Recruiting

Virtual Reality

Sponsor:

Western University, Canada

Code:

NCT04347668

Conditions

Moderate Dementia

Severe Dementia

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Usual Care

Study Details

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

Study ID

NCT04347668

Start date

Apr 1, 2019

Status verified date

Aug, 2019

Completion date

Sep 27, 2020

Anticipated

Primary completion date

May 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

266 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Usual Care

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.

experimental: Virtual Reality

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.

Interventions

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.

Primary outcome measure

  • Cornell Scale for Depression [ Time Frame: This will be completed weekly to compare this to the change from baseline over a 2 week period. ]

Central Contacts and Locations

Locations

Henley Place

Recruiting

London, Ontario, Canada, N5X 0K2

Contacts

Karen E Campbell, PhD

5198714616KCAMPBEL@UWO.CA

Alexandra G Campbell

1-647-463-8611acampbell@primacareliving.com

Henley House

Recruiting

St. Catherines, Ontario, Canada, L2N 7T2

Contacts

Karen E Campbell, PhD

15198714616KCAMPBEL@UWO.CA

Alexandra Campbell

6474638611acampbell@primacareliving.com

More Information

Sponsor

Western University, Canada

Last update posted

Apr 15, 2020

Last verified

Aug, 2019

Keywords

  • Depression
  • Agitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2020-04-15.