Trial Outcomes & Findings for Tandem VR: Synchronized Nature-Based Experiences in Virtual Reality for Hospice Patients and Their Caregivers (NCT NCT06186960)

NCT ID: NCT06186960

Last Updated: 2026-04-06

Results Overview

Semi-structured interview data will be gathered and examined using a thematic analysis to capture the perceived benefits and value of Tandem VR.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

20 minutes

Results posted on

2026-04-06

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
13
13
Overall Study
COMPLETED
11
11
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Adverse Event
1
1
Overall Study
Withdrawal by Subject
1
1

Baseline Characteristics

No differences in population numbers should be observed in the provided data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tandem Virtual Reality Experience for Patients
n=11 Participants
This arm describes the baseline characteristics of the patients enrolled in the Tandem VR intervention.
Tandem Virtual Reality Experience for Informal Caregivers
n=11 Participants
This arm describes the baseline characteristics of the informal caregivers enrolled in the Tandem VR intervention.
Total
n=22 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
8 Participants
n=5 Participants
9 Participants
n=10 Participants
Age, Categorical
>=65 years
10 Participants
n=5 Participants
3 Participants
n=5 Participants
13 Participants
n=10 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
9 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
16 Participants
n=10 Participants • No differences in population numbers should be observed in the provided data.
Sex: Female, Male
Male
4 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
2 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
6 Participants
n=10 Participants • No differences in population numbers should be observed in the provided data.
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
1 Participants
n=5 Participants
2 Participants
n=10 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
10 Participants
n=5 Participants
20 Participants
n=10 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
0 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
0 Participants
n=10 Participants • No differences in population numbers should be observed in the provided data.
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
11 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
22 Participants
n=10 Participants • No differences in population numbers should be observed in the provided data.
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
0 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
0 Participants
n=10 Participants • No differences in population numbers should be observed in the provided data.
Region of Enrollment
United States
11 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
11 Participants
n=5 Participants • No differences in population numbers should be observed in the provided data.
22 Participants
n=10 Participants • No differences in population numbers should be observed in the provided data.
Virtual Reality Content
Past Home Videos
5 Participants
n=5 Participants
5 Participants
n=5 Participants
10 Participants
n=10 Participants
Virtual Reality Content
Bucket List Destinations
6 Participants
n=5 Participants
6 Participants
n=5 Participants
12 Participants
n=10 Participants
Virtual Reality Content
Bucket List Experiences
6 Participants
n=5 Participants
6 Participants
n=5 Participants
12 Participants
n=10 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: 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

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.

Outcome measures

Outcome measures
Measure
Quality of Life-Patients
n=11 Participants
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.
Quality of Life-Informal Caregivers
n=11 Participants
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.
Fear of Another Person's Death-Patients
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Patients
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Their Own Death-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Dying Process-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Death-Informal Cargivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Quality of Life Domains
1.68 units on a scale
Standard Deviation 3.66
1.27 units on a scale
Standard Deviation 1.90

PRIMARY outcome

Timeframe: 15 minutes

Population: 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

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.

Outcome measures

Outcome measures
Measure
Quality of Life-Patients
n=11 Participants
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.
Quality of Life-Informal Caregivers
n=11 Participants
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.
Fear of Another Person's Death-Patients
n=11 Participants
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Patients
n=11 Participants
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Their Own Death-Informal Caregivers
n=11 Participants
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Dying Process-Informal Caregivers
n=11 Participants
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Death-Informal Cargivers
n=11 Participants
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Informal Caregivers
n=11 Participants
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Death
-0.04 units on a scale
Standard Deviation 0.24
0.50 units on a scale
Standard Deviation 0.96
-0.31 units on a scale
Standard Deviation 1.18
-0.11 units on a scale
Standard Deviation 1.75
0.00 units on a scale
Standard Deviation 0.33
0.50 units on a scale
Standard Deviation 0.40
-0.51 units on a scale
Standard Deviation 0.64
-0.23 units on a scale
Standard Deviation 0.61

PRIMARY outcome

Timeframe: 15 minutes

Population: 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

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.

Outcome measures

Outcome measures
Measure
Quality of Life-Patients
n=11 Participants
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.
Quality of Life-Informal Caregivers
n=11 Participants
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.
Fear of Another Person's Death-Patients
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Patients
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Their Own Death-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Dying Process-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Death-Informal Cargivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Perception of Pain
-0.64 units on a scale
Standard Deviation 1.43
-0.18 units on a scale
Standard Deviation 1.66

PRIMARY outcome

Timeframe: 1 minute

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.

Outcome measures

Outcome measures
Measure
Quality of Life-Patients
n=22 Participants
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.
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.
Fear of Another Person's Death-Patients
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Patients
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Their Own Death-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Dying Process-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Death-Informal Cargivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Acceptance of Tandem VR
22 Participants

PRIMARY outcome

Timeframe: 20 minutes

Population: Major Themes of the Semi-Structured Interviews with an exemplar: 1. Found Joy 2. Together Again 3. Great Experience

Semi-structured interview data will be gathered and examined using a thematic analysis to capture the perceived benefits and value of Tandem VR.

Outcome measures

Outcome measures
Measure
Quality of Life-Patients
n=22 Participants
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.
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.
Fear of Another Person's Death-Patients
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Patients
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Their Own Death-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Dying Process-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Death-Informal Cargivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Fear of Another Person's Dying Process-Informal Caregivers
The Fear of Death Questionnaire assessed the patient and informal caregivers on the following parameters: Fear of their own death Fear of the 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.
Perceived Benefits and Value of Tandem VR
Found Joy
22 Participants
Perceived Benefits and Value of Tandem VR
Together Again
4 Participants
Perceived Benefits and Value of Tandem VR
Great Experience
8 Participants

Adverse Events

Adverse Events During Tandem VR Intervention Reported by Patient

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Adverse Events During Tandem VR Intervention Reported by Informal Caregiver

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Adverse Events During Tandem VR Intervention Reported by Patient
n=13 participants at risk
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.
Adverse Events During Tandem VR Intervention Reported by Informal Caregiver
n=13 participants at risk
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.
Social circumstances
Dizziness in Tandem VR Intervention
7.7%
1/13 • From the initiation of the intervention until the intervention was stopped before completion, 10 minutes
0.00%
0/13 • From the initiation of the intervention until the intervention was stopped before completion, 10 minutes

Additional Information

Jason Thrift, Assistant Professor

Clemson University

Phone: 8649408536

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60