GamePlan4Care: Web-based Delivery System for REACH II
Phase: NA
Conditions: Dementia
Sponsor: Baylor Research Institute

R01 AG061973-01  
                                                                    Protocol 
 
 
 
 
Protocol  
 
Date 1/11/22 
 
 
 
Sponsor Name: 
 
NIH/National Institute on Aging (NIA)  
Sponsor Type: 
 
Federal - NIH  
Sponsor Role: 
 
Funding 
Grant/Contract Number: 
R01 AG061973-01   
Funding Through: 
 
Federal-NIH  
Award Number: 
 
R01 AG061973-01   
Grant Title: 
 
 
GamePlan4Care: Web-based Delivery System for REACH II  
 
ClinicalTrials.gov Identifier:  
NCT04540198 
 
 
 
 
 
 
 

IRB Submitted 01/11/22 
 
SPECIFIC AIMS 
Family care of an older adult is a valued tradition of society and has become an essential element of the 
US healthcare system with 83% of long term care provided to older adults coming from family members or other 
unpaid helpers1. As the population of older adults grows, almost doubling in size from 2012 to 20402, so too will 
the expectations placed on American families. This is especially true of families who support community living 
for individuals living with Alzheimer’s disease and related dementias (ADRD), which has been defined as “intense 
caregiving” and is associated with significant daily burdens and an overall threat to the caregiver’s quality of life3. 
A robust body of ADRD research demonstrates that interventions aimed at supporting and educating caregivers 
can significantly improve the quality of care delivery and improve the well-being and quality of life for both 
caregivers and persons with dementia (PWD)4. Despite the fact that over 200 interventions have been found to 
be effective for dementia caregivers in randomized clinical trials (results confirmed in 7 meta-analyses and 17 
systematic reviews), only six have undergone translation efforts resulting in publication5.  The lack of credible 
translation of evidence-based interventions into widely available community-based services means that the clear 
majority of the current 16.1 million family caregivers do not have access to evidence informed long term care 
supports and services. Thus, family caregivers remain at risk of the known negative consequences of caregiving 
despite evidence suggesting that those negative consequence can be remediated. There is an immediate and 
critical need to address this issue which is of significant societal impact.    
This study is based on a practical approach of applying technology to an existing evidence-based 
intervention, Resources for Enhancing Alzheimer’s Caregiver Health II (REACH II), refined with real-world user 
feedback and rigorously tested with the goal of creating an online family caregiver support system that has the 
potential of both scalability and sustainability. The feasibility of our proposition has been established by the 
creation of the proof-of-concept system GamePlan4Care (GP4C), demonstrating that modern internet 
technology can be used to automate key components of REACH II delivery. Such automated REACH II 
components include active engagement of caregivers in skill-building to address diverse challenges in caregiving 
and flexible tailoring of the intervention based on participant needs. Therefore, GamePlan4Care is positioned 
for a Phase 1 study to incorporate the full breadth of REACH II material and optimize the user experience 
for efficacy testing in a randomization clinical trial that engages BSWH clinics and community-based 
organizations (CBOs) where family caregivers already seek services. 
Two specific staged AIMS are proposed in this study. 
AIM 1. Advance the current proof-of-concept GP4C into a viable delivery system for the REACH II 
intervention. Further development will include uploading the full breadth of REACH II education and skill-
building materials, usability testing and updates to the user interface/user experience (UI/UX), creating a portal 
of delivery tools used by Dementia Care Specialist (DCS; i.e., interventionist), and establishing a comparable 
education-focused online system (Resources4Care; R4C) to be used in comparison to the multicomponent, 
skills-training GP4C system. Development activities will be conducted by the Baylor Scott & White Health 
(BSWH) Office of Digital Health with engagement of community-based organizations, family caregivers, and 
external advisors, with oversight by the GP4C research team. 
H1: Within 12 months of usability testing with 32 family caregivers, the GP4C research team will reach 
consensus with the BSWH Office of Digit Health and an external Advisory Committee that GP4C is a viable 
platform for online delivery of REACH II with R4C as an appropriate comparison condition.  
AIM 2. Compare the relative impact of GP4C and R4C, both of which include access to a Dementia Care 
Specialist, on a wide range of family caregiver outcomes. Family caregivers will be randomized to one of 
the two conditions and will complete an assessment battery at baseline and at the 6-month follow-up. Primary 
outcome measures will include burden, depression, social support, and caregiver’s health and interaction with 
health care providers. Secondary outcomes will include caregiver stress, positive aspects of caregiving (PAC), 
cognitive change in care-recipient. The CBOs will designate a “GP4C Champion” to promote the enrollment of 
240 family caregivers who have computer access and report regular use of the internet. Use of GP4C & R4C 
and contact with DCS will be recorded by the system as implementation data.  
H1: Family caregivers randomized to the GP4C condition will report greater improvement on primary and 
secondary outcomes as compared to family caregivers in the R4C condition. 
GP4C will fill a critical gap in caregiver support services as an evidence-based, internet-enabled system capable 
of providing immediate, tailored education and skills training to caregivers who can access live support from a 
DCS via phone or web-based video. Compared to existing evidence-based interventions, CBOs will face fewer 
Supplemental File 2: GP4C Study Protocol
 

IRB Submitted 01/11/22 
 
barriers to scaling and sustaining GP4C, a critical achievement in efforts to serve the growing number of family 
caregivers who face the challenges of dementia caregivers. 
RESEARCH STRATEGY 
SIGNIFICANCE 
As the population of older adults grows, almost doubling in size from 2012 to 2040, so too will the need 
for family caregiving. For most family caregivers, caregiving is not a short-term obligation. As reported in the 
National Academies’ report Families Caring for an Aging America6, nearly 70 percent of caregivers in a nationally 
representative survey had provided 2 to 10 years of care, and 15 percent had already provided care for more 
than 10 years by the time of the survey. This is significant because caregivers are more likely to suffer the 
negative consequences of caregiving the longer they are engaged in it. Caregiving is associated with negative 
psychosocial outcomes such as depression, anxiety, and burden3; social isolation and family conflict7; and 
financial strain due to costs of care8. Some caregivers also experience negative health outcomes such as poorer 
self-reported health, more chronic conditions/healthcare utilization, and decreased immune functioning9. The 
data therefore suggests that an average person in their fourth decade of life is expected to eventually spend 5.1 
years (or 10% of their remaining life) caring for an older adult, a situation known to have negative consequences 
to one’s health and well-being. 
Dementia caregivers, in particular, are likely to experience these negative outcomes.  In the United 
States, an estimated 5.7 million persons are affected by Alzheimer’s disease, the most common type of dementia 
and an estimated 16.1 caregivers provide daily care to family members living with Alzheimer’s disease10. 
Compared to non-dementia caregivers, dementia caregivers spend significantly more time providing care, assist 
with more activities of daily living, face greater impact on work and career, and experience more negative social 
and emotional consequences11.  For dementia caregivers, these compounded negative outcomes are associated 
with increased intensity of caregiving, presence of care recipient problem-behaviors, and lower levels of informal 
support12,13.  
There are proven management techniques that can address these unique aspects of dementia caregiving 
and mitigate negative consequences experience by family caregivers. More specifically, interventions that 
actively engage caregivers in skill-building14, utilize a multi-component strategy to address different challenges 
of caregiving15, and allow for flexible tailoring of the intervention based on participant needs16 can positively 
impact family caregivers. Yet, these services remain elusive to the vast majority of family caregivers as caregiving 
services remain extremely fragmented, poorly adapted to caregiver needs and preferences, and, in the case of 
technology-based solutions, underdeveloped.  
Barriers to the provision of caregiver services have been well documented and include the lack of a 
reliable infrastructure capable of standing up service programs, failure to provide services in a format and location 
that can be accessed by family caregivers who often provide continuous supervision of a family member living 
with dementia, failure to create a workforce versed in “family-centered care”, and the absence of a typical third 
party payer (i.e., commercial health insurance, Medicare)6. While strategies to overcome barriers to the provision 
of caregiver services have been tried, currently evidence-based interventions share a fundamental restriction – 
the development and testing environment from which the interventions emerged is not characteristic of real-
world service delivery and did not include input from the end users (i.e., providers of caregiving services and 
family caregivers). The failure of current evidence-based intervention to result in meaningful community-based 
services lead the authors of Family caring for an Aging America6 to call for the “development and testing of 
dissemination and implementation strategies to enable reach and scaling up of proven programs and integration 
in existing systems of care.” P. 180 
INNOVATION 
Application of technology as a strategy towards greater reach and scaling has shown promise in the 
delivery of health care and social services but has been underutilized in efforts to support family caregivers. We 
propose modern internet technology as a feasibility strategy to scaling currently evidence-based caregiving 
interventions. More specifically, internet-enabled technology can be part of the solution in efforts to adapt costly 
and labor-intensive caregiver interventions into more scalable and sustainable formats acceptable to today’s 
caregivers.  Innovations demonstrated in this study is the use of modern internet technology in the delivery of an 
existing, well studied, effective approach to improving the quality of life of dementia caregivers, the Resources 
for Enhancing Alzheimer’s Caregivers Health II (REACH II) intervention. Development activities will focus on the 
consumer experience and will benefit from access to the latest digital technology in healthcare. Unlike prior 
approaches to using web-based supports, we will conduct a methodologically rigorous randomized clinical trial 

IRB Submitted 01/11/22 
 
followed by, if appropriate, dissemination of an online version of REACH II to CBOs who will face fewer barriers 
to scaling and sustaining an evidence-based intervention. 
As access to the internet is becoming ubiquitous17 even among groups with historically low rates of 
technology adoption (older adults, less educated, lower income, rural)17,18, technology-based adaptation of 
caregiver support has emerged as a potential avenue to overcoming barriers of access, scalability, and 
sustainability.  Caregivers have already demonstrated a collective desire to access the internet to gather health 
information, track their own health indicators, and seek others with similar health concerns19. Caregivers believe 
that technology solutions can bring significant benefits to both them and the care recipients20. Once established, 
technology solutions that make use of automation (which cannot deviate from standardized protocols 
[implementation fidelity]) can be rapidly scaled with minimal marginal cost. Therefore, it is through technology 
that the rapidly growing number of family caregivers can gain access to information and support in an easily 
implemented, standardized, and cost-effective format they find acceptable (and continue using) to potentially 
reduce the burden of care and enable them to stay in the caregiving role longer.   
There are concerns, however, to the quality and utility of information currently being accessed by 
caregivers on the internet21. Utilizing content from evidence-based programs, whose impact on caregiver 
outcomes has been previously verified using rigorous scientific methodology, offers the strongest likelihood that 
caregivers will benefit from technology-enabled platforms. Previous research has shown that adaptations of 
existing evidence-based programs to internet-based applications is feasible and acceptable for culturally diverse 
groups22. For dementia caregiver support specifically, initial work using telecommunications and computer-based 
interventions have demonstrated the approach to be a viable mode of intervention delivery23,24. Many studies 
have reported significant improvements in caregiver outcomes and caregiver satisfaction and comfortable with 
telehealth25. However, there are concerns about the methodological rigor in the testing of many of these early 
internet-based caregiver interventions, as many do not use a control condition or assess caregiver compliance 
with the intervention21. 
In order to expand access to evidence-based education and support through technology, Stevens and 
Ory have created an internet-based delivery system for one of the most respected family caregiver interventions, 
REACH II. While REACH II has been made available in both healthcare systems and community-based 
organizations, it has failed to achieve the scaling and sustainability needed to accommodate family caregivers. 
The product created by Stevens and Ory, called GamePlan4Care (GP4C), serves as a “proof-of-concept” that 
modern internet technology can provide family caregivers with access to the highly efficacious REACH II 
intervention. The result of their efforts is a consumer-friendly website running on a scalable technical architecture 
that fosters skills-acquisition in the home setting. The system facilitates high levels of exposure to effective 
caregiving materials all the while circumventing the need for home visits which can otherwise limit intervention 
access due to factors related to cost, time constraints, and client preferences. Further efficiencies in intervention 
delivery are achieved using automating the individualization and tailoring process of caregiver materials, 
automate email outreach to promote caregiver engagement with the system, automate prompts for regular DCS 
outreach, and automate aspects of fidelity monitoring. Online delivery and automation of core REACH II 
components reduces the human resources needed for delivering the interventions, promotes standardization 
(fidelity), and conforms to caregiver preferences by allowing them to engage with the materials at times they 
choose. Professional support is provided by a Dementia Care Specialist who the caregiver may access by email, 
phone or web video (by appointment). The availability of real-time, interactive engagement with the online 
materials by the Caregiver and DCS enhances the therapeutic experience compared to phone-based delivery 
systems. Since GP4C is based on the REACH II materials, it is culturally appropriate for the three groups 
included in the REACH II trail (Caucasian/White, AA/Black, Hispanic).  
With further development of the existing proof-of-concept, the refined GamePlan4Care system will 
represent a viable product for REACH II delivery, appropriate for efficacy testing in a randomization clinical trial 
that engages BSWH clinics and community-based organizations (CBOs) where family caregivers already seek 
services. 
APPROACH 
Relevant Experience with REACH II and Web-based Facilitation of Intervention Delivery  
The GP4C design and research team assembled in this study is particularly well-positioned to complete 
all proposed aims. In the role of NIH Program Director (1981-2001), Ory launched the multi-site Resources for 
Enhancing Alzheimer’s Caregiver Health (REACH I) Initiative15. As an early career investigator, Stevens was 
part of the original REACH I consortium, and emerged as a leading investigator of the REACH II project26,27. 

IRB Submitted 01/11/22 
 
Since publication of the REACH II outcomes in 200627, Stevens has implemented the REACH II intervention 
within a large integrated healthcare system and in multiple community based organizations (CBOs), including  
serving as designer and senior evaluator of one 
of the largest implementations of REACH II in the 
US28. Stevens and colleagues have also created 
a training and certification program for REACH II. 
In September 2016, Stevens & Ory 
obtained funding from the Texas Alzheimer’s 
Research and Care Consortium (TARCC), a 
collaborative of seven leading medical research 
institutes across the state focusing on persons 
with dementia, to develop TEXAS CARES, a 
model of memory capable communities in Texas. 
One of three core objectives of TEXAS CARES 
was to explore technology as an avenue to 
increase family caregivers’ accessibility to the 
evidence-based intervention, REACH II. REACH 
II is a well-known and respected program but is 
rarely available in both urban and rural Texas 
communities. GamePlan4Care (GP4C) resulted 
from this effort as a proof-of-concept that the 
REACH II intervention was amenable for 
adaptation into an online, interactive platform that 
could maintain the therapeutic materials and 
techniques while reducing the resource demands 
of delivering the program to family caregivers. 
Stevens and Ory guided the scientific process of 
maintaining the integrity of the REACH II 
intervention according the principles delineated in 
Table 1.  
Consistent with Gitlin and Czaja’s29 
proposition 
for 
adapting 
evidence 
based 
interventions, GP4C maintains REACH II’s 
“active ingredients” which include the theory 
guiding the intervention and target population 
while exploring other aspects of the intervention 
(dosage, 
duration, 
modality, 
setting, 
etc.) 
amendable to change. In adapting the REACH II 
intervention to the GP4C platform, an extensive 
review of the original REACH II manuals and 
publications was conducted to identify and 
protect in translation the immutable aspects of the 
intervention (including its guiding theory, content, 
and essential delivery characteristics) that could not be compromised without significantly risking efficacy of the 
intervention. Conversely, other aspects of the REACH II intervention were judged to be modifiable and include 
limited changes to content (order/sequence of components, formatting), treatment dosage and duration, modality 
(format of intervention, use of technology), delivery setting, delivery approach (aspects amenable to tailoring, 
criteria for tailoring), and staffing requirements. Through this process, the GP4C team defined and were guided 
by nine principles in the adaptation of REACH II into GP4C (see Table 1). The current GP4C proof of concept 
abides by each of these nine principles. 
Stevens and Ory contracted with Clairvoyant Network, LLC. for technological assistance to achieve the 
desired internet-based system. The system includes a flexible database and server-side code to allow granular 
information storage and complex data queries. The site was developed using the Microsoft Azure platform which 
meets all technical safeguards for HIPAA compliance concerning protected health information. A primary 
development goal to establish a proof-of-concept was to replicate the burdensome process of tailoring the 
 
 
 
Table 1: Principles Guiding the translation of REACH II 
into online system GP4C  
 
The stress-health process model should remain as the 
theoretical framework for understanding processes by which 
caregiver stressors ultimately lead to negative outcomes, and 
a multi-component/multi-modal approach for addressing 
specific aspects of the model is still warranted.   
 
All REACH II educational and skill training tools should be 
made available to family caregivers who access online 
materials via a computer at time and place that is 
possible/convenient to the caregiver.  
 
Caregiver exposure to educational and skill building content 
should be tailored to the caregiver’s unique needs and 
caregiving situation using reliable risk assessment tools 
 
Tailoring should be based on caregiver’s risk results and 
presented in a written plan to guide the caregiver and shape 
the Dementia Care Specialist’s therapeutic interaction to 
promote fidelity to therapeutic content of REACH II 
 
Reassessment of caregiving characteristics that are important 
to tailoring of materials should occur so that the intervention 
continues to be tailored to their needs, and caregivers should 
continue to maintain access to all intervention content as new 
areas of concern arise 
 
Automated features of the web-based system should be 
integrated with live support from a trained Dementia Care 
Specialist (DCS) to promote skills development in the REACH 
II core therapeutic areas of problem solving skills/ABC of 
managing dementia behaviors, stress management, mood 
management, pleasant activities 
 
Caregiver and DCS should engage in at least the minimal 
number of therapeutic interactions needed to ensure 
Caregiver has been fully exposed to the therapeutic 
experience 
 
Access to other services and supports that may be of value to 
the family caregiver should be facilitated by the online system 
and interactions with the DCS  
 
The system supporting the online experience should also 
track caregiver engagement with the site, all DCS interactions 
with the caregiver, and will alert the DCS to high risks 
experienced by the Caregiver. 

IRB Submitted 01/11/22 
 
REACH II materials based on caregiver reported risks. GP4C achieves this goal using condition-based logic and 
modern internet technology to achieve the following with its users: a) introduce to the system and invite to use a 
secure sign up on an opening page, b) provide an initial risk assessment based on REACH II RAM, c) offer 
IMMEDIATE, tailored recommendations drawn from REACH II materials that is formatted in to a plan of care to 
address both caregiver and care recipient issues, d) invite to email a Dementia Care Specialist (DCS), e) notify 
the DCS of the user’s risk profile and recommendation identified using conditional–based logic. In addition to the 
tailored recommendations provided in response to the caregiver risk assessment, the caregiver has access to a 
large library of content adapted from REACH II materials and commonly available online resources.  
Figure 1 presents a graphic representation of the GP4C system in its current state of development. As 
illustrated, the GP4C system replicates a core feature of REACH II, assessing caregiver risks and tailoring 
supports to those risks. GP4C builds on this core feature by providing the caregiver an opportunity to engage in 
a similar process (i.e., answer risk assessing questions and get feedback) on each of the target intervention 
areas (e.g., stress management, depression, burden, self-care and healthy behaviors, social support, problem 
behaviors) topic areas. As demonstrated in Figure 1, the caregiver has chosen the topic of stress management, 
which has yielded tailored feedback on managing stress and has linked the caregiver to skills training tools within 
the GP4C system.  
 
Achieving proof of concepts means that GP4C has technical viability and that desired features, functions, 
and benefits have been established and demonstrated. Thus, the scope of work delineated in the original TARCC 
contract to establish a proof-of-concept has been accomplished which was documented in the final report 
submitted to TARCC. It does not mean that product development has been completed or that the product is 
market ready. In the case of GP4C, only a limited amount of REACH II therapeutic material has been loaded 
into the system, and we have not supplemented written information with video content. Nor have we fully 
achieved integrated support from a DCS via emails and live support via telephone/web video. These activities 
will be the focus of AIM 1 as we propose to move GP4C from a proof-of-concept to a viable delivery system for 
REACH II. Stevens and Ory will solicit consultation from dementia caregiving experts from 5 universities who 
serve on the TARCC Care Steering Committee to complete AIM 1. These five experts have reviewed the TEXAS 
CARES products created by Stevens & Ory and have agreed to serve as an Advisory Committee to this study. 
Our CBO partners will be represented in development activities by the president of Alzheimer’s Texas and the 
Directors of each of the AAAs.  
 
AIM 1 – Advance the current proof-of-concept GP4C into a viable delivery system for the REACH II 
intervention. 
GP4C will fully replicate the REACH II intervention upon completion. We propose development is needed 
to: 1) enhance usability by the caregiver, 2) upload the full breadth of education and skill-building materials, 3) 
improve the user interface/user experience (UI/UX), and 4) optimize presentation of material so that GP4C 
operates as an engaging, consumer-driven product suitable for testing in a RCT. Further development is also 
needed to facilitate DCS/Caregiver interaction and tracking of all therapeutic interactions the caregiver has with 
the website and DCS (i.e., DCS portal to guide and track service delivery).  Lastly, R4C, an on-line education-
based minimal intervention strategy will be created to serve as a comparison condition. Following usability testing 
and a review by the study external advisory committee the GP4C Study team will work with UI/UX designers to 
inform updates and refine the user-facing elements based on feedback and usability testing results (i.e. problems 
encountered while performing system tasks). The result will be a comprehensive digital tool to facilitate delivery 
of the REACH II intervention that is consumer informed.  

IRB Submitted 01/11/22 
 
Figure 2 illustrates the sequence 
of events that will occur for completion of 
AIM 1. The GP4C Study team will 
capitalize on the resources, experience, 
and expertise of the BSWH Office of 
Digital 
Health. 
The 
Digital 
Health 
Development team is comprised of 35 
web, mobile, middle-tier, and database 
developers 
with 
embedded 
UI/UX 
designers. The team has considerable 
experience in the development of clinical 
applications that interface with both 
providers and clients including a top 
medical application in the Apple App 
Store being used by over 600,000 users. 
The team is also responsible for 
developing 
the 
software 
security 
standards for BSWH and conducting 
software audits to ensure development 
and 
security 
best 
practices 
are 
maintained.  
The Digital Health Development 
team will import GP4C code into its 
development environment, conduct a review of the code, and make updates to take advantage of opportunities 
to optimize the code for improved functionality, better integration with existing BSWH systems, and better 
position the system to leverage previously developed software modules to improve GP4C. The UI/UX designers 
will review and begin updating user-facing elements of GP4C based on industry standards and best practices 
as well as their own experience designing clinical applications. As prototypes become available, they will be 
made accessible to the GP4C study team for internal usability testing.  
Usability evaluation will occur concurrently to content enhancement via a method of iterative evaluation 
using concurrent think-aloud technique (Kushniruk & Patel30). This method characterizes ease in which a user 
can complete a task, by what means a user attains mastery of system features, and problems a user encounters 
while using the system. The GP4C research team will work with the Digital Health Development team to develop 
a task hierarchy cataloging individual tasks to accomplish within the system and salient design questions 
appropriate for experimenter prompts. Such tasks will include registering, logging in, answering user 
assessments, and navigating to education and skill-building content. Participants will be scheduled to test either 
the technical-related aspects (user interface and design) or content-related aspects (wording/appropriateness of 
questions and feedback, satisfaction with education and skill-building content) of both GP4C and R4C.  
Participants will perform system tasks while vocalizing their thoughts, feelings, and satisfaction with the 
system. Research staff may prompt the participant with a question to elicit specific feedback regarding that 
feature. Participants will be engaged in a brief 10-minute interview regarding their overall impression/opinions of 
their experience with the system and be administered a brief satisfaction survey upon completion of their 
experience with the online system. User tests will be video/audio recorded, transcribed, and coded for 
occurrences of user problems and aspects of cognitive processes. Audio recordings from usability testing will be 
transcribed and coded using a coding scheme that includes categories for information content, 
comprehensiveness of graphics and text, problems in navigation, overall system understandability. The 
transcribed audio will also be coded for specific instances of user problems. Results of the usability testing of 
both content and technical aspects of the system for each participant will be summarized into a report with 
emphasis on type and frequency of problems encountered.  
Data will be reviewed by research staff after the completion of 4 participant experiences to identify issues 
that warrant addressing in subsequent design iterations. Prior to the fourth and final caregiver testing, the 
external Advisory Committee will be engaged for review and feedback. Recommendations from the external 
Advisory Committee will be carefully considered by the GP4C research and Digital Health teams with 
modifications made before the final round of caregiver testing. Upon completion of the 4 cycles of UI/UX, Stevens 
and Ory will review all findings from caregiver UI/UX, feedback from the External Advisors and consultation from 

IRB Submitted 01/11/22 
 
the Office of Digital Health to judge if GP4C and R4C are sufficiently developed for testing in the proposed 
randomized clinical trial (AIM 2). In the unlikely event that Stevens and Ory identify significant concerns, 
additional testing and modifications will be requested from the Office of Digital Health. 
Sixteen family caregivers will be engaged in user testing of technical-related aspects of the system and 
16 family caregivers will test content-related aspects of the GP4C systems. Since both GP4C & R4C will run 
from the same platform, the UI/UX activities proposed will apply to both ensuring that both are equally user 
friendly. However, GP4C will have more functionality. The 32 participants engaged in UI/UX will be selected 
according to participant eligibility criteria delineated in AIM 2.  To ensure representation of expected users, user 
testing will include at least 2 family caregivers of the three racial/ethnic groups included in REACH II. Moreover, 
equal number of participants will come from the urban and rural counties of the target recruitment area used for 
the RCT (Aim 2; Figure 3). Testing will occur in private office space within the three partner CBOs. 
 
AIM 2: Randomized Clinical Trial of GP4C 
GP4C and R4C will be tested as two intervention arms in a randomized clinical trial with 240 dementia 
caregivers and compared on well-accepted measures of the caregiving experience. See Figure 3 below. 
 
Participants 
Multiple strategies will be followed to facilitate recruitment. A list of patients at participating clinics, with a 
diagnosis of dementia established by charge diagnosis (ICD 9/10) or on the problem list will be forwarded to the 
PCPs, practice nurses, or likely partnering physicians to review and obtain permission to contact 
patient/caregiver. Additionally, providers can add to the list for patients/caregivers they think would be a good fit 
for the study. Once the revised lists is received from the provider, research staff will follow-up with a phone call 
to confirm eligibility and proceed with enrollment.  Participants will also be recruited in partnership with various 
community-based organizations such as Alzheimer’s Texas, Area Agency on Aging (AAA) of the Capital Area, 
AAA of Central Texas, and the Greater Dallas Chapter of the Alzheimer’s Association. Additionally, referrals will 
be accepted directly to the study team from within the Baylor Scott & White System through a redcap referral 
link.  Eligible participants must be age 18 years or older and providing care and/or supervision for a family 
member for at least the past 6 months and currently providing an average of 8hrs/wk. of care and/or supervision.  
Family will be subjectively determined by the caregiver to enable a broader definition of a” “family” member often 
found in minority communities (e.g., a person not related by blood but who serves in the role of an “aunt” or 
“grandchild”). The family member, named as the care recipient (CR) in this proposal, must be diagnosed with 
ADRD (self-report from the caregiver accepted) and is experiencing signs of dementia as verified by the family 
caregiver on the AD8 informant interview. AD8 is an 8-question interview using a yes/no scoring system31. The 
informant (i.e, family caregiver) is asked if there have been changes in areas of cognition and functioning 
including memory, orientation, executive function and interest in activities. A score of 2 or greater is the inclusion 
criteria. Use of this validated tool will provide some evidence of dementia while avoiding the need of direct testing 
of the CR which would require obtaining informed consent. This approach is more in line with future use of the 
system by CBOs. Eligible caregivers must demonstrate access to a home computer with internet access to 
research staff and report using the computer to access the internet at least three times per week, on average. 
They must not be currently participating in another evidence-based caregiver education and support program. 
Enrollment is limited to English-speaking caregivers. While the Spanish translation of REACH II has been proven 
valid, translation of GP4C/ R4C from English to Spanish is not possible within the limited budget of this study 
  

IRB Submitted 01/11/22 
 
Recruitment and Consenting 
Recruitment through physician referral: 
PCPs will be made aware of the trial through e-mail, fliers, 
and other traditional marketing techniques. In addition, 
project staff will make presentations at meetings of 
participating medical practices. Some physicians or practices 
may opt to provide a “blanket” referral for all their patients with 
dementia and, if so, study team members may reach out 
directly to recruit participants. Alternatively, PCPs may 
choose to review their lists of persons with dementia and 
delete any patients who should not be contacted about the 
study and/or add any patients/caregivers who they think 
would be a good fit. Providers can also refer through an 
ambulatory referral via EPIC. Referrals will be sent to the 
department of geriatrics, which will then be funneled into the 
research work que where research staff will be able to 
outreach.  
Referrals will also be solicited through reports ran through 
data metrics which will help identify patients who have been 
recently discharged from the hospital and who have an 
upcoming appointment with their PCP and/or geriatrics.  
Research staff will then send a message via epic to the 
provider for patient’s upcoming appointment as well as 
append appointment note to let provider know about the study 
and sending a referral for the study. Additionally, for patients 
who have not been enrolled but their provider agreed for 
research staff to contact, messages will be sent to the 
providers prior to the patient’s upcoming appointment where 
the 
provider 
can 
talk 
about 
the 
study 
with 
the 
patient/caregiver and send a referral. Research staff will 
follow-up with a phone call shortly after the visit.  
Recruitment through Community-based organizations: 
Dr. Stevens has collaborated with the CBOs for over 10 years 
on multiple research and service programs for family 
caregivers in Central Texas. Counties served by the Central 
Texas AAA and AAACAP are presented in Table 2 along with 
counties served by the Area Agencies on Aging/Councils of 
Government that overlap with the Baylor Scott & White 
Service area (Brazos Valley AAA, AAA of East Texas, AAA of 
Ark. Tex, Texoma AAA, and North Central Texas Council of 
Governments). Alzheimer’s Texas is the primary Alzheimer’s 
focused not-for-profit in Central Texas and provides service 
to all eligible counties. Our long-term partnership with the 
named CBOs includes the practice of compensating CBOs 
for research related activities which are typically outside the 
core mission of the CBO. Thus, the three organizations will be provided stipends to apply to staff salaries based 
on services each is expected to provide. Stipends will support the staff person charged to be the organization’s 
“Program Champion”.  The Program Champion will be fully versed in the study and should be able to answer 
some basic questions. Program Champions will facilitate referral of interested caregivers to the research team 
via the secure REDCap site. Referrals will include basic demographic and contact information (See Human 
Subjects for details). GP4C research staff will conduct a formal screening. Participants will be enrolled in Months 
13-48 of the study period (See Timeline.) 
Recruitment through existing research studies: 
Table 2: Recruitment Area
Target Area
Bell
Milam
Coryell
Mills
Hamilton
San Saba
Lampasas
Bastrop
Hays
Blanco
Lee
Burnet
Llano
Caldwell
Travils
Fayette
Williamson
Brazos
Madison
Burleson
Robertson
Grimes
Washington
Leon
Panola
Anderson
Rains
Camp
Rusk
Cherokee
Smith
Gregg
Upshur
Harrison
Van Zandt
Henderson
Wood
Marion
Bowie
Lamar
Cass
Miller
Delta
Morris
Frankling
Red River
Hopkins
Titus
Cooke
Grayson
Fannin
Collin
Kaufman
Dallas
Navarro
Denton
Palo Pinto
Ellis
Parker
Erath
Rockwall
Hood
Somervell
Hunt
Tarrant
Johnson
Wise
Bosque
Hill
Falls
Limestone
Freestone
Mclennan
Heart of Texas
TEXOMA
North Central Texas
Counties
AAACAP
AAACT
BVAAA
AAAET
AAAAT

IRB Submitted 01/11/22 
 
The Dementia Care Study (D-CARE study, site PI: Alan Stevens) funded through the National Institutes of Health 
(NIH) and Patient Centered Outcomes Research Institute (PCORI) targets the similar population as the current 
GP4C study. Caregivers enrolled in D-Care study have the opportunity to indicate on their consent form if they 
would like to be contacted for future research studies. These CGs after completing the DCare study will be 
contacted by research staff to assess interest and eligibility for participation in GP4C.  
Individuals referred for possible enrollment will be contacted by phone within 3 business days of referral 
for the initial screening interview. Part of confirming eligibility will require the caregiver to demonstrate a functional 
home computer with internet access. While the GP4C systems will be accessible regardless of connection 
speed, GP4C research staff will review key computer/internet characteristics over the phone such as use of 
internet browsers, possible system and software updates and conduct an internet speed test. It is expected that 
all homes will have at least 1mb/s download speed. Those eligible and expressing interest in the project will be 
scheduled for a second phone call for consenting and baseline data collection. During the second phone call, 
participants will review the consent form with study personnel on the phone before providing a digital signature. 
The REDCap survey feature will allow the consent form to be updated in the participant’s record where the 
consenting staff can add his/her own signature. Participants will then be administered baseline instruments over 
the phone while following along with their PDF copy. 
All data collection systems and services will be based on REDCap, the CTSA-supported data 
management tool (http://project-redcap.org). While REDCap provides many essential features, its main strength 
is its open architecture and support for user-designed extensions ("plugins" and "hooks"). Many of the services 
described below are highly customized REDCap extensions that appear to the user as stand-alone web 
applications. Through these extensions, we can customize the interface of any REDCap-based web tool to match 
the workflow of the study activity.  After confirming eligibility, study personnel will administer the informed consent 
procedure, collect intake information, and conduct the baseline assessments over the phone (Aim 2). 
Study Design 
The proposed study of AIM 2 is a two-group randomized controlled trial that compares the impact of the 
GP4C system, an online system with functionality designed to be comparable to the REACH II intervention of 
education, skill building and ongoing support to R4C, an online system of caregiver education. Random 
assignment will occur after Project Manager (Jordan Reese) confirms that all eligibility criteria have been satisfied 
and that a valid signed consent form is in the REDCap system. The project’s co-investigator and biostatistician, 
G. Han, will design and oversee the randomization protocol. After randomization, participants will be contacted 
by study personnel to assist with logging on to the appropriate online system based on their group assignment. 
At six months following randomization, all participants will be contacted by study personnel to conduct follow up 
assessments. In addition to measures collected at baseline, the follow-up assessment will include questions 
regarding participant satisfaction with the online systems and other supports.  Assessments will occur over the 
phone at baseline and 6 months post baseline. Project staff conducting the 6-month interview will be blinded to 
caregiver’s condition assignment. Participants will maintain access to the system in which they were assigned 
through the duration of the project. 
 
 GP4C. Participants in the GP4C intervention arm will have access to full system functionality.  This includes the 
ability to answer additional assessment items and receive additional automated, individualized feedback on their 
responses with links to site educational and skill-building content.   
Participants can also access site educational and skill-building content directly by using menu 
navigation.  Each participant will also be assigned a bachelors or masters level Dementia Care Specialist (DCS) 
who will facilitate caregiver interactions with the online material and provide skill training via telephone or web-
based video. Study participants in the intervention arm will receive 9 automated emails and 4 phone calls over 
a 6-month period (See Table 3).  
Replicating the schedule of in-home contacts used in REACH II, each of nine emails will focus on a major 
topic area covered in the system, encourage the study participant to log into the system to access more 
information related to the topic, and remind the participant that an interventionist is available for telephonic 
consultation as needed.  Scheduled therapeutic contacts will not be influenced by the degree in which the 
participant is interacting with the GP4C online materials.  
The goal of the telephonic core contacts will be to encourage use of GamePlan4Care to address 
participant educational and skills-training needs and to assist participants with applying knowledge and skills to 
their specific caregiving situation through role-playing and problem-solving.  If the interventionist receives 

IRB Submitted 01/11/22 
 
negative feedback regarding the participant's ability to use the site, they will attempt to troubleshoot the problem 
on the phone or invite the participant to a one-on-one training on system use.  If there is consistent negative 
feedback regarding a specific aspect of the system, these observations will be reported to the project team for 
consideration for possible system updates.  The DCS will discuss the value of support groups on all four of the 
telephone calls, each time referring the caregiver to a complete list of support groups provided by Alzheimer’s 
Texas, including telephone and web enabled video (i.e., Zoom).  

IRB Submitted 01/11/22 
 
While REACH II provided tailored support 
groups as part of the intervention, our approach 
encourages the use of existing community 
resources reducing future barriers to translation 
of GP4C from a research environment into a 
service environment. (Alzheimer’s Texas will be 
provided a stipend in Years 2 – 5 to provide 
support groups.) 
R4C. Participants in the R4C comparison will be 
able to access a standard set of educational 
materials. Materials will cover all topics included 
in the education-based comparison condition 
used in the REACH II trial.  We have used the 
REACH II comparison conditions as a guide. 
Educational materials on the following topics will 
be 
included: 
1) 
General 
information 
on 
Alzheimer’s Disease and Dementia, 2) General 
information on caregiving, 3) Information on 
caregiving related stress and 4) Home safety. 
R4C will present one page on each topic and will 
include active links to two additional online 
sources on the same topic. System functionality 
will be limited to a welcome screen with direct 
navigation to a subset of the educational content 
by using menu navigation.  Study participants 
assigned to R4C will receive two emails from their 
DCS encouraging the caregiver to review specific 
education materials. Each email will be followed 
by brief "check-in" calls (15-min each) at three 
months and five months after randomization. This 
replicates the REACH II control condition. 
Treatment Implementation Monitoring 
Treatment 
fidelity 
assessments 
will 
document the degree to which the GP4C and 
R4C was delivered by the system and research 
staff and received and used by caregivers34. 
Treatment implementation refers to a class of 
procedures and process measures that make up 
treatment delivery, receipt, and enactment35,36. 
Treatment implementation procedures promote 
the accurate and consistent delivery of the 
intervention 
protocol. 
Process 
measures 
document the amount and quality of the 
treatment delivered. Treatment implementation 
data will be used to determine if individual 
caregivers 
meet 
treatment 
compliance 
thresholds. 
Distributions 
on 
treatment 
implementation indicators will also be considered 
in exploratory analysis, which will link “dose” of 
treatment to outcomes.  
A number of methods will by employed to ensure treatment implementation according to protocols. The 
pre-programmed computerized nature of the intervention will ensure a high level of treatment consistency.  Initial 
and booster training will be conducted with CBO points of contact to ensure they are describing the study and 
 
 
 
 
Table 3: Schedule of GP4C Therapeutic Activities 
Timeline 
GP4C Intervention Activities 
Week 1 of 
Enrollment 
Login & Initial Assessment 
Send login credentials 
Confirm first login 
Completion of user initial assessment 
Drafting of domain feedback by DCS 
Week 2 of 
Enrollment 
Confirm Dashboard Visit 
User first visit to dashboard confirmed 
Week 3 of 
Enrollment 
Email Contact 1 
Topic: Welcome and Setting Goals 
Week 4 of 
Enrollment 
Phone Contact 1 
Introduction to DCS 
Orientation to system and therapeutic 
contacts 
Clarifying needs/setting goals 
Review safety issues 
Action items and next steps 
Week 6 of 
Enrollment 
Email Contact 2 
Topic: Documentation 
Week 8 of 
Enrollment 
Email Contact 3 
Topic: Problem-solving 
Week 9 of 
Enrollment 
Phone Contact 2 
Review new issues/recent changes 
Assess progress to goals/troubleshoot 
barriers 
Review social support issues 
Action items and next steps 
Week 11 of 
Enrollment 
Email Contact 4 
Topic: Staying Flexible 
Week 13 of 
Enrollment 
Email Contact 5 
Topic: Midpoint Review 
Week 15 of 
Enrollment 
Email Contact 6 
Topic: Empowerment 
Week 16 of 
Enrollment 
Phone Contact 3 
Review new issues/recent changes 
Assess progress to goals/troubleshoot 
barriers 
Review physical/emotional health issues 
Action items and next steps 
Week 18 of 
Enrollment 
Email Contact 7 
Topic: Acknowledging Your Needs 
Week 20 of 
Enrollment 
Email Contact 8 
Topic: Prioritization 
Week 22 of 
Enrollment 
Phone Contact 4 
Review new issues/recent changes 
Assess progress to goals/troubleshoot 
barriers 
Review disruptive behavioral issues 
Discuss closing of intervention and ongoing 
needs 
Action items and next steps  
Week 23 of 
Enrollment 
Email Contact 9 
Topic: Wrapping Up 

IRB Submitted 01/11/22 
 
recruiting in a consistent manner to meet study goals.  Further, all DCSs will be trained and certified in the 
REACH II using the training workshop created by Stevens that has been conducted for CBOs across Texas by 
Birchfield.  The project team will conduct weekly meetings with DCSs to discuss cases and special topics related 
to the GP4C system.  Finally, the project team will conduct regular audits of DCS to review documentation and 
ensure the appropriate number, duration, timing, and content of participant interactions. 
Measures and Outcomes 
The primary outcome measures will be those that informed the multi-domain quality of life measure 
utilized in the original REACH II randomized clinical trial. This approach is similar to that used by Nichols and 
colleagues in two REACH VA studies37,38. Burden is considered the signature outcome since it is used for power 
and sample size estimates for analysis purposes.  
Measures include:  
 
Burden: A 12-item version of the Zarit Caregiver Burden Interview41.  Each item represents a statement 
related to some aspect of perceived burden.  Caregivers rate each item with higher scores indicating 
higher rates of burden. 
 
Depression: A 10-item version of the Center for Epidemiological Studies Depression Scale39,40.  Each 
item represents a statement for which respondents indicate how often in the past week they have felt that 
way in the past week. Total score is computed by summing scores for all items with higher scores 
indicating higher levels of depressed symptoms. 
 
Social support: Two subscales of Social Provision Scale (8 items), Reliable Alliance and Guidance will 
be used to assess availability of support and satisfaction with support from others. 
 
Self-rated health: A single item of caregiver’s perception on his/her own health is included.   
 
Interactions with health care providers: Medical care management and coordination is measured with a 
9-items of NSOC survey for how caregivers manage medical needs for care recipients and provide 
substantial help with health care activities including interaction with health care providers. 
 
Additional outcome measures will include those that capture a more diverse aspect of dementia care than 
capture by the QoL REACH II measure and include:  
 
Caregiver stress: Perceived Stress Scale is a 10-item classic stress assessment, designed to help 
measure individual stress levels. Individual scores on the PSS can range from 0 to 40 with higher scores 
indicating higher perceived stress.  
 
Positive caregiver: Positive Aspect of caregiving (PAC) is measured with eleven items of the favorable 
aspects of their caregiving experience46. The items ask about their mental or affective state related to 
their caregiving experience, for example, providing help to care recipients has ‘made me feel more useful’, 
‘made me feel strong and confident’, ‘given more meaning to my life’, ‘enabled me to develop a more 
positive attitude toward life’, and ‘enabled me to learn new skills’. 
 
Cognitive change in care-recipient: A 12-item self-administered questionnaire (NPI-Q), completed by the 
caregivers about patients for whom they care, that measures the presence and severity of 12 
Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as the caregiver’s distress. 
 
Additional process measures will be generated from user logs of the systems to document treatment 
implementation, including the total duration of time spent on GamePlan4Care. A program evaluation 
measure, the USE questionnaire, will be provided to caregivers after completion of the 6-month battery 
has been administrated. The USE questionnaire consisting of 30 items on usefulness, ease of use, ease 
of learning, and satisfaction will evaluate participant’s attitude toward GP4C system. 
 
For participants whose care recipient has passed in the last 6 months, caregiver burden and cognitive change 
in care recipient will not be assessed at 6 months . 
 
Data Analysis 
Caregiver participants will be randomized to the two intervention arms (GP4C and R4C) with the ratio of 
1:1. Primary and secondary outcomes, including the Zarit’s caregiving burden interview, will be assessed at 
baseline and 6-month follow-up. Covariates in the analysis include demographic characteristics of the caregivers. 

IRB Submitted 01/11/22 
 
Common descriptive statistics (mean, standard deviation, median, interquartile range for continuous variable; 
frequency and percentage for categorical variables) will be calculated for all covariates in each intervention arm 
and the two arms will be compared at baseline. Goals of our statistical analysis will be to evaluate the 
effectiveness of each intervention arm and to compare the two arms. For each intervention arm, the difference 
between 6-month follow-up and baseline will be computed. Paired t-test and Wilcoxon signed-rank test will be 
used to detect significant changes in outcome variables at 6-month follow-up since the baseline. Medians, 
means, and 95% confidence intervals of the differences will be calculated using both empirical percentiles and 
normal approximation. The two intervention arms will be compared at each follow-up time and for the whole trial 
period. We will compare the two arms at 6-month follow-up using the two-sample t-test and Wilcoxon rank sum 
test for each of the two outcomes.  
The Anderson-Darling test will be used to check the normality assumption at baseline and follow-up times 
for the two outcome variables. If normal assumption is significantly violated then only nonparametric estimates 
and tests (i.e., median, IQR, empirical confidence intervals, Wilcoxon signed-rank test, and Wilcoxon rank sum 
test) will be reported, and data transformation, such as log and square root transformations, will be considered 
to normalize the outcome variables for further model-based testing. The two arms will also be compared 
incorporating observations baseline and the two follow-ups in longitudinal analysis of covariance (ANCOVA) 
models having the follow-up time and adjusting for covariates.  
Given the fact that participants will be randomized into the two arms, the outcome variables will likely be 
comparable between the two arms at baseline. As a result, the interaction effect between the treatment arm and 
follow-up time (while adjusting for covariates) will be tested in the longitudinal analysis to evaluate the difference 
between the two intervention arms because a significant interaction indicates the caregiver’s outcome has 
followed significantly different trajectories in the follow-up period depending on the treatment arm. Missing values 
may be possible because 1) some caregivers may be lost to follow-up, and 2) some caregiving recipients can be 
deceased prior to the follow-up. Missing patterns will be inspected and multiple imputation methods, including 
regression imputation, propensity score imputation, and MCMC imputation will be considered based on the 
missing mechanism47. All tests will be two-sided and a p-value less than or equal to 0.05 will be reported as 
statistically significant. Statistical Analysis Software (SAS software, version 9.4; SAS Inc., Cary, NC) will be used 
to conduct the proposed analysis.  
 
Sample size considerations 
The primary endpoint in this power 
analysis is the Zarit’s caregiving burden 
score. Assuming 20% attrition rate at the 6-
month follow-up, we plan to initially enroll 
totally 240 family caregivers who will be 
equally randomized into two will be equally 
randomized into two arms (120 per arm), 
and we expect a minimum of 100 caregivers 
per 
arm 
to 
complete 
the 
6-month 
assessment. The sample size of 100 in each 
arm 
can 
guarantee 
80% 
power 
at 
significance level 0.05 to detect the effect 
size of 0.28 standard deviation (SD) 
difference between baseline and 6 months follow-up in a two-sided paired t-test. (See Table 4). Nicholas et al.38 
reported the effect size of 0.33SD of Zarit’s score from the REACH VA intervention (also between baseline and 
6-month follow-up). While GP4C will use a different delivery strategy than used in the REACH II and REACH VA 
trials, core therapeutic materials and techniques of the intervention are maintained. Thus, we expect GP4C to 
have a similar impact on caregiver outcomes as observed in prior REACH II trial. Thus, we conclude that enrolling 
120 caregivers per arm (100 available at 6 months) will achieve sufficient statistical power to detect the 
effectiveness of the proposed interventions, even if the GP4C full functionality intervention is slightly less robust 
than the original REACH interventions.  
 
 
 

IRB Submitted 01/11/22 
 
Refinement for Future Testing and Dissemination  
 While Aim 1 usability testing will yield the in-depth feedback needed to produce the best possible 
version of the GP4C system for testing in the field, 3.5 years of testing to achieve Aim 2 will also produce a 
considerable amount of feedback regarding its functionality and utility. In order to realize the full value of the 
project, feedback from GP4C users during Aim 2 project activities (including community partners, 
interventionists, and caregiver participants) will be used during a final round of iterative design and system 
updates by the Baylor Scott & White Office of Digital Health. These updates are judged to be critical as they 
will best position the GP4C for ongoing clinical trials, future cultural adaptations, and eventual dissemination to 
CBOs. 
Timeline of Study Activities  
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Aim and Activity 
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 
Aim 1: Prepare GP4C for Testing in a RCT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 GP4C System Import & Integration w/BSWH IT Systems 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Digital Health Team UI/UX Review and Updates 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Engage Community Partners for CG Usability Testing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Usability Testing with Dementia Caregivers  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 External Advisory Committee Review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 2: Randomized Clinical Trial of GP4C 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Recruitment Materials Development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Engage Program Champion within Community Partners 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Interventionist Training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Participant Recruitment & Screening & Consent    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Intervention Delivery 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Participant 6-month Reassessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Project Completion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 External Advisory Committee Review Preliminary Findings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Post study refinements to GP4C system 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Final Report Preparation & Dissemination of Findings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Alternative approaches 
Successful completion of the two AIMs of this study will advance a proof of concept that the REACH II 
intervention can be made available online to caregivers and that the burden of intervention delivery can be 
lessened with web technologies that automate many of the tasks that required human resources. This will fill a 
significant gap in the availability of online evidence-based services for caregivers. It will not, however, be the 
only online resource for caregivers. Alzheimer’s Navigator® is a content navigation tool that takes user 
responses to survey questions to direct them outside the site to relevant educational content, mostly related to 
the planning and provision of care for the care recipient. GP4C provides individual feedback, and link users to 
internal, tailored content for skill-development related to caregiver self-care and dementia care management. 
The intervention includes an integrated live-support element with regular interventionist outreach for coaching 
sessions to facilitate skills acquisition and problem-solving.  
Access to the BSWH Office of Digital Health is a significant and unique asset to this project, allowing us 
to bring GP4C in-house for UI/UX (and hosting). While there are commercial usability laboratories, using 
resources within the BSWH system provides a more cost-effective approach and ensure secure hosting during 
the testing phase. We have allotted one year for this process that we believe is reasonable. The BSWH Digital 
Health Office is committed to having a product within a year. 
Recruitment is often a challenge in caregiving studies. Stevens and Ory have a long and strong record 
of completing research trails as expected. Moreover, Stevens has worked closely with the partner CBOs on 
number projects. Establishing a “champion” within the organizations will demonstrate our mutual commitment to 
project success. While our monthly recruitment goals are reasonable given the target recruitment area, BSWH 
is the largest not for profit healthcare provider in Texas, and we can expand recruitment internally if needed. 

IRB Submitted 01/11/22 
 
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