Socially Isolated Older Adults Living With Dementia
Phase: NA
Conditions: Alzheimer Disease, Dementia
Sponsor: University of Washington

 
 
 
 
Socially Isolated Older Adults Living with Dementia 
 
Study Protocol 
 
 
Multiple Principal Investigators: 
Karen Fredriksen-Goldsen, PhD 
Hyun-Jun Kim, PhD 
Linda Teri, PhD 
 
 
 
NCT03666624 
 
 
 
 
 
Version Number: v.6.0 
 
September 22 2020 
 
 

1. Overview 
a. Study Title: Socially Isolated Older Adults Living with Dementia 
b. Research site: University of Washington, Seattle 
c. Objectives: Healthy People 2020 identified sexual/gender minority (SGM) older adults 
as a health disparate population. The lack of efficacious research-based interventions 
for such vulnerable older adults with Alzheimer’s disease and related dementias 
(AD/RD) is a significant public health problem. AD/RD will affect up to four million SGM 
older adults by 2050.1,2  SGM older adults are at elevated risk of social isolation and 
experience significant barriers to healthcare access.3  Existing interventions for older 
adults with dementia have been found to be effective for caregiving dyads. 4   Yet, SGM 
older adults, compared to heterosexuals, are significantly less likely to be married or to 
have biological family members to support them,1 and a significant proportion of SGM 
older adults living with dementia have no caregiver or care network.5 The goal of the 
proposed research is to design and pilot test an innovative translation of a modified 
version of Reducing Disability in Alzheimer’s Disease (RDAD) to support those living 
with dementia without a family caregiver, directly addressing unique SGM-specific risk 
factors for sustainable and comprehensive dementia care including social stigma, 
marginalization, identity management, and increased need for social support. Given that 
the RDAD6,7 has been evaluated in a randomized controlled trial and has shown to 
successfully train community-dwelling care-recipient (CR) and care-giver (CG) dyads to 
increase the physical activity and functioning of individuals with AD/RD and their CGs 
and to teaches CGs techniques for managing behavioral symptoms of CRs, this study 
adds a modification that will provide an intervention for  SGM older adults with AD/RD 
without caregivers. Building on the success of two previous NIH-funded studies (NHAS: 
2R01 AG026526; K. Fredriksen-Goldsen, PI; RDAD: R01 AG10845; L. Teri, PI), we will 
address the following aims: Aim 1. Develop a personalized RDAD intervention 
(hereafter referred as Personalized Care Network suitable for SGM older adults living 
with dementia without caregivers; Aim 2. Implement a preliminary randomized controlled 
trial (RCT) of 30 participants with 2 arms (routine medical care vs. the Personalized 
Care Network approach) to assess the acceptability, feasibility, and initial efficacy of the 
intervention. 
d. Study design: This study will utilize a 2-group randomized controlled trial design 
including two  assessments, i.e. a pre-treatment and a post-treatment 
e. Background: Lesbian, gay, bisexual, and transgender (LGBT) older adults are an at-
risk, underserved, and rapidly growing population with elevated risk for Alzheimer’s 
disease and related dementias (AD/RD). RDAD, which is grounded in social-learning 
and gerontological theories, is a present-focused cognitive-behavioral intervention 
aimed on increasing physical activity and problem-solving while engaging both 
members of caregiver (CG)-care recipient (CR) dyad. The focus of problem-solving in 
RDAD is specific to the needs of the CR and CG.  RDAD, however, has not been 
translated to a highly stigmatized and marginalized population, such as LGBT older 
adults. Discrimination and stigma across the life course necessitate continual identity 
management for many LGBT older adults (e.g., nondisclosure), which may be 
complicated by cognitive decline in ways that increase stress. For example, with 
advanced memory decline the CR may inadvertently disclose to an intolerant family 
member or provider from whom they had previously concealed their identity, resulting in 
conflict or interpersonal discomfort that the CG must manage and negotiate. Thus, it is 
essential to address the unique characteristics in RDAD to improve treatment effects. In 
addition to these unique situations, LGBT older adults are significantly less likely to be 

married or to have biological family members, and a significant proportion of LGBT older 
adults living with AD/RD has no caregiver or care network. This study adds a 
modification to RDAD that will deliver the intervention to LGBT older adults with AD/RD 
who do not have caregivers. Building off of the study that is to extend and test the 
RDAD intervention with a growing underserved and stigmatized population (IRB 
STUDY00003076), this study pilot-tests feasibility and efficacy of Aging with Pride: 
Innovations in Dementia Empowerment and Action (IDEA), a modified version of RDAD 
tailored to better respond to distinct risks, particularly among LGBT older adults living 
with AD/RD without a caregiver. In this pilot study the modified version of RDAD 
intervention is referred to the Personalized Care Network. 
 
2. Participants 
a. General characteristics: 30 LGBT individuals with AD/RD aged 50 or older will participate 
in the study. 
b. Inclusion criteria: 1) 50 years of age or older at enrollment; 2) sexual or gender minority; 
3) has early stage dementia including Alzheimer’s disease; 4) lives in the community (not 
in a care facility). Based on the definition of dementia suggested by Alzheimer’s 
Association and scientific literature, dementia will be determined by asking of potentially 
participating individuals 1) their current diagnostic status of AD/RD or 2) any difficulties in 
the domains of dementia AND any help needed with complex daily activities. This method 
has two positive aspects: (1) it precludes considerable increased costs that would be 
necessitated by providing a physical exam and (2) avoids unnecessary delays (and 
potentially loss of subjects) by scheduling an exam or waiting for receipt of patient charts. 
c. Exclusion criteria: 1) Have plans to move to a long-term care setting within 6 months of 
enrollment; 2) have a known terminal illness (with death anticipated within the next 12 
months); 3) have had a hospitalization for a psychiatric disorder in the 12 months prior to 
baseline; 4) to be actively suicidal, hallucinating, or delusional; 5)  have any physical 
limitations/chronic conditions preventing participation in an exercise program and 6) have 
more than early stage dementia. More than early stage dementia will be determined by 
1) their current diagnostic status of AD/RD or 2) having difficulties in more than one 
cognitive domain AND significant difficulty in simple daily activities such as bathing, 
dressing, grooming, using the shower, transferring from bed to chair, using the telephone, 
or doing minor household chores. The final exclusion criteria will allow us to exclude 
individuals with severe cognitive impairment from the study.  
d. Number of subjects 
Group name/description 
Maximum desired number of individuals 
(or other subject unit, such as families) 
who will complete the research 
Personalized Care Network 
15 individuals with early stage memory loss 
RMC (Routine medical care) 
15 individuals with early stage memory loss 
 
3. Recruiting and Screening Participants 
a. Recruiting and screening:  

Study announcements will be distributed by aging and health service agencies 
using organizational contact lists via mail and email. In addition, study 
announcements will be posted at various health, human service and community-
based organizations (e.g., health clinics, support groups, buddy programs, 
community-based churches, and social groups) and published in community-based 
newspapers and newsletters. Potential participants (LGBT older adults with 
dementia) will be asked to contact the study directly after learning about it.  Callers 
who contacted the Aging with Pride: Innovations in Dementia Empowerment and 
Action (IDEA) original study and who did not have caregivers were asked if we 
could contact them when this study is available.  We will call or email those who 
responded “yes” to announce this study.  
 
Using chain referral sampling we will send an email or letter inviting participants 
who have completed the study to tell their friends about the study.  We will ask 
these participants to share the flyer provided in the email or letter.  We will 
reimburse individuals $20 for each person that successfully enrolls in the study.  
We will ask those who call how they learned about the study. The caller will need 
to name the referring individual for us to send the referring individual $20.  Callers 
won’t be required to provide the name of the referring individual if they wish to 
keep their participation in the study confidential.  If the caller doesn’t name a 
referring individual, the caller may still enroll in the study if eligible.  Referring 
individuals will be paid no more than $60 for 3 people that enroll.   
 
b. Recruitment materials: Study announcements will be distributed by mail and email using 
aging and health service agencies’ contact lists and will be posted at various health, 
human service and community-based organizations, and published in community-based 
newspapers and newsletters. Upon expressing interest in participating, initial screening 
of eligibility will be conducted by telephone using a script including the purpose and 
design of the study and a brief review of key elements of the consent form and an 
eligibility screen assessment form. 
c. Payment to participants: Participants will receive $25 for each assessment they 
complete; there are two assessments in total: a pre-treatment and a post-treatment 
assessment. 
d. Consent for recruiting and screening: Potential participants will be asked to contact the 
UW research team directly after learning about the study. 1) When a potential 
participant contacts the research team: A UW research staff will describe the study. If 
the potential participant is interested in participating in the study and determined to have 
decision making capacity, the research staff will ask if they are willing to voluntarily 
answer questions assessing eligibility over the phone and will be informed that they can 
refuse to answer any questions.  
 
4. Study procedures:  
a. A total of 30 individuals with early stage memory loss will be recruited from Washington, 
Oregon and California and randomly assigned to one of two groups: Personalized Care 
Network (n=15) or RMC (n=15).  
b. Pre-treatment (baseline) assessment: The UW research staff will contact the 30 
participants to schedule a pre-treatment assessment via telephone. They will complete 

a 40-minute telephone assessment with either the study research coordinator or 
research study assistant. 
c. Interventions: For the Personalized Care Network group, the intervention will be done 
virtually using a video conferencing platform such as Zoom. Two coaches will meet with 
4-6 individuals for 9 one-hour sessions over six weeks. We will use the treatment 
manual developed and used for an earlier translational research (IRB STUDY00003076, 
Title: Older Adults Living with Alzheimer’s Disease and their Caregivers, PI: Karen 
Fredriksen-Goldsen). The manual was modified in March 2020 in order to transition 
from an in-home intervention to a virtual intervention. The manual includes text for the 
coaches, graphic illustrations of exercises, handouts, and process/treatment fidelity 
forms. A video link demonstrating exercises will be provided to participants.  The 
coaches will encourage and help participants with their exercises, and develop plans to 
address difficult behaviors.  The exercise component includes seated exercises with 
aerobic/endurance activities, strength training, and exercises to improve balance and 
flexibility. Exercises are introduced incrementally and individualized to meet the needs 
of each person. Each exercise is first demonstrated by the coach, then practiced by the 
participants. Coaches monitor the exercises closely in order to ensure that they are 
practiced safely and correctly. In the behavior management component, the ABC 
technique is applied. Study participants  are taught to identify the antecedent (A) to a 
behavioral issue or problem (B) as well as the consequences (C) of the behavior. 
Participants are instructed to identify and modify behavioral problems that can impair 
day-to-day function and interfere with exercise participation. They are given specific 
training in how to identify precipitants of problem behaviors, and how to modulate their 
own responses to these problems. Participants are also encouraged to identify pleasant 
activities that can be incorporated into the exercise program. An Exercise Coach will 
meet via a video conferencing platform individually with each treatment group 
participant once a week for 6 weeks to ensure exercises are done safely and correctly.   
Participants in the treatment group will be invited to participate in a focus group after 
their post treatment assessment is completed.   
d. Participants in the RMC group will use the same routine medical care they are currently 
using as needed. Exercise and behavioral management training will not be provided to 
the RMC group.  An online workshop will be offered to RMC participants after their post 
assessment.  The workshop will focus on aging, memory loss and maximizing health 
and independence.  
e. Post-treatment assessments: The UW research staff will conduct, via telephone, a post-
treatment assessment after all sessions are completed to evaluate treatment 
effectiveness outcomes for participants. Participants will receive $25 for each 
assessment. 
 
5. Outcome Measure(s): 
a. Change in Physical Activity [Time Frame: Baseline (pre-treatment) and 7 weeks (post-
treatment)] 
- Minutes spent on exercising per week in the past month were calculated from the 
following two questions: (1) How much time did you spend on exercises (hours 
per day) on a typical day during the last month; (2) How many days did you 
spend on exercises during the last month. 

b. Change in Physical Functioning [Time Frame: Baseline (pre-treatment) and 7 weeks 
(post-treatment)] 
- Physical functioning subscale of SF-36 (Medical Outcomes Study [MOS] 36-Item 
Short Form), consisting of 10 items assessing if participants' health limit them in 
activities such as walking, climbing, lifting, etc. on a 3-point scale ranging from 
'yes, limited a lot' to 'no, not limited at all.' 
c. Change in Quality of Life [Time Frame: Baseline (pre-treatment) and 7 weeks (post-
treatment)] 
- Quality of Life-AD scale assessed via interviews with participants, consisting of 
13 items with a 4-point response scale (1 = poor to 4 = excellent) asking about 
their feeling about different aspects of life. Summary scores are a sum of the 13 
items. 
 
 
6. Identifiability of data 
a. Each and every subject will be assigned a unique identification number. This number 
serves as an indirect link between the assessment data collected and any identifying 
information gathered as a part of the study. Only the PIs and authorized research staff 
will have access to the link between data and the direct identifiers. 
b. Participants’ name and their contact information (home address, email address, phone 
numbers) will be accessed by research staff to contact participants regarding the 
intervention and to schedule pre and post treatment assessments with participants.  
c. The direct subject identifiers will be stored in a password-protected computer in an 
encrypted file. Any physical copies of direct identifiers (such as consent forms) will be 
stored in a secured and locked cabinet. Only the PIs and authorized research staff will 
have access to the link between data and the direct identifiers. Only the PIs and 
authorized research staff will have keys to the cabinet. 
 
7. Consent 
a. Consent process: Once interested participants have been identified. eligibility criteria 
met, and they have agreed to a consent visit,  the study assessment staff will schedule 
a virtual  consent visit using Zoom. The UW office will also mail or email the consent 
form prior to  the consent visit so the participant may review it. An electronic consent will 
be sent to the participants through REDCap. During the consent visit the staff person 
will ask the participant if they read their consent form. If  not, the staff person will ask 
them to read the forms, or if they would like staff person to read their consent form out 
loud.  
b. Comprehension: after the consent form has been read the staff person will ask if they 
have any questions and answer all of their questions. Before signing the consent, the 
staff person  will check in with the participants: 1) whether they understand the consent 
form; 2) whether they have asked all of their questions and have had enough time to 
discuss the study; 3) whether they have received satisfactory answers to all their 
questions; 4) whether they have received enough information about study to decide if 
they want to participate; 5) whether they understand that they are free to leave the study 
at any time without having to give a reason and without affecting their medical care.  
When the participant demonstrates an understanding of the study, they will be asked to 

electronically sign the consent using a touch screen on an electronic device and to 
submit the consent.   
c. Ongoing process: Each session of the interventions and the assessments will be 
preceded by a brief review of the participants’ rights, including their right to withdraw 
from the study and the right to refuse to answer any questions 
d. Documentation of consent will be obtained for all of the research procedures. 
e. Cognitively impaired adults and other adults unable to consent:  
- 
This study includes participants with early stage memory loss who will be able to 
consent for themselves.  Potential participants who cannot consent for 
themselves will not be included in the study.  
 
8. Privacy and Confidentiality 
a. Privacy protections: Only UW research staff members will contact study subjects. All 
intervention sessions will be conducted by trained coaches via a HIPAA-compliant 
video conferencing platform such as Zoom. Assessment data collected will be 
available only to the project staff and investigators directly involved in with this study. 
No others will have access to the data. Collected data are confidential. Each subject 
will be assigned a unique identification number. Direct identifiers including contact 
information will be stored separately from the data collected through questionnaires, 
interviews, and assessments. The data cannot identify a subject without having access 
to the link between the identification number and the direct identifiers. A study subject 
cannot be identified by anyone except the UW lead researchers and authorized 
research staff members who have legitimate access to the single record identifying 
subjects by their research ID number. This record will be stored and maintained 
completely separate from all data and other information gathered. All data will be 
stored in secure computer files and records will be identified by a unique identification 
number that are assigned by the study. The data files will not contain any identifying 
information. 
b. All members of the research team will have completed required training in human 
subjects and HIPAA, including training in data management and confidentiality. 
c. Retention of identifiers and data: We will not destroy any identifiers (or links between 
identifiers and data/specimens) and data that are part of your research records until 
after the end of the applicable records retention requirements. 
9. Risk/Benefit Assessment 
a. Anticipated risks: Subjects in the study may be inconvenienced or experience psychological 
discomfort related to assessment questions including previous experiences of LGBT-specific 
adverse experiences and everyday discrimination. Subjects may also experience mild physical 
discomfort related to engaging in new physical exercise activities. These problems have not 
previously occurred in Drs. Teri or Fredriksen-Goldsen’s studies, and we estimate the risks to 
be minimal. Subjects are informed that they are free to not answer any question and not to 
participate in any exercises.  
b. Protections against psychological discomfort: To minimize the risk of distress or 
emotional upset, the following steps will be taken: A) The PIs are experienced in 
conducting interviews and assessments by phone and in-person with subjects 
experiencing cognitive impairment and mood or behavioral disturbance; they are also 
experienced with research involving LGBT older adult health. Throughout the study they 

will respond in a sensitive and respectful manner, in-person or by phone, to individuals 
who are distressed. B) The coaches will receive training from the PIs to monitor for 
distress and will be advised to immediately contact the PIs with any concerns related to 
the intervention or assessments resulting in psychological discomfort to the subjects. All 
concerns will be addressed in collaboration with the PIs. Subjects will be advised of 
their right to not answer any question(s) and/or to withdraw from the study at any time. 
No adverse emotional responses have been reported in our prior experience with 
training staff to deliver behavioral strategies. All sensitive questions in the proposed 
study are worded respectfully and have been used in previous studies with no adverse 
consequences. C) The coaches and assessment staff receive training  on how to 
monitor for distress and how to identify and monitor potential triggers and redirect 
participants to other activities with more pleasant memories. D) If psychological distress 
is identified, for example severe depression or anxiety, referral to a primary care 
provider or mental health provider will be initiated. Resources (e.g. contact information 
of participants primary doctor or mental health provider) will be identified at the 
beginning of the intervention. Distress requiring referral has never occurred in previous 
studies of the intervention.  
c. Protections against physical discomfort: If subjects experience mild physical discomfort 
related to engaging in new physical exercise activities, they will be informed that they do 
not need to participate in any exercises. We estimate physical discomfort to be minimal 
in the proposed study. 
 
d. A potential breach of confidentiality regarding subjects' sexual/gender identity and/or 
medical condition may cause psychological or social harm. All team members have 
signed a confidentiality agreement prior to being involved in the study. All participant 
information is to be kept strictly confidential with the only exception being incidents of 
abuse of a dependent adult or minor child and risks of imminent harm to others or to the 
subject. All researchers have completed training in research with human subjects. 
 
 
10. Analysis plan 
a. The point estimates of the proportions of eligible participants who agree to participate in 
the study and enrolled participants who comply with exercise assignments and adhere 
to the program sessions will be computed to test enrollment feasibility and intervention 
acceptability. Data from all measures at each time point will be examined utilizing 
univariate statistics in which psychometric properties of each variable will be 
determined. While random assignment is expected to produce comparable intervention 
groups, this will be ensured by comparing demographic characteristics and outcomes of 
interest at the baseline across intervention groups. To test initial efficacy of the 
Personalized Care Network approach  and RMC on primary outcomes, we will use 
ANCOVA, which helps to reduce error variance, yielding a more powerful test. The 
proposed sample size is sufficient to detect a medium effect of the preliminary 
intervention,8 which is greater than a clinically important difference level.9 We will 
compute and assess confidence intervals to evaluate precision of sample estimates and 
effect sizes for each outcome variable so as to derive proper sample size for the next 
stage of the study. 

 
 
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