Tandem VR: Synchronized Nature-Based Experiences in Virtual Reality for Hospice Patients and Their Caregivers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Tandem VR: Synchronized Nature-Based Experiences in Virtual Reality for Hospice Patients and Their Caregivers (NCT06186960), a na na study. The primary outcome is Quality of Life Domains.

2. Clinical Question

The study addresses whether a shared, nature-based VR experience can be evaluated in the context of hospice care, where the registry describes patient and caregiver distress as interconnected. Its design is descriptive rather than comparative: the record does not identify a control arm or randomized allocation. Consequently, the clinical question reflected in the recorded design is about experience and measured change within a single group, not whether Tandem VR performs better than another approach. The registry record does not report a numerical pre-intervention value, post-intervention value, change estimate, or uncertainty interval for the primary outcome. No conclusion about the size or direction of quality-of-life change can be drawn from the recorded outcome information.

3. Trial Design

NCT06186960 is a completed, single-group study sponsored by Prisma Health-Upstate. Its title is “Tandem VR: Synchronized Nature-Based Experiences in Virtual Reality for Hospice Patients and Their Caregivers.” The record lists the phase as NA, allocation as NA, masking as none, and the model as single group. Enrollment is listed as 26. The recorded start date is 2024-03-01 and the primary completion date is 2024-11-20.

The intervention is named Tandem Virtual Reality and classified as a device. The description says that, after surveys, researchers would share a personalized library of immersive, nature-based, 360-degree VR experiences, with the dyad choosing an experience based on its VR Intake Form. The remaining intervention description is incomplete in the registry record, so other procedural details are not reported there.

A single-group design can describe participants’ measured outcomes over time, but without a separate comparison group it cannot distinguish change associated with the intervention from change that might occur for other reasons. The record does not describe random assignment, and its allocation field is NA. It also does not describe masking beyond recording none. The study therefore should not be read as a randomized, masked comparison.

The registry lists five outcome measures and zero analyses. The primary measure is “Quality of Life Domains,” assessed with the MQOL-E at a timeframe of 15 minutes. The record gives the scale’s general structure and scoring direction, but does not report an analyzed estimate for the primary outcome. The record also does not report a protocol-based sample-size justification, a planned statistical analysis, interim analyses, or a detailed participant flow. Such information is not reported in the registry record and should not be inferred from the design fields or enrollment figure.

The safety entries separately describe adverse events reported by patients and informal caregivers. Each entry lists 13 participants at risk. These safety counts are descriptive and do not create a control comparison. The registry record does not state that the 26 enrolled participants can be divided into particular dyads or explain how the analysis handled pairing between patients and caregivers.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 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

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: 11 dyads were subjects in the intervention, 11 patients and 11 informal caregivers for a total of 22 individuals participating.

6. Primary Endpoint

The registry lists the primary outcome as Quality of Life Domains, measured over 15 minutes.

The primary endpoint is titled “Quality of Life Domains.” It uses the McGill Quality of Life Questionnaire (MQOL-E), which the registry describes as a 16-item questionnaire with a 0-10 response scale. The questionnaire assesses eight important life domains, including cognition, healthcare, environment, feeling like a burden, and physical, psychological, social, and existential or spiritual relationships. A higher score indicates higher quality of life.

The registry describes the endpoint as assessing the patient-caregiver dyad’s perception of benefit over the past 2 days. It states that positive post-pre values would indicate benefit, described as greater well-being. The outcome is reported in units on a scale, with the mean and standard deviation identified as the summary measures. Its listed timeframe is 15 minutes.

In general, a quality-of-life measure can capture aspects of experience that are not represented by a single clinical event. A multidomain questionnaire can also describe different areas of well-being rather than reducing the construct to one symptom. Those general strengths do not establish that a measured change occurred in this study. The registry record does not report the endpoint’s observed mean, standard deviation, pre-post change, or confidence interval. It also does not give enough detail to determine how domain scores were combined or whether each domain was analyzed separately. The endpoint’s measurement description is available, but its numerical result and analytic interpretation are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a continuous measure summarized by a mean and standard deviation. In general, a mean describes the central value of observations on a numeric scale, while a standard deviation describes how spread out individual observations are around that mean. These summaries can help characterize a group, but they do not by themselves establish a treatment effect. For a pre-post question, an analysis might summarize the change for each participant or compare measurements over time using a specified model. The registry record does not report which analysis was planned or performed, nor does it report a numerical result.

What does a confidence interval communicate?

In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the statistical method used. A narrow interval indicates greater precision than a wide interval, while an interval spanning values in different directions can leave the direction and size of an effect uncertain. A confidence interval is not reported for the primary endpoint in the registry record. There is therefore no basis for describing the precision of a quality-of-life estimate or for judging which effect sizes remain compatible with the data.

What can a single-group design establish?

In general, repeated measurements in one group can describe whether recorded values differ over time. They cannot, on their own, separate a change associated with an intervention from other changes occurring during the same period. A control group can offer a contemporaneous reference, and randomization can help make groups comparable on average. This study is listed as single group, with allocation recorded as NA. It does not provide the like-for-like control comparison needed to interpret a between-group treatment contrast. The registry record also does not report a detailed pre-post analysis plan.

Why does the dyad matter for analysis?

The study concerns patients and informal caregivers, and the registry describes their distress as interconnected. In general, measurements from members of a dyad may be statistically related. If an analysis includes both members, a method that assumes every observation is independent may understate uncertainty when observations are correlated. A paired or otherwise correlation-aware method can account for that structure, depending on the research question and data collected. The registry record does not report whether both members contributed to the primary endpoint, how their observations were combined, or whether dependence within dyads was modeled. The safety entries are separated by reporter, but that alone does not identify the primary outcome analysis structure.

What do the planning assumptions mean?

The registry record describes a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. In general, a sample-size calculation estimates the number of participants that would be needed under specified assumptions to have a chosen probability of detecting an effect of a given size. Such an illustration is not observed power and does not show that the completed study had adequate power. Its two-arm equal-allocation assumption also does not match the recorded single-group design. No sample-size justification for the study’s own design is reported in the registry record, and no planning output is stated in the information available for interpretation.

Why does over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a statistical model assumes. If a model understates variability, standard errors may be too small and uncertainty may appear lower than it is. This concept is particularly relevant when modeling counts, where a simple model may not capture extra variation across people or settings. The primary endpoint is described as a continuous scale, and the registry record does not report a model, variance estimate, or evidence of over-dispersion. It would therefore be inappropriate to claim that over-dispersion was present or addressed in this study.

The record lists five outcome measures but does not report the statistical plan, analysis populations, handling of missing data, or analysis results. Those omissions prevent evaluation of model selection, assumptions, confidence intervals, hypothesis tests, or robustness checks. Statistical methods can explain what reported estimates would mean, but cannot replace the missing estimates or establish an unreported analysis.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Quality of Life-Patients", "Quality of Life-Informal Caregivers")
n   <- c(11, 11)
m   <- c(1.68, 1.27)
sp  <- c(3.66, 1.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Quality of Life-Patients  11  1.680  3.660  -0.779  4.139
CARM  Quality of Life-Informal Caregivers  11  1.270  1.900  -0.006  2.546

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and zero analyses. It does not report whether the primary outcome was designated before data collection in a protocol, whether secondary outcomes were tested, or whether any adjustment for multiple comparisons was planned. When several outcomes or tests are examined, the chance of obtaining at least one apparently unusual result can increase. In general, a prespecified hierarchy or a multiplicity adjustment can help control the interpretation of multiple tests. No such strategy is reported in the registry record, so it cannot be assessed.

The record does not report the number of participants with available primary outcome data, the number completing each assessment, or reasons for missing measurements. It also does not describe imputation, complete-case analysis, or any other method for handling missing data. In general, missingness can affect an estimate when the availability of a measurement is related to a participant’s outcome or characteristics. Without counts and methods, the extent and possible influence of missing data cannot be evaluated.

Analysis populations are not described in the registry record. It is not reported whether the primary outcome was analyzed among all enrolled participants, those who received the intervention, those with complete measurements, or another defined group. The enrollment figure of 26 does not establish the outcome-analysis denominator. Likewise, the 13 participants at risk in each safety entry describe safety reporting and should not be taken as a denominator for the primary endpoint.

The registry record does not report a statistical analysis plan, interim analyses, or rules for excluding observations. These are not assumptions that can be reconstructed from the outcome description. As a result, the choice of analysis population, treatment of missing values, and approach to multiple outcomes remain unknown.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists serious adverse events separately for events reported by patients and by informal caregivers during the Tandem VR intervention. In the patient-reported group, 13 were at risk, zero serious adverse events were recorded, one other adverse event was recorded, and zero deaths were listed. In the informal-caregiver-reported group, 13 were at risk, zero serious adverse events were recorded, zero other adverse events were recorded, and zero deaths were listed.

These are counts in the registry record, not estimates of comparative risk. There is no control group in the listed design, and the record does not provide a comparison of event frequency against another intervention or usual care. The patient and caregiver entries are separate reporting groups; they should not be interpreted as independent trial arms or as a randomized comparison.

In general, a zero count means no event of that category was recorded among the listed participants at risk; it does not prove that the underlying risk is zero. The registry record does not report detailed event definitions, the method or completeness of event collection, exposure duration, or an event-level narrative. It also lists no serious-event terms. The figures therefore describe the posted safety counts but do not support broader claims about safety beyond those entries.

13. What the Result Does, and Does Not, Mean

The registry record describes a completed single-group study of Tandem Virtual Reality for hospice patients and their caregivers. It identifies a quality-of-life endpoint measured with the MQOL-E and provides the scale’s response range, domains, and scoring direction. It also records adverse-event counts separately for patients and informal caregivers. Those details establish what the study set out to measure and what safety counts were entered.

The record does not report the primary outcome results or any analysis results. It therefore does not show whether quality of life changed, how large any change was, or how precisely it was estimated. The endpoint’s description that positive post-pre values would indicate greater well-being is not itself evidence that a positive change occurred. No conclusion about the direction or size of an outcome can be drawn without the observed values and their uncertainty.

The single-group design also limits causal interpretation. In general, an observed pre-post change cannot by itself determine whether an intervention caused that change, because other influences over time are not separated by a concurrent control group. Here, the registry record does not give an outcome estimate to interpret in the first place.

The safety entries show zero serious adverse events in each reporting group, one other adverse event in the patient group, zero other adverse events in the caregiver group, and zero deaths in both groups. They should be read as recorded counts, not as proof of no risk or as a comparison with another treatment.

Overall, the registry record is informative about the study’s design, intended endpoint, and recorded safety counts, but it does not provide the analyzed quality-of-life findings. Missing outcome results should not be interpreted as evidence of no change, and they should not be used to infer benefit or lack of benefit.

14. Why This Trial Matters Statistically

This study is statistically notable because it frames the patient and informal caregiver as a connected dyad rather than treating hospice experience as an individual outcome alone. The registry’s background describes their psychological distress as interconnected. That framing raises an important design and analysis question: if both members contribute measurements, the relationship between their observations may need to be represented in the statistical method. The registry record does not report how the primary endpoint handled dyadic data, making that a relevant point for interpreting any future results.

The study also highlights the difference between a clearly described measure and a reported result. The MQOL-E description specifies domains, a response scale, and the direction of scoring. Those details clarify what the endpoint is intended to represent. They do not provide an estimate of change, uncertainty, or evidence of a contrast. Statistical interpretation depends on reported data and analysis, not solely on a well-defined measurement instrument.

The single-group design is another important statistical feature. Such a design can support description of outcomes in the participants studied, but it does not offer a randomized comparison. Any within-group change, if reported, would require cautious interpretation because the design does not separate intervention-related change from other influences over time. The present registry record does not report that change.

Finally, the registry lists five outcome measures but no analyses. This makes transparent reporting of outcome estimates, participant denominators, missingness, and analytic methods especially important for a reader assessing the evidence. The record’s safety counts are available, while the primary outcome findings are not. The distinction between recorded study activity and interpretable outcome evidence is central to reading this trial statistically.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main trial-specific limitation is the absence of reported primary outcome results. Although the registry describes the MQOL-E endpoint and its intended interpretation, it provides no observed means, changes, standard deviations, confidence intervals, or hypothesis-test results. The magnitude, direction, and precision of any quality-of-life change are therefore not reported in the registry record.

The single-group design has no separate control arm and is not a randomized comparison. This limits the ability to attribute any pre-post change to the intervention. The registry also records no masking. The record does not describe whether participants or outcome assessors were blinded, beyond the masking field stating none.

The intervention description is incomplete in the registry record. It mentions a personalized library of nature-based, 360-degree VR experiences selected using a VR Intake Form, but further intervention details are not reported there. The record also does not explain how dyads were represented in the primary analysis, whether both members completed the outcome, or whether within-dyad dependence was handled.

Enrollment is listed as 26, but the primary outcome denominator and participant flow are not reported. Missing-data methods, analysis populations, outcome-specific completion, and reasons for missing measurements are also not reported in the registry record. Without these details, the amount of information contributing to an outcome estimate cannot be assessed.

The registry lists five outcome measures and zero analyses, but does not report a statistical analysis plan, multiplicity strategy, protocol-based sample-size justification, or interim analyses. The listed planning assumptions describe a two-arm illustration, which does not match the recorded single-group design; they are not evidence of observed power. Safety information is limited to aggregate counts, with no detailed event descriptions or ascertainment information reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Tandem VR: Synchronized Nature-Based Experiences in Virtual Reality for Hospice Patients and Their Caregivers — NCT06186960.
• Registry record last updated 2026-04-06; status last verified 2026-02.
• Results first posted 2026-03-13.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT06186960 is a completed, single-group study sponsored by Prisma Health-Upstate, with enrollment listed as 26. The record identifies Tandem Virtual Reality as the intervention and lists hospice, end of life, palliative care, pain, anxiety, and fear of death among the conditions. Allocation is recorded as NA and masking as none.

The primary outcome is quality-of-life domains measured with the MQOL-E, with a listed timeframe of 15 minutes. The registry describes the scale and its scoring direction but does not report the primary outcome results. Five outcome measures and zero analyses are listed.

Safety entries list zero serious adverse events and zero deaths in both the patient-reported and informal-caregiver-reported groups. One other adverse event is listed for patients and none for caregivers. These are descriptive registry counts. The record does not report a control comparison, analysis populations, missing-data methods, or outcome estimates.