Optimizing Dementia Care Through Collaborative Recovery Interventions
Phase: NA
Conditions: Alzheimer's Disease, Dementia, Dementia, Vascular, Caregivers, Veterans
Sponsor: VA Office of Research and Development

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Official Title: Optimizing Dementia Care through Collaborative Recovery Interventions 
NCT: NCT02585232 
 
1. Principal Investigator: Michelle Hilgeman, PhD 
 
2. All co-investigators: Rebecca S. Allen, PhD; Phoebe Block, MA; Amber Collins, 
MS; Lynn Snow, PhD; Kimberly Alexander, MEd; Whitney Gay, MA; Julia Loup, BA; 
Judy Burt, Teddy Bishop, BS 
 
3. Consultants: David Bass, PhD; Lori Davis, MD; Mark Kunik, MD; Daniel W. Durkin, 
PhD  
 
4. Sponsor of the study of funding agency (if applicable): VA Rehabilitation 
Research & Development Service (Rehab R&D) (D1824-W; Application Number: 
1IK2RX001824-01A1) 
 
5. Research setting:  
This is a community-based study. All in-person study procedures will occur in a 
convenient community-based setting of the participant’s choosing (e.g., their home, a 
local library, a community center, TVAMC campus, etc.). Most interactions (intervention 
& assessment) will occur over the telephone.  
 
6. Purpose of the study (including hypothesis to be tested): 
The purpose of this randomized controlled pilot study is to examine the preliminary 
effectiveness, feasibility, and potential treatment moderators (e.g., behavioral symptoms 
and spousal relationship status) of a newly developed intervention that combines 
elements of the established care consultation (CC) approach with additional counseling 
modules (CC+C).  
 
Our specific aims and hypotheses follow: 
 
Aim 1: Manualize the integration of care consultation and counseling components. The 
study team will begin this five-year study by refining and operationalizing the CC+C 
intervention. The CC+C intervention is guided by a rehabilitation and recovery-based 
conceptual model to address the most common high distress situations (e.g., 
relationship distress, veteran or caregiver depression, anxiety, or pain).  
 
Aim 2: Evaluate preliminary effectiveness and feasibility of the CC+C Intervention. A 
randomized controlled pilot study of distressed dyads will be completed to compare: 1) 
the established CC intervention, to 2) the CC+C intervention on veteran and caregiver 
outcomes at 6 months.   
 
Aim 3: Conduct exploratory analyses of the CC+C intervention on veteran long-term 
care placement at 6 and 12 months and examine two key treatment moderators 

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(behavioral symptoms and spousal relationship status) that may impact intervention 
engagement and response to treatment.   
 
Hypotheses for Aims 2 and 3:  
Participants assigned to both groups will have: 1) reduced unmet needs, 2) reduced 
depressive symptoms, and 3) higher levels of satisfaction with care at 6 months than 
their baseline assessment values.  
 
Caregivers assigned to CC+C will have greater reductions in caregiver burden at 6 
months than those assigned to CC alone. Indicators of relationship strain (e.g., marital 
distress and/or mutuality) will show greater improvement in CC+C than CC at 6 months. 
6 month gains in shared pleasant events, social engagement, and quality of life will also 
be greater in CC+C than in CC alone. 6-month desire to institutionalize will be lower in 
the CC+C group than those randomized to CC. Treatment engagement (e.g. action plan 
completion, attendance) is also predicted to be higher in the CC+C group than in CC. 
 
For Aim 3, we anticipate that individuals who receive the CC+C intervention will have 
lower rates of placement in long-term care facilities at 6 and 12 months than those who 
receive CC alone. We also expect that behavioral problems will impact treatment 
outcomes such that those dyads with higher levels of behavioral disturbance at baseline 
will have greater change scores at 6 months. Spousal relationship to the veteran is also 
expected to moderate treatment outcome such that spousal caregivers are anticipated to 
have lower change scores compared to non-spousal caregivers across time; however, 
we expect this effect to be attenuated in the CC+C condition. 
 
7. Background, including results of relevant research, gaps in the current 
knowledge. 
 
Scope of the Problem 
Over five million Americans are diagnosed with Alzheimer’s disease or a related disorder 
(ADRD) and rates are expected to triple by 20501. It is the 6th leading cause of death in 
the United States and one in three older adults will have dementia when they die2. 
Veterans have high rates of known risk factors that place them at increased risk of 
developing dementia including: PTSD,3 diabetes4,5, substance use disorders,6 and 
cardiovascular disorders.7 Over 7% of veterans 65 and over receiving care through the 
Veteran’s Health Administration (VHA) are currently diagnosed with dementia.8 In a 
study of dementia prevalence among VHA system users, Snow, Kunik, and colleagues 
found that diagnosis by VISN varied between 5.8% to 9.4%.8 VISN 7, where the current 
work is proposed, had the highest dementia rates of any VISN in the country and was in 
the region with the greatest rates overall (i.e., the southeast) perhaps reflecting 
differences by race,9 educational achievement,10 rurality,11 and/or cardiovascular 
morbidities.  
 
Spouses comprise the largest group of caregivers for individuals with ADRD. This is 
particularly true for veterans with dementia, most of whom are men cared for by their 

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wives.12 Decades of research suggests that spousal caregivers are uniquely vulnerable 
due to increased isolation, older age, and cohabitation status which reduce opportunities 
for respite.13 Couples in which one individual is diagnosed with dementia often 
experience substantial depression and frustration adjusting to functional changes and 
losses in roles, relationship, and independence of the declining loved one.14-16 Changes 
in shared intimacy, emotional support, companionship, and reciprocity are 
consequences of memory loss17 and associated cognitive changes resulting in grief 
reactions in up to 71% of caregivers.18 Some research has cited loss of the relationship 
with the person as the most distressing element of the disease for caregivers and 
directly predictive of depression above other aspects of the caregiving context.14,17 The 
unique functional and behavioral impairments associated with ADRD contribute 
substantially to psychological and physical morbidity of family caregivers and high rates 
of nursing home placement, with 60% of ADRD caregivers rating the emotional stress of 
caregiving as “high or very high,” and over one third reporting depressive symptoms.  
 
Gaps in Current Knowledge 
Numerous interventions have been developed by researchers and private organizations 
to reduce caregiver burden and target mental health and functional outcomes, often 
trying to simultaneously delay institutionalization.19,20 With few exceptions, interventions 
take an either/or approach - focusing on the needs of either the individual with dementia 
or the family member who is providing care in the home.21 Yet, the social, physical, 
medical, and mental health needs of these individuals are often intimately linked – 
particularly for those who live together – and maintaining or restoring the relationship is 
essential for optimizing outcomes and maintaining care in the home for as long as 
possible.14 In a 2009 review article assessing the frequency that a dyadic perspective 
was taken in spousal caregiving research, Braun and colleagues22 noted that only five of 
270 articles directly included the perspectives of both individuals. This reflects an urgent 
need to consider the reality of dementia caregiving – that it occurs between two 
individuals who often share a long pre-illness relationship history that directly impacts 
the social, functional, emotional, and ultimately physical health of both individuals 
impacted by the disease. 
A recent systematic review noted almost none of the evidence-based interventions 
developed to reduce caregiver burden and improve mental health and functional 
outcomes of the person with dementia “make it off of the shelf” to be readily available in 
clinical settings. Care Consultation (CC) has emerged as a rare exception.  
 
CC is an evidence-based telephone intervention delivering psychoeducation, care 
coordination, and resource referrals in diverse areas such as safety and mental and 
behavioral health support. Exclusive telephone delivery drastically improves access and 
translatability. A critical barrier to accessing needed services for individuals with 
dementia and their caregivers is the challenge associated with leaving the home to 
attend appointments in medical center settings. Limited mobility, rural residence, 
challenges with orientation and transportation, and other burdens make attending 
consistent, in-person sessions nearly impossible. Many research interventions have 
worked around this limitation by sending research staff into the home of those with 
dementia to provide brief (4-10 session) interventions.23,24,25 Unfortunately, due to the 

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progressive nature of dementia, the caregiving context and level of distress changes 
across the course of the disease making sustained support necessary. Long-term, 
home-based care is difficult and expensive to sustain in clinical settings and is therefore 
unrealistic for the large number of individuals that could benefit from services. Providing 
care over the telephone is responsive to the needs of patients and families and provides 
care in a low-cost, sustainable format. 
 
CC may be limited in its effectiveness for dyads suffering from high levels of distress. Dr. 
Bass, developer of CC and consultant on this study, has estimated 20% or more of 
families in care consultation studies were referred for mental health services for issues 
that were beyond the scope of care consultation alone. Estimates are even higher 
among veteran populations impacted by dementia. Though some benefits were 
observed for all caregivers enrolled in CC (e.g., reduced depressive symptoms, 
increased satisfaction, reduced unmet needs), care consultation has not consistently 
had an impact on relationship strain in spousal caregivers.22 Caregivers who utilize care 
consultation in combination with other supports (e.g., support groups) have greater 
reductions in health deterioration and perceived role captivity. Complex mental and 
physical health comorbidities common in veteran populations (PTSD, substance use, 
chronic pain), long-standing patterns of marital interactions, and grief as roles shift are 
intensified by dementia onset and have direct implications for functional outcomes and 
the ability to maintain a loved one at home.   
Dyads in high distress cannot fully benefit from CC unless their high distress condition is 
also addressed. By layering counseling modules in when needed (CC+C), the current 
work will establish a manualized framework for integrating distress treatment targets 
(e.g., relationship distress, depression, pain) for those too distressed to fully engage in 
CC alone. A stepped intervention approach would address the VA’s efficiency needs 
while allowing the flexibility for more resource-intensive counseling beyond the 
established CC framework when warranted by high dyad distress.  
 
Next Steps 
The goal of this project is to develop a manual for integrating CC and counseling, which 
is necessary to ensure standardization across clinicians. Preliminary clinical pilot work 
has been completed in the TVAMC Telephone Assisted Dementia Outreach (TADO) 
program. However, the TADO clinical program was not established with the resources or 
scientific rigor necessary to contribute meaningfully to the scientific literature. Therefore 
the current protocol is a funded research study that will collect preliminary outcome data 
to examine the potential efficacy of CC+C. 
 
The impact of this work will be fully realized when an efficacious and highly-accessible 
collaborative-recovery intervention, such as the one being explored, promotes improved 
quality of living for community-dwelling veterans and their families rather than resorting 
to more expensive and undesirable intensive care settings.  
 
8. Potential benefits to the research subject and the knowledge to be gained 

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The intervention may provide some psychological relief to the participants and their 
caregivers. Since all participants will be receiving active treatments, this is more likely in 
this study than in other designs.  
 
Though veterans with dementia who are in the early stages of the disease may be more 
able to engage in the dyadic intervention, family caregivers of loved ones in the later 
stages of the disease are equally likely to be distressed and benefit from counseling 
targets.32 Care consultation interventions and counseling interventions have both been 
used successfully with heterogeneous dementia diagnoses and severity samples.9,12 
The primary benefit of a telephone-delivered intervention is increasing access to 
services for those with limitations on transportation or their ability to attend in-person 
sessions. 
 
The participants and caregivers may also benefit by gaining a general sense of well-
being and satisfaction from the attention that is paid to them during the course of the 
study. For example, many individuals enjoy discussing their experiences in assessment 
interviews and through intervention contacts in similar studies.  
 
9. Definition of population to which study is directed and justification 
This study involves two groups of participants: 1) the Veteran and 2) their caregiver, 
selected because they are impacted by a dementia-related disorder. See scope of the 
problem section above for the justification for conducting an intervention study with this 
population. 
 
10. Number of the subjects that will be recruited for study 
At least seventy dyads (i.e. 70 veterans and 70 caregivers) will be recruited to achieve a 
final sample. However, caregivers can participate independently if the veteran is too 
impaired to participate meaningfully in the study.  
 
11. Subject inclusion/selection criteria 
 
Veterans: 
a. Must be age 19 or older 
b. Must have a diagnosis of dementia or a related disorder 
c. Must live in the community (i.e. not in a VA Community Living Center, nursing 
home, or other facility) 
d. Must cohabitate with a caregiver; 
e. Must have reliable access to a telephone 
f. Must be willing to consent to participate or provide assent in conjunction with 
proxy consent if their decision-making capacity is compromised. 
 
Caregivers: 
a. Must be age 19 or older 
b. Must self-identify as assisting with care for at least 8 hours/week 
c. Must be willing to consent to participate. 
 

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The study will include women and minorities and aim to represent the percentage 
reflected in Tuscaloosa VAMC medical care system (12% women, 44% minorities, and 
1% Hispanic origin; though numbers of minorities might be slightly lower in the older 
cohorts targeted for this study as indicated above). No specific inclusion/exclusion 
criteria related to race/ethnicity are required.  
 
12. Subject exclusion criteria 
 
In addition to meeting the inclusion criteria outlined above, participants will be excluded 
in the following cases.  
 
Veterans: 
a. Currently incarcerated 
b. Currently pregnant 
c. Dyads experiencing low levels of distress (as defined by a score of 0 or 1 on the 
Dementia Services Mini-Screen32, see below) 
 
Note. Baseline or post-assessment interviews will be discontinued for Veterans 
experiencing severe cognitive impairment that would impair their ability to communicate 
during an interview, consistent with good clinical practices. However, they will not be 
excluded from participating in intervention sessions as appropriate and their available 
data (self-report or proxy report) will be retained for analyses.   
 
Caregivers: 
a. Currently incarcerated 
b. Currently pregnant 
c. Experiencing severe cognitive impairment that would impair their ability to 
communicate during an interview  
d. Dyads experiencing low levels of distress (as defined by a score of 0 or 1 on the 
Dementia Services Mini-Screen32, see below) 
 
13. Subject exit criteria 
a. Subjects will exit the study once one of the following conditions are met: 
b. Completion of the study protocol 
c. Serious or life threatening adverse effects (including death) 
d. Withdrawal of consent by the Veteran or the Veteran’s caregiver 
 
14. Justification for use of special subject populations who may present informed 
consent issues (for example, incompetent patients, children, elderly, etc.) and 
reason for inclusion. 
The study will not enroll prisoners, children, those who are terminally ill, or pregnant 
women. The study sample will include participants with varying degrees of cognitive 
impairment (from intact to severely impaired) and other mental health diagnoses (e.g., 
serious mental illness) that would classify them as vulnerable populations. In the event 
that these participants have impaired decision-making capacity, appropriate surrogate 

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consent will be obtained as described below. This vulnerable population is necessary to 
include in the current feasibility study to examine whether the intervention will ultimately 
be beneficial for this principal group. It is also possible that veterans over the age of 89 
will be included in this research. However, veterans over the age of 89 will not be 
specifically targeted for enrollment. 
 
15. Scientific and ethical justification for excluding classes (gender, race, etc.) of 
persons who might benefit from the research 
No participant will be excluded from participation in the study on the basis of gender, 
race, ethnicity, socio-economic status, or physical disability. 
 
16. Appropriateness of Impact of Study design on risk. 
The risk of this study is low to minimal since it does not involve study medication or 
invasive procedures. Furthermore, all participants will receive an active treatment / 
intervention.  
 
Minimal risks for veterans and their family members include:  
a. they may feel coerced to participate in interviews,  
b. they may feel uncomfortable, tired, or become bored during interviews,  
c. raw data from interviews may contain sensitive information that could cause 
embarrassment if it was obtained by others in an identifiable form.  
 
It is unlikely that any discomfort or negative emotions will exceed those encountered as 
part of daily life. Interviews will be conducted separately for the veteran and their family 
member unless the veteran requests otherwise to increase privacy and minimize risk of 
embarrassment or discomfort. Given the benefits possible and minimal risks involved, 
the risk-benefit ratio for this study is favorable. 
 
17. Description of procedures to be performed.  
 
The assessment schedule is summarized in Table 1 for screening (phone), baseline (in-
person), 6-month assessment visit (in-person), and 12-month (phone) assessments. 
However, if a dyad prefers to complete the telephone assessments in person (e.g., while 
they are on station for another appointment), arrangements will be made to 
accommodate that request.  
 
Table 1. Assessment Schedule 
Measure 
(completed by  
Veteran or caregiver) 
Admin. 
Time  
S 
B 
6 mo 
12 mo 
Eligibility Screening (CG) 
5m 
X 
 
 
 
Dem Serv Mini-Screen (CG) 
< 2m 
X 
 
 
 
Subjective Stress/ Subjective Health (V, CG) 
1m 
 
X 
X 
X 
Demographics (CG, CG*) 
< 10m 
 
X 
 
 
Health Literacy Screener (CG) 
< 2m 
 
X 
 
 
MoCA (V) 
10m 
 
X 
 
 

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PSM IADL/ADL (CG*) 
10-12m 
 
X 
 
 
RMBPC (CG*) 
5-10m 
 
X 
X 
 
CSDD (V, CG*) 
10-20m 
 
X 
X 
 
Veteran QOL-AD (V, CG*) 
5-10m 
 
X 
X 
X 
EuroQoL-5 Domain (V, CG*) 
<5m 
 
X 
X 
 
Social Engagement (V, CG*) 
<5m 
 
X 
X 
 
Dyadic Adj. Scale (V, CG) 
5-10m 
 
X 
X 
 
Mutuality Scale (V, CG) 
5m 
 
X 
X 
X 
Zarit Burden (CG) 
< 5m 
 
X 
X 
X 
GAD-7 (CG) 
< 5m 
 
X 
X 
X 
CES-D (CG) 
5m 
 
X 
X 
X 
WHO-QOL-OLD (CG) 
3m 
 
X 
X 
 
FFMQ (V, CG) 
10m 
 
X 
X 
X 
Desire to Inst. (DTI) (CG) 
<5m 
 
X 
X 
X 
NH Placement (EHR, CG) 
<1m 
 
 
X 
X 
Care Consultation Satisfaction Survey (CG) 
<5m 
 
 
X 
 
Caregiver Time Burden (min) 
 
 
<130 
<105 
<50 
Veteran Time Burden (min) 
 
 
<80 
<75 
<30  
Note. V = measures completed by veteran; CG = completed by caregiver; EHR = 
extracted from the electronic health record.  
 
Screening 
A HIPAA waiver for screening purposes will be obtained. Eligibility screening for 
interested dyads will typically occur over the telephone. If the Veteran and/or caregiver 
meets the inclusion criteria and do not meet exclusion criteria, a baseline assessment 
appointment will be scheduled.  Informed consent procedures will be performed at 
baseline in accordance with the consensus recommendations for research with 
cognitively impaired populations developed by the Alzheimer’s Association33 and 
described in detail below. Proxy consent and participant assent will be collected when 
the participant is willing to assent for the study but is determined by the capacity 
assessment at the time of consent to be lacking capacity. Caregivers will also complete 
an informed consent. Veterans and their family caregivers will complete separate 
consent forms. 
 
The Dementia Services Mini-Screen32 will be used to identify dyads who are in distress 
and most likely to benefit from enhanced dementia services. This brief assessment tool 
was developed for use in primary care settings and has established cut-off points with 
strong sensitivity and specificity data that categorize individuals with dementia and their 
caregivers into low, moderate, or high stress groups based on the presence of 
behavioral disturbances and service needs (psychosocial and medical). Using this tool, 
dyads that endorse only low-moderate stress and few behavioral problems (0 or 1) will 
be excluded from the study. Excluded dyads will be offered a referral for clinical 
services. There will be no restrictions on gender or race for veterans with dementia or 
their caregivers.  
 
Baseline, 6-month, and 12-month Assessments 

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Baseline and 6-month assessments will occur in the participant’s homes or another 
convenient location of their choice (e.g., local public library). Informed consent will be the 
first thing addressed during the baseline assessment. Patient data will be collected 
interview-style by a trained assessor (research assistant) for the veteran with dementia, 
while the caregiver measures will be completed independently (paper and pencil). The 
brief 12-month assessment will occur over the telephone to reduce participant burden.  
 
Measures  
See assessment schedule described in Table 1 above. All measures are peer-reviewed 
and frequently used in the research literature with the proposed population. One 
measure that is likely less familiar to the IRB (i.e., Dyadic Adjustment Scale) has been 
uploaded with the submission package on IRBNet.  
 
a. Subjective Health will be measured using the sum of three items, with higher scores 
indicating better health.34 Subjective Stress will be measured using two items, with 
higher ratings indicating increasing levels of stress. 
 
b. Demographics including: sex, age, primary racial or ethnic group, education, living 
arrangement, time since diagnosis, years married, number of marriages, number of 
children, and income adequacy will be collected for the veteran and their caregiver. 
Income adequacy will be assessed with a single item asking about difficulty paying for 
the basics, (1 = very difficult to 5 = not very difficult). Individuals will be asked if they 
have had any previous counseling experience, are taking any antidepressants, 
anxiolytics, or memory enhancers and whether doses have been stable for the past 3 
months. 
 
c. Health Literacy will be measured using a 4-item screener to identify individuals with 
health literacy issues that could impact their ability to complete self-report measures. 
57,58 
 
d. The Montreal Cognitive Assessment (MoCA) 35 a 30-point cognitive screening 
instrument with excellent discriminative power to detect mild cognitive deficits will be 
used to measure cognitive status. 
 
e. The Physical Self-Maintenance (PSM) and Instrumental Activities of Daily 
Living (IADL) Scale36 will be used to assess functional status or independence in daily 
care needs across six physical care domains (i.e., activities of daily living, ADL) and 
eight IADL domains. 
 
f. The Revised Memory and Behavior Problems Checklist (RMBPC37) which 
provides an estimate of the frequency of problems and the impact that these problems 
have on the caregiver will be used to rate behavioral symptoms of dementia. 
 
g. The Cornell Scale for Depression in Dementia (CSDD38) which relies on an 
interview with the individual and the caregiver will be used to assess depressive and 
anxiety symptoms.  

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h. The Quality of Life in Alzheimer’s Disease scale (QOL-AD) will be used to assess 
quality of life.39 Patients and caregivers rate thirteen domains: physical health, energy, 
mood, living situation, memory, family, marriage, friends, chores, fun, money, self and 
life as a whole, using a Likert-type scale.  
 
i. The Euro-QoL-5 Domain (EQ-5D) mobility, selfcare, and usual activities subscales 
will be used to assess autonomy and functional dependence.40 Health-related quality of 
life is assessed for five domains: mobility, self-care, usual activities, pain/discomfort and 
anxiety/depression. Caregivers also complete this measure, as has been done in 
previous studies with individuals with mild to moderate dementia.40,41,42  
 
j. Social engagement and isolation will be assessed using items modified from the 
Minimum Data Set questionnaire.43 This six-item measure includes the ability to take 
advantage of social interactions and to initiate meaningful social contacts (e.g., ease 
interacting with others, establishment of own goals).  
 
k. The 11-item Dyadic Adjustment Scale,44 a widely used measure of marital 
satisfaction/distress will be used to assess relationship quality in spousal dyads.  
 
l. The Mutuality Scale45 is a 15-item instrument measuring positive qualities of the 
relationship on a 5-point scale (0=never to 4=a great deal). Four domains are calculated: 
shared values, affective closeness, shared pleasurable activities, and reciprocity.  
 
m. The Zarit Caregiver Burden Interview46 a caregiver self-report measure will be 
used to assess caregiver burden. Each item is rated on a 5-point scale (0 = never to 4 = 
nearly always). 
 
n. A 7-item Generalized Anxiety Disorder Screener (GAD-7)56 will be used to assess 
caregiver symptoms of anxiety on a 4-point scale (0-3).  
 
o. An 11-item abbreviated version of the Center for Epidemiologic Studies of 
Depression Scale (CES-D) will be used to measure depressive symptoms.47 Caregivers 
will rate the frequency with which they experience depressive symptoms within the past 
week on a 3-point scale (0 = hardly ever or never, 2 = much or most of the time). Anxiety 
symptoms will be assessed using the 20-item Geriatric Anxiety Inventory.48 Items on 
this measure are rated as either “agree” or “disagree.”  
 
p. An abbreviated 6-item version of the World Health Organization Quality of Life 
measure (WHO-QOL)50, 49 designed to assess domains that are specific for older adults 
will be used to measure quality of life. Items are rated for the past 2 weeks on a 5-point 
scale (indicating either frequency or valence).  
 
q. The short form, 15-item version of the Five-Facet Mindfulness Questionnaire 
(FFMQ)59 will be used to measure facets of mindfulness. The five facets are observing, 

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describing, acting with awareness, non-judging of inner experience, and non-reactivity to 
inner experience. The 15-item FFMQ includes three items for each facet. 
 
r. The 6-item Desire to Institutionalize (DTI) Scale51, which assesses the caregivers 
planning, thoughts, and actions about long-term care (LTC) placement over the past 6 
months will be used to assess intentions to institutionalize their loved one. Six yes/no 
items (e.g., taken steps toward placement) are summed for a score of 0-6. Long-term 
care placement and/or hospitalization of the veteran (institutionalization) will be 
assessed using a single item rated either by the caregiver or via electronic health record 
review if the dyad is no longer enrolled in the study (e.g., due to attrition). 
 
s. The 21-item Care Consultation Satisfaction Survey will be used to measure the 
participants’ satisfaction with the Care Consultant and the Care Consultation services 
provided. 
 
Once baseline data are collected, dyads will be randomly assigned to a condition (see 
interventions delivered below).  
 
Randomization  
Blocked randomization stratified by race and gender will be used to assign participants 
to either the: (a) CC group, or the (b) CC+C group. This two-group experimental design 
was chosen over other approaches (e.g., no comparison group designs, three-group 
design, cross-over design, etc.) because it most closely approximates the next level of 
clinical research (e.g., an efficacy study), which allows for the most directly applicable 
conclusions.  
 
Interventions Delivered 
1. Care Consultation (CC): is an established telephone-based, empowerment 
intervention that uses coaching and emotional support to mobilize family caregivers and 
individuals with dementia through psychoeducation, resource referral, psychosocial 
support, and encouragement of informal and formal service use utilization. A 
computerized clinical tool utilizing a password-protected VA-hosted website (i.e., 
operated within the VA server system) called the Care Consultation Information System 
(CCIS) guides the care consultant through a standardized delivery of protocol 
components, replacing a paper-based clinicians manual. Rather than a strong focus on 
assessment, this intervention is designed to quickly identify areas of unmet need 
through brief trigger questions called the “initial assessment” – much like an interview 
guide – which then immediately shapes development of concreate action plans.  
 
The CCIS has been successfully used by the TADO team clinically at the TVAMC. 
Fidelity reviews, technical support, and problem-solving are available on an ongoing 
basis through a nominal annual renewal fee. Care consultation has demonstrated robust 
outcomes across community and VA settings (e.g., Partners in Dementia Care, PIs 
Kunik & Bass both on the study team) and has been translated successfully beyond 
research protocols into clinic settings.  

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2. Care Consultation + Counseling (CC+C): is consistent with the original CC protocol 
and a collaborative recovery model in that the therapist partners with each dyad in a 
patient-centered way to prioritize unmet needs as identified during the CC initial 
assessment. Once this phase has been completed, typically within the first 2 sessions, 
the CC+C therapist will determine when to initiate counseling (Table 2, below). The 
counseling component of the recovery-informed CC+C intervention incorporates 
elements of existing manualized interventions that follow a cognitive behavioral therapy 
framework (i.e., active engagement, assigning in-session and out-of-session exercises, 
reframing or restructuring cognitions, interpreting, and educating). The therapist has the 
flexibility to individualize care such that immediate needs identified by the dyad at the 
beginning of the care consultation partnership will take priority. For many families this 
will mean that concrete action plans related to CC domains of care (e.g., arranging 
benefits, questions about medication) will be implemented before the counseling 
protocol is initiated. Based on preliminary clinical work in the TADO clinic, it is expected 
that the course for most cases will follow three phases:  
1. Phase 1: Care Consultation (initial assessment and addressing immediate practical 
needs); 
2. Phase 2: Counseling (to address distress and mental health needs beyond the scope 
of CC alone);  
3. Phase 3: Care Consultation (to maintain progress, provide ongoing support, and 
continue to address lingering needs or those that surface for the first time after core 
distress elements have been addressed). 
Including the individual with dementia is encouraged in CC and CC+C, though 
many of the original resource materials available focus on the skill development for the 
caregiver. To continue movement toward a dyad-focused approach in CC+C, phone 
sessions with the veteran with dementia will be completed whenever possible either 
before or after the caregiver phone session. Though shared sessions may be possible 
for some dyads, and more readily available in the future with videoconferencing 
technology, sequential interactions will be the focus of CC+C.  
 
Table 2. CC+C Session Content  
Telephone Session Content (approximately 6-8 Sessions) 
1. Introduction to Stress Management (required): Impact of dementia on relationships, 
impact of stress on caregiving, and introduction to stress management/skills.  
2. Mindfulness (required): What is mindfulness, types of mindfulness, and mindfulness in 
everyday activities. 
3. Increasing Pleasant Activities (required): Introduce how discomfort and mood are 
related to activity level, explore current activity, and discuss ways to modify activities for 
greater comfort and enjoyment. 
4. Grief & Loss (required): ambiguous loss, identifying grief-related emotions, shifting 
roles & needs fulfillment; disconnect between expectations and current course. 

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5. Preserving Identity (required): Values/goals; maintaining individual identity of the 
caregiver and person with dementia, documenting memories, and creating shared 
meaningful/pleasant activities. 
6. Physical Affection & Sexual Intimacy (elective): Touch as nonverbal communication 
and social connection, building intimacy through shared rituals/routines. 
7. Managing Chronic Pain and Distress (elective): Pain education and distress behaviors 
as indicators of pain. 
8. Resentment, Hostility, & Conflict Resolution (elective): Lean about arguments you 
cannot win; hurtful lapses in memory, accusations & paranoia, and impact of previous 
patterns of relating on current relationship; commitment to relationship, etc.  
9. Alcohol, Substances, and Medications Misuse (elective): Safety planning and 
management of alcohol/substance of abuse, the impact of memory problems on 
management of medications and an introduction to resources for sustained support.  
 
Treatment Implementation, Fidelity, and Process Variables:  
Treatment delivery: The MSW-level interventionist will be trained to criterion and 
will be certified before administering the intervention. Accuracy of treatment delivery will 
be monitored. The interventionist will also complete a fidelity checklist to ensure that all 
treatment components are delivered during each session.  As one measure of potential 
bias, the treatment fidelity checklist will include a self-reported item assessing the 
interventionists’ desire/pressure to alter the randomly assigned condition for each dyad 
(i.e., agreement with the following statement will be assessed: “I believe the other arm of 
the study would have been a better fit for this dyad than the one they were randomly 
assigned”). Sessions will be audiotaped and 30% of sessions will be randomly selected 
and reviewed to ensure treatment fidelity to the CC and CC+C protocols. Treatment 
receipt: will be assessed by documenting the length of all intervention sessions (i.e., 
direct time spent with the dyads) and indirect time (e.g., documentation, case 
management, etc.). Participant knowledge of interventions components, which is 
sometimes included in measures of treatment receipt, is not appropriate for this study.110 
Treatment enactment: will be monitored by: 1) the number of completed Action Plans 
and homework assignments in each group CC & CC+C, and 2) attendance/adherence 
to scheduled appointments. Other treatment implementation notes that do not directly 
impact human subjects protections include interventionists notes about “Process 
Considerations and Interventionist Pressures” including the interventionists’ opinions 
about the two interventions (CC and CC+C).   
 
18. Differentiation of “usual (standard) care” from research activities.  
 
All procedures listed are voluntary in nature and unrelated to current clinical care. 
Participation in a similar clinical pilot program may be available to some families (e.g., 
those who live in rural areas may qualify for the Telephone Assisted Dementia Outreach 
Program, pending sustainment and availability which is unknown at the time this protocol 
is being submitted). However, no permanent services or “usual” treatment options 
similar to the one being studied are available at the Tuscaloosa VAMC.  
 
 

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19. Enlisting clinical expertise. 
 
The study team has extensive clinical expertise in the delivery of interventions for 
individuals with dementia and their caregivers. See CVs and Bios uploaded and 
attached to this protocol for sample publications by the study team.  
 
20. Description of the anticipated data and how the data will be analyzed to test 
the specific hypotheses results. 
 
Study Design, Power, & Target Sample Size 
We plan to recruit at least 70 dyads across the 3-5 year study period to ensure 50 
completers at 6 months. This rate of 2 dyads per month is feasible given that there are 
421 veterans with dementia currently receiving services from the TVAMC outpatient 
clinics (FY2013 clinical data). If 50% of them are in moderate to high distress (a 
conservative estimate based on our preliminary work), there would be over 200 
individuals eligible. Power analyses were conducted to support this sample size (see 
attached grant text for more details).  
 
Data Management and Analysis 
 
Data Entry: 
Data will be entered using Remark Office Optical Mark Recognition software and 
analyzed using Statistical Package for the Social Sciences (SPSS). Data analysis will be 
conducted using the VA Informatics and Computing Infrastructure (VINCI) server behind 
the VA firewall, as has been done for other TVAMC IRB approved studies. The research 
assistant will review all data for accuracy and will complete data tracking forms. A 
descriptive analysis of all assessment data will be conducted in order to examine 
distributional properties and correlations between the measures and the assumptions of 
statistical tests will be examined. Where necessary and sensible, data transformations, 
including the elimination of outliers, will be considered for variables with problematic 
properties. 
 
Treatment of Missing Values:  
Missing values are unavoidable in applied clinical intervention research. Where possible, 
variables to index the number and reasons for missing values will be documented. 
Based on the distribution of these missing value indices we may choose to eliminate 
some participants from the analyses (“list-wise deletion”). The extent that missing values 
are related to the independent (treatment group) or outcome variables will be assessed 
and if necessary controlled for statistically. Individuals who complete at least four 
sessions of the intervention (CC or CC+C) will be included in final analyses when time 2 
data are available. Strict intention-to-treat methodologies are too conservative for this 
relatively small initial pilot study. 
 
 
 

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Data Analysis:  
A series of one-way between subjects analyses of covariance (ANCOVAs) will be used 
to examine the main effect of “group” on 6 month variables of interest while controlling 
for values at baseline. The dependent variable in these analyses will be change scores 
with pre-treatment scores as the covariate. This analysis is statistically equivalent to 
ANCOVA with pre-treatment scores as the covariate and 6-month scores as the 
dependent variable, but it has an interpretational advantage in that the change scores 
represent an individual treatment effect (change during treatment). The change scores 
also represent the interaction term of a 2 (Group) X 2 (Time) repeated measures 
ANOVA. Consequently, when other covariates are added to the ANCOVAs to address 
treatment moderation effects, those covariate effects will be directly interpretable as 
moderator effects. That is, the added terms will assess the effects of the covariates on 
changes during treatment irrespective of Group (essentially a Time by Covariate 
interaction). When the interaction (multiplicative product) of covariate and Group is also 
added as another term in the ANCOVA, that interaction term will supply the moderating 
effect of the covariate on change during treatment as function of Group (i.e., differential 
effect of treatment as a function of the covariate). 
 
Outcome measures for caregivers will be run in separate analyses from those of the 
veterans with dementia, such that a series of ANCOVAs are anticipated for 1) self-report 
measures for the caregiver; 2) self-report measures for the veteran with dementia; and 
3) proxy-reported measures for the veteran with dementia (as rated by their caregiver). 
Partial eta squared statistics of effect will be used as the primary indicator of likely 
treatment effects in this small sample. A large effect is indicated by a partial eta squared 
(hp2) greater than or equal to 0.14, a medium effect is determined by a value greater 
than or equal to 0.06, and small effects are determined by values greater than or equal 
to 0.01. For the purposes of the current study, between groups effect sizes greater than 
or equal to .01 (a small effect) will be interpreted as potentially clinically meaningful in 
the interpretation of results since two active treatments are being compared. Cohen’s d 
statistics will also be calculated for the purposes of the current feasibility study because 
they are one of the most common methods of estimating effect sizes and are more 
easily interpreted than the partial eta squared effects. In order to calculate Cohen’s d 
statistics, standard error terms will be converted into standard deviations and used with 
the estimated marginal means from the post-treatment ANCOVAs. Both types of effect 
sizes will be calculated. Finally, logistic regression analyses will be conducted to 
determine if NH placement at 6 and 12 months is differentially related to treatment 
condition (i.e., group assignment) for individuals with dementia. NH placement (or not) 
will be the dependent variable in these analyses, and independent variables 
will include Group and relevant covariates. 
 
21. Risks (physical, psychological, social, and economic) and steps taken to 
minimize these risks. 
 
Physical Risks: There are no anticipated physical risks with this study. All activities in 
the study will be within the normal limits of participants’ everyday physical demands. 
Increased veteran activity and/or range of motion could potentially result in exacerbation 

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of pre-existing pain conditions (e.g., arthritis, etc.); however, potential benefits in 
strength/decreased disability exceed potential risks.  
 
Psychological Risks: The risks to participants are minimal because this study utilizes a 
strengths-based intervention that has been evaluated and supported by other studies 
without negative psychological effects. Participants may feel that the interview process 
and completion of the self-report forms are an invasion of privacy. While answering 
questions about their life experiences or their physical and psychological symptoms, 
participants may experience transient anxiety, discomfort or embarrassment, or distressing 
memories may be triggered. To minimize any further discomfort, participants will be 
allowed to take breaks during the intervention sessions and when completing 
assessments. If necessary, the appointment may be rescheduled or ended early. 
Furthermore, the content of self-report data through one-on-one interviews will not 
exceed self-report information that is requested for clinical purposes as part of routine 
daily care. Furthermore, intervention exercises (e.g., relaxation training, engagement in 
pleasant events, practicing communication strategies, etc.) are unlikely to cause distress 
beyond what would be experienced in a typical day. Home-based data collection may 
make some participants uncomfortable or embarrassed; however this has not 
materialized as a measurable risk in other studies using this procedure. There is also a 
slight chance that despite privacy procedures confidential clinical information could be 
accessible by individuals not related to the study or the facility. Steps will be followed to 
protect against this research-related risk. 
 
Risks to caregiver participants could include boredom with the study procedures; 
frustration, or distress related to discussing their situation in the role of caregiver. They 
may experience transient anxiety, discomfort, or embarrassment related to their feelings 
about their role as caregiver or the impact of dementia on their relationships. Study 
procedures are not anticipated to exceed frustrations or distress encountered in their 
daily experiences. Any observations or reports of acute distress that could compromise 
safety (e.g., risk of harm or neglect to self or others) will be handled in compliance with 
standard operating procedures and within VA ethical guidelines. Acute risk to non-VA 
patients (i.e., caregivers) will be handled through community mental health networks, 
emergency rooms, and involvement of local law enforcement if necessary. Specific 
protocols for staff safety and risk management during home assessment visits were 
developed during the CDA1 in collaboration with VA experts and the mentoring team. As 
with other telehealth delivery modalities, the physical addresses of the participants will 
be identified on or before the first telephone appointment should emergency personnel 
involvement become indicated during a telephone interaction. Procedures will be 
implemented to minimize risks. Members of the investigative team have extensive 
experience in remote risk assessment (e.g., telehealth interventions within the VA) and 
have published articles on suicide assessment (see Letters of Support) including a 
recent online article that I developed on this topic.  
 
Legal and Social Risks: An unlikely legal or social risk that must be acknowledged in 
research is the risk associated with compromised privacy in the unlikely event of a 
breach of confidentiality for data considered VA sensitive information. These risks are 

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not unique to this study and are not associated with the intervention or staff training in 
this proposal. TVAMC has strict and detailed standard operating procedures in place to 
guard against these risks including policies on the use and storage of data containing 
PHI. Data collected in the field will remain behind two locks during transport from home 
interviews to the VA Medical Center where data will be stored (e.g., in a locked HIPAA-
compliant secure bag in a locked trunk as is done for home based primary care services 
and research during the CDA1 period).  
 
Economic Risks: Although most participants are unlikely to be employed, it is possible 
that some participants may have to miss work in order to attend an assessment visit or a 
VA health care visit. Every effort will be made to avoid economic risk due to a participant 
having to miss work during an appointment time. Since assessments occur in the 
veteran’s community and the intervention and some assessments are delivered over the 
phone, travel-related expenses for study participants are estimated to be minimal. A 
government car will be used for home visits by project staff.  
 
22. Describe in detail the provisions for managing adverse reactions and for 
monitoring data to ensure the safety of subjects. Describe any plans for Data 
and Safety Monitoring Board (DSMB). 
 
As described above, serious adverse reactions are not expected. The following details 
and re-iterates plans for managing adverse reactions: 
 
Medical and Psychiatric Safety Contingency Plan:  While in the home, the research 
team member may call 911 from their government issued cell phone for emergency 
services at any time if they judge any immediate risk to self or others.  Prior to going 
into the community setting, research team members are trained in the Prevention and 
Management of Disruptive Behaviors, and home-safety protocols (e.g., like the one 
used by the TVAMC Home Based Primary Care Team) which involves identification of 
early warning signs of threat and early means to de-escalate the situation, as well as 
more advanced escape techniques.  For signs of threat to personal safety, the research 
team member is instructed to leave the premises and contact the PI for addition 
instructions.  During a visit, the research team member may consult directly with the PI 
for advice and input regarding these situations.  The consultation can take place either 
during or immediately following the assessment visit.  If medically or psychiatrically 
indicated, the Veteran may be seen immediately at the nearest emergency room or VA 
clinic. 
 
Emergency Response for Unanticipated Adverse Events during HBPC Visit: The 
research team members will be trained in recognizing medical or psychiatric 
emergencies.  In the unlikely event that a research team member encounters such an 
unanticipated adverse event during the visit, the research team member will either call 
911 (if immediate medical attention is needed) or call the PI.  Usual TVAMC 
procedures will be followed in the event of a serious adverse event or emergency. All 
serious adverse events (SAEs) related to the study procedures and unanticipated 

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adverse events will be reported to the IRB and Data Safety Monitoring Board (see 
below). 
 
In the unlikely event of a level of psychological distress that requires professional 
intervention for the subject, same day or next business day psychology support and/or 
counseling will be offered.  
 
The PI will audit case report forms and informed consent forms for compliance with 
procedures for data safety and human subject protection. Training of the study staff will 
include steps to assure accuracy and integrity of the data through all stages of the study 
including accuracy with log entries, case report file entries, and data base entries from 
case report files. Study staff will be trained with regards to adverse events and 
unforeseen problems that may occur, and the required procedures for communicating 
about these events, including IRB report forms. The PI will promptly review all adverse 
events and unforeseen problems. These will be reviewed and reported per TVAMC IRB 
guidelines. 
 
A Data Safety Monitoring Board [DSMB] will be formed within 30 days of enrolling the 
first participant. On a biannual basis, the DSMB will convene a meeting, review the 
progress of the study and evaluate the ongoing safety of participants. At the initial 
meeting, the DSMB will review the protocol in detail. If at any time during the course of 
the study, the DSMB judges that risk to participants outweighs the potential benefits, the 
DSMB has the discretion and responsibility to recommend that the study be terminated. 
Study stopping rules will be established at the initial meeting. All unanticipated AEs, 
deaths, and SAEs due to the study procedures will be reported to the DSMB chair within 
72 hours. Reports for unanticipated events determined by either the investigator or 
DSMB to be possibly or definitely related to participation and reports of events resulting 
in death will be promptly forwarded to all regulatory agencies. In addition to safety 
monitoring, the DSMB will monitor data quality. At least annually during the study, The 
DSMB will receive a report on data quality and completeness. At a minimum, this will 
include an overview of the progress of participants’ screened, summary reports 
describing participant demographics, and summary of data entry progress and query 
resolution. These reports will be used by the DSMB to evaluate the capacity of the data 
capture and processing to support scientifically valid findings. 
 
23. Planned procedure for obtaining informed consent including the 
circumstances surrounding consent procedures  
 
Prior to resident enrollment, the potential participant or legally authorized representative 
(LAR) will be provided with detailed information regarding the study’s purpose, 
procedures, potential risks and benefits, alternatives to participating in the study, and 
other required elements of informed consent approved by the TVAMC IRB. Potential 
participants will be given ample time to consider enrollment into the study and can 
involve family members, significant others and his/her primary treatment providers in 
their decision. Participants are informed that refusal to participate in this research 
protocol will not penalize them or change their eligibility for VA services, treatment, or 

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disability payments. When persons with impaired decision-making capacity are included, 
surrogate consent will be obtained (described below). Including persons with impaired 
decision-making capacity as participants is essential in this study and will allow us to 
gain an understanding of quality of care needs for this population of veterans. In the 
case of compromised capacity, legally authorized representatives will be able to 
complete proxy consent procedures. Specifically, the participants’ legally authorized 
representatives (LAR) will receive details about the research study. Participant assent 
(i.e., patient’s willingness to take part in the study) will also be required for their 
involvement and noted in the source documentation. Note, however, that caregivers can 
participate without the veteran when that is consistent with the wishes of a given family 
or the veteran is too impaired to participate meaningfully. Subsequently, the participant’s 
original informed consent documents will be maintained with other essential documents.  
 
Location of the consent process: A private setting, such as TVAMC office or in the 
participants’ home or private room in a community setting (library or veteran service 
office).  
 
Who will conduct consent: A qualified IRB-approved member of the research team will 
be responsible for explaining the study, answering questions, and obtaining informed 
consent. All individuals completing the consent procedure for the research team will 
have extensive training on the informed consent process and their training will be 
approved by the PI prior to any procedures being performed. 
 
Decision-making Capacity of the Potential Volunteer: Participants who provide their 
own consent must have decision-making capacity at the time of the consent discussion 
and assessment visit. Members of the investigative team have prior experience 
conducting research with individuals with impaired decision-making capacity; the person 
obtaining consent will be thoroughly trained using IRB-approved procedures to ensure 
decision-making capacity before consenting participants. Under all circumstances, the 
participant’s autonomy will be respected. Specifically, the following protocol has been 
used in the PI’s prior research with individuals with dementia:  
 
Capacity Protocol  
Individuals with probable dementia are considered to be a vulnerable population so 
extra cautionary steps will be taken to ensure that participants have capacity to consent 
to the research study. However, diminished cognitive functioning alone is not considered 
to be synonymous with capacity to consent to research, which is situation-specific.29 
Moye and Marson’s30 article on assessment of decision making capacity in older adults 
points out that consenting to research is a fairly specific, “narrow cognitive task” (p. P4). 
Furthermore, capacity to consent to any given study is based on the complexity of the 
task and the level of risk involved. Applebaum & Grisso53 suggest that complex medical 
or clinical trials may be more difficult for individuals with mild levels of impairment than 
psychosocial research.  
 
Informed consent procedures will be conducted in accordance with the consensus 
recommendations for research with cognitively impaired populations,54 described in 

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detail below. Proxy consent and participant assent will be collected when the participant 
is willing to assent for the study but is determined to have diminished capacity at the 
time of consent. Family caregivers will also complete informed consent for the use of 
their information in the study. Although many of the outcomes of the intervention are 
about the individual with dementia, family caregivers will provided their perspective of 
the individual with dementia’s functioning as well as information about their own feelings 
and opinions and therefore will have to complete a separate informed consent 
procedure. Informed consent will be completed at the beginning of the baseline 
assessment visit.  
 
Researchers who conducted the baseline assessment will be trained to assess capacity 
to consent prior to the first assessment. Consent procedures will be supervised by the PI 
who has experience conducting capacity assessments within the VHA and in community 
settings (e.g., The University of Alabama’s Elder Law Clinic).  
 
In order to determine capacity to consent, the participant’s ability to do the following will 
be assessed: (a) understand the nature of the research and of his/her participation (e.g., 
by asking the participant to repeat back in their own words what the study is about); (b) 
appreciate the consequences of the participation, including personal consequences 
(e.g., is the participant able to spontaneously provide both negative and positive 
potential consequences of participating in the study); (c) understand alternatives, 
including the option not to participate (e.g., do they understand that participation is 
voluntary); and (d) to make a reasoned and consistent choice (e.g., are they providing 
logical reasons for wanting to participate and are they consistent over time in their 
expressed desire to do so).  
 
Investigators will use both orally and visually presented information and the participant 
will be offered a copy of the informed consent for their records.55 The researcher will 
also stop several times during the consent procedure to test for understanding and 
requested that the participant “put it into their own words,” before moving forward. A 
capacity to consent checklist has been developed to aid in assessment and 
documentation of capacity procedures in accordance with the TVAMC IRB. If 
participants are unable to complete the steps outlined above and express interest in 
participating, participant assent and proxy consent will be completed.  
 
In accordance with VA Handbook 1200.5 requirement that there be documentation of 
impaired decision-making capacity by a clinician in the electronic record before 
surrogate consent can be obtained, when evidence of lack of decision-making capacity 
is identified, the person obtaining consent will confer with a clinician co-investigator (i.e., 
the PI) from the study and if indicated that clinician will enter a note in the electronic 
record.  The Veteran and caregiver will receive a copy of the informed consents and  
HIPAA or Notice of Privacy Practices. The informed consent and HIPPA will not be 
scanned into the Veteran’s medical record.   Whether consent or assent is given, a 
participant’s decision to withdraw at any time (whether expressed verbally or by 
resistance to participation) will be honored.  
 

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Surrogate Consent Procedures: VHA Handbook 1200.5 describes the conditions 
under which consent from authorized representatives (i.e. surrogate consent) can be 
obtained in lieu of consent from the veteran. Similarly, a procedure for informed consent 
for patients who lack decision-making capacity is spelled out in the TVAMC Center 
Memorandum and Standard Operating Procedures. Surrogate consent is allowed when 
a participant is deemed to lack decision-making capacity and the surrogate is provided 
the same information that would be given the potential participant if competent. 
Surrogates must have intact decision-making capacity. Whenever possible, surrogates 
should make decisions based on “substituted judgment”, using views the individual 
expressed while fully capable; if the values of the participant are not known, “best 
interest” standards may be used. The surrogate signs the informed consent on the 
appropriate signature line and the process of the surrogate consent is documented in 
the patient’s medical record. Consistent with these policies, the investigators will 
recognize the following, in descending order of priority, as authorized representatives for 
research informed consent when potential research participants lack decision-making 
capacity: 
1) Persons appointed as health care agents under a Durable Powers of Attorney for 
Health Care or a similar document (Legally Authorized Representative for 
Surrogate Consent);  
2) Court-appointed guardian (Legally Authorized Representative for Surrogate 
Consent); 
3) Next-of-kin willing to participate in surrogate informed consent, in the following 
order of priority as dictated by the state of Alabama (unless otherwise specified in 
the VAMC medical record for designated next of kin): spouse, adult child (age 19 
or older), parent, adult sibling (age 19 or older), grandparent, or adult grandchild 
(age 19 or older).  
 
If needed, the PI may consult with the TVAMC Privacy Officer, IRB, TVAMC Integrated 
Ethics Council, or VA Regional Counsel if there are uncertainties about who should 
serve as a surrogate for an individual patient. When needed, the PI, Privacy Officer, IRB, 
or other staff on behalf of the TVAMC Human Research Protections Program can 
consult with VA Regional Council for assistance in applying laws involving authorized 
representative surrogate consent. 
 
24. Compensation for participation, if offered, and amount 
No compensation will be provided for study participants. 
 
25. Plans for protection of patient privacy and confidentiality  
Efforts to maintain privacy of veterans and families enrolled will be a top priority. 
Safeguards to protect privacy include conducting all interviews in a private and secure 
area. Whenever possible, the research team will encourage the veteran and caregiver to 
be in different rooms during the assessment visits (e.g., the researcher will be 
interviewing the veteran in one room while the caregiver fills out paper and pencil self-
report measures independently in another room). This will add to privacy by allowing 
each member of the dyad to be engaged with the project simultaneously yet separately.  

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Considerations of privacy during the intervention sessions (conducted over the phone) 
may be outside the research team’s control, in that it will be difficult to know the level of 
privacy on the other end of the phone (i.e., in the participant’s home). As has been done 
with other studies, the interventionist will thoroughly discuss privacy considerations on 
initial calls and will be available to answer any questions or problem-solve privacy issues 
in the home. Before intervention calls, the researcher will also prompt the caregiver or 
veteran about privacy issues that may arise during the call and will encourage them to 
move to a private location in the home if possible.  
 
Privacy will also be protected within the VA research space. All study documents will be 
kept in a locked office or on a computer located in a secure area that is password 
protected. Electronic information including audio recordings of the intervention sessions 
will also be password protected. Telephone sessions will be taped in one of two ways: 1) 
by directly connecting the VA office telephone to the PC through an adapter so that the 
session can be recorded directly onto the secured VA Network Server (preferred); or 2) 
using a VA-approved, encrypted digital recorder that is FIPS 140-2 validated (Phillips 
model as is used on other currently approved IRB studies). Furthermore, fidelity audits 
of a subset of the interviews will be completed within the VA firewall. All phone 
interactions with participants will occur in private, secure locations (e.g., private offices); 
and therefore, the mobile recording device also remains within the VA research space 
(Building 3, 1st floor, Rooms 127, 130, 131) at all times. Original electronic VA research 
data stored on a mobile device will be backed up regularly (approximately weekly) and 
stored securely within VA’s protected environment, as described elsewhere. 
 
Additionally, participant PHI will be de-identified in the data analyses, publications, and 
presentations of research results. Lastly, a Health Insurance Portability and Accountability 
Act (HIPAA) authorization will be given with the ICF to notify the participant or LAR in 
what capacity their identifiable personal health information will be used. Both 
documents provide a detailed outline of the provisions utilized to protect the 
confidentiality of research data.  
 
26. Plans for information security. 
 
Upon enrollment, each study participant will be assigned a unique study identification 
number (study ID). Personal identifiers (name, SSN, date of birth) will be collected on 
source documentation only and protected with strict confidentiality in a secure 
environment. The study ID will identify each individual case report form (CRF) so that 
data entered into the database will be de-identified. All personally identifying information 
(PII) will be maintained in a separate secure location from the database. Additionally, 
information connecting the study ID with the participant is accessible only to study 
personnel. Access to research study data will be removed for study personnel when they 
are no longer part of the research team. 
 
Data Management and Access Plan: Paper documents will be stored behind two locks 
under the PI’s supervision (TVAMC Building 3, Room 127, 130, or 131). Electronic study 
files, including the de-identified databases, will be maintained on the VA secured 

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network (SNOW/HIGEMAN/MAHANEY or Research Drive/Investigator Files/Hilgeman’s 
Studies) with restricted access and only accessible through a password-protected 
encrypted computer at TVAMC.  
 
The web-based version of the CCIS (described in the intervention section above) is 
placed on the SQL 2012 R2 consolidation server. Only trained, verified users with a 
current username and password (established with confirmation of the PI) can access the 
CCIS research application.  
Data collected in the field will remain behind two locks during transport from home 
interviews to the VA Medical Center where data will be stored (e.g., in a locked HIPAA-
compliant secure bag in a locked trunk as is done for home based primary care services 
and research during the CDA1 period). Only co-investigators who are listed on the 
current approved IRB protocol and have up to date VA trainings on HIPAA and data 
security will transport the data from the community back to the VA.  
 
Data Use Agreement for Analysis of Deidentified Data: A data use agreement(s) will 
be used to establish the terms and conditions under which Michelle Hilgeman, Principal 
Investigator (for the ODeC study of the Research Service at the Tuscaloosa VA Medical 
Center (TVAMC), a component of the U.S. Department of Veterans Affairs) will provide a 
de-identified dataset to a University Consultant assisting with the analyses. This data 
use agreement (DUA) covers the transfer of this dataset from the Tuscaloosa VA where 
it currently resides (only members of the ODeC VA investigator team as described in the 
ODeC protocol) have access; to the ODeC study Consultant located at the University 
(e.g., The University of West Florida or The University of Alabama) regarding the study 
specified in the agreement. The DUA will be uploaded to IRBNet when completed. The 
PI, Dr. Michelle Hilgeman will ensure data is de-identified and that all 18 PHI criteria 
have been removed. The Privacy Officer will be provided with a copy of the data for his 
review to confirm it has been appropriately de-identified. A copy of the password 
protected de-identified data file (Excel file) will be emailed. As specified in the IRB 
protocol, no private health information (PHI) will be transported outside of VA.   
 
Data Access and Accounting: See Appendix A ODeC Data Use Agreement (DUA) for 
a list of those with access to a copy of the deidentified ODeC data outside of the VA 
network. 
 
The investigator’s research records for this study will be maintained according to the 
disposition instructions by the National Archives and Records Administration and are 
published in VHA’ s Records Control Schedule (RCS) 10-1, in accordance with the new 
VHA’ s Records Control Schedule 10-1 (RCS) policies for the Office of Research and 
Development; section 7.6. At study closure or at the PI's expiration of VA appointment, 
research records will be retained by the research office for storage at the completion of 
the research study. Documents with private health information data that are not part of 
the research will be placed in the Shred-it boxes located in the Research suite at 
TVAMC. For a study such as this one (i.e. not FDA-regulated), the PI may destroy 

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research records 6 years after the end of the fiscal year after completion of the research 
project, but the investigator may retain longer if needed. 
 
Public access to publications resulting from the research:  The proposed research is to 
be funded by VA. Publications resulting from the research will be made available to the 
public through the National Library of Medicine (NLM) PubMed Central website within 
one year after the date of publication.  [Submission procedures are provided on the 
Office of Research and Development (ORD) website at 
http://www.research.va.gov/resources/policies/public_access.cfm.] 
Public access to final data sets underlying publications resulting from the research:  
Final data sets underlying publications resulting from the proposed research will not be 
shared outside VA, except as required under the Freedom of Information Act (FOIA) as 
this study team does not have access to the necessary infrastructure (e.g., a data 
repository) to make data publicly available, at this time.  
Mechanisms for public access to final data sets underlying publications resulting from 
the research:  Final data sets underlying publications resulting from the proposed 
research will not be shared outside VA. 
 
Planned Procedure for Misuse, Loss or Theft of VA Sensitive Information: The 
investigators will comply with VHA policies on prompt reporting of loss, theft, or actual or 
suspected breaches involving sensitive information, along with any other privacy or 
security incident or complaint. The ISO will promptly determine whether an incident 
warrants further reporting and actions.  At a minimum, the following should occur as 
soon as it is discovered that there has been a loss: 
1) Report the loss or theft to the VA security/police officers immediately 
2) During travel or at another institution, notify the security/police officers at the 
institution such as hotel security, university security, etc. as well as the police in 
the jurisdiction where the event occurred 
3) Obtain the case number and the name and badge number of the investigating 
officer(s). If possible, obtain a copy of the case report 
4) Immediately (within 1 hour of discovery) call, and email a description describing 
the event to the following regarding the incident: 
o The PI (if investigators other than the PI are reporting the loss, theft, or 
actual or suspected breach) 
o The person’s immediate supervisor 
o The local Information Security Officer (ISO) 
o The Chief of Staff 
o The Medical Center Director  
o The Associate Chief of Staff for Research and Development 
o The Privacy Officer must be notified when there is any unauthorized use, 
loss, or disclosure of individually-identifiable patient information.   
Any such event must also be reported to the IRB as an unexpected adverse event.   
 
27. Methods used to identify and recruit patients.  
 

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Recruitment will occur in one of four ways.  
 
a) Through a Clinical Partner: Participants receiving clinical services for dementia or 
a related disorder at the TVAMC will be offered the opportunity to learn more about 
this study by a member of their clinical team. Veterans or their caregivers who 
express interest in learning more to their clinical team, will be contacted by telephone 
by a member of the study to provide additional information and determine interest 
and screening for eligibility.  
 
b) Self-Referral: Recruitment materials will also be distributed in clinical areas so 
that self-referrals can be made.  
 
c) Research Outreach / Introductory Letter & Opt-Out Card:  
When a referral is made by a clinical partner or administrative staff without speaking to 
the veteran or family first, initial contact will be made by mail using an introductory letter. 
No “cold calls” will be conducted. Introductory invitation letters  and IRB approved 
brochures will be mailed to potential veterans with dementia or a related disorder and 
their family caregivers with an addressed, postage paid reply card, which will allow 
participants to express interest in being contacted by the study team. Materials will be 
created with sensitivity to ensure that receiving a letter invitation to a study is not 
perceived as distressing. Once consent to be contacted is obtained (either through the 
health care provider or by returning a reply card), the study team will call the potential 
participants to give them more information about the study, conduct a brief screening 
over the telephone, and schedule a home visit if they are interested. A HIPAA waiver for 
screening and recruitment is requested for this purpose.  
 
 
 
 
 
 
d) VINCI Data Pull:   
The study would like to contact potential, appropriate, participants for this study through 
the use of a referral list extracted from the VINCI. We will use VINCI to obtain a listing of 
potential participants based on study inclusion and exclusion criteria.  VINCI is 
collaboration between the VHA Office of R&D and the VA Office of Information 
Technology to provide a secure and central analytic platform for research activities. It 
facilitates access to CDW and provides a secure storage location for all data acquired as 
well as analytic tools used to manage and analyze the data. All data will be stored within 
the secure VINCI project folders. VINCI grants access on an as-needed basis to IRB-
approved study personnel. Our research team has experience accessing and using 
VINCI in order to reduce potential problems in data collection, as well as in controlling 
the quality of the data collected.  The research coordinator or Health Science Specialist 
for the study will request data for this study and a VINCI-identified data manager will 
assist in identifying and pulling the appropriate data to recruit an adequate number of 
appropriate subjects more rapidly. Targeting our recruitment efforts also means that 
non-eligible subjects will not receive extraneous paper or flyers. Study data will be kept 
in accordance with the Department of Veterans Affairs record control schedule 10-1 
(RCS 10-1).  The study team will keep all sensitive patient data on VINCI project servers 
maintained by VINCI OI&T personnel.  Any PHI data to be downloaded from VINCI to 
local storage media must have VINCI data steward permission. Research staff will use 

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Version Date: August 13, 2020 
 
an audited VINCI download utility to move summarized data from VINCI servers to local 
storage media. The VINCI download utility provides an audit path including a copy of the 
downloaded material. 
 
28. Safeguards to prevent coercion or undue influence for study subjects. 
 
Subjects will be given ample time to read and consider the informed consent.  Subjects 
may have as much time as needed (no time limit) to read and consider the risks and 
benefits of the study participation.  Subjects may involve family members, or significant 
others in the decision on whether or not to participate in the study.  Subjects are 
informed that refusal to participate in research projects will not change their eligibility for 
VA services, treatment, or disability payments.  No guarantees are made for benefit 
during the research study. Given this study population, it is anticipated that the consent 
process will take longer than most participant groups. 
 
29. Resources. 
 
All named investigators and research assistants are currently qualified and are trained 
and experienced in clinical research. They all have adequate offices and space and 
adequate access to patient’s needed for the study. 
 
30. Safeguards to protect the rights and welfare of mentally disabled and/or 
decisionally impaired subjects (vulnerable patient populations). 
This study sample will include participants with varying degrees of cognitive impairment 
(from intact to severely impaired) and other mental health diagnoses (e.g., serious mental 
illness) that would classify them as vulnerable populations. In the event that these 
participants have impaired decision-making capacity, appropriate surrogate consent will 
be obtained as described above. All members of the investigative team have previous 
experience conducting research with individuals with impaired decision-making capacity. 
In addition, the Data Safety Monitoring Board (DSMB) will convene on a biannual basis to 
review the progress of the study and evaluate the ongoing safety of participants. If at any 
time during the course of the study, the DSMB judges that risk to participants outweighs 
the potential benefits, the DSMB has the discretion and responsibility to recommend that 
the study be terminated. 
 
31. Plans for Adherence to VA Policies and Regulations Regarding Research 
Involving Controlled Drugs N:\HRPP POLICIES\Use of Controlled Substance in 
Research 102706.TIF: 
Not applicable - Controlled drugs will not be used in this research study. 
 
32. Reuse of data 
The data collected for this study will be used to write one or more manuscripts for 
publication. If results of this study are reported in medical journals or at meetings, the 
veterans will not be identified by name, by recognizable photograph, or by any other 
means without their specific consent. Audio recordings collected during data collection will 

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not be used during presentations. Information gathered from this study will also be used 
as pilot data to write future grant proposals. 
 
33. Research at external sites and multi-site research in which the investigator is 
lead investigator.  
Not applicable 
 
34. References 
1. Sandelowski M. Whatever happened to qualitative description?  Res Nurs  
Health. 2000; 23(4):334-40 
2. Alzheimer's Association. 2010 Alzheimer's disease facts and figures. 
Alzheimers Dement. 2010;6 (2):158. 
3. Qureshi SU, Kimbrell T, Pyne JM,  et al. Greater prevalence and incidence of 
dementia in older veterans with posttraumatic stress disorder. JAGS. 
2010;58(9):1627-1633.  
4.  Leibson C, Rocca W, Hanson V, et al. Risk of dementia among persons with 
diabetes mellitus: a population-based cohort study. Am J Epidemiol. 1997; 
145(4):301-8. 
5.  Luchsinger JA, Tang MX, Stern Y, Shea S, Mayeux R. Diabetes mellitus and 
risk of Alzheimer's disease and dementia with stroke in a multiethnic cohort. Am J 
Epidemiol. 2001;154(7):635–41 
6. Saunders PA, Copeland JR, Dewey ME, et al. Heavy drinking as a risk factor 
for depression and dementia in elderly men. Findings from the Liverpool 
Longitudinal Community Study. Br J Psychiatry 1991;159:213–216. 
7. Whitmer RA, Sidney S, Selby J, Johnston SC,  Yaffe K. Midlife cardiovascular 
risk factors and risk of dementia in late life. Neurology. 2005; 64(2): 277-81. 
8. Krishnan LL, Peternen NJ, Snow AL, et al. Prevalence of dementia among 
Veterans Affairs Medical Care systems users. Dement Geriatr Cogn Disord. 2005; 
20 (4):245-53. 
9. Heyman A, Fillenbaum G, Prosnitz B, Raiford K, Burchett B, Clark, C. 
Estimated prevalence of dementia among elderly black and white community 
residents. Arch Neurol. 1991;48 (6):594-8. 
10.  Hall KS, Gao S, Unverzagt FW, Hendric HC. Low education and childhood 
rural residence: risk for Alzheimer’s disease in African Americans. Neurology. 
2000;54(1):95-9. 
11. Jorm AF, Korten AE, Henderson AS. The prevalence of dementia: A 
quantitative integration of the literature. Acta Psychiatr Scand 1987;76 (5):465-79. 
12.  Bass DM, Judge KS, Snow AL, et al. Caregiver outcomes of partners in 
dementia care: effect of a care coordination program for veterans with dementia 
and their family members and friends. J Am Geriatr Soc. 2013;61(8):1377-86 
13.  Deimling GT, Bass DM, Townsend AL, et al: Care-related stress: a 
comparison of spouse and adult-child caregivers in shared and separate 
households. J Aging Health. 1989; 1(1):67- 82. 
14.  Robinson L, Clare L, Evans K. Making sense of dementia and adjusting to loss: 
Psychological  reactions to a diagnosis of dementia in couples. Aging Ment 
Health. 2005; 9(4):337-47. 

28  
Version Date: August 13, 2020 
 
15.  Keady J, Nolan M. The dynamics of dementia: Working together, working 
separately, or  working alone? In: Partnerships in family care. Buckinghamshire: 
Open University Press; 2003:15-32. 
16.  Schulz R, O’Brien AT, Bookwala J, Fleissner K. Psychiatric and physical 
morbidity effects  of dementia caregiving: prevalence, correlates, and causes. 
Gerontologist.1995;35:(6):771-91. 
17.  Rankin E D, Haut MW, Keefover RW. Current marital functioning as a 
mediating factor in depression among spouse caregivers in dementia. Clin 
Gerontol. 2001;23(3/4):27-44. 
18. Chan D, Livingston G, Jones L, Sampson EL. Grief reactions in dementia 
carers: a systematic review. Int J Geriatr Psychiatry 2013; 28:1–17. 
19. Eloniemi-Sulkava U, Notkola IL, Hentinen M, Kivela SL, Sivenius J, Sulkava R. 
Effects of supporting community-living demented patients and their caregivers. J Am 
Geriatr Soc. 2001;49(10):1282-7. 
20.  Thompson C, Briggs M. Support for careers of people with Alzheimer’s 
type dementia. Cochrane  Database Syst Rev. 2000 ;(2):CD000454. 
21.  Judge KS, Yarry SJ, Orsulic-Jeras S, Piercy K. Acceptability and feasibility 
results of a strength-based skills training program for dementia caregiving dyads. 
Gerontologist. 2010; 50(3):408-17. 
22.  Braun M, Scholz U, Bailey B, Perren S, Hornung R, Martin M. Dementia 
caregiving in spousal relationships: a dyadic perspective. Aging Ment Health. 
2009; 13(3); 426-36. 
23. Kunik ME. Preventing aggression in veterans with dementia (PAVeD). 
Clinician Manual. 2011;1:7-4. 
24. Hilgeman MM, Allen RS, Snow AL, Durkin DW, DeCoster J, Burgio L. 
Preserving identity and planning for advance care: preliminary outcomes from a 
patient-centered intervention. Aging Ment Health. 2013;18(4):411. 
25. Belle SH, Zhang S, Czaja SJ, Burns R, Schultz R. Use of cognitive 
enhancement medication in persons with AD with a family caregiver: results 
from REACH project. Am J Geriatr Psychiatry 2004;12(3):250-7. 
26. Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being 
delays nursing home placement of patients with Alzheimer’s Disease. Neurology 
2006;67(9):1592-9. 
27. Katon W, Russo J, Von Korff M, et al. Long-term effects of a collaborative 
care intervention in persistently depressed primary care patients. J Gen Intern 
Med. 2002;17(10):741–8. 
28. Hill L, Roberts G, Wildgoose J, Perkins R, Hahn S. Recovery and person-
centered care in dementia: common purpose, common practice?. Adv Psychiatr 
Treat. 2010; 16(4):288-298. 
29. U.S. Department of Veteran Affairs. Veterans Health Administration: Patient 
Centered Care. 
30. S. 1963--111th Congress: Caregivers and veterans omnibus health services 
act of 2010. (2009) In (database of federal legislation). 
31. Department of Veterans Affairs: Public and Intergovernmental Affairs press 
release. VA partners with Easter seals to train family caregivers of wounded 
warriors. Press release on May 9, 2011. Accessed 05/09/2011. 

29  
Version Date: August 13, 2020 
 
32. Borson S, Scanlan JM, Sadak T, Lessig M, Vitaliano P. Dementia Services 
Mini-Screen: A Simple Method to Identify Patients and Caregivers in Need of 
Enhance Dementia Care Services. Am J Geriatr Psychiatry,2014; 22(8): 746-
7554. 
33. Alzheimer’s Association. Research consent for cognitively impaired adults: 
Recommendations for institutional review boards and investigators. Alzheimer 
Dis Assoc Disord. 2004;18(3):171-175. 
34. Levy-Cushraan J, Abeles N. Memory complaints in the able elderly. Clin 
Gerontol. 1998;19(2):3-24. 
35. Nasreddine ZS, Phillips NA, Bédirian V, et al. The Montreal Cognitive 
Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am 
Geriatr Soc. 2005;53(4):695-699. 
36. Lawton MP, Brody EM. Assessment of older people: self-maintaining and 
instrumental activities of daily living. Gerontologist. 1969;9(3):179-186. 
37. Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of 
behavioral problems in dementia: The Revised Memory and Behavior Problems 
Checklist. Psychol Aging. 1992;7(4):622–631. 
38. Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell scale for 
depression in dementia. Biol Psychiat. 1988;23(3):271-284. 
39. Gibbons LE, Teri L, Logsdon RG, McCurry SM. Assessment of anxiety in 
dementia: an investigation into the association of different methods of 
measurement. J Geriatr Psych Neur. 2006;19(4):202-208. 
40. EuroQol Group. EuroQol-a new facility for the measurement of health-
related quality of life. Health Policy.1990;16(3):199. 
41. Vogel A, Mortensen EL, Hasselbalch SG, Andersen BB, Waldemar G. 
Patient versus informant reported quality of life in the earliest phases of 
Alzheimer's disease. Int J Geriatr Psych. 2006;21(12):1132-1138. 
42. Coucill W, Bryan S, Bentham P, Buckley A, Laight A. EQ-5D in patients with 
dementia: An investigation of inter-rater agreement. US National Library of 
Medicine National Institute of Health. Medical care 2001;39(8):760–771. 
43. Hawes C, Morris JN, Phillips CD, Mor V, Fries BE, Nonemaker S. Reliability 
estimates for the Minimum Data Set for nursing home resident assessment and 
care screening (MDS). Gerontologist. 1995;35(2):172-8. 
44. Busby DM, Christensen C, Crane DR, Larson JH. A revision of the Dyadic 
Adjustment Scale for use with distressed and no distressed couples: Construct 
hierarchy and multidimensional scales. J Marital Fam Ther.1995;21(3):289-308. 
45. Archbold PG, Stewart BJ. Family caregiving inventory. Portland, OR: 
Department of Family Nursing, School of Nursing, Oregon Health Sciences 
University; 1986. 
46. Zarit SH, Reever KE, Back-Peterson J. Relatives of the impaired elderly: 
correlates of feelings of burden.Gerontologist. 1980;20(6):649-655. 
47. Kohout FJ, Berkman LF, Evans DA, Cornoni-Huntley J. Two shorter forms of 
the CES-D depression symptoms index. J Aging Health. 1993;5(2):179-193. 
48. Pachana N, Byrne G, Siddle H, Koloski N, Harley E, Arnold E. Development 
and validation of the Geriatric Anxiety Inventory. Int Psychogeriatr. 
2007;19(1):103-114. doi:10.1017/S1041610206003504. 

30  
Version Date: August 13, 2020 
 
49. WHOQoL Group. Development of the World Health Organization WHOQOL-
BREF quality of life assessment. Psychol Med. 1998;28(3):551-558. 
50. Fang J, Power M, Lin Y, Zhang J, Hao Y, Chatterji S. Development of short 
versions for the WHOQOLOLD Module. Gerontologist. 2012;52(1):66-78. 
51. Morycz RK. Caregiving strain and the desire to institutionalize family 
members with alzheimer's disease possible predictors and model development. 
Res Aging. 1985;7(3):329-361. 
52. Kolanowski AM, Buettner L, Moeller J. Treatment fidelity plan for an activity 
intervention designed for persons with dementia. Am J Alzheimers Dis Other 
Demen. 2006;21(5):326-332. 
53. Appelbaum PS, Grisso T. MacArthur Competence Assessment Tool for 
Clinical Research (MacCAT-CR).Sarasota, FL: Professional Resource Press; 
2001 
54. Marson DC, Schmitt FA, Ingram KK, Harrell LE. Determining the 
competency of Alzheimer patients to consent to treatment and research. 
Alzheimer Dis Assoc Disord. 1994;8(4):5-18. 
55. Alzheimer’s Association. Research consent for cognitively impaired adults: 
Recommendations for institutional review boards and investigators. Alzheimer 
Dis Assoc Disord. 2004;18(3):171-175. 
56. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing 
generalized anxiety disorder: the GAD-7. Archives of internal medicine. May 22 
2006;166(10):1092-1097. PMID: 16717171  
57. Chew LD, Griffin JM, Partin MR, et. al. Validation of screening questions for limited 
health literacy in a large VA outpatient population. J Gen Intern Med, 2007;23(5):561-
566. 
58. Morris NS, MacLean CD, Chew LD, Littenberg B. The single item literacy screener: 
Evaluation of a brief instrument to identify limited reading ability. BMC Family Practice, 
2006;7(1):1-7 
59. Baer RA, Smith GT, Lykins E, et al. Construct validity of the Five Facet Mindfulness 
Questionnaire in meditating and nonmeditating samples. Assessments, 2008;15(3):329-
342.  
 
35. Appendix A ODeC DUA – (for analysis of a copy of the deidentified dataset) 
 
Michelle M. Hilgeman, PhD, Research Psychologist / PI 
Rebecca S. Allen, PhD, Professor / Co-Investigator – University of Alabama  
Daniel W. Durkin, PhD, Associate Professor / Consultant – University of West Florida