Cognitive Impairment, Dementia
Conditions
Keywords
Dementia, Caregiver, Family Relations, Oral Hygiene, Cognitive Impairment, Functional Level, Oral Health Education
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.
Interventions
BEHAVIORALFunctionally 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.
BEHAVIORALControl 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.
Sponsors
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Xi Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
control vs. intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Person With Dementia: Oral Hygiene | Baseline and 3 Months | 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. |
| Self-perceived Oral Care-giving Efficacy | Baseline and 3 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyadic Relationship | Baseline and 3 Months | 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. We used the percentage change in dyadic relationship scores between the baseline and 3 months to examine how this intervention affected PWD/CG relationships. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control PWD/CG dyads
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. | 14 |
| Interventional PWD/CG dyads
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. | 38 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Unsafe home environment for research staff | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Interventional | Control |
|---|---|---|---|
| Age, Continuous Family caregiver | 68.0 year STANDARD_DEVIATION 13.5 | 68.0 year STANDARD_DEVIATION 10.3 | 68.0 year STANDARD_DEVIATION 21.2 |
| Age, Continuous Participants with dementia | 69.9 year STANDARD_DEVIATION 16.8 | 69.7 year STANDARD_DEVIATION 17.8 | 70.7 year STANDARD_DEVIATION 15.1 |
| Race (NIH/OMB) FCG American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) FCG Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) FCG Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) FCG More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) FCG Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) FCG Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) FCG White | 24 Participants | 17 Participants | 7 Participants |
| Race (NIH/OMB) PWD American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PWD Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PWD Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) PWD More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PWD Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PWD Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) PWD White | 23 Participants | 16 Participants | 7 Participants |
| Region of Enrollment United States | 52 participants | 38 participants | 14 participants |
| Sex: Female, Male Family caregivers Female | 16 Participants | 12 Participants | 4 Participants |
| Sex: Female, Male Family caregivers Male | 10 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Participants with dementia Female | 16 Participants | 12 Participants | 4 Participants |
| Sex: Female, Male Participants with dementia Male | 10 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 2 / 13 |
| other Total, other adverse events | 0 / 5 | 0 / 13 |
| serious Total, serious adverse events | 0 / 5 | 0 / 13 |
Outcome results
Primary
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.
Time frame: Baseline and 3 Months
Population: The percentage change in plaque scores between baseline and 3 months was compared between the PWD in the control group and PWD in the study group. 26 PWD (7 in the control and 19 in the study group) with completed data at the baseline. A total of 18 PWD (control group=5 and study group=13) completed the study with data on this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - PWD | Person With Dementia: Oral Hygiene | 29.6 percentage change in plaque scores | Standard Deviation 32.9 |
| Interventional - PWD | Person With Dementia: Oral Hygiene | 37.3 percentage change in plaque scores | Standard Deviation 23.4 |
Primary
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.
Time frame: Baseline and 3 Months
Population: The percentage change in Self-perceived Oral Care-giving Efficacy scores between baseline and 3 months was compared between the control and study groups. 26 FCG with complete data were included in the baseline analysis. A total of 18 completed the study with data on this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - PWD | Self-perceived Oral Care-giving Efficacy | 12.6 percentage change in Self-perceived Oral | Standard Deviation 8.3 |
| Interventional - PWD | Self-perceived Oral Care-giving Efficacy | 17.5 percentage change in Self-perceived Oral | Standard Deviation 24.8 |
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. We used the percentage change in dyadic relationship scores between the baseline and 3 months to examine how this intervention affected PWD/CG relationships.
Time frame: Baseline and 3 Months
Population: The percentage change in dyadic relationship scores between baseline and 3 months was compared between the control and study groups. 12 dyads with missing data at the baseline were eliminated from the analysis. A total of 8 dyads completed the study with data on this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - PWD | Dyadic Relationship | -10.7 percentage change in dyadic relationship | Standard Deviation 20.3 |
| Interventional - PWD | Dyadic Relationship | 14.1 percentage change in dyadic relationship | Standard Deviation 27.1 |