N/A
N=26
Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers
Dementia · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04238520 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Person With Dementia: Oral Hygiene — 29.6; 37.3 percentage change in plaque scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Functionally Tailored Oral Care Intervention (Behavioral); Control Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xi Chen
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Person With Dementia: Oral Hygiene |
29.6; 37.3 | — |
| PRIMARY Self-perceived Oral Care-giving Efficacy |
12.6; 17.5 | — |
| SECONDARY Dyadic Relationship |
-10.7; 14.1 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04238520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.