Adults 18 to 100, any sex, with Dementia or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Person With Dementia: Oral HygienePrimary· Baseline and 3 Months
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.
Group
Value
95% CI
Control - PWD
29.6
± 32.9
Interventional - PWD
37.3
± 23.4
Self-perceived Oral Care-giving EfficacyPrimary· Baseline and 3 Months
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.
Group
Value
95% CI
Control - FCG
12.6
± 8.3
Interventional - FCG
17.5
± 24.8
Dyadic RelationshipSecondary· Baseline and 3 Months
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.
Group
Value
95% CI
Control - PWD/FCG Dyad
-10.7
± 20.3
Interventional - PWD/FCG Dyad
14.1
± 27.1
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Xi Chen
Last refreshed: 25 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04238520.