The Perceived Efficiency and Acceptability of Remote Real-time Health Monitoring System in Elderly Residential Setting and Community Isolation Facility: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Perceived Efficiency and Acceptability of Remote Real-time Health Monitoring System in Elderly Residential Setting and Community Isolation Facility (NCT05302440), a registered phase not stated study. The primary outcome is Average Staff Perceived Overall Time-saving of the System Over 14 Days.

2. Clinical Question

3. Trial Design

The registry describes a completed, single-group study of a remote real-time health monitoring system with a ring-like sensor. It lists enrollment of 20 and identifies care staff in residential care homes for the elderly as the target of the research questions. The record does not give further participant characteristics or clarify whether the enrollment count refers exclusively to staff.

According to the arm description, staff who manage the system complete a very brief survey after each work shift for 14 days. The system records detection of abnormal vital signs, and the care team documents hospital admissions and further medical assistance due to use of the system. The description ends mid-sentence, so the registry record does not report the remainder of that arm description.

The registry lists the intervention as a device and names the system as the study intervention. It does not report a randomized allocation method or a like-for-like control comparison. A comparator condition is not reported in the registry record. The study status is completed, and the listed start and primary completion dates are 2022-03-21 and 2022-05-09.

The primary endpoint is average staff-perceived overall time-saving over 14 days, measured with a scale score. The record also lists secondary questions about admissions and further medical assistance, staff stress, perceived benefits and acceptability, implementation considerations, set-up barriers, and connection preferences. Secondary outcome descriptions include several staff agreement items about monitoring, sensor detachment, accuracy, and fit. Although the registry lists 10 outcome measures, it reports zero analyses. Observed endpoint results and statistical comparisons 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.

Before assignment: Failure to read and understand Chinese will deter smooth communication and undermine the objectivity 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 Average Staff Perceived Overall Time-saving of the System Over 14 Days, measured over every day during the 2-week trial period.

The primary endpoint is the average staff-perceived overall time-saving of the system over 14 days. Each day during the 2-week trial period, staff were asked after every shift to rate agreement with the statement that the remote real-time health monitoring system reduces time spent measuring residents’ vital signs during the previous shift. The response uses a 5-point Likert scale, with 5 meaning Strongly Agree and 1 meaning Strongly Disagree.

This endpoint captures staff perception of workflow efficiency, one of the study’s stated primary research questions. It is a report of perceived time-saving, rather than a direct measure of minutes saved, objective workload, vital-sign measurement performance, or clinical outcomes. The distinction matters: a rating can describe staff experience, but by itself it does not quantify actual time saved or establish whether monitoring led to earlier detection or medical support.

The registry specifies that the endpoint is summarized as a mean with a standard deviation. It does not report the observed mean, standard deviation, number of completed surveys, or any estimate of uncertainty. Therefore, the direction and precision of the staff ratings cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous score summarized as a mean and standard deviation. The score comes from a 5-point Likert item, where 5 means Strongly Agree and 1 means Strongly Disagree. In general, a mean describes the average score across the observations included in the calculation. A standard deviation describes how spread out those scores are around their mean. Neither statistic is reported for this endpoint in the registry record, so the average response and its variability cannot be interpreted.

What does the Likert score measure?

In general, a Likert response records an ordered level of agreement. Its values convey an order, but the distance between adjacent response options need not represent an identical change in perception for every respondent. Reporting a mean is a common way to summarize such scores, but it should be understood as a summary of the recorded ratings, not as a direct measurement of time saved. The survey asks staff to judge whether the system reduces time spent measuring vital signs during the previous shift; it does not ask for elapsed time or a count of measurements.

The endpoint is described as an average over 14 days, with the rating requested after every shift. This makes the measurement schedule relevant to interpretation. The registry record does not report whether a participant-level average, a shift-level average, or another aggregation was used, nor how repeated responses from the same staff member were handled. Because the outcome description does not specify those details, the analysis structure cannot be reconstructed from the record.

What would a confidence interval add?

In general, a confidence interval expresses the uncertainty around an estimated quantity under a statistical model and sampling procedure. It helps readers distinguish the estimated average from the range of values compatible with the observed data and assumptions. The registry record does not report a confidence interval for the time-saving endpoint, or any other primary-endpoint estimate. The precision of the average is therefore not available for assessment.

In general, a p-value addresses how compatible the observed data are with a specified null hypothesis under the statistical assumptions used. It is not a measure of effect size, practical importance, or the probability that a hypothesis is true. The registry record does not report a hypothesis test, p-value, or comparison for the primary endpoint. There is consequently no basis in the registry record to describe a statistically significant or non-significant result.

What is the role of the other outcomes?

The registry lists secondary outcomes on hospital admissions and further medical assistance, staff stress, agreement with statements about remote monitoring, sensor detachment, measurement accuracy and sensor fit, and preferences about cable or wireless connection. These outcomes address different aspects of feasibility, perception, and care processes. They should not be treated as interchangeable with the primary time-saving score. The registry record does not report their observed values or analyses.

For count outcomes, general statistical interpretation depends on what is counted, the time at risk, and how events are defined. The registry description says that the system records detection of abnormal vital signs and that the care team documents admissions and further medical assistance due to use of the system. It does not provide observed event counts for those outcomes. For staff-agreement outcomes, counts of people agreeing would depend on the response definition and available responses; those details and results are not reported in the registry record.

What can be inferred from the study design?

In general, a single-group design describes outcomes in a group exposed to an intervention, but without a like-for-like control it does not by itself distinguish intervention effects from other explanations. The registry identifies a single-group study and does not state an allocation method or a control comparison. No causal contrast can be derived from the design information reported.

The registry includes sample-size planning assumptions described as an illustration based on the observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. It also notes that time-to-event calculations use a total event count and other calculations use participants per arm. These assumptions do not describe the single-group design as reported, and the registry record does not report the resulting planning values or the observed effect. They cannot be read as the study’s own design justification, observed power, or evidence that a planned sample size was achieved. Sample-size illustrations are planning aids, not observed results.

The record lists zero analyses. That means the registry entry does not provide a statistical analysis result to interpret. The methods information available describes the endpoint, scale, summary statistic, and some planning assumptions, but it does not report a full statistical analysis plan, missing-data method, adjustment strategy, or uncertainty estimate. Those details are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Single-group")
n   <- c(20)
m   <- c(2.8)
sp  <- c(0.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Single-group  20  2.800  0.900  2.379  3.221

11. Multiplicity, Missing Data and Analysis Populations

The registry lists three primary research questions and multiple secondary questions, as well as 10 outcome measures. It does not report how the questions were prioritized for statistical testing, whether any adjustment for multiple comparisons was planned, or which outcomes were intended to be confirmatory versus exploratory. The statistical plan for handling multiplicity is not reported in the registry record.

Multiplicity matters in general when several outcomes or hypotheses are examined: the chance of at least one apparently unusual result can increase as more tests are considered. That concern cannot be quantified for this study from the registry entry because no test results, analysis plan, or adjustment method is reported. The record also does not state whether interim analyses were planned or conducted.

Missing-data handling is not reported in the registry record. The study description calls for staff surveys after each shift for 14 days, but gives no number of completed surveys, missing responses, reasons for missingness, or method for summarizing incomplete repeated measurements. Enrollment of 20 does not reveal how many endpoint ratings were available.

The analysis population is not defined in the registry record. It does not state which participants or staff were included in each outcome analysis, how eligibility for analysis was determined, or whether any participants were excluded from summaries. The record lists zero analyses and does not provide outcome estimates or analysis populations. These omissions limit assessment of completeness, selection, and the reliability of any inferred result; the registry record does not provide the information needed to resolve them.

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 0% reporting threshold.

The registry lists a single group with 20 people at risk for serious adverse events and zero affected, and 20 at risk for other adverse events and zero affected. It also lists zero deaths. These are the event counts recorded in the registry entry; they are not evidence that every possible harm was assessed or that no unreported event occurred.

In general, an observed count of zero means that no events in that category were recorded for the stated group in the registry data. It does not establish that the underlying risk is zero. Interpretation depends on the event definitions, follow-up, completeness of reporting, and the amount of observation. The registry record does not provide event definitions, detailed follow-up information, or a narrative explaining the zero counts.

The listed at-risk count should not be mistaken for a count of events, and the adverse-event summary should be kept separate from the study’s primary staff-perceived time-saving endpoint. The record does not report analyses linking the monitoring system to adverse events, nor does it provide a comparison group for assessing relative safety. These counts are descriptive registry entries, not a comparative safety estimate.

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

The registry record establishes that the study examined staff perceptions of a remote real-time monitoring system with a ring-like sensor in an elderly residential setting. Its specified primary endpoint concerns agreement that the system reduces staff time spent measuring residents’ vital signs. The study description also indicates a survey after each shift for 14 days, system recording of abnormal vital-sign detection, and documentation of admissions and further medical assistance by the care team.

Those details describe the questions and measurement approach, not the findings. The registry does not report the primary endpoint mean or standard deviation, completed survey counts, secondary outcome results, or statistical analyses. It is therefore not possible to determine from the registry record whether staff reported time-saving, how consistent their ratings were, or how precisely any average was estimated.

The stated research questions include early detection and early delivery of medical support. A time-saving rating cannot answer those questions on its own. Likewise, the listed secondary questions about stress, acceptability, device fit, sensor detachment, and connection preference concern distinct outcomes. Without their results, the registry record does not establish staff acceptability, reduced stress, improved detection, or a change in medical assistance.

The single-group design also limits what could be concluded about cause and effect even if outcome summaries were available. The registry does not report a like-for-like control comparison. Any within-group description would not, by itself, separate effects associated with the system from other changes or circumstances during the observation period.

The most defensible interpretation is therefore bounded: the registry documents a completed study, its broad design, survey-based primary measure, and several related research questions, but it does not report the results needed to judge the measured outcomes. The recorded zero adverse-event counts are descriptive and do not establish zero underlying risk. No treatment or clinical-effect conclusion can be drawn from the information in the registry record.

14. Why This Trial Matters Statistically

This study is statistically notable for the distinction between the research questions and the result information recorded. The primary endpoint is specific and interpretable as a staff-reported perception: agreement that the monitoring system reduces time spent measuring vital signs during the previous shift. The registry also specifies a mean and standard deviation as the summary, which indicates the intended form of description. Yet neither statistic is reported. A well-defined endpoint without its observed estimate cannot answer whether the measured perception was favorable, neutral, or unfavorable.

The study also highlights the importance of matching the analysis to repeated measurements. Surveys were planned after each shift for 14 days, so responses could recur within staff members. In general, repeated responses from the same person are not automatically independent observations. The registry record does not report how repeated ratings were aggregated or modeled. This missing detail matters for interpreting both the average and its uncertainty.

Another statistical issue is the separation of subjective and operational outcomes. Staff-reported time-saving, recorded abnormal vital-sign detection, hospital admissions, further medical assistance, and staff acceptability capture different dimensions. A result for one would not stand in for the others. The registry lists these areas but reports no analyses or observed outcomes, leaving their relationships and individual patterns unknown.

Finally, the single-group design and absent analysis results constrain inference. In general, a control comparison can help distinguish intervention-associated differences from background changes, while an analysis plan clarifies how outcomes, missing responses, and multiple questions are handled. The registry does not report a like-for-like control comparison or these analysis details. The case therefore illustrates why design, endpoint definition, observed estimates, and uncertainty all matter: without the latter elements, the research question can be described, but the statistical evidence cannot be evaluated.

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 registry record does not report the observed primary endpoint mean, standard deviation, confidence interval, or test result. It also lists zero analyses. As a result, the primary outcome cannot be evaluated for direction, magnitude, variability, or precision. Results for the secondary outcomes are likewise not reported in the registry record.

The study is described as single-group, with no like-for-like control comparison identified. Allocation is not stated. This limits the ability to distinguish intervention-associated outcomes from other influences, even if descriptive outcome results were available. The registry does not report whether staff experience or practice changed over the monitoring period.

The intended survey schedule is described as after every shift for 14 days, but the registry does not report the number of completed surveys, the number of staff contributing ratings, or the handling of incomplete repeated responses. The analysis population, missing-data approach, and method for accounting for repeated responses are not reported. The enrollment count alone does not resolve these issues.

The primary measure is a staff perception rating rather than a direct measure of elapsed time. It captures agreement with a statement about time-saving, not the amount of time saved or an objective measure of workflow. Other stated questions, including early detection and medical support, require separate outcome information that is not reported in the registry record.

The registry lists multiple primary and secondary questions, but does not report a multiplicity strategy or a full statistical analysis plan. It also does not report interim analyses or a sample-size justification for the study. The planning assumptions listed in the record are presented as an illustration, and no resulting planning values are reported. Finally, the adverse-event summary contains zero recorded events, but event definitions and further safety details are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Perceived Efficiency and Acceptability of Remote Real-time Health Monitoring System in Elderly Residential Setting and Community Isolation Facility — NCT05302440.
• Registry record last updated 2024-07-05; status last verified 2024-01.
• Results first posted 2024-07-05.
• 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 completed, single-group study of a remote real-time health monitoring system with a ring-like sensor, with enrollment of 20. Its primary endpoint is average staff-perceived time-saving over 14 days, measured with a 5-point Likert item completed after every shift. The study description also covers detection of abnormal vital signs, hospital admissions, further medical assistance, stress, acceptability, device fit, and connection preferences.

The registry reports no statistical analyses and does not report observed primary or secondary outcome results. It does not identify a control comparison, define analysis populations, or describe missing-data or multiplicity methods. The adverse-event entry lists zero serious adverse events, zero other adverse events, and zero deaths. These registry entries describe the recorded design and counts, but do not provide estimates of endpoint effects or their precision.