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 Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life (NCT01507688), a randomized na study. The primary outcome is Total Stroke Specific Quality of Life.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01507688 |
| Phase | NA |
| Condition | Stroke |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 258 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Patients discharged after an acute stroke or transient ischemic attack as the primary diagnosis. The record reports an enrollment of 258 participants across three sites.
Intervention
A stroke self-management program with telephone sessions during the first three months, followed by monthly telephone reinforcement sessions and monthly group support sessions during months 4–6.
Comparator
Usual care.
Primary question
How did the groups compare in change from baseline to 6 months in Total Stroke Specific Quality of Life?
The clinical question concerns whether a structured self-management program is associated with a different change in stroke-specific quality of life than usual care over the six-month period. The outcome is a mean score formed from a 49-item instrument covering 12 health-related quality-of-life domains. The instrument’s scale ranges from 1 to 5; higher scores indicate better functioning and lower scores indicate poorer functioning.
The question is about the average change in a patient-reported measure, not a direct count of clinical events. The population includes people discharged with stroke or transient ischemic attack as their primary diagnosis. The trial was randomized and parallel-group, with 129 participants assigned to each arm according to the arm-level registry counts.
The registry record does not report a numerical estimate of the groups’ changes, a between-group contrast, or its uncertainty. It therefore does not permit a quantitative answer about the size or precision of the difference in quality-of-life change.
3. Trial Design
This was a randomized, parallel-group trial with single masking, listed as completed. The registry reports enrollment of 258 participants, with 129 in the stroke self-management arm and 129 in usual care. The study involved three sites: Jesse Brown VAMC in Chicago, Roudebush VAMC in Indianapolis, and IU Health Methodist Hospital in Indianapolis, Indiana. The sponsor was the VA Office of Research and Development. The phase is listed as not applicable.
The intervention was behavioral. Participants assigned to it were scheduled to receive six bi-weekly telephone sessions during the first three months. During months 4–6, the arm description specifies three monthly reinforcement telephone sessions together with three monthly group sessions. The comparator was usual care; the registry record does not describe its components in further detail.
The primary outcome was Total Stroke Specific Quality of Life, measured as change from baseline to 6 months. The record describes the score as the mean of 49 items across 12 domains. It lists a mean and standard deviation as the outcome measure and gives the scale limits as 1 and 5.
The registry lists the study as completed and records its enrollment and intervention structure, but it does not report the numerical primary-outcome results in the record used for this analysis. The people who were masked, allocation-concealment procedures, adherence to assigned sessions, and details of the analysis plan are not reported in the registry record. The registry lists two analyses, but their specifications and results are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Baseline to 6 Month Assessment
| Stage | Arm 1 SSM Intervention | Arm 2 Usual Care |
|---|---|---|
| STARTED | 129 | 129 |
| COMPLETED | 113 | 119 |
| NOT COMPLETED | 16 | 10 |
6 Month to 12 Month Assessment
| Stage | Arm 1 SSM Intervention | Arm 2 Usual Care |
|---|---|---|
| STARTED | 113 | 119 |
| COMPLETED | 108 | 116 |
| NOT COMPLETED | 5 | 3 |
Analysis population for the primary outcome, as defined in the registry: Participants were patients discharged with an acute stroke or TIA as the primary diagnoses.
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 | SSM Intervention Arm 1 | Usual Care Arm 2 | Total |
|---|---|---|---|---|
| Participants analysed | 129 | 129 | 258 | |
| Age, Continuous | years | 61.09 (SD 10.77) | 62.41 (SD 10.87) | 61.75 (SD 10.82) |
| Sex: Female, Male: Female | Participants | 23 | 26 | 49 |
| Sex: Female, Male: Male | Participants | 106 | 103 | 209 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 127 | 127 | 254 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 46 | 32 | 78 |
| Race (NIH/OMB): White | Participants | 77 | 89 | 166 |
| Race (NIH/OMB): More than one race | Participants | 6 | 6 | 12 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 129 | 129 | 258 |
| Cerebrovascular Events: Stroke | Participants | 109 | 109 | 218 |
| Cerebrovascular Events: Transient Ischemic Attack (TIA) | Participants | 20 | 20 | 40 |
| National Institute on Health Stroke Scale (NIHSS) | units on a scale | 3.00 (SD 3.20) | 2.96 (SD 2.81) | 2.98 (SD 3.01) |
| Length of time (days) | Days | 85.74 | 77.20 | 81.47 |
| Stroke Specific Quality of Life | units on a scale | 3.06 (SD 0.76) | 3.16 (SD 0.73) | 3.11 (SD 0.75) |
| Self-Efficacy to Manage Stroke Symptoms | units on a scale | 8.27 (SD 1.72) | 8.47 (SD 1.55) | 8.37 (SD 1.64) |
6. Primary Endpoint
The registry lists the primary outcome as Total Stroke Specific Quality of Life, measured over Change from baseline to 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
Total Stroke Specific Quality of Life is a patient-reported measure intended to capture several aspects of life affected by stroke. The 49 items cover 12 domains: energy, mobility, work, upper extremity function, activities of daily living, family roles, social roles, vision, language, thinking, mood, and personality. The total score is calculated as the mean of the item scores.
The scale runs from 1 to 5. A lower score indicates poorer functioning, while a higher score indicates better functioning. The registry identifies the primary endpoint as change from baseline to 6 months, so the intended measure concerns how scores changed over the follow-up interval rather than only the score at one assessment.
A multi-domain quality-of-life measure can capture experiences that are not represented by a single clinical event or impairment. It is used to assess the effect of the intervention on participants’ reported health-related quality of life. As a mean score, it summarizes responses across items; it does not show whether every domain changed in the same direction or by the same amount.
The registry record does not include the group means, standard deviations, or a between-group estimate for this outcome. Consequently, the magnitude and precision of the reported change cannot be described from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The design sets up a comparison between participants assigned to stroke self-management and participants assigned to usual care. Randomization is intended to support a fair comparison by creating groups that, on average, are comparable at the start of the study. The record reports 129 participants in each arm. It does not describe the randomization procedure or report baseline characteristics, so those aspects cannot be assessed from the registry record.
The primary question concerns change in Total Stroke Specific Quality of Life from baseline to 6 months. For a continuous outcome, a useful group comparison would ordinarily describe the change in each arm and estimate the difference in change between arms, together with an uncertainty measure such as a confidence interval. The registry record does not report those numerical results. No direction, size, or precision of a quality-of-life difference can therefore be stated.
This absence is important for interpretation. The enrollment count alone does not show whether the intervention was associated with a larger or smaller mean change, and it cannot establish how compatible the data are with different possible effects. Without an estimate and its uncertainty, the primary outcome cannot be interpreted as evidence for or against a particular magnitude of difference.
The record includes adverse-event figures separately from the primary quality-of-life outcome. It records serious events affecting 44 participants in the intervention arm and 35 in usual care, with 129 at risk in each arm. Other events affected 72 and 61 participants, respectively, and the record lists 2 deaths in each arm. These are descriptive counts; the record does not provide a statistical comparison or enough detail to determine the circumstances, timing, or overlap among event categories. They should not be treated as a substitute for the primary endpoint results.
The listed serious-event terms include CVD related health event at 15.5%, General disorders at 10.1%, Bone fractures and strains at 5.4%, Infection at 3.9%, Pain at 3.1%, and Kidney stones at 1.6%. The registry record does not specify the denominator or full coding and aggregation rules for these percentages. They can be reported as listed, but should not be converted into a comparison of risk between arms.
The trial is marked completed, and its enrollment is reported. Completion status does not itself provide evidence about the primary outcome. Since the registry record lacks the relevant outcome estimates and analysis details, conclusions about the intervention’s comparative effect on quality-of-life change remain unquantified.
9. Statistical Methods Explained
What does the primary outcome measure?
The primary outcome is continuous: it is a mean score on a scale rather than a count of events or a yes/no response. The score averages 49 items covering 12 quality-of-life domains. The record states that its range is 1 to 5 and that higher scores indicate better functioning. The stated endpoint is change from baseline to 6 months, which focuses on movement in the score over time.
For a continuous outcome, investigators commonly summarize each group using a mean and a measure of variability such as the standard deviation. The mean describes the group’s average score or average change. The standard deviation describes how spread out individual participants’ scores are around that average. These are different quantities: a standard deviation is not the uncertainty in the group mean or in the difference between groups.
How should a randomized comparison be read?
The main comparison should focus on the difference between the intervention and usual-care groups, not on whether one group changed significantly from its own baseline while the other did not. A direct between-group estimate addresses the randomized comparison. Its interpretation depends on the definition of change, the analysis population, and any adjustment or modeling choices. These details, along with the numerical estimate, are not reported in the registry record.
A confidence interval is a range of values expressing the statistical uncertainty around an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while the interval’s location indicates which effect values are compatible with the data and method. The record does not report a confidence interval for the primary outcome, so precision cannot be evaluated.
A p-value, if reported, would address how compatible the observed data are with a specified null hypothesis under a statistical model. It would not by itself describe the size or practical importance of an effect. No primary-outcome p-value is reported in the registry record. Accordingly, neither statistical significance nor the likely range of effect sizes can be assessed from the posted registry information.
What can the sample-size illustrations tell readers?
Planning illustrations are not trial results. The assumptions described for these illustrations include a two-sided significance level of 0.05, equal allocation, and a normal approximation. They consider effects expressed as fractions of an observed effect. Such calculations can illustrate how a hypothetical effect size and design assumptions relate to a planning sample size. They are not observed power and do not demonstrate that a study was adequately powered for its actual outcome.
The registry record does not report the trial’s own sample-size justification or the assumptions used in its original design. The numerical primary-outcome estimate needed to understand an observed-effect-based illustration is also not reported in the registry record. Therefore, the illustrations cannot establish the original design rationale or the trial’s ability to detect a particular clinically meaningful difference.
Why does variability matter?
Continuous outcomes can vary substantially among participants, even when their group means are similar. The standard deviation helps describe this spread. If the data have more variability than a statistical model assumes, the model may represent uncertainty poorly. This is one reason analysts check model assumptions and consider methods that accommodate the observed distribution. The registry record does not report the outcome distribution or diagnostics, so no conclusion about these features can be made.
For a mean-based analysis, the quality and completeness of measurements matter as well. The record does not report how missing scores were handled, whether repeated measurements were modeled jointly, or whether baseline values were included as covariates. These choices can affect the estimate and its uncertainty. They should not be inferred from the fact that the endpoint is defined as change from baseline to 6 months.
What does the event information represent?
Adverse-event counts are descriptive safety information and are distinct from the continuous primary outcome. Counts of participants affected do not, on their own, give the timing, duration, severity distribution, or statistical uncertainty of a between-arm comparison. Event categories can also differ in how they are defined and collected. The registry record lists counts and selected serious-event terms but does not report a comparative statistical analysis of these events.
Overall, the record identifies a randomized design and a clearly described quality-of-life measure, but it does not contain the numerical outcome results or enough analysis detail for a full statistical appraisal. The design description explains what was intended to be compared; it does not fill in the missing estimate, confidence interval, or analysis specification.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies Total Stroke Specific Quality of Life as the primary outcome and gives change from baseline to 6 months as its timeframe. It also indicates that the primary outcome has several categories or time points and is not reduced to one comparison in the posted results. The registry record does not report a single numerical comparison that can be interpreted as the primary treatment-effect estimate.
Multiplicity arises when several outcomes, time points, subgroups, or statistical tests are examined. If many tests are conducted, the chance of at least one apparently notable result can increase. Analysts may address this through a prespecified hierarchy, adjustment procedures, or a clear distinction between primary and exploratory analyses. The registry record does not report a multiplicity strategy, a testing hierarchy, or whether adjustment was used.
The record lists two analyses, but their methods, populations, and results are not reported in the registry record. It does not describe whether analyses followed intention-to-treat principles, whether participants were analyzed according to assigned group, or whether any per-protocol analysis was conducted. The number of randomized participants per arm does not establish which participants contributed to a particular endpoint analysis.
Missing-data handling is not reported in the registry record. The record does not describe the number of missing outcome measurements, reasons for missingness, imputation, sensitivity analyses, or assumptions about participants without six-month scores. These details matter because an analysis of observed scores may represent a different set of participants from the randomized population, and conclusions can depend on how missing outcomes are handled.
Interim analyses and stopping rules are also not reported in the registry record. Neither their presence nor absence can be inferred from the completion status. Without the analysis plan and missing-data information, the reported enrollment and endpoint definition alone are insufficient to assess these aspects of the statistical analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arm 1 SSM Intervention | 44 | 129 | 34.1% |
| Arm 2 Usual Care | 35 | 129 | 27.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm 1 SSM Intervention | 2 of 129 |
| Arm 2 Usual Care | 2 of 129 |
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 SSM Intervention | 72 of 129 |
| Arm 2 Usual Care | 61 of 129 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1 SSM Intervention | Arm 2 Usual Care |
|---|---|---|---|
| CVD related health event | Vascular disorders | 20 of 129 | 8 of 129 |
| General disorders | General disorders | 9 of 129 | 13 of 129 |
| Bone fractures and strains | Musculoskeletal and connective tissue disorders | 4 of 129 | 7 of 129 |
| Infection | Infections and infestations | 5 of 129 | 3 of 129 |
| Pain | General disorders | 4 of 129 | 3 of 129 |
| Kidney stones | Renal and urinary disorders | 2 of 129 | 1 of 129 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1 SSM Intervention | Arm 2 Usual Care |
|---|---|---|---|
| General Outpatient Care | General disorders | 72 of 129 | 61 of 129 |
Serious events with the highest arm-level rate: cvd related health event (15.5%), general disorders (10.1%), bone fractures and strains (5.4%), infection (3.9%), pain (3.1%).
The registry records serious adverse events among 44 of 129 participants at risk in the stroke self-management arm and 35 of 129 at risk in usual care. It also records other adverse events affecting 72 participants in the intervention arm and 61 in usual care. Deaths are listed as 2 in each arm. These figures are counts of affected participants as recorded, not estimates of a causal effect.
The registry lists the leading serious-event terms and their reported percentages: CVD related health event, 15.5%; General disorders, 10.1%; Bone fractures and strains, 5.4%; Infection, 3.9%; Pain, 3.1%; and Kidney stones, 1.6%. The record does not explain the denominator for these percentages or whether a participant could contribute to multiple terms. The percentages should therefore be read as registry-listed descriptions, not as directly comparable arm-specific risks.
These counts do not convey event timing, duration, severity beyond the serious classification, or statistical uncertainty. The registry record also does not report a formal between-arm analysis of safety outcomes. Differences in counts should not be interpreted as evidence that the intervention caused or prevented events. The figures provide descriptive context alongside the trial’s primary quality-of-life question.
12. What the Result Does, and Does Not, Mean
The trial addresses a relevant statistical question: whether assignment to a structured stroke self-management program was associated with a different six-month change in stroke-specific quality of life than assignment to usual care. Its randomized, parallel-group design provides a framework for that comparison. The registry also describes the intervention schedule and a patient-reported endpoint covering multiple aspects of life after stroke.
However, the registry record does not report the numerical primary-outcome results. There is no reported group change, between-group estimate, confidence interval, or p-value from which to describe the direction, size, or precision of an effect. Enrollment and completion do not supply those missing quantities. Thus, the record does not support a quantitative conclusion about comparative quality-of-life change.
Even when a numerical difference is available, statistical interpretation distinguishes the estimated effect from its uncertainty and from its clinical importance. A confidence interval can show how imprecisely an effect is estimated, while a prespecified threshold or substantive context is needed to judge whether a difference matters to patients. The registry record does not report such a threshold or enough results for these judgments.
The adverse-event counts and listed event terms are separate descriptive information. They do not answer the primary quality-of-life question and, without additional definitions and comparative analyses, cannot establish that the program changed safety outcomes. Likewise, the described intervention schedule does not show whether participants attended or completed the sessions.
The sound interpretation is therefore limited: the record documents the trial’s design, enrollment, intervention, comparator, endpoint definition, and selected adverse-event figures. It does not report the primary estimates needed to determine how the groups compared on the stated endpoint. No conclusion about treatment benefit or lack of benefit follows from this missing information.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how a clinical question can be clearly framed even when its numerical outcome results are not available in the registry record. It defines a population, randomized comparison, intervention period, and patient-reported endpoint. Those elements help identify the estimand that a complete analysis would need to address: the difference between assigned groups in change in quality-of-life score through 6 months.
The endpoint also illustrates a common feature of clinical research: a single reported score may summarize several domains. The total mean can be useful for a broad comparison, but it can conceal differing patterns across energy, mobility, work, family and social roles, and other domains. Domain-level interpretation would require results for those domains and a plan for handling multiple outcomes. Such results and a multiplicity plan are not reported in the registry record.
The registry’s missing numerical primary-outcome estimate highlights why design information and results serve different purposes. Randomization supports a comparative design, but interpretation still requires an effect estimate and a measure of uncertainty. Enrollment counts do not reveal the observed effect, its precision, or how missing outcome data may have influenced the analysis.
The record’s safety counts further show why event summaries need careful context. Counts without definitions, denominators for listed percentages, timing, and comparative analyses are not equivalent to a risk estimate. Keeping descriptive safety information distinct from the primary continuous endpoint helps avoid treating unlike measures as though they answer the same question.
For readers assessing a trial statistically, the central lesson is to separate what the record specifies from what it reports numerically. Here, the protocol-level comparison and outcome are identifiable, but the registry record does not give the primary result or key analysis details needed to judge its magnitude and precision.
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 limitation for interpretation is that the registry record does not report numerical results for the primary quality-of-life outcome. No group-specific change, between-group estimate, confidence interval, or p-value is available in the record. This prevents assessment of the size, direction, and precision of the primary comparison.
Although enrollment and arm counts are listed, the record does not give baseline outcome scores or other baseline characteristics. It also does not specify the people masked, the randomization procedure, or allocation concealment. These details are important for evaluating implementation of the randomized design but cannot be assessed from the registry record.
The outcome is described as a mean across 49 items, but the record does not provide domain-specific results, measurement completeness, or information about the distribution of scores. It does not report the analysis population, model, covariate adjustment, or missing-data approach. The number of analyses is listed, but their specifications are not reported in the registry record.
The intervention schedule is described, but participant attendance, adherence, deviations, and receipt of usual care are not reported in the registry record. Consequently, the planned contrast can be described, but implementation and exposure cannot be evaluated. The listed adverse-event counts also lack reported timing, detailed event definitions, and a formal comparative analysis. The denominator for the serious-event term percentages is not stated.
These limitations concern what can be evaluated from the registry record; they do not establish that relevant methods or results were absent from other materials. No additional publication or source is identified in the record used.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life — NCT01507688.
- Registry record last updated 2023-07-27; status last verified 2023-07.
- Results first posted 2019-04-01.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT01507688 is a completed, randomized, single-masked, parallel-group trial with enrollment of 258 participants. It compared a stroke self-management program with usual care among patients discharged with acute stroke or transient ischemic attack as the primary diagnosis. The intervention included telephone sessions and group support over 6 months. The trial was conducted at three sites and sponsored by the VA Office of Research and Development.
The primary outcome was change from baseline to 6 months in Total Stroke Specific Quality of Life, a mean score based on 49 items across 12 domains and ranging from 1 to 5. Higher scores indicate better functioning. The registry record reports 129 participants at risk in each arm and lists serious adverse events, other events, deaths, and selected serious-event terms.
The numerical primary-outcome results, analysis methods, missing-data handling, and multiplicity approach are not reported in the registry record. The posted information therefore describes the study design and endpoint but does not permit a quantitative interpretation of the primary comparison.