Bingocize: A Novel Mobile Application for Older Adult Health: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Bingocize: A Novel Mobile Application for Older Adult Health (NCT03629912), a randomized na study. The primary outcome is Executive Function Inhibition Measure 1: Flanker Task.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, parallel behavioral study sponsored by Western Kentucky University. The enrollment is 241. The record lists four conditions: Exercise + Health Education + Bingo, Exercise + Bingo, Health Education + Bingo, and Bingo Only. Their descriptions distinguish whether participants used the app for exercises, health information on fall risks and diet/nutrition, both, or bingo only. The registry record does not describe the allocation procedure beyond identifying the study as randomized.

Masking is listed as none. Thus, the record does not indicate that participants or study personnel were masked to the assigned condition. The record identifies the study as completed, with the start date listed as 2018-08-13 and primary completion as 2022-05-13. It does not report participant flow, group-specific enrollment at randomization, or how many participants contributed data at each assessment.

The primary endpoint is the Flanker Task score within the EXAMINER Battery, measured at baseline and 12 weeks. The record also lists secondary outcomes covering knowledge of fall risks and diet/nutrition, grip strength, fall efficacy, added sugar intake, quality of life, weight, and blood pressure. Sixteen outcome measures are noted, but the registry record does not provide a statistical analysis for them. The study’s allocation model and outcome schedule give context for interpreting results; they do not establish that all participants completed every assessment or that every outcome was analyzed.

Specific eligibility criteria, intervention duration beyond the stated outcome timeframe, app-use frequency, adherence monitoring, and procedures for handling departures from assigned activities are not reported in the registry record. These details would help explain how participants experienced the conditions and how closely the implementation followed the intended activities.

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: Twelve participants expressed interest but were then excluded prior to assignment to an arm or group due to failing to meet inclusion criteria. Ten participants expressed interest but then prior to assignment to an arm or group, elected to withdraw.

Overall Study

Reasons for not completing this period:

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: All participants with baseline data.

6. Primary Endpoint

The registry lists the primary outcome as Executive Function Inhibition Measure 1: Flanker Task, measured over Baseline and 12 Weeks.

The primary endpoint is an executive-function inhibition measure based on the Flanker Task, assessed at baseline and 12 weeks. The task is described as part of the EXAMINER Battery. Its score combines reaction time and accuracy data from incongruent trials, producing accuracy and reaction-time sub-scales that range from 0 to 5 and a composite score that ranges from 0 to 10. Higher scores indicate better performance.

In general, an inhibition task is used to assess the ability to respond to relevant information while suppressing competing or distracting information. The Flanker Task score is therefore intended to represent one component of executive function, rather than cognition as a whole. Combining accuracy and reaction-time information can characterize task performance across these dimensions, but the score remains dependent on the specified scoring method.

The endpoint is relevant to the study’s stated interest in cognition among older adults. Its baseline and 12-week assessments could support a comparison of change over time, if results and the analysis approach were available. However, the registry record does not report the observed scores, changes, uncertainty estimates, or an inferential comparison. The task description explains what the endpoint measures; it does not establish an observed change or a treatment effect.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the study as randomized and parallel, with no masking. In general, random assignment is intended to make assigned groups comparable on average at the start of a study, including with respect to characteristics that were not measured. It does not guarantee identical groups in a particular study. The registry record does not describe the randomization sequence, allocation concealment, or any procedures used to preserve the assignment process.

What does a parallel design mean?

In general, a parallel design assigns participants to a condition and follows those groups over the study period. The four listed conditions vary in whether app activities include exercise, health education, both, or bingo only. This design allows comparisons among assigned conditions, but the specific planned contrasts are not reported in the registry record. The four conditions should not be treated as a particular factorial analysis unless that analysis is documented.

How should a continuous endpoint be read?

The primary outcome is a continuous score summarized by a mean and standard deviation in the registry’s outcome description. In general, a mean describes the central value of a set of scores, while a standard deviation describes how dispersed individual scores are around that mean. The score range is 0 to 10, and higher values indicate better performance. Neither the means nor the standard deviations for the study groups are reported in the registry record, so the observed score distributions and group differences cannot be assessed.

For a baseline and follow-up outcome, statistical analyses may compare follow-up scores, changes from baseline, or group differences in trajectories over time. These approaches answer related but not identical questions and can depend on how baseline values and repeated measurements are handled. The registry record does not report which model or comparison was used for the Flanker Task. It also does not report whether analyses adjusted for baseline scores or other participant characteristics.

What does uncertainty convey?

In general, a confidence interval gives a range of values compatible with the data and a specified statistical procedure. A narrow interval indicates greater precision than a wide interval, although precision does not establish that an effect is important. A p-value, when used, measures how unusual data at least as incompatible with a null hypothesis would be under the assumptions of that test; it is not the probability that the null hypothesis is true. Neither confidence intervals nor p-values for the primary endpoint are reported in the registry record.

Variability matters because participants can have different Flanker Task scores even when assigned to the same condition. In general, greater spread in scores makes it harder to estimate a group mean or difference precisely, while the number of observed participants also affects precision. The overall enrollment does not identify the number with usable primary-outcome data. Group-specific analyzed counts and outcome variability are not reported in the registry record.

Why does the analysis plan matter?

In general, a statistical analysis plan specifies outcomes, comparisons, models, and approaches to missing data before results are examined. Prespecification can reduce the risk of selectively emphasizing favorable analyses. The registry record does not report the primary analysis plan, the planned contrast or contrasts, whether analyses followed intention-to-treat principles, or whether any sensitivity analyses were conducted. It also does not report interim analyses or a sample-size justification.

Multiplicity is relevant when a study measures many outcomes or makes several comparisons. In general, the more hypotheses tested, the greater the chance that at least one result appears statistically unusual by chance if no adjustment or interpretation strategy is used. The registry record notes 16 outcome measures, but does not describe any multiplicity adjustment or testing hierarchy. That information is needed to understand how confirmatory or exploratory results would be distinguished.

Over-dispersion is a general issue for count data when variability exceeds what a simple count model assumes. It is not a direct description of the primary endpoint, which is a continuous Flanker Task score. No count-outcome analysis or over-dispersion assessment is reported in the registry record. This concept should not be used to infer a feature of the primary-outcome analysis.

The record includes an illustrative sample-size assumption stating a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect described as a fraction of the observed effect. Such calculations are planning illustrations based on an observed effect, not the trial’s own design justification and not observed power. No numerical planning sample sizes are present in the registry record. They cannot be used to infer the trial’s original enrollment target or the likelihood that the study detected an effect.

Overall, the registry record makes the design and endpoint recognizable but leaves key inferential methods undocumented. Without the analysis specification and outcome estimates, the study’s statistical evidence for the primary question cannot be evaluated from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 16 outcome measures, including the primary Flanker Task endpoint and secondary measures of health knowledge, grip strength, fall efficacy, dietary habits, quality of life, weight, and blood pressure. Testing several outcomes can create multiplicity: in general, the chance of at least one apparently notable result can increase as the number of comparisons grows. Whether and how that issue was addressed is not reported in the registry record. The record does not describe a testing hierarchy, adjustment procedure, or distinction between confirmatory and exploratory analyses.

The record identifies zero analyses and does not report a primary-outcome result. It therefore supplies no basis for assessing the statistical handling of multiple comparisons or the interpretation of results across endpoints. The primary outcome is noted as having several categories or time points and not being reduced to one comparison. A prespecified analysis would be needed to clarify which comparison was intended to answer the primary question.

Missing-data methods are also not reported in the registry record. The overall enrollment is 241, but the number of participants with observed Flanker Task scores at baseline and 12 weeks, reasons for missing assessments, and any imputation or sensitivity analyses are not given. The analysis population is not reported: the record does not specify whether all randomized participants, participants who completed assessments, or another defined group contributed to an analysis.

These omissions matter because exclusions and incomplete follow-up can affect both the precision and interpretation of a comparison. The registry record does not show whether any such issue occurred in this study; it does not report enough information to assess it.

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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: unspecified health issues (7.5%), cancer diagnosis (2.3%), aneuryism (2.0%), edema (1.9%), stroke (1.9%).

The registry record lists serious adverse events, other adverse events, and deaths by condition. For Exercise + Health Education + Bingo, the serious-event at-risk count is 73 and serious events affected 3; the other-event at-risk count is 73 and other events affected 0; deaths are listed as 1. For Exercise + Bingo, the corresponding counts are 53, 6, 53, 0, and 0. For Health Education + Bingo, they are 50, 3, 50, 0, and 0. For Bingo Only, they are 43, 1, 43, 0, and 0.

These are descriptive registry counts. In general, an at-risk count indicates the group size used for the adverse-event category, while an affected count records participants reported as affected. The record does not provide event timing, seriousness criteria, relatedness assessments, exposure duration, or an explanation of the death. It also does not state whether the death was considered related to an intervention. A count by itself cannot establish causation.

The registry lists serious-event terms with percentages: Unspecified Health Issues, 7.5%; Cancer Diagnosis, 2.3%; Aneuryism, 2.0%; Edema, 1.9%; stroke, 1.9%; and Wrist Fracture, 1.4%. The denominator and the relationship of these terms to each group are not reported in the registry record. These entries should therefore be read as listed safety information, not as comparative risks or evidence about the cause of an event.

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

The record establishes that a randomized, parallel study evaluated four Bingocize app conditions and specified a Flanker Task measure of executive-function inhibition as its primary endpoint. The score combines reaction time and accuracy for incongruent trials, ranges from 0 to 10, and is assessed at baseline and 12 weeks. This information identifies the study question and the intended cognitive measurement.

What the record does not establish is whether scores changed, how the four conditions compared, or how precisely any difference was estimated. The registry record does not report means, standard deviations, effect estimates, confidence intervals, or a primary-outcome statistical test. The listed enrollment is not a substitute for an outcome analysis, and the endpoint’s description is not evidence that a change occurred.

In general, a statistically detectable difference and a practically meaningful difference are separate considerations. Statistical uncertainty concerns how precisely an effect is estimated; practical meaning concerns whether the size and context of that effect matter. Neither can be judged for this primary endpoint without a reported result and its uncertainty. No medical advice or conclusion about benefit or lack of benefit follows from the information in the registry record.

The study also lists a range of secondary outcomes and adverse-event counts. Those details broaden the scope of what the registry records, but they do not fill the gap in the primary analysis. The adverse-event entries are descriptive, and the registry does not report enough context to attribute events to the app or compare risks causally.

Accordingly, the defensible conclusion is limited: the registry record describes the design, assigned activities, endpoint, and selected safety counts, while leaving the primary statistical result unreported. It does not establish equivalence among conditions, a difference among conditions, or an effect of Bingocize on executive function.

13. Why This Trial Matters Statistically

This study is statistically notable for asking a multi-part question through four app conditions that separate exercise, health education, and bingo activities. The condition descriptions make clear that the active content differs, while the endpoint focuses on a specific cognitive task. That combination raises an important design and interpretation issue: a comparison can only answer the question defined by the assigned conditions and the planned analysis.

The primary endpoint is not a broad measure of all cognition. It is a Flanker Task score combining reaction time and accuracy on incongruent trials, within the EXAMINER Battery. Distinguishing a specific task score from an overall claim about cognition is essential when interpreting behavioral research. The registry’s scale description and assessment timing help readers understand what was intended to be measured, even though results are not reported.

The record also illustrates why registration details alone are not a complete statistical report. Randomization, a parallel model, enrollment, endpoint definition, and outcome timing describe important elements of a study. Interpretation additionally requires the analysis population, comparison plan, observed estimates, uncertainty, and approach to missing data. Those items are not reported in the registry record for the primary endpoint.

Finally, the listing of 16 outcome measures makes multiplicity a relevant general consideration. Without a reported hierarchy or adjustment strategy, readers cannot determine how outcomes were prioritized statistically. This matters especially when a study evaluates several dimensions of health and function. The record’s value is in clarifying the intended study structure and the limits of the available statistical evidence, not in resolving the clinical question.

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 trial-specific limitation for statistical interpretation is that the registry record does not report a primary-outcome analysis. Although it defines the Flanker Task score and specifies baseline and 12-week assessments, it gives no group means, standard deviations, comparison estimates, confidence intervals, or test results. The direction, size, and precision of any difference therefore cannot be assessed.

The record lists four conditions but does not report the planned primary contrast or contrasts. It is not possible to determine from the registry record whether the primary question concerned one condition versus another, a set of pairwise comparisons, or another model. The study should not be assumed to have used a factorial analysis simply because its four conditions differ in exercise and education content.

Masking is listed as none, but the registry does not explain how outcome assessment was conducted or whether assessors were masked. Randomization is reported, but its sequence generation and allocation concealment are not described. Eligibility criteria, participant characteristics, adherence, and group-specific participant flow are also not reported in the registry record.

The record does not describe the analysis population, missing-data handling, baseline adjustment, or sensitivity analyses. It lists 16 outcomes and zero analyses, without reporting a multiplicity strategy. The overall enrollment of 241 does not establish how many participants had complete primary-outcome data or how many were analyzed in each condition.

Safety entries are limited to counts and listed event terms. Their timing, relatedness, definitions, and denominators for the listed terms are not reported. These gaps constrain comparison and causal interpretation. They are limits of what the registry record reports and should not be read as evidence that a particular procedure or event did or did not occur.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Bingocize: A Novel Mobile Application for Older Adult Health — NCT03629912.
• Registry record last updated 2024-03-12; status last verified 2024-02.
• Results first posted 2024-03-12.
• 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

NCT03629912, titled Bingocize: A Novel Mobile Application for Older Adult Health, is listed as a completed, randomized, parallel behavioral study sponsored by Western Kentucky University. Enrollment is 241; masking is listed as none. The registry record describes four conditions: Exercise + Health Education + Bingo, Exercise + Bingo, Health Education + Bingo, and Bingo Only.

The primary endpoint is Executive Function Inhibition Measure 1: Flanker Task, assessed at baseline and 12 weeks. The score combines reaction time and accuracy data from incongruent trials, ranges from 0 to 10, and higher scores indicate better performance. The record lists 16 outcome measures and zero analyses. A numerical primary-outcome result and the statistical analysis plan are not reported in the registry record.

Serious adverse-event counts, other adverse-event counts, deaths, and selected serious-event terms are recorded. The registry record does not report enough detail to establish causation or interpret those entries as comparative risks.