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; Gary Yu; A Leak Bryant; Ruth A Anderson

doi:10.1136/bmjopen-2021-057099

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

BMJ Open. 2022 Jun 22;12(6):e057099. doi: 10.1136/bmjopen-2021-057099.

Authors

Affiliations

¹ Rory Meyers College of Nursing, New York University, New York, New York, USA bei.wu@nyu.edu.
² Departments of Psychiatry and Neurology, Duke University, Durham, North Carolina, USA.
³ Rory Meyers College of Nursing, New York University, New York, New York, USA.
⁴ School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁵ Adams School of Dentistry, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.
⁶ Department of Periodontology and Implant Dentistry, New York University, New York, New York, USA.

Abstract

Introduction: Individuals 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.

Keywords: behavior change techniques; care partner; caregiver; dementia; oral health.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Caregivers
Dementia* / therapy
Humans
Multicenter Studies as Topic
Oral Health*
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT04390750

Abstract

Publication types

MeSH terms

Associated data

Grants and funding