Aging With Pride: Innovations in Dementia Empowerment and Action
Phase: NA
Conditions: Alzheimer Disease, Dementia, Mild Cognitive Impairment, Parkinson Disease Dementia, Lewy Body Dementia, Vascular Dementia
Sponsor: University of Washington

 
 
 
Aging with Pride: Innova2ons in Empowerment and Ac2on 
 
Study Protocol 
 
Mul2ple Principal Inves2gators 
Karen Fredriksen-Goldsen, PhD 
Linda Teri, PhD 
 
NCT03550131 
 
 
 
Version Number: v.13.0 
 
August 26, 2021 
 
 

1. Overview 
a. Study Title: Aging with Pride: Innova2ons in Demen2a Empowerment and Ac2on 
b. Research Site: University of Washington 
c. Objec2ves: Healthy People 2020 iden2ﬁed sexual/gender minority older adults 
as a health disparate popula2on. The lack of eﬃcacious research-based 
interven2ons for such vulnerable older adults with Alzheimer’s disease and 
related demen2as (AD/RD) and their care partners (CPs) is a signiﬁcant public 
health problem. AD/RD will aﬀect up to four million sexual/gender minority older 
adults with AD/RD and their CPs. These older adults are underserved with 
signiﬁcant barriers to healthcare access and the lack of culturally competent 
care. Caregiving of sexual/gender minority older adults with AD/RD is of concern 
due to social s2gma, marginaliza2on, and isola2on, which may be barriers to 
sustaining caregiving. It is necessary and 2mely to translate evidence-based 
culturally adaptable interven2ons for this underserved and s2gma2zed 
popula2on. Reducing Disability in Alzheimer’s Disease (RDAD) has been 
evaluated in a randomized controlled trial and has shown to successfully train 
community-dwelling CR-CP dyads to increase the physical ac2vity and 
func2oning of individuals with AD/RD, as well as their CPs. It also teaches CPs 
techniques for managing behavioral symptoms of CRs. RDAD consequently 
decreases stress of CPs, delays ins2tu2onaliza2on of CRs, and increases HRQOL 
of CRs and CPs. Thus, this study will evaluate the eﬀect of RDAD among CRs with 
AD/RD and their CPs in the sexual/gender minority popula2on, and this study will 
test an enhanced RDAD tailored to becer respond to dis2nct sexual/gender 
minority risks experienced by CPs and CRs with AD/RD, addressing unique 
sexual/gender minority risk factors (e.g., iden2ty management, s2gma-related 
adverse or trauma2c life events, and lack of social support). The enhanced RDAD 
will be referred to as Aging with Pride: Innova2ons in Demen2a Empowerment 
and Ac2on (IDEA). We will address the following aims: 
a. Aim 1. Test the transla2on of RDAD and IDEA programs designed to increase 
physical ac2vi2es of older adult care receivers (CRs) with AD/RD and their 
CPs. Aim 2. Evaluate the short- and long-term eﬀect of RDAD and IDEA on 
primary (physical ac+vity for CRs) and secondary outcomes (memory-related 
behavioral disturbances, physical func+oning, and QOL for CRs; depressive 
symptomatology; perceived stress for CRs). Aim 3. Test the modera2ng roles 
of CR-CP characteris2cs and severity of CR AD/RD on the treatment eﬀect of 
RDAD and IDEA.  
b. Study design: This study will u2lize a 2-group randomized, single blind with 
staggered mul2ple baseline design and three follow-up assessments.  

c. Background: Lesbian, gay, bisexual, and transgender (LGBT) older adults are 
an at-risk, underserved, and rapidly growing popula2on with elevated risk for 
AD/RD. RDAD, which is grounded in social-learning and gerontological 
theories, is a present-focused cogni2ve-behavioral interven2on aimed at 
increasing physical ac2vity and problem-solving while engaging both 
members of CR-CP dyad. The focus of problem-solving in RDAD is speciﬁc to 
the needs of the CR and CP. The standard RDAD, however, has not been 
translated to a highly s2gma2zed and marginalized popula2on, such as LGBT 
older adults, with unique CR-CP characteris2cs. Our previous ﬁndings indicate 
that exercise programs for older adults with AD/RD have been found to be 
more eﬀec2ve for caregiving dyads with a married spouse as caregiver. LGBT 
older adults, however, are less likely to be married and a signiﬁcant 
propor2on of caregivers in this popula2on are friends (not family). Moreover, 
discrimina2on and s2gma across the life course necessitate con2nual iden2ty 
management for many LGBT older adults (e.g., nondisclosure of LGBT iden2ty 
in contexts in which it would be unsafe to disclose or would reduce access to 
resources and services). These processes may be complicated by cogni2ve 
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 iden2ty, resul2ng in 
conﬂict or interpersonal discomfort that the CP must manage and nego2ate. 
Thus, it is essen2al to address the unique CR-CP characteris2cs in RDAD to 
improve treatment eﬀects. This study will extend and test the RDAD 
interven2on with the sexual/gender minority popula2on, and will also 
develop and test Aging with Pride: Innova2ons in Demen2a Empowerment 
and Ac2on (IDEA), a modiﬁed version of RDAD tailored to becer respond to 
dis2nct risks experienced by CPs and CRs with AD/RD in the sexual/gender 
minority popula2on. 
2. Par2cipants 
a. General characteris2cs: 150 dyads of CRs with AD/RD aged 50 or older and their 
CPs (N=300) will par2cipate in the study. Either the CR or CP will be 
sexual/gender minority. 
b. Inclusion Criteria: Inclusion criteria for CR and CP: Either CR or CP is a sexual or 
gender minority. Inclusion criteria for CR: 1) age at enrollment is 50 years of age 
or older; 2) living in the community (not in a long-term care facility with nursing 
home level care); 3) have Alzheimer’s disease or other demen2a. Based on the 
deﬁni2on of demen2a suggested by Alzheimer’s Associa2on and scien2ﬁc 
literature, demen2a will be determined 1) by asking CP the current diagnos2c 

status of CR’s AD/RD or 2) by asking CP whether CR has any diﬃcul2es in the 
domains of demen2a/memory loss AND needs any help in daily ac2vi2es. This 
method has two key aspects: (1) it precludes considerable increased costs that 
would be necessitated by providing a physical exam and (2) avoids unnecessary 
delays (and poten2ally loss of subjects) by scheduling an exam or wai2ng for 
receipt of pa2ent charts. Inclusion criteria for CP: 1) willing to spend at least 30 
minutes per day for study ac2vi2es or willing to coordinate with CR’s networks to 
do so; 2) providing care to the CR; 3) living in the community, not in a nursing 
home or long-term care facility. 
c. Exclusion Criteria: Exclusion criteria for CR and CP: 1) having plans to move to a 
long-term care sehng within 6 months of enrollment; 2) having a known 
terminal illness (with death an2cipated within the next 12 months); 3) having 
been hospitalized for a psychiatric disorder in the 12 months prior to baseline; 4) 
ac2vely being suicidal and having major hallucina2ons or delusions (occasional 
hallucina2ons or delusions are common symptoms of demen2a. CR will be 
eligible if CR’s hallucina2ons or delusions do not prevent par2cipa2on in a low 
impact exercise); and 5) having any physical limita2ons/chronic condi2ons 
preven2ng par2cipa2on in a low impact exercise program. 
d. Number of Subjects: 150 dyads (N=300) 
i. IDEA Interven2on Arm: 75 CR/CP dyads 
ii. RDAD Interven2on Arm: 75 CR/CP dyads 
3. Recrui2ng and Screening Par2cipants:  
a. Recrui2ng and screening: Study announcements will be distributed by aging and 
health service agencies and Aging with Pride community partners using 
organiza2onal contact lists via mail and email. In addi2on, study announcements 
will be posted at various health, human service and community-based 
organiza2ons (e.g., health clinics, support groups, buddy programs, community-
based churches, social groups) and published in community-based newspapers 
and newslecers.  We will post study announcements on social media plakorms.  
Study announcements include the study website address. 
Using chain referral sampling we will send an email or lecer invi2ng individuals 
on our contact list to tell their friends about the study.  We will ask these 
individuals to share the ﬂyer provided in the email or lecer.  We will reimburse 
individuals $20 for each referred pair 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 par2cipa2on in the study conﬁden2al.  If the caller doesn’t name a 
referring individual, the caller may s2ll enroll in the study if eligible.  Referring 
individuals will be paid no more than $60 for 3 pairs that enroll.  We will also use 
the same chain referral sampling to ask par2cipants who have completed the 
IDEA interven2on to tell their friends about the study.   
Poten2al par2cipants may contact the study by phone, email or through an on-
line prescreen. Poten2al par2cipants who learn about the study through the 
study website and complete a pre-screen are asked if they prefer to be contacted 
by phone, email or text.  Study staﬀ contact poten2al par2cipants using their 
preference, following an approved script.  Poten2al par2cipants who email the 
study receive an email reply asking them to call the study phone number and 
leave a message if the call is not answered. Study staﬀ return calls from poten2al 
par2cipants who leave a message and if the poten2al par2cipant is not reached 
leave a brief message reminding them about the study and request that they call 
back. Study staﬀ will reach CP poten2al par2cipants by phone so that they can 
answer CR and CP eligibility screening ques2ons with a staﬀ member to 
determine eligibility based on the inclusion and exclusion criteria.  
We will use Trialfacts to promote, screen and refer eligible par2cipants for the 
IDEA project. Trialfacts provides pa2ent recruitment services for clinical trials.   
Ads may run on a combina2on of plakorms including but not limited to: 
Facebook, Google, Google Display Network, Yahoo, Bing, Instagram, Youtube, 
Reddit, and Quorra.  The ads will be linked to the Trialfacts landing page, which in 
turn is linked to the online ques2onnaire.  Poten2al par2cipants who complete 
the on-line screening will schedule a telephone interview with Aging with Pride: 
IDEA study staﬀ to conﬁrm their eligibility. 
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 organiza2ons, and 
published in community-based newspapers, newslecers, and social media. A 
short 2-minute video will be on the study webpage and a link will be put in our 
social media announcements. Upon expressing interest in par2cipa2ng, ini2al 
screening of eligibility of CPs and CRs will be conducted by telephone using a 
script including the purpose and design of the study, a brief review of key 
elements of the consent form, and an eligibility screen assessment form. 
4. Study Procedures: 

a. A total of 150 CR/CR dyads will be recruited from all 50 U.S. states and territories 
and randomly assigned to one of two treatment arms: IDEA (75) or RDAD (75). 
b. Pre-Treatment (baseline) assessment: Pre-treatment (baseline) assessments #1 
and #2: Upon the random assignment, a research coordinator will contact 
subjects and schedule two pre-treatment assessments with a 6-week interval via 
telephone. CP will complete a 40 to 60-minute ques2onnaire via telephone for 
each assessment.  
c. Interven2ons: RDAD and IDEA are 9 1-hour sessions, conducted over 6 weeks in 
the par2cipants’ homes or a place of their choice where privacy is ensured. The 
sessions will be conducted twice a week for the ﬁrst three weeks; once a week 
for the next three weeks; in the 12-week maintenance phase 4 15- minute 
follow-up phone calls will occur once a month for the next 4 months. 
i. RDAD: For the RDAD group we will use the detailed treatment manual 
developed and used for earlier transla2onal research (IRB 41906-D, From 
Evidence-Base to Prac2ce: Implemen2ng RDAD in AAA Community-Based 
Services, PI: Linda Teri). The manual includes text for the coaches, graphic 
illustra2ons of exercises, handouts, and process/treatment ﬁdelity forms. 
CPs are taught how to encourage and help individuals with demen2a with 
their exercises, and behavioral plans are developed and implemented. 
The exercise component of RDAD includes aerobic/endurance ac2vi2es, 
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 prac2ced by the CR and CP. Coaches monitor the exercises closely in 
order to ensure that they are prac2ced safely and correctly. In the 
proposed study, both CRs and CPs will prac2ce and demonstrate the 
exercises at each session, and both will be encouraged to engage in a 
minimum of 30 minutes of moderate-intensity exercise every day. In the 
behavior management component of RDAD, the ABC technique is 
applied. CPs are taught to iden2fy the antecedent (A) to a CR behavioral 
issue or problem (B) as well as the consequences (C) of the behavior. CPs 
are instructed to iden2fy and modify CR behavioral problems that can 
impair day-to-day func2on, adversely aﬀect CP-CR interac2ons, and 
interfere with exercise par2cipa2on. They are given speciﬁc training in 
how to iden2fy precipitants of CR problem behaviors, and how to 
modulate their own responses to these problems. CPs are also 
encouraged to iden2fy pleasant ac2vi2es that can be incorporated into 
the exercise program for both persons in the dyad. Finally, CP issues, such 

as depression, burden, and stress, are assessed and sources of support 
are iden2ﬁed.  
ii. IDEA: For the IDEA group we will use the exis2ng detailed treatment 
manual, incorpora2ng three speciﬁc risk factors that have been 
empirically derived and are LGBT-speciﬁc, into the behavioral component 
of the interven2on. These include: 1) iden2ty management; 2) s2gma-
related adverse or trauma2c life events; and 3) lack of social support. The 
three LGBT-speciﬁc components are integrated into the exis2ng training 
and exercises so that the 2me and exposure to interven2on training are 
equivalent across RDAD and IDEA. As part of the behavior management 
component using ABC technique, CPs are taught how to assess and 
respond to CR’s LGBT iden2ty management challenges and the impact of 
adverse or trauma2c life events, as well as how to build and sustain social 
support to support exercise adherence for CRs and CPs. To further 
increase exercise adherence and support from peers and family members, 
an AD/RD educa2on DVD will be provided; the educa2onal component 
includes topics such as symptoms, progression, and treatment of 
demen2a; the eﬀect of exercise and support on AD/RD. IDEA coaches will 
be trained to use mo2va2onal interviewing techniques focused on 
person-centered engagement, development of par2cipant self-eﬃcacy, 
and support mobiliza2on to address barriers and facilitators to posi2ve 
change in primary outcomes. For LGBT popula2ons these may include 
lack of empowerment due to historical trauma, s2gma, non-disclosure of 
s2gma2zed iden22es, and social isola2on. 
d. Covid-19 adapta2on: During the COVID-19 outbreak the interven2on delivery 
procedures described above will be conducted virtually by a video-conferencing 
plakorm. We will ask par2cipants if they have a computer, iPad or cell phone 
capable of using any of these video conferencing plakorms.  For those 
par2cipants who do not have video conferencing capability or prefer not to use 
video conferencing we will resume in-home sessions when it is deemed safe to 
do so according to the CDC.   
e. Post-treatment assessments: Research staﬀ will conduct, via telephone, post-
treatment assessment #1 aper the in-person sessions, post-treatment 
assessment #2 aper the phone sessions, and a follow-up assessment at 13th 
month with CP par2cipants to evaluate treatment eﬀec2veness on outcomes for 
CR and CP par2cipants. Par2cipants will receive $25 for each assessment, 
described as reimbursement for 2me and exper2se in research topics. Change of 

address pre-stamped and addressed postcards will be given to all par2cipants to 
be used to no2fy project staﬀ for change of address and contact informa2on. 
5. Outcome Measures: 
a. Change in physical ac2vity (CR) [Time Frame: Baseline (pre-treatment) to 13, 30, 
and 52 weeks post-treatment] 
i. Measured by the number of days of exercise for at least 30 minutes in the 
past week. Higher scores indicate more days of ac2vity. 
b. Change in physical func2oning (CR) [Time Frame: Baseline (pre-treatment) to 13, 
30, and 52 weeks post-treatment] 
i. Assessed using mean score on physical func2oning subscale of SF-36 
(Medical Outcomes Study [MOS] 36-Item Short Form), consis2ng of 10 
items assessing if par2cipants' health limit them in ac2vi2es such as 
walking, climbing, liping, etc. on a 3-point scale ranging from 'yes, limited 
a lot' to 'no, not limited at all.' Higher scores indicate higher physical 
func2oning. 
c. QOL (CR) [Time Frame: Baseline (pre-treatment) to 13, 30, and 52 weeks post-
treatment] 
i.  Quality of life was evaluated using summed scores on the Quality of Life 
in Alzheimer’s Disease (QOL-AD), a 13-item measure widely for quality of 
life in interven2ons with persons with AD/RD. Range of scores 13-52 with 
higher scores indica2ng becer quality of life. 
d. Memory-related behavioral disturbances (CR) [Time Frame: Baseline (pre-
treatment) to 13, 30, and 52 weeks post-treatment] 
i. Assessed using mean scores on the memory-related subscale (7 items) of 
the 24-item Revised Memory and Behavior Problem Checklist (RMBPC). 
Higher scores indicate higher memory-related behavioral disturbances.  
a. Depressive symptomology (CP) [Time Frame: Baseline (pre-treatment) to 13, 30, 
and 52 weeks post-treatment] 
ii. Depressive symptomology was assessed by summed score on the 10-item 
Center for Epidemiological Studies-Depression Scale (CESD-10), validated 
among older adults and commonly used with caregiver popula2ons. 
Range of scores 0-27 with higher scores indica2ng higher levels of 
depression.  
b. Perceived stress (CP) [Time Frame: Baseline (pre-treatment) to 13, 30, and 52 
weeks post-treatment] 
iii. Assessed with mean scores on the Perceived Stress Scale (PSS) is a 14-
item self-report measure designed to measure nonspeciﬁc, appraised 
stress during the past month. Higher scores indicate more stress. 

6. Iden2ﬁability of data: 
a. Each and every subject will be assigned a unique iden2ﬁca2on number. This 
number serves as an indirect link between the assessment data collected and 
any iden2fying informa2on 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 
iden2ﬁers. 
b. Par2cipants’ name and their contact informa2on (home address, email address, 
phone numbers) will be accessed by research staﬀs to make contacts for 
interven2ons and follow-up tests with par2cipants. Par2cipants will also provide 
contact informa2on of CR’s designated LAR, if applicable. 
c. The direct subject iden2ﬁers will be stored in a password-protected computer in 
an encrypted ﬁle. Any physical copies of direct iden2ﬁers (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 iden2ﬁers. 
Only the PIs and authorized research staﬀ will have keys to the cabinet. 
7. Consent 
a. In-Person Consent Process: 1) The study office will mail two copies of the 
consent form to the CP-CR dyad prior to the visit.  The coach will visit the 
participants’ in their home or a place of their choice where privacy is ensured. 
When the coach arrives, the participants will be asked if they have read their 
forms. If they have not, the coach will ask them to read the forms. The CR will be 
asked if they would like the coach to read their consent form out loud. The coach 
will answer any questions the CP-CR dyad has about the study.  The coach will 
ask the dyad if they want to participate in the study. If they do not, the coach will 
politely end the visit. If they want to participate, the coach will ask them each to 
sign and date two copies of the consent form. If the CR is incapable of making 
informed decisions, the coach will obtain their verbal “assent” or agreement to 
participate in a study. After the consent forms have been signed, the coach will 
give each participant one copy and keep the other copy for the study’s records in 
a secured cabinet at the UW research office. 
b. Tele-Consent Process: Once eligible CP-CR dyads have been identified, eligibility 
criteria met, and interest in the study established, they will be scheduled for a 
tele-conference consent visit. The UW office will mail the consent forms to each 
member of the dyad and ask them to review them prior to a consent visit. The 
study office will also send electronic consent forms to the CP and CR with 
instructions for signing electronically during the consent visit. During the tele-
conference consent visit the coach will ask the participants if they have read 
their forms. If they have not, the coach will ask them to read the forms. CR will 
be asked if they would like Coach to read their consent form out loud. The coach 
will answer any questions the CP-CR dyad have about the study.  The coach will 
ask the dyad if they want to participate in the study. If they do not, the coach will 
politely end the visit. If they want to participate, the coach will ask them each to 

electronically sign, date and submit the consent forms. If the CR is incapable of 
making informed decisions, the coach will obtain their verbal “assent” or 
agreement to participate in a study.  
c. Comprehension: After the forms have been read, the coach will ask the 
participants if they have any questions and answer all their questions. Before 
signing the consent forms, the coach will ask 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 the 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.  
d. Ongoing Process: Each session of the interven2ons and the assessments will be 
preceded by a brief review of the par2cipants’ rights, including their right to 
withdraw from the study and the right to refuse to answer any ques2ons. 
Coaches will be carefully trained to discon2nue any assessment, interview, or 
treatment procedures if the par2cipant indicates either verbally or nonverbally 
an unwillingness to par2cipate. 
e. Documenta2on of consent will be obtained for all research procedures. 
f. Cogni2vely impaired adults and other adults unable to consent: If the subject is 
determined to be incompetent and unable to provide consent for themselves 
based on the results of the decision making capacity assessment, the assent of 
the subject will be obtained, and consent will be obtained from a legally 
authorized representa2ve (LAR). The subject will be asked to designate an 
individual to serve as a LAR who is authorized under the laws of the jurisdic2on 
in which the research is conducted. For example, in Washington State, individuals 
who are considered to be LARs (RCW 7.70.065) are the appointed guardian; the 
person to whom the subject has given a durable power of acorney, which must 
include the authority to make health care decisions; the subject’s spouse or 
state-registered domes2c partner; the adult children of the subject; the parents 
of the subject; and the adult siblings of the subject. The designated LAR will be 
contacted by the project coordinator, and the study will be explained to the 
designated LAR, including risks and beneﬁts, and that par2cipa2on is completely 
voluntary, and can be discon2nued at any 2me without aﬀec2ng the receipt of 
any other services. The consent form will be mailed (including a postage-paid 
return envelope) to the designated LAR. The LAR will then mail the signed 
consent form in the postage paid envelope to the project coordinator. 

Alterna2ves to LARs: According to previous studies, it is likely that LGBT older 
adults with Alzheimer’s disease and related demen2as (AD/RD) will not have an 
LAR. LGBT older adults are less likely to be married or partnered and less likely to 
have children. They tend to have limited contact with rela2ves, and many of 
them are reluctant to disclose their sexual and gender iden2ty to their family. 
Many LGBT people form “families of choice” as a way of coping with rejec2on by 
biological family and rela2ves. Families of choice open include non-legally-
recognized partners and close friends, who are not recognized as LARs. Thus, a 
“family of choice” CP par2cipa2ng in the study with their CR will serve as an 
alterna2ve to an LAR if there is no LAR or if the LAR’s rela2onship with the CR is 
nega2ve or estranged. 
8. Privacy and Conﬁden2ality: 
a. Privacy Protec2ons: Only UW research staﬀ members will contact study 
subjects. All interven2on sessions will be conducted by trained research staﬀ in 
a place where privacy is ensured. Coaches will ensure that sessions remain 
conﬁden2al and that they are in a place where others cannot observe. Sessions 
will be audio recorded only for the purpose of monitoring treatment ﬁdelity. 
Assessment data collected will be available only to the project staﬀ and 
inves2gators directly involved with this study. No others will have access to the 
data. Collected data are conﬁden2al. Each subject will be assigned a unique 
iden2ﬁca2on number. Direct iden2ﬁers including contact informa2on will be 
stored separately from the data collected through ques2onnaires, interviews, 
and assessments. The data cannot iden2fy a subject without having access to 
the link between the iden2ﬁca2on number and the direct iden2ﬁers. A study 
subject cannot be iden2ﬁed by anyone except the UW lead researchers and 
authorized research staﬀ members who have legi2mate access to the single 
record iden2fying subjects by their research ID number. This record will be 
stored and maintained separate from all data and other informa2on gathered. 
All data will be stored in encrypted computer ﬁles and records will be iden2ﬁed 
by a unique iden2ﬁca2on number that are assigned by the study. The data ﬁles 
will not contain any iden2fying informa2on. 
b. All members of the research team will complete required training in human 
subjects and HIPAA, including training in data management and conﬁden2ality.  
c. Reten2on of iden2ﬁers and data: We will not destroy any iden2ﬁers (or links 
between iden2ﬁers and data/specimens) and data that are part of research 
records un2l aper the end of the applicable records reten2on 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. Protec2ons against psychological discomfort: To minimize the risk of distress or 
emo2onal upset, the following steps will be taken: 1) The PIs are experienced in 
conduc2ng interviews and assessments by phone and in-person with subjects 
experiencing cogni2ve 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 sensi2ve and respeckul manner, in-person or by 
phone, to individuals who are distressed. 2) 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 interven2on or assessments resul2ng in 
psychological discomfort to the subjects. All concerns will be addressed in 
collabora2on with the PIs. Subjects will be advised of their right to not answer 
any ques2on(s) and/or to withdraw from the study at any 2me. No adverse 
emo2onal responses have been reported in our prior experience with training 
staﬀ to deliver behavioral strategies. All sensi2ve ques2ons in the proposed study 
are worded respeckully and have been used in previous studies with no adverse 
consequences. 3) The CPs will receive training from the coaches on how to 
monitor for distress and how to iden2fy and monitor poten2al triggers and 
redirect CRs to other ac2vi2es with more pleasant memories. 4) If psychological 
distress is iden2ﬁed, for example severe depression or anxiety, referral to a 
primary care provider or mental health provider will be ini2ated. Resources (e.g. 
contact informa2on of CR’s primary doctor or mental health provider) will be 
iden2ﬁed at the beginning of the interven2on. Distress requiring referral has 
never occurred in previous studies of the RDAD interven2on. 
c. Protec2ons against physical discomfort: If subjects experience mild physical 
discomfort related to engaging in new physical exercise ac2vi2es, they will be 
informed that they do not need to par2cipate in any exercises. We es2mate 
physical discomfort to be minimal in the proposed study. 
d. A poten2al breach of conﬁden2ality regarding subjects' sexual/gender iden2ty 
and/or medical condi2on may cause psychological or social harm. All team 
members signed a conﬁden2ality agreement prior to being involved in the study. 
All par2cipant informa2on is to be kept strictly conﬁden2al with the only 

excep2on 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: All par2cipant data will be included in the study, according to the intent-
to-treat principle, aper excluding par2cipants who withdrew prior to comple2ng their 
baseline assessment. Analysis will be completed using Stata/MP 16.1 (StataCorp, 2019). 
To assess whether randomiza2on of pa2ents was successful, the two treatment groups 
will be compared by baseline demographics and clinical characteris2cs using two-
sample t-tests, Chi-Square tests of independence, or Fisher’s exact tests as appropriate. 
To test eﬃcacy of the interven2ons, we will use linear mixed models to test the short- 
and long-term interven2on eﬀects on outcomes, with 2me treated as a categorical 
variable. The models included random intercepts and slopes for each par2cipant to 
account for individual variability at baseline and change over 2me of the outcome 
variables and included baseline scores of the outcomes as ﬁxed eﬀects. Mixed-eﬀects 
logis2c regression models were es2mated for binary outcomes, and con2nuous 
outcomes were es2mated with mixed-eﬀects linear regression models. Modera2on 
eﬀects were evaluated using interac2on terms in the linear mixed models. The proposed 
sample size with a two-sided signiﬁcance of 5% and a sta2s2cal power of 80% is 
suﬃcient to detect a small eﬀect (d= 0.25), which is greater than a minimal clinically 
important diﬀerence level. The sta2s2cal signiﬁcance of all hypothesis tests were set at 
two-sided level of p = .05.