Clinical trial NCT04390750: Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia
Official title: Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Dementia
Keywords: oral health
oral hygiene
dementia
care partner
periodontal disease
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Duke University
name: University of North Carolina, Chapel Hill
name: NYU Langone Health
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2020-05-18
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 Groups - 2 Treatment Groups, 1 Control Group
Primary purpose: SUPPORTIVE_CARE

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 both a tailored oral care plan and a behavioral component using the Adaptive Leadership Framework for Chronic Illness that the team introduced to manage symptoms associated with chronic conditions, such as dementia. Objective 1 is to evaluate the efficacy of an intervention to improve oral hygiene clinical outcomes (i.e. plaque index and gingival index) by improving oral hygiene behavior (i.e., frequency and duration of toothbrushing) and oral health skills among individuals with mild dementia. Objective 2A is to determine whether effects of the intervention on oral hygiene behavioral outcomes, are mediated by the following variables from the care partners' perspective: 1) oral care self-efficacy; 2) care partner self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 2B is to determine whether effects of the intervention on oral hygiene clinical outcomes, are mediated by the following variables from the care partner's perspective: 1) oral care self-efficacy; 2) care partner's self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 3A is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by oral hygiene behavioral outcomes. Objective 3B is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by the care partner's factors, which then mediate the oral hygiene behavioral outcomes on oral hygiene clinical outcomes. This innovative care partner-assisted oral care behavior intervention will assist participants and care partners in implementing a cooperative oral hygiene care plan to prevent deterioration of oral health, which in turn, will help the targeted population maintain independence in completing daily activities and quality of life for an extended period of time.

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 York. This is an unblinded, randomized trial to assess the acceptability and effectiveness of the oral health intervention among individuals with mild dementia (MD). The study will utilize qualitative and quantitative methods to learn about the oral health outcomes in individuals with mild dementia.

The study lasts 6 months. The first three months is the active intervention phase in which coaching and educational modules are delivered. The second three months is the maintenance period in which no coaching or educational modules are presented to participants. As a team, the study coordinator, the oral health evaluator (a dental hygienist), and the interventionist will conduct three visits with the participants and their care partners; baseline, 3-month (end of the active intervention phase), and 6-month (end of three-month maintenance phase).

The intervention protocol will include three groups; two treatment groups and one control group. All participants will receive oral health education material at the baseline visit. Treatment Group 1 and Treatment Group 2 will be given a smart electronic toothbrush. Only Treatment Group 2 will receive the in-home and telephone coaching throughout the duration of the study and will be instructed to record daily brushing habits. The coaching sessions include individualized instruction on oral hygiene technique, cueing strategy development, or oral hygiene monitoring and coaching. Treatment Group 1 and the Control Group will not receive the coaching sessions.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Plaque Index
timeFrame: 6 months
measure: Gingival Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York City (Participants Homes)
state: New York
city: Durham
country: United States
facility: North Carolina (Participants Homes)
state: North Carolina
Study officials:
affiliation: New York University
name: Bei Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu B, Plassman BL, Poole P, Siamdoust S, Bunn M, Burwell B, Pei Y, Downey C, Gomes D, Kamer A, Yu G, Leak Bryant A, Anderson RA. 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.