link to access the study’s videoconferencing site. The STELLA-FTD 
study coordinator will teach and support Care Partners in device use and study access. All STELLA-
FTD sessions will be video-recorded and the recordings will be stored on a secure server. Content 
experts will have access to a sample of videos for viewing via the OHSU secure file-sharing system 
(One Drive).  
 
Care Partners will access all electronic surveys on their own computers, tablets, or their smartphones.  
 
Care Partner surveys will be administered via the Qualtrics Survey Platform (FIPS 140-2 compliant 
transfer) or REDCap. These platforms provide HIPAA secure, easy-to-use surveys that Care Partners 
can complete on their Chromebook, laptop or smartphone. We used Qualtrics in our previous pilot, with 
100% Care Partner completion of surveys.  
 
7) 
Data and Specimens 
a) Handling of Data and Specimens 
No biological or genetic specimens will be collected in this study. Data from the measures described 
above will be collected via the secure Qualtrics or REDCap systems and then downloaded to a secure 
OHSU file for analyses. Video-recordings of focus groups and intervention sessions to be used for 
quality assurance and de-identified transcripts of qualitative data will also be downloaded to a secure 
OHSU file for analysis. 
 
b) Sharing of Results with Subjects 
If the burden or depression scores indicate severe depression or burden, the Care Partner may be 
informed, at the discretion of the PI. The Care Partner may be referred to appropriate services if 
deemed necessary (e.g., social worker or other counseling services). The other results may be 
provided, if asked, after all data is collected, analyzed and published.  
 
c) Data and Specimen Banking 
Data from this study may be shared with other investigators for future research studies through the data 
repository. Data from the repository will be shared with other investigators according to the IRB 
approved repository policy. 
 
8) 
Data Analysis 
STELLA-FTD will use a mixed-methods approach to assess and refine the intervention. Along with 
classic quantitative measures, we will engage focus groups to examine program acceptability.  
 
Phase 1. Audio recordings from focus groups were transcribed, and the resulting transcripts were be 
audited for accuracy and de-identified to remove any personally identifiable information. Dedoose 

 
                        Page 11 of 16 
qualitative software32 was used for data management and coding following the approach of classical 
content analysis to identify themes.33  The research team discussed emergent themes, and identified 
areas of convergence and divergence with survey and demographic data.18  Findings were used to 
adapt the STELLA intervention to address the preferences and needs identified from our focus groups. 
 
Phase 2. We will assess data from the surveys to characterize the sample and assess program 
acceptability. We will compare demographic information, computer use, out-of-pocket costs, health-
care usage, behavioral symptom frequency, Care Partner reactivity, burden, depression, and daily 
activities for those that completed the interventions to those that did not.   
 
For acceptability, we will analyze the STELLA-FTD Experience Survey results using descriptive 
statistics (mean, range, SD). A directed content analysis approach will be used to analyze the 
qualitative focus group data. The transcripts from the video recordings may be examined to identify 
contextual features, Care Partners’ goals, the influences of the other Care Partners and Guides and the 
results the Care Partners experienced. We will identify themes of acceptance, or lack thereof, of 
STELLA-FTD and the underpinnings of their impressions. These qualitative findings will be considered 
in relation to the quantitative data using a convergent mixed analysis approach, a widely-used strategy 
in mixed methods research.18 This involves separate analyses of the quantitative data (e.g., paired t 
tests, linear regression) and qualitative data, followed by an analysis that looks at areas of data 
convergence and divergence.  
 
Aim 2 (Establish the efficacy of STELLA-FTD in reducing the frequency of behavioral symptoms and 
Care Partner reactivity to the symptoms).  
 
Efficacy will be assessed by measuring pre/post changes on the RMBPC1. 
 
We may use linear regression models to examine pre-post changes in primary outcome (RMBPC1 
change scores) utilizing surveys between two points.  We may assess relationships between the Care 
Partner reactivity subscale and the following variables, controlling for age, sex, number of hours 
caregiving, rural status and education: a. number of STELLA-FTD sessions each Care Partner 
attended, b. likelihood of placement, and c. out-of-pocket costs.  
 
Using ANOVA, we may assess pre-post changes in the RMBPC (reactivity subscale)1 between four 
groups (rural White, African American; urban African American, White), with the hypothesis that there 
are no significant differences across groups.34 We may test whether the efficacy of our intervention 
differs across racial and ethnic groups using interaction terms (e.g., time*groups) in linear regression.  
 
We may also assess efficacy in the domains of Care Partner depression,26 extraversion and grief25 
before, during and after STELLA-FTD with pre-post paired t tests.   
 
If some participants participate by phone only, we may compare their scores with those completing the 
study via videoconferencing using appropriate statistical measures (e.g., ANOVA). 
 
We may assess the relationships between cost, burden and STELLA-FTD participation using linear 
regression models and other statistical analyses deemed appropriate for cost analyses. 
 
Other statistical analyses may be completed if the data suggest important relationships. 
 
9) 
Privacy, Confidentiality and Data Security 
 
Standard institutional practices will be followed as described in the OHSU Information Security and 
Research Data Resource Guide to maintain the confidentiality and security of data collected in this 
study. Study staff will be trained with regard to these procedures.   

 
                        Page 12 of 16 
 
All scales will be de-identified and a participant number will be assigned to each scale for data 
management. All data will be kept on the limited-access drives or computers at OHSU or in a locked 
location in the OHSU ADRC. Documents used for the intervention may be stored with the 
interventionist and RA in a secure location in the staff member’s home. All documents will be shredded 
or returned to the OHSU ADRC at the completion of the intervention. These documents will not contain 
any PHI, but will contain the participant’s study ID #. 
 
To help us protect subjects’ privacy, we have obtained a Certificate of Confidentiality from the National 
Institutes of Health. With this Certificate, the researchers can refuse to disclose information that may 
identify subjects, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, 
legislative, or other proceedings. The researchers will use the Certificate to resist any demands for 
information that would identify subjects, except as explained below. 
 
The Certificate cannot be used to resist a demand for information from personnel of the United States 
Government that is used for auditing or evaluation of federally funded projects or for information that 
must be disclosed in order to meet the requirements of the FDA. A Certificate of Confidentiality does 
not prevent subjects or members of subjects’ families from voluntarily releasing information about them 
or their involvement in this research. If an insurer, employer, or other person obtains subjects’ written 
consent to receive research information, then the researchers may not use the Certificate to withhold 
that information. However, if we learn about abuse of a child or elderly person or that a subject intends 
to harm him or herself or others, or about certain communicable diseases, we will report that to the 
proper authorities. 
 
Upon enrollment, subjects will be assigned a code that will be used instead of their name, medical 
record number or other personally identifying information. The video-recordings will show the subjects’ 
faces and the audio will have their voice recordings. Their names and any information discussed during 
the sessions and focus group will be heard in the audio. The faces, names and audio of any other 
people who enter the camera/audio zone will also be recorded. We will advise Care Partners that they 
do not allow anyone (besides themselves) to be in the camera/audio zone during the STELLA-FTD 
sessions. However, due to the remote nature of the intervention, we will not have control over who is in 
the camera/audio zone. On the recordings any information subjects (or anyone else) provides will be 
identifiable as coming from them and will not be private.  
 
We will provide information to subjects on how to set up a false background for their video sessions so 
that others who may enter the room have less of a chance of showing up on video.  
 
We will use participants’ electronic mail, phones and texts for communication and data collection. A key 
element of STELLA-FTD is to foster peer support. Care Partners will be, asked to share their phone 
numbers and email addresses with other participants. We will ask all participants to refrain from sharing 
this information with others outside STELLA-FTD, but we cannot prevent this. The phone numbers and 
email addresses will not be confidential. We will ask STELLA-FTD participants to only use first names 
in the intervention.  
 
Electronic mail will be used for data collection and electronic files will be used for storage of the data 
and may contain some PHI.  Each subject will have a unique ID code. The key associating the codes 
and the subjects personally identifying information will be restricted to the PI and study staff. The key 
will be kept secure on a restricted OHSU network drive in a limited access folder. Any paper files will be 
stored in the restricted-access offices at the Layton Center.  
 
Electronic data will be stored on restricted computers and/or drives on the OHSU network, to which 
access will require OHSU/ID password authentication. 
 

 
                        Page 13 of 16 
Video-recordings may be shared with other researchers and those outside of OHSU who are involved 
in conducting or overseeing research via the secure Webex portal, OneDrive. Using Webex, video 
streaming links can be sent to identified users via email (which will require a password to access). 
Study coordinators can download the video files outright from the Webex portal and saved on OHSU’s 
“X” or “H” drives in a highly secure, biometrically authenticated data center or shared via OHSU 
OneDrive.  
 
Electronic survey data will be stored in a web-accessible server at Qualtrics or REDCap. Copies of this 
data will be transferred to a secure OHSU server via Application Programming Interface call. Other 
electronic data will be stored on a secure, password protected OHSU server. Access to data is 
restricted to study personnel. Access to data requires username/password authentication. 
 
10) Risks and Benefits  
a) Risks to Subjects 
There are few risks involved in this study. Care Partners will have to meet (via videoconferencing) with the 
research team and other Care Partners for multiple visits, which may be inconvenient. Care Partners will need 
to find an activity for their care recipients during the sessions, which may cause financial hardship for some. All 
visits will be virtual, so there should be no travel costs.   
 
Some of the questions on the scales may seem very personal or embarrassing and fatiguing to participants 
and may upset them. They may refuse to answer any of the questions that they do not wish to answer. If the 
questions make them very upset, we will refer them to a social worker. 
 
There is a risk that the video-recordings may be seen by someone they know. It is possible that someone 
viewing the videos may recognize them, their family members or others and/or hear their names in the audio, 
and their identities would no longer be confidential. The Care Partners will see each other’s’ video and audio 
and share contact information, thus, their identities will not be confidential. 
 
b) Potential Benefits to Subjects 
Care Partners who complete all training sessions may experience a reduction in their feelings of burden and 
depression. They may feel less likely to want to place their care recipients in long-term care. It is possible that 
these benefits will last up to 6 months. In general, they may feel better about caregiving. Care recipients may 
experience less psychological stress as their Care Partners learn to communicate and manage behaviors.  
 
Participants who complete seven STELLA-FTD sessions and all other study activities (e.g., surveys) may 
receive at $50 ClinCard.  We will ask for the participants’ social security numbers in order to process the 
ClinCards. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
                        Page 14 of 16 
References 
 
1.  
Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of behavioral problems 
in dementia: the revised memory and behavior problems checklist. Psychol Aging. 
1992;7(4):622-631. doi:10.1037/0882-7974.7.4.622 
2.  
Caceres BA, Frank MO, Jun J, Martelly MT, Sadarangani T, De Sales PC. Family caregivers of 
patients with frontotemporal dementia: An integrative review. Int J Nurs Stud. 2016;55:71-84. 
doi:10.1016/j.ijnurstu.2015.10.016 
3.  
Besser LM, Galvin JE. Perceived burden among caregivers of patients with frontotemporal 
degeneration in the United States. Int Psychogeriatrics. 2019;31(8). 
doi:10.1017/S104161021800159X 
4.  
Nicolaou PL, Egan SJ, Gasson N, Kane RT. Identifying needs, burden, and distress of carers of 
people with Frontotemporal dementia compared to Alzheimer’s disease. Dementia. 
2010;9(2):215-235. doi:10.1177/1471301209354024 
5.  
Knopman DS, Roberts RO. Estimating the number of persons with frontotemporal lobar 
degeneration in the US population. In: Journal of Molecular Neuroscience. Vol 45. ; 2011. 
doi:10.1007/s12031-011-9538-y 
6.  
Coyle-Gilchrist ITS, Dick KM, Patterson K, et al. Prevalence, characteristics, and survival of 
frontotemporal lobar degeneration syndromes. Neurology. 2016;86(18):1736-1743. 
doi:10.1212/WNL.0000000000002638 
7.  
Liu S, Liu J, Wang XD, et al. Caregiver burden, sleep quality, depression, and anxiety in 
dementia caregivers: A comparison of frontotemporal lobar degeneration, dementia with Lewy 
bodies, and Alzheimer’s disease. Int Psychogeriatrics. 2018;30(8). 
doi:10.1017/S1041610217002630 
8.  
Riedijk SR, De Vugt ME, Duivenvoorden HJ, et al. Caregiver burden, health-related quality of life 
and coping in dementia caregivers: A comparison of frontotemporal dementia and Alzheimer’s 
disease. Dement Geriatr Cogn Disord. 2006;22(5-6). doi:10.1159/000095750 
9.  
Tyrrell M, Fossum B, Skovdahl K, Religa D, Hillerås P. Living with a well-known stranger: Voices 
of family members to older persons with frontotemporal dementia. Int J Older People Nurs. 
2020;15(1). doi:10.1111/opn.12264 
10.  
Morhardt DJ, O’Hara MC, Zachrich K, Wieneke C, Rogalski EJ. Development of a Psycho-
Educational Support Program for Individuals with Primary Progressive Aphasia and their Care-
Partners. Dementia. 2019;18(4). doi:10.1177/1471301217699675 
11.  
O’Connell ME, Crossley M, Cammer A, et al. Development and evaluation of a telehealth 
videoconferenced support group for rural spouses of individuals diagnosed with atypical early-
onset dementias. Dementia. 2014;13(3):382-395. doi:10.1177/1471301212474143 
12.  
Dowling GA, Merrilees J, Mastick J, Chang VY, Hubbard E, Moskowitz JT. Life enhancing 
activities for family caregivers of people with frontotemporal dementia. Alzheimer Dis Assoc 
Disord. 2014;28(2):175-181. doi:10.1097/WAD.0b013e3182a6b905 
13.  
Connor CMO, Clemson L, Brodaty H, et al. The tailored activity program ( TAP ) to address 
behavioral disturbances in frontotemporal dementia : a feasibility and pilot study. Disabil Rehabil. 
2019;41(3):299-310. doi:10.1080/09638288.2017.1387614 
14.  
The Association for Frontotemporal Degeneration. Find Support Near You. 
www.theaftd.org/living-with-ftd/aftd-support-groups/. Published 2020. Accessed February 15, 
2020. 
15.  
Teri L, McCurry SM, Logsdon R, Gibbons LE. Training community consultants to help family 
members improve dementia care: A randomized controlled trial. Gerontologist. 2005;45(6). 
doi:10.1093/geront/45.6.802 
16.  
Lindauer A, Croff R, Mincks K, et al. “It took the stress out of getting help”: The STAR-C-
telemedicine mixed methods pilot. Care Wkly. 2018;2:7-14. doi:10.14283/cw.2018.4 
17.  
Thomas NWD, Lindauer A, Kaye J. EVALUATE-AD and Tele-STAR: Novel methodologies for 
assessment of caregiver burden in a telehealth caregiver intervention - A case study. Dement 
Geriatr Cogn Disord. 2019;47(3):176-184. doi:10.1159/000497805 

 
                        Page 15 of 16 
18.  
Creswell JW, Plano Clark VL. Designing and Conducting Mixed-Methods Research. 3rd ed. 
Thousand Oaks, Ca: Sage Publications Inc.; 2018. 
19.  
Teri L, Logsdon RG. Identifying pleasant activities for Alzheimer’s disease patients: The Pleasant 
Events Schedule-AD. Gerontologist. 1991;31(1). doi:10.1093/geront/31.1.124 
20.  
Au A, Gallagher-Thompson D, Wong M-K, et al. Behavioral activation for dementia caregivers: 
Scheduling pleasant events and enhancing communications. Clin Interv Aging. 2015;10:611-619. 
doi:10.2147/CIA.S72348 
21.  
Pearlin LI, Mullen JT, Semple SJ, SKaff MM. Caregiving and the stress process: an overview of 
concepts and their measures. Gerontologist. 1990;30(5):583–594. 
22.  
Cipriani G, Borin G. Understanding dementia in the sociocultural context: A review. Int J Soc 
Psychiatry. 2015;61(2):198-204. doi:10.1177/0020764014560357 
23.  
Shin IS, Carter M, Masterman D, Fairbanks L, Cummings JL. Neuropsychiatric symptoms and 
quality of life in Alzheimer disease. Am J Geriatr Psychiatry. 2005;13(6):469-474. 
doi:10.1097/00019442-200506000-00005 
24.  
Onken LS. Cognitive training: Targeting cognitive processes in the development of behavioral 
interventions. Clin Psychol Sci. 2015;3(1). doi:10.1177/2167702614561512 
25.  
Marwit SJ, Meuser TM. Development of a short form inventory to assess grief in caregivers of 
dementia patients. Death Stud. 2005;29(3):191-205. doi:10.1080/07481180590916335 
26.  
Andresen EM, Byers K, Friary J, Kosloski K, Montgomery R. Performance of the 10-item Center 
for Epidemiologic Studies Depression scale for caregiving research. SAGE Open Med. 2013;1. 
doi:10.1177/2050312113514576 
27.  
Radloff LS. The CES-D Scale: A Self-Report Depression Scale for Research in the General 
Population. Appl Psychol Meas. 1977;1(3):385-401. doi:10.1177/014662167700100306 
28.  
Cohen S, Karmarck T, Mermelstein R. A global measure of perceived stress. J Health Soc 
Behav. 1983;24(4):385-396. 
29.  
Mahoney DF, Jones RN, Coon DW, Mendelsohn AB, Gitlin LN, Ory M. The caregiver vigilance 
scale: Application and validation in the resources for enhancing Alzheimer’s Caregiver Health 
(REACH) project. Am J Alzheimers Dis Other Demen. 2003;18(1):39-48. 
doi:10.1177/153331750301800110 
30.  
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with 
cognitive impairment. Psychosom Med. 2002;64(3). doi:10.1097/00006842-200205000-00016 
31.  
Bédard M, Molloy DW, Squire L, Dubois S, Lever JA, O’donnell M. The Zarit Burden Interview: A 
new short version and screening version. Gerontologist. 2001;41(5):652-657. 
doi:10.1093/geront/41.5.652 
32.  
SocioCultural Research Consultants LLC. Dedoose: A web application for managing, analyzing, 
and presenting qualitative and mixed method research data. 2018. 
www.app.dedoose.com/App/?Version=8.0.35. 
33.  
Hsieh H-F, Shannon SE. Three Approaches to Qualitative Content Analysis. Qual Health Res. 
2015;2015(1):29-42. doi:10.1177/1049732305276687 
34.  
Lindauer A, Harvath TA, Berry PH, Wros P. The meanings African American caregivers ascribe 
to dementia-related changes: The paradox of hanging on to loss. Gerontologist. 2016;56(4):733-
742. doi:10.1093/geront/gnv023 
 
 
 
 

 
                        Page 16 of 16 
 
1. 
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with 
cognitive impairment. Psychosom Med. 2002;64(3):510-9. doi: 10.1097/00006842-200205000-00016. 
PubMed PMID: 12021425. 
2. 
Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self -
efficacy for managing dementia. Aging Ment Health. 2002;6(2):153-60. Epub 2002/05/25. doi: 
10.1080/13607860220126763. PubMed PMID: 12028884. 
3. 
Fortinsky RH, Delaney C, Harel O, Pasquale K, Schjavland E, Lynch J, Kleppinger A, Crumb S. 
Results and lessons learned from a nurse practitioner-guided dementia care intervention for primary care 
patients and their family caregivers. Research in Gerontological Nursing. 2014;7(3):126-37. Epub 
2014/01/22. doi: 10.3928/19404921-20140113-01. PubMed PMID: 24444453; PMCID: PMC4040327.