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 Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness (NCT02127671), a randomized na study. The primary outcome is Global Framingham Risk Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02127671 |
| Phase | NA |
| Condition | Cardiovascular Risk Factors, Serious Mental Illness |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 269 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johns Hopkins University |
| Results posted | Yes |
2. Clinical Question
Population
People with serious mental illness and cardiovascular risk factors. The registry record describes a trial focused on cardiovascular risk reduction in this population; further eligibility details are not reported in the registry record.
Intervention
The IDEAL intervention included individual cardiovascular risk-reduction counseling, coordination with primary care providers to support risk-factor management, and collaboration with mental health staff and social supports. The intervention description also says participants would be offered group exercise classes.
Comparator
The control condition also offered group exercise classes and included instruction to provide more healthy meals. The registry record does not describe additional details of the control condition.
Primary question
The study was designed to determine whether a health-coach program coordinated with primary care could reduce overall heart disease risk among people with serious mental illness. The primary outcome was the Global Framingham Risk Score, measured at baseline and 18 months. The score is described as a cardiovascular-risk measure, with higher values indicating higher risk. A single primary comparison and its result are not reported in the registry record.
3. Trial Design
NCT02127671 is listed as a completed, randomized, parallel-group intervention trial sponsored by Johns Hopkins University. The registry lists enrollment of 269 and identifies the conditions as cardiovascular risk factors and serious mental illness. The trial phase is recorded as not applicable. The record gives a start date of 2013-12-12 and a primary completion date of 2018-11-16.
Participants were assigned to the IDEAL intervention or control. The IDEAL description includes individual cardiovascular risk-reduction counseling, coordination with primary care providers, and collaboration with mental health staff and social supports. The control description includes group exercise classes and instruction to provide more healthy meals. Both arm descriptions mention group exercise classes. The IDEAL description ends mid-sentence, so any additional detail that may have followed is not reported in the registry record.
Masking is listed as single, but the identity of the masked group is not reported in the registry record. Details of the randomization method, allocation concealment, treatment adherence, and deviations from assigned intervention are not reported in the registry record. The record describes the primary outcome as a mean with standard deviation, measured at baseline and 18 months, but does not provide a single reduced comparison across those time points.
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 | IDEAL Intervention | Control |
|---|---|---|
| STARTED | 132 | 137 |
| COMPLETED | 124 | 132 |
| NOT COMPLETED | 8 | 5 |
Reasons for not completing this period:
| Reason | IDEAL Intervention | Control |
|---|---|---|
| Death | 2 | 2 |
| Lost to Follow-up | 4 | 2 |
| Physician Decision | 1 | 0 |
| incarceration | 0 | 1 |
| Did not have full Framingham risk score measured | 1 | 0 |
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 | IDEAL Intervention | Control | Total |
|---|---|---|---|---|
| Participants analysed | 132 | 137 | 269 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 128 | 124 | 252 |
| Age, Categorical: >=65 years | Participants | 4 | 13 | 17 |
| Sex: Female, Male: Female | Participants | 70 | 71 | 141 |
| Sex: Female, Male: Male | Participants | 62 | 66 | 128 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 4 | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 130 | 133 | 263 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 4 | 5 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 61 | 63 | 124 |
| Race (NIH/OMB): White | Participants | 67 | 68 | 135 |
| Race (NIH/OMB): More than one race | Participants | 2 | 2 | 4 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 132 | 137 | 269 |
| primary psychiatric diagnosis: schizophrenia | Participants | 40 | 41 | 81 |
| primary psychiatric diagnosis: schizoaffective disorder | Participants | 46 | 32 | 78 |
| primary psychiatric diagnosis: bipolar disorder | Participants | 25 | 42 | 67 |
| primary psychiatric diagnosis: major depressive disorder | Participants | 20 | 18 | 38 |
| primary psychiatric diagnosis: other psychotic disorder | Participants | 1 | 4 | 5 |
| Number of cardiovascular disease (CVD) risk factors: 1 cvd risk factors | Participants | 14 | 20 | 34 |
| Number of cardiovascular disease (CVD) risk factors: 2 cvd risk factors | Participants | 37 | 23 | 60 |
| Number of cardiovascular disease (CVD) risk factors: 3 cvd risk factors | Participants | 39 | 47 | 86 |
| Number of cardiovascular disease (CVD) risk factors: 4 cvd risk factors | Participants | 33 | 34 | 67 |
| Number of cardiovascular disease (CVD) risk factors: 5 cvd risk factors | Participants | 9 | 13 | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Global Framingham Risk Score, measured over Baseline, 18 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Global Framingham Risk Score, described as a score on a scale. The registry says that higher scores indicate higher cardiovascular risk and that the score can range from 0-38, with higher scores yielding increased 10-year probability of stroke. The recorded measurement time points are baseline and 18 months.
A composite risk score can summarize several aspects of risk in a single measure, which can make it useful for assessing an intervention intended to address overall cardiovascular risk rather than one isolated risk factor. That is a general reason for using such scores; the registry record does not explain why this score was selected for this trial or specify its component variables.
The endpoint is specified as a mean, with standard deviation as the measure of dispersion. A mean describes the average score in a group, while a standard deviation describes how dispersed individual scores are around that average. The registry record does not report the group means, standard deviations, change estimates, confidence intervals, or a single primary comparison. Without those results, the direction and precision of any difference in the primary endpoint cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the trial’s primary outcome and timing but does not report one primary comparison reduced to a single estimate. It identifies the Global Framingham Risk Score as the primary measure and lists baseline and 18 months as measurement times. The record also notes that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, the available information does not establish the size, direction, or precision of an intervention-control difference in the primary outcome.
The endpoint is a continuous score, and its stated interpretation is that higher scores indicate higher cardiovascular risk. To evaluate a trial result, readers would ordinarily need the group-level scores and a clearly defined comparison, such as a between-group contrast at follow-up or a difference in change over time. The registry record does not report those estimates or identify which comparison should be treated as primary. No confidence interval or p-value for the primary outcome is reported in the registry record.
The listed enrollment is 269, but enrollment alone does not describe how many participants contributed data to the primary analysis. Group-specific analyzed sample sizes, missing outcome data, and the analysis population are not reported in the registry record. These details matter because estimates based on different subsets of randomized participants can have different precision and may be affected by missingness.
The record lists 20 outcome measures and 11 analyses. Those counts indicate that the registry includes multiple outcomes and analyses, but do not show which analyses were prespecified, how they were selected, or whether statistical adjustment for multiple testing was used. Those analysis-plan details are not reported in the registry record. Results for the secondary outcomes are also not present in the registry record described by this record.
Safety information is available as counts of serious adverse events and deaths by group, along with percentages for common serious-event terms. These figures describe events recorded in the two arms; they do not, by themselves, establish that an event was caused by an intervention. The record does not provide the information needed to make that causal assessment or to compare event rates with a defined statistical uncertainty.
9. Statistical Methods Explained
Random allocation is intended, in general, to create groups that are comparable on average at the time of assignment. A parallel-group design assigns participants to one of the trial arms and evaluates the groups during the same trial. The registry lists the allocation as randomized and the model as parallel. The method used to generate the assignment sequence, allocation concealment procedures, and any stratification factors are not reported in the registry record.
What does a mean and standard deviation describe?
The primary outcome is specified as a mean of a continuous score, with standard deviation as its dispersion measure. A mean gives a group’s average score. The standard deviation describes the spread of participant scores around that average. Neither quantity alone provides the uncertainty in a comparison between groups. A standard error or confidence interval for a treatment contrast would be needed to show how precisely that contrast is estimated; such an interval is not reported in the registry record.
A confidence interval is a general statistical way of expressing uncertainty around an estimate. It presents a range of values compatible with the data and the method used, rather than only a single point estimate. A narrow interval indicates greater precision than a wide interval, all else equal. The registry record does not report a confidence interval for the primary outcome, so its precision cannot be described from the available information.
How should the repeated measurement be understood?
The primary outcome is recorded at baseline and 18 months. In a trial with measurements at more than one time point, an analysis may compare follow-up values, changes from baseline, or a pattern of measurements over time. These approaches answer related but not identical questions. The registry record does not specify which approach was used for the primary analysis, nor does it provide a single comparison across the listed time points. It would therefore be inappropriate to infer an analysis method or select one comparison on the trial’s behalf.
Baseline measurements can describe the groups before follow-up, while follow-up measurements can describe their outcomes after the intervention period. In general, an analysis that accounts for baseline values may improve precision when baseline and follow-up measures are related. Whether this trial’s analysis adjusted for baseline, and what other covariates it used, are not reported in the registry record.
What can the planning illustrations establish?
The planning illustrations are described as calculations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. They use the stated fraction of the observed effect as the target effect. These are planning illustrations, not evidence of observed power, and not necessarily the assumptions used when the trial was designed. The registry record does not report the trial’s own sample-size justification or design assumptions. Because no observed primary comparison is reported in the record, no planning value or effect estimate should be inferred from the trial description alone.
In general, a sample-size calculation estimates the number of participants needed under specified assumptions to detect a chosen effect with a chosen error tolerance. It does not show that a completed trial had a particular probability of detecting an effect after its results are known. A planning calculation based on an observed effect can be especially dependent on that estimate, which may be imprecise. It should be treated as an illustration for planning rather than as a retrospective verdict on the trial’s design.
Why can over-dispersion matter?
For count outcomes, over-dispersion means the observed variation is greater than a statistical model’s assumptions would predict. In general, failing to account for over-dispersion can make uncertainty appear smaller than it is. This trial’s primary endpoint is described as a continuous score, not a count outcome, and the registry record does not report a model for the primary analysis. This general issue should not be taken as evidence that over-dispersion was present in this trial.
For continuous outcomes, the choice of model and its assumptions still matter. Analysts may need to consider the outcome’s distribution, repeated measurements, missing observations, and the form of the comparison. The registry record does not report the analysis model, diagnostics, adjustment variables, or sensitivity analyses. Thus, the statistical method underlying any trial result cannot be evaluated from the registry description alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 20 outcome measures and 11 analyses. Multiple outcomes and analyses create a multiplicity issue in general: when many statistical questions are examined, the chance of at least one apparently notable finding can increase. A prespecified primary outcome and analysis can help readers distinguish the main confirmatory question from supporting or exploratory questions. The registry record identifies the Global Framingham Risk Score as primary, but does not report a multiplicity adjustment or explain how the analyses were selected.
The primary outcome includes baseline and 18-month time points, and the record notes that it is not reduced to one comparison. If several time points, outcome definitions, or contrasts are tested, it is important to know which one was designated as primary and how other analyses were interpreted. That detail is not reported in the registry record. The listed counts alone do not establish which analyses were prespecified or whether any were exploratory.
Missing outcome data can affect both precision and interpretation. In general, the implications depend on how much data are missing, why they are missing, and whether the analysis method appropriately reflects that process. Group-specific missingness, reasons for missingness, imputation methods, and sensitivity analyses are not reported in the registry record.
The registry record also does not report the primary analysis population, such as whether the analysis included all randomized participants or only participants with available outcome measurements. Without that information and the number analyzed in each arm, it is not possible to assess how closely the analysis follows the randomized comparison or how missing data may have influenced the result.
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 |
|---|---|---|---|
| IDEAL Intervention | 29 | 132 | 22.0% |
| Control | 35 | 137 | 25.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| IDEAL Intervention | 2 of 132 |
| Control | 2 of 137 |
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 |
|---|---|
| IDEAL Intervention | 0 of 132 |
| Control | 0 of 137 |
Most frequent serious adverse event terms
| Event term | Organ system | IDEAL Intervention | Control |
|---|---|---|---|
| medical hospitalization | General disorders | 20 of 132 | 30 of 137 |
| psychiatric hospitalization | Psychiatric disorders | 10 of 132 | 9 of 137 |
Serious events with the highest arm-level rate: medical hospitalization (21.9%), psychiatric hospitalization (7.6%).
The registry record lists serious adverse events for the IDEAL Intervention group as 29 affected among 132 at risk, and for the Control group as 35 affected among 137 at risk. It also lists 2 deaths in each group. These are descriptive counts; the record does not provide a statistical comparison or confidence intervals for them.
The most common serious-event terms are listed as medical hospitalization at 21.9% and psychiatric hospitalization at 7.6%. The denominator and calculation method for these percentages are not reported in the registry record, so they should not be interpreted as rates in a particular group or as percentages of a specified population.
Adverse-event counts do not establish whether an event was caused by the intervention. The record does not report event-level timing, severity details beyond the serious-event classification, relatedness assessments, or the causes of death. Counts can be influenced by the observation period, how events were collected, and participants’ underlying health. These figures should therefore be read as registry-reported safety information, not as a causal estimate of comparative risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, parallel-group trial compared an IDEAL cardiovascular risk-reduction program with a control condition in people with serious mental illness and cardiovascular risk factors. It identifies the Global Framingham Risk Score as the primary outcome and states that it was measured at baseline and 18 months. It also provides descriptive serious adverse-event counts and lists several secondary outcomes.
However, the registry record does not provide a single primary-outcome comparison or the numerical information needed to assess its direction and precision. It therefore does not show, in the information, whether the intervention group’s mean score differed from the control group’s mean score, or how uncertain any such difference would be. No conclusion about the intervention’s effect on the primary endpoint can be drawn from the trial description alone.
More generally, a reported difference would need to be interpreted in light of its confidence interval, analysis population, missing data, and prespecified analysis plan. Statistical uncertainty is not the same as clinical importance: an estimate can be precise yet have limited practical relevance, or be uncertain even when its point estimate appears notable. The registry record does not provide the primary effect estimate or the details needed for those assessments.
The listed serious adverse events and deaths are descriptive, and do not establish causation. The record also does not include the detail needed to assess the balance of benefits and harms. As a result, the available information supports a description of the trial’s question, design, endpoint, and recorded safety counts, but not a definitive judgment about the intervention’s effects.
13. Why This Trial Matters Statistically
This trial addresses a statistical challenge that arises when cardiovascular risk reduction is studied in a population with serious mental illness: the intervention combines several forms of support, while the primary endpoint is a summary score rather than a single behavior or risk factor. The registry describes counseling, coordination with primary care, and collaboration with mental health staff and social supports. Evaluating such a program requires a clear comparison and a transparent account of how multiple components and outcomes are analyzed.
The Global Framingham Risk Score is identified as the primary measure, with higher scores indicating higher cardiovascular risk. A score can provide a compact outcome for an intervention aimed at overall risk, but its interpretation depends on the comparison, measurement timing, and analytic method. The registry record identifies baseline and 18 months but does not report one reduced primary comparison. This makes the distinction between a clearly stated endpoint and a fully reported analysis especially important.
The record also lists many outcome measures and analyses. In general, this makes prespecification and multiplicity procedures important for separating the main trial question from secondary or exploratory findings. Details of those procedures are not reported in the registry record. The absent information on missingness and analysis populations also limits assessment of how the randomized comparison was preserved in the analysis.
These issues are not unique to this trial. They illustrate why registration details, results, and statistical methods need to be read together. A completed-trial status and a defined primary outcome do not alone convey the estimated effect or its precision. Transparent reporting of the comparison and analysis is necessary for readers to evaluate what the data support.
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 central limitation for interpreting the trial is that the registry record does not report a single primary-outcome comparison. Although the endpoint and its measurement times are specified, no group means, standard deviations, effect estimate, confidence interval, or primary-outcome p-value are included in the record. The direction and precision of the primary result therefore cannot be assessed.
The record does not report group-specific numbers analyzed for the primary outcome, missing-data patterns, reasons for missingness, or the analysis population. It also does not describe the statistical model, baseline adjustment, prespecified contrasts, or sensitivity analyses. These omissions prevent assessment of whether the analysis matched the randomized design and how robust any estimate would be.
The masking designation is single, but the record does not identify who was masked. Details of sequence generation and allocation concealment are not reported. The available IDEAL intervention description ends mid-sentence, and the control description is limited; additional intervention-delivery details are not reported in the registry record. This restricts assessment of how consistently the interventions were delivered or how distinct the conditions were in practice.
Safety information is limited to summary counts, deaths, and the listed serious-event terms. Event timing, relatedness, group-specific denominators for the listed percentages, and statistical uncertainty are not reported. The record’s lists of outcome measures and analyses also do not explain prespecification or multiplicity handling. These limitations concern the information in the registry record and do not establish that the trial lacked procedures that are not described there.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness — NCT02127671.
- Registry record last updated 2025-08-11; status last verified 2025-07.
- Results first posted 2025-08-11.
- 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
NCT02127671 is a completed randomized, parallel-group trial sponsored by Johns Hopkins University. The registry lists enrollment of 269 and identifies people with serious mental illness and cardiovascular risk factors as the population of interest. The IDEAL intervention included cardiovascular risk-reduction counseling and coordination with primary care and mental health supports; the control condition included group exercise classes and instruction to provide more healthy meals.
The primary endpoint was the Global Framingham Risk Score, recorded at baseline and 18 months. Higher scores indicate higher cardiovascular risk. The registry record does not report a single primary comparison or its precision. It lists serious adverse-event counts of 29 among 132 at risk in the IDEAL group and 35 among 137 at risk in the Control group, with 2 deaths in each group. The record also lists 20 outcome measures and 11 analyses; details of multiplicity handling, missing data, and analysis populations are not reported in the registry record.