Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers

NCT04238520 | Completed Results DMC

• 2 other identifiers: 201803835R21NR017347
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are: Aim 1. Develop a staged and modifiable dyadic oral care intervention to provide functionally-tailored oral care rehabilitation for community-dwelling persons with dementia (PWD) and need-based skills training their family caregivers (CGs). Based on the literature review and MCWB, a 4-week intervention with 8 modules, including universal modules (e.g., environmental changes), CG modules (e.g., cuing strategies) and modules for both PWD and CGs (e.g., oral care techniques), will be developed addressing the relevant SCT constructs (e.g., functional deficits of PWD and caregiving needs of CGs). Guided by a validated, widely-used theory of rehabilitation medicine, modules will be used alone or in combination to provide personalized, hand-on, functionally-tailored oral care rehabilitation for PWD along with skills training for CGs to match their caregiving needs. The training focus shifts from the PWD to the CG, as the independence of the PWD decreases. Semi-structured interviews with family CGs will then be conducted (until data saturation is reached) to understand their oral care needs, desired intervention approaches, and the perceived feasibility and utility of the intervention. The intervention will be revised and then pilot tested with 4 dyads, one per each of the four functional levels of the DAT. Aim 2. Evaluate the feasibility and efficacy of the intervention in home settings through a randomized, controlled trial with 40 pairs of PWD and their primary CGs, including immediate post-intervention and 3-month follow-up. Dyads will be stratified into 4 functional levels based on the PWD's DAT score and then randomly assigned to the intervention or control (non-tailored usual care) group.

Conditions

Dementia; Cognitive Impairment

Keywords

Dementia; Caregiver; Family Relations; Oral Hygiene; Cognitive Impairment; Functional Level; Oral Health Education

Outcome Measures

Primary Outcomes (2)

• Person With Dementia: Oral Hygiene

  We used the Debris Index (DI) of the Oral Hygiene Index (a scale of 0 to 3, with lower values indicating no debris present and higher values indicating more soft debris on the tooth. Also called plaque score) to assess PWD's oral hygiene status. We used the percentage change in plaque scores between baseline and 3 months to evaluate the effectiveness of the proposed intervention on improving PWD's oral hygiene.

  Baseline and 3 Months

• Self-perceived Oral Care-giving Efficacy

  Self-perceived Oral Care-giving Efficacy scale included 19 items to assess self-perceived efficacy in providing oral care to care recipients. We assessed CG's self-perceived oral care-giving efficacy at the baseline and 3-month follow-up visit. We used the percentage change in Self-perceived Oral Care-giving Efficacy scores between the baseline and 3-month follow-up to examine the effectiveness of the proposed intervention on improving CG's oral care-giving skills. Higher scores indicate a better improvement in self-perceived efficacy.

  Baseline and 3 Months

Secondary Outcomes (1)

• Dyadic Relationship

  Baseline and 3 Months

Study Arms (2)

Control

OTHER

PWD/CG dyads

Behavioral: Control Intervention

Interventional

EXPERIMENTAL

PWD/CG dyads

Behavioral: Functionally Tailored Oral Care Intervention

Interventions

Functionally Tailored Oral Care Intervention BEHAVIORAL

Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.

Interventional

Control Intervention BEHAVIORAL

Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• English-speaking
• Willing to participate in the study

You may not qualify if:

• Cognitively impaired
• Blind, deaf, or severely disabled
• Diagnosis of Dementia
• Age 50 years or older or 18 years or older with Huntington's Disease
• Community-dwelling
• English speaking
• Have natural teeth
• Not blind, deaf, or severely disabled
• Have a caregiver that is age equal or 18+ years old, English speaking, cognitively intact, and willing to participate in the study
• Joint replacement with a history of prosthetic joint infection
• Requires immediate dental referrals
• Have oral cancer or active oral infection or 3) is actively dying.
• Actively dying

Sponsors & Collaborators

• Xi Chen: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

UIowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Limitations and Caveats

We are not able to reach the targeted recruitment goal because of the impact of COVID. Therefore, this trial was inadequately powered to detect the potential differences between the study group and the control group in all of the outcome measures.

Results Point of Contact

• Title: Dr. Xi Chen, Associate Professor
• Organization: The Ohio State University

chen.13047@osu.edu

614-2920474

Study Officials

• Xi Chen, DDS, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single Blind- Study participants will be aware of the treatment assigned. The investigator and statistician will not know the group allocation. To check the success or failure of the blinding, the oral examiners and data collectors will be asked after each assessment whether they have been told or know for sure to which group each dyad has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: control vs. intervention

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 23, 2020
• Study Start: April 22, 2020
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)