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The main purpose of this study is to test a method of providing mouth care to persons with dementia who live in nursing homes. The method of providing mouth care is designed to reduce fear in persons with dementia, so that these persons do not resist mouth care.
Nursing home (NH) residents with dementia are often dependent on others for mouth care, yet will react with care-resistant behavior (CRB) when receiving assistance. The oral health of these elders deteriorates in the absence of daily oral hygiene, predisposing them to harmful systemic problems such as pneumonia, hyperglycemia, cardiac disease, and cerebral vascular accidents. The purpose of this study is to determine whether CRBs can be reduced, and oral health improved, through the application of an intervention based on the neurobiological principles of threat perception and fear response. When faced with a threat, all organisms react with "flight-fight" responses. These responses are both autonomic (e.g. elevated heart rate, sweating) and behavioral (e.g. moving away, attacking). Persons with dementia have heightened threat perception as a result of neurobiological changes that affect the cerebral cortex, hippocampus, and amygdala. These individuals may interpret mouth care as a threatening action by threatening people. The intervention, called Managing Oral Hygiene Using Threat Reduction (MOUTh), combines best mouth care practices with a constellation of behavioral techniques that reduce threat perception and thereby prevent or de-escalate CRB. The primary specific aims of the study are to: 1)Evaluate the efficacy of the MOUTh intervention for reducing CRBs in persons with dementia; 2)Validate the overall efficacy of the MOUTh intervention using nurse-sensitive oral health outcomes--swollen and bleeding gums, cleanliness of the oral cavity, saliva, and integrity of the lips and oral mucosa; and 3)Calculate the cost of the MOUTh intervention. Using a randomized repeated measures design, 80 elders with dementia from 5 different NHs will be randomized at the individual level to the experimental group, which will receive the intervention, or to the control group, which will receive standard mouth care from research team members who receive training in the proper methods for providing mouth care but no training in resistance recognition or prevention/mediation. Oral health assessments and CRB measurements will be obtained during a 7-day observation period and a 21-day intervention period. Individual growth models using multilevel analysis will be used to estimate the efficacy of the intervention for reducing CRBs in persons with dementia, and to estimate the overall efficacy of the intervention using oral health outcomes. Activity-based costing methods will be used to determine the cost of the MOUTh intervention. At the end of this study, the research team anticipates having a proven intervention that prevents and reduces CRB within the context of mouth care. Long-term objectives include testing the effect of the intervention on systemic illnesses among persons with dementia; examining the transferability of this intervention to other activities of daily living; and disseminating threat reduction interventions to NH staff, which may radically change the way care is provided to persons with dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care-resistant mouth care (MOUTh) | Experimental | These nursing home residents with dementia receive mouth care from study personnel who use strategies to reduce care-resistant behavior (Managing Oral Hygiene Using Threat Reduction or MOUTh) while providing evidence-based mouth care. |
|
| Evidence Base Mouth Care | Active Comparator | Nursing home residents with dementia received mouth care from study personnel who were trained in evidence-based mouth care only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care-resistant mouth care (MOUTh) | Behavioral | The intervention combines best mouth care practices with a constellation of behavioral techniques that reduce threat perception and thereby prevent or de-escalate care-resistant behavior. |
| Measure | Description | Time Frame |
|---|---|---|
| Care-Resistant Behavior | Care-resistant behavior will be measured using the Resistiveness to Care Scale.This instrument is a checklist. The 13 care-resistant behaviors (e.g., turn away, hit/kick, say "no", etc.) are listed on the left side of the instrument. There are 3 columns for each behavior (mild, moderate, and severe). When behaviors occur, a tick mark is placed in the appropriate column (mild, moderate, or severe). The final score is obtained by multiplying the sums for mild by 1, the sums for moderate by 2, and the sums for severe behavior by 3. These subtotals are then summed together for a final care-resistant behavior score. One cannot determine the frequency and quality of behaviors from raw scores alone. For example, a score of 12 could mean 12 "mild" behaviors or 4 "severe" behaviors. The sums were used as global care-resistant behavior. Higher numbers signify more frequent and intense care-resistant behavior. Minimum value was 0, max value was 25. | Baseline (observation) to follow-up (week 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Health | The oral health will be measured as the total score obtained from the Oral Health Assessment Tool. The OHAT contains 8 categories (e.g., status of gums, dentition, moisture of oral cavity, general cleanliness, etc.). Each category is assigned a value of 0=healthy, 1=problematic, and 2=unhealthy. Scores range from 0 (healthy) to 16 (unhealthy). | Baseline (observation) to follow-up (week 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita A Jablonski-Jaudon, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Crest | Bellefonte | Pennsylvania | 16823 | United States | ||
| Spring Creek Rehabilitation &Health Care Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21592161 | Background | Jablonski RA, Therrien B, Mahoney EK, Kolanowski A, Gabello M, Brock A. An intervention to reduce care-resistant behavior in persons with dementia during oral hygiene: a pilot study. Spec Care Dentist. 2011 May-Jun;31(3):77-87. doi: 10.1111/j.1754-4505.2011.00190.x. | |
| 22100010 | Derived | Jablonski RA, Kolanowski A, Therrien B, Mahoney EK, Kassab C, Leslie DL. Reducing care-resistant behaviors during oral hygiene in persons with dementia. BMC Oral Health. 2011 Nov 19;11:30. doi: 10.1186/1472-6831-11-30. |
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Once potential participants were identified, we obtained consent from the legally authorized representative, screened them against inclusion/exclusion criteria, and then randomly assigned them to control or experimental groups.
Recruitment occurred sequentially in 9 United States NHs.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse. |
| FG001 | Experimental | The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures [all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Care-Resistant Behavior | Care-resistant behavior will be measured using the Resistiveness to Care Scale.This instrument is a checklist. The 13 care-resistant behaviors (e.g., turn away, hit/kick, say "no", etc.) are listed on the left side of the instrument. There are 3 columns for each behavior (mild, moderate, and severe). When behaviors occur, a tick mark is placed in the appropriate column (mild, moderate, or severe). The final score is obtained by multiplying the sums for mild by 1, the sums for moderate by 2, and the sums for severe behavior by 3. These subtotals are then summed together for a final care-resistant behavior score. One cannot determine the frequency and quality of behaviors from raw scores alone. For example, a score of 12 could mean 12 "mild" behaviors or 4 "severe" behaviors. The sums were used as global care-resistant behavior. Higher numbers signify more frequent and intense care-resistant behavior. Minimum value was 0, max value was 25. | One-hundred nine NH residents were enrolled; 101 were randomized, 100 contributed data for analyses, and 91 completed the 3-week intervention period. | Posted | Mean | Standard Error | units on a scale | Baseline (observation) to follow-up (week 3) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rita Jablonski | UAB School of Nursing | 205-975-9019 | rjablonski@uabmc.edu |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Evidence-based mouth care | Procedure | Mouth care tailored to the needs of older adults, including care of dentures. |
|
| Harrisburg |
| Pennsylvania |
| 17111 |
| United States |
| Rest Haven Rehabilitation &Nursing Center | York | Pennsylvania | 17043 | United States |
| Pleasant Acres Nursing &Rehabilitation Center | York | Pennsylvania | 17402 | United States |
| BG001 | Experimental | The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures [all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Months in nursing home | Mean | Standard Deviation | months |
|
| Global Deterioration Scale | The Global Deterioration Scales is an ordinal measure that captures the severity of the dementia based on cognitive and functional abilities. Ranges from 1 (normal) to 7 (severe dementia). | Mean | Standard Deviation | units on a scale |
|
| Katz Index of ADLs | The Katz Index of Activities of Daily Living is an ordinal measure of functional abilities. Higher numbers denote greater impairment, where 0 is completely independent and 18 is completely dependent on others for care. | Mean | Standard Deviation | units on a scale |
|
| Charlson Comorbidity Index | The Charlson Comorbidity Index assigns weighted values to specific medical conditions, for example, a diagnosis of hypertension may receive a "1" while a diagnosis of uncontrolled diabetes may receive a "2." The higher the number, the more severe the accompanying medical conditions. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Control | Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse. |
| OG001 | Experimental | The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures [all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care. |
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|
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| Secondary | Oral Health | The oral health will be measured as the total score obtained from the Oral Health Assessment Tool. The OHAT contains 8 categories (e.g., status of gums, dentition, moisture of oral cavity, general cleanliness, etc.). Each category is assigned a value of 0=healthy, 1=problematic, and 2=unhealthy. Scores range from 0 (healthy) to 16 (unhealthy). | Posted | Mean | Standard Error | units on a scale | Baseline (observation) to follow-up (week 3) |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Experimental | The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures [all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care. | 0 | 46 | 0 | 46 |
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| D001523 | Mental Disorders |