Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers
Phase: NA
Conditions: Dementia, Cognitive Impairment
Sponsor: Xi Chen

Study title: 
Functionally-tailored Oral Care Intervention for Community-dwelling Older 
Adults With Dementia and Their Caregivers 
 
Identifiers: 
NCT04238520 
 
Document date: 
02-17-2023 
 
 

I.  Purpose   
 
 
The purpose of this project is to develop and validate an oral care intervention to support 
community-dwelling older adults with dementia and their family caregivers (FCG).   
 
 
II.  Research Team 
 
Table 1 Providers and roles 
 
 
III.  Project Overview 
 
Persons with dementia (PWD) gradually lose their ability to perform oral self-care, leading to 
poor oral hygiene. Poor oral hygiene increases the risk of dental caries, periodontal disease and 
other oral pathologies, and initiates a cascade of oral health decline among PWD, which in turn 
may accelerate cognitive decline.  Importantly, these changes often begin before nursing home 
(NH) placement. Besides pain and discomfort, poor oral health can lead to agitation and 
delirium and increase caregiver (CG) stress. It can also affect quality of life, cause malnutrition, 
increase insulin resistance, and lead to aspiration pneumonia, cardiovascular complications, 
and other life-threatening conditions in these vulnerable individuals. Early intervention is 
essential to stop/slow down the oral health decline and its cognitive/systemic impacts in PWD.  
 
Existing oral hygiene interventions have demonstrated efficacy in improving oral health, 
reducing aspiration pneumonia and even slowing down cognitive decline. However, these 
programs were designed for NH residents and are not tailored for the great majority of PWD 
who reside in the community. As such, they fail to account for the reciprocal physical and 
emotional relationship between the PWD and their family caregivers and its influence on oral 
care. Furthermore, although oral hygiene education is a standard component of dementia dental 
care, it is usually not tailored to each patient’s level of oral self-care function.  In response to 
these gaps, we propose a study to develop and evaluate a functionally-tailored oral hygiene 
intervention to improve oral health for community-dwelling PWD while reducing caregiver 
burdens and improving care partner relationships.  
 
The study consists of two phases corresponding to two aims. For Aim 1 we will develop a 
modularized, functionally-tailored oral care intervention based on literature review and CG 
interview input. We anticipate eight training modules that can be used alone or in varying 
combinations to provide functionally-appropriate oral care rehabilitation for PWD and need-
based skills training to their family CGs. These will be adapted from Mouth Care Without a 
Battle, a validated oral hygiene intervention developed for NH residents with dementia. Aim 2 
will examine the efficacy and feasibility of the proposed intervention using a randomized 
controlled design among 40 PWD/CG pairs. After baseline assessment, a 4-week, dyadic, 
hands-on, functionally-tailored oral care intervention will be delivered to 20 PWD/CG dyads.  
Control group participants (n=20) will receive the oral hygiene education that is commonly 
provided to PWD during dental care. Data collection will occur at baseline, 4-weeks and 3 
months. Differences between the control and intervention groups with regard to PWD outcomes 
(e.g., oral hygiene and behavior symptoms during oral care), caregiver outcomes (e.g., burden, 
self-efficacy) and the care partner relationship will be explored.    

This protocol has been developed to guide the study of Aim I and the Aim II study.  
 
IV.  Eligibility, Enrollment, and Consent 
 
Sources of Recruitment.  Tentatively, the study participants will be recruited from the sites 
listed below. The site names and IDs are as follows:   
 
Table 2 recruitment sites and ID 
Recruitment site 
Site ID 
Phase I study 
10 
Dementia registry  
20 
UI Memory Care Clinic (Dr. Denburg) 
30 
UI Dental School  
40 
UI Geriatric Clinic (Dr. Wilbur/Larson) 
50 
Local Community (mass email) 
60 
UIHC list (TrinetX) 
70 
Mercy Caregiver Group 
80 
Huntington’s Clinic 
 
 
90 
Mercy Center for Memory Health 
11 
Heritage Area Agency on Aging 
12 
   
 
 
 
 
 
 
 
 
 
 
     
Eligibility and Recruitment.  40 PWD/CG pairs will be recruited for the Aim 2 validation study. 
The eligibility criteria and recruitment strategies for both studies are the same. Recruitment 
letter will be mailed to the participants from site 10, 20, 40, 50 and 70. Approximately one week 
after mailing the letter, a member of the research team will contact the PWD or their legally 
authorized representatives (LARS). Recruitment material will also be distributed at site 30 and 
50. A research team member will contact other participants from site 60 and 80 who expressed 
their interest to further explain the study and invite them to participate. All of the potential 
participants (PWD and FCG) will be screened according to the criteria below using screening 
forms. 
 
The participant screening and recruitment form must be completed for ALL candidate 
participants who are approached for participation.  All enrollments, refusals, withdrawn and 
excludes must be carefully documented for each approached PWD/CG and cross-checked 
among the recruitment sites.   
 
 
PWD eligible for the study are those who meet the following criteria:  
• 
50 years of age or older 18 years or older with Huntington’s Disease with a diagnosis of 
neurodegenerative disorder 
• 
≥1 natural teeth 
• 
Not blind, deaf, or with severe physical disability (e.g., hemiplegia) 
• 
English-speaking 
• 
have a family CG who is age≥18, English-speaking, and willing to participate 
PWD with the following condition will be excluded:      
• 
Joint replacement with a history of prosthetic joint infection and/or that requires immediate dental 
referrals 

• 
Oral health conditions (cancer, acute infection) that require an immediate dental referral  
• 
Actively dying 
 
The first seven conditions are included in the exclusionary criteria because the American Dental 
Association recommends antibiotic treatment prior to receiving dental care, which is not feasible 
in this study.  
 
CG eligible for the study are those who meet the following criteria: 
• 
Age≥18  
• 
English-speaking 
CG with the following conditions will be excluded: 
• 
Cognitively impaired (based on 6-item cognitive screening tool);  
• 
Blind, deaf, or severely disabled 
Once eligibility is identified for both FCG and PWD, the research team member will ask if the 
dyad are self-responsible for consenting to research. If they are not, the research team member 
will ask for LAR contact information and proceed to contact the LAR, explain the study, and mail 
the informed consent to the LAR. 
  
If dyad is self-responsible, prior to informed consent, the research assistant should evaluate the 
ability to provide informed consent of both PWD and FCG using The Evaluation to Sign an 
Informed Consent.  If PWD, are deemed unable to consent, and have no designated LAR or 
POA , the research assistant should obtain written informed consent from the patient’s next of 
kin in accordance with the UI IRB standard operating procedures for obtaining consent of 
human subjects with impairment in decision-making, specifically, in the order of spouse, adult 
child, siblings and relatives. Adequate time should be given for participants to process the 
information, and the research assistant should encourage participants to ask questions during 
the informed consent process. 
 
Informed consent will be obtained from cognitively-intact caregivers using the protocol described 
above. If caregivers have legal guardians or power of attorney (POA), informed consent will be 
obtained from the responsible party. If the candidate caregivers are unable to consent and has 
no legal guardian or POA, the dyad will be excluded. 
 
Either the self-responsible PWD, CG or his/her LAR will be asked to provide written informed 
consent  
 
 
 
IV. Pilot study design  
Pilot study: was conducted December 2020 to March 2021  
V. Stratification and Randomization  
After informed consent, PWD will be assessed using the Dental Activities Test (DAT). Based 
on the DAT score, PWD and their FCG will be classified into 4 levels. Each level contains 10 
dyads of PWD and FCG.  All participants will be assigned to the intervention until we 

reach 20 dyads then we will resume a control group. Each group has 5 dyads of PWD 
and FCG. 
Table 3 Group assignment criteria  
 
Independent 
(DAT=9, N=10) 
Needs Supervision 
(DAT=6-8, N=10) 
Needs Assistance  
(DAT=3-5, N=10) 
Full Care  
(DAT=0-2, N=10) 
Study group 
5 
5 
5 
5 
Control group  
5 
5 
5 
5 
 
VI. Oral Hygiene Intervention  
Study group: a functionally-tailored oral care intervention will be provided to the dyads. The 
goal of the intervention is to improve oral hygiene for PWD while reducing the burden of the 
caregiver. Different modules will be combined to provide personalized oral care interventions 
for PWD and their FCGs based on their needs. The following table provides a general guide to 
develop an oral care intervention based on PWD’s oral self-care function. Note that the 
intervention will need to be individualized based dyad’s needs.  
 
Table 4 Functionally Tailored Oral Care Interventions Corresponding to Dental Activities Test 
(DAT) Scores 
 
Independent 
(DAT Score 9) 
Needs Supervision 
(DAT Score 6-8) 
Needs Assistance 
(DAT Score 3-5) 
Full Care 
(DAT Score 0-2) 
PWD§ 
Caregive
r 
PWD 
Caregiver 
PWD 
Caregiver 
PWD 
Caregiver 
Goals of 
intervention 
1. Regain/ 
Maintai
n 
function 
2. Improve 
quality 
of self-
care 
 
1. Ensure 
quality of 
care 
 
1. Maintai
n 
function 
2. Improv
e 
quality 
of self-
care 
1. Ensure 
oral care 
quality 
2. Provide 
assistance 
to facilitate 
oral self-
care  
1. Maintai
n 
functio
n 
 
1. Provide 
assistance to 
facilitate oral care  
2. Provide oral care 
as needed 
3. Ensure quality of 
care 
4. Manage behavior 
symptoms 
N/A 
1. Provide oral 
care  
2. Ensure quality 
of care 
3. Manage 
disruptive 
behaviors 
4. Identify PWD 
in pain or 
infection 
Common 
intervention 
1. Adapt environment for good care (module 7, as needed); 2. Oral hygiene products for special needs (module 8, 
as needed) 
Personalize
d Modules** 
1, 2 
1, 3 
2 
1, 3, 4 
2  
1 - 5 
N/A 
1 - 6 
* ACLs-Allen Cognitive Levels; § PWD-Persons with dementia; ** Module 1-Oral disease and impacts; 2-Oral care techniques; 
3-Quality improvement; 4-Cuing strategies; 5-working with behavior symptoms; 6-Recognizing oral pain/infection. 
The intervention will consist of 4 sessions. The OCC will first assess dyad’s oral care needs in 
the first visit and then develop the intervention protocol with Dr. Chen based on the guidance 
listed in table 3. The goals and intervention tasks of each visit are summarized in the following 
table. 
 
 
 

Table 4. Tentative Intervention Sessions and Contents for the Control Group 
Visit  
Goal 
Intervention 
1 
• Program 
overview  
• Dyad education 
• Goal 
identification 
• Need 
assessment  
• Reviews intervention program   
• Deliver Module 1.1 and 3.1 to the dyad  
• Through dyad’s demonstration, OCC assesses dyad’s oral care 
skills (e.g., tooth brushing with disclosing solution and denture 
care, if applicable), preferences (e.g., floss vs. interdental 
brush), related challenges, and needs for adaptive oral hygiene 
products (specially-designed toothbrush, mouth prop) 
• Assesses need for environmental changes (e.g., lighting, 
contrast, set-up of oral care products) 
• Complete the rest of the items in the First visit assessment 
form  
OCC develops functionally-tailored intervention plan to enhance what is currently 
working and compensate what needs to improve 
2 
• Tooth brushing  
• Denture care (if 
applicable) 
  
• 
Reviews intervention plan and materials  
• 
Works with dyads to develop mutually agreed upon oral 
care plan (e.g., when and how often to perform oral care, 
use of oral care products) Module 2.0 
• 
Works with dyad to eliminate environmental obstacles 
Module 4.1 and other Modules and Scenarios as 
identified. 
• 
Reviews personalized oral hygiene products (e.g., special 
toothbrush, toothpaste, or mouth prop) with dyad. 
• 
Following the previously designed intervention plan, 
delivers hands-on, basic oral care (tooth brushing, 
denture care) and related skills training (e.g., cueing, 
quality improvement, behavior management as needed) 
via the trial & error strategy (tailor to dyad’s needs and 
repeat until dyad demonstrates and fully learns the skills)  
• 
Delivers daily oral hygiene logs and instructions. 
3 
• Interdental 
brushing 
• Dry mouth care  
• Review, discuss, and reinforce the basic skill set learned at the 
last visit.  
• Review and reinforcement daily oral hygiene log 
• Review oral care products required for interdental brushing, 
and dry mouth care. 
• Delivers training on cleaning between teeth, and dry mouth 
management.  
• Provide hand-on practice and real time feedback until dyads 
fully learn the skills. 
4 
• Advanced skills 
reinforcement 
• Program 
review, and 
wrap-up 
• Reviews dyad’s progress to date.  
• OCC assesses and gives feedback of a dyad’s final 
demonstration of oral care skills with disclosing solution. 
• Review, discuss, and reinforce basic and advanced skill sets 
and tailor skills as needed. Discuss Modules that have not been 
reviewed, if necessary. 
• Trainer and dyad work together to develop maintenance plan 
(with the minimum goal of once-a-day oral care)  

• Distributes the educational packet and resources for future use. 
 
Control group:  
• 
Control group will have 3 visits: Initial visit, 4th week and F/U at 3 months. Control dyads 
will receive a 15-minute, home-based, untailored oral care training, using only Module 1 
and Control Group OHI Module 2.7, in the first visit. After a demonstration, the OCC 
should allow participating dyads time to practice the oral care skills and provide real time 
feedback for the participants. After the demonstration, the1 Care recipient Feasibility 
Evaluation Questionnaire (if applicable) and the Caregiver Feasibility Evaluation 
questionnaire should be completed. 
 
VII. Data Collection 
Validation study.    
The oral care coach (OCC) and research assistant (RA) will visit participants. The following 
data (Table 5.) needs to be collected during the validation study. Some of the data will be 
collected multiple times. Specifically, to avoid overburden to the study participants, the study 
coordinator should arrange an appointment before the intervention to collect all the baseline 
data. All the interviews and assessments should be given in a relaxed, comfortable 
environment and format. Breaks should be given if participants become tired, anxious or 
frustrated.  
If a subject is identified as in need of immediate dental attention in the oral exam or during the 
intervention, the research assistant or OCC will document and communicate this need to the 
study coordinator. In accordance with approved IRB procedures and the data safety 
monitoring plan, the study coordinator will then send the consenting party a standardized 
notice recommending a follow-up examination. If needed, the identified issue will be reported 
to the IRB and the data safety monitoring committee. 
The assessments should be given in the following order: 
 
 

 Visit 0 
 
Visit 4 
 
 
10.  Mini-Cog 
11. Control Group Education (if applicable) and FCG, PWD program feasibility evaluation
8. Self-perceived oral health, Anosognosia
7. Apathy assessment (LD)
5. VAS andCESD Depression assessments (CESD only done in MMSE 24 or higher)
4. FCG Self-efficacy (LD)
3. Oral Exam
3. FCG Interview (LD)
2.DAT, NCST
1. MMSE, ADL, IADL 
6CIT (CG) (LD)
Consent

 
 
Visit 3-month 
Dyad dy
 

Table 5. Data to be collected in the validation study 
 

Data  
Measure/Tool 
Subject 
Time 
Examiner 
Oral self-care function 
Dental Activities Test (DAT) 
PWD 
Baseline 
RA 
Cognition  
• 
MMSE 
• 
New cognitive 
screening tool (NCST) 
• 
Mini-Cog 
PWD 
Baseline 
RA 
 
Daily function  
ADL and IADL 
FCG 
Baseline 
RA 
Depression  
• 
Visual analogue scale 
• 
CESD depression scale 
PWD 
Baseline 
RA 
Apathy  
Dementia Apathy Interview 
and Rating 
FCG 
Baseline 
RA 
Anosognosia  
• 
Anosognosia 
• 
Self-perceived oral 
health 
PWD/FCG 
Baseline 
RA 
 
 
 
 
 
Oral hygiene  
• 
Plaque index 
• 
Gingival index 
PWD 
• Baseline 
• 4-week 
follow-up 
• 3-month 
follow-up 
Dentist 
• 
Sociodemographics 
• 
Medical history & 
medication 
• 
Dental care pattern 
Caregiver Interview  
FCG 
Baseline  
RA OCC 
• 
Oral hygiene practice 
• 
Perceived oral hygiene 
and oral health  
• 
Behavior symptoms 
during oral care 
• 
Mouth Care Related 
Caregiver Burden 
• 
Dyadic relationship   
Caregiver Interview  
FCG 
• Baseline 
• 4-week 
follow-up 
• 3-month 
follow-up 
LD &RA 
CG efficacy in providing oral 
care 
Caregiver Self-efficacy 
Scale 
FCG 
• Baseline 
• 4-week 
follow-up 
• 3-month 
follow-up 
RA 
First visit assessment  
First visit assessment form 
PWD/FCG 
1st visit 
LD 
Feasibility assessment 
(session) 
• 
Care recipient 
Feasibility Evaluation 
Questionnaire 
• 
Caregiver Feasibility 
Evaluation 
Questionnaire 
PWD/FCG 
• Every 
session 
LDRA 
Trainer assessment 
• 
Trainer evaluation 
questionnaire 
Trainer 
Every 
session 
LD 
Daily oral care practice 
• 
Daily oral care log 
PWD/FCG 
• Every 
session 
• 3-month 
follow-up 
LD 

Feasibility assessment 
(program) 
• 
Care recipient Program 
Feasibility Evaluation 
Questionnaire 
• 
Caregiver Feasibility 
Program Evaluation 
Questionnaire 
PWD/FCG 
• 4-week 
follow-up  
RA 
Implementation assessment 
• 
Training log & trainer 
interview 
Trainer 
Every 
session 
XC