Dementia Clinical Trial
Official title:
Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05686486 -
Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes
|
N/A | |
Terminated |
NCT05451693 -
Outreach-ER: A Dementia Care Intervention Program
|
||
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Enrolling by invitation |
NCT06040294 -
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
|
N/A | |
Completed |
NCT05114187 -
An Internet-Based Education Program for Care Partners of People Living With Dementia
|
N/A | |
Recruiting |
NCT06322121 -
Vascular Aspects in Dementia: Part 2
|
||
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Recruiting |
NCT03462485 -
Pilot Study of the Effects of Playing Golf on People With Dementia
|
N/A | |
Active, not recruiting |
NCT03677284 -
Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia
|
N/A | |
Completed |
NCT03849937 -
Changing Talk Online (CHATO) Study
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Completed |
NCT04571697 -
A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Recruiting |
NCT06033066 -
Financial Incentives and Recruitment to the APT Webstudy
|
N/A | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT05684783 -
Dementia Champions in Homecare
|
||
Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A |