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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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ClinicalTrials.gov Identifier: NCT03941119
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
Centre for Aging and Brain Health Innovation
Michael Garron Hospital
Information provided by (Responsible Party):
Lora Appel, University Health Network, Toronto

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).


Condition or disease Intervention/treatment Phase
Dementia Delirium Superimposed on Dementia Other: VR-therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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.
Other: VR-therapy
Wearing a Virtual Reality head mounted device allows the user to become immersed in a virtual environment. We have assembled a library of 3-10 minute 360-degree films from a variety of nature settings. The VR films were intentionally chosen to be calming in distinctive ways, as supported by the literature around nature visualization and wellbeing. By varying 1) the lengths of the films (3, 5, and 10 minutes), 2) the types of natural elements (greenery, earth, sky, water), 3) distance of view (close-ups, vistas), 4) motion (flowing water, wind in trees), 5) sound, and 6) presence of different elements (humans/animals, scenery, urban sites, etc.), the content provides a wide range of attributes that can be collaboratively selected by the individual, caregiver, or health care provider for each individual. We will display these films on commercially available VR equipment and will provide audio matching the film using commercially available headphones.
Other Names:
  • Oculus Go Standalone Virtual Reality Headset
  • Oculus Go
  • Virtual Reality Headset
  • VR Headset
  • VR HMD
  • Virtual Reality

No Intervention: Control
The control arm will not receive any VR-therapy sessions during their hospital stay.



Primary Outcome Measures :
  1. Changes in Behavioural and Psychological Symptoms of Dementia (BPSD) during the hospital stay [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    BPSD recorded in the electronic medical record during the acute hospitalization, averaging 10.6 days, will be assessed for all participants. The E-BEHAVE-AD will be administered to all participants on days 1 and 4-7 of hospitalization

  2. Number of falls without injury during the hospital stay [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    All falls without injury that occurred during the current acute hospitalization that were recorded in the electronic medical record will be assessed for all participants

  3. Number of falls with injury during the hospital stay [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    All falls with injury that occurred during the acute hospitalization that were recorded in the electronic medical record will be assessed for all participants

  4. Number of pressure ulcers during the hospital stay [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    All pressure ulcers that developed during the acute hospitalization that were recorded in the electronic medical record will be assessed for all participants

  5. All-cause in-patient mortality during the hospital stay [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    If a participant expires during the acute hospitalization, all-cause in-patient mortality will be recorded as described in the electronic medical record including 24 hours after death

  6. Length of acute hospital stay [ Time Frame: At the end of the acute hospitalization, an average of 10.6 days ]
    Number of days of acute hospitalization as recorded by the site staff, will be collected from the electronic medical record after patient's discharge from acute care for all study participants

  7. Discharge disposition [ Time Frame: At the end of the acute hospitalization, an average of 10.6 days ]
    Discharge disposition - The disposition (also called Status) of the patient at time of hospital discharge (i.e., discharged to home, expired, etc.). For each participant, the discharge disposition, will be collected from the electronic medical record on the last day of acute hospitalization

  8. 30-day readmission rate [ Time Frame: Within 30 days following the last day of acute hospitalization which is an average of 10.6 days ]
    The number of re-admissions to acute care at this hospital site in the 30 days following discharge will be collected for all participants.


Secondary Outcome Measures :
  1. Usability of VR-therapy [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    Usability of VR-therapy will be assessed at each study session (every 24-72 hours of the hospital stay) through a semi-structured interview conducted immediately after VR-therapy. Usability of VR-therapy will only be assessed in the intervention arm.

  2. Number of participants with VR-therapy related adverse events as assessed by the post-intervention semi-structured interview and research coordinator observations [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    Participants in the intervention arm will be asked if the VR head mounted display was painful, too heavy, or otherwise uncomfortable. Participants with hearing aids will be asked if they heard buzzing noises during VR-therapy. Participants will be asked if VR-therapy made them feel nervous/anxious, confused/disoriented, nauseous, or any other negative side effect. The research coordinator will observe participant reactions during VR-therapy and record behavior suggesting an unpleasant experience. Participant reactions during VR-therapy will be monitored and the semi-structured interview will be administered immediately after VR-therapy at each session (every 24-72 hours of the hospital stay) for participants in the intervention arm.

  3. In-Hospital Quality of Life Observational Scale [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    The scale contains 11 items. Total scores range from -22 to 22. Higher scores indicate a higher in-hospital quality of life. This scale is adapted from the Quality of Life in Late-Stage Dementia (QUALID) Scale. Scale will be administered at the beginning of each study session (every 24-72 hours of the hospital stay) for all participants.

  4. Participant Experience and Satisfaction of VR-therapy [ Time Frame: Throughout the acute hospitalization, an average of 10.6 days ]
    Participants in the intervention arm will be asked if they had fun and felt relaxed during VR-therapy. They will be asked open-ended questions about what content they enjoyed most and would like to see in the future. They will be asked if they would like to own VR, recommend VR to a friend, and would like to try VR again. Participant reactions during VR-therapy will be monitored by the research coordinator. Perceived participant enjoyment, relaxation, and engagement will be recorded. Instances of participant vocalizations and reminiscence will be recorded. Participant experience and satisfaction will be assessed at each study session (every 24-72 hours of the hospital stay) for participants in the intervention arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941119


Contacts
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Contact: Christopher A Smith, MD 416-461-8272 ext 6252 Christopher.smith@tehn.ca
Contact: Lora Appel, PhD Lora.appel@uhn.ca

Locations
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Canada, Ont
Michael Garron Hospital Recruiting
Toronto, Ont, Canada, M4C 3E7
Contact: Christopher Smith         
Sponsors and Collaborators
University Health Network, Toronto
Centre for Aging and Brain Health Innovation
Michael Garron Hospital
Investigators
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Principal Investigator: Lora Appel, PhD OpenLab, University Health Network

Additional Information:
Publications:
Kaplan R. The Nature of the View from Home: Psychological Benefits. Sage Publications 33(4): 507-542, 2001.
Kaplan S. The restorative benefits of nature: toward an integrative framework. Journal of Environmental Psychology 15: 169-182
Ulrich, RS. Natural Versus Urban Scenes: Some Psychophysiological Effects. Environment and Behavior 13(5): 523-556, 1981.
Ulrich RS. Health Benefits of Gardens in Hospitals. Plants for People International Exhibition Floriade 2002.
Ulrich RS, Simons RF, Losito BD, Fiorito E, Miles MA, Zelson M. Stress recovery during exposure to natural and urban environments. Journal of Environmental Psychology 11: 201-230, 1991.

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Responsible Party: Lora Appel, Collaborating Scientist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03941119     History of Changes
Other Study ID Numbers: 782-1812-Mis-332
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lora Appel, University Health Network, Toronto:
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
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Delirium
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms