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 A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes (NCT01940705), a randomized na study. The primary outcome is Hearing Aid Skills and Knowledge Test.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01940705 |
| Phase | NA |
| Condition | Hearing Loss |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 269 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Veterans with hearing loss who were receiving hearing aids. The registry record does not report detailed eligibility criteria or participant characteristics.
Intervention
Standard hearing-aid orientation plus one of three educational approaches: a take-home informational guide, a take-home DVD, or a teach-back session reviewing hearing-aid information.
Comparator
Standard-of-care hearing-aid orientation delivered by a clinical audiologist.
Primary question
At 4 weeks after hearing-aid fitting, how did hearing-aid skills and knowledge compare across the educational approaches and standard orientation?
The trial addressed whether adding a patient-centered educational tool to routine orientation was associated with better performance on tasks involving hearing-aid management. The primary outcome was the Hearing Aid Skills and Knowledge Test, expressed as percentage of correct responses. It covers both knowledge, such as knowing how to change batteries, and practical skills, such as inserting a hearing aid.
The registry record describes a comparison among four parallel groups: standard orientation alone and standard orientation supplemented by a guide, DVD, or teach-back technique. It does not report the group results for the primary outcome. Therefore, the clinical question can be described, but the posted record does not establish which approach had higher scores or how large any differences were.
The record also names the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids and the International Outcome Inventory for Hearing Aids as secondary outcomes. Their results are not reported in the registry record.
3. Trial Design
This was a randomized, single-masked, parallel-group trial sponsored by the VA Office of Research and Development. The registry lists an enrollment of 269 and the condition as hearing loss. The study is marked completed. Its start date was 2014-01-01, and its primary completion date was 2016-09-30. The phase is listed as NA.
Participants were assigned to standard-of-care hearing-aid orientation or to that orientation plus one of three educational additions. The guide and DVD were take-home materials. The teach-back group received a session reviewing hearing-aid information using the teach-back technique. The record does not describe the randomization procedure, allocation concealment, or which people were masked.
The parallel design means the groups were compared as separate assigned groups rather than as a crossover in which each participant received multiple approaches. Random allocation can, in general, help balance participant characteristics across groups, although chance imbalances can remain. The registry record does not provide enough detail to assess how allocation was implemented or whether the groups were comparable at baseline.
The primary outcome was assessed at 4 weeks after hearing-aid fitting. The record describes three outcome measures and four analyses, but does not identify the complete set of analyses or specify how the analysis count relates to the listed outcomes and group comparisons. No statistical analysis plan, planned sample-size justification, or interim analysis information is reported in the registry record.
The trial compared educational supports added to clinical audiologist orientation, not the educational tools in isolation from that orientation. That distinction matters when interpreting the intended contrast: the registry describes each added approach as an adjunct to standard care.
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 | Standard of Care | Standard of Care Plus Hearing-aid Informational Guide | Standard of Care Plus a Take-home Digital Video Disc | Standard of Care Plus Counseling With the Teach-back Technique |
|---|---|---|---|---|
| STARTED | 66 | 67 | 69 | 67 |
| COMPLETED | 62 | 59 | 61 | 63 |
| NOT COMPLETED | 4 | 8 | 8 | 4 |
Reasons for not completing this period:
| Reason | Standard of Care | Standard of Care Plus Hearing-aid Informational Guide | Standard of Care Plus a Take-home Digital Video Disc | Standard of Care Plus Counseling With the Teach-back Technique |
|---|---|---|---|---|
| Lost to Follow-up | 1 | 3 | 2 | 2 |
| Withdrawal by Subject | 2 | 2 | 3 | 2 |
| Intervention not given | 0 | 3 | 3 | 0 |
| Withdrawal by team - hearing aid change | 1 | 0 | 0 | 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 | Standard of Care | SoC Plus Hearing-aid Informational Guide | SoC Plus a Take-home DVD | SoC Plus Counseling With the Teach-back Technique | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 66 | 67 | 69 | 67 | 269 | |
| Age, Continuous | years | 70.1 (SD 6.7) | 68.7 (SD 7.6) | 69.3 (SD 6.4) | 68.8 (SD 7.0) | 69.2 (SD 6.9) |
| Sex: Female, Male: Female | Participants | 2 | 1 | 1 | 1 | 5 |
| Sex: Female, Male: Male | Participants | 64 | 66 | 68 | 66 | 264 |
| Region of Enrollment: United States | participants | 66 | 67 | 69 | 67 | 269 |
6. Primary Endpoint
The registry lists the primary outcome as Hearing Aid Skills and Knowledge Test, measured over 4 weeks after the hearing-aid fitting.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage of correct responses |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the Hearing Aid Skills and Knowledge Test, assessed 4 weeks after hearing-aid fitting. It measures knowledge and practical ability related to hearing-aid management, including changing batteries and inserting a hearing aid. The registry reports the outcome as a mean percentage of correct responses, with standard deviation as the measure of dispersion.
The knowledge scale uses verbal responses scored as correct or incorrect. The skills scale is based on performing tasks: a task that could not be performed receives no credit, completing it with some difficulty or more than one attempt receives partial credit, and completing it without difficulty on the first attempt receives full credit. The record describes 15 knowledge items and 19 skill items. Percent correct was calculated separately for each scale, using items with valid data and a correction to equate the subscales. For the skills scale, a score of 2 was treated as 100% correct and a score of 1 as 50% correct.
This outcome was used because the trial focused on whether educational approaches were associated with hearing-aid management knowledge and skills. A test of task performance and knowledge is distinct from a measure of self-efficacy or a broader report of hearing-aid outcomes. The registry record does not report the scale-specific or group-level primary outcome results, nor does it explain how the two subscales were combined or presented in the analyses.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the question and outcome but does not report the primary endpoint results. It contains no group means, standard deviations, estimated differences, confidence intervals, or p-values for the Hearing Aid Skills and Knowledge Test. As a result, the posted information does not show the direction, size, or precision of any primary-outcome differences among standard orientation and the three educational additions.
This absence limits interpretation in a specific way: the trial design alone cannot establish whether one group scored higher, whether differences were small or large, or whether the data were compatible with a range of possible effects. A randomized design can support comparisons between assigned groups when analyzed appropriately, but it does not substitute for the outcome estimates and their uncertainty.
The record describes two secondary outcome measures: the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids and the International Outcome Inventory for Hearing Aids. Their results are not reported in the registry record. The record identifies three outcome measures overall and four analyses, but does not identify the third measure or give enough detail to match the analyses to particular outcomes or contrasts.
Safety information is available in the record. One serious adverse event was recorded in the informational-guide group, and none were recorded in the standard-of-care, DVD, or teach-back groups. The listed serious-event term is “Non-study-related adverse event,” with a percentage of 1.7%. These counts describe events recorded by group; they do not establish that an educational approach caused or prevented an event. The registry does not report details that would allow a broader assessment of safety.
The completed status and study dates describe the trial’s administrative record, not its findings. Without outcome estimates and analysis details, there is no basis in this record for a statistical conclusion about comparative effectiveness. This is a limitation of what the record reports, rather than evidence that there was no difference.
9. Statistical Methods Explained
The registry describes a randomized, single-masked, parallel-group trial with a continuous primary outcome summarized as a mean and standard deviation. It does not report the inferential methods used to compare groups. The concepts below explain how such data are generally interpreted; they do not describe a confirmed analysis plan for this trial.
What does a mean represent?
For a continuous outcome, a group mean describes the average score among participants included in that group’s analysis. Here the score is expressed as a percentage of correct responses on the Hearing Aid Skills and Knowledge Test. A mean can make the overall level of test performance easier to compare, but it does not show how scores vary between individuals or whether a small number of unusually high or low scores influenced the average.
A difference between group means is a common way to express a comparison of continuous outcomes. Its meaning depends on the measurement scale and on the uncertainty around the estimate. The registry record does not report the group means or any estimated differences for this endpoint, so no such comparison can be interpreted from the posted results.
What does a standard deviation describe?
A standard deviation describes the spread of individual observations around a group mean. It is not the same as the standard error, which describes the precision of an estimated mean. In general, greater spread makes it harder to estimate a group mean precisely when the amount of data is unchanged. The record identifies standard deviation as the endpoint’s dispersion measure but gives no primary-outcome values.
How should uncertainty be read?
A confidence interval, when reported, gives a range of values compatible with the data and the method used to construct the interval. Its width reflects uncertainty: a narrower interval indicates more precision under that method, while a wider interval indicates less. The interval does not guarantee that the true effect lies within its endpoints, and it does not replace consideration of the size and relevance of an estimated difference. No confidence intervals for the primary outcome are reported in the registry record.
A p-value, when reported, measures how unusual data at least as extreme as the observed data would be under a specified null model and analysis. It is not the probability that the null hypothesis is true, nor does it measure the magnitude or practical importance of an effect. The registry record does not report primary-outcome p-values or identify the tests used.
Why do the four groups matter?
The four arms create several possible comparisons: each educational addition could be contrasted with standard orientation, and the additions could also be compared with one another. Which comparisons were intended as primary, and whether comparisons among the added approaches were planned, are not reported in the registry record. The choice of comparison affects the question answered by an estimate.
When multiple comparisons are considered, the chance of obtaining at least one apparently unusual result can increase if each test is interpreted separately without accounting for multiplicity. General approaches include identifying a primary comparison in advance, adjusting inference for a family of tests, or treating additional comparisons as exploratory. The registry record does not report a multiplicity strategy, so it is not possible to determine how any multiple testing was handled.
What does randomization contribute?
Random assignment is intended to reduce systematic differences between groups at the time of assignment. It supports an interpretation based on assigned group, provided the analysis and follow-up preserve that comparison. Randomization does not guarantee exact balance, prevent missing outcome data, or establish that the assigned approaches were delivered as intended. The registry record does not report baseline characteristics, adherence, or analysis population definitions.
What can sample-size planning illustrations show?
Planning calculations can illustrate how many participants per arm might be needed under specified assumptions about an effect, significance level, allocation, and statistical approximation. Such calculations are not observed power and do not demonstrate what effect the trial detected. The planning illustration described in the record is based on a fraction of the observed effect and assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The registry record does not report the trial’s own sample-size justification or design assumptions. The illustration therefore should not be mistaken for the trial’s original design calculation.
Because the primary outcome estimates and analysis methods are not reported, these general statistical ideas cannot be applied to assess the strength or precision of this trial’s comparative outcome findings.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists the Hearing Aid Skills and Knowledge Test as the primary outcome and names two secondary outcomes: the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids and the International Outcome Inventory for Hearing Aids. It also identifies three outcome measures overall and four analyses. The third outcome measure, the mapping of analyses to outcomes, and the specific group contrasts are not reported in the registry record.
Multiplicity is relevant because four groups and multiple outcomes can generate several possible statistical comparisons. If many tests are conducted, interpreting each one as if it were the sole planned test can increase the chance of a false-positive finding. The record does not report whether analyses were prespecified, whether a particular contrast was primary, or whether any adjustment for multiple testing was used. Consequently, the status of any possible secondary or additional analysis cannot be assessed.
Missing-data methods and the amount of missing outcome data are not reported in the registry record. The primary outcome description says that the percentage calculation used items with valid data, but it does not explain how incomplete test records were handled in the group-level analysis. The record also does not state whether participants were analyzed according to randomized assignment, whether any participants were excluded, or how missing follow-up assessments were addressed.
Analysis populations are therefore unclear. In general, an intention-to-treat analysis compares participants according to their assigned groups and can preserve the benefits of randomization, while other analysis populations may answer different questions and introduce additional assumptions. The registry record does not identify the population used for the primary analysis. These reporting gaps prevent assessment of the analysis choices and the potential influence of missing data or multiple testing on the results.
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 |
|---|---|---|---|
| Standard of Care | 0 | 62 | 0.0% |
| SoC Plus Hearing-aid Informational Guide | 1 | 59 | 1.7% |
| SoC Plus a Take-home DVD | 0 | 61 | 0.0% |
| SoC Plus Counseling With the Teach-back Technique | 0 | 63 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Standard of Care | 0 of 62 |
| SoC Plus Hearing-aid Informational Guide | 0 of 59 |
| SoC Plus a Take-home DVD | 0 of 61 |
| SoC Plus Counseling With the Teach-back Technique | 0 of 63 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Standard of Care | 0 of 62 |
| SoC Plus Hearing-aid Informational Guide | 0 of 59 |
| SoC Plus a Take-home DVD | 0 of 61 |
| SoC Plus Counseling With the Teach-back Technique | 0 of 63 |
Most frequent serious adverse event terms
| Event term | Organ system | Standard of Care | SoC Plus Hearing-aid Informational Guide | SoC Plus a Take-home DVD | SoC Plus Counseling With the Teach-back Technique |
|---|---|---|---|---|---|
| Non-study-related adverse event | Ear and labyrinth disorders | 0 of 62 | 1 of 59 | 0 of 61 | 0 of 63 |
Serious events with the highest arm-level rate: non-study-related adverse event (1.7%).
The registry lists serious adverse event counts by group. The standard-of-care group had zero serious adverse events; the informational-guide group had one; the DVD group had zero; and the teach-back group had zero. The listed serious adverse event was classified as “Non-study-related adverse event,” with a reported percentage of 1.7%.
These figures are event counts recorded in the registry, not evidence that an intervention caused an event. The “non-study-related” classification also indicates that the event was not described as study-related in the record. A count of zero means no serious adverse event was recorded for that group in this entry; it does not prove that the possibility of such an event is absent.
The record separately shows zero other adverse events in each group and zero deaths. The listed numbers at risk were 62 for standard of care, 59 for the informational guide, 61 for the DVD, and 63 for teach-back. A comparison of sparse counts cannot by itself establish a safety difference, particularly without details about event definitions, follow-up, ascertainment, or statistical methods. Those details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group trial compared standard hearing-aid orientation with three additions: a take-home guide, a take-home DVD, and a teach-back session. It identifies hearing-aid knowledge and skills at 4 weeks after fitting as the primary outcome and describes how that measure was constructed. This defines the research question and the intended outcome, but it does not supply the primary outcome results.
Because group scores and estimates are not reported, the registry record does not show whether any educational addition was associated with higher or lower test scores, how large differences might have been, or how precisely they were estimated. It also does not report the listed secondary outcome results. The absence of those data should not be interpreted as proof that groups had identical outcomes, or as evidence for or against an effect.
The endpoint concerns knowledge and performance on hearing-aid management tasks. It is not, by itself, a complete measure of hearing-aid use, satisfaction, or broader health outcomes. The record’s secondary measures address self-efficacy and reported hearing-aid outcomes, but their results are not available in the registry record. Even if the test results were available, their interpretation would depend on the magnitude and precision of group differences and on the relationship between test performance and outcomes beyond the test.
The safety entry records one serious adverse event in the informational-guide group and none in the other groups, with the event described as non-study-related. These sparse registry counts do not determine whether an intervention caused an event or establish a comparative safety profile.
Overall, the posted information supports a description of the trial design, endpoint, and recorded adverse events. It does not support a conclusion about the comparative results of the educational approaches. Statistical interpretation would require the group-level outcome data, estimates of uncertainty, and enough analysis detail to understand how the comparisons were conducted.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it compares several ways of supplementing routine hearing-aid orientation while focusing on an outcome that combines knowledge and practical task performance. The four-arm design raises a clear issue of contrast definition: a comparison of each addition with standard orientation addresses a different question from a comparison among the three additions. The registry record does not identify which contrasts were designated as primary.
The endpoint also illustrates why measurement details matter. Knowledge responses and practical skills have different scoring rules, and the record describes separate percentage calculations with a correction to equate the subscales. Interpretation of a combined or overall score would depend on how those components were handled in the analysis, a detail not reported in the registry record.
The trial has a randomized design, but randomization alone does not resolve questions about missing follow-up data, analysis populations, or multiplicity. Those details affect how confidently results can be interpreted, especially when multiple arms and outcome measures are involved. The record identifies four analyses but does not describe their relationship to the outcomes and comparisons.
Finally, the registry entry illustrates the difference between a completed trial record and a report containing interpretable effect estimates. Enrollment, design, timing, outcome definitions, and safety counts are useful context. Without primary and secondary outcome results or analysis details, however, readers cannot assess the estimated effects or their precision. That distinction is central to statistical reading: design describes how evidence was intended to be generated, while estimates and uncertainty are needed to evaluate what the data show.
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.
A major limitation of the registry record is that it does not report results for the primary Hearing Aid Skills and Knowledge Test. Group means, standard deviations, between-group estimates, confidence intervals, and p-values are absent. The secondary outcome results are also not reported. This prevents assessment of effect direction, magnitude, or precision.
The record gives limited information about trial conduct. It identifies randomization, single masking, and a parallel model, but does not specify the randomization process, allocation concealment, or who was masked. It does not provide baseline characteristics, intervention adherence, or details about delivery of the educational approaches beyond their brief descriptions.
The analysis plan is not reported. The record does not state which comparisons were prespecified, how multiple outcomes and comparisons were handled, or how the four listed analyses correspond to the outcome measures. It also does not identify the analysis population or describe missing-data methods. These omissions limit evaluation of potential bias and the interpretation of any unreported comparisons.
The primary outcome was assessed at 4 weeks after hearing-aid fitting. The registry does not describe longer-term assessment of this outcome. The test includes knowledge and task-performance components, but the group-level analysis and treatment of the components are not reported. Thus, the record does not show how the test results relate to outcomes beyond measured test performance.
Safety reporting is also limited to event counts and a listed event term; fuller event descriptions, ascertainment methods, and comparative analyses are not reported in the registry record. These limitations concern the information available in the record and do not establish that the trial itself lacked methods or analyses that were not posted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes — NCT01940705.
- Registry record last updated 2019-02-21; status last verified 2019-02.
- Results first posted 2019-02-21.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT01940705, “A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes,” is a completed randomized, single-masked, parallel-group trial sponsored by the VA Office of Research and Development. The registry lists an enrollment of 269, a start date of 2014-01-01, and a primary completion date of 2016-09-30. The condition is hearing loss.
The four groups received standard hearing-aid orientation alone or with a take-home informational guide, a take-home DVD, or a teach-back session. The primary outcome was the Hearing Aid Skills and Knowledge Test at 4 weeks after fitting, reported as mean percentage correct with standard deviation. The record also names two secondary outcomes.
Primary and secondary outcome results, detailed analysis methods, missing-data handling, and the analysis populations are not reported in the registry record. Safety entries list one serious adverse event in the informational-guide group and none in the other groups; the event is described as non-study-related.