This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP (NCT05292365), a randomized na study. The primary outcome is Acceptability: Participant Drop Out Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05292365 |
| Phase | NA |
| Condition | Cerebral Palsy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Wisconsin, Madison |
| Results posted | Yes |
2. Clinical Question
Population
Children with severe cerebral palsy and their caregivers are the intended study population. The registry record describes recruitment from the University of Wisconsin-Madison and the University of California, Los Angeles. It records enrollment of 60, while the brief summary describes a total of n=90 caregivers. These figures do not agree, and the registry record does not explain the difference. The primary outcome description says it was assessed by child.
Intervention
RE-PACT combines respiratory illness action plans with weekly mobile health confidence surveillance. When confidence is low or a hospitalization occurs, the program offers just-in-time action planning and coaching. The study description frames these activities as timely and customized, with mobile text messaging used to identify when hospitalization risk is elevated.
Comparator
The active control group receives usual comprehensive medical care and coordination. The registry record describes a randomized, parallel-group comparison and reports no masking. It does not state the allocation ratio or provide further detail about how the comparison groups were formed.
Primary question
The primary outcome is acceptability, measured in part by participant dropout rate over up to 6 months. This is a question about whether participants remain in the study, not a direct test of whether RE-PACT reduces respiratory illness. The registry record also lists respiratory diagnoses requiring hospitalization, hospital days, systemic steroid and antibiotic courses, respiratory emergency department visits, and child mortality as secondary outcomes. Numerical results for these outcomes are not reported in the registry record.
3. Trial Design
The registry record describes NCT05292365 as a randomized, parallel-group study with no masking. Its status is completed. The recorded enrollment is 60, and the primary outcome timeframe is up to 6 months. The record lists the University of Wisconsin, Madison as sponsor and gives a start date of 2022-04-27 and a primary completion date of 2024-02-27.
There is an unresolved difference in the record’s descriptions of enrollment. The enrollment field states 60, whereas the brief summary says that n=90 caregivers will be enrolled from the University of Wisconsin-Madison and the University of California, Los Angeles. The registry record does not explain whether these descriptions reflect different versions of the study or different ways of counting participants. The distinction should be kept visible rather than reconciled by assumption.
Participants assigned to RE-PACT receive respiratory action plans and weekly mobile health confidence surveillance, with planning and coaching activities at times of low confidence or hospitalization. Participants assigned to Active Control receive usual comprehensive medical care and coordination. The record does not report the allocation ratio, the randomization procedure, or whether any features of usual care were standardized across sites.
The primary outcome is participant dropout rate, described as an acceptability measure and assessed by child. The record also lists several respiratory and health-service outcomes as secondary measures. It names 37 outcome measures overall but records 0 analyses. A numerical result for the primary outcome, along with results for the listed secondary outcomes, is not reported in the registry record. Consequently, the design can be described, but the study’s observed comparative outcomes cannot be assessed from this 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.
Overall Study
| Stage | RE-PACT Intervention: Child | RE-PACT Intervention: Caregiver | Active Control (AC): Child | Active Control (AC): Caregiver |
|---|---|---|---|---|
| STARTED | 36 | 35 | 24 | 24 |
| COMPLETED | 35 | 34 | 24 | 24 |
| NOT COMPLETED | 1 | 1 | 0 | 0 |
Reasons for not completing this period:
| Reason | RE-PACT Intervention: Child | RE-PACT Intervention: Caregiver | Active Control (AC): Child | Active Control (AC): Caregiver |
|---|---|---|---|---|
| Met Exclusion Criteria: Participant disenrolled from their complex care program | 1 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: \*Recruitment duration was not stratified by arm.
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.
| Characteristic | Unit | RE-PACT Intervention: Child | RE-PACT Intervention: Caregiver | Active Control (AC): Child | Active Control (AC): Caregiver | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 36 | 35 | 24 | 24 | 119 | |
| Age, Categorical: <=18 years | Participants | 36 | 0 | 24 | 0 | 60 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 35 | 0 | 24 | 59 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous: Child | years | 11 (5 to 14.5) | — | 9 (6 to 12) | — | 10 (5 to 14) |
| Age, Continuous: Caregiver | years | — | 42 (37 to 48) | — | 37 (34 to 42) | 40 (35 to 46) |
| Sex: Female, Male: Female | Participants | 10 | 32 | 11 | 22 | 75 |
| Sex: Female, Male: Male | Participants | 26 | 3 | 11 | 0 | 40 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 11 | 12 | 9 | 7 | 39 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 22 | 21 | 12 | 15 | 70 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 | 2 | 3 | 2 | 10 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 1 | 2 | 0 | 0 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 1 | 3 | 3 | 10 |
| Race (NIH/OMB): White | Participants | 26 | 25 | 12 | 15 | 78 |
| Race (NIH/OMB): More than one race | Participants | 3 | 2 | 2 | 1 | 8 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 4 | 7 | 5 | 19 |
| Region of Enrollment: United States | participants | 36 | 35 | 24 | 24 | 119 |
6. Primary Endpoint
The registry lists the primary outcome as Acceptability: Participant Drop Out Rate, measured over up to 6 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
Participant dropout rate is the primary outcome and is described as one part of the study’s assessment of acceptability. The measure concerns whether participants leave the study during a timeframe of up to 6 months. The registry record says the outcome was assessed by child, but it does not give a numerical dropout count or rate for either group, a comparison between groups, or a definition of what counts as dropout.
As a general statistical concept, retention is useful in a pilot study because it indicates whether participants remain engaged long enough for planned follow-up and outcome collection. It is not itself a measure of respiratory illness severity or a direct measure of the intervention’s effect on hospitalization. Dropout can also affect how other outcomes are observed: when participants leave, later measurements may be unavailable. The extent and handling of missing follow-up data are not reported in the registry record.
The word “rate” in the outcome title should not be taken as evidence that a rate was calculated or reported. The registry record describes a count of participants as the measurement type, and the primary outcome description gives no numerical results. The outcome therefore identifies the study’s stated acceptability question, but the record does not allow readers to estimate retention or compare it between the randomized groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that RE-PACT was compared with an active control in a randomized, parallel-group study without masking. It also identifies participant dropout as the primary outcome and lists respiratory and health-service outcomes as secondary outcomes. These details describe the study’s question and structure; they do not, by themselves, establish what happened to participants or whether the groups differed.
No numerical result for the primary dropout outcome is reported in the registry record. The record also lists 0 analyses. This means there is no posted primary comparison from which to evaluate the size or precision of a difference in dropout. A direction of effect, confidence interval, or significance test for that outcome cannot be stated from the registry record. The absence of a reported analysis is not evidence that the groups had the same outcome.
Likewise, the secondary outcomes identify topics the study intended to assess, including respiratory diagnoses requiring hospitalization, hospital days during severe respiratory illness, systemic steroid and antibiotic courses, emergency department visits, and child mortality. Their listing is not a report of observed outcomes. Numerical results and comparative analyses for them are not reported in the registry record.
The adverse-event record contains counts for serious events, other adverse events, and deaths by group. Those counts are safety reporting information and should be read separately from the primary acceptability endpoint. They do not supply the missing dropout result or the missing analyses of respiratory outcomes. Nor do the counts, on their own, establish whether an event was caused by an intervention.
The enrollment descriptions also warrant caution when interpreting the record. The enrollment field reports 60, whereas the brief summary describes n=90 caregivers. Because the registry record does not reconcile these figures, the participant total should not be inferred from one description as though the other were absent. The record also does not report how many participants completed follow-up in each group.
Overall, the posted information supports a description of the randomized pilot design and the outcomes named in the record. It does not provide enough outcome data to quantify comparative effects, assess their precision, or draw conclusions about acceptability or respiratory outcomes. Statistical interpretation should remain limited to that distinction between what was planned or recorded and what was numerically reported.
9. Statistical Methods Explained
What randomization means
In general, randomization uses a chance-based process to assign participants to study groups. Its purpose is to reduce systematic differences between groups at the point of assignment, making a later comparison more interpretable. Randomization does not guarantee that groups will be identical, especially in a pilot study, and it does not replace reporting of the outcomes or analysis. The registry record identifies the study as randomized but does not report the allocation procedure or ratio.
What a parallel design means
In a parallel-group design, participants are assigned to a group and the groups are compared over the study period. Here, the registry record names RE-PACT and Active Control as the groups. It describes RE-PACT as action plans, weekly mobile health confidence surveillance, and timely planning and coaching activities, while the control receives usual comprehensive medical care and coordination. The record does not describe masking; it explicitly lists masking as none. In general, lack of masking can matter when outcomes involve participant reports or judgments, but the record does not report how outcome assessment was conducted beyond saying that the primary outcome was assessed by child.
What the primary outcome can measure
The primary endpoint is a participant count related to dropout, under an outcome titled “Acceptability: Participant Drop Out Rate.” A count can describe how many participants meet a defined event criterion. To compare groups, an analysis would also need clearly specified denominators, a definition of dropout, a follow-up period, and a statistical method suited to the data. The record gives a timeframe of up to 6 months, but does not report the group counts, denominators for the primary endpoint, definition, or analysis. No estimate of the dropout difference or its uncertainty can therefore be described.
How uncertainty is usually expressed
As a general explanation, a confidence interval gives a range of values compatible with the observed data under a statistical model and communicates the precision of an estimate. A narrow interval indicates greater precision than a wide interval, though neither alone determines whether a result is important. A hypothesis test can assess how compatible observed data are with a specified null model, but a p-value does not measure the size or importance of an effect. The registry record does not report a confidence interval, p-value, or primary-outcome estimate.
Counts, rates, and event data
The registry record describes the primary measure as a count of participants. A count is not automatically a rate: a rate generally relates events to a period of observation or another exposure quantity. The title uses the word “rate,” but the record does not give a calculation method. Some secondary outcomes are counts of events or courses, while others concern whether a diagnosis or visit occurred. General statistical methods differ according to whether the outcome is a count, a binary event, or a time-to-event measure. The record does not report which methods were used for the secondary outcomes.
For count outcomes, one general concern is over-dispersion, which occurs when observed variability exceeds what a simple count model assumes. Ignoring over-dispersion can make uncertainty appear smaller than it is. This is a general methodological consideration, not a claim about these data: the registry record reports no outcome distributions or fitted models from which to determine whether over-dispersion occurred or how it was addressed.
Planning illustrations and observed evidence
The record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. It specifies that illustrations for time-to-event outcomes concern total events, while other illustrations concern participants per arm. These are planning assumptions, not evidence that the study was designed using those assumptions, and the record explicitly characterizes them as not being the trial’s own design. Sample-size illustrations are not observed power and do not substitute for an outcome estimate or uncertainty interval. Numerical illustration results are not reported in the registry record.
What can be concluded from the record
The registry record names the randomized design, the groups, the outcomes, and some planning assumptions. It does not report the primary outcome result, the analyses, or the statistical methods used to analyze trial outcomes. A reader can therefore explain what the trial set out to measure and describe general principles for analyzing such data, but cannot reconstruct or validate an unreported analysis. Any numerical interpretation of comparative efficacy, acceptability, or precision would go beyond the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 37 outcome measures and 0 analyses. It identifies participant dropout as the primary outcome and lists respiratory diagnoses requiring hospitalization, hospital days, systemic steroid and antibiotic courses, respiratory emergency department visits, and child mortality among the secondary outcomes. The presence of multiple outcomes raises a general statistical issue: when many outcomes or comparisons are examined, the chance of at least one apparently unusual finding can increase. Methods for addressing multiplicity may include defining a primary outcome in advance, specifying a testing hierarchy, or adjusting inference. The registry record does not report a multiplicity plan, so it is not possible to say whether or how this issue was handled.
Missing data are also relevant because the primary endpoint concerns dropout. As a general matter, missing follow-up can reduce the information available and can affect interpretation if people without measurements differ from those with measurements. Assessing this requires knowing how much data are missing, when they are missing, and what assumptions or methods were used. Those details, including group-specific completion and dropout results, are not reported in the registry record.
The registry record does not report the analysis populations, such as which randomized participants were included in each analysis, nor does it describe exclusions or a plan for handling participants who did not follow their assigned group. It also does not report an analysis method for the primary outcome or secondary outcomes. These omissions limit reproducibility and prevent readers from determining how the stated randomized comparison was translated into an analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| RE-PACT Intervention | 0 | 36 | 0.0% |
| Active Control (AC) | 1 | 24 | 4.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| RE-PACT Intervention | 0 of 36 |
| Active Control (AC) | 0 of 24 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| RE-PACT Intervention | 0 of 36 |
| Active Control (AC) | 0 of 24 |
Most frequent serious adverse event terms
| Event term | Organ system | RE-PACT Intervention | Active Control (AC) |
|---|---|---|---|
| Cardiac arrest | Cardiac disorders | 0 of 36 | 1 of 24 |
Serious events with the highest arm-level rate: cardiac arrest (4.2%).
The serious adverse event counts are reported by group. For RE-PACT Intervention, 0 of 36 were listed as at risk for serious adverse events and 0 serious events were reported. For Active Control (AC), 1 of 24 was listed as at risk and 1 serious event was reported. Other adverse events were reported as 0 of 36 for RE-PACT Intervention and 0 of 24 for Active Control (AC). Deaths were 0 in each group.
The record lists Cardiac arrest at 4.2% as the top serious term. It does not specify in that term listing which group the term belongs to, or provide further event-level details. The percentage should therefore be read as the percentage attached to the listed term, not as a group-specific comparison. The record does not report whether the serious event was judged related to an intervention.
As a general principle, adverse-event counts describe events recorded under the registry’s reporting framework; they do not by themselves establish causation. Small or unequal group counts also make simple comparisons difficult to interpret, and the record does not provide a formal safety analysis. These figures should be kept distinct from the primary dropout outcome and the unreported respiratory outcome analyses.
12. What the Result Does, and Does Not, Mean
The registry record describes a pilot comparison of a tailored action-planning and coaching program with usual comprehensive medical care and coordination. The primary endpoint is participant dropout, framed as an acceptability measure over up to 6 months. The record also names respiratory and health-service outcomes that could address illness burden. These details show what the study was designed to examine, but they do not provide numerical evidence about the comparative outcomes.
Because the primary dropout result is not reported in the registry record, it is not possible to say how many participants left either group, whether retention differed, or how precise any difference might be. The record’s listing of secondary outcomes likewise does not establish whether any outcome was more or less frequent in one group. It reports 0 analyses, so there is no posted inferential result to interpret.
The study’s completed status does not resolve this evidence gap. Completion indicates the registry status, not that results are available in the record. Nor should the serious adverse event counts be taken as a measure of the intervention’s effect on respiratory illness. They are separate safety figures and do not establish that an event was caused by either group assignment.
The enrollment field states 60, while the brief summary describes n=90 caregivers. The record does not explain the discrepancy, so neither figure should be used to infer unreported outcome denominators or follow-up completion. The appropriate conclusion is limited: the registry record documents a randomized pilot design and its stated outcome domains, but it does not provide enough analysis results to estimate effects or judge their precision. This is a limitation of what is reported, not a finding that the groups were equivalent.
13. Why This Trial Matters Statistically
This trial is statistically notable for the distinction between a pilot study’s design and the evidence needed to interpret its outcomes. The record describes randomization, parallel groups, an intervention intended to respond to changing confidence or hospitalization risk, and an active control. It also identifies participant dropout as the primary outcome. Yet the record reports 0 analyses and no numerical primary result. A well-described question is not the same as a reported estimate.
Retention is especially relevant to a study that plans follow-up over up to 6 months and includes multiple clinical outcomes. In general, if participants leave, the amount and pattern of missing outcome information can affect later comparisons. Reporting dropout counts and analysis populations would help readers understand how much follow-up was available. Those details are not reported in the registry record.
The record’s listing of 37 outcome measures also highlights why statistical plans matter. Multiple outcomes can create interpretive challenges, and readers need to know how primary and secondary analyses were prioritized. The record does not report such a plan. This does not establish that analyses were inappropriate; it means the record does not permit assessment of the issue.
Finally, the enrollment descriptions differ: the enrollment field states 60, while the brief summary describes n=90 caregivers. Transparent reconciliation would help readers understand the study population and the basis for any denominators. Without numerical outcome analyses and clarification of this difference, the trial’s statistical contribution in the registry record is chiefly its documented design and measurement aims rather than an interpretable estimate of comparative outcomes.
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 principal limitation for statistical interpretation is that the registry record reports 0 analyses and does not give a numerical result for the primary outcome. It also provides no comparative estimates, confidence intervals, or significance tests for the listed secondary outcomes. The completed status does not supply those missing results.
The record describes enrollment as 60, while the brief summary says n=90 caregivers. It does not explain the difference or state how the figures relate to the number of children, caregivers, or randomized participants. This makes it difficult to establish which total should be used when interpreting participation or potential denominators.
For the primary outcome, the record does not define dropout, report group-specific counts, or describe how participants with incomplete follow-up were handled. It says the measure was assessed by child, but does not clarify the operational procedure. The record also does not report analysis populations, statistical methods, or a multiplicity plan for the 37 outcome measures.
The study is listed as unmasked, but details of outcome assessment beyond the primary outcome being assessed by child are not reported. The allocation ratio and randomization procedure are also not reported in the registry record. These absences limit evaluation of the study’s methods; they do not establish that any particular procedure was or was not used outside the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP — NCT05292365.
- Registry record last updated 2024-12-19; status last verified 2024-11.
- Results first posted 2024-12-19.
- 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.
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18. Record Summary
NCT05292365 is a completed, randomized, parallel-group study with no masking, sponsored by the University of Wisconsin, Madison. The record gives a start date of 2022-04-27, a primary completion date of 2024-02-27, and enrollment of 60. Its brief summary instead describes n=90 caregivers, a difference the record does not explain.
The intervention is RE-PACT, which includes respiratory action plans, weekly mobile health confidence surveillance, and just-in-time planning and coaching. The active control receives usual comprehensive medical care and coordination. The primary outcome is participant dropout as an acceptability measure over up to 6 months. The record lists 37 outcome measures and 0 analyses. Numerical primary and secondary outcome results are not reported in the registry record.