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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01363258
First received: May 27, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363258

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
Sponsors and Collaborators
Penn State University
Investigators
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 August 20, 2014