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

NCT04347668 | Unknown

• 1 other identifier: PRO 0032743
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 3

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.

Conditions

Moderate Dementia; Severe Dementia

Keywords

Depression; Agitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The Cohen Mansfield Agitation Inventory

  This will be completed weekly to compare this to the change from baseline over a 2 week period.

• Percentage Sleep

  This will be completed weekly to compare this to the change from baseline over a 2 week period.

• Psychotropic medication

  This will be completed weekly to compare this to the change from baseline over a 2 week period.

• Weight

  Weight will be recorded before and after the intervention to compare the change from baseline over a 2 month period.

• 1 to 1 staff

  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.

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Virtual Reality

EXPERIMENTAL

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.

Other: Virtual Reality

Interventions

Virtual Reality OTHER

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

Also known as: BroomX

Virtual Reality

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (3)

Burton Manor

Brampton, Ontario, L6Y 5P3, Canada

ACTIVE NOT RECRUITING

Henley Place

London, Ontario, N5X 0K2, Canada

RECRUITING

Henley House

Saint Catherines, Ontario, L2N 7T2, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 3760436 BACKGROUND

• 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.

  PMID: 3337862 RESULT

MeSH Terms

Conditions

Dementia; Depression; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial, VR will be compared to usual care for residents with moderate to severe dementia.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: April 15, 2020
• Study Start: April 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: September 27, 2020
• Last Updated: April 15, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)