Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Care-resistant Behavior Dementia |
Behavioral: Managing Oral Hygiene Using Threat Reduction (MOUTh ) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia |
- Reduction in care-resistant behavior [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Care-resistant behavior will be measured using a refinement of the Resistiveness to Care Scale, which was developed specifically for use with persons with dementia.
- Oral health [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]The oral health will be measured as the total score obtained from the Oral Health Assessment Tool.
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Care-resistant mouth care
These nursing home residents with dementia will receive mouth care from study personnel who use strategies to reduce care-resistant behavior while providing the mouth care.
|
Behavioral: Managing Oral Hygiene Using Threat Reduction (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.
|
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| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- English-speaking
- age 65 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 6
- 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
Contacts and Locations| United States, Pennsylvania | |
| Centre Crest | |
| Bellefonte, Pennsylvania, United States, 16823 | |
| Spring Creek Rehabilitation &Health Care Center | |
| Harrisburg, Pennsylvania, United States, 17111 | |
| Valley View Nursing Center | |
| Montoursville, Pennsylvania, United States, 17754 | |
| Pleasant Acres Nursing &Rehabilitation Center | |
| York, Pennsylvania, United States, 17402 | |
| Rest Haven Rehabilitation &Nursing Center | |
| York, Pennsylvania, United States, 17043 | |
| Principal Investigator: | Rita A Jablonski, PhD | Penn State |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rita A. Jablonski, Penn State |
| ClinicalTrials.gov Identifier: | NCT01363258 History of Changes |
| Other Study ID Numbers: | R01NR012737 |
| Study First Received: | May 27, 2011 |
| Last Updated: | May 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Penn State University:
|
Elderly Dementia Care-resistant behavior Oral health Long-term care |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013