Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA
Phase: NA
Conditions: Dementia, Alzheimer Disease, Caregiver Burnout, Family Members
Sponsor: Oregon Health and Science University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Official Title: 
Using Technology to Support Care Partners for Persons With 
Alzheimer’s Disease: Tele-STELLA 
 
ClinicalTrials.gov Identifier: 
NCT04627662 
 
Document Date: 
November 19, 2025 
 
 
 
 
 
 

 
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Tele-STELLA Protocol v. 1 
Minimal Risk Protocol Template 
 
Using Technology to Support Care Partners for Persons with Alzheimer's Disease: 
Tele-STELLA 
 
Objectives 
The purpose of this study is to test a revised psychoeducational intervention to help Care Partners for family 
members with dementia understand and reduce the distressing behaviors that come with progressive 
dementia. Tele-STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer’s disease 
and related dementias) is a multicomponent videoconference-based intervention designed to facilitate effective 
management of behavioral and psychological symptoms that are common in the later stages of dementia. In 
the Tele-STELLA intervention, professionals ("Guides") meet with family members ("Care Partners") who care 
for persons with dementia. 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. 
 
The NIA-approved specific aims of this study are: 
 
Aim 1. Establish the feasibility and acceptability of Tele-STELLA 
a. Assess the feasibility of implementing Tele-STELLA with a national participant pool, including 
participants from multiple Alzheimer’s Disease Research Centers. 
b. Assess feasibility and acceptability of the Constellation component of Tele-STELLA. 
c. Assess user acceptability of Tele-STELLA and fidelity to the intervention protocol. Refine and 
optimize Tele-STELLA, as needed, based on above findings. 
 
Aim 2. Establish the efficacy of Tele-STELLA in reducing the frequency of behavioral and psychological 
symptoms of dementia (BPSD) and Care Partner reactivity to the symptoms. 
H1:  Participants who completed the Tele-STELLA intervention will report a significant reduction 
in the frequency of BPSD and Care Partner reactivity to the BPSD. 
 
 
Background 
Providing care for a family member with Alzheimer’s disease and related dementias (ADRD, aka, 
“dementia”) is both rewarding and risky.1,2 Care Partners exposed to chronic stress, often over years, 
are susceptible to physical and psychological ailments.2 Effective interventions that reduce Care 
Partner burden and health risks are available,3-5 but various factors impede participation, including 
distance, cost, behavioral symptoms of dementia, stigma and social anxiety.6-9 Recognizing the need to 
reduce barriers to access, scientists have turned to Internet-based interventions.10,11 Recent research 
indicates that multi-component, technology-facilitated interventions which allow Care Partner 
engagement with health professionals are effective and favored by Care Partners. However, a minority 
of telehealth-based interventions allow for health professional engagement and, of these, only a handful 
provide real-time interaction.10 Further, Hopwood et al. concluded that, despite the fact that family 
needs vary across ADRD stages, the interventions reviewed were not targeted to specific stages of 
dementia.10  
 
To address the needs of families living with dementia, we have completed two pilot studies using 
Internet-based Care Partner interventions.12,13 These studies tested the feasibility and consumer 
acceptability of the evidence-based, STAR-C 4 intervention, the precursor to Tele-STELLA, when 
delivered via telehealth. Qualitative data revealed the telehealth intervention was acceptable to Care 
Partners and preferred over a potential in-home intervention. We found that burden was reduced, but 
depression was not. This may be because the interaction with the Guide formally ended after Session 
8, leaving Care Partners with a sense of isolation, as this one commented: “I went through 
withdrawals… I wanted to call her (the Guide)—who can I turn to?”14 The prototype interventions did 
not include meaningful opportunities for Care Partners to interact with each other post-intervention. 

 
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Tele-STELLA Protocol v. 1 
Care Partners felt their support vanished and did not like “the fact that it was over.”12 Care Partners 
advised that future interventions should include both one-to-one sessions and one-to-multiple sessions. 
 
Based on the qualitative and quantitative data from the pilot work,12 Tele-STELLA was designed to 
address the specific needs of families living with moderate to severe dementia. Tele-STELLA is a multi-
component, tailored intervention that begins with one-to-one sessions with each Care Partner and 
Guide, then links Care Partners to each other in a meaningful way to sustain support post 
intervention.15 Tele-STELLA is designed for families living in the later stages of dementia, where 
behavioral symptoms are more prominent and distressing. 16 
 
The ultimate goal of this study is to diminish the frequency of behavioral symptoms that persons with 
dementia experience, and Care Partner reactivity to these symptoms. Based on Kales et al.17 
framework, behavioral symptoms arise from unmet needs, overburdened Care Partners and 
environmental factors, all within the context of cultural background and beliefs. Behavioral symptoms 
are bidirectional in that the person with dementia’s behaviors affects the Care Partner’s behaviors and 
vice versa.18-20 We hypothesize that addressing these factors will reduce behavioral symptom 
frequency, and, in turn, Care Partner reactivity to them, resulting in reduced Care Partner burden, 
depression and grief.  
 
Tele-STELLA allows all study activities to be done in Care Partners’ homes, using videoconferencing, 
email and phones. This includes assessments of burden and depression using electronic versions of 
classic measures. No visits to university sites are needed.  
 
 
Study Design  
Tele-STELLA is a prospective, mixed methods clinical trial. Care Partners for people with dementia will 
receive a psychoeducational intervention to facilitate effective management of behavioral symptoms of 
dementia. We will assess efficacy with pre/post measures.  
 
 
Study Population 
a) Number of Subjects 
 
A power analysis was performed to determine sample size.  Based on previous work, we will need 124 
care partners to find a significant difference of 2 points using paired t-tests on the reactivity portion of 
the RMBPC, as well as significant differences in depression and grief. With 124 participants, we’ll have 
90% power to detect a 2-point reduction in CP reactivity over the Tele-STELLA intervention period, 
using multiple comparison adjusted p-value of p=0.016 (0.05/3). In the pilot studies, the attrition rates 
were as high as 15%. Our current attrition rate is 30, thus we will aim to enroll 200 CPs. We will also 
enroll the 200 Care Recipients of the CPs, but will not collect data from them. We will collect data about 
them (demographics, Quality of Life) from the CPs.   
 
Based on previous work, we will recruit up to 200 Care Partners and their 200 care recipients with 
dementia. This allows for 30% attrition. We will recruit participants nationally, including those from the 
catchment areas from national  Alzheimer’s Disease Research Centers. 
 
b) Inclusion and Exclusion Criteria 
Inclusion criteria. The Tele-STELLA sample will be made up of participants who self-identify as a 
Care Partner for a family member, close friend or fictive kin 21 with moderate to severe ADRD, and their 
care Recipients with dementia. The care recipients will be enrolled with their Care Partners, but will not 
engage in the intervention. We will collect data such as demographics, health care use and quality of 
life. We will seek their consent for data management and confidentiality. 
 
The Care Partner must speak English in order to participate in Tele-STELLA. However, the person with 
dementia does not need to speak English, as long as the person with dementia can consent, or the 
LAR can consent on their behalf. 

 
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Tele-STELLA Protocol v. 1 
 
The Care Partner must be able to see and hear the videoconference-based interactions. 
 
The Care Partner must provide care for the person with dementia (e.g., assistance with ADLs, 
transportation, medication management, care oversight) for at least 4 hours/week. Due to COVID and 
other unforeseen conditions, this care does not need to be in-person. For example, a daughter may talk 
with her mother with dementia on the phone every night and supervise her care in a memory unit. Care 
Partners experience burden regardless of the location of the person with dementia, thus they do not 
have to live with them (Table 1).22   
 
To be included, all Care Partners must be able to identify two or more behavioral symptoms that are 
distressing for him or her (the Care Partner) as described on the Revised Memory and Behavioral 
Problems Checklist (RMBPC), or other commonly cited behavioral symptoms related to dementia.23 We 
will enroll Care Partners whose care recipients are in the moderate to late stages of dementia. To 
assess stage, the Care Partners will be given information describing the three stages of dementia, as 
identified by the Alzheimer’s Association (Box 1).24 They will be asked to choose the stage that best 
aligns with their care recipient’s current state.  
 
Care Partners who attend an external support group can participate, however, it cannot be a STAR-C 4 
(or a version thereof) intervention. We found in our earlier work that support group attendance did not 
affect our outcome (RMBPC) scores.12,25   
 
 
Exclusion Criteria. Care Partners with hearing and/or vision problems severe enough to prevent participation 
will be excluded. See Table 1 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 advanced dementia will die of natural causes while in Tele-STELLA. If this occurs, the Care 
Partner may remain in the study with PI approval. We may reduce the number of surveys for these Care 
Partners. 
 
 
If a Care Recipient does not consent to be in Tele-STELLA, the Care Partner cannot enroll in Tele-
STELLA.  
 
Care Partners must consent to be video-recorded while in Tele-STELLA sessions. They may turn off 
their cameras if they prefer. 
 
Box 1:  Stages of Dementia 
Mild:  Able to function independently, but some problems with memory (e.g., difficulty finding the 
right words, remembering names). May have trouble with losing items, planning and organization. 
Moderate:  Memory problems prominent (forgetting important facts about personal history, difficulty 
recalling basic information, such as home address, confusion about time or season).  Behavioral 
symptoms notable:  Anger, suspiciousness, frustration.  May wander, have problems with 
incontinence.  May need help with dressing, toileting. 
Severe:  Memory and functional problems impaired. Needs assistance with bathing, dressing, 
toileting. Difficulty with communication, expressing needs. Personality changes more apparent 
(agitation, apathy, aggression). 

 
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Tele-STELLA Protocol v. 1 
 
Screening and enrollment. Care partners will be recruited from across the United States, from ADRCs, 
other professionals, and the community at large The teams at the OHSU, University of Kentucky, Emory 
and UTHSCA ADRCs and other sites will support recruitment in the following ways: 
 
• 
Inform prospective subjects about the availability of the research 
• 
Provide prospective subjects information about the research which may include IRB-approved 
recruitment materials 
• 
Inform prospective subjects about the Tele-STELLA website (www.tele-stella.org) and pre-
screening link 
• 
Provide prospective subjects with information about contacting the investigators for information 
• 
Seek or obtain the prospective subjects’ permission for the investigators to contact them  
• 
Provide OHSU the prospective subjects’ contact information. Remote teams and community 
contacts may email OHSU with information or enter it into a secure file on OneDrive (see Partial 
Waiver of Authorization, 3/10/2021). Per the HIPAA waiver, OHSU teams will not email 
information PHI to referring entities.  
 
The University of Kentucky, Emory, and UTHSCA teams will not: 
• 
Pre-screen prospective subjects for Tele-STELLA 
• 
Answer specific questions about study details (they will refer to the OHSU team for detailed 
information) 
• 
Consent participants 
• 
Participate in any research activities 
 
When the OHSU team is notified of a prospective subject, they will complete a full screen.If the 
prospective participant is not eligible, the OHSU team will ask the subject permission to share their 
contact information with the recruitment teams and document their permission. They will also be given 
the phone number of the OHSU recruitment specialist for further information on other studies.  
 
If eligible, the OHSU team will proceed with the consent procedures (below). Screening will be 
completed using telephone or videoconferencing and documented on paper (Fillable PDF) or electronic 
(Qualtrics26 or REDCap27) forms. 
 
In the event of a screen failure, data collected during screening will be destroyed prior to 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.  
 
The remote ADRC locations will only recruit participants for this study. The remote locations  including 
Emory, UK, UTHSCSA, will not participate in any research activities (e.g., full screening, consent, 
intervention, assessment, identified data analysis). They may participate in analysis of deidentified 
data, research presentations and manuscript production. 
 
a) Vulnerable Populations 
The primary focus of this study is to assess the acceptability, feasibility and efficacy of the Tele-
STELLA intervention. Therefore, in order for this study to be successful, Care Partners of care 
recipients with moderate-to-late stage ADRD will be recruited. The care recipients with dementia will 
not partake in the intervention, but we will collect data about them, such as their health system use and 
expenses, behavioral symptoms and their quality of life. Further, if they inadvertently enter Care 
Partners’ rooms during the recorded Tele-STELLA sessions, they may be recorded. Care recipients in 
this study will be in the moderate to late stages of dementia. They will likely be decisionally impaired 
and unable to provide informed consent. Thus, we may obtain the informed consent of the  care 
recipient’s legally authorized representative (LAR) prior to the Care Partner engaging in any study 
activities.  

 
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Tele-STELLA Protocol v. 1 
 
 
 
The risks of persons with dementia participating in Tele-STELLA are limited to loss of confidentiality (if 
they come into view of the Care Partner’s computer screen). Care Partners will discuss their family 
member with dementia’s behaviors with other study participants. They will fill out demographic, mood 
and behavioral surveys on their behalf. It may be distressing for the person with dementia if they 
overhear their Care Partner discussing difficult behaviors.  
 
To minimize these risks, we will ask Care Partners to identify an activity that will keep the person with 
dementia occupied and out of computer range during the weekly Tele-STELLA visits.   
 
We will follow OHSU’s POLICY HRP-021 to identify appropriate LARs. 
 
a) Setting 
This study will occur primarily at OHSU. The University of Kentucky, and the Emory University, and the 
UTHSCA ADRC research teams will recruit and pre-screen Care Partners from their regions. We will 
send the recruitment flyer to other ADRC’s around the nation and use national registries 
(ResearchMatch, RISE) to recruit nationwide. All other 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. 
 
b) Recruitment Methods 
We will take a multi-pronged approach to subject identification and recruitment. . Care Partners may be 
recruited from across the US from clinics, electronic medical record systems, ADRC research cohorts, 
Table 1: Inclusion/Exclusion Criteria 
Participant 
Inclusion 
Exclusion 
Care  
Recipient 
with 
Dementia 
• 
Diagnosis of ADRD, moderate to late stages as 
defined by family member (Box 1) 
• 
Exhibits 2 or more behaviors, including those 
       listed on RMBPC16, that occur 3 or more times/ 
       week at study enrollment that are bothersome  
       to the Care Partner      
• 
Family member of Care Partner (this can be a  
relative, spouse or close kin that is considered  
family) 
• 
Provides informed consent to participate in the  
Research, or has LAR who can consent on their 
      behalf 
• 
Lives in ADRC catchment area at enrollment 
• 
Dementia not related to ADRD  
• 
Unable to leave Care Partner 
during Tele-STELLA sessions 
• 
Early stage dementia, as defined  
by family member (Box 1) 
 
  
Care  
Partner 
• 
Adult caring for family member with ADRD 
• 
Provides care for at least 4 hours/week28  
• 
Age of 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 
• 
Lives in ADRC catchment area at enrollment 
• 
Unable to find activity for care recipient  
during Tele-STELLA sessions to allow  
Care Partner to work privately with Guide  
and other Care Partners  
• 
Completed similar telehealth intervention  
within the last year 
• 
Hearing and/or vision problems severe  
enough to prevent participation  
• 
Refuses to be video-recorded during  
Tele-STELLA sessions. 
• 
Unwilling or unable to adequately                
follow study instructions and participate  
in study procedures                                     

 
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Tele-STELLA Protocol v. 1 
Researchmatchand other electronic registries, community advisory committees, faith communities and 
the community at large. We will use social media (e.g., Facebook, Twitter) advertisements to recruit 
Care Partners from the ADRC regions.  “This study will also recruit from the Research Inclusion 
Supports Equity (RISE) Registry (Emory IRB No. 3337).” All media will receive IRB approval prior to 
use.  
 
Potential volunteers will be contacted by ResearchMatch via an email contact message containing 
IRB-approved recruitment language for this study (not including direct study contact information such 
as study phone number). Volunteers will then have the option of replying by clicking ‘yes’ or ‘no’  in the 
contact message. If a volunteer chooses to respond in the affirmative, they will authorize 
ResearchMatch to release their contact information to the PI (or ResearchMatch designee) who will be 
responsible for managing that information according to institutional guidelines. 
 
The RAs at the ADRCs will provide interested parties with information about the study and provide 
them with the website link. The website (www.tele-stella.org) contains a pre-screening tool that asks 
interested individuals for basic information such as:  Do you care for a family member with dementia 
(like Alzheimer’s disease) for at least 4 hours per week? (by “care” we mean physical care, and/or 
oversight, for example, managing the care of a family member in memory care); Does your family 
member with dementia do things that upset you? Do you livein the US? ? If yes to all three, they will be 
asked to provide their contact information (see Facebook Ad, HIPAA waiver). Recruitment screening 
responses will be documented in a secure Qualtrics26 or REDCap27 survey system, within a secure 
Excel file on the OHSU Box or OneDrive site, or by phone to an identified Tele-STELLA RA.  
Advocacy organizations, such as the Alzheimer’s Association and the Lewy Body Dementia Association 
may be asked to promote Tele-STELLA in their community events. We may present information about 
Tele-STELLA for these organizations and other community groups.   
 
d)  Retention Methods 
Payment for Participation.  Care Partners will receive gift cards from OHSU for participation. They will 
receive a ClinCard for a total of $100. They will receive the first installment of $40 after completing the first 
component of Tele-STELLA, the second installment of $30 after completing the second component, and the 
third installment of compensation of $30 after completing all study activities (Table 2). In order to receive the 
payments, the subjects will need complete the surveys within the allotted time window (1 week) and provide 
OHSU with their social security number. The PI may allow provisional compensation if a participant does not 
complete all the required activities but otherwise demonstrates commitment to the study processes.   
 
Emails and Letters.  We may send periodic emails, newsletters, letters or cards to Care Partners to 
thank them for their participation and to wish them happy holidays. We may send these 
communications to current and past participants as long as the study is active. 
 
We may send emails and/or texts to Care Partners to communicate appointment times, address 
technology issues, or address concerns.  
 
e) Consent Process 
If the screening process finds the Care Partner is eligible to participate, the OHSU coordinator or research 
assistant (RA) will send the consent information to the Care Partner and the Care Recipient with dementia via 

 
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Tele-STELLA Protocol v. 1 
traditional mail or email, depending on the family’s choice. RA will schedule a consent appointment with the 
Care Partner and ask them to read the consent information prior to appointment.   
 
The RA will arrange a follow up appointment to review the consent forms. This will start with the “Consent 
Knowledge Check.” If the care partner provides two or more incorrect answers, the RA will contact the PI or 
her delegate. If the PI judges the care partner unable to consent, they will not be enrolled in Tele-STELLA. 
 
If the Care Partner passes the Consent Knowledge Check, the RA will review the key points of the consent 
information sheet and answer any questions they may have. 
 
The consent process will occur by phone or videoconferencing by the OHSU team. Prior to consenting, the 
identified Tele-STELLA RA will confirm that the potential Care Partner participant is comfortable and actively 
listening to the conversation. The RA will begin by asking if the Care Partner has any questions about the 
consent information or process. RA will then administer the knowledge consent check. If 4 or more questions 
are answers correctly, RA can assume the Care Partner has read and comprehended the consent information, 
and continue consent process. 
Care Partners are responsible for the safe care of their family member with dementia. It is assumed they will 
have the capacity to consent. However, if the study team has concerns about a Care Partner’s cognitive 
capacity, they will not consent them and will inform the PI (Lindauer). The PI will contact the potential 
participant to further assess their trial comprehension and consent capacity.  
 
After comprehension is verified, the RA will ask the Care Partner to verbally consent to the study. When the 
Care Partner verbally consents to participate in the study, the research team member who conducts the 
informed consent conversation will sign and date a copy of the forms, indicating that the forms were reviewed 
with the Care Partner and that consent/assent was obtained. A copy of the forms will be sent to the participants 
(email or traditional mail). We have used this process with our other studies and it has worked well. If the 
consent is revised, care partners will be sent the updated consent for both them and their care recipient. They 
will be advised to contact us if any concerns or if they want to withdraw.  The revised consent will not be 
reviewed with the care partner by the RA or signed by the RA. 
 
If a Care Partner withdraws they will receive an email or letter confirming their withdrawal and thanking them 
for their participation. All study activities will end; however, if they consented to be in a focus group, we will 
contact them after they withdraw to give them the option to participate in a focus group. They will have the 
option to decline focus group participation.  
The person with dementia will not partake in the Tele-STELLA intervention, but we will collect and analyze data 
about them from their Care Partner (see Care Partner Consent) during the study period. Our previous 
experience has taught us that the person with dementia may enter the room of the Care Partner during Tele-
STELLA sessions and inadvertently appear in the videoconferencing recordings. We will seek the consent of 
the person with dementia or their LAR to participate in this study using an Information Sheet.  Care Recipients 
who are not able to provide informed consent are given the option to assent for the study; this decision will 
ideally be discussed between the Care Recipient and their LAR, but the final decision is the LAR’s to make. If 
we are unable to obtain the Care Recipient’s consent (from them or the LAR), the Care Partner cannot be in 
the study. 
 
The Information Sheet for the person with dementia advises them of their family member’s involvement in the 
study, the data we collect on them, and the risk of loss of confidentiality if the person with dementia enters their 
family member’s camera field (on their computer) during the live videoconferencing sessions. We will ask the 
Care Partner or LAR if their family member would be able to understand the information sheet. If the Care 
Partner or LAR  identifies the person with dementia is unable to consent for themselves, , we will ask the LAR 
to accept responsibility for understanding and communicating the information provided on the Information 
Sheet. 
 

 
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Tele-STELLA Protocol v. 1 
If the Care Recipient and LAR agrees to assent, RA will complete the assent process over the phone with both 
parties present. RA will highlight key information in each section of the Care Recipient consent form and ask 
Care Recipient if they have any questions or concerns about the participation of their Care Partners or selves.  
In our similar studies, many of the participants with dementia were not capable of consenting. The extra step of 
a full formal consent for the person with dementia was stressful for Care Partners (often the LARs). The 
Information Sheet provides the family with information they need to safely participate in Tele-STELLA, while at 
the same time removing a barrier (full consent of the person with dementia) for study participation.   
The study team has the legal and ethical obligation to ensure that prospective subjects, or their LARs, have the 
sufficient knowledge and comprehension of the information contained in the consent/assent documents to 
enable them to make an informed decision about whether or not to participate in Tele-STELLA.  Participants 
will be advised in the consenting process 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. 
 
 
 
Procedures 
 
Enrollment and Set-up. After consenting to the study, Care 
Partners will be contacted by the study research assistants (RA) 
to collect enrollment information (e.g., demographics, contact 
information) and orient them to logging on to the Tele-STELLA on 
their computers (see “Technology” below). The RA’s will mail or 
email the “Tele-STELLA Care Partner Handbook” and ClinCard to 
the Care Partner, which provides details about all study activities 
as well as contact information for nationally-available support 
programs (e.g., the Alzheimer’s Association). 
 
The RA will manage all scheduling with participants using 
telephone, text, and email (see Table 5).  
 
Tele-STELLA Components. Tele-STELLA consists of two components: Nova and Constellation 
(Figures 1 and 2). Each component is made of up of approximately one-hour sessions over about eight 
weeks. The sessions are taught by the professional “Guides” (e.g., nurses, social workers) or trained 
lay personnel. The Nova component is designed to introduce Care Partners to Tele-STELLA, first in a 
one-to-one format, then in small groups (Figure 1). The Constellation 
component is the same intervention, but provided at a group level, after 
Nova. IRB-approved PowerPoint slides will be shared with Care 
Partners as needed. The study coordinator may join any if needed. 
 
The Nova component. In the first four weeks of Nova, one Care 
Partner will meet with one Guide via synchronous videoconferencing 
(Figure 1). The one-to-one sessions orient the Care Partners to the 
learning environment, allow for mutual trust to develop between the 
Care Partners and Guide, and give Care Partners the authority to select 
the behavioral symptoms they want to address.29  
 
During, or after the first Nova session the Care Partners and Guides will 
document the problem behaviors the Care Partners want to work on while in Nova. They will rate how 
frequently the behaviors occur and how much the behaviors bother the Care Partner. This information 
will be entered into the Qualtrics26 or REDCap27 program. 
 
In the first weeks of Nova, the Care Partner will learn the Tele-STELLA ABC approach, which focuses 
on identifying the activator of a behavior, describing the behavior in detail, and discussing the 
Figure 1. Nova Component of Tele-STELLA  
Figure 2.  Constellation Component of Tele 
STELLA  

 
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Tele-STELLA Protocol v. 1 
consequences of the behavior. With a deeper understanding of the behavior, Care Partners can 
develop strategies to prevent or modify it.30 While Tele-STELLA encourages Care Partners to consider 
and address their own behavioral symptoms (e.g., depression, grief), the intervention starts with 
focusing on at least two behavioral symptoms experienced by the family member with dementia.  
 
At Week 5, after the 4-week induction period, up to five Care Partners will join one Guide, via 
videoconferencing, for the remaining four weeks in Nova (Figure 1). In these small group sessions the 
Guide presents didactic information on pleasant events,31 affective symptoms of caregiving and Care 
Partner coping. After the didactic section, Care Partners will be encouraged to share their stories about 
their experiences, their ABC plans and their successes.  
 
The Constellation component.  After completing the Nova component, Care Partners will join the 
Tele-STELLA Constellation via synchronous videoconferencing (Figure 2). Here up to 20 Care Partners 
meet as a group with up to three Tele-STELLA Guides for 8 weeks to review and discuss the key 
lessons of Tele-STELLA. Any Care Partner who completes the Nova component can join a 
Constellation. The Constellation allows experiential adult learning by having Care Partners practice 
what they learned in Nova and to provide support for their Care Partner colleagues.29  Up to four 
Constellations will be provided/year. Care Partners can join any Constellation, but they need to start it 
within 1 year of starting Nova. If they delay participation, they may be in the study longer than a year. 
 
During, or after the first Constellation session the Care Partners and Guides will document the problem 
behaviors the Care Partners want to work on while in Constellation. They will rate how frequently the 
behaviors occur and how much the behaviors bother the Care Partner.  This information will be entered 
into the Qualtrics26 or REDCap27 programs. 
 
Each Constellation session starts with a brief didactic lesson presented by the Guides (the “hub”) for 
the Care Partners in the “spokes” (Figure 2). Following the lesson, a Care Partner will share their story 
about their family’s experience with dementia and distressing symptoms. The participating spokes and 
the hub may seek more details about the Care Partner’s story and discuss approaches to the 
symptoms. This approach encourages dialogue between all Care Partners to gain a fuller 
understanding of each Care Partner’s experience. The Guides responsible for ensuring respectful 
exchange and closes with positive feedback for the Care Partners. Should Care Partners be reluctant 
to share their experiences, the Guides will have example stories to discuss.  
 
Adult learning is most effective when learners share their knowledge with each other.29 Thus, the 
Constellation sessions are designed to allow Care Partners to practice and discuss their ABC plans 
with a larger group of peers.  
 
Care Partners who are unable to complete all Tele-STELLA components may remain in the study and 
we may collect the data noted in Table 4. Care Partners who do not complete any sessions, 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 and attend focus groups, despite not completing all of the sessions.  
 
Anticipated challenges.  Scheduling Care Partners may be difficult. Thus, the protocol allows the 
following concessions: 
• 
The study team may alter the session schedules due to holidays, illness or other scheduling 
issues. 
• 
Up to two weeks break between Nova session #4 (one-to-one) and #5 (small group). 
• 
Nova and Constellation sessions may be doubled in a week if scheduling challenges. 
• 
Care Partners can delay joining a Constellation for up to a year after starting Nova.  However, 
they will need to repeat the Earth Survey (which they complete 1 month after the last Nova 
session) prior to starting the Constellation. 

 
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Tele-STELLA Protocol v. 1 
• 
If Care Partners delay joining a Constellation, they may be in the study longer than one year. 
• 
Care Partners can skip up to 2 Nova sessions and 2 Constellation sessions and still remain in 
the study. 
• 
If a Care Partner misses a session, they can catch up by doing two sessions in one week. 
• 
There may be two Constellation sessions in one week if schedules conflict with holidays or other 
challenges.  
• 
If there are more Care Partners than available Guides, the Care Partners may have to wait to 
join the Nova or Constellations components. We will enroll them and have them do the weekly 
survey until there is space for them in the sessions. We will provide them with “usual care” 
which includes referral to local support agencies, such as the Alzheimer’s Association. 
 
Focus groups. Any Care Partner who signed a consent, whether or not they participated in the 
intervention, can participate in a focus group. Focus groups may be held about twice a year. Focus 
group leaders will use a semi-structured interview guide to facilitate discussion about the Care Partners’ 
experiences with Tele-STELLA. The focus groups will be video-recorded and transcribed. Transcripts 
will be analyzed for themes of acceptability. We have successfully used videoconferencing for focus 
groups in the previous two pilots.12,25  
 
Table 2: Tele-STELLA Care Partner Activities  
Activity 
Description 
Due 
Screen 
Screen for study eligibility (see HIPAA waiver) 
Prior to consent 
Consent 
Care Partner and care recipient consent 
Prior to study activities 
Preliminary session(s) 
Collect enrollment information 
Set up and test videoconferencing link 
Mail handbook and email PDF Handbook 
After consent completed 
Nova Component (8 weeks) 
MecurySurvey 
(Survey 1) 
Baseline surveys (Table 4) 
Prior to intervention start 
Target Problem  
Assessment 
Guides complete during or after Session 1 
Intervention: Nova 1 
Meet with Guide for 4 weekly one-to-one  
sessions  
After Mercury Survey completed 
Intervention: Nova 2 
 
Meet with Guide and up to 5 other Care  
Partners for 4 more weekly sessions  
After Nova session #4 
Venus Survey 
(Survey 2) 
See Table 4 
Within one week of completion of Nova 
Target Problem 
 Assessment 
Earth Survey 
(Survey 3) 
Assessment of behaviors, mood, quality of life 
1 month after last Nova Session 
Target Problem 
Assessment 
(Subjects who complete all above activities will receive $40) 
Constellation Component (8 weeks) 
Earth Survey*  
(Survey 4) 
See Table 4 
About 1 week prior to Constellation start 
Target Problem 
Assessment 
Prior to or during Constellation Week 1 
Intervention 
Meet with up to 20 Care Partners for 8 weekly  
Sessions 
After Earth Survey completed 
Mars Survey 
(Survey 5) 
See Table 4 
Within one week of completion of  
Constellation  
Target Problem  
Assessment 
(Subjects who complete all Constellation activities will receive $30) 

 
Page 11 of 25 
Tele-STELLA Protocol v. 1 
 
Guide training. Guides will be trained by the principal investigator (PI), Project Director (PD), andother 
Guides. Guides will participate in standardized didactic and experiential training. Best practices in 
managing and facilitating both individual and group sessions will be emphasized.  
Guides will review the Guide Handbook and recordings of other Guides. . They will record mock 
sessions with models acting as a Care Partner. The models (e.g., staff, Tele-STELLA Community 
Advisors) will use a scripted format, “stage” names and false stories. Models will be advised not to use 
any PHI. Mock practice sessions will allow guides to practice group strategies such as management of 
inappropriate behavior (e.g. use of disparaging comments), and inclusion of reticent participants. 
Guides will demonstrate essential competencies in behavior identification, intervention delivery and 
data documentation prior to implementing Tele-STELLA. The PI and PD will determine when Guides 
are adequately trained to do the Tele-STELLA intervention. All training will be completed via 
videoconferencing and recorded to maintain consistency across guides. The PI/PD may join any Tele-
STELLA session to assess Guide competency. 
 
Fidelity Assessment. The Tele- STELLA trial utilizes a vigorous fidelity assessment protocol that 
examines interventionist (Guide) adherence to protocols during delivery monitoring. This protocol is 
informed by evidence-based standards, including recommendations from the NIH Treatment Fidelity 
Workgroup Behavior Change Consortium  and advised by Onken et al.30 We utilize this protocol to 
reduce threats to internal validity and facilitate dissemination of findings and procedures  
 
We will videotape all Tele-STELLA sessions and recordings will be stored on a secure server  
(OneDrive) that the fidelity assessment team can access via the OHSU secure filesharing system. The 
fidelity assessment team will consist of content experts, including experienced Guides. They may view 
a randomly-identified subsample of up to 20% of videos. The assessment will evaluate procedural 
fidelity, documentation fidelity, and theoretical fidelity. Fidelity items are scored using a binary rating of 
“1” (present) or “0” (absent), with clearly defined characteristics required for either rating. Inter-rater 
agreement on video assessments will be measured (77). 
 
STAR Council. The STELLA Team Advisory Resource (STAR) Council is made up of former study 
participants, caregivers, and community members with lived experience and an interest in dementia 
caregiver well-being. The Council provides structured input to ensure study activities reflect 
community perspectives and are culturally and contextually appropriate. 
 
STAR Council  members may: 
1. Review study materials, communication tools, and recruitment strategies and provide user-
centered feedback. 
2. Participate in beta testing of websites and technology tools (via Webex; sessions may be 
recorded for internal review by authorized staff). 
3. Attend mock intervention sessions as practice participants to support staff training (via 
Webex; may be recorded for internal review). 
4. Review dissemination products (e.g., manuscripts, posters, newsletters). 
5. Participate in selected recruitment and outreach events with study staff. 
Earth Survey 
(Survey 6) 
See Table 4 
2 months after last Constellation session. 
Target Problem  
Assessment 
Weekly Orbit Surveys: Distributed weekly (Table 4) 
Orbit surveys start after enrollment and continue until all surveys are completed 
(Subjects who complete last Earth Survey and 80% of Orbit Surveys may receive $30) 
*Earth Survey should be completed within approximately two weeks of starting Constellation.  If Constellation start is delayed, Care Partner will need 
to repeat Earth Survey.   

 
Page 12 of 25 
Tele-STELLA Protocol v. 1 
6. Provide guidance on community outreach and dissemination of study findings to community 
members in ways that are meaningful, engaging, and culturally appropriate for the 
communities the study aims to benefit. 
 
The Council will primarily meet via Webex. All members will complete a brief orientation covering 
STAR Council goals, expectations, use of technology, and compensation procedures. Ongoing 
training and support will be provided to promote meaningful engagement. The STAR Council 
members will be provided with up to $50/hour of service as funds allow. No PHI of any study 
participants will be shared with STAR Council members. Council feedback will be reviewed by the 
study team to inform materials, procedures, and dissemination. Engagement quality will be 
assessed annually. 
 
Implementation. Tele-STELLA will be implemented in two phases. Phase 1 will be a pilot phase to 
address the goals stated in Aim 1 (“Establish the feasibility and acceptability of Tele-STELLA”).  In 
Phase 2, we will complete the intervention with the remaining Care Partners to address Aim 2 
(“Establish the efficacy of Tele-STELLA in reducing the frequency of BPSD and Care Partner reactivity 
to the symptoms”). 
 
  
Phase 1. The first Care Partners (up to 36) will receive the intervention as described above. 
Feasibility will be assessed by tracking recruitment patterns across the ADRCs, as well as enrollment 
and retention rates. We will document and compare completion rates for both the Nova and 
Constellation components. We will compare completion rates for each location. Acceptability will be 
assessed by engaging focus groups with Care Partners via videoconferencing, and fidelity will be 
assessed using the procedures discussed above. 
 
Table 3.  Plan for Refining and Optimizing Tele-STELLA (Aim 1) 
Aim 
Criteria 
Possible Modifications 
Feasibility 
• 
80% of Care Partners will complete Tele-
STELLA within 12 months of starting the 
intervention 
• 
70% of Care Partners will complete at least one 
Constellation component 
• 
80% will report accessing internet with minimal 
challenges.  
• 
Identify barriers to participation in 
focus groups and modify as 
indicated.  
• 
Discuss and address technology 
challenges with ORCATECH team 
Acceptability 
• 
80% will report overall satisfaction with program 
on the Tele-STELLA Satisfaction Survey 
• 
50% will attend focus groups 
• 
In their focus groups, Care Partners will report 
positive experiences with Tele-STELLA  
• 
Address concerns in focus groups 
• 
Implement changes, if they align with 
Tele-STELLA theory and principles, 
as suggested by focus groups 
Fidelity 
• 
There will be moderate to high protocol 
adherence as measured on the Protocol 
Adherence Checklist 
• 
Inter-rater agreement on video assessments 
will range from 0.42-1.0034 
• 
Identify and address areas of poor 
adherence, re-train Guides as 
needed 
• 
Review video rating protocol and 
adjust as needed 
Preliminary 
Efficacy 
• 
Trends will suggest improvement in behavioral 
symptom frequency, Care Partner reactivity, 
burden and grief.  We may see improvements 
in quality of life for both the person with 
dementia and the Care Partner. 
• 
Identify where improvement (or lack 
thereof) was seen across the 
intervention 
• 
Work with Consultant (Teri) and/or 
co-investigators to modify 
intervention to target areas of 
weakness 
 

 
Page 13 of 25 
Tele-STELLA Protocol v. 1 
Should findings from Phase 1 indicate a need for substantial revisions, the study team will discuss the 
revisions and implement changes that align with the theoretical basis of the intervention.17 We will 
repeat procedures with another sample of Care Partners. We will repeat this process until we meet the 
criteria outlined in Table 3.  
 
Phase 2. Once the intervention is refined, and meets the criteria in Table 3, we will implement Tele-
STELLA until up to 124 Care Partners have completed the full intervention. We will assess the efficacy 
of Tele-STELLA as described in Aim 2 (Establish the efficacy of Tele-STELLA in reducing the 
frequency of behavioral symptoms and Care Partner reactivity to the symptoms). 
 
Measures. For all measures, please see Table 4 for descriptions and Table 2 (Care Partner Activities) 
for timing of distribution to the Care Partners. Demographic information (such as address, age, sex, 
race, rural status) will be collected upon enrollment. Care-recipient dementia diagnosis and diagnosis 
year will be documented. Dementia stage will be identified by Care Partner report (Box 1). The number 
of years and hours of caregiving will be recorded.12,25  
 
The primary outcome, caregiver burden will be assessed with the RMBPC,23 which measures the 
frequency of BPSD and caregivers’ reactions to these behaviors. The RMBPC is among the most 
commonly-used measures of burden in caregiver research and has strong internal consistency 
(α=.86).35 Six questions additional questions as about care recipient behaviors.  
Tele-STELLA requires Care Partners to work on their specific family behavioral symptoms. This 
information is documented in Qualtrics26 or REDCap.27 The Guide and Care Partner discuss the 
behavioral symptoms in the first Tele-STELLA Nova sessions and document them for reference during 
and after the Nova sessions. The Care Partners will complete their own assessments at the end of 
Nova and in Constellation. 
 
We will assess burden with the 4-item ZBI, a brief measure of burden (α=.78).36 Pre-death grief will be 
assessed with the Marwit Meuser Caregiver Grief Index-Short Form (MMCGI-SF).37 The MMCGI-SF is 
an 18-item assessment of pre-death grief with high internal consistency (α=.80).37  The Ten-Item 
Personality Inventory provides information on extraversion and introversion.38 
 
Quality of life (QOL) will be assessed with the QOL in Alzheimer’s Disease (QOL-AD) 39 scale, a 13-
item measure of factors such as physical health and energy. Care Partners will complete their own 
QOL-AD. The Care Partner may complete the QoL AD for the care recipient. The QOL-AD has high 
internal consistency (α=.80) with those with high cognitive function. Internal consistency is high when 
Care Partners reports on their care recipient’s QOL (α=.86). Care Partner depression will be measured 
with the CESD-10 (α=.88).40 We will assess satisfaction with Tele-STELLA using the Tele-STELLA 
Experience Survey.12,25  
Table 4. Tele-STELLA Survey Descriptions 
Target Problem Assessment: Care partner documents target problems prior to and after Nova and 
Constellation 
Mercury (Baseline) 
Revised Memory & Behavioral Problems 
Checklist (RMBPC) 23 
Measure of frequency and reactivity to behavioral and psychological 
symptoms of dementia23 
Center for Epidemiologic Studies Depression 
Scale (CESD-10)41 
10-item depression measure 
Marwit Meuser Caregiver Grief Index-Short 
Form (MMCGI-SF)37 
Care Partner pre-death grief37 
Placement plan scale42 
One-item assessment of plans for placement of family member with 
dementia42 
QoL AD39 
13-item assessment of quality of life for the Care Partner  
QoL AD39 (person with dementia) 
13-item assessment of quality of life for completed by the Care Partner 
on behalf of the person with dementia. 

 
Page 14 of 25 
Tele-STELLA Protocol v. 1 
 
Care Partners will 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 such variables as Care Partner emotional and physical strain, 
medication use 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. 
 
We will assess Care Partner likelihood of placing their family member into long-term care (e.g., assisted 
living, memory care) using a single item question (“In the next 6 months, how likely are you to move 
your care recipient to another living arrangement?”). Care Partners will rate this on a scale of 1 (not at 
all likely) to 5 (very likely). 
 
If the Care Partners drop out of the study, we will ask them to complete the Exit Survey so we can get 
their feedback. 
 
The Guides may collect qualitative data during the intervention that highlights challenges for the 
Guides, technological issues, and/or provides insightful comments from the Care Partners (see Guide 
Tracking Sheet). A notes section is provided for each session on the Attendance and Content 
Checklist. 
 
Venus Survey 
RMBPC23  
(see Baseline for descriptions) 
CESD-1041 
MMCGI-SF37  
Placement plan scale42 
QoL-AD39 
QoL-AD39  (person with dementia) 
Tele-STELLA contact (includes TIPI)38 
Tele-STELLA Care Partner contact post intervention, extraversion, 
introversion 
Tele-STELLA Nova Experience Survey 
16-item + comments on satisfaction, privacy, ease of use 
Earth Survey 
RMBPC23 
(same as “Venus” but without Experience Survey) 
 
CESD-1041 
MMCGI-SF37 
Placement plan scale42 
QoL-AD39 
QoL-AD39  (person with dementia) 
Tele-STELLA contact 
Mars Survey 
RMBPC23  
(see Baseline for descriptions) 
CESD-1041 
 
MMCGI-SF37  
 
Placement plan scale42 
 
QoL-AD39 
 
QoL-AD39  (person with dementia) 
 
Tele-STELLA contact 
Tele-STELLA Care Partner contact post intervention 
Tele-STELLA Constellation 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 use of ABC plans. 

 
Page 15 of 25 
Tele-STELLA Protocol v. 1 
We will implement the above measures using Qualtrics26 or REDCap27 Survey Platforms26 The surveys 
will be emailed to the Care Partners.26 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 Tele-STELLA 
coordinator may call, email or text them to identify barriers to completing the surveys. If they would like 
to stay in the study, they will need to complete at least 80% of each survey and submit survey 
responses within two weeks of receiving them. However, final disenrollment of a participant due to 
incomplete surveys is subject to PI discretion.  
 
Care Partners will need to complete their first planet survey (Mercury) the week prior to their first Nova 
session with the Guide. They are not allowed to begin the intervention until they complete the Mercury 
survey.  If they do not complete their Mercury survey within one month of receiving it, they may be 
removed from the study. The electronic functionality allows Care Partners to complete surveys in the 
privacy of their homes, at a time that works for them. The Qualtrics26 and REDCap27 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. 
 
g) Technology and Participant Communication. All contacts, surveys and interventions may be completed 
by phone, email, texting, videoconferencing and/or electronically-administered assessments (see Table 5).  
The pre-screen will be online at www.tele-stella.org. All other study activities (screening, consenting, 
intervention and surveys) will be done at OHSU by OHSU scientists, interventionists and staff. There are no in-
person research activities. We will send occasional newsletters with study updates via OHSU’s Marketing 
Cloud system. Marketing Cloud is managed within OHSU and is HIPAA compliant..We will send the 
newsletters through 2026. Care partners will have the option of opting out if they do not want to receive the 
newsletters.  
 
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.  
 
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 Guides will meet with Care Partners via videoconferencing using either an OHSU computer or their own 
computer and an OHSU, HIPAA-secure link. The Guides will not contact the Care Partners outside of the 
videoconferencing sessions without making a reasonable effort to have the study coordinator contact the Care 
Partner first. The Guide may complete the visit from his or her home, 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 Tele-STELLA 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. Some Care Partners 
may not have a device to access the study. These Care Partners will be loaned a Chromebook with a 
simplified user interface allowing for only study activities to be conducted using the device. Care 
Partners will access the intervention using the OHSU secure videoconferencing link which will be 
visible upon opening the Chromebook. Chromebooks will be mailed to Care Partners and pre-paid 
postage and packaging will be provided for the return mailing. Care Partners can keep the 
Chromebooks while they participate in the Tele-STELLA intervention, the post-intervention survey, and 
a focus group.  

 
Page 16 of 25 
Tele-STELLA Protocol v. 1 
 
Care Partners who use their own computers, and those using the loaner Chromebooks, may need a 
hotspot device that uses cellular service to access the internet. The study will provide this device. 
Whether they use their own devices or the Chromebooks, Care Partners will have the option to use 
internet or cellular service to access the study, but the study will only pay for cellular service. If all 
efforts to correct connection issues fails, the Care Partner may participate in Tele-STELLA via phone. 
 
We will work with the Oregon Roybal Aging & Technology Team (ORCATECH) to manage the 
computers and accompanying technology. A Tele-STELLA research assistant may teach and support 
Care Partners in device use and study access. All Tele-STELLA sessions may be video-recorded and 
the recordings will be stored on a secure server and/or OneDrive. Videos that are not needed for fidelity 
assessments may be deleted. Videos saved on staff webex accounts will be deleted should the staff 
member leave OHSU. Content experts will have access to a sample of videos for viewing via the OHSU 
secure file-sharing system (Box43 or OneDrive).  
 
Care Partners will access all electronic surveys on their Chromebooks, their own computers, tablets, 
their smartphones, or other devices.   
 
Care Partner surveys will be administered via the REDCap27 or Qualtrics26 Survey Platform26 (FIPS 
140-2 compliant transfer). This platform provides HIPAA secure, easy-to-use surveys that Care 
Partners can complete on their Chromebook, laptop or smartphone. We used Qualtrics26 in our 
previous pilot, with 100% Care Partner completion of surveys.25  
 
6) Data and Specimens 
 
h) Handling of Data 
No biological or genetic specimens will be collected in this study. Data from the measures described 
above will be collected via the secure Qualtrics26 or REDCap27 systems and then downloaded to a 
secure OHSU file for analysis. 
 
i) Sharing of Results with Subjects 
Results of the RMBPC and the Personalized Target Behavior Problem Assessment may be shared with 
the Care Partner prior to the intervention. This will help the Care Partner identify behaviors they want to 
target in the training sessions. If the burden or depression scores indicate severe depression or burden, 
the Care Partner may be informed, at the discretion of the PI (see DSMP) 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.  
 
j) 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 (OHSU IRB # 6845). 
 
 
Data Analysis 
Tele-STELLA 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.  
 
Aim 1(Establish the feasibility and acceptability of Tele-STELLA). We will assess data from the surveys 
to characterize the sample, assess program acceptability, and measure treatment fidelity. We will 
compare demographic information, computer use, out-of-pocket costs, health-care usage, behavioral 
symptom frequency, Care Partner reactivity, burden, depression, quality of life and daily activities for 
those that completed the interventions to those that did not.   
 

 
Page 17 of 25 
Tele-STELLA Protocol v. 1 
For acceptability, we will analyze the Tele-STELLA Experience Survey results using descriptive 
statistics. A narrative analysis approach may be used to analyze the qualitative focus group data and 
the data from the Guide Tracking Sheet. 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 Tele-STELLA and the underpinnings of their impressions.45 These qualitative findings will be 
considered in relation to the quantitative data using a parallel mixed analysis approach, a widely-used 
strategy in mixed methods research.46 This involves separate analyses of the quantitative data (e.g., 
paired t tests, linear regression) and qualitative data. This may be followed by an analysis that looks at 
areas of data convergence and divergence. We have used this approach in our pilots 12,25 where we 
found that Care Partners with higher reactivity scores on the RMBPC23 voiced in the focus groups 
preference for a one-to-one intervention. Those with lower scores were inclined to prefer a group 
intervention.47 These findings informed our decision to include both one-to-one and group sessions in 
Tele-STELLA. Similarly, the parallel mixed analysis findings may be incorporated into any needed 
revisions of Tele-STELLA.  
 
For treatment fidelity, we will document the proportion of Care Partners who completed the full Tele-
STELLA intervention. For the video assessments, Cohen’s kappa coefficient will be used to calculate 
inter-rater agreement, with the following coefficients:  Almost perfect 0.81-1.00; Substantial 0.61-0.80; 
Moderate, 0.41-0.60, Fair 0.21-0.40; Slight/poor, <0.34 
 
Aim 2 (Establish the efficacy of Tele-STELLA 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 RMBPC (frequency and reactivity) 
after NOVA (primary analyses) and after Constellation (exploratory analyses). We may also assess 
efficacy in the domains of Care Partner depression, QOL and grief before and after each component 
(Nova and Constellation), with pre-post paired t tests.46   
 
Using hierarchical linear modeling, we may assess the effect of Tele-STELLA controlling for number of 
days between the end of Nova and the beginning of Constellation as a sensitivity analysis. 
 
We may use linear regression models to examine pre-post changes in primary outcome (RMBPC 
change scores) utilizing surveys between two points. We may assess relationships between the Care 
Partner reactivity subscale and other variables, controlling for variables such as age, sex, number of 
hours caregiving, rural status and education: a. number of Tele-STELLA sessions each Care Partner 
attended, b. likelihood of placement, and c. out-of-pocket costs. Other linear regression models will be 
used as indicated. 
 
Using linear regression modeling, 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. the number of days prior to starting Nova sessions, b. the number of days prior to 
starting Constellation sessions.  
 
We may assess differences in the RMBPC (reactivity subscale) between four groups (rural White, 
African American; urban African American, White) with multiple comparisons assessed post-hoc using 
Tukeys HSD correction.  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. 
 
Using ANOVA, we may assess pre-post changes in the RMBPC23 (reactivity subscale) between four 
groups (rural White, African American; urban African American, White), with the hypothesis that there 
are no significant differences across groups. 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.  

 
Page 18 of 25 
Tele-STELLA Protocol v. 1 
   
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 will summarize costs and may assess the relationships between cost, burden and Tele-STELLA 
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. 
 
 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.   
 
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 (Individual and Group Logs, Pre-
treatment survey, Visit Information Sheet) 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. However, video-recordings will show their 
faces and their names--any information discussed during the sessions will be heard in the audio. In this 
case, the information subjects give us will be identifiable as coming from them and will not be private.  
 
We will use participants’ electronic mail, phones and texts for communication and data collection. A key 
element of Tele-STELLA 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 Tele-STELLA, but we cannot prevent this. The phone numbers and 
email addresses will not be confidential. We will ask Tele-STELLA participants to only use first names 
in the intervention. Care Partners can opt out of sharing their contact information.  
 
Electronic mail for data collection, and electronic files for data analysis may not contain any PHI. Codes 
will not contain any of the 18 HIPPA identifiers. 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 

 
Page 19 of 25 
Tele-STELLA Protocol v. 1 
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. 
 
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, or via OHSU Box.com or 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” drive in a highly secure, biometrically authenticated data center or shared via 
OHSU Box.com or OneDrive. Using OHSU Box.com (or OneDrive).The transcripts of the videos will be 
available to study staff to review sessions and address any concerns.  
 
Electronic survey data will be stored in a web-accessible server (e.g., Qualtrics26 or REDCap27). 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 or similar professional. 
 
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 or their family members 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. 
 
No part of Tele-STELLA study participation for the Care Partners should result in a serious adverse 
event as defined by the NIA Adverse Event and Serious Adverse Event Guidelines: (86) 
Any adverse event that results in death; is life threatening or places the participant at immediate 
risk of death from the event as it occurred; requires or prolongs hospitalization; causes 
persistent or significant disability or incapacity; results in congenital anomalies or birth defects; 
and/or is another condition which investigators just to represent significant hazard.  
 
There may be other adverse events for Care Partners as defined by the NIA Adverse Event and 
Serious Adverse Event Guidelines(86) 
 
Any untoward or unfavorable medical occurrence in a human study participant, including 
any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, 
temporally associated with the participants’ involvement in the research, whether or not 
considered related to participation in the research.  
 
Due to the known strain of caregiving, Care Partners may report mental health issues (e.g., anxiety, 
depression) or physical manifestations of stress (e.g., hypertension, low back pain).  These will likely 
not be related to the intervention, however, emotional distress is a potential risk of study participation, 

 
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Tele-STELLA Protocol v. 1 
thus training will be provided to all study team members (including all study investigators, Guides and 
research assistants) to (a) sensitize them to the signs, symptoms and/or indicators of extreme 
emotional upset, (b) enable them to make an appropriate immediate response and (c) ensure that 
project protocol, below, for providing information about resources is carried out appropriately.  
 
Brief Description of the Emergency Response Protocol: In the event that any 
participant displays significant psychological stress as identified by any member 
of the study team, the Principal Investigator will be notified within 24 hours 
(Lindauer) (off hours and on weekends, one of the co-PIs or experienced 
Guides will be notified). Dr. Lindauer (or her delegate) will reach out to the 
participant with appropriate resources (hotlines, websites, etc.). To the extent 
possible, these resources will be local to the participant in question. Resources 
provided to Care Partners are detailed in section 1.3 “Protection Against Study 
Risks.” Dr. Lindauer (or her delegate) will be responsible for reporting adverse 
events to SO, NIA, IRB during normal reporting intervals.  
 
 
It is possible that the persons with dementia who are enrolled in Tele-STELLA may experience a 
serious adverse event as defined by the NIA Adverse Event and Serious Adverse Event Guidelines.  
These SAEs would not be a result of the intervention (the persons with dementia do not participate the 
intervention). Rather, these events will likely be due to advancing dementia and/or health concerns that 
come with advancing age (e.g., agitation, falls, urinary tract infections, pneumonia) and are expected. It 
is expected that some participants with dementia will die, and/or be placed in hospice while they are 
enrolled in the study. 
 
Hospitalizations and deaths in persons with dementia will be considered expected SAEs for 
the participants with advancing dementia or conditions associated with aging and therefore 
reported in quarterly reports 
 
We also expect adverse events for the persons with dementia as defined by the NIA Adverse Event 
and Serious Adverse Event Guidelines.(86)  These AEs would not be a result of the intervention (the 
persons with dementia do not participate the intervention). Rather, these events will likely be due to 
advancing dementia and/or health concerns that come with advancing age (e.g., agitation, urinary tract 
infections, pneumonia).  
 
We will report SAEs and AE’s per directions laid out by the NIA: 
 
• 
Only Unexpected SAEs for those who participate in the intervention (i.e., only care 
partners and not the persons with dementia, who are still considered research 
participants due to measures being collected about them but do not receive the 
intervention) will be reportable to the IRB, SO and NIA via expedited reporting (i.e., 
within 48 hours).  
 
• 
Expedited reporting to NIA PO, SO and IRB (i.e., within 48 hours of study team’s awareness) 
will only be required for care partners who experience adverse events that are 
both serious (SAE) and unexpected (i.e., have not been previously reported for the study's 
intervention).  
 
• The summary of all other SAEs will be reported to NIA Program Officer and to the 
Safety Officer quarterly, unless otherwise requested by the Safety Officer. SAEs for 
those who do not participate in the intervention (i.e., persons with dementia) will be 
reportable quarterly (i.e., in quarterly summary reports).  

 
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Tele-STELLA Protocol v. 1 
 
• Hospitalizations and deaths will be considered expected SAEs for the participants with 
advancing dementia or conditions associated with aging (i.e., PLWD) and therefore 
reported in quarterly reports.  
 
a. 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.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Tele-STELLA Protocol v. 1 
 
 
 
 
 
 
 
 
 
 
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