A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting (NCT03209570), a randomized na study. The primary outcome is Wet Events Per 24 Hours.

2. Clinical Question

The study also set out to examine whether sensor-informed care planning differentially affected nursing effort, product use, and wet-time. The named secondary outcomes are time wet per 24 hours and number of brief changes per 24 hours. The registry lists three outcome measures in total, but does not give numerical results for these outcomes.

This is a question about a care-planning strategy in a nursing home setting, not simply whether a sensor can record events. The intervention incorporates sensor wear data into care planning, while the control arm’s care planning does not use those data. That distinction defines the comparison. The registry record does not report how care plans were created, how consistently the strategies were followed, or how nursing effort was measured.

3. Trial Design

The registry classifies the study as randomized, single-masked, and parallel-group. It describes a two-group, two-time-point, four-site randomized longitudinal clinical trial and records an enrollment of 49. The study is completed. Its recorded start date is 2017-10-19 and its primary completion date is 2018-08-11.

The two arms are TENA Identifi with sensor wear data and TENA Identifi without sensor wear data. The intervention descriptions distinguish whether sensor wear data were used in care planning. The registry does not report the method used to generate the random allocation sequence, how allocation was concealed, or who was masked. The meaning of single masking for this trial is therefore not specified in the registry record.

The primary outcome description refers to a pre-intervention and post-intervention assessment period for each group. The registry says that group means were generated by averaging the three daily counts in each assessment period for each participant. It identifies a six-day timeframe for the primary endpoint. More detail about assessment scheduling, the timing of the periods, and whether all participants contributed data at both assessments is not reported in the registry record.

Random assignment is intended to support a fair comparison by reducing systematic differences between groups, although it does not ensure that groups are identical in a trial of this size. The registry does not report baseline characteristics, the number of participants assigned to each arm, participant flow, or reasons for withdrawal. The planned enrollment is not a substitute for those details or for the number included in any outcome analysis.

The brief summary describes the trial as a prospective comparison of standard manual toileting and toileting patterns recorded by the sensor system. It also refers to care planning, nursing effort, product use, and wet-time as topics of interest. The registered primary endpoint is the number of wet events per 24 hours, recorded by TENA Identifi, with an intervention-versus-control comparison.

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: The study design is a two group, two time-point, four site, randomized, longitudinal clinical trial. Means were generated by averaging the 3 daily counts in each assessment period (pre-intervention and post-intervention) for each group (control versus intervention).

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 Wet Events Per 24 Hours, measured over 6 days.

The primary endpoint is wet events per 24 hours, with the registry describing a comparison of the number of events recorded by TENA Identifi between the intervention and control groups. The unit is events per 24 hours, and the specified timeframe is six days. This is an event-rate outcome: it expresses event frequency relative to a period of time rather than reporting only a raw event total.

In general, an event rate can help describe how often events occur during a defined exposure period. Expressing counts per unit of time can make observations easier to interpret when the periods of observation are relevant to the comparison. The registry identifies the endpoint as a rate but does not provide further detail about the exposure-time calculation or handling of incomplete observation periods.

The outcome is relevant to the registered question because the study compares care planning with and without sensor wear data and uses TENA Identifi to record wet events. However, an event count alone does not describe every aspect of incontinence care. The registry separately names time wet per 24 hours and brief changes per 24 hours as secondary outcomes, and the brief summary also refers to nursing effort and product use.

The registry specifies least-squares means as the primary outcome measure and standard error as its dispersion measure. It describes averaging three daily counts in each assessment period for each group. Numerical estimates, standard errors, confidence intervals, and a between-group test result are not reported in the registry record, so the magnitude and precision of the primary comparison cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as a least-squares mean and its dispersion as a standard error. It also describes a randomized, longitudinal comparison with two groups and two assessment time points. Those labels provide some methodological context, but they do not specify the full statistical analysis. The model, contrast, assumptions, handling of repeated observations, and analysis population are not reported in the registry record.

What does a least-squares mean represent?

In general, a least-squares mean is a model-based estimate of a group mean. Depending on the model, it may account for variables or design features rather than simply average all raw observations. In a repeated-measures study, a model can be used to represent data from different assessment periods while accounting for the fact that observations from the same participant may be related. The registry does not identify which variables or correlations were included in its model, so the exact meaning of its least-squares mean cannot be reconstructed from the record.

The registry’s outcome description says that means were generated by averaging the three daily counts in each assessment period for each group. It does not report how those participant-level averages were used in the final comparison. For example, whether the analysis compared post-intervention means, modeled both periods jointly, or estimated a change between periods is not reported in the registry record. These approaches can answer related but distinct questions, and the distinction matters when interpreting an estimate.

What does the standard error describe?

In general, the standard error measures the estimated uncertainty of a statistic arising from sampling variability under the analysis model. A smaller standard error indicates a more precisely estimated mean, all else being equal. It does not describe the range of values observed among individual participants. The actual standard errors are not reported in the registry record, so the precision of the registered outcome estimates cannot be assessed.

A confidence interval is generally constructed from an estimate and its standard error, with a method that also depends on the analysis assumptions. It expresses a range of values compatible with the data and model at a chosen confidence level. No confidence interval level or interval estimate is reported for the primary comparison. The registry record therefore does not permit a reader to judge whether plausible differences are narrowly or widely bounded.

Why does the event-rate scale matter?

The primary outcome is a rate, expressed as wet events per 24 hours. In general, count outcomes may be analyzed with methods that account for their count-like distribution and the amount of observation time. A simple model may not fit well if the data are more variable than its assumptions allow. Over-dispersion is one such situation: the observed variation exceeds what a model expects. In general, accounting for over-dispersion can affect uncertainty estimates and tests of group differences.

The registry does not report the distribution of observed counts, a count model, a dispersion assessment, or a method for handling variation in observation time. It is therefore not possible to determine whether over-dispersion was considered or which assumptions governed the reported analysis. These are general considerations for count-rate outcomes, not claims about the methods used in this trial.

How should the sample-size illustrations be read?

The registry describes sample-size planning illustrations based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. For non-time-to-event outcomes, the stated convention is participants per arm for 80% power or 90% power, as applicable to each illustration. The illustrations are planning aids, not observed power and not the trial’s original design justification. The trial-specific design justification is not reported in the registry record.

Because the numerical observed effect and the resulting planning values are not reported in the registry record, no sample-size illustration can be interpreted quantitatively from the record. In general, such calculations depend on assumptions about the effect to detect, variability, allocation, and statistical method. A planning result should not be read as evidence that a completed study had a particular probability of detecting an effect after its data were collected.

What analysis details remain unknown?

The registry does not report the statistical test, model formula, covariates, treatment of repeated observations, missing-data method, or criteria for inclusion in the analysis. It does not report whether the analysis followed the randomized assignment regardless of adherence or used another analysis population. The identities of any masked parties are not reported either. These omissions limit reproducibility and prevent a detailed appraisal of whether the statistical method matched the design and outcome.

In general, randomization supports a comparison of assigned groups, while analysis choices determine how available observations are used to estimate that comparison. Statistical interpretation requires both an effect estimate and its uncertainty, as well as enough methodological detail to understand how they were obtained. Those elements are not reported for the primary outcome in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies wet events per 24 hours as the primary outcome and names time wet per 24 hours and number of brief changes per 24 hours as secondary outcomes. It lists three outcome measures in total. The record does not describe a multiplicity strategy, such as an adjustment to account for testing several outcomes, nor does it report a hierarchy or decision rule for interpreting multiple results. This information is not reported in the registry record.

In general, when several outcomes or contrasts are tested, the chance of obtaining at least one apparently unusual result can increase. A prespecified testing strategy can clarify which comparisons are confirmatory and how evidence across outcomes should be interpreted. Without the registry’s statistical analysis plan or result estimates, it is not possible to determine whether or how multiplicity was addressed. The registry lists zero analyses, so it gives no reported outcome tests to evaluate.

Missing-data handling is not reported in the registry record. The record does not provide participant flow, numbers with observed outcomes at each assessment period, reasons for missing observations, or any imputation or sensitivity analysis method. The planned enrollment of 49 does not establish how many participants contributed to each endpoint analysis.

The record describes randomization but does not specify the analysis population. Whether participants were analyzed according to randomized assignment, according to the care actually received, or by another rule is not reported in the registry record. This matters because departures from assignment and missing observations can affect the interpretation of a group comparison. No assumptions about those issues can be inferred from the completed status or the design labels alone.

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: acute hypoxic respiratory failure (7.1%).

The registry reports serious adverse events and deaths separately for the two arms. In the TENA Identifi with sensor wear data group, 14 participants were listed as at risk for serious events, one was affected, and one death was recorded. In the group without sensor wear data, 12 participants were listed as at risk, zero were affected by serious events, and zero deaths were recorded. The record lists zero affected by other adverse events in each arm.

The registry identifies acute hypoxic respiratory failure as the top serious-event term, with 7.1%. It does not specify in the listed term whether this event occurred in a particular arm, so the term should not be assigned to one group based on the posted information. The relationship between the recorded death and the serious adverse event is not stated.

These counts describe the safety entries in the registry; they do not establish that an event was caused by an intervention. The group sizes are small, and the record does not provide event narratives, timing, attribution, or a detailed safety analysis. The figures should be read as reported counts, not as a basis for comparing safety rates or drawing causal conclusions.

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

The posted registry information establishes that a randomized pilot trial compared care planning with TENA Identifi sensor wear data against care planning without those data. It also identifies wet events per 24 hours as the primary endpoint and describes the assessment as involving pre-intervention and post-intervention periods. These details define the study question and the type of outcome intended to address it.

The registry does not report the primary outcome estimates, their standard errors, confidence intervals, or a statistical test. It therefore does not show how many wet events per 24 hours were recorded in either group or how large and precise any between-group difference was. The absence of a reported estimate is not evidence that the groups were the same, and it is not evidence that they differed.

The same caution applies to the named secondary outcomes. Numerical findings for time wet per 24 hours and brief changes per 24 hours are not reported in the registry record. Although the brief summary describes interest in nursing effort and product use, results for those topics are not reported either. The registry record alone cannot establish whether sensor-informed care planning changed any of these measures.

In general, statistical evidence is best interpreted through an estimated effect together with its uncertainty and the methods used to calculate it. A completed study designation or a list of outcome names cannot substitute for that information. The registry’s sample-size planning description is also not an observed-power result and does not provide a test of the study’s findings.

The appropriate interpretation is limited to the design and endpoints documented in the record. Claims about effectiveness, lack of effect, clinical importance, or comparative safety would go beyond the numerical results available in the registry record. Further outcome and analysis information would be needed to characterize the findings.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its intervention changes the information used in care planning rather than simply contrasting two named products. The comparison asks whether incorporating sensor wear data into planning is associated with different recorded wet-event outcomes than planning without those data. That makes it important to distinguish the intervention strategy from the measurement system used to record the primary endpoint.

The primary measure is an event rate, and the registry describes repeated daily counts grouped into pre-intervention and post-intervention assessment periods. Such a design raises general analytical questions about count distributions, repeated observations, and the relationship between measurements from the same participant. The registry does not report how those features were handled, so the trial also illustrates why a design description and a fully specified analysis are both needed for interpretation.

The study is identified as a pilot with enrollment of 49 and was conducted across four sites. Pilot data can be useful for understanding measurement procedures and planning future research, but the registry does not report feasibility results or a justification for the planned enrollment. The information available does not establish whether the study was sized to estimate a particular effect precisely.

Most importantly, the registry identifies outcomes without reporting their numerical results. This distinction is central to statistical literacy: knowing the endpoint and design does not reveal the observed effect, its uncertainty, or whether a comparison supports a clear conclusion. A sound reading preserves that boundary rather than filling it with assumptions about the intervention or the underlying data.

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 of the registry record for interpreting this trial is that it does not report numerical results for the primary endpoint. Least-squares means and standard errors are identified as the intended summary, but the actual estimates and uncertainty are not reported in the registry record. The direction and magnitude of the group comparison therefore cannot be assessed.

The analysis is not described in enough detail to reconstruct it. The record does not identify the model, statistical test, covariates, repeated-measures structure, or method for handling count-rate variation. It also does not state which assessment-period contrast produced the primary comparison. These details are especially relevant because the outcome is a rate and the design includes pre-intervention and post-intervention measurements.

Participant flow and analyzed sample sizes are not reported. Although enrollment is listed as 49, the record does not say how many participants were assigned to each arm, contributed data at each time point, or were included in each outcome analysis. Missing-data methods and the analysis population are also not reported. The masking designation is given, but which parties were masked is not stated.

The record names secondary outcomes but gives no numerical findings for them. It does not report a multiplicity plan or the trial’s own sample-size justification. The registry’s planning assumptions do not resolve these gaps because they are described as illustrations based on an observed effect, and the numerical effect is not reported in the registry record. Finally, safety counts are limited to the entries listed; timing, attribution, and event details are not given.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting — NCT03209570.
• Registry record last updated 2019-07-26; status last verified 2019-07.
• Results first posted 2019-07-26.
• 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

The registry record describes a completed, randomized, single-masked, parallel-group pilot trial of care planning with versus without TENA Identifi sensor wear data in a nursing home setting. Enrollment was 49, and the study design description identifies four sites and pre-intervention and post-intervention assessment periods.

The primary endpoint was wet events per 24 hours, recorded by TENA Identifi, with a six-day timeframe. The registry identifies least-squares means and standard errors as the summary approach and names time wet per 24 hours and brief changes per 24 hours as secondary outcomes. It lists zero analyses.

Numerical outcome estimates, inferential results, detailed analysis methods, missing-data procedures, and analysis populations are not reported in the registry record. The available information describes the question and design but does not quantify the outcome comparison.