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| Name | Class |
|---|---|
| Clemson University | OTHER |
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Background: Nature-based virtual reality (VR) and other outdoor experiences in head-mounted displays (HMDs) offer powerful, non-pharmacological tools for hospice teams to help patients undergoing end-of-life (EOL) transitions. However, the psychological distress of the patient-caregiver dyad is interconnected and highlights the interdependence and responsiveness to distress as a unit. Hospice care services and healthcare need strategies to help patients and informal caregivers with EOL transitions.
Methods: This study uses a synchronized Tandem VR approach where patient- caregiver dyads experience immersive nature-based and other outdoor VR content. This mixed methods study will recruit 20 patient-caregiver dyads (N = 40) enrolled in home hospice services nearing the end-of-life. Dyads will experience a personalized nature-based or other outdoor VR experience lasting 5-15 minutes. Self-reported questionnaires and semi-structured interviews will be collected before and after the VR intervention to identify the impacts of personalized nature-based and other outdoor Tandem VR experiences on the QOL, pain, and fear of death in patient-caregiver dyads enrolled with hospice services. Additionally, this protocol will determine the acceptance of personalized nature-based and other outdoor Tandem VR experiences by dyads as a non-pharmacological modality for addressing patient and caregiver needs. Acceptance was quantified by the number of dyads accepting or declining the VR experience during recruitment.
Discussion: Using personalized, nature-based and other outdoor VR experiences, the patient-caregiver dyads can simultaneously engage in an immersive encounter to help alleviate symptoms associated with declining health and EOL phases for the patient and the often overburdened caregiver. This protocol focuses on meeting the need for person- and caregiver-centered, non-pharmacological interventions to reduce physical, psychological, and spiritual distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tandem Virtual Reality Experience | Experimental | Tandem VR Intervention After the surveys are completed, the researchers will share a personalized library of immersive, nature-based, 360-degree VR experiences for the participant-caregiver dyads to choose from based on their VR Intake Form. Once the dyad has determined their desired Tandem VR experience from the library, the researchers will assist the dyads in donning the VR head mounted display (HMD). The researchers will ensure the safety of both dyads while using the HMDs. The researchers will then initiate the Tandem VR experience. The duration of the Tandem VR experience will be 5-15 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem Virtual Reality | Device | Hospice patients and their primary caregiver will each wear virtual reality headsets and will experience a customized and synchronized 5-15min virtual reality experience. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Domains | Quality of life will be measured with the McGill Quality of Life Questionnaire (MQOL-E). This assesses eight important life domains: cognition, healthcare, environment, feeling like a burden, and their relationships with physical, psychological, social, and existential/spiritual domains. The 16-item questionnaire uses a 0-10 response scale with a higher score indicating a higher quality of life. | 15 minutes |
| Fear of Death | The Collett-Lester Fear of Death Scale (CL-FODS), measures changes in perception of fear of death and 28 items. The CL-FODS uses a 5-Likert scale ranging from 1= not to 5=very for how disturbed or made anxious a person is by different aspects of death and dying. A higher score indicates a higher fear of death. Some example items include rating how disturbed or made anxious you are about the shortness of life, the lack of control over dying, and feeling lonely without your person. The CL-FODS has four subsections: Death of Self, Death of Others, Dying of Self, and Dying of Others. The means of each subsection and then the total scale scores illustrate the degree of anxiety about death and dying, with a higher value indicating the severity of anxiety about death and dying. | 15 minutes |
| Perception of Pain | Wisconsin Brief Pain Scale Questionnaire will assess perception of pain. Patients will rate their pain from 0=no pain to 10=worst pain imaginable in response to items such as "average pain," "worst pain," "least pain" over the last seven days, and "pain right now." An average of the responses to these items is used to create a single pain severity score. A higher score indicates more perceptions of pain. | 15 minutes |
| Acceptance of Tandem VR | Determine the acceptance of personalized nature-based Tandem VR experiences by dyads as a non-pharmacological modality for addressing the needs of dyads. Acceptance is quantified by the number of dyads accepting or declining the VR experience during recruitment. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua K Pope | Prisma Health Hospice of the Foothills | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cottingham Hospice House | Seneca | South Carolina | 29672 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39045392 | Derived | McAnirlin O, Thrift J, Li F, Pope JK, Browning MHEM, Moutogiannis PP, Thomas G, Farrell E, Evatt MM, Fasolino T. The Tandem VR protocol: Synchronized nature-based and other outdoor experiences in virtual reality for hospice patients and their caregivers. Contemp Clin Trials Commun. 2024 Jun 22;40:101318. doi: 10.1016/j.conctc.2024.101318. eCollection 2024 Aug. |
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The patient and informal caregiver were screened for the inclusion criteria in the clinic setting before being presented to the intervention team for consent and approval. Upon presenting to the intervention team, a patient and their informal caregiver were then assigned a dyad number. Verbal consent for the intervention was obtained via a phone conversation, which also included setting the date and time of the intervention. Written consent was obtained on the date and time of the intervention.
Recruitment began February 1, 2024, and concluded November 20, 2024. Recruitment began in the clinic setting, using the Uptake Form to assess the patient and informal caregiver interest in the VR intervention for deployment in the home environment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tandem Virtual Reality Experience for Patients | Tandem VR Intervention After the surveys are completed, the researchers will share a personalized library of immersive, nature-based, 360-degree VR experiences for the patient-caregiver dyads to choose from based on their VR Intake Form. Once the dyad has determined their desired Tandem VR experience from the library, the researchers will assist the dyads in donning the VR head-mounted display (HMD). The researchers will ensure the safety of the dyads during HMD use. The researchers will then initiate the Tandem VR experience. The Tandem VR experience will last 5-15 minutes. |
| FG001 | Tandem Virtual Reality Experience for Informal Caregivers | Tandem VR Intervention After the surveys are completed, the researchers will share a personalized library of immersive, nature-based, 360-degree VR experiences for the patient-caregiver dyads to choose from based on their VR Intake Form. Once the dyad has determined their desired Tandem VR experience from the library, the researchers will assist the dyads in donning the VR head-mounted display (HMD). The researchers will ensure the safety of the dyads during HMD use. The researchers will then initiate the Tandem VR experience. The Tandem VR experience will last 5-15 minutes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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11 dyads were subjects in the intervention, 11 patients and 11 informal caregivers for a total of 22 individuals participating.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tandem Virtual Reality Experience for Patients | This arm describes the baseline characteristics of the patients enrolled in the Tandem VR intervention. |
| BG001 | Tandem Virtual Reality Experience for Informal Caregivers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number of participants for the dyads (patient and informal caregiver). |
| 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 | Quality of Life Domains | Quality of life will be measured with the McGill Quality of Life Questionnaire (MQOL-E). This assesses eight important life domains: cognition, healthcare, environment, feeling like a burden, and their relationships with physical, psychological, social, and existential/spiritual domains. The 16-item questionnaire uses a 0-10 response scale with a higher score indicating a higher quality of life. | The quality of life questionnaire assessed the impact of the Tandem VR experience on the patient-caregiver dyad's perception of benefit over the past 2 days. Positive values would have indicated a benefit (ie, greater well-being); Post-pre | Posted | Dec 2025 | Mean | Standard Deviation | units on a scale | 15 minutes |
|
From the initiation of the intervention until the intervention was stopped before completion, 10 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events During Tandem VR Intervention Reported by Patient | Reported Adverse Events occurring based on protocol eligibility criteria related to cybersickness, such as patients with motion sickness, patients with claustrophobia, patients with visual and hearing impairment, patients with inability to speak English. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness in Tandem VR Intervention | Social circumstances | Non-systematic Assessment | Patient and Caregiver were engaged in Tandem VR intervention when the patient reported feeling dizzy.Tandem VR intervention was halted immediately upon self-report by the patient. |
Limitations of the study:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Thrift, Assistant Professor | Clemson University | 8649408536 | jasont@clemson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 21, 2024 | Mar 10, 2026 | Prot_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2024 | Mar 10, 2026 | SAP_008.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2024 | Mar 16, 2026 | ICF_010.pdf |
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| ID | Term |
|---|---|
| D003643 | Death |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| C000719207 | Necrophobia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Multiple Method Design
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| 1 minute |
| Perceived Benefits and Value of Tandem VR | Semi-structured interview data will be gathered and examined using a thematic analysis to capture the perceived benefits and value of Tandem VR. | 20 minutes |
This arm describes the baseline characteristics of the informal caregivers enrolled in the Tandem VR intervention.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Number of participants for the dyads (patient and informal caregiver). | No differences in population numbers should be observed in the provided data. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number of participants for the dyads (patient and informal caregiver). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Number of participants for the dyads (patient and informal caregiver). | No differences in population numbers should be observed in the provided data. | Count of Participants | Participants |
|
| Region of Enrollment | Number of participants for the dyads (patient and informal caregiver). | No differences in population numbers should be observed in the provided data. | Count of Participants | Participants |
|
| Virtual Reality Content | This measure pertains to the type of 360-degree videos that patient and caregiver dyads selected | Count of Participants | Participants |
|
| OG001 | Quality of Life-Informal Caregivers | The Quality of Life Questionnaire assesses how the individual perceives their physical, emotional, social, spiritual, and financial well-being over the previous days, typically the last 2 days, and allows them to rate those perceptions on a 0-10 scale. |
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| Primary | Fear of Death | The Collett-Lester Fear of Death Scale (CL-FODS), measures changes in perception of fear of death and 28 items. The CL-FODS uses a 5-Likert scale ranging from 1= not to 5=very for how disturbed or made anxious a person is by different aspects of death and dying. A higher score indicates a higher fear of death. Some example items include rating how disturbed or made anxious you are about the shortness of life, the lack of control over dying, and feeling lonely without your person. The CL-FODS has four subsections: Death of Self, Death of Others, Dying of Self, and Dying of Others. The means of each subsection and then the total scale scores illustrate the degree of anxiety about death and dying, with a higher value indicating the severity of anxiety about death and dying. | Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of they dying process Fear of another person's death Fear of another person's dying process These were assessed Pre and Post experience in Tandem VR. Negative values indicate a benefit (ie, reduced fear); Post-pre | Posted | Mean | Standard Deviation | units on a scale | 15 minutes |
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| Primary | Perception of Pain | Wisconsin Brief Pain Scale Questionnaire will assess perception of pain. Patients will rate their pain from 0=no pain to 10=worst pain imaginable in response to items such as "average pain," "worst pain," "least pain" over the last seven days, and "pain right now." An average of the responses to these items is used to create a single pain severity score. A higher score indicates more perceptions of pain. | Means of the effects of the Tandem VR experience on the patient-caregiver dyad perceptions of pain, with negative values indicating a benefit (ie less pain); Post-pre | Posted | Mean | Standard Deviation | units on a scale | 15 minutes |
|
|
|
| Primary | Acceptance of Tandem VR | Determine the acceptance of personalized nature-based Tandem VR experiences by dyads as a non-pharmacological modality for addressing the needs of dyads. Acceptance is quantified by the number of dyads accepting or declining the VR experience during recruitment. | Posted | Count of Participants | Participants | 1 minute |
|
|
|
| Primary | Perceived Benefits and Value of Tandem VR | Semi-structured interview data will be gathered and examined using a thematic analysis to capture the perceived benefits and value of Tandem VR. | Major Themes of the Semi-Structured Interviews with an exemplar:
| Posted | Count of Participants | Participants | 20 minutes |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Adverse Events During Tandem VR Intervention Reported by Informal Caregiver | Reported Adverse Events occurring based on protocol eligibility criteria related to cybersickness, such as patients with motion sickness, patients with claustrophobia, patients with visual and hearing impairment, patients with inability to speak English. | 0 | 13 | 0 | 13 | 0 | 13 |
|
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| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|