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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Care-resistant Behavior
Dementia

Treatments

Behavioral: Care-resistant mouth care (MOUTh)
Procedure: Evidence-based mouth care

Study type

Interventional

Funder types

Other

Identifiers

NCT01363258
R01NR012737

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups

Care-resistant mouth care (MOUTh)
Experimental group
Description:
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.
Treatment:
Behavioral: Care-resistant mouth care (MOUTh)
Evidence Base Mouth Care
Active Comparator group
Description:
Nursing home residents with dementia received mouth care from study personnel who were trained in evidence-based mouth care only.
Treatment:
Procedure: Evidence-based mouth care

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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