Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology: Living and Learning With Advancing AD
Phase: NA
Conditions: Dementia, Alzheimer Disease, Caregiver Burnout, Family Members
Sponsor: Oregon Health and Science University

 
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Assessing Acceptability, Cost, and Efficacy of STELLA-Support via Technology: Living and 
Learning with Advancing AD 
 
01/31/2022 
 
NCT04335110 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Protocol Title: 
 
Assessing Acceptability, Cost, and Efficacy of STELLA-Support via Technology: Living and Learning 
with Advancing AD 
 
Objectives 
STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer’s disease and 
related dementias) is a multicomponent video-conference based intervention designed to facilitate 
effective management of behavioral and psychological symptoms of dementia (BPSD). In the STELLA 
intervention, professionals ("Guides") meet with family members ("Care Partners") caring for persons 
with dementia. Working together, the Care Partners and Guides identify strategies to address upsetting 
behaviors in the moderate to late stages of dementia. The goal of this intervention is to reduce 
upsetting behaviors and thus care partner burden including costs. 
 
The specific aims of this study are: 
 
Phase 1 
1. Using quantitative and qualitative approaches, assess feasibility and participant acceptability 
of (a) STELLA, and (b) the assessment methods (subjective measures and unobtrusive 
objective monitoring).  
2. Using quantitative strategies, assess the preliminary effect of STELLA on (a) the affective 
impact of caregiving, Care Partner cognitive function and person with dementia quality of life, 
and on (b) Care Partner and person with dementia objective digital behavioral biomarkers 
(activity, sleep and time together).  
3. Test the feasibility of employing digital behavioral biomarker data, combined with qualitative 
Care Partner feedback, to assess mechanisms of behavior change before, during and after the 
STELLA intervention.  
 
Phase 2 
1. Quantify the costs of delivering the STELLA intervention.  
2. Quantify the cost efficacy of STELLA in relation to BPSD frequency and CP reactivity and 
assess the relationship between costs, BPSD, and care partner burden.  
H1: There is a relationship between BPSD and cost: More BPSD behaviors and more CP 
reactivity to the BPSD are associated with higher out-of-pocket and implicit costs for 
families living with dementia. 
H2: There is a relationship between out-of-pocket and implicit costs and objective 
measures of burden identified in the ORCASTRAIT Living Lab continuous home 
assessment. Higher objective burden will correlate with higher implicit and out-of-pocket 
costs. 
STELLA is an ancillary study embedded in the Oregon Roybal Center for CAre Support 
Translational Research Advantaged by Integrating Technology (ORCASTRAIT) parent study 
(IRB#20236). 
 
1. Background 
 
Phase 1  
 

 
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Providing care for a family member with Alzheimer’s disease or related dementia (ADRD) is both 
rewarding and risky.(1, 2) Care Partners exposed to chronic stress, often over years, are susceptible to 
physical and psychological ailments.(2) In addition, the caregiving experience increases the risk of 
cognitive impairment in Care Partners, with spouses being particularly vulnerable (3-5), thus potentially 
perpetuating a cycle when yet another family member has to care for the former Care Partner. 
Effective interventions that reduce Care Partner burden and health risks are available,(6-8) but various 
factors impede Care Partner participation, including distance, cost, behavioral symptoms of dementia, 
stigma and social anxiety.(9-12) Recognizing the need to reduce barriers to access, scientists have 
turned to Internet-based interventions.(13, 14) 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, only a minority of studies allow for health 
professional engagement, and of these, only a handful provide real-time interaction.(13) Further, 
Hopwood et al. concluded that, despite the fact that family needs vary across ADRD stages, the 
interventions reviewed were not targeted to a specific stage of ADRD.(13)  
 
To address the needs of families living with dementia, we have completed two pilot studies using 
Internet-based Care Partner interventions.(15, 16) These studies tested the feasibility and consumer 
acceptability of the evidence-based, STAR-C (7) intervention, the precursor to STELLA, when delivered 
via telehealth. Qualitative data revealed the telehealth intervention was acceptable to Care Partners 
and preferred over a potential in-home (“live”) 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?”(17) The prototype interventions did 
not include meaningful opportunities for Care Partners to interact with each other post-intervention. 
Care Partners felt their support vanished and did not like “the fact that it was over.” (15) 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, (15) STELLA was designed to 
address the specific needs of families living with moderate to severe dementia. 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.(18) STELLA is designed for families living in the later stages of dementia, where behavioral 
symptoms are more prominent and distressing for all. (19) 
This study is unique in that along with classic measurements of Care Partner burden and depression, 
we are also measuring these affective symptoms objectively. Further we will assess the effect of 
STELLA on the person with dementia’s objective measures (e.g., sleep time). 
 
STELLA allows all study activities to be done in the Care Partner’s homes. This includes assessments 
of burden and depression using electronic versions of classic measures.  
 
Phase 2 
 
Dementia is the most expensive condition in the United States (US).(1) The high costs are driven in part 
by the prolonged course and intensity of the disease and heavy care demands on family members.(2) A  
significant  contributor  to  care  demands  are  the  behavioral  and  psychological  symptoms  of 
dementia (BPSD) (e.g., depression, irritability, agitation, anxiety) that the majority of persons with 
dementia (PwD) experience.(3)These BPSD have been linked to care partner (CP) depression, burden, 
and grief,(4, 5 )and in turn, BPSD frequency increases when CPs are depressed and burdened.(5, 6)De 
Vugt et al.(7) found that CP reactivity to BPSD predicted skilled care placement, which is concerning 

 
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because skilled care makes up the largest portion of the average annual cost per person of US 
$50,201.(8) Despite evidence that BPSD contribute to care costs, the literature on the cost efficacy of 
Telehealth-based interventions for BPSD is limited. Further, while numerous technology-based 
interventions exist, little attention is given to implementation costs or to the potential cost savings of 
these interventions.  
 
STELLA (Support via TEchnology: Living and Learning with Advancing ADRD) is an intervention 
designed to address the need for a personalized approach to teach CPs strategies in managing BPSD. 
This real-time educational intervention is designed for families  caring for  those  in moderate to late-
stages of dementia. STELLA uses videoconferencing to connect CPs, in their own homes, with 
experienced Guides. The Guides use cognitive behavioral techniques to assist CPs in identifying and 
implementing strategies to reduce distressing behavioral symptoms in the PwD. This in turn diminishes 
CP burden and depression.(9) Our pilot work found that early versions of -STELLA reduced the 
frequency BPSD and CP reactivity to them.(10, 11) The subjective and objective outcomes of STELLA are 
now being tested in the ORCASTRAIT Living Lab, with the goal of scaling STELLA up to address the 
needs of the 16 million CPs in the US. To prepare for effective future scaling of STELLA, the longer-
term costs of implementing the intervention, as well as the cost benefits of the intervention need to be 
determined.  
 
As many as 90% of all US managed care organizations (MCOs) report using cost in determining 
coverage of  treatments,  drugs,  and  other  interventions,  while  40%  specifically  report  the  use  of  
cost-effectiveness analyses.(12) An increasing awareness of the fiscal challenges confronting the 
Medicare program and other public payors in the US suggest that interventions which improve 
outcomes and decrease costs will be well-received.(13) Approval by both public and private payors is 
therefore a first step in wide dissemination of a new intervention in the  US  health  system. The 
approval process begins with quantifying an intervention’s cost as well as the intervention’s cost-
efficacy compared to other interventions. Thus, understanding the costs of STELLA will advance the 
program toward a pragmatic trial and ultimately toward widespread adoption in the US health system. 
 
3. Project Description 
 
Care Partners will participate in an 8-week intervention in which a Guide (e.g., nurse or social worker) 
will help them identify and modify distressing behavioral symptoms of dementia. We will measure Care 
Partner affective symptoms, including depression and burden, as well as quality of life for both the 
Care Partner and the person with dementia. Assessments will occur prior to, during, and after the 
intervention (Table 3). 
 
This study is ancillary to an existing IRB-approved prospective longitudinal observational study which 
enables and accelerates the process of developing, translating and disseminating innovative Care 
Partner interventions facilitated by technology. The ORCASTRAIT study (IRB#20236) is currently 
enrolling 120 dyads (patients with dementia, and a family Care Partners). ORCASTRAIT uses sensors 
and other technologies in participants’ home setting to monitor and detect (through novel algorithms) 
early changes in health, cognitive function, activity, and behavioral-functional signatures of patients 
and Care Partners. The proposed ancillary study will target informal Care Partners enrolled in 
ORCASTRAIT, and follow changes in their stress and health over the study period. This ancillary study 
will incorporate data from the parent study, will add the Care Partner (STELLA) intervention and 
measure Care Partner coping with an additional 5 surveys to the electronic (online) surveys that 
informal Care Partners are already completing over the parent study period.  
 
4. Study Population 
 

 
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a. Care Partners and Persons with Dementia. Up to 40 Care Partners and their 40 care-recipients 
with ADRD will participate in this study. The primary focus of this study is on Care Partners, however, 
we will gather subjective and objective data on participants with ADRD to assess the effect of the 
intervention on Care Partner affective responses to caregiving and quality of life for both. STELLA 
participants will be recruited from the existing cohort of patients, and their Care Partners, who are 
enrolled in the ORCASTRAIT Life Laboratory (OSLL). 
 
There has been no pilot testing of STELLA with non-English speaking care partners, and all materials 
have been tested in English. Therefore, only English-speaking participants are included in STELLA.  
 
b. Inclusion and exclusion criteria. The research team will assess eligibility of interested parties 
based on the criteria listed in Table 1. 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 
contacted for the study, the number consented, the number of those that dropped out and the number 
of those that completed the entire intervention.  
 
 
c. Vulnerable populations. The primary focus of this study is to assess the feasibility, costs, and 
efficacy of subjective and objective measurements of Care Partner and person with dementia 
responses to the STELLA intervention. Therefore, in order for this study to be successful, participants 
with moderate to late stage ADRD will be recruited. Few interventions address the needs of families in 
these later stages.  
  
We will ask that a legally authorized representative (LAR) and, if appropriate, the person with ADRD, if 
the person with ADRD is competent to make a decision about participation. If the LAR and/or the 
person with ADRD are concerned about competency, the LAR will be asked to make the participation 
decision. No other vulnerable populations such as children, prisoners, or pregnant women will be 
included in this study. All Care Partners will be 18 or older. 
 
d. Setting. This study will take place at OHSU. Participants will connect (from their homes or another 
convenient location) to the research team via direct-to-home, telehealth, video-conferencing and over 
the telephone at the Layton Aging and Alzheimer’s Disease Center. Interventionists will meet with 
Table 1: Inclusion/Exclusion Criteria 
Participant 
Inclusion 
Exclusion 
Care  
Recipient 
• 
Diagnosis of ADRD, moderate to late stages 
• 
Exhibits 2 or more behaviors listed on RMBPC16   
that are bothersome to the Care Partner and        
occur 3 or more times/week at study enrollment 
• 
Family member of Care Partner (this can be a     
relative, spouse or close kin that is considered    
 family) 
• 
Dementia not related to ADRD  
• 
Unable to leave Care Partner during   
Partner training 
• 
Early stage dementia, as defined by    
MoCA of about 15/30 or higher. 
  
Care Partner 
• 
Adult caring for family member with ADRD 
• 
Lives with care recipient OR spends at least 4  
hours/week with care recipient(21)  
• 
Age of 18 years or older 
• 
Speak English 
• 
Own a computer/device with a reliable internet 
connection and compatible operating system 
 
• 
Unable to find activity for care 
recipient during training which         
would allow Care Partner to work        
privately, one-on-one during training 
• 
Completed similar telehealth  
intervention within the last year 
• 
Hearing and vision problems severe   
enough to prevent participation  
• 
Unwilling or unable to adequately        
follow study instructions and        
participate in study procedures            
Both 
Participate in ORCASTRAIT (IRB#20236)                                               

 
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caregivers via videoconferencing on an OHSU computer and HIPAA secure link. The interventionist 
may complete the visit from his or her home, OHSU office or other convenient private location. They 
will use a privacy screen so that participants will not see their home or office environments. No others 
(e.g., family members of interventionists) will be allowed in the room during the intervention. Please 
see ORCASTRAIT (IRB#20236) protocol for details of living lab. 
 
e. Recruitment Methods. Participants may be recruited from the OHSU patient population and 
broader community. Recruitment devices may include websites such as the OHSU Study Participants 
Opportunities page; newsletters; advertisements; flyers and other printed study materials; social media; 
institutional communication and events; presentations; and outreach at community events. Direct 
outreach methods may include telephone contact, mailings, electronic communications, in-person 
communication, and distribution of recruitment materials.  
 
Potential subjects may be identified from publicly available data (e.g. voter records); from external or 
internal registries including OHSU databases such as the research data warehouse, NeuroNEXT 
Department of Neurology Research Contact and Health Information Repository (IRB # 8049), and 
ACTNOW Research Contact and Health Information Registry (IRB #11606); from existing Layton 
Center and ORCATECH research participant repositories (IRBs #6845 and (#17189); from word-of-
mouth or self-referrals, or via chart review (an IRB-approved HIPAA waiver will be obtained prior to the 
use or disclosure of any PHI in the recruitment process). We may also recruit by working with 
community partners and related stakeholders – for example by obtaining physician referrals from 
outside providers – using IRB approved recruitment materials when applicable.  
  
f. Consent Process. Interested Care Partners and their family members with dementia will be 
screened prior to consent (either in person, by phone or videoconferencing) to assess eligibility (please 
see Telephone Script and HIPAA WoA). Information sheets will be made available to the participants. 
The participants will review the information sheets with the research team and there will be a full 
informed consent discussion (by phone, videoconference or in person) before verbal consent is 
obtained. Study staff will conduct a thorough review and discussion of the information sheets, answer 
any questions the subjects may have, and obtain their verbal consent to participate.  
 
 
This study requests a waiver of documentation of consent because subjects will have telehealth visits, 
which means they would have to make a trip to OHSU just to physically sign consent forms; this is 
unnecessarily burdensome. When the subjects verbally consent to participate in the study, the 
research team member who conducts the informed consent conversation will sign and date a copy of 
the information sheets, indicating that the forms were reviewed with the participants and that consent 
was obtained. 
 
  The person with ADRD may not have the cognitive function to understand the study or agree to 
consent. In this case, we will arrange for a LAR to consent for the person with ADRD. We will adhere to 
the standards set forth in the OHSU Guidelines for Decisionally Impaired Adults. Similarly, the Care 
Partner will also be asked to review and agree to the family member’s information sheet. The 
information sheets will be discussed and consent will be obtained prior to the first visit (see Consent - 
Information Sheet (Care Partner) and Consent – Information Sheet (Family Member)).  
 
The person with dementia will not partake in any STELLA activities, but we will analyze their data 
during the study period. Furthermore, our experience has taught us that some family members seek 
out their Care Partners during the video sessions. Thus, the person with dementia may be video-
recorded. Therefore, we will seek the consent of the person with dementia, or their LAR’s, to 
participate in this study. 

 
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5. Procedures Involved 
Phase 1  
 
Technology. Participants will be enrolled in the ORCASTAIT Life Lab (OSLL) enabling automatic 
generation of the full suite of digital biomarkers. As per the OSLL protocol, Care Partners and their 
family members with dementia both wear a long battery life (charged every 6 months) actigraph watch 
assessing activity (daily steps) and sleep patterns. Passive room sensors will provide activity location 
information (e.g., time out of home, time together). 
Care Partners and their family members with dementia will participate in STELLA for a total of 18 
months (Table 3); however, most of the participatory effort will occur in the first two months. In this two-
month period, Care Partners will participate in the STELLA intervention and complete surveys listed in 
Table 4. In the next 16 months, we will ask them to complete on-line surveys per the schedule noted in 
Table 4. Care Partners will receive an email from the study team asking them to open the Qualtrics or 
REDCap survey.  Once they are in Qualtrics or REDCap, they will receive a welcome message from 
the PI and study team (see invites and reminder messages). Their family members with dementia will 
not have any STELLA activities, but we will be analyzing their data during the 18-month period.  
 
All STELLA sessions will occur via videoconferencing and will be video-recorded. The video-
conferencing and 
recording will occur via 
the OHSU Telehealth 
Department’s HIPAA-
compliant, secure 
systems. Participants will 
use their own computers 
to access the study. 
However, some Care 
Partners may need to 
borrow a device.  If this is 
the case, we will lend them a Chromebook.  Chromebooks require an internet connection to 
function and a Google email (Gmail) account to use the STELLA application.  We will advise 
participants in the consent form that they may use their own Gmail account but there is a risk 
that some of their personal information may be stored on the Chromebook. Alternatively, we can 
create a Gmail account for them.  
 
We will provide them with the secure link to the videoconferencing system. The direct-to-home 
STELLA visits will be done using real-time delivery of telehealth interactions over distance using video-
conferencing technology. The basic mode of connectivity between the study participants and the 
research team will be via the OHSU Telehealth Department’s identified interface. This technology 
allows face-to-face, highly secure video connections to remote locations. Using their existing device 
(PC, Mac, iPad, smartphone, etc.), with both visual and audio capabilities, participants will be 
connected with the research team. The visits will be recorded using the OHSU server. The recorded 
visits will can be used (with participant consent) to teach and instruct students and clinicians in how to 
conduct high-quality telehealth care, thus facilitating dissemination of the approach in Oregon and 
nationally. We have successfully used this clinical-grade telehealth technology in our previous 
intervention studies. (15, 22)  On occasion, Care Partners may not be able to connect to the 
videoconferencing connection due to low bandwidth.  In this case, they may meet with the Guide via 
phone.   
Table 2: STELLA Curriculum 
Week
Format 
Topic 
1 
One Guide to one Care 
Partner 
Introduction to dementia and behavior management 
2 
Addressing behaviors 
3 
Care Partner care 
4 
ABCs in action 
5* 
One Guide with up to 4 Care  
Partners 
Communication and dementia 
6 
Pleasant events 
7 
Putting it altogether 
8 
Moving forward, staying connected 
*There may be a 2 week break between weeks 4 and 5 if there are scheduling challenges

 
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The STELLA Intervention. STELLA consists of 8 sessions: 4 sessions one-to-one, with the Care 
Partner and a Guide, and then 4 sessions with one Guide with up to four Care Partners (total small 
group will include as few as two and as many as 4 Care Partners) (Table 2). Each weekly session 
takes about 1 hour. The first four sessions allow for development of the Care Partner-Guide working 
relationship. In these sessions, the Care Partners identify behaviors (both the person with dementia's 
and the Care Partner’s) which are upsetting to the family. Care Partners will be taught to use an “ABC” 
approach to identify activators of behaviors, the behaviors, and consequences of the behaviors. After 
they identify the ABCs, they will develop a plan to address the behavior and then test it. Based on Care 
Partner feedback from our pilots, we adapted the prototype intervention so that STELLA uses the ABC 
plan for both the person with dementia behaviors and Care Partner behaviors. After the four one-to-
one sessions, Care Partners will meet in small groups with a Guide. Effective communication 
strategies, engagement in pleasant events, and coping will be addressed (Table 2). (7) The Guide will 
facilitate conversation and support between the Care Partners. Care Partners will be provided with 
each other’s contact information. They will be encouraged to contact each other during and after the 
intervention. Due to schedule conflicts, there may be an up to two-week gap between Sessions 4 and 
5.  
 
Each Care Partner will have their own STELLA workbook to document their plans and progress (see 
“The STELLA Collaborative Handbook”). The booklet will be given or mailed to them prior to the first 
STELLA visit. They will have access to information on caring for person with dementia on the STELLA 
password-protected website which is under production. STELLA allows for some flexibility in 
scheduling if Care Partners have to re-schedule. Care Partners will be advised that the one hour 
sessions may be tiring and that they may end a session early if needed. In addition, Care Partners will 
need to find an activity for their care-recipients while they are engaged in the training session so they 
can focus on the material and protect their care-recipients’ dignity. Some of the conversations will 
include discussions about challenging behaviors, which if overheard by the care recipient, may be 
upsetting. 
Surveys and subjective assessments will be administered in person via video conferencing or 
delivered to Care Partners email via a secure system.  
 
Care Partners will be assigned a study ID number which will be used to identify all documents. 
The key to study ID numbers will be kept in a secure file on a secure OHSU computer. 
 
After the intervention and the second assessment, Care Partners will be asked to participate in 
a focus group. No less than 3 and no more than 10 Care Partners will participate in each focus 
group. Focus group participation will be assigned sequentially (e.g., Care Partners 1 through 6 
will be in the first focus group) unless Care Partner availability prevents otherwise. The focus 
groups will be moderated by the PI or a designated team member. 
 
Care Partners who are unable to complete all 8 training sessions will remain in the study and we 
may collect the data noted in Table 4. These Care Partners may join a focus group if they 
choose. Care Partners who do not complete any trainings, or are unwilling or unable to 
adequately follow study instructions and participate in study procedures, will be withdrawn from 
the study. We will retain and analyze any data from their participation. They may also be asked 
to complete the assessments, despite not completing all of the trainings.  
 
For some participants, internet connectivity may be problematic. Every effort will be made to help Care 
Partner maintain a good connection for each visit. A research team member will test their ability to 
connect and the quality of their connection prior to Session 1 and later visits if needed. In some cases, 

 
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at PI discretion, computer (e.g., Chromebook) may be loaned to the research participant for use in the 
study if available. If, after multiple efforts, a Care Partner cannot maintain a reliable connection for a 
telehealth visit, they will be excused from the study. They will be allowed to keep the STELLA 
Handbook. 
 
Guides will be trained by the PI using the Guide Handbook. The PI or other study staff will review their 
videos for fidelity, using the Consultant Adherence Checklist.  During STELLA, videos will be reviewed 
by the study team for fidelity and team discussion. 
 
Phase 1 
 
Measures.  Aim 1: Feasibility will be assessed by measuring how many Care Partners who start the 
program successfully complete it. Care Partners will fill out our telehealth survey that asks them about 
acceptability.(23, 24) Acceptability will also be assessed qualitatively using focus groups.(25) The focus 
groups will be conducted via videoconferencing and will be recorded and transcribed for analysis.(15, 16) 
Aim 2: Standard quantitative measures that were used in the earlier pilots (15, 16) will be used to 
provide preliminary evidence for efficacy. The quantitative measures are grouped into 5 surveys: 
Mercury Baseline, Starlet,, Venus, Earth (6 months post intervention) and Earth (12 months post 
intervention). Along with the ORCASTRAIT Living Lab suite of measures (demographics, 
activity, time with person with dementia, sleep-related behaviors), we assess burden using the 
RMBPC(26) and the 22-item Zarit Burden Interview (ZBI). To provide focus for the intervention, 
each Care Partner will identify and rate 2-3 specific target problems to address in STELLA. Pre-
death grief will be assessed with the Marwit Meuser Caregiver Grief Index, Short Form (MMCGI-
SF). (27) Care Partner plans for person with dementia placement will be assessed with the 
Table 3: STELLA Activities 
 
Activity 
Description 
Due 
Preliminary session 
Set up and test videoconferencing link 
After consent completed 
Mercury Baseline  
(Survey 1) 
Baseline assessment (Table 4) 
Prior to intervention start 
Intervention 
(4 weekly sessions) 
Meet with for 4 weekly sessions, 
beginning with Session 1. 
(see Table 2) 
After Mercury Baseline survey 
completed 
Starlet Survey 
(Survey 2) 
Electronic assessment of  
depression, burden 
1 month after Session 1 
Intervention 
(4 weekly sessions)  
Meet with Guide and up to 4 other Care  
Partners for 4 more weekly sessions 
(See Table 2)  
After session #8 
Venus Survey 
(Survey 3)  
Full assessment, including program  
survey 
2 months after Session 1  
 
Post-STELLA 
Assessment 
Complete personalized target problem  
assessment via Qualtrics or via video or  
phone call with a Research Assistant 
After Venus survey completed 
Focus Groups 
Optional focus group to provide  
study team with feedback 
After Venus survey completed 
Earth Survey 
(Survey 4) 
Full assessment (Table 4) 
6 months post-intervention 
Earth Survey 
(Survey 5) 
Full assessment (Table 4) 
12 months post intervention 
ORCASTAIT Surveys 
Cost, burden as described in  
ORCASTRAIT Protocol  
Weekly, while in ORCASTRAIT 

 
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revised Desire to Institutionalize (DTI) scale.(28) Care Partner depression will be measured with 
the CESD-10(30) and role captivity will also be assessed.(31) In addition to subjective 
assessments, we will evaluate the effect of STELLA on digital behavioral biomarkers (activity, 
time spent together and sleep) obtained from the ORCASTRAIT platform. Total daily activity, 
time together and alone, and sleep duration, will be assessed prior to, during, and after the 
intervention. Care Partners will complete all assessments electronically. A secure link to each 
assessment will be emailed to each CP.  We will ask the CPs to complete the assessments 
within 5 days of receiving the email.  If they do not, we will call them to assess their situation.  If 
they do not complete surveys as outlined on the times listed in Table 3 they may not continue 
with the intervention. 
 
Aim 3. To identify which components of STELLA are most helpful to Care Partners, we will assess the 
mechanisms of action for reducing burden, depression and grief and improving cognitive function and 
sleep. Care Partners will complete the surveys (Table 3) before the intervention, after Session 4 and 
after the intervention.  An analysis of objective data (Figure 1) will also be done during the intervention. 
We will ask Care Partners in our focus groups to report what they found most helpful about STELLA. 
 
Table 4:  Subjective Assessment Descriptions 
Measure 
Description 
Mercury Baseline 
Demographics 
Demographics, including hours/week caregiving 
Revised Memory & Behavioral Problems 
Checklist (RMBPC) 23 
Measure of frequency and reactivity to behavioral and 
psychological symptoms of dementia23 
Personalized target problem assessment Care partner-identified targeted problem assessment 
Zarit Burden Interview (ZBI)33 
4-item measure of burden 
Center for Epidemiologic Studies 
Depression Scale (CESD-10)34 
10-item depression measure 
Marwit Meuser Caregiver Grief Index-
Short Form (MMCGI-SF)35 
Care partner pre-death grief35 
Placement plan scale37 
One-item assessment of plans for plans for placement for family 
member with dementia37 
QoL AD36 
13-item assessment of quality of life for both the care partner and 
the person with dementia. 
Starlet Survey 
ZBI33 
 
CESD-1034 
Venus Survey 
RMBPC23  
• 
See Baseline for descriptions 
• 
Baseline:  
+ STELLA contact survey 
+ Experience Survey 
-Demographic survey 
 
Personalized target problem assessment 
ZBI33 
CESD-1034 
MMCGI-SF35  
Placement plan scale37 
QoL-AD 
STELLA contact 
STELLA care partner contact post intervention 
STELLA Experience Survey 
16-item + comments on satisfaction, privacy, ease of use 
Earth Assessment 
RMBPC23 
 
• 
See Baseline for descriptions 
• 
Baseline:  
+ STELLA contact survey 
-Experience Survey 
ZBI33 
CESD-1034 
MMCGI-SF)35 
Placement plan scale37 

 
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Phase 2 
 
Aim 1. Quantify the costs of delivering the STELLA intervention. This will measure the direct 
costs of delivering the intervention (wage multiplied by time of all personnel supporting the 
intervention) as well costs of technology and equipment, and any in-kind donations of 
equipment or time to support the intervention.   
 
Aim 2. Quantify the cost efficacy of STELLA in relation to BPSD frequency and CP reactivity 
and assess the relationship between costs, BPSD, and care partner burden.  
 
Out-of-pocket costs for participating dyads will be collected using an addition to the weekly 
online ORCASTRAIT survey. CPs will be queried about personal funds spent on health care 
services, co-pays, medications, or equipment. CP time dedicated to these care-related activities 
will also be collected. Implicit costs for families will be calculated by multiplying the average 
weekly hours of care provided by the CP by the average hourly wage of paid caregivers in 
Portland, Oregon (approx. $29).  
 
Analytic Plan.  
 
Phase 1  
 
Aim 1: Feasibility will be assessed by calculating the proportion of enrolled Care Partners who 
completed the full intervention. Reasons for drop-out and discontinuation will be investigated 
carefully.  Focus group transcriptions will be analyzed for themes of acceptability using narrative 
analysis.(25) 
 
Aim 1 Anticipated Results and Implication. We anticipate that the Care Partner will find the 
STELLA intervention feasible and acceptable. This will provide foundational information for 
future proposals. 
 
Aim 2: Efficacy will be assessed by calculating changes in the subjective scores before, during 
and after the intervention using linear regression models and controlling for age, sex and 
education. Since this is an exploratory (proof-of-concept) study with a small sample size, we do 
not expect statistically significant findings, but pre-post change and standard deviation of the 
change will be used to calculate the sample sizes for the next stage, a RCT (NIH Stage II (32), 
Phase 1) study.  
 
Objective digital behavioral biomarker data collected from the ORCASTRAIT Living Lab (e.g., 
daily activity (steps), total sleep time, times together) will be assessed before, during and after 
the intervention and compared to subjective findings. Simple Spearman correlations will be used 
to explore the relationship of the objective continuous sensor-derived data to the subjective 
data, where the continuous objective digital data is collapsed to mean values which will serve as 
a point estimate prior to, during and after the intervention. We will compare the shift in the 
distribution of each of the digital behavioral biomarkers from baseline to identify relative changes 
during and after the intervention. We will compare the objective and subjective findings of the 
dyad to identify trends that correlate with burden (Figure 1) (33). 
 
Aim 2 Anticipated Results and Implications. We anticipate that STELLA will reduce Care Partner 
burden and grief and improve family quality of life. These improvements in turn will decrease 
QoL-AD 
-Demographic survey 
 
STELLA contact 

 
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Care Partner desire to place family members in long-term care. We expect these findings will be 
supported by both subjective and objective data. 
 
Aim 3: Before Session 5, subjective and objective data (Table 4) will be compared to pre, mid- and 
post-intervention data to identify trends. Qualitative data will be gathered during the focus groups. 
Participants will be asked what they thought was most helpful about the intervention and what they 
thought of the format. The objective and subjective results will be used to identify which components of 
STELLA were most effective and which need to be modified to improve the potency of future iterations.  
 
Aim 3 Anticipated Results and Implications. We 
expect to see an improvement in the objectives 
and subjective data, and we expect that we will 
need to write revise the STELLA intervention. 
We will use information from the focus groups 
and the accrued data to revise as needed.  
 
Other quantitative analyses may be performed if 
they data reveal important trends. 
 
PHASE 2  
 
Aim 1: We will carry out a costing of the 
intervention to determine implementation costs 
of STELLA.  
 
Aim 1 Anticipated Results and Implications. The costing will demonstrate the actual costs of 
delivering the intervention. This is essential for future pragmatic trials and ultimately for 
widespread adoption in the US health system. 
 
Aim 2: Assess data collected from CPs for correlations between BPSD frequency and explicit 
costs to measure the direct cost impact of the intervention. We then assess the relationship 
between BPSD frequency, CP reactivity, and out-of-pocket costs for families using linear 
regression models and controlling for salient covariates based on preliminary correlational 
analysis We will repeat this analysis for implicit costs. We will then compare both the explicit and 
implicit out-of-pocket costs for participating CPs to those who do not participate.  
 
Aim 2 Anticipated Results and Implications. We expect to see a relationship between BPSD and 
cost. Specifically, more BPSD behaviors and more CP reactivity to the BPSD will be associated 
with higher out-of-pocket and implicit costs for families living with dementia. Further, we expect 
to find a relationship between out-of-pocket and implicit costs and objective measures of burden 
identified in the ORCASTRAIT Living Lab continuous home assessment. Higher objective 
burden will correlate with higher implicit and out-of-pocket costs. This will provide much needed 
data on the intervention’s cost-efficacy compared to other interventions to support people living 
with dementia.  
 
6. Data and Specimens. No genetic material or specimens will be collected in this study. 
 
a. Sharing of Results with Subjects 
Results of the RMBPC and the Pre-Treatment Survey will 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 memory, depression, burden or grief scores are abnormal, the Care Partner may be 
Figure 1: Composite model spider plot of digital behavioral biomarkers 
in a dyad showing potential domains associated with the degree of 
caregiver burden (49). Numbers are odds of having the behavior relative 
to low burden. Similar comparisons can be made relative to baseline 
(e.g. sleep time or time alone before relative to after intervention).  

 
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informed, at the discretion of the PI, that his or her score is of concern. The Care Partner will be 
referred to appropriate services if deemed necessary (e.g., social worker or other counseling services). 
The other results will be provided, if asked, after all data is collected and analyzed.  
 
b. Data and Specimen Banking 
The video-recordings will ultimately be stored, indefinitely, in the Layton Center and 
ORCATECH Research Repository (IRB #6845). The video-recordings will show subjects’ faces 
and their names, and any information discussed during the sessions and focus groups will be 
heard in the audio. Thus, the video-recordings will not be de-identified prior to repository 
storage. The researchers may use or share this information to conduct future research. Other 
researchers and those outside of OHSU (who are involved in conducting or overseeing 
research) may have access to the video-recordings as specified in the “Privacy, Confidentiality, 
and Data Security” section. To obtain this data, researchers must read the Layton Center for 
Aging and Alzheimer's Disease Research Data Use and Disclosure and Authorship Policies, 
then fill out the Layton Center’s “Request for Research Data” form. This form is used across the 
Center for data requests. The form asks for the PI’s information, project name and goals, and a 
signature (PI) agreeing to comply with the policies. The Data Core team, at the direction of the 
Data Core Lead (Hiroko Dodge) at the Layton Center reviews and approves these requests. 
 
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 Layton Center. Documents used for the intervention (Individual and Group Logs, Pre-
treatment survey, Visit Information Sheet) will be stored with the interventionist and RA in a locked file 
or briefcase in the staff member’s home.  All documents will be shredded or returned to the Layton 
Center at the completion of the intervention. These documents will not contain and PHI, but will contain 
the participant’s study ID #. 
 
7. 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.   
 
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 names, medical 
record number or other personally identifying information. However, video-recordings will show their 
faces and their first names and any information discussed during the sessions will be heard in the 

 
Page 14 of 17 
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audio. In this case, the information subjects give us will be identifiable as coming from them, and will 
not be private. Electronic files for data analysis will contain only the subject code. 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 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.  
 
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). 
 
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 research team will use the “Invite Collaborators.” To ensure the videos cannot 
be downloaded, the “Invitee Permissions” will be set at “Previewer.”   
 
Electronic survey data will be stored in a web-accessible server at Qualtrics or REDCap, though copies 
of this data will be transferred to a secure OHSU server via API 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. 
 
8. Risks and Benefits 
 
a. Risks to Subjects 
 
There are few risks involved in this study. Care Partners will have to meet (via telehealth) with the 
research team 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 via telehealth, so there should be no travel costs involved.   
 
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 or their family members and/or hear their names in 
the audio, and their identities would no longer be confidential.  
 

 
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b. Potential Benefits to Subjects 
Care Partners who complete all 8 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 2 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.  
 
 
References 
 
1. 
Lindauer A, Harvath TA. The meanings caregivers ascribe to dementia-related changes in care 
recipients: A meta-ethnography. Research in Gerontological Nursing. 2015;8(1):39-48. doi: 
10.3928/19404921-20141121-01. 
2. 
Fonareva I, Oken BS. Physiological and functional consequences of caregiving for relatives with 
dementia. International Psychogeriatrics / IPA,. 2014;26(5):725-47. doi: 10.1017/S1041610214000039. 
3. 
Norton MC, Smith KR, Ostbye T, Tschanz JT, Corcoran C, Schwartz S, Piercy KW, Rabins PV, 
Steffens DC, Skoog I, Breitner JC, Welsh-Bohmer KA, Cache County I. Greater risk of dementia when 
spouse has dementia? The Cache County study. J Am Geriatr Soc. 2010;58(5):895-900. doi: 
10.1111/j.1532-5415.2010.02806.x. PubMed PMID: 20722820; PMCID: PMC2945313. 
4. 
Dassel KB, Carr DC, Vitaliano P. Does caring for a spouse with dementia accelerate cognitive 
decline? Findings from the Health and Retirement Study. Gerontologist. 2017;57(2):319-28. doi: 
10.1093/geront/gnv148. PubMed PMID: 26582383. 
5. 
Mallya S, Fiocco AJ. Impact of informal caregiving on cognitive function and well-being in 
Canada. Int Psychogeriatr. 2018;30(7):1049-55. doi: 10.1017/S1041610217002605. PubMed PMID: 
29235432. 
6. 
Vandepitte S, Van Den Noortgate N, Putman K, Verhaeghe S, Faes K, Annemans L. Effectiveness 
of Supporting Informal Caregivers of People with Dementia: A Systematic Review of Randomized and 
Non-Randomized Controlled Trials. J Alzheimers Dis. 2016;52(3):929-65. Epub 2016/04/16. doi: 
10.3233/JAD-151011. PubMed PMID: 27079704. 
7. 
Teri L, McCurry SM, Logsdon R, Gibbons LE. Training community consultants to help family 
members improve dementia care: A randomized controlled trial. The Gerontologist. 2005;45(6):802-11. 
doi: /10.1093/geront/45.6.802. 
8. 
Mackenzie CS, Wiprzycka UJ, Khatri N, Cheng J. Clinically significant effects of group cognitive 
behavioral therapy on spouse caregivers' mental health and cognitive functioning: a pilot study. J Gerontol 
Soc Work. 2013;56(8):675-92. Epub 2013/10/15. doi: 10.1080/01634372.2013.834857. PubMed PMID: 
24116878. 
9. 
Karlin NJ, Bell PA, Noah JL, Martichuski DK, Knight BL. Assessing Alzheimer's support group 
participation: A retrospective follow-up. American Journal of Alzheimer's Disease. 1999;14(6):326-33. 
10. 
Brodaty H, Thomson C, Thompson C, Fine M. Why caregivers of people with dementia and 
memory loss don't use services. Int J Geriatr Psychiatry. 2005;20(6):537-46. doi: 10.1002/gps.1322. 
PubMed PMID: 15920707. 
11. 
Karlsson B, Sigström, R., Östling,S., Waern, M., Börjesson-Hanson, A.,Skoog, I. . DSM-IV and 
DSM-5 prevalence of social anxiety disorder in a population sample of older people. Am J Geriatr 
Psychiatry. 2016;24:1237-45. 
12. 
Herrmann LK, Welter E, Leverenz J, Lerner AJ, Udelson N, Kanetsky C, Sajatovic M. A 
systematic review of dementia-related stigma research: Can we move the stigma dial? Am J Geriatr 
Psychiatry. 2018;26(3):316-31. doi: 10.1016/j.jagp.2017.09.006. PubMed PMID: 29426607. 
13. 
Hopwood J, Walker N, McDonagh L, Rait G, Walters K, Iliffe S, Ross J, Davies N. Internet-based 
interventions aimed at supporting family caregivers of people with dementia: Systematic review. J Med 
Internet Res. 2018;20(6):e216. doi: 10.2196/jmir.9548. PubMed PMID: 29895512. 

 
Page 16 of 17 
8-14-2019 
14. 
Boots LM, de Vugt ME, van Knippenberg RJ, Kempen GI, Verhey FR. A systematic review of 
Internet-based supportive interventions for caregivers of patients with dementia. International Journal of 
Geriatric Psychiatry. 2014;29(4):331-44. doi: 10.1002/gps.4016 [doi]. 
15. 
Lindauer A, Croff, R., Mincks, K., Mattek, N., Shofner, S.J., Bouranis, N., Teri, L. "It took the 
stress out of getting help": The STAR-C-Telemedicine mixed methods pilot. Care Weekly. 2018;2:7-14. 
Epub 7/3/2018. doi: dx.doi.org/10.14283/cw.2018.4. 
16. 
Lindauer A, McKenzie, G., La Fazia, D.M., McNeill, L., Mincks, K., Myers, M., Spoden, N., 
Mattek, N., Teri, L. , editor. Tele-STAR for dementia caregivers: Methods and preliminary findings 
(Poster). Alzheimer's Associaion International Conference; 2018 July 2018; Chicago, IL. 
17. 
Caregivers. Focus group transcript, 8-2018. 2018. 
18. 
Drentea P, Clay OJ, Roth DL, Mittelman MS. Predictors of improvement in social support: Five-
year effects of a structured intervention for caregivers of spouses with Alzheimer's disease. Soc Sci Med. 
2006;63(4):957-67. doi: 10.1016/j.socscimed.2006.02.020. PubMed PMID: 16616406. 
19. 
Garcia-Alberca JM, Lara JP, Garrido V, Gris E, Gonzalez-Herero V, Lara A. Neuropsychiatric 
Symptoms in Patients With Alzheimer's Disease: The Role of Caregiver Burden and Coping Strategies. 
Am J Alzheimers Dis Other Demen. 2014;29(4):354-61. doi: 10.1177/1533317513518649. PubMed 
PMID: 24408750. 
20. 
Onken LS. Cognitive training: Targeting cognitive processes in the development of behavioral 
interventions. Clinical Psychological Science : A Journal of the Association for Psychological Science. 
2015;31(1):39-44. doi: 10.1177/2167702614561512. 
21. 
McCurry SM, Logsdon RG, Mead J, Pike KC, La Fazia DM, Stevens L, Teri L. Adopting 
evidence-based caregiver training programs in the real world: Outcomes and lessons learned from the 
STAR-C Oregon Translation Study. Journal of Applied Gerontology : The Official Journal of the 
Southern Gerontological Society. 2015. Epub 2015. doi: 0733464815581483 [pii]. 
22. 
Lindauer A, Seelye, A., Lyons, B., Dodge, H.H., Mattek, N., Mincks,K., Kaye, J., Erten-Lyons, D. 
Dementia care comes home: Patient and caregiver assessment via telemedicine. The Gerontologist. 
2017;Oct(57(5):e85-e93). doi: doi: 10.1093/geront/gnw206. 
23. 
Chang H. Evaluation framework for telemedicine using the logical framework approach and a 
fishbone diagram. Healthcare Informatics Research,. 2015;21(4):230-8. doi: 10.4258/hir.2015.21.4.230. 
24. 
Poulsen KA, Millen CM, Lakshman UI, Buttner PG, Roberts LJ. Satisfaction with rural 
rheumatology telemedicine service. International Journal of Rheumatic Diseases. 2015;18(3):304-14. doi: 
10.1111/1756-185X.12491. 
25. 
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, 
Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009;36(5):452-
7. doi: 10.1016/j.amepre.2009.02.002. PubMed PMID: 19362699; PMCID: PMC2859314. 
26. 
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):622-31. 
doi: 10.1037//0882-7974.7.4.622. PubMed PMID: 1466831. 
27. 
Marwit SJ, Meuser TM. Development of a short form inventory to assess grief in caregivers of 
dementia patients. Death Studies. 2005;29:191-205. doi: 10.1080/07481180590916335. 
28. 
Morycz RK. Caregiving strain and the desire to institutionalize family members with Alzheimer's 
disease. Possible predictors and model development. Research on Aging. 1985;7(3):329-61. doi: 
10.1177/0164027585007003002. 
29. 
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. 
30. 
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;1:2050312113514576. doi: 10.1177/2050312113514576. PubMed PMID: 26770693; PMCID: 
PMC4687763. 

 
Page 17 of 17 
8-14-2019 
31. 
Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of 
concepts and their measures. Gerontologist. 1990;30(5):583-94. doi: 10.1093/geront/30.5.583. PubMed 
PMID: 2276631. 
32. 
Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Reenvisioning clinical science: 
Unifying the discipline to improve the public health. Clinical Psychological Science : A Journal of the 
Association for Psychological Science. 2014;2(1):22-34. doi: 10.1177/2167702613497932. 
33. 
Thomas NW, Lindauer, A., Kaye, J. EVALUATE-Tele-STAR: Novel Methodologies for 
Assessment of Caregiver Burden in a Telehealth Caregiver Intervention: A Case Study. Dementia and 
geriatric cognitive disorders. in press. 
34. 
Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”: A practical method for grading the 
cognitive state of patients for the clinician. Journal of psychiatric research. 1975;12(3):189-98. doi: 
10.1016/0022-3956(75)90026-6. 
35. 
Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The 
Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 
1994;44(12):2308-14. PubMed PMID: 7991117. 
36. 
Pfeffer RI, Kurosaki TT, Harrah CH, Jr., Chance JM, Filos S. Measurement of functional activities 
in older adults in the community. J Gerontol. 1982;37(3):323-9. PubMed PMID: 7069156. 
37. 
Bédard M, Molloy DW, Squire L, Dubois BA, Lever JA, O'Donnell M. The Zarit Burden 
Interview: A New Short Version and Screening Version. The Gerontologist. 2001;41(5):652-7. 
38. 
Sheikh JI, Yesavage JA. Geriatric Depression Scale (GDS): Recent evidence and development of 
a shorter version. Clinical Gerontology. 1986;5:165-73.