Rory Meyers College of Nursing, New York University, New York, New York, USA
Departments of Psychiatry and Neurology, Duke University, Durham, North Carolina, USA.
BMJ Open. 2022 Jun 22;12(6):e057099. doi: 10.1136/bmjopen-2021-057099.
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.
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.
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.
NCT04390750.
轻度痴呆症患者的口腔健康结果较差的风险较高。为了解决这个问题，我们描述了一种干预措施，旨在教授护理人员指导轻度痴呆症患者正确进行口腔卫生技术和提供口腔卫生护理提醒的技能。通过为成功执行这些任务提供支持，我们旨在延缓这一脆弱人群的口腔健康状况下降。
这是一项多中心的随机对照试验研究。主要目标是评估一项干预措施的疗效，该干预措施通过促进轻度痴呆症患者积极的口腔卫生行为和技能来改善口腔卫生结果。护理人员的行为因素，如口腔护理自我效能和护理计划的实施，作为干预措施的中介。参与者-护理人员二人组将被随机分配到治疗组 1、治疗组 2 或对照组。所有组都将收到一本教育手册。治疗组 1 和治疗组 2 将收到智能电子牙刷。治疗组 2（干预组）还将接受口腔卫生护理技能评估、个性化口腔卫生指导和治疗计划；护理人员将接受家庭和电话行为改变辅导。将比较三组的口腔健康结果。主动干预的持续时间为 3 个月，随后是 3 个月的维持期。数据收集将涉及三次家访：基线、3 个月和 6 个月。该研究于 2021 年 11 月开始，数据收集将于 2024 年春季结束。
该研究已获得纽约大学格罗斯曼医学院和杜克大学机构审查委员会的批准，并在 ClinicalTrials.gov 上注册。成立了一个数据安全监测委员会。研究结果将通过同行评议的出版物、会议演讲和社交媒体进行传播。
NCT04390750。
