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Completed

NCT Number: NCT03303638

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Research Education and Clinical Center, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-sensory Environment

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2017
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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