Creating a Faith-Based Toolbox for African Americans Living With Moderate and Severe Dementia
Phase: NA
Conditions: Alzheimer Disease, Dementia
Sponsor: Emory University

Study Protocol 
 
Title: Creating a Faith-Based Toolbox for African Americans Living With 
Moderate and Severe Dementia 
 
NCT Number: NCT04325204 
 
Protocol date: September 6, 2019 

1
Creating a Faith-Based Toolbox for African Americans Living
 with Moderate and Severe Dementia 
Short title: K23
PI: Fayron Epps, PhD, RN
Sponsor: Pending
Protocol v1
9-6-2019

2
Research Protocol
(A) Background and Significance
African Americans (AAs) are more likely than other racial/ethnic groups to be diagnosed with Alzheimer’s 
disease and related dementias (ADRD) and will account for 20% of persons living with dementia (PLWD) by 
2050.2 PLWD experience progressive distress and confusion, which decreases their quality of life and also 
contributes to the emotional strain, burden, social isolation, and depression experienced by caregivers.16 
Research indicates that religiosity (the inner commitment to one’s faith through integration of religious beliefs 
and practices into one's life) can serve as a protective factor against the stressors associated with caregiving 
and living with ADRD.5 Religiosity affirms the significance and sacredness of life and the value of a person, even 
in the face of loss.34 The progression of ADRD often restricts the person and the caregiver from participating in 
religious communities and familiar church-based religious practices.12,16  Religion is usually defined by individuals 
identifying with an organized system of beliefs, practices, rituals, and symbols concerning the sacred.35 Religious 
beliefs shape family values, motivations and behaviors toward the commitment to care for their loved ones.5 
Religious involvement and practices are associated with religious coping that positively influences health 
outcomes.36,37  Through religious coping, religiosity frequently provides the basis for hope and a framework for 
finding meaning, even when navigating difficult life events and transitions.38,39  Religious coping encompasses a 
wide array of religious behaviors, activities, and beliefs (e.g., praying, reading scriptures, attending religious 
services, seeking congregational and clergy support, relying on faith in God) that are used to manage the 
psychological perception and consequences of an unfavorable situation.38
Religiosity has been shown to be beneficial in improving the quality of life of PLWD and family 
caregivers.40-42  Engaging in personal faith and prayer can help enhance positive attitudes in PLWD by increasing 
feelings of security, support, and meaning in their lives.34,43 Meditative practice contributes to psychological and 
physiological well-being by bringing self-control, inner peace regardless of outer conflicts, and patience and joy 
even in difficult circumstances.23,44,45 In addition to private religious practices, religious engagement can occur 
via television, podcast, and live streaming connections from faith communities.41  There is evidence that, for a 
PLWD, the spiritual connectedness (internal feelings and beliefs to the sacred) related to personhood does not 
disappear as ADRD progresses, but the relationship with and expression of one’s own spiritual life changes over 
time with illness-produced decreases in cognitive functioning.12,15,26-28 If caregivers cannot find ways to facilitate 
spiritual connectedness and engagement in pleasant and meaningful activities, such as religious activities, a 
PLWD may experience an unmet emotional need that could lead to behavioral problems due to loneliness, 
sadness and frustration; 19,29 such problems can adversely affect caregiver well-being. This association 
underscores the need to strengthen support services and identify resources, nonpharmacological approaches, 
and meaningful activities, including faith-based ones, that promote the well-being of AA family caregivers and 
community-dwelling PLWD.  
The majority of older adults in the United States consider religion to be significant in their lives.1,2 Indeed,  
75% of AA older adults deem religion to be substantially important to their well-being1 and  have a stronger 
presence of religiosity compared to other racial/ethnic groups.3-8 Historically, faith communities have been the 
backbone of support for AA families when in distress.9,10  AAs living with ADRD may particularly benefit from 
engaging in religious practices.41 Overall, religious practices and activities serve a common good for AA older 
adults living with ADRD.23,45  Participation in organized religion provides meaningful connections and enhances 
spiritual connectedness and quality of life for AA older adults through accepting diagnoses and life situations, 
maintaining relationships, maintaining hope, and finding meaning in their lives.11-15 Participating in religious 
traditions and belonging to a faith community provides a positive sense of identity and continuity as 
circumstances change in life and reduces stress by providing stability.46,47  Physical health may diminish, financial 
and social circumstances may change, but religious and spiritual engagement may contribute to the preservation 
of personhood.34 However, many faith communities, AA faith communities included, do not have programs to 
support the families and congregants living with ADRD. 
The goal of this clinical feasibility trial and NIH stage 1 intervention development project48 is to go beyond 
the four walls of the church to find ways to meet the spiritual needs of persons living with moderate and severe 
ADRD “where they are” in order to help them remain religiously and spiritually engaged. This study is premised 
on the notion that religious/spiritual engagement is possible and beneficial for PLWD19,28 and that this beneficial  
effect will extend to their caregivers. Robust evidence suggests that family caregivers have poor health outcomes 
and significantly higher rates of psychological and physiological difficulties, relative to age-matched non-

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caregiver adults.49-51 This relationship is even more pronounced among AA caregivers.50,52-54 Dementia 
caregiving is stressful and associated with negative effects on caregivers’ health including high caregiver burden, 
physiological as well as psychological stress, depression, poor sleep, and poorer quality of life.50,51,55,56 Thus, 
caregivers observing the beneficial effects and engaging in meaningful religious and spiritual activities with their 
family member living with ADRD may potentially improve their psychological and physiological well-being.3,4,19,30-
33,36 Despite the growing evidence of the benefits of meaningful activity engagement,18-20,24,25 a gap exists about 
the kinds of faith-based activities that might be acceptable to and useful for engaging AA adults living with 
moderate and severe ADRD. Meaningful engagement in faith-based home activities could provide a culturally 
organic way for PLWD to retain a spiritual connection and decrease behavioral symptoms while enhancing 
caregiver well-being. 11,12,18-20,42 The purpose of this project is to design and test the feasibility of employing 
components of a Faith-based Home Activity Toolbox (Faith-HAT) and create intervention tools for a full-scale 
randomized controlled trial (RCT) to test the efficacy-effectiveness of faith-based programs on patient and 
caregiver outcomes. This faith-based, family-oriented, highly person-centered approach to enhancing a greater 
quality of life for families draws on powerful Christian principles from within the AA community. This toolbox will 
be a readily scalable strategy for planning successful activity engagement and enabling faith communities to 
continue to support persons living with moderate and severe ADRD.
Theoretical Framework: The Meaningful, Enjoyable, and Doable Approach (MED) will serve as the conceptual 
basis for this proposed intervention.25 This approach draws primarily on the Selective Optimization with 
Compensation (SOC)57 and the Needs-Driven Dementia Compromised Behavior (NDB)29 models. The SOC has 
been useful in explaining how to support optimal development in the face of losses that occur across the 
lifespan.57 The NDB is specific to supporting adaptation in the context of living with ADRD as all behavior is a 
result of an unmet need arising from the interactions between a person’s functional abilities and their immediate 
personal state and their physical or social environment.29 Activities tailored to both functional abilities and 
personal preference result in higher levels of engagement as the activities are viewed as meaningful and 
enjoyable.25 Thus, meaningfulness of activities that reflect an individual’s values can lead to positive benefits of 
a sense of normalcy for a PLWD.25,58 
Innovation
This project is innovative and moves beyond existing interventions that merely provide ADRD-related 
education to church leaders and congregants within the AA community. The proposed project will provide a 
framework for religious practices specific to engaging PLWD to be used in the home setting. This project is 
innovative in that stakeholder engagement is significant to the design of the toolbox, allowing those affected by 
ADRD to influence design and implementation of the toolbox. Addressing one of the main recommendations of 
the Research Summit on Dementia Care,59 we are including caregivers and PLWD on the research team. 
Stakeholder engagement will occur throughout the project as caregivers and PLWD will be members of the 
design team, along with church leaders. The design team will routinely meet throughout the project to advise on 
the design and implementation of the Faith-HAT. 
To date, no evidence has been published to correlate meaningful faith and spiritual activities on the 
physiological health of caregivers. Exposure of an individual to a physical or mental stressor activates their stress 
response through the sympathetic nervous system (SNS) axis.60 The SNS response involves increased heart 
and respiratory rate and a shift in blood flow delivery toward the heart, brain, lungs, and skeletal muscles at the 
expense of other organs, thus preparing the host to fight or flee from the stressor.60 This project is innovative in 
that we are proposing to introduce physiological measures of stress response in AA caregivers related to 
engaging in Faith-HAT which adds promise to advancing the field of caregiving research. We include an 
ecologically and stress response measure through the use of a wearable wristband.  To measure stress, we 
have traditionally relied on standard questionnaire instruments whose capacity to measure similar concepts 
across racial/ethnic groups has been problematic.61-64 Further, such instruments are subjective, confounded by 
the participant’s willingness to disclose, and are able only to capture stress perception and exposure65 and not 
truly stress response. In this study, we measure both aspects of this construct (exposure/response). Additionally, 
measuring stress response unobtrusively in the participant’s home-setting adds a novel dimension not previously 
tackled in ADRD. In the essence of moving science forward, we hope that objectively assessing the physiological 
measures of stress response in caregivers will corroborate (or not) these standard questionnaire instruments 
and allow scientists and clinicians to precisely tailor and test interventions to improve the health and well-being 
of caregivers.66 

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Fig 1: Correlation between skin conductance level (SCL) and RR-mean measured simultaneously using 
wristband and standard method (chest ECG and EDA using finger electrodes). A: SCL correlation: R2=0.99, 
p<.0001; B: HR R2 =0.7, p<.0001.
 (B) Aims
The project will have 3 aims: 
Aim 1. Develop a prototype Faith-HAT for AA families living with moderate and severe ADRD. 
Brainstorming workshops with a purposefully created design team and at least 15 semi-structured interviews 
with faith leaders, caregivers, and PLWD will be used to explore capabilities and resources available to support 
faith-based home activities and the key spiritual and religious practices families and PLWD consider essential, 
engaging, and meaningful. Results will be used to develop the content of Faith-HAT. Member checking will occur 
to validate fittingness and readiness of Faith-HAT for testing.
Aim 2. Test the feasibility and explore preliminary effectiveness of employing Faith-HAT. Our feasibility 
outcomes include success in recruitment, engagement, and retention in a purposive sample of 30 dyads. Our 
effectiveness outcomes include: caregiver-reported behavioral problems in PLWD; caregivers’ self-reported 
psychological well-being (stress, burden, depression); and objective physiological measures of stress response 
(heart rate variability, skin conductance) to be measured at baseline and 12 weeks.
Aim 3. Construct a refined toolbox of meaningful faith-based home activities. Using integration and 
refinement of quantitative and qualitative data, results from Aim 2 will be matched, compared, and validated with 
the design team to refine the meaningful Faith-HAT for AA families living with moderate/severe dementia. The 
goal of this aim is to have materials ready for deployment for a fully powered clinical trial. 
(C) Study Designs
Preliminary Studies: My previous qualitative work showed that families view participation in religious 
activities as a way to promote the physical and emotional health of AA older adults living with ADRD.17,41 The 
results of this study with 18 AA older adults living with ADRD  and their family caregivers stressed the importance 
of religiosity to the well-being of PLWD.17,41 In fact, many PLWD were unable to physically attend church to 
worship as the disease progressed to the later stages, and families were left to come up with meaningful religious 
activities to do at home with their family member (i.e., singing gospel songs, praying, watching worship on the 
television).17,41  In my current work with the Atlanta-based Ministerial Alliance, we have found that families 
affected by ADRD do not attend church due to fear of embarrassment and uncertainty about the PLWD’s 
behavior (Alzheimer’s Association Research Diversity Grant 18-56229). These findings support the need for 
further exploration of religions’ impact on AA families affected ADRD. 
Previous work in stress and physiological monitoring. For the past year, I have worked with my proposed 
mentor, Dr. Hajjar, and his research team for the Brain, Stress, Hypertension and Aging Research Program 
(BSHARP) to measure stress in adults. Preliminary 
results using simultaneous wristband and standard 
measures of skin conductance and 3-chest ECG 
lead HR data (EDA100C and ECG100C, Biopac 
Systems, Goleta, CA) were collected from 16 
participants (mean age=64 (SD=7); 7 women; 4 
AA; 9 with mild cognitive impairment). Moving 
average was plotted for the SCL (by applying a 
lowpass filter on the EDA signal)  and HR derived 
from RR interval from ECG or Peak-to-Peak (PP) 
intervals from the photoplethysmography (PPG) 
volume tracing from the wristband. The correlation between the 2 methods ranged from ρ = 0.99 for SCL EDA 
(Figure 1A)  0.8 for the HRV (Figure 1B) all p <0.0001. 
Design: A multi-phase mixed methods intervention design67 with iterative member checks will be used 
to design, test, and refine a faith-based home activity toolbox for AA older adults living with moderate and severe 
ADRD (Figure 2). This NIH stage 1 intervention development project will include intervention generation and 
refinement.48 Using a mixed methods approach in this project allows the research team to evaluate the 
acceptability and utility of intervention components and the potential barriers to adherence and behavioral 
change.68 The mixed methods design will maximize study strengths and counterbalance single approach 
Fi
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5
weaknesses.67,68 For this clinical feasibility trial, the aims will be implemented in phases. Initially, brainstorming 
workshops with a purposefully created design team and at least 15 semi-structured interviews with faith leaders, 
caregivers, and PLWD will be conducted to design the Faith-HAT. Next, the Faith-HAT will be assessed for 
feasibility and preliminary effectiveness, examining psychological and physiological outcomes that will be 
measured through surveys, online caregiver diaries, an automated BP monitor, and a wearable wristband. 
Finally, integration and refinement of quantitative and qualitative data will be used to refine the Faith-HAT. This 
project will further build on the collaborative relationship with Emory Alzheimer’s Disease Research Center’s 
(ADRC) Minority Engagement Core, Registry of Remembrance (coalition of 20 AA churches and community 
organizations). Additionally,  selected church leaders from  South Fulton Ministerial Alliance that have supported 
prior research projects will be actively engaged in the development of the Faith-HAT. 
Setting: This study 
will take place in the 
Atlanta Metropolitan 
area 
of 
Georgia, 
Fulton and DeKalb 
counties.The Atlanta 
Metropolitan area is 
the 
9th 
largest 
metropolitan area in 
the U.S., and Atlanta 
is the 2nd largest 
majority AA metro 
area in the country69 
with 
1.9 
million 
AAs.70 The region’s 
population of older 
adults is expected to
increase significantly during the next 25 years. By 2040, approximately one in five residents will be 65 years of 
age or older.71 Older adults 65 and older are not only the second fastest growing age group but have increased 
by 45% since 2010 in this region.71
Setting:
This study will take place in the Atlanta Metropolitan area of Georgia.
Procedures: (include population, recruitment, and field methods)
Aim 1. Develop a prototype faith-based home activity toolbox (Faith-HAT) for AA families living with 
moderate and severe ADRD. Through leveraging existing resources, a design team (n= 10-12) will be formed 
consisting of family caregivers, PLWD, and members from Emory ADRC’s Registry for Remembrance and South 
Fulton Ministerial Alliance (coalitions of AA churches in Atlanta, GA). This design team will meet quarterly (in-
person or via videoconference) over the course of the project to brainstorm, review data, and co-design the 
Faith-HAT. The design team will also assist in recruiting a purposeful sample (n = 15) of stakeholders, including 
church leaders, community partners, dementia family caregivers, and PLWD to participate in individual 1-hour 
semi-structured interviews (in person, phone, or videoconference) to further inform the design of the Faith-HAT 
through an iterative process. Interested stakeholders will be consented as research subjects and receive a $25 
honorarium post-interview. Initially, participants will be queried on: (a) capabilities and resources available to 
support faith-based home activities; and (b) key spiritual and faith-based practices families and PLWD consider 
essential, engaging, and meaningful. All interviews will be conducted by the PI, audio-recorded, and transcribed 
verbatim. Field notes and journaling will be maintained for each interview. Data will be managed in NVivo 12 
software. Data collection and analysis will be performed concurrently. Qualitative content analysis will examine 
manifest and latent content of the interview data.72 Content analysis of transcripts will lead to the identification of 
key components and delivery characteristics for Faith-HAT. Results will be shared with the design team, in which 
their role will be to examine the results and provide substantive feedback that will be used to design the prototype 
toolbox. The anticipated product for Aim 1 is a preliminary model for a faith-based home activity toolbox. We 
anticipate that toolbox activities will likely include devotional readings, prayer, music, religious images, and audio- 
Phase 1:
Aim 1. Design a
prototype for Faith-HAT
Phase 2:
Aim 2. Test the feasibility of employing components
of the Faith-HAT
Phase 3:
Aim 3. Construct a
refined toolbox of
meaningful faith-based
home activities
Pre-Test
Intervention
Faith-based Home
Activity Toolbox
(Faith-HAT)
Qualitative
Data Collection & Analysis
Caregiver Diaries
Post-Test
Support
Qualitative:
Data
Collection &
Analysis
Interviews
post-
intervention
with care
givers
(Explanatory)
Identify
Sample
Explain
Qualitative:
Data collection &
Analysis
Interviews with stake
holders (Exploratory)
Refined
Toolbox
Narrative
discussion
& Joint
display
Design
Figure 2. Multi-phase Mixed Methods Intervention Design
Embed
Connect
Build

6
or video-recorded sermons. We anticipate that families will have up 30 activities to choose from with the average 
activity length to be 10 minutes. The toolbox will be placed online. Participants will be able to access the toolbox 
via a tablet computer that will be provided to them. Before testing, member checks will occur with the design 
team and stakeholders for their feedback on fittingness and readiness for testing of Faith-HAT.
Aim 2. Test the feasibility and explore preliminary effectiveness of employing Faith-HAT. We will achieve 
this aim by conducting a feasibility clinical trial (n = 30). Our feasibility outcomes will include success in 
recruitment, engagement, and retention. Our effectiveness outcomes will include caregiver-reported perceived 
change in behavioral problems in PLWD as the primary outcome and caregivers’ self-reported perceived 
psychological well-being (e.g., stress, burden, depression) and objectively measured physiological stress 
response (e.g., heart rate variability, skin conductance) as the secondary outcomes. We will use quantitative 
surveys, qualitative interview data, and caregiver diaries to assess psychological well-being and a wearable 
wristband to assess the physiological wellbeing.
Aims
Aim 1. Design a
prototype for Faith-HAT
Aim 2. Test the
feasibility of
employing
components of the
Faith-HAT
Aim 3. Construct a
refined toolbox of
meaningful faith-
based home activities
Timeframes
Data Collection Procedures
Analytic
Procedures
Expected
Outcomes
6-12 months
Interviews with stakeholders (i.e., church leaders, community
partners, caregivers, & persons living with dementia) (n = 15)
•
Capabilities and resources available
•
Key spiritual and faith-based elements families and persons
living with dementia consider essential, pleasurable and
meaningful
•
Readiness for testing of the developed activities
Content analysis
Member check of the design to
improve the accuracy and
validity
A preliminary prototype for Faith-
HAT based on qualitative
interviews
12-18 months
Mixed Methods Intervention:
Single Arm Pre-Post Design: Baseline and 3 months
1a. Measures: (n = 30 caregivers)
•
Zarit Burden Inventory (22-items; α = .88-.91)
•
Perceived Stress Scale (14-items; α = .84-.86)
•
Center for Epidemiological Studies-Depression (20-items, α =
.85-.90)
•
Revised Memory & Behavior Problem Checklist(24-items; α=.90)
•
24 hr BP monitor and E4 wristband for HR variability & stress
response
1b. Weekly caregiver diaries
2. Post interviews (n = 15 caregivers)
1a. Descriptive statistics, general
linear mixed models, multilevel
modeling
1b. Content analysis, Member
check for validity and credibility
2. Content analysis, Member
check for validity and credibility
6 months
Joint Display
Narrative Discussion
Refinement of the faith-based home activity toolbox
Match and compare results from
all data collection methods
Member check of the design
with stakeholders and
participants to improve the
accuracy, validity, and
transferability
Figure 3. Implementation Matrix
In-depth understanding of the
feasibility & preliminary efficacy
of employing components of the
Faith-HAT based on quantitative
and qualitative testing
A readily scalable toolbox of
meaningful faith-based home
activities based on mixed methods
integrated data collection and
analysis procedures
Integration: Build & Design
Integration: Embed & Connect
1-Design: A single arm pre-post design will be employed.  Participants will be asked to take part in in-person 
survey and physiological baseline data collection, engage weekly in at least 3 activities from the Faith-HAT with 
person caring for living with ADRD for 6 weeks, complete 12 weekly diary entries online through RedCap 
platform, and provide in-person survey and physiological endline data immediately post-intervention and at 6-
weeks post-intervention. In addition to qualitative and qualitative measures, tracking of the enrollment and 
attrition rate will enable us to compute the “feasibility” of the program. Within the framework of a feasibility 
study,73-75 12 weeks is a reasonable amount of time for the behavior toward the use of the Faith-HAT to be 
adopted and show meaningful effects.  
2. Participants: Despite AA family networks being complex and large involving blood and non-blood related 
individuals, there is often a family member that has the primary caring responsibility.76 Therefore, a total of 30 
dyads of AAs with moderate and severe ADRD and primary male or female caregivers will be recruited from the 
greater Atlanta area.  Caregiver inclusion criteria: (a) at least 18 years of age; (b) reside with and care for 
(average of 4 hours/per day of unpaid assistance) for a family or friend experiencing signs and symptoms of 
moderate or severe ADRD as indicated through self-report or family caregiver report (c) able to read, speak, and 
understand English; (d) cognitively intact; (e) access to a wireless internet connection (wi-fi); and (f) access to a 
phone or mobile device that accepts text messages. PLWD inclusion criteria: (a) community-dwelling 
experiencing signs and symptoms of moderate or severe ADRD through self-report or family caregiver report; 
and (b) has a family caregiver that resides with them and is willing to participate; (c) no plan for institutionalization 
in the next month; (d) history of participating in private or public religious activities; and (e) understands English 
(toolbox activities will be produced in English). Family and self-reporting of the level of cognitive impairment will 

7
be identified according to the signs and symptoms of moderate and severe ADRD associated with the 
Alzheimer’s Association16 categorization of  moderate/middle, and severe/late stages of dementia.
Caregiver exclusion criteria: does not have a history of participating in private or public religious activities; 
hostile to PLWD religious expression; and has active plans to move to another residence without family member 
with ADRD . PLWD exclusion criteria: has active plans to move from under care of primary caregiver; routinely 
attends church; hostile to religion; and unwilling to engage in Faith-HAT.
3. Recruitment: A non-probability sampling strategy will be used to recruit a modest sample of 30 dyads of AA 
persons living with moderate and severe ADRD and their family caregivers to participate in Phase 2 of this clinical 
feasibility trial. The proposed sample size is justified through Browne’s77 general rule of using a minimum of 30 
participants to have the capacity to estimate a parameter in a feasibility study. We will recruit participants over a 
12- month period, with a target recruitment rate of 2-3 participants per month. We will recruit participants through 
churches in the South Fulton Ministerial Alliance and of the Emory ADRC Registry of Remembrance coalition 
(see letters of support).  Announcements will also be placed in church bulletins of these churches. Church leaders 
and congregation members may also refer a caregiver that they know who may be interested in the study. If 
additional family caregivers are needed, we will use snowball recruitment by asking caregivers enrolled to refer 
other caregivers like them to participate. 
Interested participants will be screened by the PI for eligibility via phone. If eligible, times will be scheduled 
to consent in person prior to beginning the study. Questions posed after explaining the project during eligibility 
determination and the consent process will be used to gauge participants’ cognitive ability to take part in the 
project. The cognitive capacities of the caregiver and PLWD to provide consent will be assessed by using a five-
item open-ended “Evaluation to Sign Consent” questionnaire with an established interrater reliability of 0.81.78 
Caregivers who are not able to correctly answer all items will be determined not to have the cognitive capacity 
to provide consent and participate. PLWD who are not able to correctly answer all items will also be deemed not 
to have cognitive capacity to provide consent; thus, they will provide assent and their primary caregiver will 
provide informed consent on their behalf. 
4- Intervention: The caregiver/PLWD dyad will engage in Faith-HAT for 6 weeks. They will select activities from 
Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, 
music, religious images, and video and audio recorded sermons. Results from Aim 1 will further specify delivery 
characteristics for Faith-HAT. Faith-HAT will be placed on online, which requires little technical know-how by 
users. The PI will provide training to participants on how to use the Faith-HAT and online diary on the tablet 
computer provided by the project. Training and implementation will be monitored with a checklist documenting 
the participant’s ability to use the device, access the toolbox through Brightspace, implement the intervention, 
and understand the feedback in relation to troubleshooting. The “dose” and frequency of use of the interventions 
will be calculated by determining the number of days/weeks the intervention was used for 6 weeks. The quality 
of delivery of Faith-HAT will be assessed during weekly online diary checks. 
5- Study visits: Enrollment, Baseline, and Endline: Once eligible, the PI will schedule a visit with the participating 
caregiver to consent and enroll, provide training and instruction on Faith-HAT, and obtain baseline data.  Baseline 
caregiver-reported behavioral problems in PLWD; caregivers’ self-reported psychological well-being (stress, 
burden, depression); and objective physiological measures of stress response (heart rate variability, skin 
conductance) will be collected. Each week for 6 weeks the dyad will be asked to complete at least 3 activities 
from the Faith-HAT, and the caregiver will complete 12 weekly diary entries online.  At the end of the intervention, 
the PI will schedule a visit and participants will provide survey and physiological endline data  immediately post-
intervention and at 6-weeks post-intervention.  Figure 3 shows the various measures collected at each visit. 
6. Study procedures: Figure 3 illustrates the project’s associated procedures and analytic plan.
(a) Interview and instruments: Demographic and psychological well-being will be collected by an interview 
conducted by the PI with the caregiver. Measures will specifically include: (a) caregiver burden, (b) perceived 
stress, (c) depression, and (d) behavior and psychological symptoms of the PLWD. The following surveys will 
be used: (a) Zarit Burden Inventory,79 (b) Perceived Stress Scale,65 (c) Center for Epidemiologic Studies 
Depression Scale,80 (d) Revised Memory Behavior and Problem Checklist81, and Sleep Scale from the Medical 
Outcomes Study (see Figure 3 for further instrument details). The demographic questionnaire will assess basic 
demographic characteristics (e.g., age, gender, education, caregiving length, PLWD age and gender). 

8
Additionally, caregivers will report current chronic illnesses and medication use before and after the intervention 
to assist in determining the accurate effect of Faith-HAT on physiological stress response measures. Caregiver 
participants  will  be supported by receiving a $25 honorarium for each baseline, endline, and qualitative interview 
completed. Caregivers will also receive $5 for each weekly diary entry completed. 
(b) Caregiver diary: Participants will complete weekly diary entries online the same day every week to evaluate 
their engagement in Faith-HAT through a survey software system (RedCap) that will be placed in Brightspace. 
Each entry will prompt caregivers to describe their experiences based on the following: (a) changes in your family 
member’s condition since last week; (b) activities from the Faith-HAT that were used in the last week and 
frequency; (c) experience engaging in the Faith-HAT with your family member; (d) other religious activities used 
with your family member that were not included in Faith-HAT (e) a decrease or increase in behavioral problems 
of the family member this week using a 5-point Likert scale; (f) personal feelings of stress, burden, depression; 
(g) noticeable changes in your physical health this week using a 5-point Likert scale; and (h) experience caring 
for your family member this week. Recognizing the busy schedules of caregivers, weekly reminders (phone calls 
or texts) will be sent to caregivers to complete online diary entries on the tablet computer.
(c) Stress response using a wristband: We propose to use a wristband, a wearable-sensor (i.e., wristwatch), that 
detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical 
site), and to collect longer-duration measurement of the physiological signals.84-86 We will use the E4© watch 
(Empatica, Boston MA) which includes a photo-plethysmography (PPG) sensor for blood volume pulse and 
heartrate variability (HRV) measurement and a galvanic skin response (GSR) sensor activity as well as an 
infrared thermopile.84-86 Caregiver participants will be asked to wear the wristband for 24 hours, simultaneously 
with the ABPM, prior to starting the intervention and again at the end of the intervention. Empatica® has provided 
validity data for the wristband suggesting a correlation with standard measures of 0.66-0.99, p=2*10-11 for skin 
conductance levels (SCL)87 and similar values 0.98-0.99, p < 2*10-7 for HRV (time- & frequency- domains).88 We 
hope to find a reduction in caregiver HRV and GSR, signifying reduced stress reactivity, post-intervention.
(d) Qualitative Interviews:  A subsample of 15 caregiver participants will be selected for in-depth interviews (1-
hour to be held in person, phone, or videoconference) at post-test to further elaborate on feasibility, acceptability, 
and preliminary changes related to Faith-HAT. (i.e., How well did using the Faith-HAT go? Did you notice a 
behavior change in your family member? Did your family member seem comfortable and engaged while using 
the Faith-HAT? How has your physical and psychological health changed? Have emotions toward caring for your 
family member changed? Do you feel closer to your family member? Do you have further ideas on additional 
religious activities that would be effective to include in the Faith-HAT? Are there any changes you would make 
to the program?).
7. Data Collection and Analytical plan:
(a) Quantitative Analysis: Quantitative data will be entered at the time of each interview directly into the dedicated 
project tablet computer and saved on Emory’s secure REDCAP platform.  All data entry screens are set up in 
REDCAP and, where possible, include data delimiters (i.e., skip patterns, valid range limits) to ensure 
correctness and minimize missing data.  Data will be exported into SPSS monthly and syntax run for cleaning, 
further data verification and file concatenation. Descriptive statistics will be computed through SPSS v 24 to 
examine patient characteristics. Sex as a biological factor will also be considered as a variable for analysis. 
While the primary expected products of this work pertain to feasibility, and our study is not powered to conduct 
formal hypothesis testing, we will perform preliminary analyses with a multilevel modeling framework to assess 
relative group changes in scores for measures of stress, burden, and behavioral problems of PLWD. Although 
effect sizes will not be estimated,89 general linear mixed models will be applied to account for the repeated 
measurements for each study participant and a group by time term will be included in the model to gauge trends 
and direction of effects. In preliminary analyses, descriptive statistics and frequency distributions will be 
examined to identify outliers and ensure integrity of merged files.  For all multi-item scales, internal consistency 
will be examined using Cronbach’s alpha and associated statistics (e.g., item-total correlations, alpha if item 
deleted).  Formal test-retest/inter-rater reliability coefficients will be computed as data are concatenated. 
(b) Qualitative Analysis:  All interviews will be conducted by the PI, audio-recorded, and transcribed verbatim. 
To reduce bias, field notes and journaling will be maintained during this phase. Interviews and diary entry data 

9
will be managed in NVivo 12 software. Data collection and analysis will be performed concurrently. Qualitative 
content analysis will examine manifest and latent content of the diary entry data.90 The PI will work with another 
member of the research team to independently review transcripts and identify codes and the research team will 
be brought in to resolve any discrepancies among the independently developed codes. Member check will occur 
to serve as validation of the interpretation. 
Aim 3. Construct a refined toolbox of meaningful faith-based home activities. No recruitment of participants 
and active data collection will occur for this aim. Qualitative and quantitative results from all data collection points 
from Aim 2 will be matched and compared to assist in refining the design of the Faith-HAT. The integration and 
interpretation of results through joint display and narrative discussion will be shared with the design team. Details 
of narrative discussion including caregiver discussion of activities to add, other ways to use the Faith-HAT, and 
circumstances under which engagement in Faith-HAT with the family member were optimal will be reviewed by 
the research and design team to develop a plan for program revision. Reasons for participant withdrawal and 
participant feedback on delivery characteristics will also be used to determine what components of the Faith-
HAT will need to be revised. The research and design team will work together to produce a refined Faith-HAT 
program. Member checks of the refined toolbox with participants in Aims 1 and 2 will be conducted to improve 
the authenticity of the work and improve the accuracy, validity, and transferability of  design readiness for 
deployment for a fully powered clinical trial.
Informed Consent Process:
Interested stakeholders and caregivers will be contacted by the PI or member of the research team to schedule 
a time to consent prior to data collection. Consents will be obtained at mutually agreed locations or via 
videoconference platform. Participants will be given the option to provide verbal consent after a discussion 
using a videoconference platform. After the videoconference discussion and verbatim review of verbal consent 
document, verbal informed consent will be obtained from the participant or legal representative and a copy of 
the consent will be mailed to them for their records.  
Consents will be obtained at mutually agreed locations or provided by phone/videoconference. Consents will 
be obtained prior to data collection and the primary investigator will be responsible for obtaining consent.
Persons with dementia will be participating in Phase 1 and 2 of this research project. For Phase 1 and Phase 
2, if the person living with dementia is unable to give a legally effective informed consent, verbal assent will be 
obtained with informed consent to be obtained from their legally authorized representative. If the family 
caregiver participating in the study is not the legally authorized representative, the PI will have to meet with the 
legally authorized representative for them to provide consent on behalf of the decisionally impaired adult.
For Phase 1 and 2, questions posed during the consent process will be used to gauge the person living with 
dementia cognitive ability to take part in the project and give consent. For participants with dementia providing 
verbal consent, questions will be posed during the videoconference discussion with their caregiver or legal 
representative present to gauge the person living with dementia cognitive ability to take part in the project and 
give consent. If there remain concern about their capabilities to consent, an "Evaluation to Sign an Informed 
Consent" will be completed by the primary investigator.
If the person living with dementia is determined unable to give a legally effective informed consent, verbal 
assent will be obtained with informed consent to be obtained from their legally authorized representative. 
Participant eligibility requires for caregivers to be able to read, speak, and understand English and for persons 
living with dementia to be able to speak and understand English. The investigator will orally review the consent 
form with them and answer any questions they may have. Potential participants will be asked to describe what 
their participation in the study will involve and what is meant by voluntary participation. Potential participants 
needing more time to decide whether to participate will be allowed more time as needed.
The following measures will be implemented to minimize the possibility of coercion or undue influence: explaining the 
(a) voluntary nature of participation; (b) any alternatives to participating; (c) ability to withdraw at any time; and (d) fact 

1
that the decision whether or not to participate will have no impact on the availability of care through Emory 
Healthcare System.
All aspects of the study will be communicated to the participant or legally authorized representative.
Organizational Structure:
The study team for this K23 will be comprised of the Principal Investigator and applicant (Dr. Epps), Primary 
Mentor (Dr. Kenneth Hepburn), and Co-Mentors (Drs. Hajjar and Kemp). Dr. Epps will gain clinical
trial research experience under the supervision of mentoring team. Dr. Hepburn will be primarily responsible for 
monitoring Dr. Epps implementation of all components of the study. The Co-Mentors will collaborate with and 
provide input to the PI in their given areas of expertise. The PI will responsible for the day to day operations of 
the study including recruitment and data collection management and analysis. The administrative site will be at 
Emory University, Nell Hodgson Woodruff School of Nursing.
Study Team Training:
All team members have completed CITI training. Study-specific training for staff who will be obtaining data by 
interview.
Data Management and Monitoring:
Ongoing monitoring of this clinical feasibility trial will be conducted by the PI and mentor team throughout the 
study to ensure the trial is conducted according to the approved protocol. Drs. Hepburn and Hajjar, both have 
experience with conducting clinical trials, will assist Dr. Epps in monitoring the study for safety and ensure that 
protection is assured throughout data collection. In addition, the Emory IRB will conduct regular reviews of 
study protocols, changes in study protocols, and adherence to protocols in the field. The PI is required to report 
any unexpected study-related adverse events to the Emory IRB and NIH. An independent safety monitor or a 
data and safety monitoring board will not be used. 
Plans for Assuring Compliance with Requirements Regarding the Reporting of Adverse Events: The 
Principal Investigator is responsible for reporting serious adverse events to the Emory IRB and NIH within 48 
hours of the occurrence. 
A serious adverse event is defined as one that: is fatal or life-threatening (i.e., results in an immediate risk of 
death); requires or prolongs hospitalization; results in persistent or significant disability; is a birth defect; or is 
an important medical event that when based upon appropriate medical judgment, may jeopardize the 
participant, and may require medical or surgical intervention to prevent one of the outcomes listed above. 
Serious adverse events are not expected to occur during this study. 
If there are instances of severe distress observed during the interviews, the we will provide the caregiver with a 
list of resources that the caregiver may use, such as counseling services or resources offered by Alzheimer’s 
association. In emergent circumstances, the we will make a referral to the local emergency room. 
Plans for Assuring Data Accuracy and Protocol Compliance: Under the direction of Dr. Epps, all data will 
be managed in a secure fashion. All of the data will be kept on a secure server. In all of the data files, data will 
be coded by identification number only. Participants’ names will be separated from the data and kept on a 
secure server or in a locked file cabinet. Access to the secure server and the file cabinet will be strictly 
controlled by the Principal Investigator. 
Data Maintenance: We will use REDCAP to minimize data entry errors. All data entry screens are set up in 
REDCAP and, where possible, include data delimiters (i.e., skip patterns, valid range limits) to ensure 
correctness and minimize missing data. 
Confidentiality:

1
Interactions with participants will take place in a private setting. All data will be coded by participants’ 
identification numbers and kept in a locked file cabinet in the investigators’ office. Consent forms will be stored 
separately from the data and will be limited to a few key personnel (PI and research team) involved in the 
study. When the interviews are transcribed, any identifiable information that was inadvertently mentioned 
(about anyone) will be removed from the transcript.
Benefits:
We are designing and testing the feasibility of an intervention and participants may not directly benefit. 
However, participants may derive some benefit from an increased awareness of meaningful activities for 
PLWD and their family caregivers. The potential risk for emotional distress is believed to be minimal and 
considered reasonable in view of the potential benefits for reducing stress and promoting well-being of 
dementia family caregivers of persons. 
Compensation:
Phase 1 participants will receive $25 honorarium upon completion of their semi-structured interview. Phase 2 
caregiver participants will receive a $25 honorarium for each baseline, endline, and qualitative interview 
completed for a total of $75. In addition, they will also receive $5 for each weekly diary entry completion, for an 
additional honorarium of $60. Caregiver participants in Phase 2 possible compensation for total study 
participation is $135. 
Limitations, Challenges, and Strategies: This clinical trial feasibility study is an early stage of intervention 
development. A limitation of this study is related to not incorporating a control group into the design to avoid bias. 
Therefore, causal inferences regarding effects will not be made from the results of implementing the Faith-HAT. 
Accuracy of family caregiver report of behavior changes  of the PLWD might be questionable due to recall bias. 
To counterbalance this challenge, caregiver participants will complete weekly entries about behavioral 
occurrences by their family member in their caregiver diaries. Asking participants to complete diaries of their 
weekly experiences allows for the gathering of their perceptions, thoughts, and feelings, as well as their family 
member’s behavior and caregiving in context. However, using weekly caregiver diaries for data collection 
presents a challenge of maintaining caregiver motivation to ensure the diary entries are completed. Members of 
the research team will send weekly text message reminders, establish good working relationships with 
participants, and provide positive reinforcements to maintain motivation throughout study period. Recruiting AA 
participants into clinical research has been an ongoing challenge. If the aforementioned recruitment strategies 
do not obtain the desired sample, recruitment will be extended to advertising through social media, radio, senior 
centers, community newsletters, and other public venues. 
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