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Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia

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ClinicalTrials.gov Identifier: NCT04390750
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : April 4, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Duke University
University of North Carolina, Chapel Hill
NYU Langone Health
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
New York University

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.

Condition or disease Intervention/treatment Phase
Mild Dementia Behavioral: Care Partner-Assisted Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 Groups - 2 Treatment Groups, 1 Control Group
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia
Actual Study Start Date : October 22, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Treatment Group 1
Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush.
Experimental: Treatment Group 2
Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.
Behavioral: Care Partner-Assisted Intervention
Tailored teaching and coaching

No Intervention: Control Group
The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided.



Primary Outcome Measures :
  1. Plaque Index [ Time Frame: 6 months ]
  2. Gingival Index [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390750


Contacts
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Contact: Shahrzad Siamdoust, MPH 12129925966 ss10680@nyu.edu

Locations
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United States, New York
New York City (Participants Homes) Recruiting
New York, New York, United States, 10010
Contact: Shahrzad Siamdoust, MPH    212-992-5966    ss10680@nyu.edu   
Principal Investigator: Bei Wu, PhD         
United States, North Carolina
North Carolina (Participants Homes) Recruiting
Durham, North Carolina, United States, 27708
Contact: Cappye Mott, BA       catharine.mott@duke.edu   
Principal Investigator: Brenda Plassman, PhD         
Sponsors and Collaborators
New York University
National Institutes of Health (NIH)
Duke University
University of North Carolina, Chapel Hill
NYU Langone Health
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Bei Wu, PhD New York University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: New York University
ClinicalTrials.gov Identifier: NCT04390750    
Other Study ID Numbers: 18-068-E
U01DE027512 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified individual participant data collected during the trial will be shared between 9 months and 36 months following article publication or as required by a condition of awards and agreements supporting the research, for researchers who provide a methodologically sound proposal. Data will be made available at https://www.icpsr.umich.edu/web/pages (Note: a specific link will be provided after the study is published/when the DOI is obtained.) The protocol, statistical analysis plan, and analytic code will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: Data will be made available at Clinicaltrials.gov and ICPSR (a specific link will be provided after the study is published/when the DOI is obtained).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by New York University:
oral health
oral hygiene
dementia
care partner
periodontal disease
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders