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 Evaluation of Videoconferencing Versus Telephone Genetic Counseling (NCT02108977), a randomized na study. The primary outcome is Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02108977 |
| Phase | NA |
| Condition | Remote Consultation, Teleconsultation, Remote Consultation, Video |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 38 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns Veterans for whom in-person genetic counseling was not feasible. The registry record gives no further description of the primary outcome population, such as eligibility details or participant characteristics.
Intervention
Patients assigned to the videoconferencing consultation were to travel to a CBOC and receive genetic counseling by videoconferencing.
Comparator
Patients assigned to the telephone consultation were to receive genetic counseling by telephone, described in the registry record as usual treatment.
Primary question
The study sought to assess knowledge retention associated with genetic counseling using an eight-question True/False assessment before counseling and after counseling, within 2 weeks. The clinical question is whether knowledge scores changed after counseling and how the findings compare between the videoconferencing and telephone groups. The registry record does not report outcome values or a comparison between groups, so it does not answer that question.
The registry describes the purpose as understanding the relative advantages and disadvantages of these two ways of delivering genetic counseling. It notes that the information could also be relevant to other interventions using telephone or videoconferencing to reach patients. No broader outcomes or findings are reported in the registry record.
3. Trial Design
This was a randomized, parallel-group study with no masking recorded. The registry lists an enrollment of 38 and identifies the sponsor as the VA Office of Research and Development. The study status is completed. Its start is recorded as 2014-04 and its primary completion as 2015-03. The phase is listed as NA.
The two interventions were named Videoconferencing Genetic Consultation and Teleconferencing Genetic Consultation. The first involved participants traveling to a CBOC for a counseling session by videoconferencing. The second involved a counseling session by telephone and was described as usual treatment. The record therefore distinguishes the groups by the consultation modality; it does not describe additional treatment components.
Random allocation means that assignment to the groups was intended to be determined by a chance process. In general, randomization can reduce systematic differences between groups at baseline, but it does not guarantee that groups will be identical, particularly in a study with limited enrollment. The record does not report the allocation sequence method, allocation concealment, stratification, or other implementation details.
The parallel model means that participants were assigned to a group rather than described as receiving both modalities in sequence. Masking is recorded as none. The registry does not report whether outcome assessment was conducted independently of the counseling modality or whether participants knew the study's comparative objective.
The enrollment figure is not the same as the number with a recorded primary outcome: outcome-specific participant counts are not reported in the registry record. The safety group counts are reported separately, and should not be treated as a complete account of the primary outcome population. The record gives no participant flow, withdrawal, or follow-up completion information.
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 | Videoconferencing Genetic Consultation | Teleconferencing Genetic Consultation |
|---|---|---|
| STARTED | 18 | 20 |
| COMPLETED | 8 | 19 |
| NOT COMPLETED | 10 | 1 |
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.
Population: We define baseline participants as those who enrolled in the study and participated in the knowledge pre-test.
| Characteristic | Unit | Videoconferencing Genetic Consultation | Telephone Genetic Consultation | Total |
|---|---|---|---|---|
| Participants analysed | 8 | 19 | 27 | |
| Age, Customized | Not collected | NA | NA | NA |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 8 | 19 | 27 |
6. Primary Endpoint
The registry lists the primary outcome as Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment, measured over Pre- and post- (within 2 weeks) genetic counseling.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Number of correct answers (out of 8) |
| Endpoint classification | Continuous Endpoint |
The primary measure is knowledge retention of genetic counseling information, assessed with eight True/False genetics-related questions. The registry describes the outcome as the number of correct answers out of 8, with a mean and standard deviation as the planned summary. Participants were to complete the assessment before counseling and again after counseling, within 2 weeks.
A knowledge assessment is intended to capture whether participants can answer questions about information addressed in counseling. In general, comparing pre-counseling and post-counseling scores can describe changes in measured knowledge over that interval. A mean summarizes the average score in a group, while a standard deviation describes the spread of scores around that mean. Neither summary alone shows how individual participants' scores changed.
The registry record does not give the actual pre- or post-counseling means, standard deviations, participant counts for these measurements, or a numerical estimate comparing the modalities. It also does not report a specific primary contrast, such as a between-group difference in change scores. Consequently, the endpoint's definition is available, but the observed knowledge results and their precision are not reported in the registry record.
The assessment is one measure of knowledge retention. It does not, by itself, characterize every advantage or disadvantage of telephone or videoconferencing counseling. The registry record does not report additional outcome definitions in enough detail to interpret the other listed outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of telephone and videoconferencing genetic counseling, but it does not provide the results needed to interpret the primary knowledge-retention outcome. There are no reported group means, standard deviations, changes from baseline, effect estimates, or confidence intervals for the eight-question assessment. The record also lists no recorded analyses. Thus, the available information establishes what the investigators intended to evaluate, not what the outcome measurements showed.
Without a numerical outcome comparison, it is not possible to assess the direction or size of any difference between counseling modalities. It is also not possible to assess how precise such a difference might be. A confidence interval, when reported, gives a range of values compatible with the data and analysis under its assumptions; its width helps communicate uncertainty. No such interval for the primary comparison is reported in the registry record.
The absence of a reported difference is not evidence that the modalities produced the same result. Equivalence or non-inferiority requires a defined analytical framework and results interpreted against a prespecified margin. Those margins and analyses are not reported in the registry record. Nor does the record permit a conclusion that either modality increased or failed to increase knowledge.
The listed enrollment is 38, whereas the reported safety groups have different at-risk counts. Those safety counts do not provide the number contributing to the knowledge outcome. Participant flow, missing outcome data, and analysis populations are not reported in the registry record, so the extent to which the planned assessment was completed cannot be established.
The study's stated aim included understanding the advantages and disadvantages of the two delivery approaches. The primary outcome described in the record concerns knowledge scores; results for this outcome would not necessarily answer every question about access, experience, or other potential trade-offs. The registry record does not report findings for those broader considerations. Overall, the record supports a description of the trial setup and measurement plan, but not a conclusion about comparative outcome performance.
9. Statistical Methods Explained
The design is recorded as randomized and parallel, with no masking. In general, random allocation aims to make assignment independent of measured and unmeasured baseline characteristics. This supports a causal comparison when allocation is implemented appropriately and participants are followed and analyzed in ways that preserve the assigned groups. The registry record does not describe the randomization procedure, concealment, or analysis method, so these aspects cannot be evaluated from the record.
What does the primary measure summarize?
The primary outcome is a continuous measure: the number of correct answers on an eight-question assessment. A mean describes the average score for a group at a particular assessment time. A standard deviation describes how dispersed individual scores are around that average. These statistics can help characterize a group's score distribution, but they do not fully describe it, and they do not automatically show the treatment contrast of interest.
Because the assessment was planned before and after counseling, several summaries could be relevant in principle: scores at each time, within-person change, or a contrast between groups in change. These approaches answer related but distinct questions. The registry record identifies the pre- and post-counseling assessment and the mean and standard deviation, but does not specify which numerical contrast was used for the primary analysis. The actual results and analysis are not reported in the registry record.
Why does the comparison method matter?
In general, a between-group estimate should be interpreted together with its uncertainty and the analysis definition. A confidence interval communicates the range of estimates compatible with the observed data under the model's assumptions. A p-value, if reported, describes how unusual the data would be under a specified null model; it does not measure the probability that a hypothesis is true or the practical importance of a difference. No primary estimate, confidence interval, or p-value is reported in the registry record.
Repeated measurements on the same participant are related rather than independent. A method analyzing change or jointly modeling repeated scores should account for that relationship. This is a general statistical consideration, not a description of the method used in this study: the analysis method is not reported in the registry record.
What can the planning illustration tell readers?
The registry's planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These are assumptions for a planning illustration, not evidence that the trial was designed with those assumptions or that a particular power was achieved. The registry record does not report the trial's own sample-size justification or the numerical inputs and outputs of the illustration. The observed effect itself is also not reported in the registry record.
Sample-size calculations are prospective planning tools: they describe the number of participants that might be needed under specified assumptions. They are not a measure of the probability that a completed study's result is correct. In particular, an illustration based on an observed effect should not be read as observed power or as proof that a result is conclusive. When the effect estimate and its uncertainty are unavailable, the illustration cannot be independently interpreted from the registry record.
Why should over-dispersion be considered generally?
For count or categorical outcomes, over-dispersion means that the observed variability exceeds what a simple statistical model expects. In general, failing to account for over-dispersion can make uncertainty appear too small. The primary endpoint in this study is described as a continuous score summarized by a mean and standard deviation; the registry does not report a model or indicate that over-dispersion was assessed. This general concept therefore should not be mistaken for a reported feature of this analysis.
Overall, the study design and intended measurement are identifiable, but the statistical analysis plan and outcome analysis are not. Details such as the primary estimand, model, handling of repeated measurements, covariate adjustment, and confidence-interval construction are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, while the primary measure itself includes assessment before counseling and after counseling, within 2 weeks. Multiple outcomes, time points, or possible contrasts can create multiplicity: the more analyses considered, the greater the chance that an apparently notable result may occur by chance. In general, investigators can address this by prespecifying a primary contrast or using an appropriate adjustment, but the registry record does not report a multiplicity strategy or detailed hierarchy of outcomes.
The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. This matters because an endpoint description is not equivalent to a fully specified statistical estimand. Without a stated primary contrast, it is unclear which comparison would serve as the main basis for interpretation. The record lists no analyses, so it does not establish how the multiple time points or outcomes were handled.
Missing-data details are also not reported in the registry record. There is no account of how many participants completed the pre- and post-counseling assessment, whether any scores were incomplete, or how missing measurements were handled. In general, missing data can affect both the number of observations analyzed and the validity of a comparison, depending on why measurements are absent and on the analytical approach.
The registry record does not describe an intention-to-treat or per-protocol analysis population, exclusions after randomization, or sensitivity analyses. These details are important for understanding whether the analysis followed assigned groups and how robust findings might be to assumptions about missing outcomes. In the absence of reported results and analysis details, no conclusion about multiplicity or missing-data impact is possible.
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 |
|---|---|---|---|
| Videoconferencing Genetic Consultation | 0 | 8 | 0.0% |
| Teleconferencing Genetic Consultation | 0 | 19 | 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 |
|---|---|
| Videoconferencing Genetic Consultation | 0 of 8 |
| Teleconferencing Genetic Consultation | 0 of 19 |
The safety record lists 8 participants at risk in the videoconferencing group and 19 in the telephone group. For serious adverse events, the recorded number affected is 0 in each group. The record also lists 8 and 19 participants at risk, respectively, for other adverse events, with 0 affected in each group. Death counts are not reported as numerical values.
These entries are counts, not a complete safety analysis. They describe the reported groups and recorded events; they do not establish that no adverse events occurred outside the recorded categories or observation period. The registry record does not describe the safety follow-up duration, event-collection procedures, or whether participants with missing safety information were included.
In general, zero recorded events in a group does not prove that the underlying risk is zero. Estimates based on few participants can be imprecise, and interpretation depends on follow-up and event ascertainment. The reported serious-event counts should therefore be read as the registry's recorded counts, not as evidence that one counseling modality is safer than the other. The record does not report a formal comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group study compared genetic counseling by videoconferencing with counseling by telephone. It identifies knowledge retention as the primary outcome and describes a pre- and post-counseling assessment based on eight True/False questions. It also describes the intended delivery of each consultation modality and records the study as completed.
Those details do not establish how participants scored or whether scores changed after counseling. No numerical primary outcome results, between-group estimate, uncertainty interval, or analysis are reported in the registry record. As a result, the available record does not show whether the modalities differed, whether either group improved, or how precisely any estimated difference could be known.
The record also cannot support a conclusion of equivalence or non-inferiority. Such conclusions require a specified comparison framework and appropriate results, neither of which is reported. Similarly, the absence of a recorded serious adverse event in the listed groups is not proof that the risk is absent, and it does not establish a safety advantage for either approach.
The stated study purpose extends beyond knowledge scores to the relative advantages and disadvantages of telephone and videoconferencing. The registry record does not report findings that address those broader considerations. A defined outcome can illuminate one aspect of an intervention, but it should not be treated as a complete measure of all relevant experiences or consequences.
The most defensible interpretation is therefore descriptive: the registry records the trial's design, intervention descriptions, intended primary measure, and limited safety counts, but not the comparative outcome evidence needed to answer the main effectiveness question. Missing results should not be interpreted as a null finding.
13. Why This Trial Matters Statistically
This study is statistically notable because it places the same type of genetic counseling in a randomized comparison of two remote delivery modalities. Randomization provides a framework for comparing groups, while the parallel design distinguishes assignment to videoconferencing from assignment to telephone counseling. The record also makes clear that the primary measure was intended to capture knowledge around the counseling session.
The endpoint's timing matters. A pre-counseling assessment describes knowledge before the session, while a post-counseling assessment within 2 weeks describes knowledge after it. To compare modalities, the analysis must clarify whether the key quantity is post-counseling score, within-person change, or a between-group difference in change. These are not interchangeable statistical questions. The registry record does not specify a single primary comparison or report its result.
The limited enrollment and the absence of outcome results in the registry record make precision impossible to assess. Enrollment alone cannot show whether an estimate would be stable or whether clinically or practically meaningful differences could be distinguished. Nor can planning illustrations, which rely on assumptions and an observed effect, replace reported outcome estimates and uncertainty.
More broadly, this record illustrates why trial registration details and results serve different purposes. Design information describes the intended experiment; results are needed to assess observed effects. Without the latter, the registry can clarify what was planned but cannot determine the comparative statistical evidence. The distinction is essential when interpreting completed trials and when separating a study question from an answer supported by analyzed data.
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 primary limitation for interpretation is that the registry record does not report outcome results or analyses. It gives the measure and assessment timing, but no group-specific scores, change estimates, comparison, or precision measure. Therefore, the main comparative question cannot be answered from this record.
The record does not specify the primary analysis contrast, model, or analysis population. It also does not report allocation implementation, participant flow, baseline characteristics, completion of the assessments, or missing-data handling. These omissions prevent evaluation of how closely the analyzed groups would reflect randomized assignment and how complete the outcome information was.
The primary measure is an eight-question knowledge assessment. The registry describes its format and scoring range but does not report information about its development, validation, reliability, or interpretation. It also does not specify a threshold for a meaningful change. The registry record therefore supports understanding what was measured, but not how a score difference should be judged in practical terms.
The primary outcome includes assessments at more than one time point, yet the record does not identify a single comparison. Five outcome measures are listed, and no multiplicity approach is described. The absence of a reported statistical analysis plan leaves uncertainty about how outcomes and time points were prioritized.
Finally, the safety counts are limited to the entries listed in the registry, and the record does not describe observation duration or ascertainment. The study's stated interest in advantages and disadvantages is broader than the reported primary knowledge measure; findings on such broader considerations are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Videoconferencing Versus Telephone Genetic Counseling — NCT02108977.
- Registry record last updated 2019-03-28; status last verified 2019-03.
- Results first posted 2016-04-21.
- 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
NCT02108977 is a completed randomized, parallel-group study of genetic counseling by videoconferencing versus telephone. The registry lists enrollment of 38, no masking, and the VA Office of Research and Development as sponsor. The recorded study start is 2014-04, and primary completion is 2015-03.
The primary outcome was knowledge retention assessed with eight True/False questions before counseling and after counseling, within 2 weeks. The registry describes the outcome as the number correct, summarized by a mean and standard deviation. It does not report primary outcome results or analyses, and does not specify a single comparison across the assessment time points.
Safety entries record 0 serious adverse events and 0 other adverse events in the listed groups. Those counts do not substitute for a comparative analysis. The registry record documents the study question and design, but does not provide results sufficient to determine how the counseling modalities compared.