Clinical trial NCT04347668: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Moderate Dementia
Severe Dementia
Keywords: Depression
Agitation
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 266
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial, VR will be compared to usual care for residents with moderate to severe dementia.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cornell Scale for Depression
timeFrame: This will be completed weekly to compare this to the change from baseline over a 2 week period.
Secondary outcomes:
measure: The Cohen Mansfield Agitation Inventory
timeFrame: This will be completed weekly to compare this to the change from baseline over a 2 week period.
measure: Percentage Sleep
timeFrame: This will be completed weekly to compare this to the change from baseline over a 2 week period.
measure: Psychotropic medication
timeFrame: This will be completed weekly to compare this to the change from baseline over a 2 week period.
measure: Weight
timeFrame: Weight will be recorded before and after the intervention to compare the change from baseline over a 2 month period.
measure: 1 to 1 staff
timeFrame: 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.
measure: Transfers to the emergency department (ED)
timeFrame: 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.
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Burton Manor
state: Ontario
city: London
country: Canada
facility: Henley Place
state: Ontario
city: St. Catherines
country: Canada
facility: Henley House
state: Ontario
Study officials:
References:
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.
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.