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Evaluating the Impact of VR-therapy on BPSD and QoL of Individuals With Dementia Admitted to Hospital (VRx-RCT)

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University Health Network, Toronto

Status

Terminated

Conditions

Delirium Superimposed on Dementia
Dementia

Treatments

Other: VR-therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03941119
782-1812-Mis-332

Details and patient eligibility

About

Behavioural and Psychological Symptoms of Dementia (BPSD) (such as aggression, restlessness, agitation, wandering, anxiety, depression) are common to most people with dementia at some point during their illness and represent an aspect of dementia particularly difficult to manage. There is growing attention to the therapeutic effects of natural environments on people's health. Exposure to natural environments (seeing greenery, hearing outside natural sounds) has been shown to enhance wellbeing, reduce depression, anxiety and stress levels, and decrease hospital length-of-stay for inpatients. Virtual Reality (VR) is a novel technology that uses a Head Mounted Display (HMD) to generate simulated immersive experiences that elicit perceptions and behaviors similar to those in real life and can make one feel as though they are truly present in another place. Based on scientific research, previous studies, and expert consultation, we created a library of VR experiences depicting calming nature scenes designed specifically for people with dementia.

The objectives of this RCT are 1) to evaluate the effects of VR-therapy on BPSD and the hospital care experience of in-patients with dementia and/or delirium admitted to an acute care hospital, 2) to determine the usability, tolerability, and safety of VR-therapy for patients with dementia and/or delirium admitted to acute care, 3) determine the effect of VR-therapy on quality of life for patients with dementia and/or delirium admitted to acute care and 4) to explore a framework for introducing non-pharmacological therapies in acute care hospitals.

Our hypotheses are 1) VR-therapy helps manage BPSD (e.g. decrease anxiety, aggression, depression, violent behaviors, incidents of wandering), and may decrease the amount and/or frequency of sedatives and anti-depressant medication administered and/or the number of incidents that require restraints, and the number of falls, in people with dementia and/or delirium admitted to an acute care hospital. 2) VR-therapy will improve the quality of life for individuals with dementia and/or delirium admitted to an acute care hospital (operationalized through conducting a validated instrument to measure quality of life for people with dementia). 3) VR-therapy is safe and feasible to administer to individuals with dementia and/or delirium admitted to an acute care hospital (with assistance from their circle of care members and/or caregivers).

Full description

Behavioural and Psychological Symptoms of Dementia (BPSD) (including hallucinations, delusions, aggression, restlessness, agitation, wandering, anxiety, depression, elation, euphoria, disinhibition, motor disturbances, nighttime behaviours, and appetite disturbances) represent an aspect of dementia particularly difficult to manage for which new treatments are urgently needed. Current means to manage BPSD typically involve medications (e.g. anti-psychotics, anti-depressants, sedatives) associated with negative side effects such as lethargy, loss-of-self, cognitive decline, and increased risk of falls, and/or applying physical barriers and restraints (alarms, locks, Buxton chairs, tethers) that can cause pressure sores, injury, infection, as well as negative psychological effects such as anxiety, distress, and aggression. Although options for non-pharmacological management of BPSD in acute care exist (e.g. reminiscence therapy, therapeutic touch, music therapy), they are seldom implemented in practice due to lack of time, resources, and/or training.

Exposure to natural environments (seeing greenery, hearing outside natural sounds) has been shown to enhance wellbeing, reduce depression, anxiety, and stress levels, and decrease hospital length-of-stay for inpatients. Through VR technology, one's surroundings can be seamlessly replaced by a virtual world of their choosing. Based on previous studies and expert consultation, we created a library of VR experiences depicting calming nature scenes (peaceful lake, refreshing forest, cheerful playground) designed specifically for people with dementia, as a prototype for introducing immersive VR-therapy to hospitals, long term care facilities and private homes. The goal of VR-therapy is to help manage BPSD and stimulate psychological/cognitive health and daytime engagement for people with dementia.

The RCT will be informed by our prior pilot study conducted in the hospitalist medicine department of Michael Garron Hospital with inpatients with dementia to validate the proposed RCT study protocol (processes, methods, recruitment strategy, resource requirements, timelines) as well as by previous feasibility studies in outpatients that showed it is safe and feasible to use VR/HMDs for people with dementia.

Enrollment

77 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who are 65 years of age or older.
  • Patients admitted to Michael Garron Hospital (MGH).
  • Patients diagnosed with, or suspected to have, dementia.

Exclusion criteria

  • Patients with open wounds on face (sutured lacerations exempted).
  • Patients with a history of seizures or epilepsy.
  • Patients with a pacemaker.
  • Patients with head trauma or stroke leading to their current admission.
  • Patients with cervical conditions or injuries that would make it unsafe for them to use the VR headset.
  • Patients with alcohol related dementia/ Korsakoff syndrome.
  • Patients admitted to the Intensive Care Unit (ICU) or Adult Mental Health Inpatient Service.
  • Patients who require but do not have a Substitute Decision Maker (SDM) or patients from which there is no contactable SDM.
  • Patients who have a Public Guardian and Trustee (PGT) as SDM.
  • Patients who participated in the VRx study during their previous hospitalization and are readmitted less than 30-days after previous hospital discharge.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

77 participants in 2 patient groups

Intervention
Experimental group
Description:
The intervention arm will receive a VR-therapy session every 24-72 hours of their stay in the hospital. Participants will view specially designed 360-degree VR films using a Virtual Reality head mounted display for a maximum of 20 minutes per session.
Treatment:
Other: VR-therapy
Control
No Intervention group
Description:
The control arm will not receive any VR-therapy sessions during their hospital stay.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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