DementiaVRx-RCTNCT03941119
Evaluating the Impact of VR-therapy on BPSD and QoL of Individuals With Dementia Admitted to Hospital
A study testing VR-therapy in people with Dementia and Delirium Superimposed on Dementia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Delirium Superimposed on Dementia
- What is being tested?
- VR-therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2019to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who are 65 years of age or older.
- Patients admitted to Michael Garron Hospital (MGH).
- Patients diagnosed with, or suspected to have, dementia.
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Dementia, Delirium Superimposed on Dementia
- Being tested
- VR-therapy
- 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
- Medical subject headings
- Dementia, Behavioral Symptoms, Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-therapyOther
Also called Oculus Go Standalone Virtual Reality Headset, Oculus Go, Virtual Reality Headset, VR Headset
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: VR-therapy |
| Control | No intervention | The control arm will not receive any VR-therapy sessions during their hospital stay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Throughout the acute hospitalization, an average of 10.6 days
In-Hospital Quality of Life Observational Scale
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.
Measured: Throughout the acute hospitalization, an average of 10.6 days
Participant Experience and Satisfaction of VR-therapy
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.
Measured: Throughout the acute hospitalization, an average of 10.6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start6 May 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: All recruitment activities for this study (with acutely ill inpatients with dementia) stopped due to the COVID pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, Michael Garron Hospital
- Responsible party
- Principal investigator, Lora Appel, University Health Network, Toronto
- Investigators
- Lora Appel, PhD, Principal investigator, OpenLab, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941119
- Sponsor's protocol ID
- 782-1812-Mis-332
- Acronym
- VRx-RCT
- Status last verified
- Nov 2020
- First submitted
- 15 Jan 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22464936Brodaty 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.
PubMed 19585957Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.
PubMed 12628899Hughes 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.
PubMed 12386013Kaplan 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
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.
PubMed 17055544Park 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.
PubMed 19568835Park 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.
PubMed 19715461Robinson 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.
PubMed 16849002Ulrich RS. View through a window may influence recovery from surgery. Science. 1984 Apr 27;224(4647):420-1. doi: 10.1126/science.6143402.
PubMed 6143402Ulrich, 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.
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.
PubMed 12818023
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03941119
- Acronym / sponsor ID
- VRx-RCT / 782-1812-Mis-332
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All recruitment activities for this study (with acutely ill inpatients with dementia) stopped due to the COVID pandemic.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, Michael Garron Hospital
- Study start
- 6 May 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: VR-therapyThe 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. |
| Control | No intervention | –The control arm will not receive any VR-therapy sessions during their hospital stay. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients who are 65 years of age or older.
- Patients admitted to Michael Garron Hospital (MGH).
- Patients diagnosed with, or suspected to have, dementia.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-therapyAlso: Oculus Go Standalone Virtual Reality Headset, Oculus Go, Virtual Reality Headset, VR HeadsetWearing 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 | Intervention |
Primary outcome
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
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
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
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
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
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
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
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.
4 secondary outcomes
Usability of VR-therapy
Time frame: 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
Time frame: Throughout the acute hospitalization, an average of 10.6 days
In-Hospital Quality of Life Observational Scale
Time frame: Throughout the acute hospitalization, an average of 10.6 days
Participant Experience and Satisfaction of VR-therapy
Time frame: Throughout the acute hospitalization, an average of 10.6 days
Results and safety
The study was stopped early (reason given: All recruitment activities for this study (with acutely ill inpatients with dementia) stopped due to the COVID pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 22464936Berman 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.
- Background: PubMed 19585957Brodaty 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.
- Background: PubMed 12628899Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.
- Background: PubMed 12386013Hughes 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.
- BackgroundKaplan R. The Nature of the View from Home: Psychological Benefits. Sage Publications 33(4): 507-542, 2001.
- BackgroundKaplan S. The restorative benefits of nature: toward an integrative framework. Journal of Environmental Psychology 15: 169-182
- Background: PubMed 17055544Morita 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.
- Background: PubMed 19568835Park 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.
- Background: PubMed 19715461Park 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.
- Background: PubMed 16849002Robinson 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.
- Background: PubMed 6143402Ulrich RS. View through a window may influence recovery from surgery. Science. 1984 Apr 27;224(4647):420-1. doi: 10.1126/science.6143402.
- BackgroundUlrich, RS. Natural Versus Urban Scenes: Some Psychophysiological Effects. Environment and Behavior 13(5): 523-556, 1981.
- Elderly women with dementia view virtual reality films and provide feedback on their experience.Link provided by the sponsor.
- The VRx RCT website offered to participants and/or their substitute decision makers to learn more about VR and the study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora Appel, PhD principal investigator
OpenLab, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-therapy in people with Dementia and Delirium Superimposed on Dementia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: All recruitment activities for this study (with acutely ill inpatients with dementia) stopped due to the COVID pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941119, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.