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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Hygiene in Assisted Living

NCT03892200

Aging Long-Term Care

COMPLETED NA

Coaching Dementia Caregivers to Master Care-Resistant Behavior

NCT05098652

Care-resistant Behavior Dementia

RECRUITING NA

Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia

NCT04390750

Mild Dementia

COMPLETED NA

Supporting Family Caregivers of Persons Living With Dementia: Effectiveness and Sustainability of MT4C-In Care

NCT04226872

Dementia Family

COMPLETED NA

Impact of a Multimodal Lifestyle Intervention on Dementia Risk Factors and Attitude Related to Dementia Risk: A Logistical Pilot Study

NCT07146412

Cognitive Impairment Alzheimer Blood Biomarkers Alzheimer Disease (AD) +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Care-resistant Behavior Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Care-resistant mouth care (MOUTh)

Intervention Type BEHAVIORAL

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.

Evidence Base Mouth Care

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

Group Type ACTIVE_COMPARATOR

Evidence-based mouth care

Intervention Type PROCEDURE

Mouth care tailored to the needs of older adults, including care of dentures.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Evidence-based mouth care

Mouth care tailored to the needs of older adults, including care of dentures.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No