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

Primary Purpose

Care-resistant Behavior, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care-resistant mouth care (MOUTh)
Evidence-based mouth care
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Care-resistant Behavior focused on measuring Elderly, Dementia, Care-resistant behavior, Oral health, Long-term care

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Crest
  • Spring Creek Rehabilitation &Health Care Center
  • Rest Haven Rehabilitation &Nursing Center
  • Pleasant Acres Nursing &Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Care-resistant mouth care (MOUTh)

Evidence Base Mouth Care

Arm 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.

Nursing home residents with dementia received mouth care from study personnel who were trained in evidence-based mouth care only.

Outcomes

Primary Outcome Measures

Care-Resistant Behavior
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

Oral Health
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).

Full Information

First Posted
May 27, 2011
Last Updated
May 7, 2018
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01363258
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Care-resistant Behavior, Dementia
Keywords
Elderly, Dementia, Care-resistant behavior, Oral health, Long-term care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care-resistant mouth care (MOUTh)
Arm Type
Experimental
Arm 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.
Arm Title
Evidence Base Mouth Care
Arm Type
Active Comparator
Arm Description
Nursing home residents with dementia received mouth care from study personnel who were trained in evidence-based mouth care only.
Intervention Type
Behavioral
Intervention Name(s)
Care-resistant mouth care (MOUTh)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Evidence-based mouth care
Intervention Description
Mouth care tailored to the needs of older adults, including care of dentures.
Primary Outcome Measure Information:
Title
Care-Resistant Behavior
Description
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.
Time Frame
Baseline (observation) to follow-up (week 3)
Secondary Outcome Measure Information:
Title
Oral Health
Description
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).
Time Frame
Baseline (observation) to follow-up (week 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita A Jablonski-Jaudon, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Crest
City
Bellefonte
State/Province
Pennsylvania
ZIP/Postal Code
16823
Country
United States
Facility Name
Spring Creek Rehabilitation &Health Care Center
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17111
Country
United States
Facility Name
Rest Haven Rehabilitation &Nursing Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Pleasant Acres Nursing &Rehabilitation Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17402
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21592161
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.
Results Reference
background
PubMed Identifier
22100010
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.
Results Reference
derived

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

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