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Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia

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ClinicalTrials.gov Identifier: NCT03303638
Recruitment Status : Completed
First Posted : October 6, 2017
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Behavioral and psychological symptoms of dementia (BPSD) greatly impact quality of life (QoL) for people with dementia, and pharmacological interventions are costly, ineffective or life-threatening. Law-makers support non-pharmacological interventions like multi-sensory environments (MSE) but they have not been widely studied. There is a critical need for investigation of MSE, particularly during assisted bathing, showering, and/or tub bathing, where most BPSD occur.

Condition or disease Intervention/treatment Phase
Dementia BPSD Behavioral: Multi-sensory Environment Not Applicable

Detailed Description:
Dementia is a debilitating and increasingly pervasive condition impacting cognitive decline across the globe. Behavioral and psychological symptoms of dementia (BPSD) impact quality of life (QoL) for people with dementia and are key interventional targets. Pharmacological interventions for BPSD can be costly, ineffective or life-threatening prompting law makers and the Federal Drug Administration (FDA) to support non-pharmacological interventions like multi-sensory environments (MSE) as the preferred first line of treatment. Despite this support for non-pharmacological interventions like MSE, there has been inconsistency in evaluative methodologies and application of MSE interventions, impeding the widespread use of MSE in dementia-care settings. Therefore, there is a critical need for empirical investigation of well-defined MSE in non-pharmacological dementia-care. The purpose of this study is to investigate the impact of MSE on aggression/agitation during assisted bathing, showering and/or tub bathing for veterans with dementia. The VA has implemented MSE therapy for veterans with dementia since 2010 and the impact of MSE on aggression remains to be evaluated. In 2013, due to favorable initial results, the VA installed both fixed-room and mobile cart MSE applications in 53 VA community living centers (CLCs) across the US, including one in Lake City, Florida which received mobile MSE carts and waterproof MSE equipment for use during assisted bathing, showering, and/or tub bathing. Most acts of aggression/agitation for people with dementia occur during assisted bathing and there is a strong need for evidence-based research of non-pharmacological interventions to reduce problem behaviors, decrease healthcare provider burden and improve quality of life (QoL) for people with dementia. The overall goal of this study is to investigate the effectiveness of MSE in the reduction of agitation/aggression during assisted bathing, showering, and/or tub bathing for veterans with dementia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia
Actual Study Start Date : January 23, 2018
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Multi-sensory Environment during bathing
The MSE intervention will be provided by an interactive waterproof fiber optic kit that includes: a light-emitting diode (LED) wall-washer light, a waterproof fiber optic cable that can be controlled by a waterproof switch held by the participant while bathing, showering, and or tub bathing, and a mobile MSE cart. The wall-washer LED light creates the illusion that the room is painted a variety of bright colors that can be changed by the veteran being bathed. The mobile MSE cart includes an LED solar projector providing visual sensory stimulation by projecting scenes on the wall, an aroma therapy diffuser and a portable bubble tube to create positive distraction during the bathing process.
Behavioral: Multi-sensory Environment
Multi-sensory environments (MSE), also known as Snoezelen® environments, are defined as behavioral environmental intervention to help people with cognitive and physical impairments reach sensory equilibrium. Typical elements within MSE include visual, auditory, tactile and olfactory stimuli, ergonomic vibro-acoustic furniture, bubble tubes, color-changing LED lighting solutions, music, fiber optics and aromatherapy.




Primary Outcome Measures :
  1. Behavior during assisted bathing [ Time Frame: 20 weeks ]
    Physically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.


Secondary Outcome Measures :
  1. Impact of MSE related to medication use [ Time Frame: 20 weeks ]
    Scatter plots indicating daily medication use will be overlaid with scatter plots indicating behavior to assess impact of MSE related to medication use.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Veterans being bathed and the healthcare providers providing the bath will be consented in this study.

Inclusion Criteria Veteran with dementia: A veteran with dementia is eligible to participate if they meet the following inclusion criteria:

  1. Medical diagnosis of advanced stage dementia (MMSE rating 0-20)
  2. Residing within the VA CLC in Lake City, Florida for at least three months
  3. Consistently demonstrate high levels of aggression/agitation during assisted bathing, showering, and/or tub bathing.
  4. Must have legally authorized representative (LAR) on record

Exclusion criteria Veteran with dementia: A veteran with dementia is ineligible to participate if they meet one of the following exclusion criteria:

  1. Predominant diagnosis of psychosis including schizophrenia
  2. Patients whom care staff believe would not benefit from MSE.

Inclusion Criteria VA healthcare provider: VA healthcare provider is eligible to participate if they meet the following inclusion criteria:

  1. Provides assisted bathing, showering, and/or tub bathing to veterans with dementia at the VA CLC in Lake City, Florida
  2. Has worked at the VA CLC in Lake City, Florida for at least three months
  3. Speaks English

Exclusion criteria VA healthcare provider: VA healthcare provider is ineligible to participate if they meet one of the following exclusion criteria:

  1. Has any limitations that will prevent him/her from providing assisted bathing, showering, and/or tub bathing within a MSE
  2. Has any condition which could, in the opinion of the investigator, place the participating veteran at risk or interfere with data integrity

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): NCT03303638


Locations
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United States, Florida
Geriatric Research Education and Clinical Center
Gainesville, Florida, United States, 32608
Lake City VA Medical Center
Lake City, Florida, United States, 32025
Sponsors and Collaborators
University of Florida
US Department of Veterans Affairs
Investigators
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Principal Investigator: Ronald I Shorr, MD University of Florida & Veterans Health Administration

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03303638     History of Changes
Other Study ID Numbers: IRB201700547
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Per VA regulations, all data will be stored securely or a server behind VA firewall, only accessible to VA researchers assigned to this study. All data will be de-identified and no names will be referenced in any publications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Multi-sensory environment
Snoezelen
Bathing
Showering
Tub Bathing

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