An interventional study of Multi-sensory Environment in Dementia and BPSD, sponsored by University of Florida. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-22.
Sponsored by University of Florida · Not applicable, Interventional, and Basic science
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.
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:
Exclusion criteria Veteran with dementia: A veteran with dementia is ineligible to participate if they meet one of the following exclusion criteria:
Inclusion Criteria VA healthcare provider: VA healthcare provider is eligible to participate if they meet the following inclusion criteria:
Exclusion criteria VA healthcare provider: VA healthcare provider is ineligible to participate if they meet one of the following exclusion criteria:
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.
Behavior during assisted bathing
Physically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.
Time frame: 20 weeks
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.
Time frame: 20 weeks
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Florida