An interventional study of Functionally Tailored Oral Care Intervention and Control Intervention in Dementia and Cognitive Impairment, sponsored by Xi Chen. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by Xi Chen · Not applicable, Interventional, and Treatment
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 26 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
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Inclusion Criteria for Caregivers:
Exclusion Criteria for Caregivers:
Inclusion Criteria for Persons with Dementia
Exclusion Criteria for Persons with Dementia:
PWD/CG dyads
Behavioral: Control Intervention
PWD/CG dyads
Behavioral: Functionally Tailored Oral Care Intervention
Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.
Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.
Person With Dementia: Oral Hygiene
We used the Debris Index (DI) of the Oral Hygiene Index (a scale of 0 to 3, with lower values indicating no debris present and higher values indicating more soft debris on the tooth. Also called plaque score) to assess PWD's oral hygiene status. We used the percentage change in plaque scores between baseline and 3 months to evaluate the effectiveness of the proposed intervention on improving PWD's oral hygiene.
Time frame: Baseline and 3 Months
Self-perceived Oral Care-giving Efficacy
Self-perceived Oral Care-giving Efficacy scale included 19 items to assess self-perceived efficacy in providing oral care to care recipients. We assessed CG's self-perceived oral care-giving efficacy at the baseline and 3-month follow-up visit. We used the percentage change in Self-perceived Oral Care-giving Efficacy scores between the baseline and 3-month follow-up to examine the effectiveness of the proposed intervention on improving CG's oral care-giving skills. Higher scores indicate a better improvement in self-perceived efficacy.
Time frame: Baseline and 3 Months
Dyadic Relationship
Dyadic Relationship Scale (DRS) to measure strain between the caregiver and recipient within the past month on a scale of 1 to 4. The original DRS 11 items will be used for caregivers and 10 items will be used for care recipients. High scores indicate high levels of strain and positive interaction. We used the percentage change in dyadic relationship scores between the baseline and 3 months to examine how this intervention affected PWD/CG relationships.
Time frame: Baseline and 3 Months
| Milestone | Control | Interventional |
|---|---|---|
| Started | 7 | 19 |
| Completed | 5 | 13 |
| Not completed | 2 | 6 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Unsafe home environment for research staff | 0 | 1 |
We used the Debris Index (DI) of the Oral Hygiene Index (a scale of 0 to 3, with lower values indicating no debris present and higher values indicating more soft debris on the tooth. Also called plaque score) to assess PWD's oral hygiene status. We used the percentage change in plaque scores between baseline and 3 months to evaluate the effectiveness of the proposed intervention on improving PWD's oral hygiene.
| percentage change in plaque scores | Control - PWD | Interventional - PWD |
|---|---|---|
| Person With Dementia: Oral Hygiene | 29.6 ± 32.9 | 37.3 ± 23.4 |
Self-perceived Oral Care-giving Efficacy scale included 19 items to assess self-perceived efficacy in providing oral care to care recipients. We assessed CG's self-perceived oral care-giving efficacy at the baseline and 3-month follow-up visit. We used the percentage change in Self-perceived Oral Care-giving Efficacy scores between the baseline and 3-month follow-up to examine the effectiveness of the proposed intervention on improving CG's oral care-giving skills. Higher scores indicate a better improvement in self-perceived efficacy.
| percentage change in Self-perceived Oral | Control - FCG | Interventional - FCG |
|---|---|---|
| Self-perceived Oral Care-giving Efficacy | 12.6 ± 8.3 | 17.5 ± 24.8 |
Dyadic Relationship Scale (DRS) to measure strain between the caregiver and recipient within the past month on a scale of 1 to 4. The original DRS 11 items will be used for caregivers and 10 items will be used for care recipients. High scores indicate high levels of strain and positive interaction. We used the percentage change in dyadic relationship scores between the baseline and 3 months to examine how this intervention affected PWD/CG relationships.
| percentage change in dyadic relationship | Control - PWD/FCG Dyad | Interventional - PWD/FCG Dyad |
|---|---|---|
| Dyadic Relationship | -10.7 ± 20.3 | 14.1 ± 27.1 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Interventional | 2/13 (15.4%) | 0/13 (0%) | 0/13 (0%) |
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.
| Age, Continuous(year) | Control | Interventional | Total |
|---|---|---|---|
| Participants with dementia | 70.7 ± 15.1 | 69.7 ± 17.8 | 69.9 ± 16.8 |
| Family caregiver | 68.0 ± 21.2 | 68.0 ± 10.3 | 68.0 ± 13.5 |
| Sex: Female, Male(Participants) | Control | Interventional | Total |
|---|---|---|---|
| Participants with dementia — Female | 4 | 12 | 16 |
| Participants with dementia — Male | 3 | 7 | 10 |
| Family caregivers — Female | 4 | 12 | 16 |
| Family caregivers — Male | 3 | 7 | 10 |
| Race (NIH/OMB)(Participants) | Control | Interventional | Total |
|---|---|---|---|
| PWD — American Indian or Alaska Native | 0 | 0 | 0 |
| PWD — Asian | 0 | 0 | 0 |
| PWD — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| PWD — Black or African American | 0 | 2 | 2 |
| PWD — White | 7 | 16 | 23 |
| PWD — More than one race | 0 | 0 | 0 |
| PWD — Unknown or Not Reported | 0 | 1 | 1 |
| FCG — American Indian or Alaska Native | 0 | 0 | 0 |
| FCG — Asian | 0 | 0 | 0 |
| FCG — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| FCG — Black or African American | 0 | 1 | 1 |
| FCG — White | 7 | 17 | 24 |
| FCG — More than one race | 0 | 0 | 0 |
| FCG — Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Control | Interventional | Total |
|---|---|---|---|
| United States | 14 | 38 | 52 |
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