This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Feasibility and Validity of A Novel Computer Based Battery of Assessments in the Elderly (NCT02109419), a registered phase not stated study. The primary outcome is Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02109419 |
| Phase | Phase not stated |
| Condition | Computerized Assessment Feasibility and Validity |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 57 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pennington Biomedical Research Center |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled males and females between the ages of 60 and 85 years, inclusive, with MMSE scores of 10-30, inclusive. The enrolled groups included control participants, people with mild cognitive impairment, and people with dementia. The registry record reports enrollment of 57 participants.
Intervention
The assessments of interest were HHT-G, a computerized global cognitive function screener, and HHT-D, a computerized depression test. Higher HHT-G scores indicate better cognition; higher HHT-D scores indicate higher depression. The study description says the computerized assessments were developed on principles found in existing pencil-and-paper assessments.
Comparator
For validity, HHT-G and HHT-D scores were correlated with established pencil-and-paper measures: the MMSE for cognitive functioning and the Geriatric Depression Scale (GDS) for depression. The registry also lists control, mild cognitive impairment, and dementia groups. Allocation and a like-for-like control comparison are not stated.
Primary question
The primary question was whether the computerized assessments showed reliability, validity, and internal consistency, including whether their scores correlated with the corresponding established assessments. The primary outcome description specifies correlation analysis over a visit completed over 16 day period. Numerical correlation estimates and their uncertainty are not reported in the registry record.
3. Trial Design
This completed study was registered as NCT02109419 and was sponsored by Pennington Biomedical Research Center. Its title describes a feasibility and validity study of a computer-based assessment battery for older adults. The registry lists a total enrollment of 57 and identifies computerized assessment feasibility and validity as the condition.
The target population was males and females between the ages of 60 and 85 years, inclusive, with MMSE scores of 10-30, inclusive. The participant groups were control, mild cognitive impairment, and dementia. The registry describes all participants as including those three groups. It does not report how participants were assigned to groups, and allocation is listed as not stated. This was not a randomized comparison, and the groups should not be treated as a like-for-like control comparison.
The assessments listed include HHT-G and HHT-D, along with the MMSE and Geriatric Depression Scale (GDS). HHT-G was described as a computerized global cognitive function screener, while HHT-D was described as a computerized depression test. The MMSE and GDS were existing pencil-and-paper assessments used as reference measures in the validity analysis. The record also lists the intervention names as HHT-G, HHT-D, Geriatric Depression Scale (DGS), and MMSE; the primary outcome description refers to GDS.
The start is recorded as 2014-03, primary completion as 2014-09, and status as completed. The primary outcome timeframe is a visit completed over 16 day period. Further details about recruitment procedures, the number of visits per participant, or the timing of individual assessments are not reported in the registry record.
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
| Stage | All Participants |
|---|---|
| STARTED | 57 |
| COMPLETED | 57 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Males and females between the ages of 60 and 85 years, inclusive, with MMSE scores of 10-30, inclusive.
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.
| Characteristic | Unit | All Participants |
|---|---|---|
| Participants analysed | 57 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 12 |
| Age, Categorical: >=65 years | Participants | 45 |
| Age, Continuous | years | 71.7 (SD 6.0) |
| Sex: Female, Male: Female | Participants | 35 |
| Sex: Female, Male: Male | Participants | 22 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 57 |
| Geriatric Depression Scale (GDS) | units on a scale | 1 (SD 1.5) |
| Mini Mental State Questionnaire (MMSE) | units on a scale | 28 (SD 2.9) |
6. Primary Endpoint
The registry lists the primary outcome as Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis., measured over Visit completed over 16 day period.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns reliability, validity, and internal consistency of HHT-G and HHT-D, assessed by correlation analysis. HHT-G scores range from 0 to 30, with higher scores reflecting better cognition. HHT-D scores range from 0 to 30, with higher scores reflecting higher depression. The outcome description says the computerized scores were correlated with established pencil-and-paper measures: HHT-G with the MMSE, and HHT-D with the GDS. MMSE scores range from 0 to 30, with higher scores reflecting better cognitive functioning; GDS scores range from 0 to 15, with higher scores reflecting higher depression.
Correlation can describe how closely two measures vary together. In a validity assessment, correspondence with an established measure can be relevant evidence about whether a new assessment captures a related construct. Correlation alone does not establish agreement between scores, show that the instruments are interchangeable, or demonstrate that either measure predicts a later outcome. Those distinctions are general statistical considerations, not additional findings from this study.
The timeframe is a visit completed over 16 day period. The record does not report the observed correlation estimates, confidence intervals, p-values, or a separate numerical endpoint result. It therefore does not permit a quantitative assessment of the strength or precision of the reported primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a correlation-based primary outcome intended to assess the reliability, validity, and internal consistency of two computerized assessments. It describes comparisons of HHT-G with the MMSE and HHT-D with the GDS. However, the record does not report the actual correlation coefficients or other numerical findings for these comparisons. Consequently, the direction, magnitude, and precision of the observed relationships are not reported in the registry record.
The stated scoring direction is important when interpreting any correlation: higher HHT-G and MMSE scores both indicate better cognition, whereas higher HHT-D and GDS scores both indicate higher depression. A correlation would describe how scores vary together, but without the estimates it is not possible to determine how closely the paired assessments tracked in this study. Nor can correlation by itself show that two tests produce equivalent individual scores. Agreement requires a different statistical question and analysis.
The registry reports enrollment of 57 participants across control, mild cognitive impairment, and dementia groups. It does not provide group-specific outcome results or say whether correlations were calculated separately within groups or across participants. A correlation across a mixed population can reflect both within-group relationships and differences between groups; this is a general statistical caution. Since the analysis population and grouping strategy are not reported, the record does not establish which interpretation applies.
The title and stated objective concern feasibility as well as validity, but a numerical feasibility result is not reported in the registry record. The record does not give completion rates, usability measures, or an account of technical failures. It also does not report numerical reliability or internal-consistency findings beyond naming these as aims. The listed primary outcome therefore identifies the intended assessment, rather than documenting a result that can be independently interpreted from the registry information.
Planning illustrations based on an observed effect are not evidence that the study had a particular probability of detecting an effect. They are planning calculations, not observed power. The record does not report the numerical observed effect needed to interpret such illustrations. No treatment-effect conclusion follows from this design: the stated question is about computerized assessment properties and correlations with reference assessments, not the effect of a treatment.
In short, the registry describes who was studied, the assessments used, and the intended correlation-based question. It does not report the numerical results needed to judge the strength or precision of the evidence for validity, reliability, internal consistency, or feasibility. This absence limits statistical interpretation; it should not be replaced by assumptions about what the analysis might have found.
9. Statistical Methods Explained
The primary outcome is described as a continuous measure analyzed using correlation. The registry gives the outcome parameter as a mean and the dispersion as a standard deviation, but it does not report numerical means, standard deviations, or correlations. The following concepts explain how these methods are generally interpreted; they are not claims about unreported study procedures or results.
What does correlation describe?
Correlation summarizes the direction and strength of association between two measured variables. In this study, the stated validity comparisons paired scores from HHT-G with MMSE scores and HHT-D with GDS scores. A positive association would mean that higher values on one measure tend to occur with higher values on the other; a negative association would mean that higher values on one tend to occur with lower values on the other. The registry record does not identify the specific correlation coefficient used, so it is not possible to say whether the analysis used a product-moment correlation, a rank-based measure, or another method.
A correlation is not the same as agreement. Two instruments can rank participants similarly while producing scores that differ systematically in level or scale. Correlation also does not demonstrate causation, and it does not establish that scores are interchangeable for individual assessment. Those are general properties of correlation, not results from the study.
What would a confidence interval add?
A confidence interval describes uncertainty around an estimated quantity. For a correlation, it can indicate the range of values reasonably compatible with the data under the model used. A narrow interval generally indicates greater precision than a wide interval. The registry record does not report confidence intervals for the primary outcome, so the precision of any correlation estimate cannot be assessed from its posted information. No confidence interval should be inferred from the enrollment alone.
Why do distribution and model choices matter?
Different correlation methods make different assumptions about the scale and distribution of measurements and about the form of their relationship. A conventional linear correlation focuses on linear association and can be affected by influential observations. Rank-based methods focus on the ordering of observations and can capture monotonic relationships that are not necessarily linear. These are general distinctions. Which method was selected, how outliers were handled, and whether assumptions were checked are not reported in the registry record.
For a continuous outcome, a mean describes the average score, while a standard deviation describes how scores vary around that average. These summaries do not, by themselves, establish validity or reliability. The registry lists mean and standard deviation as the primary outcome parameter and dispersion, but gives no numerical values for them. It is therefore not possible to compare average scores across groups or instruments from the record.
How should reliability and internal consistency be distinguished?
Reliability concerns the consistency of measurements. Internal consistency is one aspect of reliability: it concerns how well components intended to measure the same construct relate to one another. Test-retest reliability asks whether repeated measurements are consistent over time when the underlying construct is expected to be stable. These are general concepts, and they require particular measures and analyses. Although the outcome description names reliability and internal consistency, it does not report the reliability statistic, its estimate, or the detailed analysis used. The timeframe refers to a visit completed over 16 day period, but this alone does not establish that a test-retest analysis was conducted.
What does the validity comparison establish?
Comparing a new instrument with an established assessment can provide evidence about whether the instruments measure related constructs. Here, the stated pairings are HHT-G with MMSE for cognition and HHT-D with GDS for depression. The usefulness of such a comparison depends on the measures, population, and analysis. Even a strong correlation would not prove that the computerized test has all the measurement properties of the established assessment. Conversely, without the reported estimates, the degree of correspondence cannot be evaluated. The registry does not report additional validity analyses, such as agreement or predictive performance.
The record lists six analyses and one outcome measure, but does not explain which analyses were conducted, how they map to the outcome, or which results were designated as primary. The statistical analysis plan, covariate adjustments, handling of repeated observations, and software or estimation details are not reported in the registry record. The results should therefore be read as incompletely documented statistical evidence, not as a basis for reconstructing an analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and six analyses. It does not describe how those analyses were organized, whether they addressed different comparisons or subgroups, or whether one was designated as the sole confirmatory test. A multiplicity adjustment or other approach to controlling the interpretation of multiple analyses is not reported in the registry record.
In general, making multiple statistical comparisons can increase the chance of observing a seemingly notable result by chance. Adjustments, prespecified outcome hierarchies, or clear distinctions between confirmatory and exploratory analyses can help readers understand that risk. These are general considerations; the record does not establish whether any such approach was used. Since numerical analysis results are also not reported, the effect of multiplicity on the study's conclusions cannot be assessed.
Missing-data procedures are not reported in the registry record. The record does not state whether all enrolled participants completed each assessment, how incomplete assessments were handled, or whether any imputation or other missing-data method was used. It also does not report the number of participants contributing to each analysis. Enrollment is recorded as 57, but that figure alone does not establish the analysis sample size for a particular outcome.
The analysis populations are not described. The record does not say whether analyses included all enrolled participants, only those with complete paired computerized and pencil-and-paper scores, or a different subset. The group description includes control, mild cognitive impairment, and dementia, but does not specify whether the primary correlations were estimated within groups or across them. These omissions matter because the set of participants and the handling of missing paired measurements can affect both the estimated association and its precision.
Details about a prespecified statistical analysis plan, interim analyses, or the treatment of protocol deviations are not reported in the registry record. No assumptions about these matters can be made from the stated outcome description alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Control | 0 | 25 | 0.0% |
| Mild Cognitive Impairment | 0 | 24 | 0.0% |
| Dementia | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Control | 0 of 25 |
| Mild Cognitive Impairment | 0 of 24 |
| Dementia | 0 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Control | 0 of 25 |
| Mild Cognitive Impairment | 0 of 24 |
| Dementia | 0 of 8 |
The registry reports serious adverse events and other adverse events by participant group. For control, the number at risk was 25, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For mild cognitive impairment, the number at risk was 24, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For dementia, the number at risk was 8, with 0 serious adverse events, 0 other adverse events, and 0 deaths. These are the posted event counts.
A zero count means no event was recorded in that category for the group in the registry's adverse-event results. It does not establish that the underlying risk is zero, or that an event could not occur in a larger or different population. The number at risk is relevant context for reading a count, but these counts alone do not provide a precise estimate of event risk.
The record does not list any serious adverse-event terms. It does not provide further detail about the method or timing of safety surveillance, event definitions, or whether all participants contributed to the safety assessment. The listed group counts should therefore be read descriptively, not as a comparison demonstrating a difference between groups. The registry identifies a feasibility and validity study rather than a randomized treatment comparison, and its group allocation is not stated.
12. What the Result Does, and Does Not, Mean
The registry record describes a study intended to assess whether computerized tools for cognition and mood were feasible and had measurement properties that could be examined through correlation with established pencil-and-paper assessments. It identifies HHT-G and HHT-D as the computerized measures and the MMSE and GDS as reference assessments. It also defines the direction and range of each score. Those details clarify the intended statistical question.
The record does not report the numerical primary outcome results. Without correlation estimates and their uncertainty, readers cannot determine the observed degree of association, its precision, or whether the paired assessments behaved as expected in this sample. The title and objectives alone do not establish that the assessments were feasible, valid, reliable, or internally consistent. Those are study aims, not numerical findings.
Even if numerical correlations were available, correlation would address association rather than full agreement or interchangeability. It would not, on its own, show that computerized scores can replace existing measures, that the assessments perform equally across the three participant groups, or that they predict clinical outcomes. Such conclusions would require appropriate evidence and analyses, which are not reported in the registry record.
The results also cannot be interpreted as a randomized comparison of participant groups. Allocation is not stated, and the record explicitly indicates that the arms are not a like-for-like control comparison. Differences between groups could not be attributed to an intervention on the basis of this design description. The adverse-event counts are descriptive and do not establish the absence of risk.
Accordingly, the defensible conclusion is limited: the registry records a completed study with enrollment of 57 and describes a correlation-based assessment of computerized cognitive and depression measures. It does not provide the numerical results needed to judge the strength of evidence for the stated measurement aims. No treatment-effect conclusion follows from the information reported.
13. Why This Trial Matters Statistically
This study addresses a statistical measurement problem: whether computerized assessments can capture constructs that are also assessed using established pencil-and-paper instruments. Measurement quality matters because conclusions from later research or clinical monitoring depend on how well the underlying construct is represented by the observed score. The registry's focus on cognition, mood, and life space reflects the intended scope described in its study summary, while the primary outcome specifically describes HHT-G and HHT-D comparisons with the MMSE and GDS.
The proposed computerized approach also relates to how assessments are delivered. The study summary describes practical limitations of clinic-based pencil-and-paper testing and the aim of enabling remote assessment. These are motivations stated in the record, not findings that the computerized assessments reduced costs, improved access, or could be used remotely in practice. A feasibility analysis would need reported measures of use or completion to substantiate such claims; those numerical findings are not reported in the registry record.
Statistically, the distinction between association and agreement is central. Correlation can indicate whether scores move together, but it does not answer every question needed to compare two instruments. Reliability, validity, internal consistency, and usability are related but distinct properties. Naming several of these aims without numerical estimates or analysis details leaves readers unable to determine which properties were evaluated successfully.
The study is also a reminder that registry descriptions and numerical results serve different roles. A detailed outcome definition makes clear what the investigators intended to measure, but interpretation requires estimates, uncertainty, analysis populations, and methods for missing data and multiple comparisons. These details are not reported in the registry record. Their absence limits how much can be concluded, even when enrollment, assessment names, score ranges, and group labels are available.
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.
The main limitation for statistical interpretation is that the registry record does not report numerical results for the primary correlation-based outcome. It gives no coefficients, confidence intervals, p-values, group-specific estimates, or numerical reliability and internal-consistency results. As a result, the magnitude and precision of the measurement relationships cannot be evaluated.
The record describes enrollment of 57 participants and three groups, but does not report the number contributing to each primary analysis. It does not say whether correlations were calculated across all participants, separately by group, or using another approach. This is important because the participant groups may differ in cognitive status, and a pooled association need not represent the association within each group. This is a general interpretive concern, not a claim about the study's actual data.
Allocation is not stated, and the registry cautions that the groups are not a like-for-like control comparison. Thus, the group labels should not be read as randomized treatment arms or as evidence of causal effects. The record also does not report recruitment details, participant flow, completion rates, or the handling of missing or incomplete assessment pairs.
Although the endpoint description names reliability, validity, and internal consistency, it does not specify the exact statistics or full analysis procedures used for those aims. The correlation type, uncertainty method, covariate handling, assessment of assumptions, and multiplicity approach are not reported in the registry record. Nor are results for the feasibility aim described numerically. These omissions make it difficult to assess reproducibility and to distinguish the intended aims from results that were actually obtained.
The safety figures record zero serious adverse events, zero other adverse events, and zero deaths in each listed group, but the registry does not describe surveillance details. These counts are limited descriptive information and do not establish that risk is absent.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility and Validity of A Novel Computer Based Battery of Assessments in the Elderly — NCT02109419.
- Registry record last updated 2019-09-06; status last verified 2019-08.
- Results first posted 2019-09-06.
- 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.
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18. Record Summary
NCT02109419 is a completed study sponsored by Pennington Biomedical Research Center, titled “Feasibility and Validity of A Novel Computer Based Battery of Assessments in the Elderly.” The registry records enrollment of 57, a start of 2014-03, and primary completion in 2014-09. Participants were males and females between the ages of 60 and 85 years, inclusive, with MMSE scores of 10-30, inclusive; the groups were control, mild cognitive impairment, and dementia.
The primary outcome description concerns correlation-based assessment of HHT-G and HHT-D against the MMSE and GDS, over a visit completed over 16 day period. Numerical primary results, analysis populations, missing-data procedures, and multiplicity methods are not reported in the registry record. The adverse-event counts are zero for serious events, other events, and deaths in each listed group. Allocation is not stated, and the groups are not a like-for-like control comparison.