Assessing a Novel Virtual Environment That Assists With Activities of Daily Living: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Assessing a Novel Virtual Environment That Assists With Activities of Daily Living (NCT05418296), a na na study. The primary outcome is Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe).

2. Clinical Question

3. Trial Design

The registry record describes a completed, single-group study of a digital health device in people residing in long-term care homes. The intervention description identifies a novel digital health device, while the brief study description characterizes the program as videogame-based. Its stated purpose was to help residents and care partners prepare for activities of daily living. That purpose describes the intended use, not an outcome established by the registry results.

The study model is listed as single group, and allocation is listed as NA. The arm description says residents’ activities of daily living were studied with the intervention compared with baseline without it. Thus, the relevant comparison is between measurements in the study group over time, rather than between separately allocated intervention and control groups. Masking is listed as none. Phase is listed as NA, although the brief study description calls the study Phase 1.

The registry lists enrollment as 38 and gives a start date of 2022-06-09, a primary completion date of 2023-08-30, and completed status. These entries describe the study record; they do not show how many participants contributed to each outcome. For the primary outcome, the record specifically says that twenty-four resident participant surveys were available and eight were excluded because they were not filled out or were incomplete. How the enrollment figure relates to that outcome-specific survey information is not explained.

The registry lists the primary assessment timeframe as 6 weeks. It does not report the detailed schedule of assessments, the intervention duration, or the methods used to deliver the device. The record also lists questionnaire measures concerning dementia attitudes, staff competence, and burnout as secondary outcomes. Their results and analysis details are not reported in the information available for this analysis.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: From twenty-four resident participant surveys, eight were excluded from analysis because surveys were a) not filled out or b) incomplete.

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.

6. Primary Endpoint

The registry lists the primary outcome as Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe), measured over 6 weeks.

The primary endpoint is the Alzheimer’s Disease Cooperative Study Activities of Daily Living-Severe score, recorded as a score on a scale and described as a mean with standard deviation. The measure assesses competence in basic and instrumental activities of daily living for patients with Alzheimer’s Disease. According to the registry description, it has 19 questions and a possible score range from 0 to 54; a higher score means a better outcome. It may be completed by a caregiver as a questionnaire or administered by a clinician or researcher as a structured interview with a caregiver.

This kind of measure is relevant to a study focused on activities of daily living because it records functioning in those activities rather than only a general impression of the digital device. A caregiver-completed or caregiver-interview measure also makes the source of the reported information explicit. In general, a continuous score can be summarized by its mean and standard deviation: the mean describes the group’s average score, while the standard deviation describes variation among scores.

The registry specifies a 6-week timeframe, but it does not report the actual mean or standard deviation at baseline or follow-up, or the estimated within-group change. It therefore does not show how the measured scores changed or how precisely that change was estimated. The registry’s description of higher scores as better explains the scale’s direction, but does not establish a result for this study.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean describe?

The primary outcome is a continuous score, and the registry identifies the mean as its summary measure. In general, a mean is the arithmetic average of the observed scores in the analyzed group. It describes the group’s central level on the scale, but does not show whether individuals had similar scores or very different ones. The standard deviation, also specified for this outcome, describes how spread out scores are around the mean. Neither statistic is reported as an observed result in the registry record.

How should a confidence interval be read?

In general, a confidence interval gives a range of values compatible with the data and the statistical method used. It conveys uncertainty around an estimate: a narrower interval indicates greater precision than a wider interval, all else being equal. A confidence interval does not show the distribution of individual responses, and it does not by itself establish that an observed difference was caused by an intervention. The registry record does not report a confidence interval for the primary outcome or a change estimate to which one could apply.

What does a baseline comparison estimate?

For a single-group before-and-after comparison, the quantity of interest is often the change between the group’s measurements at baseline and follow-up. In general, this can describe change over time in the measured participants. It is not equivalent to a randomized treatment-versus-control contrast: without a concurrent comparison group, other influences that change over time cannot be separated from an intervention-associated change by the comparison alone. The registry says the ADCS-ADL-Severe outcome was studied with intervention compared with baseline without intervention, but does not report the actual estimates or the exact statistical method used to compare them.

Why do allocation and masking matter?

In general, random allocation is used to create comparison groups whose differences are less likely to reflect systematic selection, while masking can limit the influence of knowledge about assigned intervention on assessment or reporting. This study is listed as single group, allocation NA, and masking none. Those entries describe the design and should be considered when interpreting any within-group change. They do not, on their own, demonstrate that a particular bias occurred or determine its direction or size.

What do planning calculations mean?

The registry’s sample-size assumptions describe a planning illustration based on an observed effect, rather than the trial’s own design. The illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is a stated fraction of the observed effect. In general, a sample-size calculation asks how much information a hypothetical study might need under specified assumptions. It is not evidence that a study of that size was conducted, and it is not observed power. The illustration’s hypothetical two-arm allocation also differs from this study’s listed single-group model. The registry does not report the study’s own sample-size justification, and the primary outcome effect needed to assess the illustration is not reported in the record.

Why can dispersion matter?

In general, greater variation among participants makes a group mean less precise when the amount of information is otherwise unchanged. A standard deviation describes variation in the scores themselves; it is not the same as the uncertainty of the mean or the uncertainty of a change estimate. If data are more variable than a statistical model assumes, conventional uncertainty estimates may be too small. This is one reason statistical analyses may account for over-dispersion when the data-generating process and outcome call for it. The registry record does not report an over-dispersion assessment, and the primary outcome’s standard deviation is not available for evaluation.

What analysis details are missing?

The record does not report the exact model, test, confidence-interval method, or assumptions used for the primary analysis. It does not state whether the analysis adjusted for any covariates, how repeated measurements were handled, or how incomplete surveys were handled beyond identifying eight exclusions. These details should not be inferred from the outcome type or from the sample-size illustration. Without the analysis method and the observed estimate, readers cannot reproduce the primary analysis or assess the sensitivity of its result to alternative reasonable choices.

The registry lists five outcome measures and five analyses, but does not describe their statistical hierarchy or identify a multiplicity procedure. In general, when multiple outcomes or analyses are examined, the chance of at least one apparently notable result can rise if each is assessed independently. Methods such as prespecifying a primary outcome or adjusting for multiple comparisons can address different aspects of that issue. The record identifies a primary outcome, but does not report whether or how the analyses were adjusted. No conclusion about statistical significance or multiplicity-adjusted evidence can be drawn from the information recorded.

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("Persons Residing in Long-term Care Homes")
n   <- c(16)
m   <- c(19.1)
sp  <- c(9.9)
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  Persons Residing in Long-term Care Homes  16  19.100  9.900  13.825  24.375

11. Multiplicity, Missing Data and Analysis Populations

The registry identifies the Alzheimer’s Disease Cooperative Study Activities of Daily Living-Severe score as the primary outcome and lists the Approaches to Dementia Questionnaire, the Sense of Competence in Dementia Care Staff Scale, and the Copenhagen Burnout Index as secondary outcomes. It also lists five outcome measures and five analyses. The record does not describe how these measures and analyses were organized into a prespecified testing hierarchy, whether secondary analyses were exploratory, or whether any adjustment for multiple comparisons was used.

In general, examining multiple outcomes or analyses can make isolated findings harder to interpret, particularly if no analysis plan specifies which results are confirmatory. A prespecified primary endpoint can help focus interpretation, but does not by itself explain how secondary results were handled. Since numerical results and the statistical analysis plan are not reported in the registry record, the relationship between the listed measures and analyses cannot be evaluated further.

For the primary outcome, the registry states that eight resident participant surveys were excluded because they were not filled out or were incomplete. It does not report the detailed amount or pattern of missing information, the reasons for incomplete surveys, or whether any missing answers were handled using a particular method. The record also does not describe the analysis population for each outcome or say whether participants with incomplete surveys contributed to other analyses.

In general, excluding incomplete observations can affect an estimate if the availability of data is related to the outcome or participant characteristics. That possibility is not evidence that the study’s estimate was biased; the registry does not provide enough information to assess it. No imputation method, sensitivity analysis, or missing-data assumption is reported. As a result, the primary analysis population and the robustness of any result to missing data are not established by the registry record.

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 0% reporting threshold.

The registry reports serious adverse events, other adverse events, and deaths separately for two groups. For persons living with dementia residing in memory care communities, the record lists 28 at risk for serious adverse events and 0 affected; it lists 28 at risk for other adverse events and 0 affected, with 0 deaths. For professional dementia caregivers in memory care communities, it lists 10 at risk for serious adverse events and 0 affected; it lists 10 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse-event terms are listed.

These are the recorded counts, not estimates of the probability of harm. In general, an event count of zero in a study does not establish that the underlying risk is zero. The amount of information available, the observation period, how events were collected, and how they were classified all matter for interpretation. The registry record does not report the adverse-event observation period or additional event-collection details in the information.

The two groups describe residents and professional caregivers, and should not be read as randomized intervention and control arms. The single-group study design and registry entries do not support a controlled comparison of safety outcomes. The recorded counts can be stated as reported, but they do not establish safety beyond the participants and circumstances documented in the registry.

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

The registry record establishes that a completed single-group study assessed a digital health device in a long-term care setting and identified the ADCS-ADL-Severe score as its primary outcome at 6 weeks. It also defines the measure’s content, score direction, and range. For readers, this clarifies what the study intended to assess: functioning in basic and instrumental activities of daily living, as reported through a caregiver questionnaire or interview.

The record does not report the primary outcome’s baseline or follow-up summary statistics, an estimated change, or its uncertainty. Therefore, it does not establish whether the score increased, decreased, or stayed similar, nor does it show the magnitude or precision of a possible change. The intended purpose of the videogame-based program is not a measured result, and should not be treated as evidence of benefit.

The design also limits causal interpretation. The comparison is intervention versus baseline in a single group, with allocation listed as NA and masking listed as none. In general, a change over time in one group can reflect more than the intervention; without a concurrent randomized comparison, the separate contribution of the device cannot be isolated from the registry description alone. This is a design limitation, not proof that the intervention had no effect.

The record reports that eight resident participant surveys were excluded because they were unfilled or incomplete, but does not explain the missing-data analysis or the characteristics of those excluded surveys. It lists secondary outcome measures but does not report their results. The adverse-event entries report zero affected participants in each listed group, but event counts from a study record do not establish that an intervention is free of risk.

The most defensible interpretation is therefore bounded: the registry describes the study question, design, primary measure, survey exclusions, and recorded adverse-event counts. It does not provide the outcome estimates needed to characterize an observed change, its statistical uncertainty, or whether any change can be attributed to the device. Conclusions beyond those points are not supported by the registry record.

14. Why This Trial Matters Statistically

This study raises a useful statistical question about how to evaluate an intervention intended to support activities of daily living: what outcome is measured, who provides the information, and what comparison makes the result interpretable? The registry specifies a caregiver-reported or caregiver-interview measure of basic and instrumental activities of daily living. That description helps readers understand the construct being assessed and the role of caregiver observation.

The single-group baseline comparison also illustrates the distinction between measuring change and estimating an intervention effect. In general, repeated measurement can document how scores differ over time, while a concurrent comparison group can help distinguish intervention-associated change from other time-related influences. The registry lists a single-group model and does not report randomized allocation, so that distinction is central to interpreting the study design.

The survey exclusions highlight why analysis populations and missing-data methods matter. The registry says that eight surveys were excluded because they were not filled out or were incomplete, but does not report how missing information was handled beyond those exclusions. A clear account of who contributed to each analysis and how incomplete observations were treated would help readers assess the context of the estimates.

The record also names several secondary measures related to dementia attitudes, staff competence, and burnout. Such measures may address different aspects of the study’s setting, but their results and their place in the analysis plan are not reported. Statistical interpretation depends not only on the outcome definitions but also on the estimates, uncertainty, and analytic choices used to assess them.

Here, the registry record is informative about the intended question and design, but does not contain the primary outcome statistics needed to quantify change. That gap matters statistically because readers cannot judge magnitude or precision from an endpoint definition alone. The study record illustrates why outcome reporting should include estimates and uncertainty alongside design and measurement details.

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 primary limitation for interpreting this specific study is the absence of numerical primary outcome results in the registry record. Although the measure, timeframe, score direction, and score range are described, no baseline or follow-up mean, standard deviation, estimated change, or confidence interval is reported. Thus, the outcome cannot be assessed for magnitude, direction, or precision from the registry information.

The design is single group, with a baseline comparison rather than a randomized concurrent control comparison. Allocation is listed as NA, and masking is listed as none. These features restrict the extent to which a change over time could be attributed specifically to the digital health device. The record does not give additional design details that would permit a more complete assessment of potential alternative explanations.

The primary outcome population description indicates that twenty-four resident participant surveys were available and eight were excluded because surveys were unfilled or incomplete. The registry does not report detailed reasons for missingness, participant characteristics for included and excluded surveys, or methods to address missing data. The enrollment figure is 38, but the relationship between that figure and the outcome-specific survey information is not explained.

The record identifies secondary measures and lists five outcome measures and five analyses, but does not report the results, analysis hierarchy, or multiplicity approach. It also does not report the statistical model, test, confidence-interval method, or the study’s own sample-size justification. The planning illustration is described as based on an observed effect, but the primary observed effect is not reported in the record, and the illustration’s assumptions do not establish the study’s actual design.

Finally, safety entries do not include an adverse-event observation period or further collection details. The registry record is therefore limited as a source for evaluating both outcome estimates and the completeness of safety ascertainment.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Assessing a Novel Virtual Environment That Assists With Activities of Daily Living — NCT05418296.
• Registry record last updated 2025-02-10; status last verified 2025-01.
• Results first posted 2025-02-10.
• 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

The registry record describes a completed, single-group study of a novel digital health device for residents in long-term care homes. Its brief description characterizes the program as videogame-based and intended to help residents and care partners prepare for activities of daily living. The primary outcome is the Alzheimer’s Disease Cooperative Study Activities of Daily Living-Severe score, with a stated 6-week timeframe.

The study is listed with enrollment of 38, allocation NA, and masking none. The primary outcome description says twenty-four resident participant surveys were available and eight were excluded because they were unfilled or incomplete. The record does not explain the relationship between enrollment and the survey information.

Numerical primary outcome results, statistical uncertainty, and detailed analysis methods are not reported in the registry record. The record lists secondary outcome measures and reports zero serious adverse events, zero other adverse events, and zero deaths for each of the two listed groups. These entries describe what the registry records; they do not provide a controlled estimate of intervention effect or establish absence of risk.