Enhanced Community-Based Asthma Monitoring Through Novel Technology: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Enhanced Community-Based Asthma Monitoring Through Novel Technology (NCT05824936), a na na study. The primary outcome is Feasibility (Retention %).

2. Clinical Question

3. Trial Design

NCT05824936 is a completed pilot interventional study titled Enhanced Community-Based Asthma Monitoring Through Novel Technology. The registry lists the condition as asthma in children and the sponsor as Nemours Children's Clinic. The study began on 2023-06-08, had a primary completion date of 2024-02-19, and is listed as completed.

The design is single-group, with 15 participants enrolled. The intervention is described as behavioral, and all participants were in the pilot arm for the technology-enhanced intervention program. Allocation is listed as NA, and masking is listed as none. These details describe a study without a separate randomized control arm; they do not support a direct comparison between the program and another intervention or usual care.

The program’s stated implementation approach included home monitoring, remote study visits and lung function testing. Its primary outcome was feasibility, assessed through retention at week 24. The registry also lists secondary areas concerning asthma control, daytime sleepiness, participant and family characteristics, psychosocial factors, and asthma-related factors associated with completion, including oral steroid usage, emergency room visits and hospital admissions.

The registry lists 9 outcome measures and 0 analyses. It does not report a statistical analysis plan, detailed intervention procedures, eligibility criteria, or the observed results for the listed outcomes. The study’s completed status indicates that the registry marks the study complete; it does not itself establish that outcome data were analyzed or that findings were posted.

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: Participants who completed the pilot through final study visit.

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: 15 participants enrolled in pilot intervention

6. Primary Endpoint

The registry lists the primary outcome as Feasibility (Retention %), measured over 24 weeks.

The primary endpoint is titled Feasibility (Retention %). It is defined as calculating retention rates at week 24, with the outcome unit listed as participants and the parameter described as a count of participants. The stated population is participants who completed the pilot through the final study visit.

Retention is used in a pilot because it gives information about whether participants remain engaged through the planned study period. In an implementation-focused program, this can inform whether the monitoring approach and study procedures are workable enough to examine further. It is not, by itself, a measure of asthma control or a direct measure of treatment benefit.

The registry record does not report the number retained at week 24, a retention percentage, or the number completing the final visit. It also does not explain how withdrawals, missed visits, or participants without a week-24 assessment were handled in calculating retention. Without those details, the endpoint’s planned definition can be described, but its observed value and precision cannot be interpreted.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes the study as a single-group pilot and lists 15 participants enrolled. It reports 9 outcome measures and 0 analyses. It does not report outcome estimates, confidence intervals, p-values, a detailed analysis plan, or the methods used to analyze the planned clinical outcomes. The methods can therefore be explained only in relation to the registered endpoint and design, with general statistical principles distinguished from study-specific information.

What does a single-group design allow?

In this study, all participants were in the pilot arm, and no separate comparison arm is listed. A single-group design can be used to describe what occurred among participants enrolled in a program, such as whether they completed follow-up. General statistical principle: a comparison group helps distinguish changes associated with an intervention from changes that might reflect time, measurement, or other influences. Without a control group, a change observed over time cannot be attributed to the program alone. The registry does not report a comparative analysis.

How should retention be understood?

The primary endpoint is feasibility assessed through retention at week 24. The outcome is expressed as a participant count, while the endpoint title refers to retention percentage. General statistical principle: a retention proportion requires a defined numerator, such as the number meeting the retention definition, and a defined denominator, such as the group eligible for that assessment. The registry record does not report the week-24 numerator, the denominator used, or the observed percentage. It also does not specify the handling of missing visits or withdrawals.

Retention is a process outcome. It can indicate whether participants stayed in the study through the specified follow-up point, but it does not by itself measure whether asthma control improved, whether the program was acceptable, or whether families could access it. The registry lists those as broader questions or secondary outcome areas, but does not post their analyses.

What does uncertainty mean?

General statistical principle: a point estimate is a single summary of the observed data. A confidence interval communicates uncertainty around that estimate under the method used; a wider interval generally indicates less precision. A p-value, when reported, addresses compatibility between observed data and a specified null hypothesis under stated assumptions. Neither a confidence interval nor a p-value can be interpreted without the underlying estimate, analysis method and relevant assumptions. The registry record reports none of these analysis results.

The enrollment of 15 is the number listed for the study, not evidence of the precision of any particular outcome estimate. Precision depends on the outcome data and its distribution, as well as the analysis method. No sample-size justification or precision target is reported in the registry record. A pilot’s enrolled count should not be treated as proof that the study could detect a particular clinical effect.

What can a planning illustration tell readers?

General statistical principle: sample-size planning examines how much information may be needed to detect a specified effect under assumptions about the design, variability, significance level and desired power. A planning calculation is not an observed result and is not evidence that a study achieved a particular power after completion. The registry record does not report a sample-size justification or the assumptions used to plan enrollment. It provides no reported clinical effect estimate from which a study-specific planning interpretation can be made.

General statistical principle: over-dispersion occurs when count data vary more than a simple statistical model expects. If present, ignoring it may make standard errors too small and intervals too narrow. The registry lists the primary measure as a participant count, but does not report a dispersion estimate or an analysis of count variation. There is therefore no basis for claiming that over-dispersion was present or that a particular model was used.

How do the safety counts fit?

The registry lists participants at risk and event counts for serious adverse events, other adverse events and deaths in the pilot group. These are descriptive safety counts, not estimates from a comparison of groups. General statistical principle: a zero observed count does not prove that the underlying risk is zero, especially when the group observed is limited. The record does not report a comparative safety analysis or additional detail about event ascertainment.

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("Pilot Study Arm for Technology-enhanced Asthma Int")
n      <- c(15)
events <- c(14)
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  Pilot Study Arm for Technology-enhanced Asthma Int  15  14  93.3  68.1  99.8  70.2  98.8  69.8  98.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 9 outcome measures, including the primary feasibility endpoint and secondary areas concerning asthma control, daytime sleepiness, participant and family characteristics, psychosocial factors, and asthma-related factors associated with successful completion. It lists 0 analyses. The registry record does not report which outcomes were formally tested, whether any hypotheses were designated in advance, or whether an adjustment for multiple testing was planned.

General statistical principle: when many outcomes or hypotheses are examined, the chance of at least one apparently notable result can increase. Multiplicity methods can address that issue, but their use depends on the analysis plan and the questions being asked. No such methods are reported in the registry record. Since analysis results are not posted, there is no basis for assessing the effect of any multiplicity approach.

The record does not explain how missing outcome data were handled, including missing week-24 retention information or missing assessments for asthma control and daytime sleepiness. It does not report whether participants were analyzed according to a specified analysis population, how withdrawals were treated, or whether any imputation or sensitivity analyses were conducted. These details matter because missingness can affect both the number of observations and the interpretation of an estimate.

The endpoint description names participants who completed the pilot through the final study visit, but it does not set out the operational rule for classifying completion. The registry also does not report whether all enrolled participants contributed to every outcome. Without those definitions and the observed data, the extent and potential consequences of missingness cannot be evaluated.

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 5% reporting threshold.

For the pilot study arm, the registry records 15 participants at risk for serious adverse events and 0 affected by serious adverse events. It also records 15 at risk for other adverse events and 0 affected by other adverse events. The death count is 0. No serious adverse event terms are listed.

These are descriptive counts in the enrolled pilot group. They should not be read as a comparison with another group, because the study is registered as single-group and no control arm is listed. Nor do the counts establish that an event is impossible or that a larger study would have the same observed pattern. General statistical principle: observing zero events in a finite group does not show that the underlying event risk is exactly zero.

The registry record does not report further detail about how adverse events were collected, the period covered by the safety counts, or an analysis comparing risks. The posted figures therefore describe what the registry records for the pilot arm, without supporting broader conclusions about safety.

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

This registry record identifies a completed pilot study of a technology-enhanced home monitoring program for children with asthma. It specifies a single-group design, 15 participants enrolled, and week-24 retention as the primary feasibility measure. It also identifies questions about acceptability, accessibility, completion factors, asthma control and daytime sleepiness. These are useful details for understanding what the investigators set out to examine.

The record does not report the observed retention result or analyses of the other stated questions. It therefore does not establish how many participants completed the program, whether participants found it acceptable or accessible, or whether asthma control or daytime sleepiness changed. The completed status is a registry status, not a result.

The design also limits what could be concluded from any within-group changes if they were reported. Because there is no separate comparator, a change over time would not by itself show that the program caused that change. The record does not provide the outcome data or analyses needed to assess even a descriptive change.

The safety entries record zero serious adverse events, zero other adverse events and zero deaths among the 15 participants at risk in the pilot arm. Those counts describe this group as recorded; they do not establish a zero risk beyond it.

Accordingly, the registry supports a description of the pilot’s aims, design and listed outcomes, but not conclusions about observed effectiveness, feasibility results, or comparative benefit. General statistical principle: conclusions should match the information actually reported, and uncertainty should be stated when estimates and their precision are unavailable.

14. Why This Trial Matters Statistically

This study illustrates why pilot trials are often interpreted differently from comparative efficacy studies. Its stated primary focus is feasibility, with retention at week 24 as the designated measure. That places attention on whether participants complete the study process, alongside planned questions about acceptability, access and completion factors. The registry also identifies asthma control and daytime sleepiness as areas of preliminary interest.

Statistically, the single-group design is central to interpretation. It can frame descriptive questions about enrolled participants, but it does not provide a concurrent control group for separating intervention-related change from other influences. The registry lists allocation as NA and identifies the model as single group, so a treatment-versus-control effect is not reported.

The record also highlights the difference between a registered question and an analyzed result. It lists 9 outcome measures but 0 analyses. Without posted estimates and methods, readers cannot assess statistical uncertainty, missing-data handling, multiplicity, or the consistency of findings across outcomes. Those omissions do not erase the study’s implementation questions, but they constrain what can be learned from the registry record.

Finally, the safety figures are counts from a pilot group rather than comparative safety estimates. General statistical principle: the amount of information in a study depends on the outcome data and design, not enrollment alone. A pilot can help define practical questions for further study, but its registry entry should not be treated as evidence of a particular clinical effect when the relevant outcomes are not reported.

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.

Several limitations are specific to the information recorded for this trial. The study is single-group, with allocation listed as NA and masking listed as none. No comparator is described, so there is no direct control-based estimate available in the registry record. The enrolled population is listed as children with asthma, but eligibility criteria and participant characteristics are not reported.

The primary endpoint is described as retention at week 24, but the record does not report the observed count or percentage. It also does not detail the calculation denominator, the definition of successful completion, or how missing visits and withdrawals were handled. Those details are important for interpreting a retention measure.

Although the registry lists secondary outcomes related to asthma control, daytime sleepiness and factors associated with completion, it reports 0 analyses. Outcome estimates, uncertainty measures, analysis methods, and results for those questions are not reported in the registry record. A statistical analysis plan and sample-size justification are also not reported.

The description of the intervention establishes that it involved a technology-enhanced pilot program with home monitoring, remote study visits and lung function testing, but further implementation details are not reported. The registry does not provide enough information to judge whether the program was delivered consistently or how acceptability and accessibility were assessed.

The safety entries are limited to the recorded participant and event counts. Additional information about event collection and follow-up is not reported. These limits mean the registry supports an account of the intended pilot and its recorded design, not a detailed assessment of outcome performance or generalizability.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Enhanced Community-Based Asthma Monitoring Through Novel Technology — NCT05824936.
• Registry record last updated 2025-05-20; status last verified 2025-05.
• Results first posted 2025-05-20.
• 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

NCT05824936 is a completed, single-group pilot interventional study of a technology-enhanced home asthma monitoring program for children. The registry lists Nemours Children's Clinic as sponsor and 15 participants enrolled. The program involved home monitoring, remote study visits and lung function testing.

The primary endpoint is feasibility assessed through retention at week 24. Secondary outcome areas include asthma control, daytime sleepiness, and participant, family and asthma-related factors associated with completion. The registry lists 9 outcome measures and 0 analyses; observed outcome results and analysis methods are not reported in the registry record.

The safety figures record 0 serious adverse events, 0 other adverse events and 0 deaths among 15 participants at risk in the pilot arm. The single-group design does not provide a comparator for estimating a between-group effect.