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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238520
• Other study ID #: 201803835
• Secondary ID: R21NR017347
• Status: Completed
• Phase: N/A
• Start date: April 22, 2020
• Est. completion date: August 4, 2023

Study information

• Verified date: November 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria for Caregivers:

• 18 years or older

• English-speaking

• Willing to participate in the study

Exclusion Criteria for Caregivers:

• Cognitively impaired

• Blind, deaf, or severely disabled

Inclusion Criteria for Persons with Dementia

• Diagnosis of Dementia

• Age 60 years or older or 50 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

Exclusion Criteria for Persons with Dementia:

• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dementia

Intervention

Behavioral:
• Functionally Tailored Oral Care Intervention
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.
• Control Intervention
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.

Locations

Country	Name	City	State
United States	UIowa	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Xi Chen	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Person with Dementia: Oral Hygiene	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).	3 Months
Primary	Caregiver: Attitude and efficacy in providing oral care	Zimmerman Self-Efficacy Scale (35 items rated on a 4-point scale assessing perceived knowledge and skills in oral care for PWD, Higher values indicate greater self-efficacy)	3 Months
Secondary	Behavioral symptoms during care in Person with Dementia	Mouth care related behavior problems checklist. Scores are computed by the presence or absence of each problem.	3 Months
Secondary	Oral Care Related Burden	Caregiver Appraisal Measure (CAM) 5 point scale measuring caregiver's appraisal of stress attributable to general and specific caregiving experiences. Higher values indicate greater caregiver burden.	3 Months
Secondary	Dyadic Relationship	Dyadic Relationship Scale (DRS) to measure strain between the caregiver and recipient within the past month on a scale of 1 to 4. The original DRS 11 items will be used for caregivers and 10 items will be used for care recipients. High scores indicate high levels of strain and positive interaction.	3 Months