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

NCT ID: NCT03303638

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-23
• Study Completion Date: 2019-07-19

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.

Conditions

Dementia; BPSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Multi-sensory Environment

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

1. Predominant diagnosis of psychosis including schizophrenia

2. Patients whom care staff believe would not benefit from MSE.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald I Shorr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida & Veterans Health Administration

Locations

Geriatric Research Education and Clinical Center

Gainesville, Florida, United States

Lake City VA Medical Center

Lake City, Florida, United States

Countries

United States

Other Identifiers

IRB201700547

Identifier Type: -

Identifier Source: org_study_id