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

Moderate Dementia Clinical Trial

Official title:

Can Virtual Reality Reduce Depression and Agitation in Older Adults With Moderate to Severe Dementia? A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347668
• Other study ID #: PRO 0032743
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 27, 2020

Study information

• Verified date: August 2019
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: September 27, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Depression
• Moderate Dementia
• Psychomotor Agitation
• Severe Dementia

Intervention

Other:
• Virtual Reality
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
• Usual Care
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.

Locations

Country	Name	City	State
Canada	Burton Manor	Brampton	Ontario
Canada	Henley Place	London	Ontario
Canada	Henley House	St. Catherines	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This will be completed weekly to compare this to the change from baseline over a 2 week period.
Secondary	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.	This will be completed weekly to compare this to the change from baseline over a 2 week period.
Secondary	Percentage Sleep	This is currently recorded in the participants electronic chart by the night staff.	This will be completed weekly to compare this to the change from baseline over a 2 week period.
Secondary	Psychotropic medication	From the chart we will record the use of psychotropic medications, both regular dose and prn's	This will be completed weekly to compare this to the change from baseline over a 2 week period.
Secondary	Weight	From the chart we will record the weights of the participants	Weight will be recorded before and after the intervention to compare the change from baseline over a 2 month period.
Secondary	1 to 1 staff	We will record the number of hours of 1 to 1 staff usage to manage behaviours.	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.
Secondary	Transfers to the emergency department (ED)	From the chart we will record and transfers to the ED for catastrophic behaviours.	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.