Mealtime Partnerships for People With Dementia in Respite Centers and at Home
Phase: NA
Conditions: Dementia, Alzheimer Type, Weight Loss
Sponsor: Medical University of South Carolina

Version #14 7/12/21 
 
 
1 
Official title: Mealtime Partnerships for People With Dementia in Respite Centers and at Home 
 
 
NCT03622814 
 
 
Document date: 10/12/2023 
 
 
Principal Investigator: 
 
Teresa Kelechi, PhD, RN 
MUSC College of Nursing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version #14 7/12/21 
 
 
2 
A. Introduction/Hypothesis  
Two of the most challenging conditions that negatively affect persons with dementia (PWD) 
living in the community are: (1) weight loss leading to frailty, and (2) social isolation leading to 
diminished quality of life (QOL). Lack of caregiver (CG) skills related to meals, dysfunctional 
CG and PWD behaviors during meals, and diminished PWD social skills leading to isolation are 
well-documented factors influencing nutritional outcomes. This study will test the efficacy of an 
intervention that empowers CGs and volunteers or staff in respite care centers (RCCs) who 
interact with PWD during mealtime. Specifically, a train-the-trainer program, Partners at Meals 
(PaM) derived from the theoretically-based C3P Model of Changing the Place (home or RCC), 
Changing the People (CG or volunteer) and Changing the Person (PWD) will be used to 
improve nutritional outcomes and QOL. Family members are the primary CGs of community 
dwelling PWD. We hypothesize our intervention will: (1) improve quality of life by better 
equipping family caregivers and respite care providers to manage a chronic illness with 
significant burden (Alzheimer’s disease and related dementias), (2) improve palliative care for 
this terminal illness while some change is feasible, and (3) enhance innovation in a community-
based practice (Respite Care Centers). As such, the products of this study are of high 
significance. 
 
Family-managed care is critical in promoting quality of life (QOL) and health in 
Alzheimer’s disease and other dementias. The Partners at Meals (PaM) intervention emphasizes 
focusing on more than just “changing” a PWD, but also intervening with the People with whom 
they interact and Place where meals occur. With this intervention, CGs and volunteers or staff at 
RCCs partner and modify mealtime at a point when the PWD is still able to express preferences 
and engage in the meal process, and develop a PWD-centered plan of mealtime care. Of note, 
our pilot work indicated that CG’s report of mealtime behavior may be inaccurate because CG 
and other family members may overlook key cues/triggers to dysfunctional behavior. Thus, to 
improve this identification process, a secure and HIPAA-compliant telehealth component 
(Doxy.me) is used to record dysfunctional behaviors displayed by the PWD on a ‘tablet’. The 
CG interacts with their “partner’ volunteer, the RCC staff or MUSC Interventionst (AIM 4) 
either through a real-time connection or sharing of the recorded file so that together, they can 
problem-solve issues and modify the plan of care. This CG-volunteer/ staff member partnership 
also fosters consistency across settings (AIMS 1-3), as well as imparts skills and self-efficacy for 
care management for both parties, improves QOL for the CG and the PWD, improves mealtime 
outcomes for the PWD, and promotes better health outcomes. 
 
Research design. A randomized cluster-design trial will be conducted in two large RCCs with 
six sites that serve primarily white and African American PWDs. RCCs will be randomized to 
the intervention condition (Partners at Meals; 2 sites) or [‘enhanced usual care’ (EUC)] (4 
sites). The primary unit of analysis is the PWD and CG: 60 PWDs, 60 CGs will be enrolled; it is 
estimated that up to 60 volunteers/staff/managers may be enrolled. The CG and RCC volunteer 
or staff member is another dyad for analysis, as is the RCC volunteer/staff member and the 
PWD. Additionally, RCC Managers at both PaM and EUC sites will be interviewed regarding 
barriers to implementation, ways to enhance the project, and possible causes of discharge of 
PWD from the study related to nutritional problems.  
 
Additionally, to explore the feasibility of program replication and widespread adoption, an online 

Version #14 7/12/21 
 
 
3 
global survey of Respite Care Providers and their respective agencies will be conducted on the 
use of telehealth/videoconferencing technologies to deliver individualized educational support 
services to families in-the-home. 
 
Partners at Meals (experimental condition) uses the C3P Model to direct change in three key 
areas (place, person, PWD) whether at the RCC or in the home. In the intervention sites, project 
staff will train the RCC volunteers or staff members, who will train CGs to more effectively 
manage meals based on assessment at the Center, and will subsequently use the telehealth 
solution in the home. Tailoring the plan to the home is critical to family-managed sustainability. 
The intervention will be delivered through each CG-volunteer /staff member dyad, and each 
PWD-CG dyad will be enrolled for 6 months. CGs and staff/volunteers in the EUC condition 
will have training focused on CG needs alone for support from family and others to manage care. 
A comprehensive process evaluation plan will be used to monitor implementation and foster 
dissemination. 
 
Specific Aims: 
Aim 1: To use a repeated-measures, randomized control design to assess the relative efficacy of 
Partners at Meals (PaM) vs. enhanced usual condition (EUC) in terms of the following PWD 
outcomes at baseline, and one-month intervals: nutritional status (weight, photography of pre- 
and post-food consumed); dysfunctional behaviors at meals (Edinburgh Feeding in Dementia 
scale XL with additional fields and questions added); quality of life (QOL-AD) 
Main hypothesis: Participation in PaM will be associated with improved weight maintenance and 
decreased dysfunctional mealtime behaviors (the latter of which is the presumed mechanism of 
change). 
Aim 2: To assess the relative efficacy of the Intervention vs. EUC in terms of the following. 
CG: quality of life (Euro-QOL), burden (Zarit Burden Scale), depression (CES-D), and self-
efficacy for managing meals at home; b) RCC volunteer or staff: self-efficacy for training and 
management of mealtime issues; c) RCC director/manager: satisfaction with the program and 
willingness to maintain the program post-funding. 
Aim 3: Conduct a process evaluation and content analysis to assure adherence, feasibility (e.g. 
using the telehealth tablet at home), reach, and maintenance to inform dissemination and 
adoption. 
Exploratory Aim 4: To assess efficacy and outcomes of PaM when research staff implements the 
Intervention. 
 
B. Significance and Innovation: 
This trial examines patient-centered (PWD) outcomes when changes occur in behavior and in the 
environment. We lay the groundwork to examine the effectiveness and sustainability of a train-
the-trainer program that could be disseminated and adopted by national organizations and 
community agencies through various media to manage mealtimes for this vulnerable population. 
With the demographic changes and resulting CG burden, comes the need for changes in the way 
health services are delivered. Tailored and dynamic plans that manage meals need to be 
developed, and care needs to be delivered in the community, where older people prefer to live 
and where resources are accessible and tailored to the culture and context. Along these lines, the 
PaM intervention focuses on two community sites – the home where meals are delivered by the 
CG, and the RCC where volunteers and staff assist with meals. Our implementation model uses 

Version #14 7/12/21 
 
 
4 
the train-the-trainer approach (train volunteers or staff to then train CGs) to deliver an 
intervention posited to change QOL issues for both the CG and the PWD, as well changing 
nutrition-related outcomes in the PWD. Several major nutritional enhancement initiatives to date 
have focused on CGs or PWDs but not both, as does the PaM program. There have been some 
successes among community-based programs that improved CGs health parameters and their 
ability to handle behavioral issues. However, studies are needed that describe capacity-building 
community interventions for the CG that influence PWD health parameters beyond QOL, which 
is notably influenced by CG health. Although our intervention is targeted to Respite centers, it 
could be easily extended to Adult Day Centers (medical model) that provide respite services to 
families.  The impact of the proposed study is translational as it effectively builds upon the 
foundational NIH supported studies (REACH, Savvy Caregiver, NYUCI) one of which, the 
Savvy Caregiver, has been translated into a ‘transportable version’, something we feel we are 
close to achieving in this efficacy study and will use a component of in our ‘enhanced usual care’ 
group. Furthermore, this study addresses an unexplored important area – patient-centered 
outcomes related to a dyadic interaction - impact on PWD health. The focus to date on CGs 
outcomes implicitly assumes that change in that domain will yield positive results for ‘patients’. 
If PWD health benefits are demonstrated, this may lead to a potential policy implications related 
to CG support. 
 
Innovations proposed by this study are five: a potential to change how and where services in 
dementia caregiving are delivered; potential to demonstrate a novel Train-the-Trainer model 
using volunteers or staff-CG dyads supported by a tele-health intervention; a focus on multiple 
dyads (i.e., PWD-CG, CG-volunteers or staff, volunteers or staff -PWD); the use of technology 
to enhance management of a disease that often leaves CGs isolated and unsupported; and a 
development of a low-cost sustainable intervention. 
 
C. Rationale and Approach: 
Study Overview:  
Collaborating with the 2 respite care organizations and up to 180 subjects, a cluster design will 
be used to determine the efficacy of the Partners at Meals (PaM) train-the-trainer program 
compared to enhanced usual care (EUC). Two groupings of sites will be created in attempt to 
balance size and racial distribution: the largest site, which is racially diverse (The ARK), will be 
paired with  a site (in the Respite Care Charleston system), which is not diverse: Together they 
will be one Site for treatment condition and analysis. The other four sites in the Respite Care 
Charleston system that together have approximately the same diversity and size, will be joined to 
create a second Site. These two Sites will then be randomized to PaM and EUC. All subjects 
(PWD, CG and RCC volunteers) will be followed for 6 months or until discharge or voluntary 
termination. The biostatistician will determine the cluster randomization. An ongoing process, 
impact and outcome monitoring plan is planned. 
 
We will conduct an ‘enhanced usual condition’ training to identify ways that CGs 
communicate with family and friends to delegate challenging aspects of caregiving. Inspired by a 
unit of the Savvy Caregiver, the EUC will include a 30-minute presentation at sites with a 
follow-up 30-minute role-play regarding identifying challenging issues, ways of communication 
and ways to share those elements of caregiving that could be accomplished by others. When the 
site ‘comes on board’, the Program Manager will deliver the training and repeated every 6 

Version #14 7/12/21 
 
 
5 
months while the project is in progress for new CGs. Additionally, the staff of the EUC sites will 
be included in the teaching, and will facilitate discussion with the CGs during the interim. The 
program staff will attend the EUC site’s support group every two months (or more frequently if 
needed) to see if CGs need guidance and discuss issues with the EUC staff.  
 
Further, every attempt will be made to include PWDs with similar levels of cognitive/behavioral 
disabilities in both the PaM and EUC conditions; however, since this is cluster design, we cannot 
assure an equal balance. 
 
In order to further assess the feasibility aim of program replication and widespread adoption, an 
online global survey of Respite Care Providers and their respective agencies will be conducted 
on the use of telehealth/videoconferencing technologies to deliver individualized educational 
support services to families in-the-home. The researcher devised survey will examine provider 
attitudes and opinions towards using these technologies to deliver individualized educational 
support services to families at their respite RCCs. 
 
D. Research Design and Method: 
AIMS 1,2 and 3 
Recruitment, enrollment, participant eligibility South Carolina is largely a rural state with more 
than 1/3 of the population identifying themselves as African American (AA). We chose two 
agencies that serve a diverse group of families at five sites in Charleston, Berkeley and 
Dorchester counties. The sites chosen are largely in Medically Underserved Areas of South 
Carolina. Both agencies and Executive Directors (PL, JH) have long-standing relationships with 
the PI (TK) and have been the sites of prior research and shared funding. Furthermore, our team 
has a long-standing relationship of improving care in the community, supporting each other in 
submissions to foundations and state agencies, teaching staff and families, acting as sites for data 
collection, and assisting with fund-raising for close to 15 years. 
 
The intervention is designed to benefit important target groups: persons with dementia (PWD); 
home caregivers (CG); volunteers or staff at the RCC sites (volunteers or staff); and RCC 
administrators/managers. In the centers, the Program Manager will work with the RCC Manager 
and volunteers or staff to identify PWD and CGs that might be willing to volunteer. They will 
support this effort by announcing the study in their web-based newsletter, through take-home 
fliers, and announcing the study at support groups where the PI and Co-PI (TK, SQ) and 
Program Manager will make planned visits to answer questions and demonstrate the tablet 
platform. Due to the 6-month project length/dyad, we will over-enroll by 25%. 
 
Exploratory AIM 4 Design Overview 
 
Exploratory AIM 4 includes MUSC research project staff to implement the intervention to CG 
and PWDS residing at home and receiving respite services. The past 14 months brought 
limitations to in-person meeting and programming in respite care centers affecting clients, 
volunteers and staff alike. Electronic platforms including Telehealth are now more commonly 
used and will be used to eliminate some of those barriers by making the intervention available to 
those not ready or able to engage in respite center programming or attending respite centers 
currently experiencing fewer Volunteers prior to the COVID pandemic.  

Version #14 7/12/21 
 
 
6 
 
Recruitment, enrollment, participant eligibility South Carolina is largely a rural state with more 
than 1/3 of the population identifying themselves as African American (AA). We recruit in 
through partnerships with agencies that serve a diverse group of families often in Medically 
Underserved Areas of South Carolina. Councils on Aging, homehealths, community centers and 
formal and informal respite centers are all places where Project Staff has formed connections to 
support and recruit for this project through web-based newsletters, through take-home fliers, 
social media announcements and announcing the study at support groups. 
 
AIMS 1, 2 and 3 Eligibility criteria for the Volunteers or Staff; be a regular volunteer or staff 
with current affiliation of working or have worked at RCC within the last 12 months and is 
amenable to commit to the 6 month length of the study; able to read and speak English, identify 
as comfortable in the teacher/coach role, and demonstrate ability to use televideo and 
photograph. 
 
(All AIMS) Eligibility criteria for Persons with Dementia (PWD): aged ≥ 45 years; diagnosis of 
Alzheimer’s disease or related dementia with mild to moderate stage as demonstrated by the 
Functional Assessment Staging Scale (FAST) of 4 or greater; absence of wasting disorders (e.g., 
HIV/AIDS, heart or renal failure or COPD, end-stage cancer) ; some supervision required or 
dysfunctional behavior present (e.g., redirection); not receiving enteral feeding or active 
treatment by a speech pathologist/therapist; not diagnosed with dysphagia as identified by CG or 
on RCC Intake Sheet. Those enrolled in or qualifying for hospice will not be included. 
Eligibility criteria for Caregiver (CG): is not paid for services; provides 4 hours or more of 
care/day; assists with ADLs including meals; be able to speak and read English. This study will 
not enroll persons for whom English is not their primary language. We acknowledge this 
essentially excludes older Hispanic persons who are solely Spanish speaking. However, we plan 
to create a culturally tailored intervention for this population in future work. AIM 4 Have or 
have access to computer with internet connection.  
 
Eligibility criteria for the Administrators/Managers: assumes an administrative position within 
the respite care site (PaM or EUC) who has worked with the organization for at least 3 months 
and plans to be in place for at least 9 more months. 
 
The introduction of the study and consenting processes are described in Protection of Human 
Subjects. 
 
Intervention (Partners at Meals):  
(AIMS 1,2,3) The intervention (PaM) is a train-the-trainer process. This process is primarily 
overseen by the PI (TK); she will also be available for further training and consultation. The 
intervention begins with 3 initial sessions (each 90-minutes over 2 weeks) by the project staff 
trained in adult education and will occur in the intervention sites; and they will be repeated as 
needed in each RCC for all new volunteers. These initial sessions will include: an introduction 
to dementia and mealtime issues along with an evaluation; principles of adult education; and 
application and refinement of assessment and teaching skills with an evaluation. There will be 
booster sessions (90-minutes) after the first 6 weeks of training or as needed with project staff 
for all volunteers that include: challenges of implementation; application and refinement of 

Version #14 7/12/21 
 
 
7 
assessment and teaching skills. There will also be observation of the volunteer or RCC staff-
CG dyad by the research project staff and RD (initially) and monthly by the project staff based 
on feedback from the RCC staff and CG through self-report questionnaires to include skills in 
assessment, mealtime issues and teaching. The plan will be reviewed during the first month, then 
monthly for the remainder of the 6-month intervention. Thus, the mealtime intervention is 
occurring, being evaluated and modified monthly based on the Place/ People/ Person of the 
Partners at Meals model.   
 
Furthermore, under the supervision of project staff trained in adult education and the Registered 
Dietician (RD) the intervention delivered by the RCC volunteer or staff with the CG and PWD 
dyad will be tailored to the PWD based on the initial assessment of health conditions, nutrient 
intake (initially assessed a pre-post measure of food consumed at the RCC and at home), 
mealtime behaviors (EdFED XL), and perceived quality of life (QoL-AD) . Cultural factors will 
be ascertained via structured checklist that will allow further modification (e.g., avoidance of 
meat/fish products, food blessing rituals, eating of hot and cold foods with certain medical 
conditions). Perceived barriers, preferences, motivation and confidence in making change will be 
assessed by the Program Manager and Registered Dietitian (RD). Working with the Program 
Manager and the RD, the RCC volunteer / staff or MUSC Project Staff (AIM 4) and CG will 
devise an initial plan of care for mealtimes. An RD was chosen to be a part of the initial 
planning since the PWD who attend RCC programs may have co-morbidities as well as 
pharmacological therapy that may influence nutritional status and diet choice. Furthermore, the 
RD will use assessment of nutrients and calories consumed based on digital pre-and post-
photos (taken on the tablet) and food logs that may warrant changes in the plan based on 
health changes or as other information is available, e.g. food insecurity.  
 
The project staff under the supervision of the PI (SQ) will be trained in the use of the tele-
health component in of the intervention; she will also be available for further training and 
consultation. Research Staff will then train the volunteers or RCC Staff and the volunteers or 
RCC Staff will train the CGs in an initial training and at the same times for booster sessions and 
observations as the mealtime plan (above). After instruction in the use of the tablet, the CG will 
make monthly photos and films of a breakfast, lunch and dinner using the tablet provided. These 
images will either be sent via a password-protected HIPAA compliant system – Doxy.me to 
be evaluated by the Volunteer or RCC Staff and the research staff. Alternatively, the tablet can 
be brought to the respite care site and images downloaded there. In partnership with the 
Volunteer or RCC Staff, and research staff, a plan will be made to either continue the activities 
in the current plan or to revise it. The plan will be made initially after enrollment based on 
the tele-health images and the evaluation measures (see next section), then monthly for the 
remainder of the 6-month intervention; the CG and Volunteer or RCC Staff will document their 
agreed upon plan with the goal of the CG becoming the ‘lead’ in the planning as time progresses 
to promote sustainability. During the intervention, the CG and Volunteer or RCC Staff or MUSC 
Project Staff (AIM 4) will meet at least monthly at the RCC in a private room or via 
DOXY.ME on the Tablet to review progress and resolve issues; the research project staff will 
attend the first two of these meetings to assure fidelity and facilitate the process (the RD may be 
consulted during these times or more frequently if needed). Thus, the mealtime intervention is 
occurring, being evaluated and modified monthly, based on the Place/ People/ Person of the 
Partners at Meals model. The RCC administrator/manager, staff and volunteers (and possibly the 

Version #14 7/12/21 
 
 
8 
RD) will have planned interactions with the Program Manager at one-month intervals to assess 
use of resources, skills and beliefs of RCC staff, satisfaction with the program and suggestions 
for improvement.  
 
Administrators/Managers at the respite sites will be interviewed by the Program Manager every 
3 months that the study is in place for satisfaction, willingness to continue the program after 
completion, any CG or volunteer dissatisfaction, and are asked for data regarding discharge or 
hospitalization of study participants to determine if the cause could be related to nutrition-related 
changes. The Administrator/Manager and the project staff will ‘check-in’ every month, or more 
often if needed, to report any urgent problems or issues that need a timely resolution. However, 
the Administrators/Managers will not be consented as they are not research subjects but engaged 
in research (Offsite form attached) and we will be collecting feasibility and 
evaluation/satisfaction information from them. Formal evaluation of the Volunteer or RCC 
Staff, CG and PWD will occur at baseline, monthly and at the end of enrollment (6 months) or 
earlier if the CG or PWD withdraw or are withdrawn (see next section).  
 
If requested, a step-by-step outline of the sessions used to train the Volunteer or RCC Staff, and 
then the CG by the Volunteer or RCC Staff as well as ‘booster’ sessions can be provided to the 
IRB, as well as weekly and monthly review activities accomplished by research team members. 
 
Measures, data sources and collection. As noted in the Aims, there are key outcome measures 
of interest as well as mediating and moderating variables to address secondary aims. This briefly 
summarizes the primary outcome measures, describes the dependent measures to address the 
primary study aims and summarizes all measures, collection mode and timing. All data will be 
collected at baseline, monthly and when completed – at 6 months to approximate the effect of 
the PaM or EUC on the groups separately and in unison. All participants at both the PaM and 
EUC sites will receive all measures. The primary measures against which the study is powered 
lie with the PWD and are weight change and change in dysfunctional behavior. 
 
1. Person with Dementia measures: 
Demographics collected only at baseline: 
• Functional Assessment Staging Scale – level of independence in physical activities 
• Mini-Mental Status Examination – rates level of dementia 
• Characteristics – age, race/ethnicity, primary diagnosis/ health problems with focus on 
swallowing problems and possible dysphagia  
Outcomes collected baseline, monthly and completion 
• Body weight and caloric intake – weight before meal in street clothing less outer 
garments; intake measured by images taken with tablet pre- and post-meals at pre-
arranged times 
• Edinburgh Feeding in Dementia Scale (EdFED XL with added questions) – 24-item scale 
for dysfunctional meal-related behaviors (images from the tablet may assist in validating 
behaviors in question) 
• Quality of Life in Alzheimer’s Disease (QOL-AD) – 13 item instrument used in person 
with MMSE as low as 4 
2. Caregiver measures: 
Demographics collected only at baseline 

Version #14 7/12/21 
 
 
9 
• Age, race/ethnicity, employment, relation to PWD, living arrangement, hours/day caring 
for PWD 
Outcomes collected baseline, monthly and completion 
• Center for Epidemiological Studies – Depression Scale (CES-D) – widely used in CG 
studies 
• Zarit 12-item Burden Scale – rated 0 – 4, used in prior CG studies 
• European Quality of Life (Euro-QL) – measures health-related quality of life 
• Self-efficacy for Change – based on CP3 Model (developed in pilot work) 
 
3. Volunteer or RCC Staff measures (AIMS 1,2 and 3): 
Demographics collected only at baseline 
• Age, race/ethnicity, preparation for volunteer role including coursework or classes or  
personal experience as CG, frequency of attendance, years in role 
Outcomes 
• Self-efficacy for Change – based on CP3 Model instrument (developed in pilot work) 
• Performance measures – self-report of fidelity to treatment, carry out or change mealtime 
plan, address questions, training issues, progress and participation (developed in pilot 
work) 
4. RCC Administrator/Managers measures 
Demographics collected only at baseline 
• Age, education, training, years in role, roles and responsibilities, role as CG 
Outcomes 
• Overall satisfaction of staff and CGs 
• Satisfaction with implementation issues, satisfaction with program, willingness to 
continue 
• Discharge status of any PWDs in study – to institutional care, hospitalized related to 
nutrition-related problems 
 
Online Global Survey of RCC providers 
An online global survey of RCC providers will be conducted using a researcher developed 
survey instrument. The survey will explore RCC telehealth/video conferencing capabilities, their 
use pre and post the onset of the COVID-19 pandemic, and RCC provider attitudes and opinions 
towards communicating and delivering individualized and in-the home educational support 
services to caregivers and their families with these types of technologies.  
 
The survey itself will be conducted via an online REDCap survey link that will be widely and 
electronically disseminated through local, state, national and international network of RCC 
provider agencies and member associations – who will in turn share the link and opportunity to 
participate in the survey with their members on their listserves and organizational websites. No 
PHI will be collected, a waiver of HIPAA authorization and consent will be utilized, as written 
consent is deemed impractical for a study of this design. Survey instructions will however be 
devised in accordance with Federal Regulations and MUSC IRB policy: - so, as to include 
information about the study, its purpose, the demands, risks, and a statement that by submitting 
their responses that the individual is voluntarily agreeing to participate in the research study. We 
are aiming to sample at least 120 participants, globally. As no identifiable PHI will be collected, 

Version #14 7/12/21 
 
 
10 
the risks associated with this participation in this portion of the study are considered minimal. 
Study compensation will not be provided for survey participation. 
 
Eligibility criteria includes:  
• aged 18 years and older; 
• male and female employees at RCCs; 
• ability to read and understand English; and, 
• must have internet access.  
 
Statistical analyses:  
Responses to all items are not required to complete the survey. All responses will be evaluated 
with descriptive analyses under the intention-to-treat principal (ITT). Descriptive analyses will 
include frequency tables for categorical variables and mean, standard deviation, minimum, 1st 
quartile, median, 3rd quartile, and maximum for continuous variables.  Data will be stratified by 
demographic variables.  Additional analyses will evaluate the association among survey elements 
using appropriate statistical techniques based on the nature of the data and the research 
question(s).  Categorical variables will be compared with other categorical variables using the 
chi-square or Fisher’s Exact test and with continuous variables using ANOVA or a non-
parametric alternative.  Associations between pairs of continuous variables will be assessed 
using the Pearson or Spearman Correlation Coefficient. Finally, generalized linear models may 
be used for exploratory statistical modeling of outcomes of interest from this survey.  Survey 
results will be shared with member associations and organizations, who will in turn share them 
with their members, ie. the survey respondents. 
 
E. Protection of Human Subjects 
 
1. Risk to subjects: 
 
a. Sample 
The proposed study will include 60 persons with dementia (PWD) and 60 caregivers (CGs) from 
5 respite care centers (RCCs), approximately 33-57 ADC volunteers or staff and 
administrators/managers (will participate but are not considered subjects). The total number of 
persons counted for the Enrollment Tables is 180 persons. Both the PWD and his/her CG will be 
enrolled in this study and the PWD must attend one of the RCC sites for care at least once 
weekly. Additionally, volunteers will be enrolled who are long-time (defined as volunteering for 
at least 3 months or longer), and are present at least weekly. RCC Staff will have current 
affiliation with or have worked at the RCC with the last 12 months and are amenable to commit 
to the 6 month length of the study. 
 
This is a cluster-randomized trial so each RCC whether in the EUC or PaM groups will be added 
every 2 months. For both types of conditions, the involvement of these participants includes: 
recruitment, consent and enrollment into the study; gathering of baseline data including an 
analysis of the percent of food eaten pre- and post-meals via a still photo, other assessments 
collected by an in-depth interview that will take about 1 hour. At this point in the Intervention 
(PaM) group, a train-the-trainer program will now be shared with RCC staff in the intervention 
site and within two weeks, under the direction of the Program Manager and with input from the 

Version #14 7/12/21 
 
 
11 
Registered Dietician, the RCC volunteer or RCC Staff will work with the CG to devise an initial 
plan of care for the PWD; this plan will be operationalized both at home and in the RCC (see 
Intervention – Partners at Meals). Additional training for new volunteer and booster sessions are 
planned. Monthly the RCC volunteer or RCC Staff and CG ‘partnership’ (dyad) will meet to 
determine if the plan is still working, and if adjustments need to be made with the help of the 
Program Manager or his/her designated staff member, and Registered Dietician, if needed. The 
intervention lasts 6 months and during that time, data are collected every month. Reasons for 
withdrawal are: death, institutionalization, and discharge from the RCC. Additionally, the 
administrator/manager of the RCC will be interviewed every 3 months that the project is ongoing 
(could be up to 2.5 years) to determine their satisfaction with the project, use of resources, and 
willingness to sustain the project.  
 
Those in the Enhanced Usual Care (EUC) group will have data collected at the same intervals 
(baseline, monthly or withdrawal) and the administrator/manager will be interviewed every 3 
months. At the conclusion of the project in each site for those in the EUC sites, the Program 
Manager will provide the initial training sessions to the RCC volunteers at these sites.  
 
The persons with dementia (PWD) and the caregivers (CG) could be considered vulnerable 
groups. Enrollment including the informed consent process and their continued participation will 
be based on several issues. All conversations, assessments and consenting will occur in a private 
room in the RCCs. The PI is very familiar will all of these sites and they all have a private room. 
The voluntariness of this research will be stressed every month that a CG completes their 
assessment; if a CG does not complete the forms requested every month after a second request, 
they will be asked by the Program Manager (not the RCC staff) if they consider the study to be 
in any way a burden, and will be withdrawn unless they state they wish to continue. PWD will be 
asked to assent to the Informed Consent and will be asked their assent to continue in the study 
every month. If at two separate times they decline, the PWD will be withdrawn from the study.   
 
All CGs enrolled in the study, whether in the PaM or EUC arm, will receive $50 at enrollment 
and $50 per month for every month they are enrolled in the trial. It is expected that since the 
CGs live with or on the same property as the PWD, that this money will be considered shared. 
RCC volunteers or RCC Staff receive $100 for every CG with whom they partner. Volunteers 
or RCC Staff receive $100 for each PWD/CG dyad they work with for at least one month; there 
is no further remuneration. It is possible that over the life of the project within any agency, the 
volunteer may work with more than one PWD/CG dyad and thus be eligible for $100 for each 
dyad with whom they assist. The total remuneration will be based on the total number; for 
example, if a volunteer works with 3 PWD/CG dyads, they would receive $300. The total 
number of dyads that any one volunteer or RCC Staff can work with is 5 and thus the 
maximum reimbursement would be $500. (This is below the  $600 limit for IRS reporting.) 
For every year that the site has participants enrolled in the study, they will receive $10,000 to 
provide for the extra resources, time, and data collection that this study will impose. 
 
To be eligible for the study, potential PWDs will need to be: aged 45+ years; receives 4 or 
more hours daily of care; Functional Assessment Staging (FAST) score of ≥4 with supervision 
required at mealtimes; not enrolled in hospice; not receiving enteral feeding or active treatment 
by a speech pathologist; not diagnosed with dysphagia. Caregivers will need to be: someone 

Version #14 7/12/21 
 
 
12 
who lives with or near the PWD who is also enrolled in this study; providing 4 hours of care/day; 
assisting with ADLs including meals. RCC volunteers must be long-term volunteers (at least 3 
months) and must be present at the RCC at least weekly. RCC Staff that participate in the study 
will have current affiliation with or have worked at the RCC with the last 12 months and are 
amenable to commit to the 6 month length of the study. 
 
Administrators/managers will be the Administrator/manager of record. 
 
b. Sources of materials: 
Research materials will be obtained directly from participant in-person or telephone interviews, 
direct observation with checklists, and direct standing weight obtained at the RCC. Data 
collected directly from participants that will be recorded include social, psychological, medical, 
functional, and health factors related to nutritional intake, weight, and dietary intake. All 
information obtained will be used solely for research purposes and participant confidentiality 
will be assured. This will be explicitly disclosed in the Informed Consent Form and carefully 
reviewed with potential participants. Private information, including name, address, telephone 
number, and address that are individually identifiable will be collected from study participants 
for the purposes of this research. Such private information will be coded and each individual will 
be assigned a study identification number. A key will be created to decipher the code. Only the 
PI and Co-I, Program Manager, Research Assistant, and Registered Dietitian will have access to 
this code. This is because they will be contacting caregivers in their homes. Furthermore, all data 
will be stored in the MUSC secure REDCap database, which was used successfully in our 
SCTR-funded pilot study. 
 
c. Potential risks and planned protection: 
This study involves the criteria for minimal potential risk to participants. Risks of the 
intervention are primarily those associated with collection of confidential information. 
Additionally, it is possible that some of the suggestions offered by the Program Manager and 
Registered Dietitian may not be part of a participant’s usual routine and these may cause 
psychological distress. Because the intervention is guided by participants’ preferences and 
individual circumstances, the likelihood of this occurring is low. It is also possible that 
participant may feel tired or burdened while participating in the study. This risk is also low based 
upon our past experience in researching CGs and PWDs. We are careful to ask about ostensible 
indicators of swallowing problems – choking, coughing, and turning the head or resistance to 
assistance. In discussion with Dr. Bonnie Martin-Harris, a leader in the field of dysphagia and 
Past President of the Dysphagia Research Society (personal communication, July, 2015), there 
will be no swallow screening in this project. The current training intervention directs any RCC 
staff or CG who observes indicators of swallowing problems to contact their healthcare provider 
immediately; Dr. Martin-Harris felt that this precaution was sufficient. Dr. Martin-Harris’s 
successor, Dr. Heather Bonilla – also an expert SLP clinician and researcher, has agreed to 
sit on our DSM group. Additionally, if any PWD is found to be losing more than 5% of their 
body weight during the 6 months of the study, we will contact the CG and ask them to notify the 
PWD’s healthcare provider. 
 
2. Adequacy of Protection against Risks 
 

Version #14 7/12/21 
 
 
13 
a. Recruitment and Informed Consent 
At this point, the Administrator/Manager of the RCC will be given an opportunity to ask any 
questions, and will be consented. Once the sites are established and matched, the PI and Program 
Manager will visit all sites and hold an informational session at a time convenient for staff, 
volunteers and CGs; we realize there may be multiple meetings required. We will publicize the 
study in newsletters and fliers sent home. We will then screen all interested volunteers and CGs 
and question the CGs generally about the PWDs mental and functional capacity. Every RCC site 
has private rooms and we will conduct initial meetings and all interviews in these private rooms. 
After meeting all eligibility requirements, we will approach the RCC administrators, volunteers, 
CGs and PWD regarding consent. 
 
Due to scheduling and coordination challenges with CGs at the RCC during their normal hours 
of operation, we will employ both face-to-face in-person consenting as well as remote Electronic 
consenting. 
 
In a private room within the RCC at a time agreeable to the potential participant, the Program 
Manager will describe the study protocol and informed consent in detail, including reading the 
informed consent form. She/he will ask the potential participant (RCC volunteer or RCC Staff, 
CG, and PWD if able) if he or she has any questions and if they understand the consent form. 
She/he will ask the participant to describe their perception of what they have read or been read in 
order to ensure informed consent. Extra care will be taken to ensure that the participant 
understands that he or she is agreeing to participate in a cluster randomized controlled trial. Care 
will be taken to ensure that he or she does not believe they will be receiving treatment in the 
study or that continued receipt RCC services is dependent upon participation in the study. 
Additionally, the consent form will explicitly describe that adverse health information (e.g., 
weight loss, possible dysphagia) related to dementia will be shared with the health provider, if 
the CG agrees. Past studies conducted by the PI affirm that PWD should at encouraged to assent 
at least monthly, and whenever possible consent to research if legally able; if not, consent will be 
given on their behalf by someone legally empowered to do so. Once RCC volunteers, CGs, and 
PWDs are consented and HIPAA forms are completed for the CG and PWD, we will randomize 
the sites. 
 
Electronic or e-Consenting will be performed on eligible CGs and PWDs that want to participate 
in the study but are unwilling for whatever reason and/or unable to attend a face-to-face 
informed consent meeting at the Center. Families identified through the study recruitment 
processes that fall into this category will already have spoken with the researchers, have been 
introduced to the study and its demands, as well as had their initial questions answered. After 
speaking with the researchers, families that are further interested in study participation will be 
asked to provide an email address at which they will receive a REDCap survey link containing a 
scanned image of the currently approved Informed Consent document (developed from the 
MUSC REDCap e-consent template). Families will be able to take as much time as they like to 
read the consent document together in the comfort and privacy of their own home or at a place 
and time of their choosing. Prior to providing their physical e-consent, the researchers will 
coordinate with these families; so as to be on the telephone and be available to further answer 
any questions that they may have during the e-consent process. Should a participant have any 
questions or concerns about the study, the researchers will address these issues to the best of 

Version #14 7/12/21 
 
 
14 
their abilities and knowledge. Upon submitting the e-consent, a REDCap trigger will 
immediately notify the researchers, who will then provide their countersignature to the 
document.  
 
Participants will be able to download a copy of their executed informed e-consent/HIPAA 
authorization forms directly to their own computer, or have copies emailed to them. They will 
also be given the option to have a copy of their executed e-form mailed to them should they elect 
to do so. A copy of the executed e-consent will also be stored in the participant's electronic case 
record for monitoring and audit purposes. 
 
b. Protection against risks including confidentiality: 
Risks to confidentiality will be protected by coding participant records as described above. 
Additionally, all study participant records will be kept in the secure REDCap System – “a 
mature, secure web application for building and managing online surveys and databases. All 
transactions are securely delivered to the application using SSL (SHA‐1th RSA Encryption;; 
2048-bits). It is then transmitted internally (behind the MUSC firewall to the database server.) 
All transactions are logged at the server layer (http logging), application layer (REDCap logs 
activity to a database table), and the database layer (using both query and binary logging.) 
Whenever possible, all data entry will be made directly into tablets fitted with the REDCap 
secure application.” Any signed documents will have the signature page scanned and uploaded 
into REDCap. A separate Regulatory Binder will also be kept in a locked cabinet in the PI’s 
(TK) locked office. 
 
Regarding protection against other forms of risk (psychological, physical, social, etc.), several 
safeguards will be in place. If at any time during any interaction with study staff, a participant 
exhibits or expresses burden or fatigue, the session will be interrupted and arrangements will be 
made to resume at a later date. If any of the CGs report a level of burden of depression that is 
considered serious, we will ask them to report this to their healthcare provider as soon as 
possible or offer to make the report with their permission. If a PWD’s weight is reduced by 5% 
or greater, or displays increased agitation during the intervention, we will inform the CG and ask 
to inform their healthcare provider. The PWD will be withdrawn from the study if the CG or the 
provider decide this is the best course. 
 
c. Payment to participants: 
As noted in Section 1.a - All CGs enrolled in the study, whether in the PaM or EUC arm, will 
receive $50 per month for every month they are enrolled in the trial. It is expected that since the 
CGs live with or on the same property as the PWD, that this money will be considered shared. 
RCC volunteers receive $100 for every CG they partner with – this will be paid at the conclusion  
of the volunteer training ($50) and another $50 after the third month of pairing with each 
Caregiver. Administrator/managers will not receive any direct reimbursement. We support a 
community-engagement approach to research and have always shared our funding with our 
community partners based on an estimate cost to the agency. 
 
3. Potential Benefits of the Proposed Research to the Subjects and Others:  
The benefits to participants of participating in the study are that PWD may increase caloric 
intake and stabilization or increase in weight. Their interaction with the CG and RCC volunteer 

Version #14 7/12/21 
 
 
15 
or RCC Staff at meals may improve their QOL. This may result in prevention of unintentional 
weight loss, improved function, reduced morbidity and mortality, and decreased adverse 
outcomes, including morbidity, institutionalization, and mortality. The benefit to others is that if 
this program is proven effective, other PWDs and CGs might benefit as well from its future 
implementation. The intervention could result in improved mental health and QOL of CGs, and 
the ability of RCC staff to influence the knowledge, skills and behaviors of CGs and PWDs on 
other issues. Administrators/managers could better manage problem issues and consider the use 
of tele-health as a meaningful way of communicating and assisting clients. 
 
4. Importance of Knowledge to be Gained: 
 
Information gathered from this study could lend support to policies designed to enhance the 
nutritional status of PWD, and mental health indicators of their CGs; it could provide a valuable 
way to increasing knowledge and skills of CGs and use RCCs as a mechanism to offer more 
integrated training and treatment in their facilities. Information gathered in this study could be 
used by foundation and organizations serving PWD such as the Alzheimer’s Association, the 
Brookdale Foundation or various state agencies that deliver care to older adults such as the 
Lieutenant Governor’s State of South Carolina Office on Aging to disseminate training programs 
specifically for community-based programs. The minimal risks involved in this study are 
reasonable in relation to important information that a non-invasive cost-effective intervention 
might provide. 
 
a. Dissemination plan: 
The investigators of this study plan to share the results with appropriate audiences – both 
scientific and 
community based. We plan to submit abstracts to the following conferences (at least 1 annually): 
1) Gerontological Society of America (November) 
2) International Academy on Nutrition and Aging on Nutrition and Alzheimer's Disease (July) 
3) American Association of Public Health (November) 
4) Academy of Nutrition and Dietetics (October/November) 
5) Alzheimer’s Association Annual Meeting (July) 
6) Local conferences that involve community organizations and ethnic/minority communities 
 
Planned publications include: 
1) The Gerontologist 
2) The Journals of Gerontology: Health Sciences 
3) Journal of Nutrition, Health & Aging 
4) Journal of Applied Gerontology 
5) Journal of Clinical Bioinformatics 
6) Journal of Telemedicine and Telecare 
The material resources used for this study (Train-the-Trainer Manual, videos, brochures, 
PowerPoint presentations, “Playbooks”) will be shared with the community and academic 
partners, NIH, and the general public. Findings from this study will be disseminated and shared 
with community and academic partners, NIH and the general public via professional and lay 
publications, presentations and forums, web-sites, newsletters, or other mechanisms. 
 
 References (key – full list of 101 references can be furnished) 

Version #14 7/12/21 
 
 
16 
 
Administration on Aging. A Profile of Older Americans: 2014. Washington DC: US Department 
of Health and Human Services; 2014 [15]. 
 
Amella E Mealtime difficulties. In: Evidence-based geriatric nursing protocols for best practice. 
National Clearinghouse Guidelines (AHRQ). 2008. Available from: 
http://www.guideline.gov/summary/summary.aspx?doc_id=12267&nbr=006351&string=mealti
me+AND+difficulties. 
 
Amella EJ, Aselage MB. Facilitating ADLs by caregivers of persons with dementia: The C3P 
Model. Occupational Therapy & Health Care. 2014;28(1):51-61. PMCID: PMC4487525. 
 
Bellg A, Resnick B, Minicucci D, Obedegbe G, Ernst D, Borrelli B, et al. Enhancing treatment 
fidelity in health behavior change studies: Best practices and recommendations from the NIH 
Behavior Change Consortium. Health Psychol. 2004; 23(5):443-51. 
 
Gaskill D, Isenring E, Black L, Hassall S, Bauer J. Maintaining nutrition in aged care residents 
with a train-the-trainer intervention and nutrition coordinator. Journal of Nutrition, Health and 
Aging. 2009;13(10):913-7. 
 
Gaugler J, Kane R, Kane R. Early community-based service utilization and its effects on 
institutionalization in dementia caregiving. The Gerontologist. 2005;45:177-ˇ85. 
 
Hepburn K, Lewis M, Tornatore J, Sherman C, Bremer K. The Savvy Caregiver Program: The 
demonstrated effectiveness of a transportable dementia caregiver psychoeducational program. 
Journal of Gerontological Nursing. 2007;33(3):30-6. 
 
Locher J, Bales C, Ellis A, Lawrence J, Newton L, Ritchie C, et al. A theoretically based 
behavioral nutrition intervention for community elders at high risk: The B-NICE randomized 
controlled clinical trial. Journal of Nutrition Gerontology & Geriatrics. 2011;30(4):384-402. 
PMCID: PMC3495161 
 
Instruments: 
Bedard M, Molloy D, Squire L, Dubois S, Lever J, O'Donnel M. The Zarit Burden Interview: a 
new short version and screening version. The Gerontologist. 2001; 41:652-7. 
 
EuroQol. What is EQ-5D? Rotterdam, The Netherlands: EuroQol Group; 2009. Available from: 
http://www.euroqol.org/home.html 
 
Folstein M, Folstein S, McHugh P. "Mini-Mental State": A practical method for grading the 
cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189-95 
 
Radloff L. The CES-D scale: a self-report depression scale for research in the general 
population. Applied Psychological Measurement. 1977; 1:385-401. 
 
Reisburg B, Ferris S, deLeon M, Crook T. The Global Deterioration Scale for assessment of 

Version #14 7/12/21 
 
 
17 
primary dementia. American Journal of Psychiatry. 1982;139:1136-9. (FAST Scale) 
 
Serrano-Aguilar P, Lopez-Bastida J, Yanes-Lopez V. Impact on health-related quality of life and 
perceived burden of informal caregivers of individuals with Alzheimer's disease. 
Neuroepidemiology. 2006;27(3):136-42. 
 
Watson R, Green S, Legg L. The Edinburgh Feeding Evaluation in Dementia Scale #2 
(EdFED #2): convergent and discriminant validity. Clinical Effectiveness in Nursing. 
2001;5(1):44-6. 
 
Watson R, MacDonald J, McReady T. The Edinburgh Feeding Evaluation in Dementia Scale 
#2 (EdFED #2): inter- and intra-rater reliability. Clinical Effectiveness in Nursing. 
2001;5(4):184-6. 
 
5. Data Safety Monitoring Plan – (2/14/17 an 8-page DSMP was filed with the NIH/NINR, is 
copied here and added to final documents at close of this IRB application) 
 
 
DATA AND SAFETY MONITORING PLAN (DSMP) 
 
We proposed a Data Safety Monitoring Committee due to the lower risk of this study and have 
received no feedback from NINR (funder) to the contrary. 
 
SECTION A. Monitoring Entity 
Considering the study rationale, population, procedures, and the risk: benefit profile, the overall 
risk level for participation in this study is classified as: Minimum Risk. The study will employ 
the use of a Safety Monitoring Committee (SMC) that will meet semi-annually across all years 
of the study. The SMC members are charged with reviewing safety and trial progress and 
providing recommendations to the PIs and MUSC IRB with respect to study continuation 
modification, and termination.  
 
1) Data Safety Monitoring Committee (DSMC) 
The study’s SMC is comprised of the following individual members: 
• Heather Bonilha, PhD CCC-SLP, Dysphagia Expert (DE) and SMC Chair 
• Frank Treiber, PhD, Technology for Healthy Lifestyle Expert (TE) 
• Martina Mueller, PhD, Biostatistician (BS) 
• Kathryn VanRavenstein, PhD, RN, Clinical Expert (CE) 
• Mohan Madisetti, MS, Project Manager (PM)   
 
2) Individual Roles and Responsibilities 
Principal Investigators, (PIs). As PIs, Drs. Kelechi and Qanungo will overall be responsible for 
the immediate protection of all human participant study participants.  
 
Dysphagia Expert (DE), Dr. Bonilha who is the Medical Director for Speech-Language 
Pathology for the MUSC hospital/clinic enterprise, and specializes in the areas of swallowing 
and voice disorders will serve as Chair of the SMC. Because of the slight chance of a person 

Version #14 7/12/21 
 
 
18 
with mild to moderate developing dysphagia, Dr. Bonilha’s expertise will be valuable. As a 
member, Dr. Bonilha will also correspond semi-annually with the other members of the SMC to 
review de-identified cumulative AE study data to assess any impact on the safety of participants 
or on the ethics of the study and provide expert safety recommendations. Dr. Bonilha has no real 
or apparent conflict of interest that would affect her performance in this role on the study. 
 
Technology for Healthy Lifestyle Expert (TE), Dr. Treiber is the MUSC Endowed Chair for the 
South Carolina Centers of Economic Excellence (CoEE) Technology Center to Advance 
Healthful Lifestyles and will serve as a member of the SMC. Dr. Treiber has a long history of 
extramural funding from the NIH and uses technology – particularly telehealth modalities to 
reach marginalized groups that otherwise would not receive innovations in healthy lifestyles. 
Because of his community telehealth expertise, Dr. Treiber’s expertise will be helpful. As a 
member, Dr. Treiber will also correspond semi-annually with the other members of the SMC to 
review de-identified cumulative AE study data to assess any impact on the safety of participants 
or on the ethics of the study and provide expert safety recommendations. Dr. Treiber has no real 
or apparent conflict of interest that would affect his performance in this role on the study. 
 
Biostatistician, (BS). Dr. Mueller will be responsible for conducting semi-annual interim data 
analyses, generating semi-annual AE safety reports from the electronic study research database 
and disseminating de-identified information to all members of the SMC. The interim data 
analyses will only include safety related results; analyses in regards to study outcome will not be 
performed. The interim AE safety reports will provide typology, frequency data and outcomes of 
all reported and documented AEs in the electronic study database. As a member of the SMC, 
Dr. Mueller will also participate in semi-annual SMC meetings. 
 
Clinical Expert (CE), Dr. VanRavenstein is an Assistant Professor at College of Nursing and 
certified by the American Nurses Credentialing Center as a Family Nurse Practitioner. As a 
nurse practitioner, she has a diverse practice background in the areas of family and internal 
medicine, urology, orthopedics, cardiovascular surgery, retail and community health. She is a 
P20 funded researcher focusing on mHealth applications for the promotion of qualitity life 
among aging populations. Dr. VanRavenstein will correspond semi-annually with the SMC to 
review de-identified cumulative adverse event (AE) study data to assess any impact on the safety 
of participants or on the ethics of the study. 
 
Project Manager, (PM). Mr. Madisetti will be responsible for the classification of all reported 
adverse events (AE) and ensuring that all serious adverse events (SAE) are forwarded to the PIs 
and CE in real time and in compliance with MUSC IRB and NINR’s reporting requirements. In 
addition, and in conjunction with the PIs, the PM will be responsible for amending the protocol 
in accordance with the SMC recommendations, submitting reportable SAEs to the IRB, and 
submitting annual Progress Reports to the NIH/NINR through MUSC’s ORSP. As part of the 
SMC, he/she will be responsible for: conducting monthly internal quality control audits on all 
participant records and notifying the PIs of any deficiencies; assisting in the generation of ad hoc 
participant data safety reports as requested; and, the forwarding of reportable SAE to the 
NIH/NINR Program Official through MUSC’s ORSP within 72hrs of IRB review and 
acknowledgement. The PM will also be responsible for following up on reported AEs to monitor 
outcomes and provide for the continuity of care for study participants. 

Version #14 7/12/21 
 
 
19 
 
SECTION B. Procedures for Safety, Risk and Confidentiality 
1) Monitoring Study Safety 
From the initial screening of participant by inclusion and exclusion criteria to the informed 
consent process to the provision of participant study instruction to staff training in Good Clinical 
Practices (GCP) and regulations pertaining to the Conduct of Human Participant Research to 
weekly contact with participants to internal quality control audits and protocol fidelity 
monitoring to the real-time review of AE by the CE and SMC to the oversight of MUSC’s IRB, 
procedures for monitoring study safety are consistently afforded throughout study. Since persons 
with dementia may have impaired judgement for decision making, their Legally Authorized 
Representative (LAR) will be included in all information sharing and decision-making related to 
this study. Specific procedures include: 
• All participants will be screened for inclusion and exclusion per the protocol. 
• All participants will be fully informed as to all known risks and the possibility of risk 
from study participation in the informed consent process. These risks are minimal. 
• AEs and changes in medical status will be elicited at every participant visit and contact. 
• All participants will be given a 24 hrs. AE reporting phone number to the research 
assistant and instructed to notify the PIs of any/all suspected or experienced adverse 
events whether they believe them to be related to the intervention or not. 
• The CE will have access to real-time AE study data and will be able to provide 
immediate recommendations to the PIs and PM. 
• The PM will track all reported participant AEs through to resolution. Please see Section 
C. 1 – 4. 
• The BS shall generate semi-annual AE reports for the PIS and SMC to review. 
• The PM will conduct a quarterly internal quality control audit of the study and all 
participant records to ensure compliance with MUSC IRB regulations and notify the PIs 
of any deficiencies; the PM will work with the PM to correct any errors. 
• The PIs and/or designee will observe and evaluate ten (10%) percent of eligibility 
screening visits, informed consents and study instructions performed by IRB approved 
study personnel and provide feedback and/or retraining of study personnel if fidelity to 
both applicable federal regulations and the protocol is not observed. 
• All investigators and researchers will maintain active CITI training. 
• Investigator performance and compliance will be provided for through MUSC IRB and 
ORI study oversight. 
• All reportable events, including protocol deviations will be forwarded to the NIH/NINR 
Program Official through MUSC’s OSRP within 72hrs of IRB review and 
acknowledgement. 
 
2) Minimizing Research-Associated Risk 
Diligent study safety monitoring will be conducted by the PIs and all members of the SMC 
throughout the conduct of this study in compliance with the following required elements of 
MUSC IRB’s continuing review process: 
1. Tracking and follow-up of participant accrual including withdrawn consents will 
minimize risk by identifying, disclosing, and mitigating any potentially unknown risk(s) 
of harm to study participants. These risks are minimal. 

Version #14 7/12/21 
 
 
20 
2. Timely and appropriate reporting of informed consent process deficiencies, protocol 
deviations, privacy breaches, conflicts of interest, and/or changes in personnel. 
3. Ongoing soliciting, monitoring and appropriate reporting of adverse event activities. 
4. Timely and appropriate IRB submission of safety-related documents such as audit 
reports, sponsor progress reports, ISM reports, and other materials or communications 
that might impact the safe conduct of this study. 
5. Active cooperation with the IRB, ACO, sponsor, and other applicable entities in the 
event of a random or for-cause internal or external audit. 
 
Institution-Wide Assurances 
This protocol will be conducted fully in keeping with the signed MUSC IRB Principal 
Investigator Statement of Assurance and Department Chair’s Statement of Assurance, when 
submitted to the IRB as a required component of the MUSC IRB Human Research Review 
Application. An application will be submitted to the MUSC IRB if/when this project is approved 
and funded by NIH/NINR. Assurances include the following safety-related agreements, signed 
and dated by the PIs. 
 
3) Protecting Confidentiality of Participant Data 
Participant Screening and Enrollment. All data from participants screened for the study will 
be entered into electronic study database. Designated research staff will collect, gather, and enter 
required data (written informed consent, HIPAA Authorization, medical history and 
demographics) onto study data forms. Screened patients who do not meet study eligibility will 
have specific screening data entered into the study database. The collected data will be helpful 
in examining the patient population and feasibility of enrollment criteria and will include gender, 
age, race and reason for exclusion. All dates will be shifted and other Personal Health 
Information (PHI) will be removed from the study database upon study completion. All data 
obtained from this study will be used for research purposes only and will comply with Federal 
HIPAA regulations.  Master Screening and Enrollment Logs will be maintained by the PM and 
will be used to prepare reports on accrual and attrition for the PIs and SMC. 
 
Case Report Forms. All proposed study specific case report forms (source documents) for data 
collection will be designed by the PM in concert with the PIs and BS, and transferred by the PM 
into electronic Case Report Forms (eCRFs) for use in the study’s REDCap database. These study 
specific eCRFs source documents (study logs for correspondence, contact with provider, 
compensation and other forms such as pre-eligibility screens) will be coded by the participant’s 
unique study ID# for all data collected including study instruments will be maintained in the 
participant research record and/or their electronic medical record that will be made accessible to 
study monitors. Completed instruments that require signature on a paper CRF will be scanned 
and uploaded into the study database to all for remote electronic safety monitoring as well as 
maintained on file in accordance with MUSC policies and applicable Federal Regulations for 
the Conduct of Human Participant Research.  
 
Binders. The PM will prepare and maintain a participant-specific binder for each participant 
containing all non-eCRFs records. A regulatory file will also be maintained to include the IRB-
approved Protocol, original Informed Consent documents, HIPAA forms and other study-related 
regulatory documents. All paper research records and CRFs will be maintained in a locked file 

Version #14 7/12/21 
 
 
21 
cabinet, stored in a room for research files that is accessible only via a password protected entry 
system that features security cameras, within the College of Nursing. Access to the research 
records, study database and PHI’s will be restricted to study personnel as approved by the PIs 
and MUSC IRB. As with all studies conducted at MUSC, this study is also eligible for a random 
audit by MUSC Office of Compliance. 
 
Data Processing. This study will use Research Electronic Data Capture (REDCap) for data 
capture and management. REDCap is a software toolset and workflow methodology for the 
electronic collection and management of research and clinical trials data. REDCap provides 
secure, web-based, flexible applications, including real-time validation rules with automated 
data type and range checks at the time of data entry. Exports are made available for several 
statistical packages including SPSS, SAS, SATA, R and Microsoft Excel. The study-specific 
REDCap electronic database will be designed and developed by the PM in concert with the 
BS.  The provision of REDCap is made available through the South Carolina Clinical & 
Translational Research (SCTR) Institute at MUSC with NIH Grant awards UL1RR029882 and 
UL1TR000062.  
 
Data Security. Ensuring data security, compliance with 45 CFR 46 and maintaining the integrity 
of PHI is a top priority. MUSC has Standard Operating Procedures (SOP) to ensure a high level 
of data security while coordinating electronic and paper data management activities for clinical 
research trials. The REDCap study database will be hosted in the Biomedical Informatics secure 
data center at MUSC, a secure environment for data systems and servers on campus, and 
includes firewall, redundancy, failover capability, backups and extensive security checks. The 
secure data center has strict access control; only authorized core personnel may access the 
facility un-escorted. Only authorized users are allowed to connect to the network, and the 
security of the network is actively monitored.  Power and environmental controls have several 
layers of backups, from interruptible power supplies to alternate and redundant feeds to the local 
utility company. The REDCap system administrator contributes to the maintenance of 
institutional disaster recovery and business continuity plans.  Load balancers and a highly fault 
tolerant SAN infrastructure contribute to high availability.  
 
The REDCap system itself has several additional layers of protection including password 
protection. Access to the data and its security is managed institutionally by sponsored login IDs 
through a Shibboleth login with an MUSC issued NetID and features a user account management 
filter that controls who can access the data and to what degree. All personnel must pass an 
employment background check before being issued an ID. Password complexity, history and 
expiration standards are implemented at the institutional level. Access to individual REDCap 
projects and their data is managed by the owner of the project. All transactions are securely 
delivered to the application using Secure Sockets Layer (SSL – SHA-1 with RSA Encryption; 
2048-bits). It is then transmitted internally (behind the firewall) to the database server. All 
transactions are logged at the server layer (httpd logging), application layers (REDCap logs 
activity to a database table), and the database layer, using both query and binary logging. This 
feature provides audit trails for all changes, queries, data exports and reports. MUSC Information 
security policies are available at: https://mainweb-v.musc.edu/security/policy/ 
 
Data Entry. Only MUSC IRB approved study personnel that are authorized to have access to 
the REDCap study database will be granted password access. Study personnel using computers 

Version #14 7/12/21 
 
 
22 
that are connected to the Internet will directly enter data into the remotely housed database. As 
such, no electronic study data will be stored on hardrives and/or any portable electronic devices. 
Additionally, all personnel with access to the database will have current University of Miami 
CITI training in the Conduct of Human Subject Protections, and their respective institution’s 
HIPAA and Information Security trainings that are completed annually. Each participant will be 
assigned a unique study identifier, all PHIs will be masked, and data exports will be limited to 
the PIs, the PM and the BS for generating reports and the conduct of statistical data analysis. 
 
Data Monitoring. Ongoing quality control procedures will be implemented for data collection, 
storage and processing. The PM will conduct monthly monitoring of the study database and 
generate a report for the PIs to review at team meetings. Standing agenda items for these 
meetings will include participant recruitment and retention, AE’s, protocol deviations, data 
integrity and overall study conduct. The PM will work to resolve and validate discrepant data. 
Discrepancies that warrant clarification will be sent to appropriate parties for review and 
resolution. All data entry and changes made in the study database by authorized study personnel 
will be automatically logged by REDCap, and provide a transparent visible audit trail for 
reviewers. 
 
SECTION C.  
Procedures for Identifying, Reviewing and Reporting Adverse Events 
1) Identifying. Potential minimum risks identified for participants are outlined in the Protection 
of Human Participants and will also be outlined in the IRB-approved informed consent 
document. Additional unknown risks may occur and, if so, will be identified through diligent 
monitoring by the PM and the frontline research team throughout the conduct of this study. 
During the informed consent process, participants will be advised of the potential minimum 
risks of participation as identified in the IRB-approved informed consent document and 
reminded throughout the study that the researchers should be promptly informed about any 
concerns regarding potential side effects, adverse events, or clinical deterioration. Participants 
will also be instructed to notify the PIs and/or designee of any suspected adverse events 
immediately if possible. Throughout the course of study enrollment, at each study visit, the 
researchers will elicit information about experienced AEs and monitor participant progress. The 
PM will maintain an electronic record of all reported adverse events and notify the PM and CM 
of all reportable events as they occur. The CM will have real-time access to the study database 
to review and monitor all SAEs that were reported as related to the intervention. The PM will 
generate and provide de-identified semi-annual administrative human participant safety reports 
for the SMC to review participant progress, accrual and attrition rates. Additionally, the BS will 
generate semi-annual safety reports for the SMC to provide for the monitoring of the frequency 
of all reported side effects and AEs. 
 
2) Reviewing. Adverse events will be assessed and evaluated by the members of the SMC 
according to the following MUSC’s IRB Adverse Event Reporting Policy 
http://academicdepartments.musc.edu/research/ori/irb/HRPP/HRPP%20Guide%20Section%204.
7: 
● 
Expected/Anticipated—Identified in nature, severity, or frequency in the current protocol, 
 
informed consent, investigator brochure, or with other current risk information. 
● 
Unexpected/Unanticipated—Not identified in nature, severity, or frequency in the current 

Version #14 7/12/21 
 
 
23 
 
protocol, informed consent, investigator brochure, or with other current risk information. 
● 
More Prevalent—Occurs more frequently than anticipated or at a higher prevalence 
 
than expected. 
● 
Serious—Results in death, is life threatening, requires inpatient hospitalization or 
 
prolongs existing hospitalization, results in persistent or significant disability/incapacity, 
 
cancer, overdose, or causes a congenital anomaly/birth defect. 
 
The relationship of adverse events to study participation will be determined by the SMC 
according to the MUSC IRB Adverse Event Reporting Policy: 
● 
Unrelated—There is not a reasonable possibility that the adverse event may have been 
 
caused by the drug, device or intervention. 
● 
Possibly Related—The adverse event may have been caused by the drug, device, or 
 
intervention, however there is insufficient information to determine the likelihood of this 
 
possibility. 
● 
Related—There is a reasonable possibility that the adverse event may have been  caused 
by the drug, device or intervention. 
 
3) Reporting. All reportable AE, SAE and unanticipated problems experienced by participants 
will be reported to the NIH/NINR and MUSC IRB in compliance with their Adverse Event 
Reporting Policy requirements, using the IRB's password protected on-line secure server 
adverse event reporting system. Within 24 hours after a reportable AE, SAE or unanticipated 
problem has been reported by the participant, it will be initially graded by the PM, forwarded to 
the study’s CE for review and approval, and then will be submitted by the PIs to MUSC IRB. 
The Institutional Official(s) will review the event and discuss the report with the IRB Chair and 
the Director of the Office of Research Integrity. After IRB review and acknowledgement, the 
PIS will further review, and the PM will forward a copy of the reportable AE, SAE or 
unanticipated problem and IRB acknowledgement letter to the NIH/NINR Program Officer 
through MUSC’s OSRP. The activities will be reported to the NIH/NINR within 72hrs. In 
addition, all cumulative reportable AE, SAE and unanticipated problems included in the ISM 
reports will be submitted to the NIH/NINR in the PI’s Annual Progress Reports. 
 
4) Examples of Potential Reportable Adverse Events: In accordance with MUSC IRB 
Adverse Event Reporting Policy, an AE is reportable is it meets all of the following criteria: 1) is 
unexpected 2) is related and/or possibly related, and 3) is serious and/or suggests that the 
research places participants or others at a greater risk of physical or psychological harm than 
was previously known or recognized. Additionally, per MUSC’s policy all participant deaths, 
protocol deviations, complaints about the research, and breaches of confidentiality are reportable 
events. From our previous work among this comorbid population, an example of an AE would 
be less than 5% weight loss due to progression of cardiac disease in a person with dementia. 
Depending on the severity, the possible steps to be taken include referral to a medical provider, 
and/or withdrawing the participant from the study and inviting him or her to restart after acute 
symptoms subside. An example of an SAE would be the death of a caregiver participant from 
acute renal failure, which although would be viewed as unexpected and unrelated to the 
intervention is nonetheless a reportable serious event. No further steps would be taken except to 
review, grade and report the event to all applicable agencies. An example of an unanticipated 
problem would be the participant volunteer has a car accident with loss of transportation but only 

Version #14 7/12/21 
 
 
24 
slight injury (bruising/contusions). The steps in this case would be to withdraw the volunteer 
participant from the study and invite him or her to restart the study after the transportation is 
reestablished and injuries have healed. These events and problems will be reported in accordance 
with the IRB and NIH/NINR policy as noted in Section C.3. 
 
SECTION D. Multi-site Monitoring and Compliance 
This is not a multi-site study. 
 
SECTION E. Assessment of External Factors 
The PIs will conduct a semi-annual assessment of external factors through a review of literature 
related to new developments in the areas of nutrition, swallowing, mealtime interventions and 
other approaches that may have an impact on the safety of participants or on the ethics of the 
study. To determine whether any changes are necessitated to the study protocol, the SMC will 
review any identified literature or product safety data that may pose as a potential impact to the 
risk benefit ratio study and/or safety of study participants. 
 
SECTION F. Interim Analysis 
Based upon our prior extensive research in this field among this same population and the 
minimal risk associated with the intervention, there is no stopping rule for this study. 
Accordingly, interim futility analysis will not be performed. However, the BS and PM will 
generate semi-annual qualitative interim analysis reports on: a) adverse events; and b) data 
obtained during phone call and returned end-of-study surveys to understand issues related to the 
uptake, usability, and adoption of new feeding techniques as the dementia progresses. We will 
evaluate the screening and enrollment procedures, barriers to participation and retention, 
including, safety, adherence, acceptability, technology problems (iPad failures, internet security, 
etc.) encountered if any, and user feedback from all types of participants. The information gained 
from this structured process will inform the design for an implementation/dissemination study 
aimed to facilitate the Partners at Meals model broadly through a non-profit organization such as 
the Alzheimer’s Association or the Brookdale Foundation, such that it becomes the standard of 
care of people with dementia living in the community.