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NCT04390750 · ClinicalTrials.gov registry record · NA

Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia

A NA study, sponsored by New York University.

Completed
Registry status
NA
Development phase
60
Enrollment target

NCT04390750: Completed NA study, sponsored by New York University.

NCT04390750 is a NA study that has completed, run by New York University. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04390750, a NA study, has completed, sponsored by New York University.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target

Study Summary

Care Partner Assisted Intervention to Improve Oral Health for Individuals with Mild Dementia is a randomized control trial (RCT) based in New York City and North Carolina. The intervention includes both a tailored oral care plan and a behavioral component using the Adaptive Leadership Framework for Chronic Illness that the team introduced to manage symptoms associated with chronic conditions, such as dementia. Objective 1 is to evaluate the efficacy of an intervention to improve oral hygiene clinical outcomes (i.e. plaque index and gingival index) by improving oral hygiene behavior (i.e., frequency and duration of toothbrushing) and oral health skills among individuals with mild dementia. Objective 2A is to determine whether effects of the intervention on oral hygiene behavioral outcomes, are mediated by the following variables from the care partners' perspective: 1) oral care self-efficacy; 2) care partner self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 2B is to determine whether effects of the intervention on oral hygiene clinical outcomes, are mediated by the following variables from the care partner's perspective: 1) oral care self-efficacy; 2) care partner's self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 3A is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by oral hygiene behavioral outcomes. Objective 3B is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by the care partner's factors, which then mediate the oral hygiene behavioral outcomes on oral hygiene clinical outcomes. This innovative care partner-assisted oral care behavior intervention will assist participants and care partners in implementing a cooperative oral hygiene care plan to prevent deterioration of oral health, which in turn, will help the targeted population maintain independence in completing daily activities and quality of life fo

Primary Outcome

UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers \<1/3 tooth, 2 = Plaque covers \>=1/3 but \<2/3 tooth and 3 = Plaque covers \>=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.

Interventions

  • BEHAVIORAL Care Partner-Assisted Intervention

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-10-22
Est. Completion 2024-03-25
Phase NA
New York University

83 total trials

What the finished NCT04390750 record still lists

NCT04390750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Care Partner-Assisted Intervention is the first listed.

NCT04390750 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04390750 about?

NCT04390750 is a clinical study titled "Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia". Care Partner Assisted Intervention to Improve Oral Health for Individuals with Mild Dementia is a randomized control trial (RCT) based in New York City and North Carolina. The intervention includes both a tailored oral care plan and a behavioral component using the Adaptive Leadership Framework for ...

What is the current status of trial NCT04390750?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-10-22. Estimated completion is 2024-03-25.

What interventions are being tested in trial NCT04390750?

The interventions under investigation include: Care Partner-Assisted Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT04390750?

This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04390750's enrollment target sits among peer trials

60 1164th of 2000 higher than 745 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04390750, the US trial registry maintained by the National Library of Medicine. NCT04390750 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.