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 Benefits Counseling to Preserve Function Among Disability Applicants (NCT00715650), a randomized phase 2 study. The primary outcome is Days of Work and Work-related Activity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00715650 |
| Phase | Phase 2 |
| Condition | Veterans' Disability Claims |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 92 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
The registry description concerns disability applicants with psychiatric disabilities and identifies the condition as Veterans' Disability Claims. Eligibility criteria and further details about the enrolled population are not reported in the registry record.
Intervention
Benefits Counseling is described as four sessions, each approximately 60 minutes. Topics include benefits and goals, work and claims, financial review, and plans after benefits. The final topic description is incomplete in the registry record.
Comparator
The comparison group received VA Orientation, described as a four-session orientation covering VHA services, primary care, pharmacy and laboratory services, and specialty services. The description ends before fully stating what participants planned to do.
Primary question
The study's stated concern is whether benefits counseling can help preserve function among disability applicants. The listed primary measure is days of work and work-related activity at baseline, not a reported follow-up contrast between the randomized groups.
That distinction matters for interpretation. A baseline measure describes participants' activity before or at the start of the intervention period; by itself, it cannot show whether activity changed after counseling or whether changes differed between groups. The registry record does not report a numerical comparison of post-intervention activity, an estimated treatment effect, or an uncertainty interval. It therefore does not establish from the posted results whether benefits counseling changed work-related activity relative to VA Orientation.
3. Trial Design
The study, titled Benefits Counseling to Preserve Function Among Disability Applicants, is listed as a phase 2 randomized trial with a parallel-group design. Participants were assigned to Benefits Counseling or VA Orientation. Masking is listed as none, so the registry record does not describe a masked trial. The sponsor is the VA Office of Research and Development.
Enrollment is listed as 92. The study is marked completed, with a start date of 2008-12 and a primary completion date of 2012-06. These registry dates indicate the recorded study milestones; they do not, by themselves, describe how long an individual participant was followed. The follow-up schedule and timing of any measurements after baseline are not reported in the registry record.
The counseling arm is described as four sessions, each approximately 60 minutes, focused on benefits, work, claims, financial implications, and participants' plans. The orientation arm is described as four sessions covering VHA and clinical services. The arm descriptions are incomplete in the registry record, so additional session content or differences in contact time cannot be established from them.
Randomization is useful in general because it aims to balance measured and unmeasured participant characteristics between groups, on average, before an intervention begins. It does not guarantee balance in a particular trial, and an interpretable treatment comparison still depends on the outcome definitions, analysis, follow-up, and handling of missing data. The registry record does not report the randomization procedure, allocation concealment, adherence, or analysis methods.
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.
Intervention
| Stage | Benefits Counseling | VA Orientation |
|---|---|---|
| STARTED | 47 | 45 |
| Received Any Session | 39 | 38 |
| Attended ≥ 2 Sessions | 36 | 33 |
| Attended ≥ 3 Sessions | 23 | 17 |
| COMPLETED | 42 | 42 |
| NOT COMPLETED | 5 | 3 |
Follow-up
| Stage | Benefits Counseling | VA Orientation |
|---|---|---|
| STARTED | 42 | 42 |
| Completed Month 1 Follow-up | 40 | 38 |
| Completed Month 3 Follow-up | 35 | 40 |
| Completed Month 6 Follow-up | 29 | 37 |
| COMPLETED | 29 | 37 |
| NOT COMPLETED | 13 | 5 |
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 | Benefits Counseling | VA Orientation | Total |
|---|---|---|---|---|
| Participants analysed | 42 | 42 | 84 | |
| Age, Continuous | years | 37 (SD 4) | 40 (SD 14) | 38.5 (SD 14) |
| Sex: Female, Male: Female | Participants | 10 | 4 | 14 |
| Sex: Female, Male: Male | Participants | 32 | 38 | 70 |
| Race/Ethnicity, Customized: White | participants | 25 | 28 | 53 |
| Race/Ethnicity, Customized: African American | participants | 6 | 5 | 11 |
| Race/Ethnicity, Customized: Latino | participants | 8 | 5 | 13 |
| Race/Ethnicity, Customized: Other | participants | 3 | 4 | 7 |
| Psychiatric diagnosis: Major depression | participants | 15 | 10 | 25 |
| Psychiatric diagnosis: PTSD | participants | 9 | 15 | 24 |
| Psychiatric diagnosis: TBI | participants | 1 | 3 | 4 |
| Psychiatric diagnosis: Schizophrenia type/Bipolar | participants | 3 | 2 | 5 |
| Psychiatric diagnosis: Substance abuse | participants | 11 | 6 | 17 |
| Attitudes and beliefs: "If a person is receiving VA benefits and starts working for pay ...": Income benefits will be reduced or stopped | Likert scale | 3.4 (SD 1.4) | 3.5 (SD 1.2) | 3.45 (SD 1.4) |
| Attitudes and beliefs: "If a person is receiving VA benefits and starts working for pay ...": Medical benefits will remain the same | Likert scale | 3.1 (SD 1.4) | 2.8 (SD 1.3) | 2.95 (SD 1.4) |
| Attitudes and beliefs: "If a person is receiving VA benefits and starts working for pay ...": Would rather turn down job than lose benefits | Likert scale | 3.3 (SD 1.0) | 3.6 (SD 1.0) | 3.45 (SD 1) |
6. Primary Endpoint
The registry lists the primary outcome as Days of Work and Work-related Activity, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | days |
| Endpoint classification | Continuous Endpoint |
The listed primary measure is Days of Work and Work-related Activity. It is expressed as a mean number of days and has standard deviation as its stated measure of dispersion. The description counts days in the past 28 spent in any kind of work or related activity, using a timeline follow-back calendar. Its listed timeframe is baseline.
This measure is intended to describe participation in work and related activities, rather than employment status alone. A calendar-based recall approach can organize reports around specific days and activities. As a general measurement point, however, retrospective reporting can be affected by recall, and the registry record does not describe procedures used to check or validate responses.
The baseline timing is essential. A baseline mean can characterize activity at study entry, but it is not a change score or a comparison of outcomes after treatment. To estimate an intervention effect, a report would need to present an appropriate comparison using measurements taken after assignment, with enough information to understand the analysis and its uncertainty. Such a comparison is not reported in the registry record. The reason this particular endpoint was selected, and whether it was intended to capture a specific mechanism of functional change, are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record contains a study description and safety counts, but it does not provide a numerical result for the listed primary measure. The measure is specified at baseline, and the registry record notes that the primary outcome has several categories or time points and was not reduced to one comparison. It also lists no analyses. Consequently, there is no posted treatment-effect estimate, standard error, confidence interval, or hypothesis-test result to interpret for work-related activity.
This absence is not evidence that the groups had the same activity, nor is it evidence that counseling did or did not change activity. A conclusion about a difference requires a reported contrast, its direction and magnitude, and information about uncertainty. Without these, the size and precision of any potential difference cannot be assessed. The baseline definition alone does not show what happened after the sessions.
The design is randomized, which can support a causal comparison when outcomes are measured and analyzed appropriately. But the design label is not itself a result. Interpretation would also require knowing which post-baseline time point or summary was analyzed, which participants contributed data, how missing observations were handled, and whether the analysis followed the assigned groups. Those details are not reported in the registry record.
The safety record lists 0 serious adverse events among 42 at risk in Benefits Counseling and 0 among 42 at risk in VA Orientation. It also lists 0 other adverse events among 42 at risk in each group. These are the recorded counts for the categories shown; they do not constitute a comparison of work-related activity. Death counts are not reported in the registry record.
Overall, the posted information supports describing the trial design, the intended counseling content, the baseline activity measure, and the listed adverse-event counts. It does not support estimating the effectiveness of either intervention, judging the precision of an effect estimate, or drawing a conclusion about post-intervention function. Those conclusions would require outcome results and their analysis, which are not reported in the registry record.
9. Statistical Methods Explained
What does the baseline mean describe?
For a continuous measure, the mean is the arithmetic average of the recorded values. In this trial, the stated measure is the number of days of work or work-related activity during the past 28, and the registry specifies that results are represented by a mean and standard deviation. The standard deviation describes how spread out individual values are around the mean; it is not the uncertainty of the mean itself and is not a treatment-effect estimate.
Because this measure is recorded at baseline, a mean would describe activity at that measurement point. It would not, on its own, estimate change during the study. A comparison of baseline means could describe how the groups started, but it would not establish an intervention effect. The registry record does not report baseline group means or standard deviations.
Why does randomization matter?
In general, random assignment aims to make treatment groups comparable at the start of a study, including on characteristics that were not measured. This supports interpretation of a between-group difference in a properly measured follow-up outcome as an estimate of the effect of assignment. Randomization does not ensure that every feature is balanced in the realized groups, and it cannot compensate for an outcome that is not reported or for unclear analysis decisions.
The study is listed as randomized and parallel, but details of sequence generation, allocation concealment, and the statistical analysis are not reported in the registry record. Without the outcome comparison, there is no effect estimate to evaluate, regardless of the design's potential strengths.
How should uncertainty be interpreted?
In general, a confidence interval gives a range of values compatible with the data and the statistical model at a stated confidence level. Its width conveys precision: a wider interval indicates less precision than a narrower one. A confidence interval for a treatment contrast would help readers assess both the range of plausible effects and whether the estimate is precise enough to distinguish among substantively different possibilities.
No confidence interval, standard error, or numerical treatment contrast for the primary measure is reported in the registry record. A p-value is also not reported. Thus, neither statistical compatibility with a null effect nor the precision of an estimated effect can be assessed from the registry information.
What does the planning description mean?
The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the effect to detect is expressed as a stated fraction of the observed effect, and that non-time-to-event illustrations are expressed as participants per arm. The particular fractions and resulting sample-size values are not reported in the registry record.
In general, such calculations explore how many participants per arm might be needed under specified assumptions. They are planning illustrations, not observed findings and not evidence that a study had a particular probability of detecting an effect. The registry does not report the assumptions used in the original trial design or a sample-size justification. The planning description therefore cannot be treated as the trial's design rationale or as evidence of observed power.
Could the outcome's distribution matter?
As a general statistical consideration, a count of days can have a distribution that differs from a continuous normal distribution. Values are bounded by the period being recalled, and participants may have many similar or low activity counts. If variability exceeds what a chosen count model expects, over-dispersion can make model-based standard errors too small unless the analysis accounts for it. The appropriate approach depends on the observed distribution and the research question.
The registry record does not report outcome distributions, a statistical model, checks of model assumptions, or adjustments for over-dispersion. No claim can therefore be made about whether a particular model was suitable or whether this issue affected an estimate. These are general considerations for interpreting day-count outcomes, not descriptions of analyses conducted in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 4 outcome measures and 0 analyses. It notes that the primary outcome has several categories or time points and was not reduced to one comparison. No single primary-result comparison is reported, so the record does not show how the multiple outcome categories or time points were prioritized or analyzed.
When a study evaluates multiple outcomes, time points, or contrasts, the chance of obtaining an apparently notable result can increase if all are tested and only selected results are emphasized. In general, a prespecified analysis plan and transparent reporting of all planned comparisons help readers assess this risk. The registry record does not report a multiplicity strategy, a statistical analysis plan, or whether any analyses were prespecified.
Missing-data methods and analysis populations are also not reported in the registry record. It is therefore unclear how many participants contributed to each outcome, whether participants were analyzed according to randomized assignment, or how incomplete follow-up was handled. These details can affect both the estimate and its uncertainty, particularly if missingness differs between groups or relates to participants' outcomes.
These omissions do not establish that analyses or missing-data procedures were absent from the conduct of the study. They mean that the registry record does not provide the information needed to assess them. Without a reported analysis and participant-level accounting, the completeness and robustness of the primary-outcome evidence cannot be evaluated.
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 |
|---|---|---|---|
| Benefits Counseling | 0 | 42 | 0.0% |
| VA Orientation | 0 | 42 | 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 |
|---|---|
| Benefits Counseling | 0 of 42 |
| VA Orientation | 0 of 42 |
For Benefits Counseling, the registry lists 0 serious adverse events among 42 participants at risk and 0 other adverse events among 42 at risk. For VA Orientation, it likewise lists 0 serious adverse events among 42 at risk and 0 other adverse events among 42 at risk. These are recorded counts, not estimates of comparative risk.
A zero count means that no event in that category was recorded in the listed at-risk group. It does not establish that the true risk is zero, and it does not rule out events that were not captured or reported. Without event definitions, surveillance details, follow-up duration, and uncertainty estimates, the precision and completeness of these safety counts cannot be assessed.
Deaths are not reported in the registry record; the unreported value should not be interpreted as a count of zero. The safety information is separate from the primary measure of days of work and work-related activity and does not provide evidence about that outcome.
12. What the Result Does, and Does Not, Mean
The posted information establishes that this was a randomized, parallel phase 2 study comparing Benefits Counseling with VA Orientation. It describes the content of the interventions, identifies a baseline measure of work and work-related activity, and gives adverse-event counts for each arm. It also records the study as completed.
It does not establish whether benefits counseling preserved function, increased or reduced work-related activity, or differed from VA Orientation on the primary measure. The listed measure is at baseline, and the registry record does not report a post-baseline treatment contrast or its uncertainty. Without those results, neither the direction nor the magnitude of a possible effect can be assessed.
Likewise, the recorded zero counts for serious and other adverse events do not establish that no risk existed. They describe the events recorded in the listed categories and at-risk groups. Death counts are not reported in the registry record.
In general, a trial's design can provide a framework for answering a clinical or policy question, but conclusions depend on the results and how they were analyzed. Here, key information about outcome follow-up, analysis populations, missing data, and statistical methods is not reported in the registry record. The appropriate interpretation is therefore limited to the descriptive details available, rather than a claim for or against either intervention.
13. Why This Trial Matters Statistically
This trial addresses a question at the intersection of disability benefits and participation in work-related activity. Its comparison is between two behavioral approaches: benefits-focused counseling and an orientation to VA services. Describing the study in statistical terms makes clear which group comparison was intended and what the registered activity measure captures.
The record also illustrates why endpoint timing matters. A baseline measure can describe participants' starting activity, but it cannot answer whether activity changed after an intervention. Readers need a follow-up comparison to distinguish the trial's motivating question from the information actually available in the record. Here, no reduced primary comparison or treatment-effect result is reported.
There are also important limits to what a randomized label can convey. Random assignment can strengthen a causal comparison when follow-up outcomes and analyses are clearly reported, but it does not supply missing results or details about missing data and analysis populations. Transparent reporting of the selected time point, effect estimate, uncertainty, and analysis decisions is essential for assessing the strength of the evidence.
The record's safety counts are similarly best read as descriptive observations, not definitive estimates of risk. This distinction between recorded counts, comparative effects, and uncertainty is central to careful interpretation of clinical research. The trial is statistically informative as an example of why a clear outcome definition must be accompanied by interpretable outcome results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation of the registry record for interpreting this trial is that it does not report a numerical result for the primary measure or a treatment-effect comparison. The listed endpoint is measured at baseline, and the record notes multiple categories or time points without reducing them to one comparison. The registry also lists 0 analyses. As a result, the effect of Benefits Counseling relative to VA Orientation cannot be estimated from the posted information.
Important design and analysis details are not reported in the registry record, including follow-up timing, the randomization procedure, allocation concealment, adherence, statistical models, analysis populations, and missing-data methods. The arm descriptions are incomplete, which limits assessment of how the interventions were delivered and whether their content or contact differed in ways relevant to interpretation.
The record lists 4 outcome measures but does not explain how outcomes or time points were selected for analysis or how multiplicity was addressed. It also does not report confidence intervals or other measures of uncertainty for the primary outcome. Consequently, neither precision nor the robustness of any potential finding can be assessed.
The safety record gives zero serious and other adverse events for the listed at-risk groups, but does not report event definitions or the duration and completeness of safety monitoring. Death counts are not reported in the registry record. These limitations concern what can be concluded from the registry information; they do not establish what methods may have been used but not recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Benefits Counseling to Preserve Function Among Disability Applicants — NCT00715650.
- Registry record last updated 2016-03-11; status last verified 2016-02.
- Results first posted 2014-10-17.
- 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
NCT00715650 is a completed, randomized, parallel phase 2 study sponsored by the VA Office of Research and Development. It compares Benefits Counseling with VA Orientation and lists enrollment of 92. The registered primary measure is mean days of work and work-related activity during the past 28, assessed by timeline follow-back at baseline.
The registry record does not report a reduced primary-outcome comparison or numerical treatment-effect results. It lists 0 analyses and notes that the primary outcome includes several categories or time points. Serious and other adverse-event counts are 0 in each arm among 42 at risk per arm; death counts are not reported in the registry record. The available record supports description of the design and measures, but not a conclusion about comparative effects on work-related activity.