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

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ClinicalTrials.gov Identifier: NCT01363258
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Rita A. Jablonski, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Care-resistant Behavior Dementia Behavioral: Care-resistant mouth care (MOUTh) Procedure: Evidence-based mouth care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
Study Start Date : April 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Care-resistant mouth care (MOUTh)
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.
Behavioral: Care-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.

Active Comparator: Evidence Base Mouth Care
Nursing home residents with dementia received mouth care from study personnel who were trained in evidence-based mouth care only.
Procedure: Evidence-based mouth care
Mouth care tailored to the needs of older adults, including care of dentures.




Primary Outcome Measures :
  1. Care-Resistant Behavior [ Time Frame: Baseline (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 Outcome Measures :
  1. Oral Health [ Time Frame: Baseline (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).



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363258


Locations
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United States, Pennsylvania
Centre Crest
Bellefonte, Pennsylvania, United States, 16823
Spring Creek Rehabilitation &Health Care Center
Harrisburg, Pennsylvania, United States, 17111
Rest Haven Rehabilitation &Nursing Center
York, Pennsylvania, United States, 17043
Pleasant Acres Nursing &Rehabilitation Center
York, Pennsylvania, United States, 17402
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Rita A Jablonski-Jaudon, PhD University of Alabama at Birmingham

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rita A. Jablonski, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01363258     History of Changes
Other Study ID Numbers: R01NR012737 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2011    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: June 7, 2018
Last Verified: May 2018

Keywords provided by Rita A. Jablonski, University of Alabama at Birmingham:
Elderly
Dementia
Care-resistant behavior
Oral health
Long-term care

Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders