- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01363258
Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
May 7, 2018 updated by: Rita A. Jablonski, University of Alabama at Birmingham
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Bellefonte, Pennsylvania, United States, 16823
- Centre Crest
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Harrisburg, Pennsylvania, United States, 17111
- Spring Creek Rehabilitation &Health Care Center
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York, Pennsylvania, United States, 17043
- Rest Haven Rehabilitation &Nursing Center
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York, Pennsylvania, United States, 17402
- Pleasant Acres Nursing &Rehabilitation Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
Mouth care tailored to the needs of older adults, including care of dentures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (observation) to follow-up (week 3)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline (observation) to follow-up (week 3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rita A Jablonski-Jaudon, PhD, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
May 27, 2011
First Submitted That Met QC Criteria
May 27, 2011
First Posted (Estimate)
June 1, 2011
Study Record Updates
Last Update Posted (Actual)
June 7, 2018
Last Update Submitted That Met QC Criteria
May 7, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01NR012737 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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