Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia
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. B...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e057099.full |
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| author | Bei Wu Gary Yu Brenda L Plassman Patricia Poole Shahrzad Siamdoust Melanie Bunn Bobbi Burwell Yaolin Pei Christine Downey Danni Gomes Angela Kamer A Leak Bryant Ruth A Anderson |
| author_facet | Bei Wu Gary Yu Brenda L Plassman Patricia Poole Shahrzad Siamdoust Melanie Bunn Bobbi Burwell Yaolin Pei Christine Downey Danni Gomes Angela Kamer A Leak Bryant Ruth A Anderson |
| author_sort | Bei Wu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a86c2a6a9b034f44bf408acd2e16a5c8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a86c2a6a9b034f44bf408acd2e16a5c82025-01-28T00:50:09ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-057099Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementiaBei Wu0Gary Yu1Brenda L Plassman2Patricia Poole3Shahrzad Siamdoust4Melanie Bunn5Bobbi Burwell6Yaolin Pei7Christine Downey8Danni Gomes9Angela Kamer10A Leak Bryant11Ruth A Anderson12Department of Anaesthesiology, Beijing Tian Tan hospital, Capital Medical University, Beijing, ChinaRory Meyers College of Nursing, New York University, New York, New York, USADepartments of Psychiatry and Neurology, Duke University, Durham, North Carolina, USADepartments of Psychiatry and Neurology, Duke University, Durham, North Carolina, USARory Meyers College of Nursing, New York University, New York, New York, USASchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USADepartments of Psychiatry and Neurology, Duke University, Durham, North Carolina, USARory Meyers College of Nursing, New York University, New York, New York, USAAdams School of Dentistry, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USARory Meyers College of Nursing, New York University, New York, New York, USADepartment of Periodontology and Implant Dentistry, New York University, New York, New York, USASchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USASchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USAIntroduction 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.https://bmjopen.bmj.com/content/12/6/e057099.full |
| spellingShingle | Bei Wu Gary Yu Brenda L Plassman Patricia Poole Shahrzad Siamdoust Melanie Bunn Bobbi Burwell Yaolin Pei Christine Downey Danni Gomes Angela Kamer A Leak Bryant Ruth A Anderson Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia BMJ Open |
| title | Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia |
| title_full | Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia |
| title_fullStr | Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia |
| title_full_unstemmed | Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia |
| title_short | Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia |
| title_sort | study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia |
| url | https://bmjopen.bmj.com/content/12/6/e057099.full |
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