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

Primary Purpose

Dementia, Cognitive Impairment

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functionally Tailored Oral Care Intervention
Control Intervention
Sponsored by
Xi Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Caregiver, Family Relations, Oral Hygiene, Cognitive Impairment, Functional Level, Oral Health Education

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UIowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Interventional

Arm Description

10 PWD/CG dyads

30 PWD/CG dyads

Outcomes

Primary Outcome Measures

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).
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)

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 10, 2020
Last Updated
August 14, 2023
Sponsor
Xi Chen
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04238520
Brief Title
Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers
Official Title
Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
August 8, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xi Chen
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Cognitive Impairment
Keywords
Dementia, Caregiver, Family Relations, Oral Hygiene, Cognitive Impairment, Functional Level, Oral Health Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control vs. intervention
Masking
Investigator
Masking Description
Single Blind- Study participants will be aware of the treatment assigned. The oral examiners and data collectors 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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
10 PWD/CG dyads
Arm Title
Interventional
Arm Type
Experimental
Arm Description
30 PWD/CG dyads
Intervention Type
Behavioral
Intervention Name(s)
Functionally Tailored Oral Care Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Person with Dementia: Oral Hygiene
Description
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).
Time Frame
3 Months
Title
Caregiver: Attitude and efficacy in providing oral care
Description
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)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Behavioral symptoms during care in Person with Dementia
Description
Mouth care related behavior problems checklist. Scores are computed by the presence or absence of each problem.
Time Frame
3 Months
Title
Oral Care Related Burden
Description
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.
Time Frame
3 Months
Title
Dyadic Relationship
Description
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.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi Chen, DDS, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
UIowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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