Evidence map›Paper›PMID 35732396›Full record

ArticleBMJ open2022

Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia.

Bei Wu, Brenda L Plassman, Patricia Poole, Shahrzad Siamdoust, Melanie Bunn, Bobbi Burwell, Yaolin Pei, Christine Downey, Danni Gomes, Angela Kamer and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04390750 (Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04390750 nacompletednot on this map

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

TypeinterventionalSponsorNew York UniversityRan2021 to 2024Enrolled60ConditionsMild DementiaArmsCare Partner-Assisted Intervention
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Bei WuRory Meyers College of Nursing, New York University, New York, New York, USA bei.wu@nyu.edu.ORCID 0000-0002-6891-244X
Brenda L PlassmanDepartments of Psychiatry and Neurology, Duke University, Durham, North Carolina, USA.
Patricia PooleDepartments of Psychiatry and Neurology, Duke University, Durham, North Carolina, USA.
Shahrzad SiamdoustRory Meyers College of Nursing, New York University, New York, New York, USA.ORCID 0000-0002-2224-2348
Melanie BunnSchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Bobbi BurwellDepartments of Psychiatry and Neurology, Duke University, Durham, North Carolina, USA.
Yaolin PeiRory Meyers College of Nursing, New York University, New York, New York, USA.
Christine DowneyAdams School of Dentistry, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.
Danni GomesRory Meyers College of Nursing, New York University, New York, New York, USA.
Angela KamerDepartment of Periodontology and Implant Dentistry, New York University, New York, New York, USA.
Gary YuRory Meyers College of Nursing, New York University, New York, New York, USA.
A Leak BryantSchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Ruth A AndersonSchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Funding

Diversity supplement to the U01 project-Care partner assisted intervention to improve oral health for person with mild dementiaU01DE027512 · NIDCR · NEW YORK UNIVERSITY · PI ANDERSON, RUTH A, PLASSMAN, BRENDA L · 2018 to 2023
$3.9M
Developing an Oral Health Intervention for Individuals with Mild DementiaR34DE023881 · NIDCR · DUKE UNIVERSITY · PI PLASSMAN, BRENDA L, WU, BEI · 2014 to 2014
$242k
NIDCR NIH HHS R34 DE023881NIDCR NIH HHS U01 DE027512
6 · The paper itself

Abstract

introductionIndividuals with mild dementia are at high risk of poor oral health outcomes. To address this issue, we describe an intervention to teach care partners skills to guide individuals with mild dementia in proper oral hygiene techniques and provide reminders to practice oral hygiene care. By providing support to perform these tasks successfully, we aim to delay oral health decline among this vulnerable population. METHODS AND ANALYSIS: This multisite study is a three-arm randomised controlled trial. The primary objective is to evaluate the efficacy of an intervention to improve oral hygiene outcomes by promoting positive oral hygiene behaviours and skills among individuals with mild dementia. Care partners' behaviour factors, such as oral care self-efficacy and implementation of the care plan, serve as mediators of the intervention. Participant-care partner dyads will be randomly assigned to either Treatment Group 1, Treatment Group 2 or the Control Group. All groups will receive an educational booklet. Treatment Group 1 and Treatment Group 2 will receive a smart electronic toothbrush. Treatment Group 2 (the intervention group) will also receive an oral hygiene care skill assessment, personalised oral hygiene instruction and treatment plan; and care partners will receive in-home and telephone coaching on behaviour change. Oral health outcomes will be compared across the three groups. The duration of the active intervention is 3 months, with an additional 3-month maintenance phase. Data collection will involve three home visits: baseline, 3 months and 6 months. The study enrollment started in November 2021, and the data collection will end in Spring 2024. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Review Board of the NYU Grossman School of Medicine and Duke University, and is registered at Clinicaltrials.gov. A Data Safety Monitoring Board has been constituted. The study findings will be disseminated via peer-reviewed publications, conference presentations and social media. TRIAL REGISTRATION NUMBER: NCT04390750.

Indexed as

DementiaOral HealthCaregiversHumansMulticenter Studies as TopicRandomized Controlled Trials as Topicbehavior change techniquescaregivercare partnerdementiaoral health

Identifiers

PMID35732396
PMCPMC9226943

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.