VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP) (NCT05379023), a randomized na study. The primary outcome is Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items.

2. Clinical Question

The clinical question is about assessment modality, not a comparison of treatments for Alzheimer’s disease. In particular, the record concerns whether cognitive testing delivered remotely yields results comparable to in-person testing for the intended assessment and diagnostic tasks. The primary outcome description focuses on raw scores across modalities and two assessment periods: Week 1 and Weeks 5-7 after exposure to the delivery conditions. It does not identify a single cognitive score as the sole outcome; several tests and domains are included.

3. Trial Design

VITAL-NP (NCT05379023) is a completed, randomized, single-masked crossover study sponsored by the University of Colorado, Denver. The registry lists enrollment of 116 and a phase of NA. The study start date is 2022-06-27, and primary completion is dated 2024-05-16. The record does not specify who was masked.

Participants were assigned to one of two modality sequences. One sequence completed face-to-face evaluation first and TeleNP second; the other completed TeleNP first and face-to-face evaluation second. Thus, the two assigned groups represent different orders of the same modalities, rather than two separate treatment regimens. In a crossover design, participants experience both conditions, allowing assessment of within-person differences as well as possible order or period effects. Whether and how those effects were addressed in analysis is not reported in the registry record.

The study’s stated aims were to assess feasibility and preliminary validity of home-based TeleNP for patients referred for cognitive assessment in a neurology clinic, and to examine whether TeleNP is equivalent to face-to-face evaluation for diagnostic adjudication of atypical versus typical Alzheimer’s disease. The registry lists six outcome measures and ten analyses. The reported primary outcome concerns mean scores on neuropsychological tests, with standard deviation as the listed measure of dispersion, after exposure to each delivery condition at Week 1 and Weeks 5-7.

Care partners did not undergo either evaluation. They completed surveys about acceptability only and are not part of the primary cognitive outcome population. Three participants who underwent the intervention signed consent but did not complete baseline. The record does not describe the order-generation procedure, allocation concealment, masking details, visit-level completion, or analysis population definitions.

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: Intervention Arms (Patients): Upon consenting for the study, randomization was conducted using a computerized process through REDCap based on block randomization with blocks of sizes 32, 24, 16, and two of 8 based on modality (FF vs TeleNP) order, test form type (standard vs alternate; used for a subset of tests), and assigned to one of two board certified neuropsychologists. Non-Intervention Arm (Care Partner): Care partners were not assigned to an intervention, no pre-assignment details

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Three participants who underwent the intervention signed a consent but did not complete baseline. Care Partners did not undergo the intervention and thus are not included in these outcomes.

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: The n=50 care partners did not undergo the intervention

6. Primary Endpoint

The registry lists the primary outcome as Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items, measured over After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7.

The primary endpoint concerns agreement in cognitive test results across face-to-face evaluation and TeleNP. It uses raw mean scores from tests covering memory, executive functions, language, and spatial abilities. The registry identifies standard deviation as the measure of score dispersion and places assessment after exposure to each delivery condition at Week 1 and Weeks 5-7.

The listed tests include delayed recall measures from the California Verbal Learning Test, second edition (CVLT), and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); Figure Copy; the Boston Naming Test (BNT); Category Fluency; and Judgment of Line Orientation (JoLO). The record gives score ranges for these measures: CVLT delayed recall, 0-16; RBANS delayed recall, 0-20; Figure Copy, 0-20; BNT, 0-15; and JoLO, 0-15. Category Fluency has a range of 0-no limit. Higher scores are described as better for CVLT delayed recall, RBANS delayed recall, BNT, Category Fluency, and JoLO.

Comparing test scores across modalities addresses whether remote and in-person delivery produce similar cognitive measurements in this setting. Agreement is not identical to a test of whether average scores differ: a small average difference can coexist with substantial person-to-person disagreement. The registry does not specify a single agreement statistic, an equivalence margin, or numerical endpoint results. The endpoint therefore describes the intended measurement question, not a demonstrated degree of agreement.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods help connect a research question to the quantity being estimated and to the uncertainty around that estimate. The registry record names mean and standard deviation for the primary outcome, but does not report a full statistical analysis plan or the methods used for the posted cognitive results. The explanations below describe general statistical ideas relevant to this design; they are not claims about analyses carried out in VITAL-NP.

What do mean and standard deviation describe?

A mean is a summary of the average score in a group or condition. A standard deviation describes how spread out individual scores are around that average. Together they provide a basic description of score level and variability, but they do not by themselves establish agreement between two ways of measuring the same participants. Similar means can occur even when individual paired scores differ considerably. For agreement, analyses often examine paired differences and how those differences vary across the range of scores. The registry record does not identify which agreement statistic was used, if any.

Why does the crossover design matter?

In a crossover trial, participants receive both conditions in a sequence, rather than receiving only one condition throughout. Each person can serve as their own reference, which can reduce the influence of stable differences between people in a paired comparison. However, the measurements within one participant are related and should not automatically be treated as independent observations. The order of conditions and the period in which a measurement occurs may also matter. Practice, fatigue, changes over time, or effects of the first assessment on the next could influence scores in general. These are considerations for crossover studies, not findings that are reported for this trial. The registry record does not describe a model for participant, period, sequence, or carryover effects.

What does equivalence require?

General equivalence testing asks whether the difference between methods is sufficiently small to fall within an acceptable range established in advance. It is not enough to observe a non-significant difference: failure to detect a difference does not demonstrate that two methods are equivalent. Interpretation typically requires a justified equivalence margin and an interval estimate for the difference, assessed against that margin. The registry describes equivalence as an aim but does not report a margin or the corresponding analysis results. Without those details, the stated aim cannot be interpreted as a registry-reported conclusion that the modalities were equivalent.

How should uncertainty be read?

A confidence interval is a range of values compatible with the observed data and the assumptions of a statistical method. Its width conveys precision: a wider interval indicates greater uncertainty about the estimate. A confidence interval for a paired difference could help show both the estimated average contrast and its uncertainty. For equivalence, its position relative to the prespecified acceptable range is especially important. No cognitive-outcome confidence intervals are reported in the registry record, so their precision cannot be assessed from the information. A p-value alone, if one were reported, would not describe the size of an effect or establish clinical or measurement equivalence.

Why can score distributions matter?

Many familiar methods for comparing means rely on assumptions about the distribution of scores or model residuals. Neuropsychological scores can be bounded by test ranges, and some may cluster near a minimum or maximum. Such features can affect how well a simple normal approximation describes uncertainty. The registry lists several score ranges, including a Category Fluency range with no upper limit, but does not report score distributions, diagnostics, transformations, or any alternative analysis strategy. The assumptions actually used for the trial’s outcome analyses are therefore not reported in the registry record.

How are the planning illustrations different from trial results?

A sample-size planning illustration is a hypothetical calculation: it estimates how many participants per arm might be needed under stated assumptions to detect a specified effect. It is not a count of observed participants, and it is not observed power. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. The record does not give the trial’s own design justification in the registry record. Planning values should not be interpreted as evidence that the trial achieved a particular power, or as a substitute for confidence intervals and outcome results.

For these methods to be interpreted fully, readers would need the analysis population, treatment of incomplete or missing assessments, the model or test used for each endpoint, any adjustment for repeated measurements or multiplicity, and the resulting estimates with uncertainty. Those analysis details are not reported in the registry record. General statistical principles can explain what would be relevant, but cannot fill in an unreported method or result.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is not a single score at a single time. It includes multiple cognitive tests across several domains and assessments after exposure to each condition at Week 1 and Weeks 5-7. The registry lists six outcome measures and ten analyses. Testing multiple outcomes or time points can raise multiplicity concerns: when many comparisons are made, the chance of at least one apparently noteworthy result can increase. General approaches include designating a primary contrast in advance or adjusting inference across a defined family of tests. The registry record does not report how multiplicity was handled, which outcomes were considered primary for inference, or whether any adjustment was used.

The record states that three participants who underwent the intervention signed consent but did not complete baseline. It does not report how many completed each modality, how many provided each follow-up assessment, or how incomplete observations were handled. The number included in each cognitive analysis, reasons for missing assessments, and any imputation or sensitivity analyses are not reported in the registry record. Without those details, the extent to which the analyzed participants represent all enrolled participants cannot be assessed.

Care partners did not undergo the evaluations and were not included in the cognitive outcomes; they completed acceptability surveys only. The record does not define an intention-to-treat, per-protocol, or other analysis population for the cognitive comparisons. It also does not state how the randomized sequence assignment was reflected in analysis. These omissions matter because crossover estimates can depend on which participants and periods contribute data. No numerical cognitive results or analysis-population counts are reported in the registry record, so neither missing-data impact nor multiplicity-adjusted inference can be reconstructed.

11. 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 event counts separately for face-to-face evaluation and TeleNP. In each group, 63 participants were listed as at risk and 0 as affected by a serious adverse event. The other adverse event counts were also 0 among 63 at risk in each group. The death count was 0 in each group. No serious adverse event terms are listed.

These are event counts as recorded for the two modality groups. Because the study is a crossover, participants were assigned to experience both modalities; the figures should not be read as if the groups necessarily represent distinct sets of people. The registry record does not give further detail about event definitions, observation windows, attribution, or whether a participant-level accounting was used across periods. The two entries therefore describe the posted safety reporting, not a basis for calculating comparative risk or drawing a broader conclusion about safety.

Zero recorded events does not establish that an event is impossible, nor does it describe outcomes beyond the reporting recorded in the registry. The counts concern adverse events and deaths; they do not provide information about cognitive-test agreement or diagnostic performance.

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

VITAL-NP addresses a practical measurement question: whether neuropsychological testing delivered at home by video yields results comparable to face-to-face evaluation for people referred with suspected typical or atypical Alzheimer’s disease. Its randomized crossover design assigns participants to different modality orders, and its primary outcome focuses on mean scores across several tests and assessment periods. The record also states aims related to feasibility and preliminary validity.

What the registry record does not establish is the observed degree of agreement. Numerical cognitive scores, estimated differences, uncertainty intervals, inferential tests, and an equivalence margin are not reported in the record available for this analysis. Consequently, the study’s completion status and its stated aims cannot be taken as proof that either modality matched the other, or that one produced better results. The findings needed to make those judgments are not reported in the registry record.

Agreement and equivalence are related but distinct statistical questions. A comparison of group means addresses average score differences, whereas agreement also concerns how closely paired measurements correspond for individuals. Equivalence is usually judged against a prespecified range of differences considered acceptably small. Without the chosen measure of agreement, margin, results, and uncertainty, the extent of comparability cannot be determined from the registry information.

The safety entries report no adverse events or deaths in the listed groups, with 63 at risk in each modality group. Those counts should be interpreted narrowly as registry event reporting and not as a general claim about safety. The record also notes three consented intervention participants who did not complete baseline, while not reporting the number contributing to each outcome analysis.

In short, the record describes a relevant design and a set of cognitive outcomes, but the numerical outcome evidence and statistical details needed to assess the central comparison are not reported in the registry record. Any interpretation of the study’s effectiveness for diagnostic equivalence or of the precision of its cognitive comparisons would go beyond the reported information.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it compares two ways of administering cognitive assessments within a randomized crossover framework. A within-person design can make each participant’s measurements informative about their own modality contrast, rather than relying only on differences between separate groups. That feature is valuable for a measurement question, where stable variation in cognitive performance between participants may otherwise complicate comparisons.

The design also makes careful analysis important. Scores gathered from the same person are correlated, and the order and period of testing may influence observed results. General interpretation therefore depends on whether the analysis accounts for the repeated measurements and evaluates sequence-related effects. The registry record does not report those methods, so the design’s statistical advantages and potential complications cannot be connected to a specific reported analysis.

The endpoint also illustrates why agreement should not be reduced to comparing averages alone. Similar mean scores can conceal individual differences, while an average contrast may be small but estimated imprecisely. For a question about whether two modalities can be considered equivalent, the estimate, its uncertainty, and a defensible equivalence margin all matter. Those numerical details are not reported in the registry record.

Finally, the outcome structure includes multiple measures, domains, and time points. This makes prespecification and multiplicity handling important for transparent interpretation, particularly when several analyses are available. The record lists six outcome measures and ten analyses but does not explain how the family of comparisons was handled. The study therefore highlights both the potential of crossover designs for evaluating measurement modalities and the need for clearly reported analysis methods and outcome estimates before conclusions about agreement can be drawn.

14. 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.

Several trial-specific limitations to interpretation follow from what the registry record does and does not report. Most importantly, it does not include numerical cognitive-test results, estimates of differences or agreement, confidence intervals, or p-values. This prevents assessment of the size and precision of the primary outcome findings. Although equivalence is a stated aim, the record does not report an equivalence margin or the analysis used to evaluate that aim.

The crossover design introduces questions about within-participant dependence, assessment period, sequence, and possible carryover. The registry describes the two modality orders but does not state whether these factors were modeled or assessed. It also identifies the study as single-masked without specifying who was masked. The order-generation process and allocation concealment are not reported in the registry record.

The primary outcome spans multiple measures, domains, and assessment periods. While six outcome measures and ten analyses are listed, the record does not state how multiplicity was addressed or which comparisons were designated for primary inference. Information about score distributions, statistical assumptions, missing-data handling, analysis-population definitions, and the number contributing to each outcome is also not reported.

Three participants who underwent the intervention signed consent but did not complete baseline. This is a documented source of incomplete baseline information, but the record does not provide enough detail to determine its effect on the analyses. Care partners completed acceptability surveys only and were excluded from the cognitive outcomes, so their role does not add cognitive-test observations to the primary comparison. These reporting gaps limit conclusions about the comparability, precision, and generalizability of the study’s cognitive findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP) — NCT05379023.
• Registry record last updated 2025-12-31; status last verified 2025-12.
• Results first posted 2025-12-31.
• 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.

18. Record Summary

VITAL-NP (NCT05379023) is a completed, randomized, single-masked crossover study sponsored by the University of Colorado, Denver. The registry lists enrollment of 116, a start date of 2022-06-27, and primary completion on 2024-05-16. Participants were assigned to complete face-to-face evaluation and home-based TeleNP in one of two orders.

The primary outcome concerns mean scores on neuropsychological measures of memory, executive functions, language, and spatial abilities, assessed at Week 1 and Weeks 5-7. The stated aims include feasibility and preliminary validity of home-based TeleNP and equivalence to face-to-face evaluation for diagnostic adjudication of typical versus atypical Alzheimer’s disease. Three consented intervention participants did not complete baseline; care partners completed acceptability surveys only and were not included in cognitive outcomes.

The registry reports zero serious adverse events, zero other adverse events, and zero deaths among 63 at risk in each modality group. Numerical cognitive results, detailed analysis methods, missing-data procedures, and an equivalence margin are not reported in the registry record.