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Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia

Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01363258
Enrollment
100
Registered
2011-06-01
Start date
2011-04-30
Completion date
2015-11-30
Last updated
2018-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Care-resistant Behavior, Dementia

Keywords

Elderly, Dementia, Care-resistant behavior, Oral health, Long-term care

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALCare-resistant mouth care (MOUTh)

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.

PROCEDUREEvidence-based mouth care

Mouth care tailored to the needs of older adults, including care of dentures.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* English-speaking * age 55 or older * documented diagnosis of dementia, Alzheimer's disease, vascular dementia, or Lewy body dementia * identified by NH staff as resistant to mouth care * at least 2 adjacent teeth AND/OR daily wearing of at least one denture plate * the ability to hold a toothbrush * the ability to move his or her hand to his or her mouth.

Exclusion criteria

* age less than 55 * no documented diagnosis of dementia * inability to hold a toothbrush * inability to raise his or her hand to his or her mouth * receiving treatment for an active dental or denture problem * a diagnosis of dysphagia requiring thickened liquids

Design outcomes

Primary

MeasureTime frameDescription
Care-Resistant BehaviorBaseline (observation) to follow-up (week 3)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.

Secondary

MeasureTime frameDescription
Oral HealthBaseline (observation) to follow-up (week 3)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).

Countries

United States

Participant flow

Recruitment details

Recruitment occurred sequentially in 9 United States NHs.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
54
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.
46
Total100

Baseline characteristics

CharacteristicControlTotalExperimental
Age, Continuous80.48 years
STANDARD_DEVIATION 11.54
81.55 years
STANDARD_DEVIATION 9.91
82.80 years
STANDARD_DEVIATION 8.92
Charlson Comorbidity Index2.40 units on a scale
STANDARD_DEVIATION 1.53
2.50 units on a scale
STANDARD_DEVIATION 2.06
2.60 units on a scale
STANDARD_DEVIATION 2.56
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
54 Participants100 Participants46 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Global Deterioration Scale5.69 units on a scale
STANDARD_DEVIATION 1.03
5.71 units on a scale
STANDARD_DEVIATION 0.89
5.73 units on a scale
STANDARD_DEVIATION 0.71
Katz Index of ADLs9.33 units on a scale
STANDARD_DEVIATION 2.67
9.53 units on a scale
STANDARD_DEVIATION 3.16
9.76 units on a scale
STANDARD_DEVIATION 3.63
Months in nursing home17.39 months
STANDARD_DEVIATION 15.99
22.66 months
STANDARD_DEVIATION 23.63
28.74 months
STANDARD_DEVIATION 29.16
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants16 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
46 Participants84 Participants38 Participants
Region of Enrollment
United States
54 participants100 participants46 participants
Sex: Female, Male
Female
40 Participants71 Participants31 Participants
Sex: Female, Male
Male
14 Participants29 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 540 / 46
serious
Total, serious adverse events
0 / 540 / 46

Outcome results

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.

Time frame: Baseline (observation) to follow-up (week 3)

Population: One-hundred nine NH residents were enrolled; 101 were randomized, 100 contributed data for analyses, and 91 completed the 3-week intervention period.

ArmMeasureGroupValue (MEAN)Dispersion
ControlCare-Resistant BehaviorObservation (Baseline)4.84 units on a scaleStandard Error 0.66
ControlCare-Resistant BehaviorFollow-up (Week 3)4.42 units on a scaleStandard Error 0.48
ExperimentalCare-Resistant BehaviorFollow-up (Week 3)4.91 units on a scaleStandard Error 0.53
ExperimentalCare-Resistant BehaviorObservation (Baseline)6.3 units on a scaleStandard Error 0.86
p-value: 0.1433Time by group interaction test
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).

Time frame: Baseline (observation) to follow-up (week 3)

ArmMeasureGroupValue (MEAN)Dispersion
ControlOral HealthObservation (Baseline)4.93 units on a scaleStandard Error 0.68
ControlOral HealthFollow-up (Week 3)3.83 units on a scaleStandard Error 0.62
ExperimentalOral HealthObservation (Baseline)4.86 units on a scaleStandard Error 0.68
ExperimentalOral HealthFollow-up (Week 3)3.42 units on a scaleStandard Error 0.61

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026