NCT03303638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2019

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

October 2, 2017

Last Update Submit

July 19, 2019

Conditions

DementiaBPSD

Keywords

Multi-sensory environmentSnoezelenBathingShoweringTub Bathing

Outcome Measures

Primary Outcomes (1)

  • Behavior during assisted bathing

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

    20 weeks

Secondary Outcomes (1)

  • Impact of MSE related to medication use

    20 weeks

Study Arms (1)

Multi-sensory Environment during bathing

OTHER

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

Interventions

Multi-sensory EnvironmentBEHAVIORAL

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.

Multi-sensory Environment during bathing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Predominant diagnosis of psychosis including schizophrenia
  • Patients whom care staff believe would not benefit from MSE.
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Geriatric Research Education and Clinical Center

Gainesville, Florida, 32608, United States

Location

Lake City VA Medical Center

Lake City, Florida, 32025, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Ronald I Shorr, MD

    University of Florida & Veterans Health Administration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 6, 2017

Study Start

January 23, 2018

Primary Completion

July 19, 2019

Study Completion

July 19, 2019

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(2)