Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R03AG078857 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.
Virtual reality (VR) imitates reality by creating an artificial 3-dimensional (3D) environment using computing technology or software. A virtual environment (VE) is created using this software with a headset, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a VE allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled VE. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. We followed in similar footsteps and designed and developed a novel, 3D simulated software platform prototype called ReCognition VR to provide VR-based cognitive exercises.
A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers (NCT05583903). The results of this study showed that ReCognitionVR-based cognitive exercises were feasible, acceptable, and tolerable by older healthy subjects. In stage 2 of our research study, we want to evaluate the safety, feasibility, acceptability, and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital (HMH). Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed environment with beach wave sounds.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Software | Experimental | Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software |
|
| Traditional Orientation Methods | Active Comparator | Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Software | Other | The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE) | Percentage of participants who experience a treatment-emergent adverse event (TEAE) in the virtual reality software (experimental) arm compared to the Traditional Orientation Methods (control) arm. | Within 1 month of enrolling in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes | Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to VR software use and 10 minutes after VR software use. Change = 10-minute oxygen saturation - baseline oxygen saturation | Baseline and 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start | For participants in the experimental (virtual reality) arm, whether the patient completed 20 minutes of use of the ReCognition VR-based software | 20 minutes after the start of software use |
| Number of Participants With a System Usability Scale (SUS) Score >35 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hina Faisal, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Software | Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions. |
| FG001 | Traditional Orientation Methods | Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods, Traditional Orientation Methods: Standard-of-care methods to orient patients after surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Software | Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE) | Percentage of participants who experience a treatment-emergent adverse event (TEAE) in the virtual reality software (experimental) arm compared to the Traditional Orientation Methods (control) arm. | Posted | Number | percent | Within 1 month of enrolling in the study |
|
From the time of surgery to the time the patient was discharged from the hospital, up to 3 months after hospital admission
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Software | Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software Virtual Reality Software: The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hina Faisal | Department of Surgery, Houston Methodist Hospital | 713-714-4973 | hfaisal@houstonmethodist.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2023 | Jun 13, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Traditional Orientation Methods | Other | Standard-of-care methods to orient patients after surgery |
|
| Change From Baseline in Respiratory Rate After 10 Minutes |
Respiratory rate at baseline (immediately prior to virtual reality software use and 10 minutes after use. Change = 10-minute respiratory rate - baseline respiratory rate |
| Baseline and 10 minutes |
| Change From Baseline in Systolic Blood Pressure After 10 Minutes | Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and 10 minutes after software use. Change = 10-minute systolic blood pressure - baseline systolic blood pressure | Baseline and 10 minutes |
| Change From Baseline in Diastolic Blood Pressure After 10 Minutes | Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and 10 minutes after software use. Change = 10-minute diastolic blood pressure - baseline diastolic blood pressure | Baseline and 10 minutes |
| Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion | Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after completion of software use. Change = completion oxygen saturation - baseline oxygen saturation | Baseline and completion of the intervention, up to 2 hours |
| Change From Baseline in Respiratory Rate After Completion | Respiratory rate at baseline (immediately prior to virtual reality software use) and after software use. Change = completion respiratory rate - baseline respiratory rate | Baseline and completion of the intervention, up to 2 hours |
| Change From Baseline in Systolic Blood Pressure After Completion | Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after completion of software use. Change = completion systolic blood pressure - baseline systolic blood pressure | Baseline and completion of the intervention, up to 2 hours |
| Change From Baseline in Diastolic Blood Pressure After Completion | Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after software use. Change = completion diastolic blood pressure - baseline diastolic blood pressure | Baseline and completion of the intervention, up to 2 hours |
| Positive Confusion Assessment Method and/or 4 A's Test | The proportion of patients who have a positive Confusion Assessment Method (CAM) or 4 A's Test for delirium | Baseline to discharge from hospital, up to 3 months |
| Change in Visual Analog Scale (VAS) Pain Score | Change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from start of intervention to end of intervention (experimental arm) or enrollment to 24 hours post-enrollment (control arm) | Enrollment in study to 24 hours after study enrollment |
| Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention | Change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from pre-virtual reality use to 10 minutes after beginning use (experimental arm) or enrollment to 8-16 hours post-enrollment (control arm) | Virtual Reality Software arm: 10 minutes after beginning use; Traditional Orientation Methods arm: 8-16 hours after enrollment (one measure, window allowed for completing the measure) |
For participants in the experimental (virtual reality) arm, the number of participants with a System Usability Scale (SUS) score >35 on a scale of 0-100, where 0 is minimum and 100 is maximum; higher scores mean better usability. |
| After completion of use of the virtual reality software, up to 2 hours after the start of software use |
| Proportion of Participants Completing Game With No Errors | The proportion of participants in the experimental (virtual reality) arm who complete the virtual reality game without any user errors | After completion of use of the virtual reality software, up to 2 hours after the start of software use |
| Number of Participants Completing Game on First Attempt | For participants in the experimental (virtual reality) arm, the number of participants who complete the virtual reality game in easy mode on the first attempt | After completion of use of the virtual reality software, up to 2 hours after the start of software use |
| BG001 |
| Traditional Orientation Methods |
Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods, Traditional Orientation Methods: Standard-of-care methods to orient patients after surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Active smoker | Count of Participants | Participants |
|
| History of hypertension | Count of Participants | Participants |
|
| History of diabetes | Count of Participants | Participants |
|
| History of hypercholesterolemia | Count of Participants | Participants |
|
Patients randomized to the traditional orientation method, were visited by a nurse at the start of each nursing shift. The nurse asked them questions to check their memory and attention. Examples of questions include asking the patient for their name, the date, where they were, and what just happened to them. This will be repeated during every nurse shift change and is the usual care they would receive, even if they were not in the study. |
|
|
| Secondary | Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes | Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to VR software use and 10 minutes after VR software use. Change = 10-minute oxygen saturation - baseline oxygen saturation | This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software | Posted | Mean | Standard Deviation | percent oxygen saturation | Baseline and 10 minutes |
|
|
|
| Secondary | Change From Baseline in Respiratory Rate After 10 Minutes | Respiratory rate at baseline (immediately prior to virtual reality software use and 10 minutes after use. Change = 10-minute respiratory rate - baseline respiratory rate | This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software | Posted | Mean | Standard Deviation | breaths per minute | Baseline and 10 minutes |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure After 10 Minutes | Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and 10 minutes after software use. Change = 10-minute systolic blood pressure - baseline systolic blood pressure | This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software | Posted | Mean | Standard Deviation | mm Hg | Baseline and 10 minutes |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure After 10 Minutes | Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and 10 minutes after software use. Change = 10-minute diastolic blood pressure - baseline diastolic blood pressure | This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software | Posted | Mean | Standard Deviation | mm Hg | Baseline and 10 minutes |
|
|
|
| Secondary | Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion | Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after completion of software use. Change = completion oxygen saturation - baseline oxygen saturation | This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software | Posted | Mean | Standard Deviation | percent oxygen saturation | Baseline and completion of the intervention, up to 2 hours |
|
|
|
| Secondary | Change From Baseline in Respiratory Rate After Completion | Respiratory rate at baseline (immediately prior to virtual reality software use) and after software use. Change = completion respiratory rate - baseline respiratory rate | This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software | Posted | Mean | Standard Deviation | breaths per minute | Baseline and completion of the intervention, up to 2 hours |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure After Completion | Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after completion of software use. Change = completion systolic blood pressure - baseline systolic blood pressure | This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software | Posted | Mean | Standard Deviation | mm Hg | Baseline and completion of the intervention, up to 2 hours |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure After Completion | Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after software use. Change = completion diastolic blood pressure - baseline diastolic blood pressure | This analysis was only performed for the experimental arm because participants in the active comparator arm (traditional orientation methods) were not exposed to the virtual reality software | Posted | Mean | Standard Deviation | mm Hg | Baseline and completion of the intervention, up to 2 hours |
|
|
|
| Secondary | Positive Confusion Assessment Method and/or 4 A's Test | The proportion of patients who have a positive Confusion Assessment Method (CAM) or 4 A's Test for delirium | Posted | Count of Participants | Participants | Baseline to discharge from hospital, up to 3 months |
|
|
|
| Secondary | Change in Visual Analog Scale (VAS) Pain Score | Change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from start of intervention to end of intervention (experimental arm) or enrollment to 24 hours post-enrollment (control arm) | Posted | Median | Inter-Quartile Range | score on a scale | Enrollment in study to 24 hours after study enrollment |
|
|
|
|
| Secondary | Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention | Change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from pre-virtual reality use to 10 minutes after beginning use (experimental arm) or enrollment to 8-16 hours post-enrollment (control arm) | Posted | Median | Inter-Quartile Range | score on a scale | Virtual Reality Software arm: 10 minutes after beginning use; Traditional Orientation Methods arm: 8-16 hours after enrollment (one measure, window allowed for completing the measure) |
|
|
|
|
| Other Pre-specified | Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start | For participants in the experimental (virtual reality) arm, whether the patient completed 20 minutes of use of the ReCognition VR-based software | Posted | Count of Participants | Participants | 20 minutes after the start of software use |
|
|
|
| Other Pre-specified | Number of Participants With a System Usability Scale (SUS) Score >35 | For participants in the experimental (virtual reality) arm, the number of participants with a System Usability Scale (SUS) score >35 on a scale of 0-100, where 0 is minimum and 100 is maximum; higher scores mean better usability. | Posted | Count of Participants | Participants | After completion of use of the virtual reality software, up to 2 hours after the start of software use |
|
|
|
| Other Pre-specified | Proportion of Participants Completing Game With No Errors | The proportion of participants in the experimental (virtual reality) arm who complete the virtual reality game without any user errors | Posted | Count of Participants | Participants | After completion of use of the virtual reality software, up to 2 hours after the start of software use |
|
|
|
| Other Pre-specified | Number of Participants Completing Game on First Attempt | For participants in the experimental (virtual reality) arm, the number of participants who complete the virtual reality game in easy mode on the first attempt | Posted | Count of Participants | Participants | After completion of use of the virtual reality software, up to 2 hours after the start of software use |
|
|
|
| Post-Hoc | Change in Virtual Analog Scale (VAS) Pain Score From Pre-virtual Reality Use to 10 Minutes After Beginning Use (Experimental Arm) or Enrollment to 8-16 Hours Post-enrollment (Control Arm) | Whether change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from pre-virtual reality use to mid-intervention (experimental)/observation (control), grouped by whether the pain score increased, stayed the same (no change), or decreased | Posted | Count of Participants | Participants | Virtual Reality Software arm: 10 minutes after beginning use; Traditional Orientation Methods arm: at 8-16 hours after enrollment (one measure, window allowed for completing the measure) |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Traditional Orientation Methods | Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods, Traditional Orientation Methods: Standard-of-care methods to orient patients after surgery | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| Increased |
|