BioButton Among Nursing Home Residents: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for BioButton Among Nursing Home Residents (NCT06665685), a non-randomized na study. The primary outcome is Number of Participants With Device-Related Adverse Events.

2. Clinical Question

3. Trial Design

This is a pilot study of BioButton use among nursing home residents. The registry identifies the design as non-randomized and parallel, with no masking. Its phase is listed as NA. Enrollment is 17. The study began on 2025-03-11, had a primary completion date of 2025-07-18, and is listed as terminated. The reason for termination is not reported in the registry record.

The Patient Group was to wear the device continuously for 30 days while receiving otherwise routine, standard care. The Nurse Group consists of nurses caring for patients wearing the device; their specified role was to help place and remove it, while otherwise providing routine care. The described groups therefore have different roles, and the record cautions that they are not a like-for-like control comparison. The nurse group should not be read as an untreated patient group.

The stated aim is to explore whether a remote wearable multi-parameter monitor can identify gait disturbances occurring as a side effect of polypharmacy. The primary outcome focuses on participant counts for device-related adverse events over 30 days, including clinically significant skin injury or discomfort attributed to wearing the BioButton. This safety endpoint is distinct from demonstrating that gait monitoring identifies medication-related disturbances or changes clinical decisions.

The registry lists four outcome measures, but the other outcome measure descriptions are not reported in the registry record. The primary endpoint result is also not reported. The record does not report a randomized allocation process, a masked assessment process, or a separate control intervention. These features limit what can be inferred from comparisons between the listed groups and from the posted outcome information.

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: Of the 17 enrolled, 16 were assigned to the "patient-arm" and 1 withdrew consent prior to being assigned. Zero (0) participants were assigned to the "nurse-arm" prior to termination of the study.

Overall Study

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 Number of Participants With Device-Related Adverse Events, measured over 30-days.

The primary endpoint is the number of participants with device-related adverse events during the 30-day monitoring period. The registry describes these as events attributable to wearing the BioButton, including clinically significant skin injury or discomfort. It is a count-based, binary endpoint at the participant level: each participant either experienced at least one qualifying event or did not. A participant count is not the same as a count of every event, since one participant could potentially experience more than one event; the registry’s endpoint wording specifies participants.

This endpoint is used to describe device tolerability and safety during the planned monitoring period. It gives a direct summary of whether any participant had a qualifying device-related event, rather than measuring gait detection accuracy, medication changes, or clinical benefit. Those concepts are not interchangeable. The study’s broader aim concerns using gait data to inform prescription practice, but the primary endpoint as defined is an adverse-event measure.

The result for this primary endpoint is not reported in the registry record. The safety summary lists serious and other adverse-event figures, but it does not establish that these events were device-related or met the primary endpoint definition. The extent of overlap between the safety summary and the primary outcome is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a participant count, making it a binary outcome at the participant level: a participant either has at least one qualifying device-related event or does not. This differs from an event total, which can count repeated events in one participant separately. The endpoint’s definition specifies the participant as the unit and includes clinically significant skin injury or discomfort attributable to wearing the device during the 30-day period.

What can a participant count tell us?

For a binary endpoint, the basic descriptive result is the number of participants meeting the definition, interpreted alongside the number assessed or at risk. The denominator matters because a count alone does not indicate how much of the group was observed. A proportion can sometimes help summarize a binary outcome, but no new proportion is calculated. The primary endpoint count and denominator are not reported in the registry record, so this endpoint cannot be summarized with a numerical estimate from the posted information.

The adverse-event summary lists 16 participants at risk in the Patient Group. It separately lists 0 serious adverse events, 3 other adverse events, and 0 deaths. These safety figures are descriptive and do not supply the missing primary endpoint result. The record does not state that the 3 other adverse events were device-related, nor does it establish whether the events occurred in distinct participants. Those distinctions are important because the primary outcome counts participants with a specific type of event, not all adverse-event entries.

Why does the design matter?

General: random allocation can help balance measured and unmeasured characteristics across comparison groups, making a causal comparison more credible. This study is listed as non-randomized, and its Patient Group and Nurse Group have different responsibilities. The patients wear the device; nurses assist with placing and removing it. As the registry cautions, these are not like-for-like control groups. A difference between them would not, by itself, estimate the effect of device use on patient outcomes.

The registry also lists no masking. General: masking can reduce the influence of knowledge about an intervention on care, event assessment, or reporting. The record does not explain how adverse events were assessed or whether assessors were independent. No assumptions about those procedures can be made from the design labels alone.

What does an uncertainty interval add?

General: an estimate describes the observed data, while a confidence interval expresses statistical uncertainty around that estimate under a chosen model and assumptions. For a binary outcome, intervals can be wide when the number of participants or observed events is limited. A zero observed count does not prove that the underlying event risk is zero. An interval would help describe uncertainty, but no primary endpoint estimate or interval is reported in the registry record.

General: sparse event counts can make standard approximations unreliable. Methods for binary outcomes may use exact or other approaches designed for small counts; the appropriate method depends on the estimand and analysis plan. The registry does not report the planned method for the primary endpoint, and no analyses are listed. It is therefore not possible to say which inferential procedure was intended or performed.

How should planning illustrations be read?

The registry’s planning description specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. It also states that participant-based results are expressed per arm, while time-to-event planning uses a total number of events. These are planning assumptions, not evidence that the study itself used that design or achieved a particular power. The study is non-randomized, and its groups are not a like-for-like comparison. The numerical planning results and the observed effect used for those illustrations are not reported in the registry record.

General: over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can make standard errors and confidence intervals too small if ignored. The primary endpoint is a participant-level binary count, and the registry does not report a dispersion estimate or an analysis model. No claim about over-dispersion or its impact on this study’s results is warranted.

Overall, the posted record supports descriptive interpretation of the listed safety counts but not an inferential estimate for the primary endpoint. The analysis method, missing-data handling, and analysis population are not reported in the registry record. Without those details and the endpoint result, the statistical precision and robustness of the primary finding cannot be evaluated.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Patient Group")
n      <- c(16)
events <- c(0)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Patient Group  16  0  0.0  0.0  20.6  0.0  19.4  0.1  19.5

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and zero analyses. The primary endpoint is described, but the other outcome measure descriptions and results are not reported in the registry record. The record does not state which outcomes were considered primary or secondary beyond the stated primary endpoint, nor does it report a prespecified hierarchy or a plan for interpreting multiple outcomes.

Multiplicity arises when several outcomes or statistical tests are examined: even when each test uses the same nominal threshold, the chance of at least one apparently notable result can increase. General methods can control or otherwise address this issue, but the registry does not report whether any such method was planned. No adjustment or unadjusted inferential result is available to interpret.

The registry does not report how missing data were handled, whether participants who did not complete monitoring were included, or how the analysis population was defined. The reason the safety summary lists 16 participants at risk while enrollment is 17 is also not reported in the registry record. These omissions prevent assessment of whether outcome data were complete or how exclusions, if any, could affect the results.

The record does not report an analysis plan, interim analyses, a sample-size justification, or details about endpoint adjudication. No assumptions should be made about these procedures. Consequently, it is not possible to assess whether analyses followed a prespecified plan, how incomplete follow-up was treated, or whether the posted counts represent all enrolled participants.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

Most frequent non-serious adverse event terms

The registry’s Patient Group safety summary lists 16 participants at risk. It reports 0 serious adverse events, 3 other adverse events, and 0 deaths. These are the posted counts; the record does not provide further event descriptions in the serious-event terms listing.

These figures should be read as safety summaries, not automatically as the primary endpoint result. The primary endpoint is defined as participants with device-related adverse events during 30 days, including clinically significant skin injury or discomfort attributed to wearing the BioButton. The summary does not identify the 3 other adverse events as device-related, and it does not state whether they occurred in separate participants. It therefore does not establish how many participants met the primary endpoint definition.

A count of 0 serious adverse events means none are listed in this summary; it does not demonstrate that the underlying risk is zero. With a small pilot and limited reported information, the precision of any underlying risk estimate cannot be judged from the count alone. The record does not report follow-up completeness or the method used to collect and classify adverse events.

Enrollment is 17, whereas the safety summary lists 16 at risk. The reason for this difference is not reported in the registry record. The counts should not be extended to participants not listed in the safety denominator.

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

The record documents a pilot intended to explore the use of BioButton gait and physiologic data in nursing home residents, with a particular interest in medication-induced gait disturbances. It also defines a 30-day primary safety endpoint focused on participants experiencing device-related adverse events. Those features describe the study’s purpose and question; they do not establish that the device identified gait disturbances or altered prescription practice.

The posted safety summary reports 0 serious adverse events, 3 other adverse events, and 0 deaths among 16 participants at risk in the Patient Group. These counts are descriptive. They do not establish that an event was caused by the device or that it met the primary endpoint definition. The primary endpoint result is not reported in the registry record, so the stated safety question cannot be answered from the posted primary outcome result.

The non-randomized design and the distinct patient and nurse roles limit comparative interpretation. The Nurse Group is not described as a patient control group, and the registry explicitly cautions against treating the arms as a like-for-like comparison. The results therefore do not provide a controlled estimate of a device effect.

The record also does not report the reason for termination, whether all participants completed monitoring, or how missing outcome information was handled. These gaps, together with the absence of a primary outcome analysis and uncertainty interval, limit assessment of the completeness and precision of the findings.

General: a pilot can be useful for describing study procedures, feasibility questions, and the kinds of outcomes that warrant further evaluation. Its descriptive information should not be mistaken for definitive evidence of effectiveness or safety. In this record, the available counts characterize only the posted safety summary. They cannot establish that BioButton monitoring improves gait assessment, prevents medication-related disturbances, or informs prescribing decisions.

14. Why This Trial Matters Statistically

This study raises a statistical question that is easy to overlook: the endpoint of interest and the broader study aim are not the same. The primary endpoint counts participants with device-related adverse events during 30 days. The broader aim is to explore whether wearable gait data can identify disturbances associated with polypharmacy and inform prescription practice. A safety count does not answer a question about detection or prescribing.

That distinction matters when interpreting pilot results. A study can describe whether events were recorded, while leaving accuracy, clinical decision-making, and comparative effects unmeasured or unreported. Here, the primary endpoint result is not reported in the registry record, and no analyses are listed. The posted safety counts therefore cannot be used as a substitute for the stated endpoint or the broader clinical question.

The design also illustrates why the meaning of a comparison depends on group roles. The patients wear the device, while nurses assist with placement and removal. Because allocation is non-randomized and the groups are not like-for-like controls, their differences cannot be treated as an estimate of the device’s effect on patient outcomes.

Finally, the denominator and follow-up context are essential to interpreting event counts. Enrollment is 17, but 16 participants are listed at risk in the Patient Group; the reason is not reported. The record does not describe completeness of monitoring or missing-data handling. These gaps constrain even a descriptive reading of the safety results, and they underscore the importance of reporting endpoint definitions, participant flow, and analysis methods alongside counts.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The record does not report the primary endpoint result, despite defining the endpoint and monitoring period. It also does not report an effect estimate or confidence interval. As a result, the number of participants meeting the device-related adverse-event definition and the precision of that result cannot be assessed.

Enrollment is 17, while the Patient Group safety summary lists 16 participants at risk. The reason for the difference is not reported in the registry record. The record also does not state whether all participants completed the 30-day monitoring period, whether any participants withdrew, or how missing outcome data were handled.

The design is non-randomized, unmasked, and parallel. The Patient Group and Nurse Group have different roles, and the registry cautions that they are not a like-for-like control comparison. The record does not describe a comparable patient control group, so comparative or causal conclusions are limited.

The safety summary lists 3 other adverse events but does not establish that they were device-related or indicate whether they occurred in distinct participants. It lists no serious adverse event terms. The relationship between these safety figures and the primary endpoint is not reported in the registry record.

The registry lists four outcome measures but does not describe the other outcomes in the record information available for interpretation. It also lists zero analyses and does not report the analysis plan, multiplicity approach, sample-size justification, event-assessment procedures, or reason for termination. These omissions limit assessment of the study’s completeness, statistical methods, and the scope of conclusions that can be drawn.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: BioButton Among Nursing Home Residents — NCT06665685.
• Registry record last updated 2026-10-14; status last verified 2025-12.
• Results first posted 2026-10-14.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a pilot study of BioButton use among nursing home residents, with the aim of exploring gait data in relation to medication-induced gait disturbances. The design is non-randomized, parallel, and unmasked; phase is listed as NA. Enrollment is 17. The study began on 2025-03-11, had a primary completion date of 2025-07-18, and is listed as terminated.

Patients in the Patient Group were to wear the device continuously for 30 days while receiving routine care. Nurses were to assist with placing and removing it. The primary endpoint counts participants with device-related adverse events during the 30-day period. Its result is not reported in the registry record.

The safety summary lists 0 serious adverse events, 3 other adverse events, and 0 deaths among 16 participants at risk in the Patient Group. The record lists four outcome measures and zero analyses. It does not explain the enrollment and at-risk denominator difference, report the reason for termination, or provide details of missing-data handling.