Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers
Condition: Dementia; Cognitive Impairment
MeSH terms: Dementia; Cognitive Dysfunction
Study type: Interventional

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.
    

Detailed description: 
      This study aims to develop and evaluate a functionally-tailored oral hygiene intervention to
      improve oral health for community-dwelling persons with dementia, while also reducing
      caregiver burden and improving the care partner relationship. The study consists of two
      phases. First, we will develop a modularized, functionally-tailorable oral care intervention
      based on caregiver qualitative interviews and existing literature. The second phase will then
      examine the efficacy and feasibility of the intervention through a randomized controlled
      trial (3 intervention: 1control ratio)with 40 Persons with Dementia/caregiver dyads. Control
      participants will receive the standard oral hygiene education currently provided to persons
      with Dementia during dental care. The Intervention group will receive 4-week, dyadic,
      hands-on, functionally-tailored oral care intervention. We will collect data at baseline,
      4-weeks, and 3 months post intervention. After data collection, the differences in the
      control and intervention groups in regard to their oral hygiene, behavioral symptoms during
      oral care, caregiver outcomes (burden, self-efficacy) and care partner relationship will be
      explored.

      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.

      Sub-Aim 2.1 Evaluate the feasibility of the intervention across four domains: acceptability,
      demand, implementation, and practicality. We will interview the dyads and review their daily
      oral care logs at both post-intervention and 3-month follow-up, assessing satisfaction with,
      acceptability of, and actual use of the intervention. Oral care trainers will complete
      intervention logs following each training session to document the extent of content delivery,
      diversion from the protocol, resources used, and perceptions about intervention success. Exit
      interviews with PWD (when possible), CGs, and trainers will be conducted to identify
      potential barriers, facilitators, and needed changes.

      Sub-Aim 2.2 Examine the efficacy of the intervention. We hypothesize that both PWD oral
      hygiene and CG self-efficacy in providing oral care will show clinically significant
      improvements for the intervention group compared to the control group. Secondary outcomes for
      PWD (e.g., behavior symptoms during oral care), CGs (e.g., oral care related burden) and the
      dyadic relationship (e.g., the Dyadic Relationship Scale) will also be explored.
    

Intervention name(s): Functionally Tailored Oral Care Intervention; Control Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control vs. intervention
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Dementia; Caregiver; Family Relations; Oral Hygiene; Cognitive Impairment; Functional Level; Oral Health Education