DementiaNCT03303638
Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia
A study testing Multi-sensory Environment in people with Dementia and BPSD, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Multi-sensory Environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2018to 19 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geriatric Research Education and Clinical Center
Gainesville, Florida, 32608
Lake City VA Medical Center
Lake City, Florida, 32025
About this study
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.
Read the 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.
- Being tested
- Multi-sensory Environment
- Keywords
- Multi-sensory environment, Snoezelen, Bathing, Showering, Tub Bathing
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-sensory EnvironmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multi-sensory Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior during assisted bathing
Physically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.
Measured: 20 weeks
Secondary outcomes (1)
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start23 Jan 2018
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Ronald I Shorr, MD, Principal investigator, University of Florida & Veterans Health Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303638
- Sponsor's protocol ID
- IRB201700547
- Status last verified
- Jul 2019
- First submitted
- 2 Oct 2017
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia
- ClinicalTrials.gov ID
- NCT03303638
- Acronym / sponsor ID
- IRB201700547
- Keywords
- Multi-sensory environment, Snoezelen, Bathing, Showering, Tub Bathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-sensory Environment during bathing | Other | Behavioral: Multi-sensory EnvironmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-sensory EnvironmentMulti-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. | Behavioural | Multi-sensory Environment during bathing |
Primary outcome
Behavior during assisted bathing
Time frame: 20 weeks
Physically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.
1 secondary outcome
Impact of MSE related to medication use
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald I Shorr, MD principal investigator
University of Florida & Veterans Health Administration
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-sensory Environment in people with Dementia and BPSD, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior during assisted bathing (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.