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Can Virtual Reality Reduce Depression and Agitation in Older Adults With Moderate to Severe Dementia?

Primary Purpose

Moderate Dementia, Severe Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Reality
Usual Care
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Dementia focused on measuring Depression, Agitation

Eligibility Criteria

65 Years - 110 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Resident of Henley Place, Henley House, and Burton Manor
  2. Cognitive Performance Scale score between 3 to 5.

Exclusion Criteria:

  1. Without a medical diagnosis of dementia,
  2. Diagnosis of epilepsy,
  3. Those who are blind,
  4. Residents at end of life,
  5. Unable to communicate in English,
  6. Residents whose substitute decision-maker is from the Public Trustee and Guardian office of Ontario.

Sites / Locations

  • Burton Manor
  • Henley PlaceRecruiting
  • Henley HouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Virtual Reality

Arm Description

All residents are seen by a RN, with care by Registered Practical Nurse (RPN) and Personal Support Worker (PSW) staff 24/7. Residents supported by behavior support Ontario staff; include Behavior responsive team. Residents prior to admission have been assessed by the Geriatric program. Residents may receive psychotropic or cognitive enhancement medications. The residents are seen routinely seen once a week by the physician. Their Dementia is monitored weekly but the physician as well as daily by the registered staff. Quarterly or more frequently cognitive assessments are completed and referrals made to appropriate specialists. A day would include meals, engagement in scheduled and non-scheduled programs such as exercise, and activities, groups. Residents are supported in their activities of daily living, and social engagement. Specific interventions based on resident needs are supported in a Dementia capable environment.

Virtual Reality (VR) is a scenario that simulates experiences. The immersive environment is similar to the real world, creating an experience. A person using virtual reality equipment is able to "look around" the artificial world, move around in it, and interact with virtual features or items. VR requires the user to use a multi-projected in their own room using BroomX to generate realistic images, sounds that simulate a user's physical presence in a virtual or imaginary environment. A library has been developed, set to music, as well, we will use library items already part of the BroomX. We will attempt to use BroomX in their own room or in a suitable room within the LTC home. The participants still get the immersive experience, and the projection device has automatic controls that conform the visuals to a 360 experience no matter what size the room is, or what chairs, window blinds, are in the room.

Outcomes

Primary Outcome Measures

Cornell Scale for Depression
The Cornell Scale for Depression is a 19 item scale that measures depression where a score of 12 or above indicates probable depression.

Secondary Outcome Measures

The Cohen Mansfield Agitation Inventory
The Cohen-Mansfield Agitation Inventory (CMAI; (Cohen-Mansfield and Kerin, 1986)) is a 29-item tool (Cohen-Mansfield et al., 1989) developed to assess agitated behaviours of people residing within nursing homes.
Percentage Sleep
This is currently recorded in the participants electronic chart by the night staff.
Psychotropic medication
From the chart we will record the use of psychotropic medications, both regular dose and prn's
Weight
From the chart we will record the weights of the participants
1 to 1 staff
We will record the number of hours of 1 to 1 staff usage to manage behaviours.
Transfers to the emergency department (ED)
From the chart we will record and transfers to the ED for catastrophic behaviours.

Full Information

First Posted
September 19, 2019
Last Updated
April 13, 2020
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04347668
Brief Title
Can Virtual Reality Reduce Depression and Agitation in Older Adults With Moderate to Severe Dementia?
Official Title
Can Virtual Reality Reduce Depression and Agitation in Older Adults With Moderate to Severe Dementia? A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
September 27, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dementia is a term used to describe a collection of symptoms including memory loss, problems with reasoning and communication, and a reduction in a person's ability to carry out daily activities. The most common types of dementia are: Alzheimer's disease, vascular dementia, mixed dementia and dementia with Lewy bodies. Clinicians and families are looking for ways to deal with this challenging group of diseases to improve quality of life, reduce depression and agitation for individuals in long term care (LTC). There are a variety of non-pharmacologic interventions for dementia often used in addressing physiological and behavioral challenges, new to this category of treatment is virtual reality (VR). Virtual reality has been studied in mild cognitive impairment. Colleagues completed a systematic review of non-pharmacological intervention to treat older people with dementia and found music to be the only intervention effective, VR was not included as no studies were found. The Registered Nurses Association of Ontario report non-pharmacological approaches are an important alternative to the use of antipsychotic medications. They recommend health-care providers should consider non-pharmacological interventions wherever possible as a first-line approach to the management of BPSD. Virtual reality as proposed in this research will include music, library items will be selected that are person specific, and will provide sensory stimulation. To date there is no published research on the use the VR in moderate to severe dementia in LTC, looking at depression.
Detailed Description
Dementia is a term used to describe a collection of symptoms including memory loss, problems with reasoning and communication, and a reduction in a person's ability to carry out daily activities such as washing, dressing and cooking. The most common types of dementia are: Alzheimer's disease, vascular dementia, mixed dementia and dementia with Lewy bodies. Dementia is a progressive condition, which means that the symptoms will gradually get worse. Clinicians and families are looking for ways to deal with this challenging group of diseases to improve quality of life, reduce depression and agitation that often accompany dementia as it progresses and individuals are placed in long term care (LTC). There are a variety of non-pharmacologic interventions for dementia ranging from traditional interventions such as behavioral therapy to newer interventions such as multisensory therapy. Often used in addressing physiological and behavioral challenges, some interventions have been shown to aid cognitive ability as well. "Cognitive stimulation," is a catchall term referring to non-pharmacologic interventions with a cognitive focus, new to this category of treatment is virtual reality (VR). Virtual reality has been studied in mild cognitive impairment. A systematic review of studies evaluating computerized cognitive training and virtual reality cognitive training interventions for individuals at high risk of cognitive decline called mild cognitive decline documented consistent improvement in the domains of attention, executive function, visual and verbal memory, and also on the psychological symptoms of depression, anxiety, and apathy in participants. Colleagues completed a systematic review of non-pharmacological intervention to treat older people with dementia and found music to be the only intervention effective, VR was not included as no studies were found. The Registered Nurses Association of Ontario completed a best practice guideline on Dementia based on current evidence in 2016. They report non-pharmacological approaches are an important alternative to the use of antipsychotic medications, which historically have been overused as a first-line strategy for managing behavioural and psychological systems of dementia (BPSD). They recommend health-care providers should consider non-pharmacological interventions wherever possible as a first-line approach to the management of BPSD. The most well-studied and effective non-pharmacological approaches include listening to music/music therapy, effective communication and person-centred approaches and other sensory stimulation. Virtual reality as proposed in this research will include music, specific library items will be selected that are person specific, and will provide sensory stimulation in keep with the RNAO guidelines. To date there is no published research on the use the VR in moderate to severe dementia in LTC looking at depression as the primary outcome measure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Dementia, Severe Dementia
Keywords
Depression, Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial, VR will be compared to usual care for residents with moderate to severe dementia.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
All residents are seen by a RN, with care by Registered Practical Nurse (RPN) and Personal Support Worker (PSW) staff 24/7. Residents supported by behavior support Ontario staff; include Behavior responsive team. Residents prior to admission have been assessed by the Geriatric program. Residents may receive psychotropic or cognitive enhancement medications. The residents are seen routinely seen once a week by the physician. Their Dementia is monitored weekly but the physician as well as daily by the registered staff. Quarterly or more frequently cognitive assessments are completed and referrals made to appropriate specialists. A day would include meals, engagement in scheduled and non-scheduled programs such as exercise, and activities, groups. Residents are supported in their activities of daily living, and social engagement. Specific interventions based on resident needs are supported in a Dementia capable environment.
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Virtual Reality (VR) is a scenario that simulates experiences. The immersive environment is similar to the real world, creating an experience. A person using virtual reality equipment is able to "look around" the artificial world, move around in it, and interact with virtual features or items. VR requires the user to use a multi-projected in their own room using BroomX to generate realistic images, sounds that simulate a user's physical presence in a virtual or imaginary environment. A library has been developed, set to music, as well, we will use library items already part of the BroomX. We will attempt to use BroomX in their own room or in a suitable room within the LTC home. The participants still get the immersive experience, and the projection device has automatic controls that conform the visuals to a 360 experience no matter what size the room is, or what chairs, window blinds, are in the room.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
BroomX
Intervention Description
VR requires the user to use a multi-projected in their own room using BroomX to generate realistic images, sounds and other sensations that simulate a user's physical presence in a virtual or imaginary environment
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
meals, engagement in scheduled and non-scheduled programs such as exercise, and activities, groups. Residents are supported in their activities of daily living, and social engagement. Specific interventions based on resident needs are supported in a Dementia capable environment.
Primary Outcome Measure Information:
Title
Cornell Scale for Depression
Description
The Cornell Scale for Depression is a 19 item scale that measures depression where a score of 12 or above indicates probable depression.
Time Frame
This will be completed weekly to compare this to the change from baseline over a 2 week period.
Secondary Outcome Measure Information:
Title
The Cohen Mansfield Agitation Inventory
Description
The Cohen-Mansfield Agitation Inventory (CMAI; (Cohen-Mansfield and Kerin, 1986)) is a 29-item tool (Cohen-Mansfield et al., 1989) developed to assess agitated behaviours of people residing within nursing homes.
Time Frame
This will be completed weekly to compare this to the change from baseline over a 2 week period.
Title
Percentage Sleep
Description
This is currently recorded in the participants electronic chart by the night staff.
Time Frame
This will be completed weekly to compare this to the change from baseline over a 2 week period.
Title
Psychotropic medication
Description
From the chart we will record the use of psychotropic medications, both regular dose and prn's
Time Frame
This will be completed weekly to compare this to the change from baseline over a 2 week period.
Title
Weight
Description
From the chart we will record the weights of the participants
Time Frame
Weight will be recorded before and after the intervention to compare the change from baseline over a 2 month period.
Title
1 to 1 staff
Description
We will record the number of hours of 1 to 1 staff usage to manage behaviours.
Time Frame
We will record from administrative data the hours of 1 to 1 staff per participant, for 1 month, before and after the intervention. This will be completed monthly to compare this to the change from baseline over a 2 month period.
Title
Transfers to the emergency department (ED)
Description
From the chart we will record and transfers to the ED for catastrophic behaviours.
Time Frame
We will record from the chart the transfer to the emergency department per participant, for 1 month, before and after the intervention. This will be completed monthly to compare this to the change from baseline over a two month period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Resident of Henley Place, Henley House, and Burton Manor Cognitive Performance Scale score between 3 to 5. Exclusion Criteria: Without a medical diagnosis of dementia, Diagnosis of epilepsy, Those who are blind, Residents at end of life, Unable to communicate in English, Residents whose substitute decision-maker is from the Public Trustee and Guardian office of Ontario.
Facility Information:
Facility Name
Burton Manor
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Y 5P3
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Henley Place
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 0K2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen E Campbell, PhD
Phone
5198714616
Email
KCAMPBEL@UWO.CA
First Name & Middle Initial & Last Name & Degree
Alexandra G Campbell
Phone
1-647-463-8611
Email
acampbell@primacareliving.com
Facility Name
Henley House
City
St. Catherines
State/Province
Ontario
ZIP/Postal Code
L2N 7T2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen E Campbell, PhD
Phone
15198714616
Email
KCAMPBEL@UWO.CA
First Name & Middle Initial & Last Name & Degree
Alexandra Campbell
Phone
6474638611
Email
acampbell@primacareliving.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3760436
Citation
Cohen-Mansfield J. Agitated behaviors in the elderly. II. Preliminary results in the cognitively deteriorated. J Am Geriatr Soc. 1986 Oct;34(10):722-7. doi: 10.1111/j.1532-5415.1986.tb04303.x.
Results Reference
background
PubMed Identifier
3337862
Citation
Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
Results Reference
result

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Can Virtual Reality Reduce Depression and Agitation in Older Adults With Moderate to Severe Dementia?

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