<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03303638</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201700547</org_study_id>
    <nct_id>NCT03303638</nct_id>
  </id_info>
  <brief_title>Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia</brief_title>
  <official_title>Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Behavioral and psychological symptoms of dementia (BPSD) greatly impact quality of life (QoL)&#xD;
      for people with dementia, and pharmacological interventions are costly, ineffective or&#xD;
      life-threatening. Law-makers support non-pharmacological interventions like multi-sensory&#xD;
      environments (MSE) but they have not been widely studied. There is a critical need for&#xD;
      investigation of MSE, particularly during assisted bathing, showering, and/or tub bathing,&#xD;
      where most BPSD occur.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dementia is a debilitating and increasingly pervasive condition impacting cognitive decline&#xD;
      across the globe. Behavioral and psychological symptoms of dementia (BPSD) impact quality of&#xD;
      life (QoL) for people with dementia and are key interventional targets. Pharmacological&#xD;
      interventions for BPSD can be costly, ineffective or life-threatening prompting law makers&#xD;
      and the Federal Drug Administration (FDA) to support non-pharmacological interventions like&#xD;
      multi-sensory environments (MSE) as the preferred first line of treatment. Despite this&#xD;
      support for non-pharmacological interventions like MSE, there has been inconsistency in&#xD;
      evaluative methodologies and application of MSE interventions, impeding the widespread use of&#xD;
      MSE in dementia-care settings. Therefore, there is a critical need for empirical&#xD;
      investigation of well-defined MSE in non-pharmacological dementia-care. The purpose of this&#xD;
      study is to investigate the impact of MSE on aggression/agitation during assisted bathing,&#xD;
      showering and/or tub bathing for veterans with dementia. The VA has implemented MSE therapy&#xD;
      for veterans with dementia since 2010 and the impact of MSE on aggression remains to be&#xD;
      evaluated. In 2013, due to favorable initial results, the VA installed both fixed-room and&#xD;
      mobile cart MSE applications in 53 VA community living centers (CLCs) across the US,&#xD;
      including one in Lake City, Florida which received mobile MSE carts and waterproof MSE&#xD;
      equipment for use during assisted bathing, showering, and/or tub bathing. Most acts of&#xD;
      aggression/agitation for people with dementia occur during assisted bathing and there is a&#xD;
      strong need for evidence-based research of non-pharmacological interventions to reduce&#xD;
      problem behaviors, decrease healthcare provider burden and improve quality of life (QoL) for&#xD;
      people with dementia. The overall goal of this study is to investigate the effectiveness of&#xD;
      MSE in the reduction of agitation/aggression during assisted bathing, showering, and/or tub&#xD;
      bathing for veterans with dementia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2018</start_date>
  <completion_date type="Actual">July 19, 2019</completion_date>
  <primary_completion_date type="Actual">July 19, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavior during assisted bathing</measure>
    <time_frame>20 weeks</time_frame>
    <description>Physically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of MSE related to medication use</measure>
    <time_frame>20 weeks</time_frame>
    <description>Scatter plots indicating daily medication use will be overlaid with scatter plots indicating behavior to assess impact of MSE related to medication use.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Dementia</condition>
  <condition>BPSD</condition>
  <arm_group>
    <arm_group_label>Multi-sensory Environment during bathing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multi-sensory Environment</intervention_name>
    <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.</description>
    <arm_group_label>Multi-sensory Environment during bathing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Veterans being bathed and the healthcare providers providing the bath will be consented in&#xD;
        this study.&#xD;
&#xD;
        Inclusion Criteria Veteran with dementia: A veteran with dementia is eligible to&#xD;
        participate if they meet the following inclusion criteria:&#xD;
&#xD;
          1. Medical diagnosis of advanced stage dementia (MMSE rating 0-20)&#xD;
&#xD;
          2. Residing within the VA CLC in Lake City, Florida for at least three months&#xD;
&#xD;
          3. Consistently demonstrate high levels of aggression/agitation during assisted bathing,&#xD;
             showering, and/or tub bathing.&#xD;
&#xD;
          4. Must have legally authorized representative (LAR) on record&#xD;
&#xD;
        Exclusion criteria Veteran with dementia: A veteran with dementia is ineligible to&#xD;
        participate if they meet one of the following exclusion criteria:&#xD;
&#xD;
          1. Predominant diagnosis of psychosis including schizophrenia&#xD;
&#xD;
          2. Patients whom care staff believe would not benefit from MSE.&#xD;
&#xD;
        Inclusion Criteria VA healthcare provider: VA healthcare provider is eligible to&#xD;
        participate if they meet the following inclusion criteria:&#xD;
&#xD;
          1. Provides assisted bathing, showering, and/or tub bathing to veterans with dementia at&#xD;
             the VA CLC in Lake City, Florida&#xD;
&#xD;
          2. Has worked at the VA CLC in Lake City, Florida for at least three months&#xD;
&#xD;
          3. Speaks English&#xD;
&#xD;
        Exclusion criteria VA healthcare provider: VA healthcare provider is ineligible to&#xD;
        participate if they meet one of the following exclusion criteria:&#xD;
&#xD;
          1. Has any limitations that will prevent him/her from providing assisted bathing,&#xD;
             showering, and/or tub bathing within a MSE&#xD;
&#xD;
          2. Has any condition which could, in the opinion of the investigator, place the&#xD;
             participating veteran at risk or interfere with data integrity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald I Shorr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida &amp; Veterans Health Administration</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geriatric Research Education and Clinical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake City VA Medical Center</name>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <zip>32025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>July 19, 2019</last_update_submitted>
  <last_update_submitted_qc>July 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multi-sensory environment</keyword>
  <keyword>Snoezelen</keyword>
  <keyword>Bathing</keyword>
  <keyword>Showering</keyword>
  <keyword>Tub Bathing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03303638
org study id: IRB201700547
nct id: NCT03303638
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Behavior during assisted bathing
time frame: 20 weeks
description: Physically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.
measure: Impact of MSE related to medication use
time frame: 20 weeks
description: Scatter plots indicating daily medication use will be overlaid with scatter plots indicating behavior to assess impact of MSE related to medication use.
arm group label: Multi-sensory Environment during bathing
arm group type: Other
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: Multi-sensory Environment
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.
arm group label: Multi-sensory Environment during bathing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ronald I Shorr, MD
role: Principal Investigator
affiliation: University of Florida & Veterans Health Administration
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: No
ipd 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.