The specific aims of this study are:

Aim 1. Develop a staged and modifiable dyadic oral care intervention to provide functionally-tailored oral care rehabilitation for community-dwelling persons with dementia (PWD) and need-based skills training their family caregivers (CGs). Based on the literature review and MCWB, a 4-week intervention with 8 modules, including universal modules (e.g., environmental changes), CG modules (e.g., cuing strategies) and modules for both PWD and CGs (e.g., oral care techniques), will be developed addressing the relevant SCT constructs (e.g., functional deficits of PWD and caregiving needs of CGs). Guided by a validated, widely-used theory of rehabilitation medicine, modules will be used alone or in combination to provide personalized, hand-on, functionally-tailored oral care rehabilitation for PWD along with skills training for CGs to match their caregiving needs. The training focus shifts from the PWD to the CG, as the independence of the PWD decreases. Semi-structured interviews with family CGs will then be conducted (until data saturation is reached) to understand their oral care needs, desired intervention approaches, and the perceived feasibility and utility of the intervention. The intervention will be revised and then pilot tested with 4 dyads, one per each of the four functional levels of the DAT.

Aim 2. Evaluate the feasibility and efficacy of the intervention in home settings through a randomized, controlled trial with 40 pairs of PWD and their primary CGs, including immediate post-intervention and 3-month follow-up. Dyads will be stratified into 4 functional levels based on the PWD's DAT score and then randomly assigned to the intervention or control (non-tailored usual care) group.

This study aims to develop and evaluate a functionally-tailored oral hygiene intervention to improve oral health for community-dwelling persons with dementia, while also reducing caregiver burden and improving the care partner relationship. The study consists of two phases. First, we will develop a modularized, functionally-tailorable oral care intervention based on caregiver qualitative interviews and existing literature. The second phase will then examine the efficacy and feasibility of the intervention through a randomized controlled trial (3 intervention: 1control ratio)with 40 Persons with Dementia/caregiver dyads. Control participants will receive the standard oral hygiene education currently provided to persons with Dementia during dental care. The Intervention group will receive 4-week, dyadic, hands-on, functionally-tailored oral care intervention. We will collect data at baseline, 4-weeks, and 3 months post intervention. After data collection, the differences in the control and intervention groups in regard to their oral hygiene, behavioral symptoms during oral care, caregiver outcomes (burden, self-efficacy) and care partner relationship will be explored.

The specific aims of this study are:

Aim 1. Develop a staged and modifiable dyadic oral care intervention to provide functionally-tailored oral care rehabilitation for community-dwelling persons with dementia (PWD) and need-based skills training their family caregivers (CGs). Based on the literature review and MCWB, a 4-week intervention with 8 modules, including universal modules (e.g., environmental changes), CG modules (e.g., cuing strategies) and modules for both PWD and CGs (e.g., oral care techniques), will be developed addressing the relevant SCT constructs (e.g., functional deficits of PWD and caregiving needs of CGs). Guided by a validated, widely-used theory of rehabilitation medicine, modules will be used alone or in combination to provide personalized, hand-on, functionally-tailored oral care rehabilitation for PWD along with skills training for CGs to match their caregiving needs. The training focus shifts from the PWD to the CG, as the independence of the PWD decreases. Semi-structured interviews with family CGs will then be conducted (until data saturation is reached) to understand their oral care needs, desired intervention approaches, and the perceived feasibility and utility of the intervention. The intervention will be revised and then pilot tested with 4 dyads, one per each of the four functional levels of the DAT.

Aim 2. Evaluate the feasibility and efficacy of the intervention in home settings through a randomized, controlled trial with 40 pairs of PWD and their primary CGs, including immediate post-intervention and 3-month follow-up. Dyads will be stratified into 4 functional levels based on the PWD's DAT score and then randomly assigned to the intervention or control (non-tailored usual care) group.

Sub-Aim 2.1 Evaluate the feasibility of the intervention across four domains: acceptability, demand, implementation, and practicality. We will interview the dyads and review their daily oral care logs at both post-intervention and 3-month follow-up, assessing satisfaction with, acceptability of, and actual use of the intervention. Oral care trainers will complete intervention logs following each training session to document the extent of content delivery, diversion from the protocol, resources used, and perceptions about intervention success. Exit interviews with PWD (when possible), CGs, and trainers will be conducted to identify potential barriers, facilitators, and needed changes.

Sub-Aim 2.2 Examine the efficacy of the intervention. We hypothesize that both PWD oral hygiene and CG self-efficacy in providing oral care will show clinically significant improvements for the intervention group compared to the control group. Secondary outcomes for PWD (e.g., behavior symptoms during oral care), CGs (e.g., oral care related burden) and the dyadic relationship (e.g., the Dyadic Relationship Scale) will also be explored.

Inclusion Criteria for Caregivers:

• 18 years or older
• English-speaking
• Willing to participate in the study

Exclusion Criteria for Caregivers:

• Cognitively impaired
• Blind, deaf, or severely disabled

Inclusion Criteria for Persons with Dementia

• Diagnosis of Dementia
• Age 50 years or older or 18 years or older with Huntington's Disease
• Community-dwelling
• English speaking
• Have natural teeth
• Not blind, deaf, or severely disabled
• Have a caregiver that is age equal or 18+ years old, English speaking, cognitively intact, and willing to participate in the study

Exclusion Criteria for Persons with Dementia:

• Joint replacement with a history of prosthetic joint infection
• Requires immediate dental referrals
• Have oral cancer or active oral infection or 3) is actively dying.
• Actively dying

26 pairs of participants with dementia (PWD) and their family caregivers (FCG) (Total=52 participants) were enrolled into the study at the baseline. A descriptive analysis was completed for PWD and FCG, respectively.

3 months

The Adverse Events data were collected for PWD only.

We are not able to reach the targeted recruitment goal because of the impact of COVID. Therefore, this trial was inadequately powered to detect the potential differences between the study group and the control group in all of the outcome measures.

Single Blind- Study participants will be aware of the treatment assigned. The investigator and statistician will not know the group allocation. To check the success or failure of the blinding, the oral examiners and data collectors will be asked after each assessment whether they have been told or know for sure to which group each dyad has been assigned.