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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG061966 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This project will modify a program that reduces pneumonia among nursing home residents with dementia, so that it is appropriate for assisted living residents with dementia. The program provides daily mouth care to reduce bacteria in the mouth that lead to aspiration pneumonia. The project will develop methods that can be taught to assisted living providers by community dental hygienists, and that are ready for evaluation in a pragmatic trial of AL residents with dementia and the staff who provide their care.
It could be said that many dementia care and caregiver support interventions are too limited, focusing solely on psychosocial and behavioral concerns. These issues are important, but so too is the physical health of people with dementia -- especially because they are living longer and require more support with health care and activities of daily living. Just imagine the benefit of a physical health care intervention provided daily.
Case in point: tooth brushing, flossing, and gum and denture care. Many people with dementia resist mouth care - almost 90% in nursing homes, in fact. As a result, only 16% have their teeth brushed regularly, putting them at risk for aspiration pneumonia when they inhale bacteria from their teeth, tongue, and gums. In 2013, the research team submitting this proposal developed one of the two existing dementia-focused mouth care programs for nursing homes -- Mouth Care Without a Battle (MCWB) -- which already has become a standard of nursing home care. MCWB changes caregivers' attitudes and behavior, improves oral health, and in a cluster randomized trial, MCWB provided by nursing assistants reduced pneumonia incidence by 32 percent.
The next frontier is to extend MCWB to assisted living (AL), the primary long-term residential care provider for persons with dementia. There are 30,200 AL communities across the country; 90% of their 835,200 residents have cognitive impairment and 42% have moderate or severe dementia (and on average, five untreated oral health conditions), meaning MCWB has the potential to improve the health and quality of life of more than 350,000 AL residents with dementia annually.
There is a unique and timely opportunity to transform MCWB so it is optimally suitable for AL, given the North Carolina Department of Health and Human Services (DHHS) Special Care Dentistry Program offer of partnership. Consequently, the investigators propose this nested cohort cluster randomized trial that will apply the NIH Stage Model and principles of the Science of Behavior Change (SOBC) to lay the groundwork for a pragmatic trial and real-world implementation of MCWB for AL residents with dementia and their caregivers.
The aims of the proposed project are to refine MCWB (NIH Stage I/Aim 1), and examine research efficacy (NIH Stage II/Aim 2) and real-world efficacy (NIH Stage III/Aim 3), focusing on structural, social, and interpersonal mechanisms as the SOBC target. Aims 2 and 3 will use separate samples of AL communities (24 for Aim 2 and 28 for Aim 3) across the state's ten regions. Within each region, one-half of AL communities will be randomized to treatment (MCWB) and one-half to control, and the oral hygiene of up to 360 residents with dementia will be assessed through eight months. For Aim 3 there will be up to 233 residents assessed for four months. In Aim 2, a research dental hygienist will train AL staff on MCWB and provide ongoing support; in Aim 3, this responsibility will be transferred to community public health dental hygienists working with the DHHS. Family members (one per resident, up to 360 for Aim 2 and up to 233 for Aim 3) will also be interviewed about the resident. Assisted Living staff will also be interviewed at each baseline and follow-up visit (up to 360 for Aim 2 and up to 360 for Aim 3).
Aim 1. Refine MCWB for implementation in assisted living (AL) communities.
Aim 2. Evaluate research efficacy of the MCWB program, with training and support provided by an experienced research dental hygienist.
Aim 3. Evaluate real-world efficacy of the MCWB program, transferring responsibility for training and support to community public health dental hygienists, thereby testing efficacy of a nationally generalizable model.
By the conclusion of this project, MCWB will be ready for evaluation in a pragmatic trial of AL residents with dementia and the staff who provide their care.
Note that the CT.gov record includes only the assisted living residents enrolled in the clinical trial, not secondary participants (staff, hygienists).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim2 - Standard Mouth Care | No Intervention | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. | |
| Aim2 - Daily Mouth Care | Experimental | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim2 the intervention training is delivered by a research dental hygienist. |
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| Aim3 - Standard Mouth Care | No Intervention | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. | |
| Aim3 - Daily Mouth Care | Experimental | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim3 the intervention training is delivered by state public health dental hygienists. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aim2 - Daily Mouth Care | Behavioral | Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim2 the intervention training is delivered by a research dental hygienist. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim2 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | Baseline Visit |
| Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | 4 Months Follow-up Visit |
| Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Diagnosed With Pneumonia-Aim2 | The total number of AL residents diagnosed with pneumonia. | Cumulative from Baseline to Completion (up to 8 months) |
| Number of Participants With Hospitalizations-Aim2 |
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RESIDENTS
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheryl Zimmerman, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36383760 | Derived | Cao Y, Liu C, Lin J, Ng L, Needleman I, Walsh T, Li C. Oral care measures for preventing nursing home-acquired pneumonia. Cochrane Database Syst Rev. 2022 Nov 16;11(11):CD012416. doi: 10.1002/14651858.CD012416.pub3. |
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All of the individual participant data collected during the trial will be shared after deidentification.
Deidentified individual data that supports the results will be shared beginning 3 months and ending 5 years following article publication.
An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.
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AL residents (n=414, primary) and dental hygienists (n=8, secondary) were interviewed at baseline and 4-months. AL staff (n=983=461+366+156, secondary) completed cross-sectional surveys at up to 3 timepoints but were not followed individually. To represent these different groups, they are shown below as "periods". The study protocol also describes instrument development in Aim 1 but it does not meet the definition for a clinical trial and is not included here.
For Aims 2 and 3, assisted living (AL) communities were recruited and randomized to treatment arms. Within communities, AL residents (primary participants) were recruited for observation at up to 3 timepoints (baseline, 4 months, 8 months). A total of 200+214=414 residents across 24+28=52 communities were enrolled. AL Staff (983=461+366+156) and public health dental hygienists (n=8) were also enrolled as secondary participants (not randomized and did not receive the intervention). Total = 1405.
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Mouth Care-Aim2 | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. |
| FG001 | Daily Mouth Care-Aim2 | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim2 the intervention training is delivered by a research dental hygienist. Aim2 - Daily Mouth Care: Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim2 the intervention training is delivered by a research dental hygienist. |
| FG002 | Standard Mouth Care-Aim3 | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. |
| FG003 | Daily Mouth Care-Aim3 | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim3 the intervention training is delivered by state public health dental hygienists. Aim3 - Daily Mouth Care: Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim3 the intervention training is delivered by state public health dental hygienists. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| AL Residents (Primary Participants) |
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| AL Staff at Baseline (Secondary) |
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| AL Staff at 4-months (Secondary) |
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| AL Staff at 8-months (Secondary) |
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| Dental Hygienists (Secondary) |
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Overall section summarizes different study populations (primary = AL residents, secondary = AL staff and dental hygienists). Aim2 and Aim3 are analyzed separately. Aim2 examines research efficacy (used research dental hygienist to deliver training). Aim3 examines real world efficacy (used state public health dental hygienists to deliver training). Each Aim has an intervention group (received training on daily mouth care) and a control group (no training/standard mouth care).
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Mouth Care-Aim2 | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. |
| BG001 | Daily Mouth Care-Aim2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Rows show different study populations (not one population followed over time). AL staff (secondary) completed cross-sectional interviews at up to 3 timepoints and were not followed individually. Baseline characteristics are summarized by the number of participants surveyed at each timepoint. |
| 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 | Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim2 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline Visit |
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Collected for n=414 primary participants from the time of baseline data collection until the end of study participation; for Aim 2 participants up to 8 months, for Aim 3 participants up to 4 months.
All-Cause Mortality, Serious and Other (Not including serious) adverse events were collected for assisted living residents (n=414, primary participants).
All-Cause Mortality, Serious and Other (Not including serious) adverse events were NOT assessed, monitored, or collected for AL staff or dental hygienists (n=8+461+366+156 secondary, participants) because they were not randomized and did not receive the intervention.
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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 | Standard Mouth Care-Aim2 | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall resulting in persistent incapacity | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy to Antibiotic | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynne Sampson, PhD, MPH | University of North Carolina at Chapel Hill | 919-843-7811 | LSampson@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 23, 2024 | Feb 4, 2026 | Prot_SAP_ICF_001.pdf |
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| Aim3 - Daily Mouth Care | Behavioral | Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim3 the intervention training is delivered by state public health dental hygienists. |
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| Change from Baseline to 4 months |
| Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim2 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | Baseline Visit |
| Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | 4 Months Follow-up Visit |
| Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | Change from Baseline to 4 Months |
| Denture Plaque Index Score (DPI) - Baseline-Aim2 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | Baseline Visit |
| Denture Plaque Index Score (DPI) - 4 Months-Aim2 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | 4 Months Follow-up Visit |
| Change in Denture Plaque Index Score (DPI) - 4 Months-Aim2 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | Change from Baseline to 4 months |
| Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim3 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | Baseline Visit |
| Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim3 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | 4 Months Follow-up Visit |
| Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim3 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | Change from Baseline to 4 months |
| Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim3 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | Baseline Visit |
| Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim3 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | 4 Months Follow-up Visit |
| Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim3 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | Change from Baseline to 4 months |
| Denture Plaque Index Score (DPI) - Baseline-Aim3 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | Baseline Visit |
| Denture Plaque Index Score (DPI) - 4 Months-Aim3 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | 4 Months Follow-up visit |
| Change in Denture Plaque Index Score (DPI) - 4 Months-Aim3 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | Change from Baseline to 4 months |
The total number AL residents with hospitalizations.
| Cumulative from Baseline to Completion (up to 8 months) |
| Number of Participants Diagnosed With Pneumonia-Aim3 | The total number of AL residents diagnosed with pneumonia. | Cumulative from Baseline to Completion (up to 4 months) |
| Number of Participants With Hospitalizations-Aim3 | The total number of AL residents with hospitalizations. | Cumulative from Baseline to Completion (up to 4 months) |
| Resident discharged from AL community |
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| Resident found to be ineligible after baseline |
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| Assisted Living (AL) community withdrew from study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED | Periods show different study populations. |
|
| NOT COMPLETED |
|
| COMPLETED | Periods show different study populations. |
|
| NOT COMPLETED |
|
The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment.
For Aim2 the intervention training is delivered by a research dental hygienist.
Aim2 - Daily Mouth Care: Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities.
For Aim2 the intervention training is delivered by a research dental hygienist.
| BG002 | Standard Mouth Care-Aim3 | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. |
| BG003 | Daily Mouth Care-Aim3 | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim3 the intervention training is delivered by state public health dental hygienists. Aim3 - Daily Mouth Care: Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim3 the intervention training is delivered by state public health dental hygienists. |
| BG004 | Total | Total of all reporting groups |
| AL Communities |
|
| Mean |
| Standard Deviation |
| years |
| Participants |
|
| Sex/Gender, Customized | Rows show different study populations (not one population followed over time). AL staff (secondary) completed cross-sectional interviews at up to 3 timepoints and were not followed individually. Baseline characteristics are summarized by the number of participants surveyed at each timepoint. | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Rows show different study populations (not one population followed over time). AL staff (secondary) completed cross-sectional interviews at up to 3 timepoints and were not followed individually. Baseline characteristics are summarized by the number of participants surveyed at each timepoint. | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Rows show different study populations (not one population followed over time). AL staff (secondary) completed cross-sectional interviews at up to 3 timepoints and were not followed individually. Baseline characteristics are summarized by the number of participants surveyed at each timepoint. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No | Participants |
|
|
| Description |
|---|
| OG000 | Standard Mouth Care-Aim2 | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. |
| OG001 | Daily Mouth Care-Aim2 | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim2 the intervention training is delivered by a research dental hygienist. Aim2 - Daily Mouth Care: Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim2 the intervention training is delivered by a research dental hygienist. |
| OG002 | Standard Mouth Care-Aim3 | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. |
| OG003 | Daily Mouth Care-Aim3 | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim3 the intervention training is delivered by state public health dental hygienists. Aim3 - Daily Mouth Care: Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim3 the intervention training is delivered by state public health dental hygienists. |
|
|
|
| Primary | Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | 4 Months Follow-up Visit |
|
|
|
| Primary | Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 4 months |
|
|
|
|
| Primary | Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim2 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline Visit |
|
|
|
|
| Primary | Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | 4 Months Follow-up Visit |
|
|
|
| Primary | Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 4 Months |
|
|
|
|
| Primary | Denture Plaque Index Score (DPI) - Baseline-Aim2 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline Visit |
|
|
|
|
| Primary | Denture Plaque Index Score (DPI) - 4 Months-Aim2 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | 4 Months Follow-up Visit |
|
|
|
| Primary | Change in Denture Plaque Index Score (DPI) - 4 Months-Aim2 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | This measure only applies to Aim2. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 4 months |
|
|
|
|
| Primary | Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim3 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline Visit |
|
|
|
|
| Primary | Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim3 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | 4 Months Follow-up Visit |
|
|
|
| Primary | Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim3 | The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 4 months |
|
|
|
|
| Primary | Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim3 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline Visit |
|
|
|
|
| Primary | Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim3 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | 4 Months Follow-up Visit |
|
|
|
| Primary | Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim3 | The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 4 months |
|
|
|
|
| Primary | Denture Plaque Index Score (DPI) - Baseline-Aim3 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline Visit |
|
|
|
|
| Primary | Denture Plaque Index Score (DPI) - 4 Months-Aim3 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | 4 Months Follow-up visit |
|
|
|
| Primary | Change in Denture Plaque Index Score (DPI) - 4 Months-Aim3 | The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better. | This measure only applies to Aim3. All data are reported. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 4 months |
|
|
|
|
| Secondary | Number of Participants Diagnosed With Pneumonia-Aim2 | The total number of AL residents diagnosed with pneumonia. | This measure only applies to Aim2. All data are reported. | Posted | Count of Participants | Participants | Cumulative from Baseline to Completion (up to 8 months) |
|
|
|
| Secondary | Number of Participants With Hospitalizations-Aim2 | The total number AL residents with hospitalizations. | This measure only applies to Aim2. All data are reported. | Posted | Count of Participants | Participants | Cumulative from Baseline to Completion (up to 8 months) |
|
|
|
| Secondary | Number of Participants Diagnosed With Pneumonia-Aim3 | The total number of AL residents diagnosed with pneumonia. | This measure only applies to Aim3. All data are reported. | Posted | Count of Participants | Participants | Cumulative from Baseline to Completion (up to 4 months) |
|
|
|
| Secondary | Number of Participants With Hospitalizations-Aim3 | The total number of AL residents with hospitalizations. | This measure only applies to Aim3. All data are reported. | Posted | Count of Participants | Participants | Cumulative from Baseline to Completion (up to 4 months) |
|
|
|
| 10 |
| 101 |
| 20 |
| 101 |
| 24 |
| 101 |
| EG001 | Daily Mouth Care-Aim2 | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim2 the intervention training is delivered by a research dental hygienist. Aim2 - Daily Mouth Care: Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim2 the intervention training is delivered by a research dental hygienist. | 19 | 99 | 23 | 99 | 35 | 99 |
| EG002 | Standard Mouth Care-Aim3 | Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition. | 2 | 121 | 14 | 121 | 21 | 121 |
| EG003 | Daily Mouth Care-Aim3 | The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment. For Aim3 the intervention training is delivered by state public health dental hygienists. Aim3 - Daily Mouth Care: Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim3 the intervention training is delivered by state public health dental hygienists. | 6 | 93 | 9 | 93 | 3 | 93 |
| Respiratory Disorder resulting in persistent incapacity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stroke symptoms results in persistent incapacity | Vascular disorders | Systematic Assessment |
|
| Cardiac problem resulting in hospitalization | Cardiac disorders | Systematic Assessment |
|
| Cellulitis resulting in hospitalization | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| COVID infection resulting in hospitalization | Infections and infestations | Systematic Assessment |
|
| Fall resulting in hospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Emergency Gall Bladder Surgery | Gastrointestinal disorders | Systematic Assessment |
|
| General decline resulting in hospitalization | General disorders | Systematic Assessment |
|
| Gastrointestinal Bleed resulting in hospitalization | Gastrointestinal disorders | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
|
| Laceration resulting in hospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Mental Status Change resulting in hospitalization | Psychiatric disorders | Systematic Assessment |
|
| Pneumonia resulting in hospitalization | Infections and infestations | Systematic Assessment |
|
| Respiratory distress resulting in hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Syncytial Virus (RSV) infection resulting in hospitalization | Infections and infestations | Systematic Assessment |
|
| Seizure resulting in hospitalization | Nervous system disorders | Systematic Assessment |
|
| Stroke symptoms resulting in hospitalization | Vascular disorders | Systematic Assessment |
|
| Urinary tract infection resulting in hospitalization | Infections and infestations | Systematic Assessment |
|
| Cancer diagnosis resulting in hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Edema resulting in hospitalization | Vascular disorders | Systematic Assessment |
|
| Syncope resulting in hospitalization | General disorders | Systematic Assessment |
|
| COVID infection | Infections and infestations | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Fall resulting in emergency department visit | Injury, poisoning and procedural complications | Systematic Assessment | Residents sent to emergency department for injury assessment |
|
| Fall with injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | Systematic Assessment |
|
| General decline | General disorders | Systematic Assessment |
|
| Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Mental status change | Psychiatric disorders | Systematic Assessment |
|
| Allergic reaction in mouth | Immune system disorders | Systematic Assessment |
|
| Sore in mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Tooth abscess | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Respiratory infection | Infections and infestations | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Shingles | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Swallowing problem | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| General distress | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
|
|
|
|
| Male |
|
| Not Reported |
|
|
|
|
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
|
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|