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

Primary Purpose

Dementia, BPSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-sensory Environment
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dementia focused on measuring Multi-sensory environment, Snoezelen, Bathing, Showering, Tub Bathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Geriatric Research Education and Clinical Center
  • Lake City VA Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Multi-sensory Environment during bathing

Arm Description

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.

Outcomes

Primary Outcome Measures

Behavior during assisted bathing
Physically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.

Secondary Outcome Measures

Impact of MSE related to medication use
Scatter plots indicating daily medication use will be overlaid with scatter plots indicating behavior to assess impact of MSE related to medication use.

Full Information

First Posted
October 2, 2017
Last Updated
July 19, 2019
Sponsor
University of Florida
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT03303638
Brief Title
Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia
Official Title
Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
July 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, BPSD
Keywords
Multi-sensory environment, Snoezelen, Bathing, Showering, Tub Bathing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-sensory Environment during bathing
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-sensory Environment
Intervention Description
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 Measure Information:
Title
Behavior during assisted bathing
Description
Physically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Impact of MSE related to medication use
Description
Scatter plots indicating daily medication use will be overlaid with scatter plots indicating behavior to assess impact of MSE related to medication use.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: Medical diagnosis of advanced stage dementia (MMSE rating 0-20) Residing within the VA CLC in Lake City, Florida for at least three months Consistently demonstrate high levels of aggression/agitation during assisted bathing, showering, and/or tub bathing. 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: Predominant diagnosis of psychosis including schizophrenia 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: Provides assisted bathing, showering, and/or tub bathing to veterans with dementia at the VA CLC in Lake City, Florida Has worked at the VA CLC in Lake City, Florida for at least three months Speaks English Exclusion criteria VA healthcare provider: VA healthcare provider is ineligible to participate if they meet one of the following exclusion criteria: Has any limitations that will prevent him/her from providing assisted bathing, showering, and/or tub bathing within a MSE Has any condition which could, in the opinion of the investigator, place the participating veteran at risk or interfere with data integrity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald I Shorr, MD
Organizational Affiliation
University of Florida & Veterans Health Administration
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Research Education and Clinical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Lake City VA Medical Center
City
Lake City
State/Province
Florida
ZIP/Postal Code
32025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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