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 Self-Management Addressing Heart Disease Risk Trial (NCT00499096), a randomized phase 3 study. The primary outcome is Systolic and Diastolic Blood Pressure (SBP, DBP).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00499096 |
| Phase | Phase 3 |
| Condition | Bipolar Disorder, Cardiovascular Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 118 |
| Arms in the primary outcome | n/a |
| Lead sponsor | US Department of Veterans Affairs |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled patients with bipolar disorder and one or more risk factors for cardiovascular disease. The registry title identifies veterans with bipolar disorder, but the record does not report further eligibility details or describe the enrolled participants’ characteristics. The stated enrollment is 118.
Intervention
The intervention was described as the chronic care model for bipolar disorder. Participants in that arm were to receive self-management group sessions followed by phone contacts from a Care Manager. The registry’s brief summary frames the study around whether self-management and care management could help participants reduce heart-disease risk.
Comparator
The comparator was enhanced usual care. Its description includes usual care, wellness-topic mailings as an attention control, and information for providers on guideline recommendations; the final part of that description is truncated in the registry record. Further details of usual care and the provider information are not reported in the registry record.
Primary question
The primary outcome was systolic and diastolic blood pressure at 24 months, measured in mm/Hg, with lower values described as better. The intended question was whether the groups differed on these blood-pressure measures at that time point. The registry record does not report a single numerical comparison for the primary outcome, so it does not establish the size or precision of a between-group difference.
3. Trial Design
This was a Phase 3, randomized, parallel-group trial with single masking. The registry record identifies the sponsor as the US Department of Veterans Affairs and lists the trial status as completed. Enrollment is recorded as 118. The study start is listed as 2008-05, and primary completion as 2012-05. These dates describe the registry record; they do not supply additional details about when participants were recruited or assessed.
The two treatment descriptions are the chronic care model for bipolar disorder and enhanced usual care. The former combines self-management group sessions with subsequent Care Manager phone contacts. The latter is described as usual care plus wellness mailings and information for providers on guideline recommendations, although that description is cut off. The record does not specify the allocation ratio, the randomization procedure, or the parties covered by single masking. Those details are not reported in the registry record.
The target population was patients with bipolar disorder and one or more cardiovascular disease risk factors. The record lists bipolar disorder and cardiovascular disease as conditions. It does not provide further eligibility criteria, recruitment settings, or baseline characteristics in the registry record for this analysis. The design is parallel, meaning the arms are compared as separate groups rather than as a crossover; this is a general description of the design label, not a claim about unreported trial procedures.
Although the trial is marked completed, a completion status alone does not indicate whether every planned outcome was reported or whether an intervention had a particular effect. The registry record gives a primary endpoint at 24 months but does not present a single primary-outcome comparison suitable for interpretation as an effect estimate.
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 | Chronic Care Model for Bipolar Disorder | Enhanced Usual Care |
|---|---|---|
| STARTED | 58 | 60 |
| COMPLETED | 35 | 40 |
| NOT COMPLETED | 23 | 20 |
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 | Chronic Care Model for Bipolar Disorder | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 58 | 60 | 118 | |
| Age, Continuous | years | 53.1 (SD 10.6) | 52.4 (SD 9.2) | 52.8 (SD 9.9) |
| Sex: Female, Male: Female | Participants | 10 | 10 | 20 |
| Sex: Female, Male: Male | Participants | 48 | 50 | 98 |
| Region of Enrollment: United States | participants | 58 | 60 | 118 |
6. Primary Endpoint
The registry lists the primary outcome as Systolic and Diastolic Blood Pressure (SBP, DBP), measured over 24 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mm/Hg |
| Endpoint classification | Continuous Endpoint |
The primary outcome is listed as systolic and diastolic blood pressure, abbreviated SBP and DBP, at 24 months. The unit is mm/Hg, the summary measure is the mean, and the dispersion measure is the standard deviation. The record describes lower blood pressure as better. Because both systolic and diastolic measures are named, the endpoint entry covers two related measurements rather than a single stated blood-pressure value.
Blood pressure is used in this trial as a measure of cardiovascular risk. In general, a continuous measure such as blood pressure can be summarized by its mean to describe the group’s average level, while the standard deviation describes variation among individual measurements. Those summaries answer different questions: the mean locates the group average, and the standard deviation characterizes spread around that average.
The registry record does not provide a primary result that reduces SBP and DBP to one between-group comparison. It also does not report the group means, standard deviations, confidence intervals, or a p-value for the endpoint in the registry record for this analysis. Without those results, the direction, magnitude, and precision of any difference cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The outcome entry identifies blood pressure at 24 months as the primary endpoint, but the registry record does not yield a single comparison for interpretation. It lists systolic and diastolic blood pressure together, and the primary outcome has several categories or time points that were not reduced to one comparison. Consequently, there is no single reported effect estimate, confidence interval, or p-value in the record for this analysis to explain.
This absence of a single comparison is not evidence that the groups had the same blood pressure. It also does not show that one group had higher or lower values. Such conclusions require the results themselves, including the group summaries and a clear definition of the contrast being tested. The registry entries available do not report those numerical results, so a direction or size of effect cannot be stated.
For a continuous outcome, an estimated difference between group means would describe the observed contrast on the measurement scale. A confidence interval would communicate the uncertainty around that estimate: narrower intervals generally indicate more precise estimates, while wider intervals indicate less precision. These are general statistical interpretations. No endpoint confidence interval or mean difference is reported in the registry record.
A p-value, if reported, would describe how compatible the observed data are with a specified statistical model and null hypothesis; it would not measure the probability that the intervention is effective. No primary-endpoint p-value is reported. Nor does the completed status of the trial substitute for an effect estimate or evidence of statistical significance.
The registry record names secondary outcomes including manic symptoms, depressive symptom score, disability based on WHO-DAS score, and BMI. It also records 7 outcome measures and 1 analysis. Those entries do not establish that each outcome has a reported result, nor do they show which outcomes were included in the single analysis entry. No secondary-outcome estimates are included in the registry record for interpretation.
Any planning illustration based on an observed effect should be read as a planning exercise under its stated assumptions, not as evidence that an effect was detected or as observed power. The assumptions listed for planning use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The registry record’s primary result is not reduced to a single comparison, so the planning assumptions cannot supply an interpretable primary treatment effect. The record does not report the trial’s own sample-size justification.
Overall, the registry entry identifies the question and endpoint but does not report enough primary-outcome information to judge the magnitude or precision of a blood-pressure contrast. The appropriate interpretation is limited to what is recorded, not an inference that the intervention succeeded, failed, or had no effect.
9. Statistical Methods Explained
The primary outcome is continuous: blood pressure is measured on a numeric scale, and the registry specifies a mean with standard deviation. In general, a mean describes the average measurement in a group. A standard deviation describes how dispersed the measurements are around that group average. The standard deviation is not the uncertainty of the mean and is not interchangeable with a confidence interval.
What would a mean difference describe?
For a two-arm comparison, a mean difference would express how far apart the group averages are, in the same units as the outcome. Since the record says lower blood pressure is better, the sign and direction of a reported contrast would need to be interpreted using the order in which the groups were subtracted. The registry entries do not specify a contrast direction or give a mean difference for SBP or DBP. No difference should therefore be inferred.
How does a confidence interval help?
In general, a confidence interval gives a range of values compatible with an estimate under the method used to construct it. Its width conveys precision: a narrower interval represents greater precision than a wider interval, under otherwise comparable conditions. An interval can also help readers judge which effect sizes remain plausible, rather than relying only on whether a p-value crosses a threshold. The registry record does not report a confidence interval for the primary blood-pressure outcome.
What does the standard deviation tell the reader?
Variation among participants matters because a mean can conceal a wide spread of individual values. The standard deviation helps describe that spread, but it does not by itself indicate how precisely the group mean or between-group difference has been estimated. Precision also depends on the amount of information available and on the analysis. The registry record names standard deviation as the dispersion measure but does not provide numerical group standard deviations in the registry record.
Why can a single primary comparison matter?
A primary outcome may include more than one measurement, such as systolic and diastolic blood pressure, or more than one time point. A clear analysis needs to identify which measurement, time point, and contrast are being tested. If multiple outcomes or comparisons are examined, the chance of obtaining a seemingly notable result by chance can increase when no adjustment or prespecified hierarchy is used. This is a general statistical concern, not a claim about the trial’s analysis. The registry record explicitly indicates that the primary outcome has several categories or time points and was not reduced to one comparison.
Because SBP and DBP are both named, their results should not be treated as though they were one interchangeable measurement. They are related but distinct endpoints. A complete report would identify the result for each relevant measure and explain which one answers the primary question. The registry entries do not give that breakdown.
What do the planning assumptions mean?
The sample-size assumptions describe a planning illustration based on the observed effect, not the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect defined as a stated fraction of the observed effect. In general, a planning calculation estimates how many participants per arm might be needed to detect a chosen effect under stated assumptions. It is not a count of observed participants and it is not observed power.
Such planning illustrations depend on the effect size, variability, analysis method, and other assumptions. A calculation tied to an observed effect is especially dependent on how that effect was estimated; an uncertain estimate can produce an uncertain planning result. The registry entries do not provide a single primary comparison from which to interpret an effect size for this endpoint. The trial’s original design rationale and sample-size justification are not reported in the registry record.
What can be concluded from the analysis entry?
The record lists 1 analysis, but that entry alone does not identify the statistical model, covariate adjustments, handling of repeated measurements, or population used for the analysis. None of those details should be inferred from the continuous outcome label. The key limitation is not that one particular method is known to be inadequate; it is that the method and a single primary numerical comparison are not reported in the registry entries. The displayed outcome specification identifies the measurement and time frame, but it does not replace the numerical result needed to assess effect and precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 7 outcome measures and 1 analysis. It names secondary outcomes of manic symptoms, depressive symptom score, disability based on WHO-DAS score, and BMI. The primary entry includes both systolic and diastolic blood pressure and notes that the primary outcome has several categories or time points, without reducing them to one comparison. These features make it important to know which outcomes and comparisons were prespecified as primary and how multiplicity was handled.
In general, testing many outcomes or contrasts can increase the chance of a false-positive finding if each is interpreted without an appropriate plan. Researchers may address this with a prespecified hierarchy, adjustment procedures, or careful emphasis on estimation and uncertainty. The registry record does not report a multiplicity adjustment, a hierarchy among blood-pressure measures, or a detailed statistical analysis plan. Their absence from the record does not show that no such plans existed; it means they are not reported in the registry record.
The registry entries do not describe missing-data rates, reasons for missing measurements, imputation, or sensitivity analyses. The analysis population is also not reported in the registry record. It is therefore not possible to determine whether all randomized participants were included in the primary analysis, how incomplete follow-up was handled, or whether the analysis followed an intention-to-treat principle.
Interim analyses and stopping rules are not reported in the registry record. The single analysis listing does not establish whether there were interim looks or whether an adjustment for them was needed. These omissions limit assessment of the analysis process, but they do not justify assuming a particular procedure was or was not used.
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 |
|---|---|---|---|
| Arm 1 | 0 | 58 | 0.0% |
| Arm 2 | 0 | 60 | 0.0% |
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 |
|---|---|
| Arm 1 | 0 of 58 |
| Arm 2 | 0 of 60 |
The registry reports serious adverse-event counts by entries labelled Arm 1 and Arm 2. For Arm 1, the number at risk is 58 and the number affected by serious adverse events is 0. For Arm 2, the number at risk is 60 and the number affected by serious adverse events is 0. The other adverse-event entries show 58 at risk and 0 affected in Arm 1, and 60 at risk and 0 affected in Arm 2.
These figures describe what is entered in the registry, not a complete characterization of safety. The record does not identify how the generic Arm 1 and Arm 2 labels map to the intervention descriptions in the registry record for this analysis. Death counts are not reported in the registry record. No top serious adverse-event terms are listed.
A recorded zero means that zero affected participants are entered for that row; it does not by itself establish that no adverse events of any kind occurred or that an intervention is safe. Interpretation also depends on definitions, observation periods, ascertainment, and completeness of reporting. Those details are not reported in the registry record. The figures should therefore be read as registry counts with the stated denominators, not as a comprehensive safety assessment.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized comparison of a chronic care model for bipolar disorder with enhanced usual care among patients with bipolar disorder and cardiovascular risk factors. The primary outcome was systolic and diastolic blood pressure at 24 months, with lower values described as better. This identifies the clinical and statistical question the trial was intended to address.
What the record does not establish is the observed difference between the groups. The primary result is not reduced to one comparison, and the registry entries available do not include group means, an effect estimate, a confidence interval, or a p-value. Therefore, the direction, magnitude, and precision of any blood-pressure effect cannot be stated. Missing numerical results do not mean that the groups were equivalent, and they do not demonstrate that the intervention had no effect.
The trial status is completed, but completion is not itself a result. Similarly, the fact that the record lists secondary outcomes and adverse-event counts does not resolve the primary question. The adverse-event entries report zero affected participants in the listed rows, but they do not constitute a full account of safety or clinical benefit.
In general, a clinical result is most informative when it reports the estimated contrast, its uncertainty, the analysis population, and the methods used to handle missing data and multiple outcomes. Those elements help distinguish a small, precisely estimated difference from a larger but uncertain one. The registry entries do not supply that complete basis for interpreting this trial’s primary endpoint.
The defensible conclusion is limited: the registry describes the trial design, intervention, comparator, and intended blood-pressure endpoint, but does not provide a single primary-outcome result for judging the between-group effect. No treatment recommendation or claim about clinical effectiveness follows from these registry entries alone.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question about how a broad clinical endpoint is represented. Systolic and diastolic blood pressure are both named as primary measures, and the record also notes several categories or time points. Readers need a clearly specified measurement, follow-up time, contrast, and analysis to understand what the primary result means. Without a single comparison, a study’s central question can remain difficult to evaluate even when its general design is described.
The record also illustrates the distinction between describing a trial and reporting its results. Randomization, parallel groups, masking, and a completed status give context for understanding the study, but they do not provide an estimate of the intervention effect. For continuous outcomes, means and measures of uncertainty are essential for assessing both magnitude and precision. Those numerical endpoint results are not reported in the registry record for this analysis.
Multiplicity and missing-data methods are also important for interpreting a trial that lists multiple outcomes. Prespecifying how related measures will be analyzed can make the primary question more transparent. Reporting who was included in each analysis and how incomplete outcome data were handled helps readers assess the reliability of the estimate. These methods are not reported in the registry record.
The planning assumptions offer a further statistical distinction: sample-size calculations are conditional illustrations, not observed power or evidence of an effect. They cannot replace a reported treatment contrast. Taken together, the record shows why transparent outcome definitions and complete numerical reporting matter for clinical research interpretation.
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 main trial-specific limitation for interpretation is that the primary endpoint is described as systolic and diastolic blood pressure, yet the registry record does not reduce the primary outcome to one comparison. It gives the measurement unit, summary type, dispersion type, and 24-month timeframe, but no numerical group results or effect estimate in the registry record. This prevents assessment of the direction, size, and precision of the primary contrast.
The comparator description is truncated after referring to information for providers on guideline recommendations. The full content of that component and further details of usual care are not reported in the registry record. The intervention is described at a broad level, without further information about session content, delivery, or adherence.
Although the record identifies a randomized, single-masked, parallel design, it does not specify the randomization procedure, allocation ratio, or which parties were masked. The analysis population, statistical model, covariate adjustments, and handling of repeated measurements are not reported in the registry record. Missing-data methods and any sensitivity analyses are also not reported.
The registry entries do not provide participant characteristics beyond the trial population description, nor do they explain the original sample-size justification. The registry’s planning assumptions should not be mistaken for that justification. These limitations describe what the record does not report; they do not establish that the trial lacked these procedures or information outside the registry entry.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Self-Management Addressing Heart Disease Risk Trial — NCT00499096.
- Registry record last updated 2014-11-20; status last verified 2014-11.
- Results first posted 2014-11-20.
- 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.
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18. Record Summary
The registry identifies NCT00499096 as the Self-Management Addressing Heart Disease Risk Trial, with the official title Cardiovascular Risk Factors in Veterans With Bipolar Disorder. It is listed as a completed Phase 3 randomized, single-masked, parallel-group trial sponsored by the US Department of Veterans Affairs. Enrollment is recorded as 118, with start in 2008-05 and primary completion in 2012-05.
The intervention was a chronic care model for bipolar disorder, compared with enhanced usual care. The primary outcome was systolic and diastolic blood pressure at 24 months, measured in mm/Hg. Lower values were described as better. The registry record does not report a single numerical primary-outcome comparison. It lists 7 outcome measures and 1 analysis, but does not report the analysis population, missing-data methods, or detailed statistical plan in the registry record for interpretation.