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

NCT03941119 | Terminated

• 1 other identifier: 782-1812-Mis-332
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (8)

• Changes in Behavioural and Psychological Symptoms of Dementia (BPSD) during the hospital stay

  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

  Throughout the acute hospitalization, an average of 10.6 days

• Number of falls without injury during the hospital stay

  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

  Throughout the acute hospitalization, an average of 10.6 days

• Number of falls with injury during the hospital stay

  All falls with injury that occurred during the acute hospitalization that were recorded in the electronic medical record will be assessed for all participants

  Throughout the acute hospitalization, an average of 10.6 days

• Number of pressure ulcers during the hospital stay

  All pressure ulcers that developed during the acute hospitalization that were recorded in the electronic medical record will be assessed for all participants

  Throughout the acute hospitalization, an average of 10.6 days

• All-cause in-patient mortality during the hospital stay

  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

  Throughout the acute hospitalization, an average of 10.6 days

• Length of acute hospital stay

  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

  At the end of the acute hospitalization, an average of 10.6 days

• Discharge disposition

  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

  At the end of the acute hospitalization, an average of 10.6 days

• 30-day readmission rate

  The number of re-admissions to acute care at this hospital site in the 30 days following discharge will be collected for all participants.

  Within 30 days following the last day of acute hospitalization which is an average of 10.6 days

Secondary Outcomes (4)

• Usability of VR-therapy

  Throughout the acute hospitalization, an average of 10.6 days

• Number of participants with VR-therapy related adverse events as assessed by the post-intervention semi-structured interview and research coordinator observations

  Throughout the acute hospitalization, an average of 10.6 days

• In-Hospital Quality of Life Observational Scale

  Throughout the acute hospitalization, an average of 10.6 days

• Participant Experience and Satisfaction of VR-therapy

  Throughout the acute hospitalization, an average of 10.6 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

The control arm will not receive any VR-therapy sessions during their hospital stay.

Interventions

VR-therapy OTHER

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.

Also known as: Oculus Go Standalone Virtual Reality Headset, Oculus Go, Virtual Reality Headset, VR Headset, VR HMD, Virtual Reality

Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Centre for Aging and Brain Health Innovation: collaborator
• Michael Garron Hospital: collaborator

Study Sites (1)

Michael Garron Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Related Publications (16)

• Berman MG, Kross E, Krpan KM, Askren MK, Burson A, Deldin PJ, Kaplan S, Sherdell L, Gotlib IH, Jonides J. Interacting with nature improves cognition and affect for individuals with depression. J Affect Disord. 2012 Nov;140(3):300-5. doi: 10.1016/j.jad.2012.03.012. Epub 2012 Mar 31.

  PMID: 22464936 BACKGROUND

• Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.

  PMID: 19585957 BACKGROUND

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  PMID: 12628899 BACKGROUND

• Hughes JC, Louw SJ. Electronic tagging of people with dementia who wander. BMJ. 2002 Oct 19;325(7369):847-8. doi: 10.1136/bmj.325.7369.847. No abstract available.

  PMID: 12386013 BACKGROUND

• Kaplan R. The Nature of the View from Home: Psychological Benefits. Sage Publications 33(4): 507-542, 2001.

  BACKGROUND

• Kaplan S. The restorative benefits of nature: toward an integrative framework. Journal of Environmental Psychology 15: 169-182

  BACKGROUND

• Morita E, Fukuda S, Nagano J, Hamajima N, Yamamoto H, Iwai Y, Nakashima T, Ohira H, Shirakawa T. Psychological effects of forest environments on healthy adults: Shinrin-yoku (forest-air bathing, walking) as a possible method of stress reduction. Public Health. 2007 Jan;121(1):54-63. doi: 10.1016/j.puhe.2006.05.024. Epub 2006 Oct 20.

  PMID: 17055544 BACKGROUND

• Park BJ, Tsunetsugu Y, Kasetani T, Kagawa T, Miyazaki Y. The physiological effects of Shinrin-yoku (taking in the forest atmosphere or forest bathing): evidence from field experiments in 24 forests across Japan. Environ Health Prev Med. 2010 Jan;15(1):18-26. doi: 10.1007/s12199-009-0086-9.

  PMID: 19568835 BACKGROUND

• Park SH, Mattson RH. Ornamental indoor plants in hospital rooms enhanced health outcomes of patients recovering from surgery. J Altern Complement Med. 2009 Sep;15(9):975-80. doi: 10.1089/acm.2009.0075.

  PMID: 19715461 BACKGROUND

• Robinson L, Hutchings D, Corner L, Beyer F, Dickinson H, Vanoli A, Finch T, Hughes J, Ballard C, May C, Bond J. A systematic literature review of the effectiveness of non-pharmacological interventions to prevent wandering in dementia and evaluation of the ethical implications and acceptability of their use. Health Technol Assess. 2006 Aug;10(26):iii, ix-108. doi: 10.3310/hta10260.

  PMID: 16849002 BACKGROUND

• Ulrich RS. View through a window may influence recovery from surgery. Science. 1984 Apr 27;224(4647):420-1. doi: 10.1126/science.6143402.

  PMID: 6143402 BACKGROUND

• Ulrich, RS. Natural Versus Urban Scenes: Some Psychophysiological Effects. Environment and Behavior 13(5): 523-556, 1981.

  BACKGROUND

• Ulrich RS. Health Benefits of Gardens in Hospitals. Plants for People International Exhibition Floriade 2002.

  BACKGROUND

• 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.

  BACKGROUND

• Weiner MF, Martin-Cook K, Svetlik DA, Saine K, Foster B, Fontaine CS. The quality of life in late-stage dementia (QUALID) scale. J Am Med Dir Assoc. 2000 May-Jun;1(3):114-6.

  PMID: 12818023 BACKGROUND

• Appel L, Appel E, Kisonas E, Lewis-Fung S, Pardini S, Rosenberg J, Appel J, Smith C. Evaluating the Impact of Virtual Reality on the Behavioral and Psychological Symptoms of Dementia and Quality of Life of Inpatients With Dementia in Acute Care: Randomized Controlled Trial (VRCT). J Med Internet Res. 2024 Jan 30;26:e51758. doi: 10.2196/51758.

  PMID: 38289666 DERIVED

Related Links

• Elderly women with dementia view virtual reality films and provide feedback on their experience.
• The VRx RCT website offered to participants and/or their substitute decision makers to learn more about VR and the study.

MeSH Terms

Conditions

Dementia; Behavioral Symptoms; Cognitive Dysfunction; Delirium

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior; Cognition Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lora Appel, PhD

  OpenLab, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborating Scientist

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: May 7, 2019
• Study Start: May 6, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)