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| ID | Type | Description | Link |
|---|---|---|---|
| 1K76AG088424-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This trial aims to evaluate the feasibility, safety, and acceptability of a virtual reality (VR)-based cognitive stimulation game to reduce postoperative delirium among older surgical patients at high risk due to pre-existing cognitive impairment.
Delirium is a sudden, fluctuating disturbance in consciousness and cognition and is highly prevalent in older surgical patients. Delirium is preventable; non-pharmacological interventions, such as cognitive stimulation (CS), are the best preventive strategies. Implementing CS in acute hospital settings is a significant challenge due to limited resources and low patient engagement. Virtual reality (VR) and gamification for CS delivery could be a scalable, engaging solution. Based on my preliminary work, I hypothesize that VR- based CS games will be safe, feasible, and acceptable in high-risk older patients (Aim 1). The proposed study will estimate the intervention's effect on cognitive functions, particularly sustained attention (Aim 2), and the incidence of postoperative delirium (Aim 3). To accomplish the above goals, I will conduct a randomized controlled pilot trial involving 90 patients ≥65 years old with pre-existing cognitive impairment admitted to the hospital following a major surgery. Patients will be randomized 1:1:1 to receive VR-based CS games (intervention), watch a VR movie (VR control), or receive standard-of-care nurse-led reality orientation (Nurse control). The trial will provide me with preliminary data to support an R01 application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR intervention: VR-based cognitive stimulation games | Experimental | Participants will engage in interactive, VR-based cognitive stimulation games. |
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| VR Control: watching a movie in VR | Experimental | Participants will watch a non-interactive VR movie experience consisting of educational material. |
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| Nurse control: standard-of-care nurse-led reality orientation | Experimental | Participants will receive standard-of-care, nurse-led reality orientation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Software | Other | The ReCognition virtual reality (VR) software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions. The VR session will occur once per day for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the trial and VR-based cognitive stimulation intervention | A composite of recruitment rate, outcomes data completion, usability of VR intervention, acceptance of the VR intervention, and adherence to VR sessions | At Postoperative day 7 or Hospital discharge (whichever comes first) |
| Adherence of VR-based cognitive stimulation intervention | Number screened, consented, enrolled, and administered VR | Baseline to Postoperative day 7 or Hospital discharge (whichever comes first) |
| Safety of VR-based cognitive stimulation intervention | adverse event | Postoperative day 1 -3 |
| Acceptability of VR-based cognitive stimulation intervention | Behavioral intention scale score | At Postoperative day 7 or Hospital discharge (whichever comes first) |
| Usability of VR-based cognitive stimulation intervention | System usability scale score | At Postoperative day 7 or Hospital discharge (whichever comes first) |
| Measure | Description | Time Frame |
|---|---|---|
| Months backward test, pre-intervention | Measurement of attention and working memory (Cognitive outcome) | At Post operative day 1 |
| Months backward test, post-intervention | Measurement of attention and working memory |
| Measure | Description | Time Frame |
|---|---|---|
| Effect size of VR cognitive simulation games on postoperative delirium (Exploratory outcome) | At least one episode of delirium from postoperative day 1 through hospital discharge usinc CAM -ICU screening tool | Postoperative day 7 or Hospital discharge (whichever comes first) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hina Faisal, MD | Contact | 346-356-1400 | hfaisal@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Hina Faisal, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Virtual Reality movies | Other | This virtual reality software is delivered via an Oculus Quest 2 device. The Oculus Quest 2 device will be used to watch an educational movie. The VR session will occur once per day for 20 minutes. |
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| Nurse led control arm | Other | Reality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts. |
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| At Post-operative Day 3 |
| NIH Flanker test, pre-intervention | Measurement of attention and working memory (Cognitive outcome) | At Post operative day 1 |
| NIH Flanker test, post-intervention | Measurement of attention and working memory (Cognitive outcome) | At Post operative day 3 |
| VR games performances | Measurement of attention and working memory (Cognitive outcome) | At Postoperative day 1, 2 and 3 |
| Houston Methodist Research Insititute | Recruiting | Houston | Texas | 77030 | United States |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |