Adapting an Evidence-Based Program That Improves Oral Hygiene and Health for Assisted Living Residents With Dementia
Phase: NA
Conditions: Aging, Long-Term Care
Sponsor: University of North Carolina, Chapel Hill

 
Adapting an Evidence-Based Program that Improves Oral Hygiene and 
Health for Assisted Living Residents with Dementia 
 
 
 
NCT number NCT03892200 
Document Date 07/23/2024 
 

Version 6.0_23 July 2024 
Adapting an Evidence-Based Program that 
Improves Oral Hygiene and Health for 
Assisted Living Residents with Dementia 
Protocol 
 
 
 

Version 6.0_23 July 2024 
PROTOCOL CHANGE LOG: 
Date 
(to HSS) 
Version 
# 
Affected 
Section(s) 
Exact Revision Made 
Date 
Modification 
was Approved 
by Executive 
Committee 
Date Modification 
Became Effective 
15 Jun 2021 
1 
N/A 
Initial Version 
N/A 
N/A 
18 Jun 2021 
2 
4.1 
4.3 
Randomization will occur 
at the AL community-
level. The project 
coordinator will work with 
the NC DHHS Special Care 
Dentistry Program 
partners to identify the AL 
communities that (a) have 
not  been trained in 
MCWB, (b) were trained 
within the last year, and 
(c) were trained longer 
than one year ago.  A 
total of 48 AL 
communities (that are 
licensed to provide care 
for at least 50 residents 
and have not been 
trained in MCWB in the 
last year) will be recruited 
across the state, eight 
from each of the two 
largest regions (Regions 4 
and 5), and four from 
each of the other eight 
regions. The project 
coordinator will recruit 
them within region, with a 
preference given to those 
that have never been 
trained. After confirming 
eligibility and willingness 
to participate, the analyst 
will randomly assign the 
community to treatment 
23 June 2021 
23 June 2021 

Version 6.0_23 July 2024 
Date 
(to HSS) 
Version 
# 
Affected 
Section(s) 
Exact Revision Made 
Date 
Modification 
was Approved 
by Executive 
Committee 
Date Modification 
Became Effective 
or control one-to-one 
within regions.   
18 Jun 2021 
2 
6.2.2 
The oral hygiene status of 
15 up to 20 residents in 
each … site …  will be 
obtained at baseline, four, 
and eight months. 
23 June 2021 
23 June 2021 
22 Nov 
2021 
3 
4.2 
AL community does not 
have at least 20 10 
residents with dementia 
(i.e., translating roughly to 
having 50 beds or more, 
given that on average, 
42% of residents have 
moderate or severe 
dementia, and taking into 
account actual census 
which is lower than 
licensed beds) 
01 December 
2021 
06 December 2021 
22 Nov 
2021 
3 
9.2 
The estimate of statistical 
power is based on Aim 2 
where the outcome is 
change in oral hygiene 
measured by the PI-LTC 
and GI-LTC at four 
months. Based on our 
completed pragmatic trial 
in NHs, 24-month 
treatment effects 
between MCWB and 
control sites suggested 
that our planned sample 
of ~ 288 230 residents 
(i.e., enrolling an average 
of 15 per home and 
allowing for a 20% 
attrition rate) should 
provide more than 80% 
01 December 
2021 
06 December 2021 

Version 6.0_23 July 2024 
Date 
(to HSS) 
Version 
# 
Affected 
Section(s) 
Exact Revision Made 
Date 
Modification 
was Approved 
by Executive 
Committee 
Date Modification 
Became Effective 
power using two-sided 
p≤0.05 significance tests 
even if the treatment 
effect was as much as 25 
24% less in AL compared 
with NHs which we 
consider a conservative 
estimate. 
15 August 
2022 
(submitted 
to HSS by 
AOR) 
4 
Precis and 
3 
Added “up to” when 
referring to number of 
potential respondents in 
the sample size and 
population (in the Precis) 
and in Section 3, 
reflecting reduced 
resident census and 
staffing shortages that 
affect anticipated sample 
size (e.g., will include up 
to 720 residents with 
dementia …) 
Consistent 
with approval 
01 December 
2021 
06 December 2021 
15 August 
2022 
(submitted 
to HSS by 
AOR) 
4 
3 
Clarified the situation 
regarding blinding 
Not applicable 
(updated to 
harmonize 
with MOP) 
Not applicable 
15 August 
2022 
(submitted 
to HSS by 
AOR) 
4 
4.3 
5.2 
6.2 
10.2 
 
Added two adverse 
events to the list of those 
queried on a regular 
basis: any new or 
worsening symptoms or 
disease, emergency 
department visit without 
hospitalization 
28 April 2022 
28 April 2022 
15 August 
2022 
(submitted 
4 
5.2.2 
For completeness, added 
material that control 
communities will continue 
standard care and may 
Not applicable 
(updated to 
harmonize 
with MOP) 
Not applicable 

Version 6.0_23 July 2024 
Date 
(to HSS) 
Version 
# 
Affected 
Section(s) 
Exact Revision Made 
Date 
Modification 
was Approved 
by Executive 
Committee 
Date Modification 
Became Effective 
to HSS by 
AOR) 
receive the training at the 
end of the project. 
15 August 
2022 
(submitted 
to HSS by 
AOR) 
4 
5.2.1 
10.2 
For completeness, 
elaborated the section 
related to assent: Able 
residents will be asked to 
provide assent. In all 
cases, residents must 
assent to the oral hygiene 
assessment; if they 
refuse, the assessment 
will not be conducted. 
Residents will be asked to 
give assent at each study 
visit; if a resident chooses 
to give assent (or not give 
assent) at one visit, study 
staff will continue to ask 
for their assent at 
subsequent visits.  
Not applicable 
(updated to 
harmonize 
with MOP) 
Not applicable 
15 August 
2022 
(submitted 
to HSS by 
AOR) 
4 
5.2.4 
Clarified procedures if 
there is an excessive delay 
between baseline visits 
and training, or between 
baseline and follow-up, 
including that if the 
intervention community 
has a delay, study staff 
will replicate that timeline 
and delay as best as they 
are able in the control 
community in the same 
region. 
Not applicable 
(updated to 
harmonize 
with MOP) 
Not applicable 
15 August 
2022 
(submitted 
to HSS by 
AOR) 
4 
6.3.1 
For clarity and 
completeness, slightly 
modified wording of 
general AE and SAE 
reporting procedures 
Not applicable 
(updated to 
harmonize 
with MOP) 
Not applicable 

Version 6.0_23 July 2024 
Date 
(to HSS) 
Version 
# 
Affected 
Section(s) 
Exact Revision Made 
Date 
Modification 
was Approved 
by Executive 
Committee 
Date Modification 
Became Effective 
15 August 
2022 
(submitted 
to HSS by 
AOR) 
4 
4.3 
5.2.1 
5.2.2 
Allow that all eligible 
residents will be recruited 
(i.e., not limiting the 
number to 20): All 
residents who fit these 
criteria will be eligible and 
allowed to join the 
study/All residents who 
meet the eligibility criteria 
will be eligible and 
allowed to join the 
study/All enrolled 
residents. 
15 September 
2022 
15 September 2022 
1 March 
2023 
(submitted 
to HSS by 
AOR) 
5 
Precis 
3.0 
4.3 
5.2.1 
5.2.2 
5.2.4 
10.2 
 
Revised the data 
collection follow up 
period to be completed 
“up to” the 8-month mark 
(only to be ended earlier 
than the 8-month follow-
up point when necessary 
for project timeline 
adherence). This allows 
for more data to be 
collected for the primary 
outcome of change – oral 
hygiene at the 4-month 
follow up. 
16 November 
2022 
16 November 2022  
(IRB approval) 
1 March 
2023 
(submitted 
to HSS by 
AOR) 
5 
4.3 
5.2.1 
5.2.3 
6.2 
10.2 
Moved the details of 
weekly adverse event 
collection from the Study 
Enrollment Procedures 
section (4.3) to the 
Adverse Event section 
(6.3) for simplicity and 
consistency: “…weekly 
contact with the AL health 
care supervisor, to collect 
adverse events and 
16 November 
2022 
16 November 2022  
(IRB approval) 

Version 6.0_23 July 2024 
Date 
(to HSS) 
Version 
# 
Affected 
Section(s) 
Exact Revision Made 
Date 
Modification 
was Approved 
by Executive 
Committee 
Date Modification 
Became Effective 
incidence of 
pneumonia…” 
1 March 
2023 
(submitted 
to HSS by 
AOR) 
5 
6.3 
Revised the definition of 
adverse events, so that 
adverse events collected 
include: infectious 
diseases such as 
coronavirus (COVID), flu, 
pneumonia, urinary tract 
infections (UTIs), and 
diarrhea. As per DSMB 
decision on 11/08/2022, 
adverse events will not 
include non-infectious 
medical occurrences such 
as cancer/decline, general 
decline, and falls. 
16 November 
2022 
8 February 2023 
(IRB approval) 
1 March 
2023 
(submitted 
to HSS by 
AOR) 
5 
8.2 
Replaced paragraph 
describing statistical 
power. Updates to the 
statistical power have 
been reflected responsive 
of protocol changes made 
(regarding number of 
enrolled residents and 
follow up period of 
enrolled residents). 
16 November 
2022 
16 November 2022  
(IRB approval) 
1 March 
2023 
(submitted 
to HSS by 
AOR) 
5 
Appendices Updated consent forms to 
reflect currently approved 
IRB consents. 
16 November 
2022 
5 December 2022 
July 2024 
6 
Precis 
5.1 
9.1 
 
Added Dental Hygienist 
self-efficacy form to lists 
(Aim 3 only) and updated 
usage (at MCWB training, 
not baseline) 
Consistent 
with Aim 3 
description in 
protocol 
11 May 2023 (IRB 
approval) 

Version 6.0_23 July 2024 
Date 
(to HSS) 
Version 
# 
Affected 
Section(s) 
Exact Revision Made 
Date 
Modification 
was Approved 
by Executive 
Committee 
Date Modification 
Became Effective 
July 2024 
6 
4.3 
5.2.1 
10.2 
Appendix A 
Clarified Dental Hygienist 
consent procedure 
(embedded consent 
consistent with staff form 
on which DH form was 
based) 
Consistent 
with Aim 3 
description in 
protocol 
11 May 2023 (IRB 
approval) 
July 2024 
6 
5.1 
5.2.3 
 
Indicated discontinuation 
of daily mouth care 
checklist. Low 
participation and poor 
feedback from Aim 2 led 
us to discontinue form for 
Aim 3. 
28 February 
2024  
(IRB 
submission) 
7 March 2024 (IRB 
approval) 
July 2024 
6 
Precis 
3 
5.2.2 
8.2.2 
Updated AL community 
recruitment to reflect that 
geographic coverage for 
Aim 3 will not be 
statewide.   
26 October 
2023 (DSMB 
Meeting) 
28 February 
2024 (IRB 
submission) 
7 March 2024 (IRB 
approval) 
July 2024 
6 
Precis 
3 
4.3 
8.2.1 
Updated sample size 
change. Aim 2 up to 360 
residents, Aim 3 up to 200 
residents. Based on 
analysis of Aim 2 data. 
26 October 
2023 (DSMB 
Meeting) 
28 February 
2024 (IRB 
submission) 
7 March 2024 (IRB 
approval)Submission 
in error based on 
DSMB meeting 
discussion. Formal 
DSMB approval not 
received. 
July 2024 
6 
4.3 
5.2.1 
10.2 
Added use of email during 
Resident/LAR recruitment 
28 February 
2024 (IRB 
submission) 
7 March 2024 (IRB 
approval) 
July 2024 
6 
4.3 
Added payment of AL 
administrators for staff 
time associated with 
recruitment 
04 April 2024 
(IRB 
submission) 
9 April 2024 
(IRB Approval) 
July 2024 
6 
Precis 
3 
4.3 
5.2.2 
8.2.1 
Increased the number of 
AL communities recruited 
from 24 to up to 28  
27 June 2024 
(Email from 
NIA project 
officer) 
1 July 2024 
(IRB Approval) 

Version 6.0_23 July 2024 
Date 
(to HSS) 
Version 
# 
Affected 
Section(s) 
Exact Revision Made 
Date 
Modification 
was Approved 
by Executive 
Committee 
Date Modification 
Became Effective 
8.2.2 
28 June 2024 
(IRB 
submission) 
 
July 2024 
6 
Precis 
3 
4.3 
8.2.1 
 
Adjusted Aim 3 resident 
recruitment (from 360 to 
up to 233) 
27 June 2024 
(Email from 
NIA project 
officer) 
28 June 2024 
(IRB 
submission) 
 
1 July 2024 
(IRB Approval) 
July 2024 
6 
Precis 
3 
4.3 
5.1 
5.2.2 
5.2.4 
8.4.1 
 
Omitted 8-month follow 
up for residents and 
dental hygienists in Aim 3 
27 June 2024 
(Email from 
NIA project 
officer) 
28 June 2024 
(IRB 
submission) 
 
1 July 2024 
(IRB Approval) 
July 2024 
6 
4.3 
5.2.2 
8.2.2 
Allowed that communities 
with as few as 13 
residents (formerly at 
least 50) may be 
contacted for recruitment 
while still striving to 
assure at least 10 
residents meet eligibility 
criteria  
8 July 2024 
Email from PI 
and IRB 
Submission 
23 July 2024 
(IRB Approval) 
 
 
 
 
 
 
 
 

Version 6.0_23 July 2024 
 
ADAPTING AN EVIDENCE-BASED PROGRAM THAT IMPROVES 
ORAL HYGIENE AND HEALTH FOR ASSISTED LIVING RESIDENTS 
WITH DEMENTIA 
Principal Investigator: 
Sheryl Zimmerman, PhD 
University Kenan Distinguished Professor 
Co-Director, Program on Aging, Disability, and Long-Term Care 
Cecil G. Sheps Center for Health Services Research 
Director of Aging Research, School of Social Work 
The University of North Carolina at Chapel Hill 
Supported by: 
The National Institute on Aging 
5R01AG061966 
Study Intervention Provided by:  
N/A  
Sponsor of IND/IDE:  
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
Version 6.0 
July 23, 2024

Version 6.0_23 July 2024 
i 
TABLE OF CONTENTS 
Page 
PROTOCOL CHANGE LOG: ..................................................................................................... i 
TABLE OF CONTENTS .............................................................................................................. i 
PRÉCIS ......................................................................................................................................... iv 
Study Title .................................................................................................................................. iv 
Specific Aims ............................................................................................................................. iv 
Design and Outcomes ................................................................................................................. v 
Interventions and Duration ......................................................................................................... v 
Sample Size and Population....................................................................................................... vi 
STUDY TEAM ROSTER ............................................................................................................ 1 
Principal Investigator: ................................................................................. Sheryl Zimmerman, PhD
 
1 
Co-Investigators: .......................................................................................... Philip Sloane, MD, MPH
 
1 
Co-Investigators: ............................................................................................... Jennifer Leeman, PhD
 
1 
Co-Investigators: ................................................................................................ Jane Weintraub, DDS
 
1 
Co-Investigators: ..................................................................................................... Sally Stearns, PhD
 
2 
Co-Investigators: ..................................................................................................... John Preisser, PhD
 
2 
PARTICIPATING STUDY SITES ............................................................................................. 2 
1 
Study objectives ..................................................................................................................... 3 
1.1 
Primary Objective ........................................................................................................... 3 
1.2 
Secondary Objectives ...................................................................................................... 3 
2 
BACKGROUND AND RATIONALE ................................................................................ 3 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 3 
2.2 
Study Rationale ............................................................................................................... 3 

Version 6.0_23 July 2024 
 
 
 
ii 
3 
STUDY DESIGN ................................................................................................................... 3 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................ 4 
4.1 
Inclusion Criteria ............................................................................................................ 4 
4.2 
Exclusion Criteria ........................................................................................................... 5 
4.3 
Study Enrollment Procedures ......................................................................................... 5 
5 
STUDY PROCEDURES ...................................................................................................... 7 
5.1 
Schedule of Evaluations .................................................................................................. 8 
5.2 
Description of Evaluations .............................................................................................. 9 
5.2.1 Screening Evaluation .................................................................................................. 9 
5.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 10 
5.2.3 Follow-up Visits........................................................................................................ 12 
5.2.4 Completion/Final Evaluation (8 months) .................................................................. 13 
6 
SAFETY ASSESSMENTS ................................................................................................. 13 
6.1 
Specification of Safety Parameters ............................................................................... 13 
6.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 13 
6.3 
Adverse Events, Serious Adverse Events, and Unanticipated Problems ...................... 14 
6.3.1 Reporting Procedures ................................................................................................ 15 
6.3.2 Follow-up for Adverse Events .................................................................................. 16 
6.4 
Safety Monitoring ......................................................................................................... 16 
7 
INTERVENTION DISCONTINUATION........................................................................ 17 
8 
STATISTICAL CONSIDERATIONS .............................................................................. 17 
8.1 
General Design Issues ................................................................................................... 17 
8.2 
Sample Size and Randomization .................................................................................. 18 
8.2.1 Sample Size ............................................................................................................... 18 
8.2.2 Randomization .......................................................................................................... 19 
8.3 
Interim analyses and Stopping Rules ............................................................................ 19 
8.4 
Outcomes ...................................................................................................................... 20 
8.4.1 Primary outcomes ..................................................................................................... 20 
8.4.2 Secondary outcomes ................................................................................................. 20 
8.5 
Data Analyses ............................................................................................................... 21 
9 
DATA COLLECTION AND QUALITY ASSURANCE ................................................ 22 
9.1 
Data Collection Forms .................................................................................................. 22 

Version 6.0_23 July 2024 
 
 
 
iii 
9.2 
Data Management ......................................................................................................... 22 
9.3 
Quality Assurance ......................................................................................................... 23 
9.3.1  Training ....................................................................................................................... 23 
9.3.2 Quality Control Committee ....................................................................................... 23 
9.3.3 Metrics ...................................................................................................................... 23 
9.3.4 Protocol Deviations ................................................................................................... 23 
9.3.5 Monitoring ................................................................................................................ 23 
10 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 23 
10.1 
Institutional Review Board (IRB) Review .................................................................... 23 
10.2 
Informed Consent Forms .............................................................................................. 24 
10.3 
Participant Confidentiality ............................................................................................ 24 
10.4 
Study Discontinuation ................................................................................................... 24 
11 ETHICAL CONSIDERATIONS ....................................................................................... 25 
12 COMMITTEES................................................................................................................... 25 
13 PUBLICATION OF RESEARCH FINDINGS ................................................................ 25 
14 REFERENCES .................................................................................................................... 25 
15 Appendix A – Consent Forms ............................................................................................ 25 
 
 
 

Version 6.0_23 July 2024 
 
 
 
iv 
PRÉCIS 
Study Title  
Adapting an Evidence-Based Program that Improves Oral Hygiene and Health for 
Assisted Living Residents with Dementia 
Specific Aims  
Aim 1. Refine Mouth Care Without a Battle (MCWB) for implementation in assisted  
living (AL) communities. 
a. Identify stakeholder perspectives. Interview (1) the administrator, health care 
supervisor, and a personal care aide (PCA) from 20 AL communities across 
North Carolina (NC) who have already been trained in MCWB by community-
based public health dental hygienists from the DHHS Special Care Dentistry 
Program; (2) the dental hygienists who provided that training; and (3) within 
each community up to two able residents with dementia who received tooth 
brushing in accordance with MCWB techniques, and two family members of 
residents with dementia who received tooth brushing in accordance with MCWB 
techniques, to learn attitudes regarding MCWB as developed for nursing homes, 
the extent to which care has changed, and recommended modifications to 
MCWB for AL. 
b. Create a one-hour MCWB training video (web and DVD format) targeted to AL. 
Modifications include videorecording AL staff providing mouth care to residents 
with dementia, and interviews with residents and families; AL administrators, 
supervisors and PCAs; and dental hygienists. 
 
Aim 2. Evaluate research efficacy of the MCWB program in a nested cohort cluster 
randomized trial of 24 ALs, with training and support provided by an experienced 
research dental hygienist. 
a. Evaluate MCWB in terms of (1) the reach of the intervention; (2) effects on 
mediators/targets of change at the organizational and individual level; (3) 
outcomes (oral hygiene, pneumonia, hospitalizations); (4) associations between 
change at the organizational and individual level and outcomes, and also 
associations with characteristics of the AL community and staff; and (5) 
attitudes, barriers, and facilitators. 
b. Develop a coaching manual for community hygienists to provide training and 
support to AL staff, reflecting lessons-learned from analyses. 
 
Aim 3. Evaluate real-world efficacy of the MCWB program using a second nested 
cohort cluster randomized trial of up to 28 ALs, transferring responsibility for training 
and support to community public health dental hygienists, thereby testing efficacy of a 
nationally generalizable model. 
a. Assess dental hygienists’ (up to N=24) self-efficacy to provide training and 
support at MCWB training and 4 months. 
b. Evaluate MCWB as per Aim 2a, including examining associations with 
characteristics of the hygienists. 

Version 6.0_23 July 2024 
 
 
 
v 
c. Compare implementation and effectiveness outcomes between research and real-
world efficacy. 
d. Refine the coaching manual for community dental hygienists to provide training 
and coaching, reflecting lessons-learned from analyses. 
 
By the conclusion of this project, MCWB will be ready for definitive evaluation in a 
larger pragmatic trial of AL residents with dementia and the staff who provide their care. 
Design and Outcomes   
The nested cohort cluster randomized trials in Aims 2 and 3 will each recruit up to 24 
assisted living (AL) communities (increased to up to 28 AL communities for Aim 3) 
across 10 statewide regions. Note that for Aim 3, the intervention will be delivered by 
dental hygienists employed by the State of North Carolina Department of Health and 
Human Services (NC DHHS) on a voluntary basis; depending on the counties to which 
they are assigned, geographic coverage may not be statewide. Within each region, one-
half of AL communities will be randomized to treatment (MCWB) and one-half to 
control.  
 
The primary outcomes pertain to the change in oral hygiene, as measured by the Plaque 
Index for Long-Term Care (PI-LTC), the Long-Term Care Gingival Index (GI-LTC), and 
the Denture Plaque Index (DPI). Secondary outcomes include pneumonia and 
hospitalizations.   
Interventions and Duration  
Description of intervention: MCWB highlights that mouth care is infection control (e.g., 
can reduce pneumonia); includes techniques and products to clean and protect the teeth, 
tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque; use of an 
interdental brush instead of floss); care provision in special situations (e.g., broken teeth); 
and a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to 
open the mouth). MCWB also includes information about potential dental emergencies 
and issues that merit assessment, which the care provider is advised to immediately 
convey to supervisory staff. 
 
In Aim 2, a research dental hygienist will train AL staff on MCWB and provide ongoing 
support; in Aim 3, this responsibility will be transferred to community public health 
dental hygienists working with the North Carolina Department of Health and Human 
Services (NC DHHS) Oral Health Section. 
 
Duration of intervention: For Aim 2, AL communities will be followed for up to 8 
months (only to be ended earlier than the 8-month follow-up point when necessary for 
project timeline adherence), with at least a 4 month follow-up period. For Aim 3, all AL 
communities will be followed for only 4 months in order to maintain project timelines 
and accommodate data collection in additional communities. 

Version 6.0_23 July 2024 
 
 
 
vi 
Sample Size and Population  
The project will include up to 593 AL residents with dementia (up to 360 for Aim 2, up 
to 233 for Aim 3), 348 AL staff, and 24 dental hygienists from up to 52 NC AL 
communities.  

Version 6.0_23 July 2024 
 
 
 
1 
STUDY TEAM ROSTER  
Principal Investigator: 
Sheryl Zimmerman, PhD 
 
725 Martin Luther King Jr. Blvd. 
 
Chapel Hill, NC 27599 
 
(919) 966-7111 
 
Sheryl_Zimmerman@unc.edu 
Main responsibilities/Key roles: Will be responsible for overall 
administration of the study, including modifying MCWB for 
AL and the conduct of the research efficacy and real-world 
efficacy trials. Oversight includes research protocol 
development and implementation; measurement development; 
assisted living partnerships; subject recruitment and 
engagement; research staff supervision; training activities; data 
analysis; and manuscript and product development and 
dissemination.  
Co-Investigators: 
Philip Sloane, MD, MPH 
 
725 Martin Luther King Jr. Blvd. 
 
Chapel Hill, NC 27599 
 
(919) 966-4439 
 
philip_sloane@med.unc.edu 
Main responsibilities/Key roles: Will provide medical and 
dementia care expertise on the project, and will be involved in 
modifying MCWB for AL. He will provide consultation to the 
dental hygienists doing the training as the coaching program is 
being developed, and he will be closely involved in the 
development of the related manual, especially for matters 
related to behavioral expressions of persons with dementia.  
Co-Investigators: 
Jennifer Leeman, PhD 
 
Carrington Hall, S. Columbia Street 
 
Chapel Hill, NC 27599 
 
(919) 966-3648 
 
jleeman@email.unc.edu 
Main responsibilities/Key roles: Will be involved in 
measurement development and data collection and analysis 
related to implementation, as well as in assuring that the 
modifications made to MCWB will be optimal for AL.   
Co-Investigators: 
Jane Weintraub, DDS 
 
385 S Columbia Street 
 
Chapel Hill, NC 27599 
 
(919) 537-3240 

Version 6.0_23 July 2024 
 
 
 
2 
 
jane_weintraub@unc.edu 
Main responsibilities/Key roles: Will oversee the quality of the 
oral hygiene data; initiate dental referrals for AL residents with 
immediate care needs; and participate in analysis, 
interpretation, and dissemination of results.  
Co-Investigators: 
Sally Stearns, PhD 
 
McGavran-Greenberg Hall, 135 Dauer Drive 
 
Chapel Hill, NC 27599 
 
(919) 843-2590 
 
sally_stearns@unc.edu 
Main responsibilities/Key roles: Will inform measurement 
development and data collection and analysis related to cost, 
and will oversee analysis determining effect size estimates for 
the subsequent pragmatic trial.  
Co-Investigators: 
John Preisser, PhD 
 
McGavran-Greenberg Hall, 135 Dauer Drive 
 
Chapel Hill, NC 27599 
 
(919) 966-7265 
 
jpreisse@bios.unc.edu 
Main responsibilities/Key roles: Will provide analytic 
consultation to the study analyst, provide guidance in project 
design and sampling, oversee analytic model creation and 
interpretation, and participate in manuscript preparation.  
 
PARTICIPATING STUDY SITES  
N/A; not a multi-site study 
 
 
 

Version 6.0_23 July 2024 
 
 
 
3 
1 
STUDY OBJECTIVES 
1.1 Primary Objective 
The primary objective is to improve oral hygiene in older adults with dementia who 
reside in assisted living communities; it is hypothesized that MCWB will result in 
improved oral hygiene.  
1.2 Secondary Objectives 
The secondary objective is to reduce pneumonia and hospitalizations by improving oral 
hygiene in older adults with dementia who reside in assisted living communities; it is 
hypothesized that MCWB will result in a lower incidence of pneumonia and 
hospitalizations.  
 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Many people with dementia resist mouth care – almost 90% in nursing homes, in fact. As 
a result, only 16% have their teeth brushed regularly, putting them at risk for aspiration 
pneumonia when they inhale bacteria from their teeth, tongue, and gums. Overall, 
persons with dementia have more oral mucosal lesions, plaque, coronal and root caries, 
and decayed tooth roots than those without dementia, and the situation is worse as 
dementia progresses.   
 
In 2013, Drs. Zimmerman and Sloane developed one of the two existing dementia-
focused mouth care programs for nursing homes -- Mouth Care Without a Battle 
(MCWB) -- which already has become a standard of nursing home care. MCWB changes 
caregivers’ attitudes and behavior, improves oral health, and in a cluster randomized trial, 
MCWB provided by nursing assistants reduced pneumonia incidence by 32 percent 
(Zimmerman et al., 2020). 
2.2 Study Rationale 
The next step is to extend MCWB to AL, the primary long-term residential care provider 
for persons with dementia. There are 30,200 AL communities across the country; 90% of 
their 835,200 residents have cognitive impairment and 42% have moderate or severe 
dementia (and on average, five untreated oral health conditions), meaning MCWB has the 
potential to improve the health and quality of life of more than 350,000 AL residents with 
dementia annually. 
3 
STUDY DESIGN 
The nested cohort cluster randomized trials will recruit up to 24 AL communities across 
10 statewide regions for Aim 2 and up to 28 AL communities for Aim 3 (total up to 
N=52). Note that for Aim 3, the intervention will be delivered by dental hygienists 
employed by the State of North Carolina Department of Health and Human Services (NC 
DHHS) on a voluntary basis; depending on the counties to which they are assigned, 
geographic coverage may not be statewide. Within each region, one-half of AL 
communities will be randomized to treatment (MCWB) and one-half to control. The 

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primary outcomes are change in oral hygiene, as measured by the Plaque Index for Long-
Term Care (PI-LTC), the Long-Term Care Gingival Index (GI-LTC) and the Denture 
Plaque Index (DPI). Secondary outcomes include pneumonia and hospitalizations.    
 
The project will include up to 593 residents with dementia (up to 360 for Aim 2, up to 
233 for Aim 3), 348 AL staff, and 24 dental hygienists from up to 52 NC AL 
communities. The duration of the study is up to eight months (for Aim 2, only to be 
ended earlier than the 8-month follow-up point when necessary for project timeline 
adherence; for Aim 3, all AL communities will be followed for only 4 months in order to 
maintain project timelines and accommodate data collection in additional AL 
communities.  
 
Description of intervention: MCWB highlights that mouth care is infection control (e.g., 
can reduce pneumonia); includes techniques and products to clean and protect the teeth, 
tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque; use of an 
interdental brush instead of floss); care provision in special situations (e.g., broken teeth); 
and a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to 
open the mouth). MCWB also includes information about potential dental emergencies 
and issues that merit assessment, which the care provider is advised to immediately 
convey to supervisory staff. 
 
Administration of intervention: AL staff will be trained on the principles of MCWB. 
They will use these techniques for eight months with the residents in the AL community.  
During Aim 2, a research dental hygienist will provide the training and coaching. During 
Aim 3, community public health dental hygienists will provide the training and coaching.   
 
Blinding and unblinding (masking and unmasking) 
AL communities in both arms will be blinded to the study hypotheses, as will the data 
collectors during the recruitment of AL communities and families.  
The data collectors are likely to become unblinded after recruitment has been completed 
due to the logistics of scheduling training sessions and differing data collection 
procedures for on-site visits in intervention versus control arms.  
The project manager will be unblinded. 
The Principal Investigator will be blinded. 
During the safety meetings, the DSMB and NIA representative(s) will review the study 
data, blinded and unblinded, to make informed decisions about the continuation of the 
study.   
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria  
AL Communities 
• Licensed as an Adult Care Home in NC (the AL category used in NC) 
• Staff in the AL community have not been trained in MCWB  
AL Staff 
• Age 18 years or older 
• Employed in a participating AL community 

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5 
Residents 
• Age 18 years or older   
• Has a diagnosis of dementia 
• Lives in a participating AL community 
Public health dental hygienists 
• Age 18 years or older 
• Employed by NC DHHS 
4.2 Exclusion Criteria  
AL Communities 
• Administrator reports that the AL community will be closing in the next year 
• 
AL community does not have at least 10 residents with dementia (i.e., 
translating roughly to having 50 beds or more, given that on average, 42% of 
residents have moderate or severe dementia, and taking into account actual 
census which is lower than licensed beds). NOTE: In AL communities that 
are exclusively memory care, the percent of residents with moderate or severe 
dementia will be 100%, therefore allowing that some communities may have 
markedly fewer than 50 beds.  
• Does not agree for staff to attend training, provide mouth care in accordance 
with MCWB, and/or keep logs regarding mouth care provision  
AL Staff 
• Not able to read and speak English fluently 
• Does not provide direct care to AL residents 
Residents 
• On hospice or tube-feeding (and does not eat or drink), meaning if the resident 
is on a feeding tube and does not eat or drink, he/she is ineligible. 
• Expected to die or be discharged in next six months 
• Does not have teeth and/or have and use a denture 
• Requires antibiotic prophylaxis prior to oral care assessment 
 
Public health dental hygienists 
• Not able to read or speak English fluently 
 
4.3 Study Enrollment Procedures  
AL Communities: A total of up to 52 AL communities will be recruited across the state. The 
research team will work in collaboration with the NC DHHS Oral Health Section to identify 
the AL communities that have been trained in MCWB. Using IRB approved procedures, an 
introductory letter will be mailed to the AL administrator describing the effort and inviting 
them to contact the research team if they do not want to learn more about the project. If they 
do not contact the research team, the letter will be followed by a telephone call from the 
principal investigator or project coordinator. All contact with the AL communities will be 
tracked and maintained recruitment databases. The number, proportion, and 
representativeness of the AL administrators willing to participate when solicited by the 
principal investigator/project coordinator will be obtained, as will the characteristics of 
participating and non-participating communities (i.e., location/region, size, for-profit status, 

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6 
ownership, affiliation with another level of care, presence of a dementia special care unit, 
resident case-mix, and physician and nurse staffing). The AL communities will be offered 
$300 to compensate them for administrative staff time spent preparing lists of eligible 
residents and other tasks related to study participation. 
 
Randomization will occur at the AL community-level. The project coordinator will work 
with the NC DHHS Special Care Dentistry Program partners to identify the AL communities 
that (a) have not been trained in MCWB, (b) were trained within the last year, and (c) were 
trained longer than one year ago.  A total of up to 52 AL communities (that are licensed to 
provide care for approximately 50 or more residents and have not been trained in MCWB in 
the last year) will be recruited across the state; Aim 3 will allow that communities with as 
few as 13 residents may  be contacted for recruitment while still striving to assure at least 10 
residents meet eligibility criteria. For Aim 2, the AL communities will include eight from 
each of the two largest regions (Regions 4 and 5), and four from each of the other eight 
regions. The project coordinator will recruit them within region, with a preference given to 
those that have never been trained. After confirming eligibility and willingness to 
participate, the analyst will randomly assign the community to treatment or control one-to-
one within regions. Note that for Aim 3, the intervention will be delivered by dental 
hygienists employed by the State of North Carolina Department of Health and Human 
Services (NC DHHS) on a voluntary basis; depending on the counties to which they are 
assigned, geographic coverage may not be statewide. Within each region, one-half of AL 
communities will be randomized to treatment (MCWB) and one-half to control.   
 
AL Staff: All PCAs who work on the first and second shifts (when mouth care is typically 
provided) will be visited on-site and asked to consent to a questionnaire related to the 
provision of mouth care (i.e., a measure of self-efficacy) at baseline, four, and up to eight 
months (only to be ended earlier than the 8-month follow-up point when necessary for 
project timeline adherence). Staff will be given the option to refuse participation without 
penalty from their employer. In addition, the administrator will be interviewed on-site or by 
telephone at baseline, four and eight months to learn about mouth care practices and policies 
in effect. Informed consent is not required for the practices and policies interview. 
 
Residents: The project will include up to 593 residents with dementia (up to 360 for Aim 2, 
up to 233 for Aim 3). A HIPAA waiver will allow the Health Care Supervisor/Liaison 
within each AL community to provide a list of residents who (1) have dementia; (2) are not 
on hospice or tube-feeding; (3) are not expected to die or be discharged in the next six 
months; (4) have teeth and/or have and use a denture; and (5) do not require antibiotic 
prophylaxis prior to oral care assessment. All residents who fit these criteria will be eligible 
and allowed to join the study. Family members who are legally authorized representatives 
will be sent an introductory letter describing the project and inviting them to contact the 
research team if they do not want to learn more about it. The letter will be followed by a 
telephone call from the research staff, who will discuss all components of informed consent 
and confirm eligibility. Participation includes (1) an oral hygiene examination of the resident 
up to three times; (2) a telephone interview with the family member regarding resident 
characteristics (e.g., cognitive and functional status); (3) weekly contact with the AL health 
care supervisor, to collect adverse events and instances of pneumonia, (4) observations of 

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7 
mouth care. If unable to reach the family/LAR by phone, the research assistant may also 
contact them by email. 
Public Health Dental Hygienists: A list of public health dental hygienists currently 
employed will be provided by NC DHHS Oral Health Section. Before the public health 
dental hygienists are trained to provide training and coaching, their own self-efficacy to 
provide training and mouth care will be assessed; this same assessment will be conducted at 
four months (after coaching is completed); consent will be obtained. Descriptive data 
obtained for public health dental hygienists will include age, years in practice, dementia-
related experience, experience in nursing homes and AL, and training received after 
licensure.  Consistent with the staff self-efficacy questionnaires, research staff will meet 
with DHHS Dental Hygienists and present the questionnaire that includes an embedded 
consent form and allow them time to read the consent form and choose to participate or 
decline participation without penalty. 
 
5 
STUDY PROCEDURES 
 

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8 
5.1 
Schedule of Evaluations 
 
 
Assessment 
Screening 
Baseline 
Month 4 (Aims 2 
and 3) and Month 
8 (Aim 2 only) 
Weekly 
Ongoing 
Informed Consent Form – Residents    
X 
  
  
  
  
Informed Consent Form - Staff 
X 
 
 
 
 
Self-efficacy Questionnaire – Public Health Dental Hygienists 
(Aim 3 only)* 
X 
 
X 
 
 
Baseline interview about resident 
 
X 
 
 
 
Post-training staff evaluation questionnaire (WEVAL) 
 
X 
 
 
 
Salaries 
 
X 
 
 
 
Assisted living characteristics 
 
X 
X 
 
 
Oral hygiene assessments 
 
X 
X 
 
 
Staff mouth care questionnaire (self-efficacy) 
 
X 
X 
 
 
Observation of mouth care 
 
 
X 
 
 
Follow-up staff program evaluation questionnaire (WAFU) 
 
 
X 
 
 
Adverse events and pneumonia 
 
 
 
X 
 
Training log (intervention sites only) 
 
X 
 
 
 
Training support log (intervention sites only) 
 
 
 
 
X 
Daily mouth care checklist (intervention sites only)** 
 
 
 
 
X 
* Delivered at initial training of DHHS Dental Hygienists, Aim 3 only 
** Discontinued after low participation and poor feedback from Aim 2, Aim 2 only 
 
 

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9 
5.2 Description of Evaluations  
5.2.1  Screening Evaluation 
Consenting Procedure 
Residents: All residents who meet the eligibility criteria will be eligible and allowed to 
join the study. The name, address, and telephone number of their legally authorized 
representative (LAR) will be obtained from the AL community. The LAR recruitment 
letter and the resident/LAR consent form will be mailed to this individual. Three 
business days after the letter is mailed, the research assistant will call the LAR to 
explain the study, answer questions, solicit consent, and encourage prompt return of the 
form. The LAR calling script will guide this call. Consent includes (1) an oral hygiene 
examination of the resident up to three times; (2) a telephone interview with the family 
member regarding resident characteristics (e.g., cognitive and functional status); (3) 
weekly contact with the AL health care supervisor, to collect adverse events and 
instances of pneumonia, (4) observations of mouth care. If unable to reach the 
family/LAR by phone, the research assistant may also contact them by email. 
 
Able residents will be asked to provide assent. In all cases, residents must assent to the 
oral hygiene assessment; if they refuse, the assessment will not be conducted. Residents 
will be asked to give assent at each study visit; if a resident chooses to give assent (or 
not give assent) at one visit, study staff will continue to ask for their assent at subsequent 
visits. 
 
A signed HIPAA authorization will be obtained for all participating residents in the 
study. The project coordinator/research assistant will explain to the family member that 
the Health Care Supervisor will be interviewed weekly to check for pneumonia cases 
and adverse events. It will also be explained that the HIPAA authorization will not stop 
unless the family member stops it in writing. 
 
Staff: PCAs who work on the first and second shifts (when mouth care is typically 
provided) will be visited on-site and asked to consent to a questionnaire related to the 
provision of mouth care (i.e., a measure of self-efficacy) at baseline, four, and up to 
eight months. Research staff will meet with PCAs and present the questionnaire that 
includes an embedded consent form and allow them time to read the consent form and 
choose to participate or decline participation without penalty. 
 
Dental hygienists: Public Health Dental Hygienists who deliver the training intervention 
in Aim 3 will be asked to consent to a questionnaire related to the provision of training 
(i.e. a measure of self-efficacy) before and after receipt of research training on how to 
deliver MCWB training to the AL staff. Consistent with the staff self-efficacy 
questionnaires, research staff will meet with DHHS Dental Hygienists and present the 
questionnaire that includes an embedded consent form and allow them time to read the 
consent form and choose to participate or decline participation without penalty. 
Screening   
Residents: Additional screening will be completed during the recruitment call to the 
family member/LAR.  The project coordinator/research assistant will confirm that the 
resident meets all the eligibility criteria for participation. The resident subject tracking 
form will be completed for all residents/LARs who are approached for participation. All 
recruitment efforts will be documented on the resident tracking form; specifically, all 

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10 
enrollments, refusals, and ineligibles (including the reasons for refusals and ineligibles) 
will be documented for each approached resident.   
 
Staff: Staff members will be screened for eligibility during the enrollment and consent 
process.  
 
Dental hygienists: Dental hygienists will be screened for eligibility during the 
enrollment and consent process.  
5.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
This study uses a single informed consent form. Date of enrollment is considered the 
date the participant completes the baseline assessment.    
Baseline Assessments 
• Assisted living characteristics, policies, practices interview: Information will be 
obtained from administrators regarding leadership endorsement and 
policy/procedure change (e.g., provision of training for new hires, retraining for 
ongoing staff, strategies for accountability, use of performance evaluations, 
highlighting mouth care in marketing materials). AL location, size, ownership, 
chain affiliation, affiliation with a nursing home or hospital, percent occupancy, 
private pay rate, staff type and ratio, presence of a special care unit, on-site 
dental or dental hygiene care, percent residents with dementia, and percent 
Medicaid residents will be obtained. 
• Baseline interview about resident: Family members will complete a brief 
interview about the resident at baseline. Resident age, gender, race, and ethnicity 
will be obtained. Function will be measured with the Minimum Data Set 
Activities of Daily Living scale (MDS-ADL) scale, which assess assistance in 
seven activities; it evidences good reliability (kappa .87-.94) and discriminant 
validity. Severity of dementia will be measured with the Minimum Data Set 
Cognition Scale (MDS-COGS), a nine-item measure that indicates no, mild, 
moderate, or severe cognitive impairment. It has been used in nursing homes and 
validated for use by AL staff, and demonstrates good specificity (84%-97%) and 
sensitivity (49%-67%) depending on the cut point. Family involvement will be 
determined based on the number of days in which family visited, discussed the 
resident’s care, and participated in a service plan meeting. 
• Staff mouth care baseline questionnaire: The Self-Efficacy for Providing Mouth 
Care questionnaire will be administered to all PCAs on the first and second shift 
at baseline. The self-efficacy measure has 11 items, scored 1 (strongly disagree) 
to 4 (strongly agree). Sample items include “I am familiar with the practical 
procedures to do this job” and “I know ways to successfully provide mouth care 
to residents who hit or scream”, both of which evidenced significant 
improvement in our prior work. 
• Oral hygiene assessments: The oral hygiene status of all enrolled residents in 
each site will be obtained at baseline, four, and up to eight months (only to be 
ended earlier than the 8-month follow-up point when necessary for project 
timeline adherence). Dentate/edentulous status, presence of dentures, and 
presence/absence of each tooth will be documented, and three measures will be 
used to assess oral hygiene, the Plaque Index for Long-Term Care (PI-LTC), 

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11 
Gingival Index for Long-Term Care (GI-LTC), and Denture Plaque Index (DPI). 
The PI-LTC is a modification of the Simplified Oral Hygiene Index (OHI-S). To 
assess debris/plaque, six teeth are selected (one from each sextant), and each is 
rated based on the proportion of the tooth surface covered with plaque or debris. 
There are directions regarding which tooth to assess, and substitution rules if 
teeth are missing. The sum of the tooth scores is divided by the number of 
segments scored. The GI-LTC is a simplification of the Gingival Index (GI). The 
GI is a measure of inflammation and gingivitis around six specific teeth (one in 
each sextant) that assesses the gingiva around the tooth’s four surfaces: mesial, 
distal, buccal and lingual. A score is assigned to each surface. The mean of the 
four scores obtained around each tooth yields the GI for that tooth. To derive the 
final score, the GI scores are summed and divided by the number of teeth 
examined. The GI-LTC is also by recording the worst score (0-3) in each sextant 
using the same scoring criteria. The DPI is scored for individuals with full 
dentures by assigning a score to each of eight quadrants, four on the facial 
surface and four on the basal (tissue contact) surface for each maxillary and 
mandibular denture. 
• Post-training staff evaluation questionnaire (WEVAL): This 22-item Likert 
measure assesses utilization (e.g., “you used similar materials in the past with 
little success”), resources (e.g., “you have enough staff to implement the 
procedures”), training (e.g., “you would attend follow-up training”), and support 
(e.g., “your director would support and encourage use”). The WEVAL will be 
administered immediately after training.   
• Salaries: Average hourly salaries of full-time PCAs and health care supervisor 
will be obtained from the administrator at baseline.   
Randomization 
Randomization will occur at the AL community-level. The project coordinator will 
work with the NC DHHS Special Care Dentistry Program partners to identify the AL 
communities that (a) have not been trained in MCWB, (b) were trained within the 
last year, and (c) were trained longer than one year ago.  For Aim 2, a total of 24 AL 
communities (that are licensed to provide care for approximately 50 or more 
residents and have not been trained in MCWB in the last year) will be recruited 
across the state, eight from each of the two largest regions (Regions 4 and 5), and 
four from each of the other eight regions. For Aim 3, the intervention will be 
delivered by dental hygienists employed by the State of North Carolina Department 
of Health and Human Services (NC DHHS) on a voluntary basis; depending on the 
counties to which they are assigned, geographic coverage may not be statewide. For 
this aim, up to 28 ALs will be recruited and it will be allowed that communities with 
as few as 13 residents will be contacted for recruitment while still striving to assure 
at least 10 residents meet eligibility criteria. The project coordinator will recruit 
them within region, with a preference given to those that have never been trained. 
After confirming eligibility and willingness to participate, the analyst will randomly 
assign the community to treatment or control one-to-one within regions.   
Communities that are randomized to the control arm will continue their standard oral 
hygiene procedures. They will not be asked to change current practice. At the end of 
the study intervention (up to 8-months for Aim 2, 4 months for Aim 3), they will be 
given MCWB training materials (including video and Toolkit). Control communities 

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12 
will also have the option of receiving training from the DHHS dental hygienist team 
if they so choose.    
 
5.2.3 Follow-up Visits 
 Four months: 
o Assisted living policies, practices interview: Information will be obtained 
from administrators regarding leadership endorsement and policy/procedure 
change (e.g., provision of training for new hires, retraining for ongoing staff, 
strategies for accountability, use of performance evaluations, highlighting 
mouth care in marketing materials). 
o Staff mouth care follow-up questionnaire: The Self-Efficacy for Providing 
Mouth Care measure will be administered to all PCAs on the first and second 
shift in control and treatment communities. In the treatment sites, the 
measure will include a retrospective pre-test that asks respondents to reflect 
on their initial self-efficacy after having learned what they might not have 
known that they did not know previously. This technique is useful to learn 
reflections about the perceived effectiveness of a program. The self-efficacy 
measure has 11 items, scored 1 (strongly disagree) to 4 (strongly agree). 
Sample items include “I am familiar with the practical procedures to do this 
job” and “I know ways to successfully provide mouth care to residents who 
hit or scream”, both of which evidenced significant improvement in our prior 
work. 
o Oral hygiene assessment: See description in baseline assessment section. 
o Observation of mouth care: At four months an estimate of the amount of 
time spent providing mouth care will be based on observations conducted 
by the research assistant of mouth care provided to participating residents. 
o Follow-up program evaluation questionnaire (WAFU): The WAFU is a 14-
item Likert measure with subscales related to training satisfaction (e.g., “do 
you expect to use these materials”) and implementation barriers. Eight 
barriers are provided, related to resources (e.g., “lack of time”) and 
procedures (e.g., “doesn’t fit my style”); other barriers are queried. 
 Weekly: 
o Adverse Events and Pneumonia: Adverse events and pneumonia cases will 
be collected weekly. The Health Care Supervisor will be contacted about 
adverse events and positive pneumonia cases diagnosed in the past week.  
 Implementation (Initial and Ongoing): 
o Training Log: The number of staff on the first and second shift who 
watched the training video and attended the in-service will be recorded.  
o Training Support Log: The number of PCAs on the first and second shift 
who participated in coaching and telephone support will be recorded by the 
dental hygienist.  
o Daily Mouth Care Checklist: The resident-specific checklist will indicate, 
by day, whether mouth care was initiated and provided, including notes 
related to implementation (e.g., successful strategies to provide care, which 

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13 
can be shared with weekend and other staff; or, if mouth care did not occur, 
the reason why. Note that this form was in use for Aim 2 only. During Aim 
2, very few ALs completed this form and feedback indicated it was a 
barrier to program participation so it was discontinued in advance of Aim 
3. 
5.2.4 Completion/Final Evaluation (8 months, Aim 2 only) 
 Assisted living policies, practices interview: See description in four-month 
follow-up visit 
 Staff mouth care follow-up questionnaire: See description in four-month follow-
up visit 
 Oral hygiene assessments: See description in baseline assessment section 
 Observation of mouth care: See description in four-month follow-up visit 
 Follow-up program evaluation questionnaire (WAFU): See description in four-
month follow-up visit 
If for some reason there is an excessive delay between baseline visits and the in-service 
training for intervention communities, 4-month visit and 8-month visits will be scheduled 
according to the in-service training date, rather than the date of Baseline data collection. 
Although these delays are not expected, they may be unavoidable due to COVID-19 
outbreaks and community procedures, and other unexpected events. In the case that an 
intervention community has a delay between baseline visit and in-service training, study 
staff will replicate that timeline and delay as best as they are able to the control community 
in the same region. This same procedure will hold true for delays that may occur between 
the 4-month and 8-month visits.  
 
6 
SAFETY ASSESSMENTS  
Safety data will only be collected for enrolled resident participants in the study.  
6.1 Specification of Safety Parameters 
Potential Risks: 
The potential risks to study participants include: 
• Emotional discomfort caused by study questions (AL staff and dental hygienists) 
• Swallowing problems caused by using foaming toothpaste to brush teeth (which is not 
advised in MCWB) or if a loose tooth becomes dislodged and swallowed during tooth 
brushing (about which information is provided in MCWB; AL residents) 
• Persistent bleeding or pain following oral hygiene assessment or daily mouth care 
(assessment conducted by professional dental hygienists; AL residents) 
• Allergic reaction to mouth care products (e.g., rash due to allergy to mint flavoring, about 
which information is provided in MCWB; AL residents) 
• Emotional or economic (employment-related) harm due to breach of confidentiality of 
data (for which precautions are in place; AL staff and dental hygienists) 
6.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
In terms of potential risks, having mouth care provided regularly is a standard activity of 
daily living that does not pose risk, unless, for example, the individual has swallowing 

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14 
problems and foaming toothpaste is used to brush the teeth (which is not advised in 
MCWB), or a loose tooth becomes dislodged and swallowed during tooth brushing (which 
is discussed in MCWB). 
 
For AL staff and dental hygienists, providing information about resident and organizational 
characteristics and attitudes and behaviors related to mouth care is not expected to pose risk, 
although it is possible that participants may become distressed if the questions raise 
sensitive issues or if they are concerned others may learn of less than favorable attitudes or 
behaviors. 
 
In order to facilitate the reporting of potential adverse events (AEs) to study staff, the 
following procedures will be in place: 
 
•    AL staff will be provided research staff contact information, including study phone and 
e-mail addresses. AL staff will be encouraged to contact research staff in the event of 
potentially adverse events of participating residents.  
•    Throughout the intervention, the health care supervisor will be contacted weekly about 
potential adverse events. If the event occurred, the health care supervisor will be asked 
to describe the event in detail.  
•    Participating staff members will be given the contact information of the PI and UNC 
IRB if they have any questions or concerns about study participation.  
6.3 Adverse Events, Serious Adverse Events, and Unanticipated Problems 
Adverse Event (AE): Unfavorable and unintended medical occurrence regardless of 
whether it is considered related to the study, including infectious diseases such as 
coronavirus (COVID), flu, pneumonia, urinary tract infections (UTIs), and diarrhea. As per 
DSMB decision on 11/08/2022, adverse events will not include non-infectious medical 
occurrences such as cancer/decline, general decline, and falls. 
Serious Adverse Event (SAE): Any AE that: 
• Results in death  
• Is life threatening, or places the participant at immediate risk of death from the event 
as it occurred  
• Requires or prolongs hospitalization  
• Causes persistent or significant disability or incapacity  
 
Unanticipated problem (UP): A risk to subjects or others that includes, in general, any 
incident, experience, or outcome that meets all of the following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
• Related or possibly related to participation in the research (in this protocol, “possibly 
related” means there is a reasonable possibility that the incident, experience, or 
outcome may have been caused by the procedures involved in the research); and 
• Suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
 

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15 
Data on AEs, SAEs, and UPs will be collected on an ongoing basis from study start to study 
completion. 
6.3.1 Reporting Procedures 
General AE Procedures. After receiving confirmation that a potential AE occurred using the 
Weekly Adverse Event Reporting Form (see DSMP Appendix A), study staff will ask the 
AL community to complete the Adverse Event Reporting Form (DSMP Appendix B). After 
the Appendix B Adverse Event Reporting Form has been received from the AL community, 
the project coordinator will report all potential AEs to the PI and Safety Officer 
immediately. The Safety Officer will determine the severity and the relatedness of the AE, 
and will confer with the DSMB as needed. If the AE is serious and/or unexpected, possibly 
related to study participation, and suggests increased risk for participants, the procedures 
outlined below will also be followed.  
 
AE reports will collected by the project coordinator, summarized, and de-identified. A 
summary report of all AEs to date will be sent to the PI, DSMB, and NIA program officer 
for both Aims 2 and 3 at mid-intervention (Aim 2); post-intervention (completion of Aim 
2); mid-intervention (Aim 3); and post-intervention (completion of Aim 3). 
As per UNC IRB guidelines, all AEs will be reported to the UNC IRB during the yearly 
study review process. 
 
Serious AE Procedures. The project coordinator will report all SAEs to the PI immediately 
using the Adverse Event Reporting Form (see DSMP Appendix B), after having gathered all 
necessary details. For all deaths and for any SAE related or possibly related to study 
participation, the PI will send this report and any additional information, including 
corrective actions already taken, within 24 hours of study team awareness of the event 
(defined by date Adverse Event Reporting Form [DSMP Appendix B] is received by study 
sites), to the DSMB chair, UNC IRB, and NIA program officer. The PI will follow any 
additional course of action recommended by the UNC IRB, NIA, and/or DSMB. 
 
Unexpected AEs/UPs with Increased Risk. All AEs deemed (1) unexpected (the nature or 
severity of the event is not consistent with information about the intervention in the protocol 
or consent form); (2) possibly or probably related to study participation; and that (3) suggest 
increased risk for study participants, will be reported to the UNC IRB, NIA project officer, 
and the DSMB chair within 48 hours of study team awareness of the event, using each 
organizations’ respective reporting formats. In these reports, the PI will identify any 
corrective action planned or already undertaken. The PI will follow any additional course of 
action recommended by the UNC IRB, NIA, and/or DSMB. 
Severity of Event 
This study uses the following AE grading scale: 
 
• Mild: An experience that is transient and requires no special treatment or 
intervention. The experience does not generally interfere with usual daily 
activities. In this study, an example includes mild emotional distress that persists 
after an interview has been completed. 
 
• Moderate: An experience that is alleviated with simple therapeutic treatments. 
The experience impacts usual daily activities. In this study, an example includes 
physical distress caused by swallowing toothpaste.   

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16 
 
• Severe: An experience that requires therapeutic intervention. The experience 
interrupts usual daily activities. In this study, an example includes swallowing a 
tooth and requiring treatment if it becomes lodged in the throat. If any 
hospitalization (or prolongation of hospitalization) is required for treatment, it 
becomes an SAE. 
Relationship To Study Intervention 
This study uses the following AE attribution scale: 
 
• Not related: The AE is clearly not related to the study procedures (i.e., another 
cause of the event is most plausible and/or a clinically plausible temporal 
sequence is inconsistent with the onset of the event). 
 
• Possibly related: An event that follows a reasonable temporal sequence from the 
initiation of study procedures, but that could readily have been produced by a 
number of other factors. 
 
• Related: The AE is clearly related to the study procedures. 
This study uses the following AE expectedness scale: 
• Unexpected: The nature or severity of the event is not consistent with information 
about the intervention in the protocol or consent form. 
 
• Expected: The event is known to be associated with the intervention under study 
(There are no expected AEs or SAEs given the study team’s experience fielding two 
previous studies of the mouth care program.)  
 
6.3.2 Follow-up for Adverse Events 
An interim project analysis will be conducted to evaluate the safety of the intervention 
after the first cluster randomized trial (Aim 2) is completed. One of the tasks of the Data 
Safety Monitoring Board (DSMB) will be to review preliminary data and make a 
recommendation regarding whether or not the study should continue. 
6.4 Safety Monitoring 
The Data and Safety Monitoring Board (DSMB) will act in an advisory capacity to the 
National Institute of Aging (NIA) Director to monitor participant safety, data quality and 
evaluate the progress of the study. The DSMB will be led by the Committee Chair, who will 
submit a report after each DSMB meeting that summarizes the state of the study and any 
recommendations. DSMB reports will be submitted to the UNC IRB and NIA staff. 
The DSMB responsibilities are to: 
• review the research protocol, informed consent documents and plans for data safety 
and monitoring; 
• advise the NIA on the readiness of the study staff to initiate recruitment; 
• evaluate the progress of the trial, including periodic assessments of data quality 

Version 6.0_23 July 2024 
 
 
 
17 
and timeliness, recruitment, accrual and retention, participant risk versus benefit, 
performance of the trial sites, and other factors that can affect study outcomes; 
• consider factors external to the study when relevant information becomes available, 
such as scientific or therapeutic developments that may have an impact on the safety 
of the participants or the ethics of the trial; 
• review study performance, make recommendations and assist in the resolution of 
problems reported by the Principal Investigator; 
• protect the safety of the study participants; 
• report to NIA on the safety and progress of the trial; 
• make recommendations to the NIA, the Principal Investigator, and, if required, to 
the Food and Drug Administration (FDA) concerning continuation, termination or 
other modifications of the trial based on the observed beneficial or adverse effects 
of the treatment under study; 
• if appropriate, review interim analyses in accordance with stopping rules, which are 
clearly defined in advance of data analysis and have the approval of the DSMB; 
• ensure the confidentiality of the study data and the results of monitoring; and, 
• assist the NIA by commenting on any problems with study conduct, enrollment, 
sample size and/or data collection. 
The DSMB will discharge itself from its duties when the last participant completes the study. 
7 
INTERVENTION DISCONTINUATION  
The following are the reasons for discontinuing the study early: 
• The occurrence of a serious adverse event, possibly or definitely related to the 
study protocol, occurring in any participant. In this study, it would include serious 
physical distress causing death or hospitalization. 
• Adverse events, possibly or definitely related to the study protocol, occurring in 
three or more participants. In this study, this would include participants who 
withdrew from the study due to new physical symptoms possibly related to allergic 
reactions. Cases will be examined carefully by the PI and DSMB to determine if 
the cases warrant study discontinuation. 
 
Interim analyses will occur at the end of Aim 2. Summary data related to the above bullets 
will be made available to the DSMB at least 2 weeks before meeting, or within 24 hours of 
becoming known to the study team in the case of a serious adverse event (e.g., 
hospitalization or death) or 48 hours in the case of an unexpected and related adverse event 
our unanticipated problem (UP) with increased risk. 
8 
STATISTICAL CONSIDERATIONS  
8.1 General Design Issues  
The evaluation of research efficacy (Aim 2) addresses (1) the reach of the intervention; (2) 
effects on mediators/targets of change at the organizational and individual level; (3) 
outcomes (oral hygiene, pneumonia, hospitalizations); (4) associations between change at 
the organizational and individual level and outcomes, and also associations with 
characteristics of the AL community and staff; and (5) attitudes, barriers, and facilitators. 
Analyses will be cross-sectional at each time point and longitudinal to assess change. 
Analyses for Aim 3 will be based on a priori specified statistical models developed in Aim 2 

Version 6.0_23 July 2024 
 
 
 
18 
with the key difference being this aim is assessing real-world efficacy in a new sample. 
Results across the two aims and samples will be comparable by using in Aim 3 the identical 
set of resident- and AL-level fixed effects and random effects identified in Aim 2. 
8.2 Sample Size and Randomization 
 
8.2.1 Sample Size  
 
Original Estimate 
 
The original estimate of statistical power is based on Aim 2 where the outcome is change in 
oral hygiene at four months; it was based on enrolling 360 residents (15 per community) in 24 
communities (12 intervention and 12 control) and allowing for a 20% attrition rate; N=288. At 
the time, we allowed for the chance that effect sizes in assisted living would be considerably 
less than observed in our nursing home study  (Weintraub et. al. 2018) because residents in the 
former are generally healthier, and so we planned for the conservatively high sample size of 
288 based on enrollment of 360 participants.  
 
Allowing for a conservative treatment effect <25% lower than found in our previous research 
(a mean difference ≥ 0.374), power would equal approximately 68%, assuming N=170 divided 
among 20 AL communities with the number of clusters in the intervention group = 9 (K1) and 
the number of clusters in the control group =11 (K2), an intraclass correlation coefficient (ICC) 
of .09 (based on previous work), a coefficient of variation (COV) among cluster sizes of 0.30, a 
between-subject SD of 0.76, and an alpha value of .05 for a two-sided test. These values reflect 
the assumptions in the original power analysis for the Plaque Index for Long-Term Care and 
scenarios that achieve 80% power by altering assumptions regarding effect size and ICC.  
 
Revised Estimate (for Aim 3 based on Aim 2) 
 
The Aim 2 trial was completed with 200 enrolled participants in 24 communities. However, 
one AL community withdrew prior to the four- month visit, and another could not be scheduled 
for the four- month data collection due to repeated cancellations responsive to COVID 
outbreaks. Thus, the Aim 2 trial had 117 participants from 22 communities having both 
baseline and four- month outcome data, which corresponds to an average of 5.3 residents per 
community. 
 
Informed by data from the completed Aim 2 trial, power analyses were re-calculated to 
determine power to detect between-group differences in mean four-month change in the oral 
health outcomes (plaque index and gingival index) in the Aim 3 trial. In most scenarios, power 
to detect anticipated mean differences in change scores between treatment groups is at least 
80% (Table 8.2.1).   
 
 
 
 
 
 
 

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19 
 
 
 
 
 
 
 
 
 
 
 
We aim to enroll 233 participants in Aim 3. Based on data from Aim 2, a small percentage of 
these (less than 5%) will be edentulous at baseline or become edentulous prior to month 4 and 
not contribute to the Primary analysis of PI-LTC and GI-LTC. Table 8.1.2 shows that 80% 
power to detect an effect size of Cohen’s d = 0.6 is attainable if we enroll a total of 28 clusters 
to achieve a total sample size for analysis of 140 residents.  Depending upon the percentage of 
participants with evaluable data (i.e., with teeth and an oral exam at both baseline and four 
month follow-up), we would need to enroll 233 residents assuming 40% are non-evaluable. 
 
 
8.2.2 Randomization 
 
Randomization will occur at the AL community-level. The project coordinator will work with 
the NC DHHS Special Care Dentistry Program partners to identify the AL communities that (a) 
have not been trained in MCWB, (b) were trained within the last year, and (c) were trained 
longer than one year ago.  For Aim 2, a total of 24 AL communities (that are licensed to 
provide care for approximately 50 or more residents and have not been trained in MCWB in 
the last year) will be recruited across the state, eight from each of the two largest regions 
(Regions 4 and 5), and four from each of the other eight regions. For Aim 3, the intervention 
will be delivered by dental hygienists employed by the State of North Carolina Department of 
Health and Human Services (NC DHHS) on a voluntary basis; depending on the counties to 
which they are assigned, geographic coverage may not be statewide. For this aim, up to 28 ALs 
will be recruited and it will be allowed that communities with as few as 13 residents will be 
contacted for recruitment while still striving to assure at least 10 residents meet eligibility 
criteria. The project coordinator will recruit them within region, with a preference given to 
those that have never been trained. After confirming eligibility and willingness to participate, 
the analyst will randomly assign the community to treatment or control one-to-one within 
regions.     
8.3 Interim analyses and Stopping Rules 
The following are the reasons for discontinuing the study early: 
• The occurrence of a serious adverse event, possibly or definitely related to the 
Table 8.2.1. Power of the Aim 3 CRT to detect standardized effect size (Cohen’s d) of change in 
Oral Hygiene score from baseline to four-months assuming unequal cluster sizes with 
Coefficient of Variation of 0.43, intraclass correlation of 0.10 and an average cluster size in the 
analysis dataset of 5 
No. of 
clusters 
Average 
Cluster 
size 
Total 
Sample 
Size 
Target Enrollment 
d=0.6 
d=0.65, 
GI-LTC in 
Aim 2 
d=0.7 
d=0.75 
PI-LTC in 
Aim 2 
d=0.80 
60% 
evaluable 
70% 
evaluable 
20 
5 
100 
167 
143 
65 
72 
78 
83 
88 
22 
5 
110 
183 
157 
70 
76 
82 
87 
91 
24 
5 
120 
200 
171 
74 
80 
86 
90 
93 
26 
5 
130 
217 
186 
77 
84 
89 
92 
95 
28 
5 
140 
233 
200 
81 
86 
91 
94 
96 
30 
5 
150 
250 
214 
83 
89 
93 
96 
97 

Version 6.0_23 July 2024 
 
 
 
20 
study protocol, occurring in any participant. In this study, it would include serious 
physical distress causing death or hospitalization. 
• Adverse events, possibly or definitely related to the study protocol, occurring in 
three or more participants. In this study, this would include participants who 
withdrew from the study due to new physical symptoms possibly related to allergic 
reactions. Cases will be examined carefully by the PI and DSMB to determine if 
the cases warrant study discontinuation. 
 
Interim analyses will occur at the end of Aim 2. Summary data related to the above bullets 
will be made available to the DSMB at least 2 weeks before meeting, or within 24 hours of 
becoming known to the study team in the case of a serious adverse event (e.g., 
hospitalization or death) or 48 hours in the case of an unexpected and related adverse event 
our unanticipated problem (UP) with increased risk. 
8.4 Outcomes  
8.4.1 Primary outcomes   
The primary comparisons are the differences between intervention and control treatment 
conditions in mean oral hygiene scores, as measured by the Plaque Index for Long-Term 
Care (PI-LTC), Long-Term Care Gingival Index (GI-LTC), and Denture Plaque Index (DPI) 
at four months adjusting for baseline scores. The three outcomes are collected at baseline, 
four months (Aims 2 and 3), and eight months (Aim 2 only); additional comparisons 
between treatment arms will be conducted at eight months, adjusting for baseline scores, to 
assess maintenance effects of the intervention. Descriptive statistics will include the 
calculation of mean outcome scores at each of the three time points for control and 
intervention conditions. Preliminary effectiveness analysis for the oral hygiene outcomes 
will compare MCWB sites to control sites for their change from baseline score through 
calculation of difference-in-differences based on mean summary scores at four and eight 
months to ascertain whether hygiene improves from baseline to follow-up. Resident and AL 
characteristics will be summarized for the two treatment arms using means for continuous 
variables and frequencies for categorical variables. Sensitivity analysis of primary models 
(described next) will include characteristics that are shown to be imbalanced despite 
randomization; in the case of continuous covariates, a criterion that differences between 
treatment arms exceed 10% relative to the control condition will be applied. 
 
For each outcome, a repeated measures linear mixed effects model for the joint analyses of 
the mean outcome at 4 months and 8 months follow-up will follow an analysis of covariance 
approach with the baseline score of oral hygiene as a covariate decomposed into individual 
and cluster level components (Klar and Darlington, 2004). The mixed effects model will 
include random effects for AL sites, residents and residual error as well as fixed effects: an 
indicator for intervention/control status of the AL community (to test the intervention effect 
at 4 months), an indicator for eight months (time), and an interaction of intervention status 
and time allowing assessment of a maintenance effect at 8 months. Due to the moderately 
small number of clusters (24), Kenward-Roger degrees of freedom correction will be used 
in all linear mixed effects models. 
8.4.2 Secondary outcomes   
Secondary outcomes include pneumonia and hospitalizations.  The secondary outcomes of 
pneumonia and hospitalization will be examined with generalized linear models for cluster-
aggregated count data with a log link function, offsets for resident-days of follow-up and 

Version 6.0_23 July 2024 
 
 
 
21 
corrections for likely overdispersed counts (i.e., negative binomial models); we expect these 
analyses to be preliminary given the limited number of events over four and eight months. 
Analyses will determine effect size and the necessary sample to detect change in pneumonia 
incidence in AL residents for the subsequent pragmatic trial. 
8.5 Data Analyses  
For quantitative data, univariate statistics will be obtained for all variables, overall and by 
setting and staff characteristics, including frequencies, proportions, and 95% confidence 
intervals. Reach will be assessed with bivariate tests (i.e., Χ2-based tests, t-tests) to detect 
differences between participating and non-participating AL sites and AL staff and residents 
to inform representativeness. Fidelity will be examined overall and across sites, to 
determine and describe variability. To assess the effect of MCWB on organizational targets 
of change, change in the number of mouth care policies/practices will be determined, overall 
and in comparison to control sites (to detect a Hawthorne effect). To assess the effect of 
MCWB on the individual-level target of change (e.g., self-efficacy), a simplified linear 
mixed model will compare change in intervention versus control at four months; the model 
will include a variable for intervention/control allocation, baseline self-efficacy, and random 
effects for sites. A second model will assess eight-month change relative to four-month data 
(as will also be done for organizational practices). For adoption, implementation, and 
maintenance of behavior change, the amount of care provision will be examined through 
four and eight months, exploring drift over time. Cost analyses will calculate a “cost per 
patient per unit of improvement in oral hygiene” but will not include other outcomes, such 
as reduction in pneumonia. These data will be useful in planning cost-effectiveness analyses 
for the subsequent pragmatic trial. 
 
For associations between implementation and effectiveness in the twelve MCWB sites, we 
will examine bivariate relationships between implementation measures (including the 
mediators of organizational- and individual-level change) and oral hygiene outcomes with 
graphical displays and summary measures of association; power is limited for more 
sophisticated analyses due to sample size. Graphs will identify monotonic associations 
between implementation success and change in oral hygiene. We will analyze staff data 
both individually and aggregated at the site level. We will use evidence gathered from the 
analyses above to guide our inquiries, noting the outcomes that did/did not experience 
change. For example, suppose (a) the MCWB arm is not significantly associated with 
reductions to residents’ PI-LTC scores but reveals a trend in the expected direction, and (b) 
the amount of organizational change or change in self-efficacy varies significantly by AL 
site and is correlated with change in PI-LTC. Our goal will be to determine whether effect in 
the targets of change (mediators) explain intervention effectiveness and, if not, whether lack 
of effectiveness is systematic or isolated. In the latter case, we will identify outlying sites 
that have poor implementation and also anomalous ALs that exhibit good implementation 
but poor effectiveness. Analyses will examine a variety of implementation variables 
although our primary focus will be on the mediators/targets of change, and developing (if 
possible) an aggregated summary score of overall implementation success from the 
individual implementation measures across the RE-AIM domains. Overall, such information 
has potential to guide selection and emphasis of materials to include in the coaching manual 
to maximize implementation and outcomes. 
 
For attitudes, barriers and facilitators, we will analyze AIM, IAM, FIM, WEVAL and 
WAFU scores similarly as with the staff self-efficacy and oral hygiene outcomes. If barriers 
remain (e.g., low scores in the measures), the research team will use this information to 
inform content of the dental hygienist coaching manual for Aim 3. 

Version 6.0_23 July 2024 
 
 
 
22 
 
For Aim 3, analyses will compare all results obtained under Aim 2 analyses with those for 
Aim 3 analyses. Comparisons will be largely descriptive in nature and will comprise 
comparison of models and their derived parameter estimates across the two samples. We 
also may consider the combined samples as a meta-analysis of two studies, with data at the 
individual level; outcomes could be combined and modeled as a function of three 
“treatments” (combining the control conditions).   
9 
DATA COLLECTION AND QUALITY ASSURANCE 
9.1 Data Collection Forms 
The following outlines the research team member(s) who will be collecting data from each 
participant group.  
 
Data Collection Form 
Research Team Member(s) 
Data obtained from residents 
   Oral hygiene assessments 
Dental hygienist 
Data obtained from LAR 
   Baseline interview about resident 
Research assistant 
Data obtained from staff members 
   Staff mouth care baseline questionnaire 
Research assistant 
   Post-training staff evaluation questionnaire (WEVAL) 
Dental hygienist 
   Staff mouth care follow-up questionnaire 
Research assistant  
   Observation of mouth care 
Research assistant 
   Follow-up staff program evaluation questionnaire (WAFU) 
Project coordinator/research assistant 
Data obtained from Administrators 
   Assisted living characteristics, polices, practices  
   interview 
Project coordinator/Research assistant 
   Salaries 
Project coordinator/Research assistant 
Data obtained from Health Care Supervisors 
    Adverse Events and Pneumonia 
Project coordinator/Research assistant 
Data obtained from training and AL records 
   Training log 
Dental hygienist 
   Training support log 
Dental hygienist 
   Daily mouth care checklist 
Dental hygienist 
Data obtained from Public Health Dental Hygienists 
 
   Dental Hygienist Self-efficacy Questionnaire 
Project coordinator/Research assistant 
9.2 Data Management  
The study’s data management process will comprise four distinct yet interrelated tasks: 
 
1. development and organization all data sources (interviews, questionnaires, assessments); 
2. development and organization of all data files; 
3. identification, classification, and correction of all data anomalies (i.e., cleaning); and 
4. development and organization of cleaned data in preparation for analysis. 
 

Version 6.0_23 July 2024 
 
 
 
23 
Three members of the study team will be assigned data management tasks and will 
comprise the data management team. The project coordinator will have primary 
responsibility for completing tasks 1 and 2. The data analyst will have primary 
responsibility for completing tasks 3 and 4. The PI will have oversight of all data 
management tasks. All three team members will share responsibility for communicating 
with the broader study team members regarding data management processes. 
 
The data management team will give specific attention to the identification of potential 
adverse events among study participants. The data management team will develop a 
specific reporting mechanism and form to track all such events and will communicate with 
the broader study team regarding any outcomes as necessary. The study team will work 
collaboratively to prevent and mitigate any such events. 
9.3 Quality Assurance  
9.3.1  Training 
All staff will be highly experienced in their job responsibilities and receive project-
specific training from the PI, dementia care specialist, dental specialist, project 
coordinator, biostatistician, and/or others as necessary. 
9.3.2 Quality Control Committee  
N/A 
9.3.3    Metrics 
Data will be double entered; data cleaning will include logic checks and examination for 
outliers. 
9.3.4 Protocol Deviations 
Protocol deviations will be monitored using the Protocol Deviations Log.  
9.3.5 Monitoring 
All research procedures will be detailed in a written protocol. Only experienced data 
collectors will be employed; they will be trained in the importance of protecting 
confidentiality and will complete NIH Human Subjects Ethics Training. They will track 
completion of all forms, including consent forms, and the project coordinator will 
review the tracking database on a weekly basis to assure that forms are completed in a 
timely manner. Further, the project coordinator will confer with the dental hygienist 
regularly to assure compliance to the intervention protocol. If compliance is poor, 
remedies will be enacted (e.g., additional training or replacement of data collectors, 
more intense training provided by the clinical specialists). All matters will be reported to 
the PI and their remedy undertaken with her guidance. 
10 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
10.1 Institutional Review Board (IRB) Review 
All procedures will be reviewed by the UNC IRB. The protocol and informed consent 
documents will be reviewed prior to the initiation of the study. Any subsequent 
modifications will be reviewed and approved by the IRB. Refer to Appendix A for the 
approved informed consent documents. 

Version 6.0_23 July 2024 
 
 
 
24 
10.2 Informed Consent Forms 
Residents: The LAR recruitment letter and the resident/LAR consent form will be mailed to 
this individual. Three business days after the letter is mailed, the research assistant will call 
the LAR to explain the study, answer questions, solicit consent, and encourage prompt 
return of the form. The LAR calling script will guide this call.  Consent includes (1) an oral 
hygiene examination of the resident up to three times; (2) a telephone interview with the 
family member regarding resident characteristics (e.g., cognitive and functional status); (3) 
weekly contact with the AL health care supervisor, to collect adverse events and incidence 
of pneumonia, (4) observations of mouth care. If unable to reach the family/LAR by phone, 
the research assistant may also contact them by email. 
 
Able residents will be asked to provide assent. In all cases, residents must assent to the oral 
hygiene assessment; if they refuse, the assessment will not be conducted. Residents will be 
asked to give assent at each study visit; if a resident chooses to give assent (or not give 
assent) at one visit, study staff will continue to ask for their assent at subsequent visits. 
 
A signed HIPAA authorization will be obtained for all participating residents in the study. 
The project coordinator/research assistant will explain to the family member that the Health 
Care Supervisor will be interviewed weekly to check for any pneumonia cases or adverse 
events. It will also be explained that the HIPAA authorization will not stop unless they stop 
it in writing. 
 
The resident subject tracking form will be completed for all residents/LARs who are 
approached for participation. All recruitment efforts will be documented on the resident 
tracking form; specifically, all enrollments, refusals, and ineligibles (including the reasons 
for refusals and ineligibles), will be documented for each approached resident.   
Staff: Research staff will meet with PCAs and present the questionnaire that includes an 
embedded consent form and allow them time to read the consent form and choose to 
participate or decline participation without penalty. 
Dental hygienists: Consistent with the staff self-efficacy questionnaires, research staff will 
meet with DHHS Dental Hygienists and present the questionnaire that includes an 
embedded consent form and allow them time to read the consent form and choose to 
participate or decline participation without penalty. 
10.3 Participant Confidentiality  
To maintain confidentiality during recruitment, subjects will be approached in private in the 
place of their choosing. Mailings will be done in an unmarked envelope that does not allude 
to the nature of the contact. For any refusals, documents will be shredded immediately. All 
other documents will be safely stored in locked cabinets. 
 
Nothing on the interview forms will enable a person to identify a participant. All data will 
be summarized in reports, presentations, or publications. It will not be possible to identify 
an individual participant from data summaries.  
10.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, or other government 
agencies as part of their duties to ensure that research participants are protected.  

Version 6.0_23 July 2024 
 
 
 
25 
11 
ETHICAL CONSIDERATIONS 
This study was reviewed in accordance with federal regulations governing human subjects 
research, including those found at 45 CFR 46 (Common Rule), 45 CFR 164 (HIPAA), 21 
CFR 50 & 56 (FDA), and 40 CFR 26 (EPA).  
12 
COMMITTEES 
None  
13 
PUBLICATION OF RESEARCH FINDINGS 
Findings from this trial that are shared in publications or presentations will be of data vetted 
past the DSMB.  
14 
REFERENCES 
 
Klar N, Darlington G. Methods of Modelling Change in Cluster Randomization Trials. 
Statist Med 2004;23:2341-2357. 
 
Zimmerman S, Sloane PD, Ward K, Wretman CJ, Stearns SC, Poole P, Preisser JS. 
Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care 
on Reducing Pneumonia Incidence: A Cluster Randomized Trial. JAMA Netw Open. 2020 
Jun 1;3(6):e204321. doi:  10.1001/jamanetworkopen.2020.4321. PMID: 32558913; PMCID: 
PMC7305523. 
 
15 
APPENDIX A – CONSENT FORMS 
 
 

Version 6.0_23 July 2024 
 
 
 
26 
16 UNIVERSITY OF NORTH CAROLINA AT 
CHAPEL HILL CONSENT TO 
PARTICIPATE IN A RESEARCH STUDY 
Adult Participants –Legally Authorized Representative 
 
Consent Form Version Date: June 28, 2024 
IRB Study # 18-2795 
Title of Study: Oral hygiene in assisted living 
Principal Investigator: Sheryl Zimmerman 
Principal Investigator Department: Cecil G. Sheps Center for Health Services Research 
Principal Investigator Phone number: (919) 962-6417 
Principal Investigator Email Address: sheryl_zimmerman@unc.edu 
Funding Source and/or Sponsor: NIH National Institute on Aging (NIA) 
 
Study Contact Telephone Number: (919) 843-7811 
Study Contact Email: LSampson@email.unc.edu 
 
 
What are some general things you should know about research studies? 
Your family member is being asked to take part in a research study. To join the study is voluntary. 
You may refuse to join, or you may withdraw your consent to be in the study, for any reason, 
without penalty. 
 
Research studies are designed to obtain new knowledge. This new information may help people in 
the future. Your family member may not receive any direct benefit from being in the research 
study. There also may be risks to being in research studies. Deciding not to be in the study or 
leaving the study before it is done will not affect your/your family member’s relationship with the 
researcher, your health care provider, or the University of North Carolina-Chapel Hill. If your 
family member is a patient with an illness, your family member does not have to be in the research 
study in order to receive health care. 
 
Details about this study are discussed below. It is important that you understand this information so 
that you can make an informed choice about being in this research study. 
 
You will be given a copy of this consent form. You should ask the researchers named above, or 
staff members who may assist them, any questions you have about this study at any time. 
 
What is the purpose of this study? 
The purpose of this research study is to learn about and improve care and outcomes in assisted 
living communities. Your family member is being asked to participate in this research study 
because he/she lives in a participating assisted living community. 
 
Are there any reasons your family member should not be in this study? 
Your family member should not be in this study if he/she is younger than 18 years of age, has no 
teeth or denture, is on hospice or tube-feeding, expected to discharge in the next six months, does 
not have a diagnosis of dementia, or requires prophylactic antibiotics prior to dental examinations.

Version 6.0_23 July 2024 
 
 
 
27 
How many people will take part in this study? 
There will be approximately 720 people in this research study. 
 
How long will your family member’s part in this study last? 
 
Your family member’s participation will last up to four months. 
 
What will happen if your family member take part in the study? 
If your family member takes part in this study, he/she will first receive an oral hygiene screening by 
a dental hygienist to assess his/her oral health. This person will examine your family member’s 
teeth and gums, and record information about how clean and healthy they are. This examination 
will last about 20 minutes. Your family member will receive a follow-up oral hygiene screening 
after beginning the study. 
 
You will also be interviewed about your family member’s current cognitive and functional status 
and your participation in the community. The research team will also contact the Health Care 
Supervisor regarding whether your family member had pneumonia or experienced an adverse event 
during the study event (death, hospitalization, experienced a life-threatening event or a new 
disability, had swallowing problems related to mouth care or allergic reactions to mouth care 
products). 
 
What are the possible benefits from being in this study? 
Research is designed to benefit society by gaining new knowledge. The benefits to your family 
member from being in this study may be the identification of serious oral conditions for which 
he/she need treatment. Although unlikely, if such a condition is found, the dentist or hygienist will 
advise the assisted living staff. 
 
What are the possible risks or discomforts involved from being in this study? 
 
The oral hygiene screening may be uncomfortable, but the discomfort is expected to be minor and 
brief. In addition, there may be uncommon or previously unknown risks. You should report any 
problems to the researcher. 
 
What if we learn about new findings or information during the study? 
You will be given any new information gained during the course of the study that might affect your 
willingness to continue your family member’s participation. 
 
How will information about your family member be protected? 
 
Participants will not be identified in any report or publication about this study. Although every 
effort will be made to keep research records private, there may be times when federal or state law 
requires the disclosure of such records, including personal information. This is very unlikely, but 
if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the 
privacy of personal information. In some cases, your family member’s information in this research 
study could be reviewed by representatives of the University, research sponsors, or government 
agencies (for example, the FDA or NIH) for purposes such as quality control or safety. 
 
Your family member’s name will not be connected to the results of the oral hygiene screening. 
Instead, a number will be used. The data will be secured in a password-protected file and not shared 
with anyone outside the research team, unless you request otherwise. 

Version 6.0_23 July 2024 
 
 
 
28 
What is a Certificate of Confidentiality? 
This research is covered by a Certificate of Confidentiality. With this Certificate, the researchers 
may not disclose or use information, documents or biospecimens that may identify you in any 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings in the United 
States, for example, if there is a court subpoena, unless you have consented for this use. 
 
The Certificate cannot be used to refuse a request for information from personnel of a federal or 
state agency that is sponsoring the study for auditing or evaluation purposes or for information that 
must be disclosed in order to meet the requirements of the federal Food and Drug Administration 
(FDA). 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law, such as mandatory reporting requirements for child abuse or neglect, disabled 
adult abuse or neglect, communicable diseases, injuries caused by suspected criminal violence, 
cancer diagnosis or benign brain or central nervous system tumors or other mandatory reporting 
requirement under applicable law. The Certificate of Confidentiality will not be used if disclosure is 
for other scientific research, as allowed by federal regulations protecting research subjects or for 
any purpose you have consented to in this informed consent document. 
 
You should understand that a Certificate of Confidentiality does not prevent you from voluntarily 
releasing information about yourself or your involvement in this research. If an insurer, employer, 
or other person obtains your written consent to receive research information, then the researchers 
may not use the Certificate to withhold that information. 
 
What will happen if your family member is injured by this research? 
All research involves a chance that something bad might happen. This may include the risk of 
personal injury. In spite of all safety measures, your family member might develop a reaction or 
injury from being in this study. If such problems occur, the researchers will help you get medical 
care, but any costs for the medical care will be billed to you and/or your family member’s insurance 
company. The University of North Carolina at Chapel Hill has not set aside funds to pay your 
family member for any such reactions or injuries, or for the related medical care. You do not give 
up any of your family member’s legal rights by signing this form. 
 
What if you want to stop before your family member’s part in the study is complete? You can 
withdraw your family member from this study at any time, without penalty. The investigators also 
have the right to stop your family member’s participation at any time. This could be because you 
have had an unexpected reaction, or have failed to follow instructions, or because the entire study 
has been stopped. 
 
Will your family member receive anything for being in this study? 
Your family member will not receive anything for taking part in this study. 
 
Will it cost your family member anything to be in this study? 
It will not cost your family member anything to be in this study. 

Version 6.0_23 July 2024 
 
 
 
29 
Who is sponsoring this study? 
This research is funded by the National Institute on Aging. This means that the research team is 
being paid by the sponsor for doing the study. The researchers do not, however, have a direct 
financial interest with the sponsor or in the final results of the study. 
 
What if you have questions about this study? 
You have the right to ask, and have answered, any questions you may have about this research. If 
you have questions about the study (including payments), complaints, concerns, or if a research- 
related injury occurs, you should contact the researchers listed on the first page of this form. 
 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time. 
 
What if you have questions about your family member’s rights as a research participant? All 
research on human volunteers is reviewed by a committee that works to protect your family 
member’s rights and welfare. If you have questions or concerns about your family member’s rights 
as a research subject, or if you would like to obtain information or offer input, you may contact the 
Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu. 
 
Unencrypted Messaging 
The study team may want to message you by email about reminders and notifications about the 
study, however you may say “no” to receiving these messages and still participate in this study. 
If you say “yes”, messages may contain personal information about you and may be sent or 
received by the study team’s personal electronic devices or in a method that is not able to be 
encrypted (protected) and there is the risk your information could be shared beyond you and the 
study team. 
 
If, at any point, you wish to stop receiving unprotected communication from the study team, please 
notify the study team. After the study is complete and all research activities finished, or you 
withdraw from the study or request to stop receiving un-encrypted (un-protected) communication, 
you will no longer receive un-encrypted messages specific to this study. 

Version 6.0_23 July 2024 
 
 
 
30 
Participant’s Agreement: 
 
 
 
 
Check here to allow study staff to be able to email you if necessary. 
 
 
 
 
I have read the information provided above. I have asked all the questions I have at this time. I 
voluntarily agree to participate in this research study. 
 
 
 
Signature of Legally Authorized Representative 
Date 
 
Printed Name of Legally Authorized Representative 
 
 
 
 
 
 
Signature of Research Team Member Obtaining Consent 
Date 
 
Printed Name of Research Team Member Obtaining Consent 
 
 
 

Version 6.0_23 July 2024 
 
 
 
31 
Staff Consent: Baseline (Control) 
 
This questionnaire is part of a research study and is designed to help us learn about how mouth 
care is thought about and provided in this assisted living community. There are no right or wrong 
answers – we are only interested in your thoughts and opinions about providing mouth care.   
 
Completing this questionnaire is voluntary and should take about 10 minutes.  You will not 
receive anything for completing this questionnaire.      
 
The risks involved in completing this questionnaire are minimal.  Your responses are 
confidential and you are not asked to provide your name.  The responses we receive from 
everyone will be combined together, with no way to identify you individually.   
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information or documents that may 
identify you in any action or suit unless you say it is okay. They also cannot provide them as 
evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings.  
There are some important things that you need to know. The Certificate does not stop reporting 
that federal, state or local laws require. Some examples are laws that require reporting of child or 
elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate 
cannot be used to stop a sponsoring United States federal or state government agency from 
checking records or evaluating programs. The Certificate does not stop disclosures required by 
the federal Food and Drug Administration (FDA). The Certificate also does not prevent your 
information from being used for other research if allowed by federal regulations. 
If you have any questions about the research study or questionnaire items, you may contact the 
Principal Investigator for this project, Sheryl Zimmerman at (919) 966-7173. 
If you have any questions about your rights as research participant, you may also contact the 
Institutional Review Board at the University of North Carolina at Chapel Hill at (919) 966-3113.   
This research study was reviewed and approved by the Institutional Review Board at the 
University of North Carolina at Chapel Hill #18-2795. 
 
By completing this form you agree to participate in the study.  
 
 
 
 
 
 
 

Version 6.0_23 July 2024 
 
 
 
32 
Staff Consent: Follow-Up (Control) 
 
This questionnaire is part of a research study and is designed to help us learn about how mouth 
care is thought about and provided in this assisted living community. There are no right or wrong 
answers – we are only interested in your thoughts and opinions about providing mouth care.   
 
Completing this questionnaire is voluntary and should take about 10 minutes.  You will not 
receive anything for completing this questionnaire.      
 
The risks involved in completing this questionnaire are minimal.  Your responses are 
confidential and you are not asked to provide your name.  The responses we receive from 
everyone will be combined together, with no way to identify you individually.   
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information or documents that may 
identify you in any action or suit unless you say it is okay. They also cannot provide them as 
evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings.  
There are some important things that you need to know. The Certificate does not stop reporting 
that federal, state or local laws require. Some examples are laws that require reporting of child or 
elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate 
cannot be used to stop a sponsoring United States federal or state government agency from 
checking records or evaluating programs. The Certificate does not stop disclosures required by 
the federal Food and Drug Administration (FDA). The Certificate also does not prevent your 
information from being used for other research if allowed by federal regulations. 
If you have any questions about the research study or questionnaire items, you may contact the 
Principal Investigator for this project, Sheryl Zimmerman at (919) 966-7173. 
If you have any questions about your rights as research participant, you may also contact the 
Institutional Review Board at the University of North Carolina at Chapel Hill at (919) 966-3113.   
This research study was reviewed and approved by the Institutional Review Board at the 
University of North Carolina at Chapel Hill #18-2795. 
 
By completing this form you agree to participate in the study.  
 
 
 
 
 

Version 6.0_23 July 2024 
 
 
 
33 
Staff Consent: Baseline (Intervention) 
 
This questionnaire is part of a research study and is designed to help us learn about how mouth 
care is thought about and provided in this assisted living community. There are no right or wrong 
answers – we are only interested in your thoughts and opinions about providing mouth care.   
 
Completing this questionnaire is voluntary and should take about 10 minutes. You will not 
receive anything for completing this questionnaire.      
 
The risks involved in completing this questionnaire are minimal. Your responses are confidential 
and you are not asked to provide your name. The responses we receive from everyone will be 
combined together, with no way to identify you individually.   
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information or documents that may 
identify you in any action or suit unless you say it is okay. They also cannot provide them as 
evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings.  
There are some important things that you need to know. The Certificate does not stop reporting 
that federal, state or local laws require. Some examples are laws that require reporting of child or 
elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate 
cannot be used to stop a sponsoring United States federal or state government agency from 
checking records or evaluating programs. The Certificate does not stop disclosures required by 
the federal Food and Drug Administration (FDA). The Certificate also does not prevent your 
information from being used for other research if allowed by federal regulations. 
If you have any questions about the research study or questionnaire, you may contact the 
Principal Investigator for this project, Sheryl Zimmerman at (919) 966-7173. 
If you have any questions about your rights as research participant, you may also contact the 
Institutional Review Board at the University of North Carolina at Chapel Hill at (919) 966-3113.   
This research study was reviewed and approved by the Institutional Review Board at the 
University of North Carolina at Chapel Hill #18-2795. 
 
By completing this form you agree to participate in the study.  
 

Version 6.0_23 July 2024 
 
 
 
34 
Staff Consent: Follow-Up (Intervention) 
 
Your assisted living community has partnered with researchers from the University of North 
Carolina at Chapel Hill on a program to train and support staff to provide better mouth care.  
This questionnaire is part of a research study designed to understand how you feel about mouth 
care at your community now and also how you felt about mouth care before you were trained.  
 
There are no right or wrong answers – we are only interested in your thoughts and opinions 
about providing mouth care.   
 
Completing this questionnaire is voluntary and should take about 10 minutes.  You will not 
receive anything for completing this questionnaire.      
 
The risks involved in completing this questionnaire are minimal.  Your responses are 
confidential and you are not asked to provide your name.  The responses we receive from 
everyone will be combined together, with no way to identify you individually.  
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information or documents that may 
identify you in any action or suit unless you say it is okay. They also cannot provide them as 
evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings.  
There are some important things that you need to know. The Certificate does not stop reporting 
that federal, state or local laws require. Some examples are laws that require reporting of child or 
elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate 
cannot be used to stop a sponsoring United States federal or state government agency from 
checking records or evaluating programs. The Certificate does not stop disclosures required by 
the federal Food and Drug Administration (FDA). The Certificate also does not prevent your 
information from being used for other research if allowed by federal regulations. 
If you have any questions about the research study or questionnaire items, you may contact the 
Principal Investigator for this project, Sheryl Zimmerman at (919) 843-7811. 
If you have any questions about your rights as research participant, you may also contact the 
Institutional Review Board at the University of North Carolina at Chapel Hill at (919) 966-3113.   
This research study was reviewed and approved by the Institutional Review Board at the 
University of North Carolina at Chapel Hill, #18-2795. 
 
By completing this form you agree to participate in the study.  
 
 
 

Version 6.0_23 July 2024 
 
 
 
35 
Dental Hygienist Mouth Care Questionnaire 
 
This questionnaire is part of a research study designed to understand how mouth care training for 
assisted living staff is perceived and provided.  There are no right or wrong answers; it asks your 
thoughts and opinions about providing mouth care training in assisted living.   
 
Completing this questionnaire is voluntary and should take approximately 10 minutes.  You will 
not receive anything for completing this questionnaire.      
 
The risks involved in completing this questionnaire are minimal.  Your responses are 
confidential; they will not be shared with your employer or any other people. Results will reflect 
only aggregate (group-level) information. 
 
If you have any questions about the questionnaire or research study, you may contact the 
Principal Investigator for this project, Sheryl Zimmerman at (919) 966-7173. 
If you have any questions about your rights as research participant, you may contact the 
Institutional Review Board at the University of North Carolina at Chapel Hill at (919) 966-3113.   
This research study was reviewed and approved by the Institutional Review Board at the 
University of North Carolina at Chapel Hill #18-2795. 
 
By completing this questionnaire you agree to participate in the study.