Reducing Stroke Risk in African-American Men: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Reducing Stroke Risk in African-American Men (NCT04402125), a randomized na study. The primary outcome is TEAM vs WL Systolic BP.

2. Clinical Question

The trial focuses on a measurable physiological outcome rather than a direct count of later strokes. Systolic blood pressure is the pressure recorded during the heart’s contraction; the study assessed it alongside other blood-pressure and blood-biomarker measures. The registry record names stroke and transient ischemic attack as the conditions of interest and describes participants as men who had experienced one of these events within the past 5 years.

The clinical question is therefore about the blood-pressure outcome over the initial comparison period, not whether TEAM prevents a future stroke. The registry record gives the outcome time points and measurement description, but does not report a numerical TEAM-versus-WL estimate, uncertainty interval, or test result for systolic blood pressure. A conclusion about the size or direction of the observed comparison cannot be drawn from those details alone.

3. Trial Design

The registry record describes a prospective randomized controlled trial with a crossover model and no masking. It lists an enrollment of 171. The brief summary describes TEAM (N=80) versus wait-list (N=80) control, while the outcome description notes that the numbers represented in outcome data differ from the numbers assigned because many participants were lost to follow-up. These figures describe different aspects of the record and should not be treated as interchangeable. The record does not explain the relationship between its enrollment figure and the arm counts in the brief summary.

Participants assigned to TEAM received the intervention for 6 months and were then observed for 6-month follow-up. Participants assigned to wait-list remained on the wait-list for 6 months and were then offered the intervention for 6 months. Thus, the initial period provides the registry’s named TEAM-versus-WL comparison, while later experience includes intervention exposure in both sequences. The record does not report enough detail to determine how the crossover period was incorporated into every analysis.

The primary outcome is listed as TEAM versus WL systolic blood pressure, assessed at baseline, Month 3, and Month 6. The registry also lists diastolic blood pressure, cholesterol, HDL, LDL, triglycerides, BMI, and HbA1c as secondary outcomes. There are 13 outcome measures and 8 analyses listed, but the record does not explain how those counts map onto specific statistical models or comparisons.

The trial is marked completed. Its listed start date is 2020-05-05 and its primary completion date is 2025-09-08. The record does not report the randomization procedure, allocation concealment, intervention content in detail, adherence, or the statistical analysis plan. The absence of masking is recorded, but the record does not specify which people involved in measurement or analysis knew participants’ assignments.

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: Peer educators and peer educator care partners are considered enrollees. Enrollment number and number of participants Started/Completed represent the number of individual participants. Nurse educators are not enrollees.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The difference between the numbers here and the numbers of participants assigned to the arms is due to a large number of participants being lost to follow. If available, health record data was extracted on blood pressure and blood biomarker values for individuals who did not provide this data at the 6-month follow-up timepoint. In addition, Blood pressure was not collected on Peer Educators or Peer Educator Care Partners

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 TEAM vs WL Systolic BP, measured over Baseline, Month 3, Month 6.

The primary endpoint is mean systolic blood pressure, expressed in mmHg, with standard error identified as the measure of dispersion. The registry lists measurements at baseline, Month 3, and Month 6. Systolic blood pressure is the pressure measured while the heart contracts. In general, it is one of the routinely measured components of blood pressure and offers a continuous outcome that can be compared across groups and over time.

A mean describes the average measurement in a group. A standard error describes the precision of an estimated mean; it is not the same quantity as the spread of individual participants’ measurements. Without the reported means and standard errors, readers cannot evaluate the observed level, between-group contrast, or precision of the primary outcome.

The registry describes multiple ways of obtaining blood-pressure readings. Assessments were primarily remote using home-based methods because enrollment began shortly before the COVID-19 pandemic. When participants could not provide multiple home readings, baseline values could come from home measurement, an in-person study or clinical research unit measurement, or electronic health records within the specified windows. At follow-up, the record describes home-based or in-person measurement as prioritized, with electronic health-record extraction used when the other methods were unavailable. These options help explain how measurements could be obtained, but they also mean the record includes more than one measurement source.

The endpoint is a blood-pressure measurement, not a direct measure of stroke occurrence. Numerical primary-outcome results and further details about how the different measurement sources were handled in analysis are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General statistical explanation: the endpoint is continuous, meaning it can take a range of numerical values rather than representing only an event count. The registry specifies the mean as the summary measure. A mean is useful for describing the average level of a continuous outcome, but it does not show the full distribution of individual readings. The record identifies standard error as dispersion. Standard error concerns the precision of an estimated mean; standard deviation, by contrast, describes how measurements vary among individuals. Because the registry lists standard error, readers should not interpret it as the typical spread of individual blood-pressure readings.

What would a between-group estimate describe?

General statistical explanation: a between-group estimate expresses the contrast between the outcome under the two assigned conditions for a defined time or period. Its meaning depends on the estimand: the precise population, treatment condition, outcome, time point, and handling of events such as nonadherence or missing measurements. A randomized comparison is commonly intended to preserve the value of assignment, but the registry record does not report the estimand or the analysis population used for this trial. It also does not report a primary contrast estimate, so no numerical comparison can be interpreted.

For a study with repeated measurements, an analysis may compare groups at a follow-up visit, compare change from baseline, or use a model that includes several visits together. These approaches answer related but not identical questions. General statistical explanation: a repeated-measures model can account for the fact that measurements from one participant are related to one another, rather than treating every visit as an independent observation. The registry lists baseline, Month 3, and Month 6, but the specific model and contrast are not reported in the registry record.

How should uncertainty be understood?

General statistical explanation: a confidence interval gives a range of estimates compatible with the data under a specified statistical model and its assumptions. A narrower interval indicates greater precision than a wider interval, but neither the interval nor its width alone determines clinical importance. A p-value assesses compatibility between data and a null hypothesis under a specified model. It does not measure the probability that the null hypothesis is true, and it does not describe the size of an effect. The registry record does not report a confidence interval or p-value for the primary outcome.

The distinction between standard error and a confidence interval also matters. A standard error is an ingredient that can be used in uncertainty calculations, but a standard error alone is not a complete interval and does not state the plausible range for the treatment contrast. The registry record identifies standard error for the mean outcome, but does not report enough numerical results to assess uncertainty around a TEAM-versus-WL estimate.

What changes in a crossover design?

General statistical explanation: in a crossover study, participants may experience more than one condition in different periods. The analysis may need to distinguish treatment effects from period effects and account for the sequence in which conditions occur. If an intervention has effects that persist into a later period, carryover can complicate interpretation. These are general considerations, not reported features of the analysis in this trial. The registry calls the model crossover and describes TEAM followed by observation for one assignment, and wait-list followed by an offer of TEAM for the other. It does not report how later-period observations were analyzed or whether period and carryover effects were assessed.

The initial randomized phase and later crossover phase should not automatically be treated as the same comparison. During the initial 6 months, the record describes TEAM versus wait-list. After that period, participants in the wait-list sequence were offered the intervention, while those initially assigned to TEAM were observed. A comparison using the later observations would therefore need to specify which conditions and periods it targets. The registry record does not report those analysis details.

What do the planning assumptions mean?

General statistical explanation: a sample-size calculation is a planning exercise about how much information might be needed to detect a chosen effect under stated assumptions. The registry’s planning description says its illustration uses the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. It also distinguishes between participants per arm for non-time-to-event calculations and total events for time-to-event calculations. These planning assumptions do not establish that the trial used the same design assumptions, and they do not represent observed power. The registry record does not report the trial’s own sample-size justification.

When planning uses an observed effect as its reference, the resulting illustration is conditional on that effect and the stated assumptions. It should not be read as evidence that the trial had a particular probability of finding a result, nor as a substitute for interpreting the observed estimate and its uncertainty. No new trial effect or power conclusion can be inferred from the planning description alone.

Finally, measurement procedures influence the data that enter an analysis. The registry says blood pressure was primarily assessed remotely with home-based methods, and describes in-person readings and health-record extraction as alternatives when home measurements were unavailable. General statistical explanation: measurement source can be relevant because methods may differ in timing or conditions, while missingness can affect which participants contribute to each estimate. The record does not state whether measurement source was included in a model or whether sensitivity analyses examined these differences.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary systolic blood-pressure outcome and secondary outcomes for diastolic blood pressure, cholesterol, HDL, LDL, triglycerides, BMI, and HbA1c. It also lists 13 outcome measures and 8 analyses. Because the primary outcome is assessed at baseline, Month 3, and Month 6, more than one time point is part of the stated outcome description. The registry record does not explain which outcomes or time points were included in each analysis, which comparison was designated as the principal test, or whether any adjustment for multiple comparisons was planned or performed.

General statistical explanation: when many outcomes, time points, or contrasts are examined, the chance of obtaining at least one apparently unusual result can increase. A multiplicity strategy may define a primary contrast in advance, adjust significance thresholds, or treat secondary analyses as exploratory. Without a stated strategy and numerical results, readers cannot tell how multiplicity was handled in this trial. No correction method is reported in the registry record.

Missing data are a specific concern in this record. The primary-outcome description says outcome counts differ from the numbers assigned to arms because of substantial loss to follow-up. It also states that blood-pressure and blood-biomarker values were extracted from health records when available for individuals who did not provide those data. The record does not report how many participants were missing at each visit, why observations were unavailable, or how the primary analysis handled missingness.

General statistical explanation: an analysis limited to participants with observed measurements can be biased if the likelihood of having an observation is related to the outcome or treatment experience. Other approaches make additional assumptions about unobserved values. The registry record does not report which approach was used, whether sensitivity analyses were conducted, or which analysis population was used. Details about adherence and withdrawals are also not reported in the registry record.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hospitalization due to underlying medical conditions (7.5%), hospitalization due to unknown reasons (2.5%), hospitalization due to combined medical and psychological conditions (1.2%), hospitalization due to psychological conditions (psychiatric or substance use problems) (0.6%).

The registry lists serious and other adverse-event figures for Intervention, Observation, Peer Educators, and Peer Educator Care Partners. For Intervention, 4 of 160 participants at risk were affected by serious adverse events and 2 of 160 by other adverse events; deaths were 0. For Observation, the corresponding figures were 14 of 160 and 10 of 160, with deaths reported as 0. For Peer Educators, the figures were 0 of 7 for serious events and 0 of 7 for other events, with deaths reported as 0. For Peer Educator Care Partners, they were 0 of 4 and 0 of 4, with deaths reported as 0.

These are registry counts, not adjusted comparisons. The record does not explain whether the categories overlap, how event attribution was determined, or how the listed groups relate to the randomized sequences across the crossover periods. The figures should therefore be read as reported group-specific counts rather than as a definitive estimate of comparative risk. The record also lists serious-event terms with percentages: hospitalization due to underlying medical conditions, 7.5%; hospitalization due to unknown reasons, 2.5%; hospitalization due to combined medical and psychological conditions, 1.2%; and hospitalization due to psychological conditions (psychiatric or substance use problems), 0.6%. The event-term percentages do not replace the group counts, and the registry record does not report statistical uncertainty for these safety figures.

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

The registry record establishes the trial’s broad question and design: a randomized comparison of TEAM with wait-list among African-American men who had experienced stroke or transient ischemic attack within the past 5 years. It identifies mean systolic blood pressure as the primary outcome, measured at baseline, Month 3, and Month 6. It also describes blood-pressure collection methods and records a substantial loss to follow-up. These details help readers understand what the study set out to compare and some conditions under which outcome data were obtained.

However, the primary numerical results are not reported in the registry record. Without group means, an estimated contrast, and a measure of uncertainty, the posted information cannot establish whether systolic blood pressure was higher or lower in one group, how large any difference was, or how precisely it was estimated. The missing numerical result also prevents assessment of whether the data are compatible with a range of possible effects.

The trial’s endpoint should not be confused with a direct count of subsequent strokes or TIAs. The primary outcome described is blood pressure, while the participant population is defined by a prior stroke or TIA. A blood-pressure comparison alone would not answer every question about later clinical events, and the record does not report a primary stroke-event result.

The intervention sequence and the wait-list sequence also matter when interpreting comparisons beyond the initial period. The record describes a 6-month intervention or wait-list period followed by 6 months in which the initial TEAM group was observed and the wait-list group was offered the intervention. It does not report how those later observations were analyzed. Consequently, the registry description supports understanding of the study structure, but not a conclusion about the effect of TEAM from the primary endpoint.

The appropriate reading is limited: the trial was completed, the primary outcome and assessment schedule are named, and safety counts are recorded. Effectiveness, precision, and the handling of missing observations cannot be judged from the numerical primary results because those results are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable because it combines a randomized wait-list comparison with a crossover sequence and repeated blood-pressure measurements. Those features make it important to distinguish the initial randomized comparison from observations after the wait-list group was offered the intervention. A clear analysis needs to match the estimate to the period and treatment contrast it is intended to describe. The registry record identifies the sequence but does not report how later periods were handled statistically.

The outcome is continuous and assessed at multiple times. That creates choices about whether to compare groups at a particular follow-up, examine change from baseline, or model measurements over time. Each choice has a different interpretation. The record names baseline, Month 3, and Month 6 but does not identify the primary statistical contrast or model, so readers cannot determine which of these questions the reported analysis was intended to answer.

Missing follow-up data also have substantive statistical importance. The record explicitly notes a large loss to follow-up and describes use of health-record measurements when available. Such retrieval may preserve information for some participants, but the registry does not report how complete the resulting data were or how missing observations were handled. Those details are needed to judge the robustness of an estimate.

Finally, the registry provides a detailed description of measurement sources and lists a set of secondary outcomes, yet does not report the primary numerical result or the analysis plan. This contrast illustrates why outcome definitions alone are not enough for interpretation. Estimates, uncertainty, missing-data handling, and a defined multiplicity approach are also needed to understand what the observed data support. The record identifies the statistical questions that matter, but leaves these key inferential details not reported in the registry record.

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.

Several trial-specific limitations are apparent from the registry description. The primary outcome population text notes that the number of participants represented in outcome data differs from the numbers assigned because many participants were lost to follow-up. The record does not give the number with usable blood-pressure data at each assessment, the reasons for missing measurements, or the methods used to address missingness. Although health-record values were extracted when available for some participants without study measurements, completeness and comparability of these data sources are not reported.

Blood pressure was collected primarily by remote, home-based methods, with in-person readings and electronic health-record values used in specified circumstances. These alternatives may not produce measurements under identical conditions. The registry describes a priority order for measurement sources, but does not report whether source was considered in analysis or whether results were checked under alternative measurement definitions.

The registry identifies a crossover model and describes the two sequences, but does not report details of the analysis after the initial 6-month period. The method for accounting for sequence, period, or possible carryover is not reported in the registry record. The record also does not state how randomization was conducted or concealed, how intervention adherence was assessed, or which analysis population was used.

There is a difference between the enrollment figure of 171 and the brief summary’s TEAM (N=80) and WL (N=80) description. The registry record does not reconcile these figures. In addition, it lists 13 outcome measures and 8 analyses without explaining their mapping or reporting a multiplicity strategy. Most importantly, numerical primary-outcome estimates and their uncertainty are not reported in the registry record, limiting interpretation of the main comparison.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Reducing Stroke Risk in African-American Men — NCT04402125.
• Registry record last updated 2026-10-28; status last verified 2026-10.
• Results first posted 2026-10-28.
• 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

The registry record describes NCT04402125, “Reducing Stroke Risk in African-American Men,” as a completed randomized, unmasked trial with a crossover model. It lists an enrollment of 171 and describes African-American men who had experienced stroke or transient ischemic attack within the past 5 years. TEAM was assigned for 6 months in one sequence; the wait-list sequence was offered the intervention after 6 months.

The primary outcome is mean systolic blood pressure in mmHg at baseline, Month 3, and Month 6, with standard error listed as the dispersion measure. Blood-pressure measurement was primarily remote and home-based, with in-person and health-record sources also described. The record notes substantial loss to follow-up and available extraction of blood-pressure and biomarker values from health records for some participants.

The registry lists several secondary outcomes and adverse-event counts. Numerical results for the primary systolic blood-pressure comparison, its uncertainty, and the analysis methods are not reported in the registry record.