Learning Skills Together Pilot Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Learning Skills Together Pilot Study (NCT04428034), a na na study. The primary outcome is Change in Caregiver Competency.

2. Clinical Question

3. Trial Design

Learning Skills Together Pilot Study (NCT04428034) is listed as a completed pilot study sponsored by The University of Texas Health Science Center at San Antonio. The registry record gives a start date of 2020-09-03 and a primary completion date of 2021-08-15. Enrollment is listed as 41. The phase is recorded as not applicable.

The design is single-group, with allocation recorded as not applicable and masking listed as none. Participants were assigned to the Learning Skills Together intervention in the study description; there is no control arm specified. The intervention is a synchronous, web-based educational program intended to support family caregivers in learning complex care tasks. The arm description also refers to a preparatory one-on-one phone call with an interventionist and subsequent group sessions. The available description ends before fully detailing the preparation process, so further protocol details are not reported in the registry record.

The study’s stated purpose is to evaluate feasibility and acceptability, and the likelihood of effects on caregiver self-efficacy and mastery. That purpose is distinct from establishing a comparative treatment effect. In a single-group design, changes between baseline and follow-up can be observed, but changes cannot be separated from other influences over time by comparison with a concurrent control group. The registry record does not report a protocol, a sample-size justification, or details of an analysis plan. It lists two outcome measures and no analyses.

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.

Enrollment to Intervention Completion

Reasons for not completing this period:

4-Week Follow Up Survey

8-Week Follow Up Survey

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: Baseline characteristics are described for the analysis population, which includes participants who were eligible according to initial criteria, but who also: 1) attended at least 2 program sessions and 2) completed the program in the same cohort (i.e., did not start in one cohort and complete "make up" sessions in the following cohort.

6. Primary Endpoint

The registry lists the primary outcome as Change in Caregiver Competency, measured over Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention.

The primary endpoint is change in caregiver competency, measured using the Caregiving Competence Scale. The registry record describes the scale as having three items about confidence, including confidence in meeting a relative’s needs. Each item has five response options, from Strongly Disagree, scored 1, to Strongly Agree, scored 5. The total score may range from 3 to 15. A lower score indicates less confidence; higher scores indicate greater confidence.

The specified time frame is change from baseline to 4 weeks post-intervention and to 8 weeks post-intervention. The outcome is described as using the average change score from baseline scores. Confidence is relevant to the study’s educational focus because the intervention is intended to build caregivers’ skills and confidence in providing complex care. A self-reported competency score, however, measures perceived confidence, not direct performance of care tasks. It should therefore be interpreted as an indicator of the construct measured by the scale rather than as a direct assessment of practical skill or care quality.

The registry record does not report the observed mean scores, changes, standard deviations, confidence intervals, or tests for this endpoint. The magnitude and precision of change cannot be determined from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a continuous primary outcome summarized using a mean and standard deviation. These statistics answer different questions. A mean describes the central level of a set of scores or changes. A standard deviation describes how spread out individual values are around that mean. Neither statistic alone indicates how precisely a mean has been estimated, and neither establishes that a change is attributable to the intervention.

What would a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated quantity, such as a mean change. A relatively narrow interval indicates greater precision than a relatively wide interval, given the method used. The interval must be read alongside the estimate and the scale: it conveys uncertainty about the estimated quantity, not the range of individual participants’ scores. No confidence interval for the primary endpoint is reported in the registry record, so precision cannot be assessed from that record.

What does a within-group change represent?

The stated endpoint compares scores at baseline with scores at follow-up. In a single-group study, such a comparison describes change among participants with measurements at the relevant times. It does not supply the counterfactual outcome—what would have happened to comparable participants over the same period without the intervention. A control group can support a between-group comparison, but none is identified in the registry record. Even a clearly estimated within-group change would therefore need to be distinguished from a causal effect.

The registry record describes the measure as using the average change score from baseline scores. It does not explain the statistical model, the method used to handle repeated measurements, or whether any covariates were included. These analysis details are not reported in the registry record. The record also lists no analyses, and it contains no numerical outcome estimates to recalculate. Consequently, there is no basis for an unadjusted recalculation or for assessing whether a reported analysis differs from a simple summary.

Why can over-dispersion matter?

In general, over-dispersion means that observed variation is greater than a statistical model expects. When a model assumes less variability than is present, uncertainty may be understated and tests may appear more precise than warranted. The relevance of over-dispersion depends on the outcome type and model. The primary endpoint is described as a continuous score, but the registry record does not report a model or diagnostics. It is not possible to determine whether over-dispersion was considered or whether it was relevant to any analysis.

How should planning calculations be read?

The registry record describes planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect; for time-to-event outcomes, the stated planning quantity is total events, while other outcomes use participants per arm. These are planning assumptions, not a description of this trial’s single-group design. The registry record does not report numerical planning estimates or the observed effect used for them. Such illustrations cannot be treated as observed power or as evidence that the pilot was designed with a particular precision.

A sample-size calculation is a planning aid: it depends on assumptions about the effect to detect, outcome variability, allocation, and analysis. It does not establish what a study actually observed. In particular, a hypothetical two-arm calculation does not create a control group where the registry describes a single-group study. Without the underlying numerical estimates and analysis details, no planning result can be interpreted as a finding from this trial.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures and no analyses. It gives details for the primary outcome but does not report numerical findings for it. The other outcome measure’s title, definition, results, and analysis are not reported in the registry record. It also does not report a prespecified statistical analysis plan, analysis populations, or a plan for handling missing outcome data.

Multiplicity arises when several outcomes, time points, or statistical tests are examined. In general, the more questions tested, the greater the chance of a nominally unusual result arising by chance if no adjustment or other strategy is used. Whether and how to address multiplicity depends on which outcomes and comparisons were prespecified and on the study’s goals. The registry record specifies the primary competency outcome at baseline and two follow-up times, but it does not say how those time points were handled analytically or whether any multiplicity strategy was planned.

Missing data can affect both the number of observations contributing to an estimate and the interpretation of that estimate. If participants with unavailable follow-up scores differ from those with observed scores, a complete-case summary may not represent the full enrolled group. General approaches include describing the extent and pattern of missingness, stating the analysis population, and explaining any imputation or sensitivity analyses. The registry record does not report follow-up completeness, reasons for missing data, exclusions, imputation, or sensitivity analyses. These omissions prevent assessment of how missing outcome information may have affected the results.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

For the Learning Skills Together Intervention group, the registry record lists 35 participants at risk and 0 affected for serious adverse events. It lists 35 at risk and 3 affected for other adverse events, and records 1 death. These are registry counts, not estimates of comparative risk. The study is single-group, and the record does not identify a control group against which to compare them.

The record lists no terms under the serious adverse event terms. It does not provide event descriptions, timing, severity details beyond the registry categories, or an assessment of whether events were caused by the intervention. The death count is recorded, but its cause and relationship to study participation are not reported in the registry record. The counts should therefore be read descriptively, without attributing events to the intervention or treating the absence of a serious event in the affected count as proof that no safety concerns exist. The registry record does not explain why the at-risk counts differ from the enrollment listing.

12. What the Result Does, and Does Not, Mean

The study is a pilot evaluation of a synchronous web-based caregiver education program, with caregiver competency identified as the primary outcome. Its measure focuses on confidence in meeting a relative’s needs, and the registry defines higher scores as better. The record specifies assessments of change from baseline to 4 weeks post-intervention and to 8 weeks post-intervention. These details clarify what the outcome was intended to capture and when it was to be assessed.

However, the registry record does not report the numerical competency results or any statistical analyses. It therefore does not establish whether scores increased, decreased, or remained similar, nor does it show how precisely any change was estimated. The intervention’s stated goals and the scale’s direction do not substitute for outcome results. The record also does not provide numerical findings for feasibility, acceptability, self-efficacy, or mastery.

Even if within-group changes were available, this study’s design would not by itself establish that the intervention caused them. A single-group assessment has no concurrent control comparison to help distinguish intervention-associated change from other influences. The record also does not report an analysis plan, missing-data handling, or outcome completeness, all of which would be relevant to judging the robustness of results.

The safety entries can be described as recorded counts, but they do not establish causation or comparative safety. Details and causal assessments are not reported in the registry record. Thus, the record is informative about the intervention’s intended population, structure, and primary measure, but does not support a conclusion about the intervention’s effect or the certainty of an effect.

13. Why This Trial Matters Statistically

Pilot studies can be statistically useful because they examine whether an intervention and its evaluation procedures can be carried out and can help identify what information a later study would need. Learning Skills Together was explicitly framed as a pilot evaluation, with aims involving feasibility, acceptability, and the likelihood of effects on caregiver self-efficacy and mastery. That context matters: a pilot’s aims are not the same as a definitive test of comparative effectiveness.

The registry record also illustrates why outcome definitions and results need to be considered together. The primary measure is a confidence-focused scale, with higher values representing greater confidence. That definition helps interpret the intended direction of a score, but no observed scores or estimates are reported. Without results, readers cannot assess the amount of variability, the uncertainty around change, or whether follow-up information was sufficiently complete to support a stable estimate.

Design is equally important. A single-group study can describe what happened to measured participants over time, but it cannot make the same comparative inference as a randomized controlled study. This distinction is especially important when the study’s stated purpose includes assessing the likelihood of an effect. An observed change, if reported, would be a signal to investigate, not by itself proof of a causal effect.

The registry record’s incomplete analysis and outcome reporting also shows why transparency about methods matters. Information about prespecified analyses, missing data, and the interpretation of safety events helps readers distinguish measured findings from uncertainty. Here, those details are not reported in the registry record. The study remains statistically relevant as a pilot design with a defined caregiver competency measure, while the absence of numerical outcome results limits what can be concluded from the registry entry.

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 direct limitation for interpreting the registry record is that it contains no numerical results for the primary competency outcome and lists no analyses. The record therefore does not allow readers to assess the observed change, its variability, or its precision. Although two outcome measures are listed, details and results for the other measure are not reported in the registry record.

The single-group design does not provide a concurrent control comparison. Any change observed over time could reflect influences other than the intervention, and the design cannot isolate the intervention’s causal contribution. The allocation is listed as not applicable and masking as none; no masked assessment procedure is described in the registry record.

The outcome is based on a self-report measure of confidence. It addresses caregivers’ perceptions of meeting a relative’s needs, not direct observation of complex care performance. The registry record does not report evidence about the scale’s performance in this study or whether changes in score corresponded to changes in practical skill.

Important reporting details are also absent: follow-up completeness, missing-data handling, analysis populations, a statistical analysis plan, and numerical feasibility or acceptability findings. The intervention description is incomplete in the registry record, limiting detail about how the program was delivered. Safety counts are listed without event descriptions or causal assessments. These limitations constrain interpretation of both outcome and safety information and prevent conclusions about efficacy or attribution.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Learning Skills Together Pilot Study — NCT04428034.
• Registry record last updated 2023-03-21; status last verified 2023-03.
• Results first posted 2022-03-04.
• 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.

18. Record Summary

NCT04428034 is a completed, single-group pilot study of Learning Skills Together, a synchronous web-based educational intervention for caregivers of people living with mid-stage Alzheimer’s disease. Enrollment is listed as 41. The primary outcome is change in caregiver competency on the Caregiving Competence Scale, assessed from baseline to 4 weeks post-intervention and to 8 weeks post-intervention. Higher scores indicate greater confidence.

The registry record lists two outcome measures and no analyses. It does not report numerical results for caregiver competency, confidence intervals, or analysis details. It also records safety counts for serious adverse events, other adverse events, and deaths, without event descriptions or causal assessments. The design permits description of change within the intervention group but has no control comparison. The registry record therefore describes the study and its intended endpoint, but does not provide enough outcome information to assess the magnitude or precision of change.