Clinical trial NCT01363258: Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
Official title: Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care-resistant Behavior
Dementia
Keywords: Elderly
Dementia
Care-resistant behavior
Oral health
Long-term care
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Care-Resistant Behavior
timeFrame: Baseline (observation) to follow-up (week 3)
Secondary outcomes:
measure: Oral Health
timeFrame: Baseline (observation) to follow-up (week 3)
Other outcomes:
Locations:
city: Bellefonte
country: United States
facility: Centre Crest
state: Pennsylvania
city: Harrisburg
country: United States
facility: Spring Creek Rehabilitation &Health Care Center
state: Pennsylvania
city: York
country: United States
facility: Rest Haven Rehabilitation &Nursing Center
state: Pennsylvania
city: York
country: United States
facility: Pleasant Acres Nursing &Rehabilitation Center
state: Pennsylvania
Study officials:
affiliation: University of Alabama at Birmingham
name: Rita A Jablonski-Jaudon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.