Youth-Led Intervention to Improve Blood Pressure: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Youth-Led Intervention to Improve Blood Pressure (NCT05029687), a na na study. The primary outcome is School Cohort: Hypertension Knowledge (Youth and Adult).

2. Clinical Question

3. Trial Design

The study is registered as NCT05029687, titled “Youth-Led Intervention to Improve Blood Pressure.” Its official title describes a youth-led digital education intervention for adults with hypertension who present to an emergency department. The sponsor is Rutgers, The State University of New Jersey. The record lists the study as completed, with a start date of 2021-10-31 and primary completion date of 2023-06-30. Enrollment is 64, and phase is listed as NA.

The brief summary describes developing a digital badge through user-centered design and community engagement, followed by a planned trial involving adult-youth dyads. It describes a 6-week hypertension education badge and a 6-week job readiness badge as the proposed arms. The summary also reports that recruitment challenges led to adding a school cohort recruited from New Brunswick Health Sciences Technology High School.

There is an important distinction between that summary and the structured design information. The registry lists the model as single group and allocation as NA, and it explicitly cautions that the arms are not a like-for-like control comparison. Thus the summary's description of a planned randomized comparison cannot be used to interpret the posted record as a completed randomized trial. The registry record does not report a valid concurrent control comparison for the primary school-cohort outcome.

The structured primary outcome is school-cohort hypertension knowledge for youth and adults, measured at the end of the 6-week intervention and 1 month post-intervention. This differs from the brief summary's stated primary aim of adult blood-pressure change 2-months post-intervention. The record does not explain this difference. It lists 9 outcome measures and 28 analyses, but does not report the analysis plan or clarify how the outcomes and cohorts relate to the summary's original aims.

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: Due to recruitment challenges for the ED cohort, Aim 2 of the study was changed from recruitment in the ED to recruitment in a school. Hence, we only have data for the school cohort. Additionally, the number of participants represents both members of each dyad (adults and youth) combined.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: High Blood Pressure Knowledge (# correct responses), Mean (SD), \[95% CI\]

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: 34 participants enrolled in Aim 2: School, 22 participants enrolled in Aim 1, 4 participants enrolled in Aim 2: ED Cohort (none completed the study from the ED cohort).

6. Primary Endpoint

The registry lists the primary outcome as School Cohort: Hypertension Knowledge (Youth and Adult), measured over At end of 6-week intervention, and 1 month post-6-week intervention.

The primary endpoint is school-cohort hypertension knowledge among youth and adults. It is measured as the mean number of correct responses on a 21-question assessment. The record says the assessment was adapted from Williams et al.'s 1998 hypertension knowledge tool. Results are described as a mean with standard deviation and a 95% confidence interval, with assessment at the end of the 6-week intervention and 1 month after the intervention.

A knowledge score captures responses to questions about hypertension; it is not a direct measure of blood pressure or blood-pressure control. In general, knowledge assessments can help describe whether participants have learned information targeted by an education program. They do not, by themselves, establish that knowledge leads to changes in behavior or clinical measurements. The record's brief summary discusses blood pressure as an intended study outcome, but the listed primary endpoint is knowledge, not blood pressure.

The record does not report the school cohort's mean scores, standard deviations, confidence intervals, or the number of participants contributing results at either assessment. It also does not explain how the assessment was scored when responses were missing. Consequently, the endpoint and its timing can be described, but its observed level, change over time, and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies a continuous outcome summarized as a mean with standard deviation. A continuous measure can take values across a scale, and its mean describes the average score among the observations included in an analysis. The standard deviation describes how dispersed individual scores are around that mean. These statistics answer different questions: a mean locates the average, while a standard deviation describes variation among participants.

What does the confidence interval describe?

The outcome description specifies a 95% confidence interval. In general, a confidence interval is an uncertainty interval for an estimated quantity under a particular statistical procedure and its assumptions. It is not a range containing a fixed proportion of individual participant scores; that role is closer to a measure of spread such as a standard deviation. A confidence interval is most informative when the estimate, interval limits, analysis population, and method are all available. The registry record does not report the primary endpoint's numerical interval or the procedure used to construct it, so neither its width nor its assumptions can be evaluated.

What does a repeated assessment show?

The primary knowledge outcome is scheduled at the end of the 6-week intervention and 1 month post-intervention. In general, measurements at more than one occasion can describe how an outcome changes over time. If observations are from the same participants, the statistical analysis may need to account for the relationship between their repeated measurements. The record does not report whether the same participants contributed data at both occasions, which model was used, or whether the reported summaries are paired or otherwise adjusted. Therefore the assessment schedule alone does not specify how change was estimated.

Why does the design label matter?

A randomized comparison is designed to compare groups assigned to different study conditions. The brief summary describes a proposed randomized study, but the structured registry design labels the model single group and allocation NA. The record also warns that the arms are not a like-for-like control comparison. These details mean that a randomized between-group estimate should not be assumed. In general, a single-group change over time is descriptive and can be influenced by factors other than the intervention. The registry record does not report an analysis that would identify a causal effect for the school-cohort endpoint.

How should the sample-size illustrations be read?

Any planning illustrations are based on the observed effect and use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a report of the study's original design justification. The record says that non-time-to-event illustrations are participants per arm and that time-to-event illustrations are total events, but the primary knowledge outcome is continuous. Such illustrations do not establish the sample size used in the trial, and they are not observed power. The study's original sample-size justification is not reported in the registry record.

In general, planning calculations depend on assumptions about the target effect, variability, significance level, allocation, and analysis. If the assumed effect is derived from an observed estimate, the illustration is conditional on that estimate; it is not independent confirmation that an effect is present. The registry record does not report a prespecified target effect or the protocol rationale for enrollment. Enrollment of 64 should therefore not be treated as evidence that the study had a particular level of statistical power.

What can be inferred from the listed analyses?

The registry lists 9 outcome measures and 28 analyses. A count of analyses does not identify which statistical tests were used, whether they were prespecified, or which estimates correspond to the primary endpoint. The record does not report model specifications, covariate adjustment, diagnostics, or the handling of multiple observations. General statistical practice would make those details relevant when assessing validity and uncertainty, but they cannot be reconstructed from the listed counts.

For count-like assessment scores, the record nevertheless specifies a mean and standard deviation, so those are the intended descriptive summaries. The record does not say whether any alternative distributional method was considered. More broadly, statistical methods should match the outcome's scale and the data structure. Because the outcome values and analysis details are not reported in the registry record, the adequacy of the selected method cannot be assessed. The available methodological description is sufficient to identify what was measured and the intended summary form, but not to reproduce or validate an estimate.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 9 outcome measures and 28 analyses, covering hypertension knowledge, youth self-efficacy, adult blood-pressure self-care, and adult self-efficacy to manage hypertension across the emergency department and school cohorts. The record does not report a multiplicity strategy, such as a designated hierarchy of tests or an adjustment to account for multiple analyses. It is therefore not possible to tell how the risk of chance findings across outcomes and analyses was addressed. This does not establish that no strategy existed; it means one is not reported in the registry record.

The primary endpoint is identified as school-cohort hypertension knowledge, but the record does not give the analysis population for that endpoint. Overall enrollment is 64; the number contributing to each cohort, assessment time, or outcome is not reported. The registry record also does not describe missing observations, withdrawals, exclusions, or how missing outcome values were handled. These details are important because the analyzed participants may differ from the enrolled group, and analyses can depend on how incomplete data are treated.

The record does not report whether analyses followed an intention-to-treat approach, a per-protocol approach, or another population definition. It also does not describe imputation, complete-case analysis, or sensitivity analyses for missing data. No assumptions about these choices should be inferred from the study's design labels or enrollment count.

Without a reported multiplicity plan, analysis population, and missing-data approach, readers cannot fully assess how the 28 analyses relate to the named primary endpoint or how robust the findings would be to analytic choices. Numerical outcome results are also not reported in the registry record, further limiting assessment of statistical uncertainty and selective emphasis.

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.

The serious adverse event figures list the intervention arm with 38 participants at risk and 0 participants affected by serious adverse events. The figures also list 38 participants at risk for other adverse events and 0 affected. Deaths are listed as 0. These counts describe what is entered in the registry record for that group; they are not a comparison between randomized treatment groups.

The record does not list serious adverse event terms, and no top serious terms are reported. A zero count in the posted results means that no affected participants are recorded in these figures. It does not, on its own, establish that no events occurred outside the recorded scope or that the intervention has no risks. The registry record does not report event definitions, collection procedures, follow-up completeness, or a comparison group suitable for estimating differences in safety outcomes.

The total enrollment is 64, whereas the adverse-event figures refer to 38 participants at risk in the intervention arm. The registry record does not explain how these counts relate to the full enrollment or the study cohorts. These safety counts should therefore be read narrowly as the adverse-event entries for the listed group, not as a complete comparative safety analysis.

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

The registry record describes a youth-led digital program in which youth learn hypertension information and teach it to an adult in their dyad over a 6-week playlist. It identifies school-cohort hypertension knowledge, measured by the mean number correct on a 21-question assessment, as the primary endpoint. These details clarify the educational target and the intended measurement schedule: at the end of the intervention and 1 month later.

The record does not report numerical primary outcome results. It therefore does not show whether scores changed, how large any change was, or how precisely an average score was estimated. The absence of these values should not be interpreted as either a positive or a negative result. It is simply an absence of posted quantitative evidence for that endpoint in the registry record.

The distinction between the brief summary and structured design information is also important. The brief summary describes a planned randomized comparison, but the structured record labels the model single group and allocation NA and warns that the arms are not a like-for-like control comparison. The record does not support interpreting the school-cohort findings as a randomized comparison against a control condition.

Even if a change over time were reported, general interpretation would require attention to who was assessed at each occasion, how missing data were handled, and whether the same participants contributed repeated measures. Those details are not reported in the registry record. The record also does not provide the planned statistical analysis or a multiplicity strategy for the listed outcomes and analyses.

The result, as represented in the registry, is therefore chiefly descriptive: it defines an intervention and a knowledge outcome but leaves the outcome estimates and key analysis details unavailable. The brief summary's intended adult blood-pressure objective is distinct from the school-cohort knowledge endpoint. No conclusion about blood-pressure change follows from the knowledge outcome description or from the adverse-event counts.

13. Why This Trial Matters Statistically

This study raises a statistical interpretation issue common in clinical research: a study's narrative summary and its structured design record may not describe the same analytic question. The brief summary describes a randomized comparison, while the registry's structured design identifies a single-group model and allocation NA. The record explicitly cautions against treating the arms as a like-for-like control comparison. Recognizing this distinction prevents an intended design from being mistaken for a completed comparative analysis.

The study also illustrates why the primary endpoint needs to be read precisely. The brief summary emphasizes adult blood-pressure change, while the listed primary outcome is school-cohort hypertension knowledge. Knowledge and blood pressure are different outcomes, measured on different scales and with different interpretations. A knowledge score cannot stand in for a clinical measurement, and the record does not report numerical primary-outcome results that would permit assessment of learning over time.

Several cohorts and outcome domains are described: youth and adults, emergency department and school settings, knowledge, self-efficacy, and blood-pressure self-care. The registry lists 9 outcome measures and 28 analyses. In general, this breadth makes clear definitions of the primary analysis, populations, timing, and multiplicity approach especially useful. Those details are not reported in the registry record, so the planned analysis structure cannot be fully evaluated.

Finally, statistical precision and design validity are separate concerns. A confidence interval can describe uncertainty around an estimate, but it cannot create a valid control comparison where one is not recorded. Here, the primary outcome's confidence interval and numerical estimate are not reported. The record therefore shows why readers need both complete results and clear design information before drawing conclusions from a clinical study.

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 most direct limitation for interpretation is that numerical results for the named primary endpoint are not reported in the registry record. The mean number correct, standard deviation, confidence interval, and participant counts at each assessment are absent. Consequently, the knowledge outcome's magnitude, direction, and precision cannot be evaluated.

The design description is not fully aligned across the record. The brief summary describes a randomized intervention-versus-control study, but the structured design lists a single-group model and allocation NA, with an explicit caution that the arms are not a like-for-like control comparison. The record does not explain this difference. It also does not reconcile the brief summary's adult blood-pressure outcome at 2-months post-intervention with the listed school-cohort knowledge endpoint assessed at the end of the 6-week intervention and 1 month afterward.

Enrollment is 64, but the number contributing to the school cohort, each outcome, and each time point is not reported. The registry record does not describe missingness, exclusions, analysis populations, or the handling of incomplete assessments. It does not report the statistical model, covariate choices, prespecified hypotheses, multiplicity strategy, or original sample-size justification. These omissions limit assessment of how the estimates were generated and how robust they may be.

The record also describes recruitment challenges for youth through adults in the emergency department and the addition of a school cohort. It does not report how the two settings were combined or compared analytically. Because the primary endpoint is specifically identified for the school cohort, findings for that outcome should not be generalized to the emergency department cohort based on the registry description alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Youth-Led Intervention to Improve Blood Pressure — NCT05029687.
• Registry record last updated 2025-12-30; status last verified 2025-12.
• Results first posted 2025-12-30.
• 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

NCT05029687 is listed as completed, sponsored by Rutgers, The State University of New Jersey, with enrollment of 64 and phase NA. The registered intervention is a youth-led hypertension education digital program organized as a 6-week sequence of weekly modules. The brief summary describes an intended randomized comparison and the addition of a school cohort after recruitment challenges; the structured record labels the design single group and allocation NA.

The listed primary outcome is school-cohort hypertension knowledge for youth and adults, measured as the mean number correct on a 21-question assessment at the end of the intervention and 1 month later. Numerical results for that endpoint are not reported in the registry record. The record lists 9 outcome measures and 28 analyses, but does not report the detailed analysis plan, missing-data approach, or multiplicity strategy. Serious adverse event figures list 0 affected participants in the intervention arm and 0 deaths.