Clinical trial NCT03941119: Evaluating the Impact of VR-therapy on BPSD and QoL of Individuals With Dementia Admitted to Hospital
Official title: VRx: Randomized Controlled Trial to Evaluate the Impact of Virtual Reality Therapy on Behavioural and Psychological Symptoms and Quality of Life of Individuals With Dementia Admitted to an Acute Care Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dementia
Delirium Superimposed on Dementia
Keywords: Virtual Reality
Biomedical Technology
Non-pharmacological Intervention
Behavioral Symptoms
Quality of Life
Geriatric Nursing
Health Services for the Aged
Hospitals, Community
Cognitive Dysfunction
Dementia
Delirium
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Centre for Aging and Brain Health Innovation
name: Michael Garron Hospital
First posted: 2019-05-07
Enrollment: 77
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open trial, unblinded to both participants and research staff, due to the nature of the intervention. The randomization into VR-therapy or standard of care (no VR-therapy) will be performed using a randomization tool within a secure web application. The sequence allocation will be concealed from those assigning participants to the intervention groups, until the moment of assignment. Participants will be assigned to groups only after informed consent has been obtained.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Behavioural and Psychological Symptoms of Dementia (BPSD) during the hospital stay
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
measure: Number of falls without injury during the hospital stay
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
measure: Number of falls with injury during the hospital stay
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
measure: Number of pressure ulcers during the hospital stay
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
measure: All-cause in-patient mortality during the hospital stay
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
measure: Length of acute hospital stay
timeFrame: At the end of the acute hospitalization, an average of 10.6 days
measure: Discharge disposition
timeFrame: At the end of the acute hospitalization, an average of 10.6 days
measure: 30-day readmission rate
timeFrame: Within 30 days following the last day of acute hospitalization which is an average of 10.6 days
Secondary outcomes:
measure: Usability of VR-therapy
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
measure: Number of participants with VR-therapy related adverse events as assessed by the post-intervention semi-structured interview and research coordinator observations
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
measure: In-Hospital Quality of Life Observational Scale
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
measure: Participant Experience and Satisfaction of VR-therapy
timeFrame: Throughout the acute hospitalization, an average of 10.6 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Michael Garron Hospital
state: Ont
Study officials:
affiliation: OpenLab, University Health Network
name: Lora Appel, PhD
role: PRINCIPAL_INVESTIGATOR
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