Status:
COMPLETED
Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia
Lead Sponsor:
New York University
Collaborating Sponsors:
Duke University
University of North Carolina, Chapel Hill
Conditions:
Mild Dementia
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 bo...
Detailed Description
Dyads that each consist of an individual with mild dementia and his/her care partner will be enrolled at two sites, Duke University in Durham, North Carolina and New York University in New York, New Y...
Eligibility Criteria
Inclusion
- a diagnosis of mild dementia
- have at least 4 natural teeth
- 60 years and older
- living with an informal caregiver (i.e. care partner) who is age 18 or older and is willing to participate in the intervention
- community-dwelling and physically able to brush own teeth
- We will use the following guidelines to identify those with mild dementia: a) a diagnosis of dementia by a physician with dementia expertise within the past year, b) from medical records, a recent Montreal Cognitive Assessment (MoCA) score \> 14 or a Mini-Mental Status Examination (MMSE) score \> 16, and c) can follow 2 to 3-step commands
Exclusion
- unable to have an oral health evaluation
- prescribed antibiotics prior to a regular dental visit
- has sensory or physical problems that prevent participation in the intervention
- has a terminal illness or behavioral or psychiatric disorder that would interfere with participation in the intervention
- has a medical condition such as serious congenital heart conditions, previous infective endocarditis, prosthetic cardiac valves, and cardiac transplantation with cardiac valvulopathy that places him/her at greater risk of infection from the manipulation of the gums to measure the gingival index
- has a medical condition that suppresses the immune system
- has had a total joint replacement and has had an infection in the replaced joint
- is at increased risk of bleeding due to bleeding disorder such as hemophilia or the use of anti-platelet therapy
Key Trial Info
Start Date :
October 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04390750
Start Date
October 22 2021
End Date
March 25 2024
Last Update
December 9 2025
Active Locations (2)
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1
New York City (Participants Homes)
New York, New York, United States, 10010
2
North Carolina (Participants Homes)
Durham, North Carolina, United States, 27708