Caregiving While Black: LIVE: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Caregiving While Black: LIVE (NCT06605391), a na na study. The primary outcome is Health Literacy Questionnaire (HLQ) Score for Feeling Understood by Healthcare Providers Subscale.

2. Clinical Question

3. Trial Design

Caregiving While Black: LIVE is a completed, single-group study sponsored by Emory University. The registry lists an enrollment of 40 and identifies dementia as the condition. The intervention is classified as behavioral. Its arm description says Black dementia caregivers participated in the psychoeducation course over an 8 week time period.

The record lists allocation as not applicable and masking as none. With a single group and no separate control arm, this design does not make a randomized, like-for-like comparison between people offered the course and a control group. Assessments at different times can describe the observed course of scores among those assessed, but a change over time in a single group does not by itself establish that the intervention caused that change.

The primary outcome is scheduled at baseline, Month 3 and Month 6. These are the assessment time points listed for the Health Literacy Questionnaire subscale; the registry does not report the actual score at any time point, the number assessed at each time point, or a statistical comparison between time points. The record also lists 15 outcome measures, but does not provide results for the primary outcome in the information available for this analysis.

The study is marked completed. Its listed start date is 2024-10-01, and its listed primary completion date is 2025-08-12. Completion status describes the registry's study status; it does not establish that outcome data or statistical results were posted. The record lists zero analyses, so no inferential analysis is available to assess the primary question.

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

Analysis population for the primary outcome, as defined in the registry: This analysis includes participants who completed study assessment at the indicated time points.

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.

6. Primary Endpoint

The registry lists the primary outcome as Health Literacy Questionnaire (HLQ) Score for Feeling Understood by Healthcare Providers Subscale, measured over Baseline, Month 3, Month 6.

The primary endpoint is the Health Literacy Questionnaire score for the subscale concerning feeling understood and supported by healthcare providers. The questionnaire assesses multiple dimensions of health literacy using 9 subscales. This subscale has 4 items, each answered on a 4-point scale from strongly disagree, scored as 1, to strongly agree, scored as 4. The reported score is the average of responses and ranges from 1 to 4. Higher scores indicate that this dimension is an area of health literacy strength.

The endpoint focuses on caregivers' reported experience of communication and support from healthcare providers, a dimension relevant to the course's stated emphasis on navigating care and the healthcare system. A subscale score offers a defined way to summarize responses to the items addressing that dimension. Its bounded scale also means that any interpretation should keep the possible score range and the meaning of higher values in view.

The planned assessment times are baseline, Month 3 and Month 6. The record does not report observed means, standard deviations, changes, confidence intervals or test results for these assessments. It therefore does not show whether scores changed, how large any change was, or how precisely an estimate was measured.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous score summarized in the registry as a mean with standard deviation. A mean describes the average score among the participants included at a specified assessment time. A standard deviation describes how spread out individual scores are around that mean. They answer different questions: the mean locates the group average, while the standard deviation describes variation among scores. Neither is reported for the primary endpoint in the registry record.

What does the score represent?

The subscale averages responses to 4 items on a 4-point response scale. Its total score ranges from 1 to 4, and higher scores indicate that feeling understood and supported by healthcare providers is an area of health literacy strength. Because the score is bounded, its possible values are constrained rather than extending indefinitely. As a general statistical point, the scale's boundaries and the pattern of individual responses can matter when interpreting an average and its spread. The registry does not report the response distributions, item-level data or score summaries needed to examine those features.

How would repeated assessments be interpreted?

Assessments are listed at baseline, Month 3 and Month 6. In general, repeated measurements can be described by reporting the mean and spread at each time point, and by estimating within-person change when the same participants contribute measurements at more than one time. The distinction matters: separate time-point averages describe the groups assessed at each time, while a within-person change uses paired observations from participants assessed at both times. The registry record does not report which statistical approach, if any, was used, nor does it provide paired data or estimated changes.

For a within-person analysis, the amount of information depends on which participants have measurements at the relevant times and on the variability of their changes. A model for repeated measurements may also account for the fact that observations from the same person are related. These are general methodological considerations, not a description of an analysis documented in this registry. No repeated-measures model or other statistical method is reported.

What do uncertainty estimates add?

A confidence interval is a statistical range expressing uncertainty around an estimate under the assumptions of the method used. A narrow interval generally indicates greater precision than a wide interval, although precision is not the same as importance or causality. A p-value, when reported, addresses compatibility between data and a specified null hypothesis under an analysis; it does not measure the size or practical meaning of an effect. The registry record reports neither confidence intervals nor p-values for the primary outcome. It is therefore not possible to evaluate statistical precision or evidence against a null hypothesis from the posted information.

Means and standard deviations alone would not establish that a difference between time points is statistically supported. The uncertainty of a change estimate also depends on the analysis and, for paired observations, the relationship between measurements within a participant. Those details and results are not reported. No calculation from the group size or scale description can replace an outcome estimate or its uncertainty.

What role does the design play?

With one study group, the primary endpoint can describe participants' scores over time, if those results are posted. It cannot provide a direct randomized contrast with a separate control group. General causal reasoning distinguishes observing a change after an intervention from estimating what would have happened to the same population without it. A single-group time pattern does not supply that counterfactual comparison. The registry's allocation entry is not applicable, and the record lists no comparator arm.

The registry also describes sample-size illustrations as planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. These are planning assumptions, not the study's design: the actual record describes a single group. The illustration values and the observed effect are not reported in the registry record. Such hypothetical planning quantities would not be observed power and would not substitute for the study's missing endpoint results.

The record identifies the primary outcome as a mean with standard deviation, but does not state the statistical model, test, significance threshold for the primary analysis, handling of missing observations, or any adjustment for multiple outcomes. These methods are not reported in the registry record. The statistical interpretation must therefore remain descriptive about the design and cautious about results: no numerical estimate of the primary outcome is available to interpret.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 15 outcome measures, while the primary measure described in this record is the Health Literacy Questionnaire subscale for feeling understood and supported by healthcare providers. Considering multiple outcomes or multiple time-point comparisons can raise a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently notable result can increase. As a general statistical principle, a prespecified analysis plan may identify which outcomes and comparisons are primary and whether any adjustment is intended. The registry record does not report a multiplicity strategy or explain how the other outcome measures relate to the primary endpoint.

There are zero analyses listed, and the record does not report primary outcome estimates or test results. It is therefore not possible to tell whether any multiplicity adjustment was used in an analysis outside the registry record. No claim about statistical significance across outcomes or time points can be made from the listed information.

The primary outcome description says the analysis includes participants who completed study assessments at the indicated time points. The number assessed at each time point and the amount or pattern of missing data are not reported in the registry record. The record does not describe imputation, a missing-data model, sensitivity analyses, or any other approach for handling absent assessments. In general, missingness can affect how representative the observed scores are of all enrolled participants, particularly if completion is related to participants' experiences or scores. Whether that concern applies in this study cannot be assessed from the information recorded.

The registry does not state a broader analysis population, such as whether analyses were planned for everyone enrolled or only for those with particular assessment records. The endpoint description identifies assessment completion at the indicated times as relevant to inclusion, but it does not provide counts or a complete analysis-population definition. These details are not reported in the registry record.

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 0% reporting threshold.

The registry reports zero serious adverse events among 40 participants at risk in the Caregiving While Black-LIVE group. It also reports zero other adverse events among 40 participants at risk, and zero deaths. No serious adverse event terms are listed. These are the recorded counts for the group and categories in the registry; they are not estimates of comparative risk because there is no separate control group.

Counts of zero mean that the registry lists no events in those categories for the stated at-risk group. They do not establish that an event is impossible or that no unrecorded event occurred. The record does not provide event narratives, follow-up completeness, or a comparison with another group. The at-risk count is listed as 40 for both serious and other adverse events, but these categories should be read as separate registry fields rather than combined into a new total.

These safety figures should be kept distinct from the primary health-literacy endpoint. They do not indicate whether that score changed, and they do not provide an estimate of the course's effect on the endpoint. The registry's serious adverse event and other adverse event counts are descriptive safety information only.

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

The record establishes that a completed, single-group study evaluated a psychoeducation course for Black caregivers of people with dementia. It identifies a primary health-literacy subscale, describes how its score is formed, and lists assessment at baseline, Month 3 and Month 6. It also records enrollment of 40 and reports zero serious adverse events, zero other adverse events and zero deaths in the intervention group.

It does not report the primary scores, changes over time, statistical estimates or uncertainty. As a result, the posted registry information does not show whether participants' scores were higher, lower or similar at later assessments. It cannot establish the size or precision of a change, or whether any observed change would be attributable to the course.

The absence of a separate control group limits causal interpretation even if within-group outcome values were available. In general, a change measured over time can reflect the intervention as well as other influences that occur during the same period. A randomized comparison can help separate those influences; the record does not describe one for this study.

The course's stated purpose is to support caregivers in coping with caregiving and navigating care in light of social and cultural context. That purpose describes the intervention's aim, not an outcome demonstrated by the registry results. The record does not establish whether the course achieved that aim or whether participants experienced a meaningful change in health literacy.

Thus, the study record is useful for understanding the intervention, population, design and intended endpoint, but it does not provide the outcome evidence needed to judge the primary question. Its completed status and safety counts should not be treated as a substitute for missing efficacy results.

13. Why This Trial Matters Statistically

This study addresses a population and caregiving context explicitly described in its registry record: Black caregivers supporting people with dementia, and their navigation of care and healthcare. Its primary measure focuses on whether caregivers feel understood and supported by healthcare providers. Statistically, the measure connects a defined set of questionnaire responses to a specific dimension of health literacy rather than treating health literacy as a single undifferentiated concept.

The assessment schedule also makes the distinction between measurement and evidence important. Baseline, Month 3 and Month 6 identify when the subscale was intended to be assessed. Without the corresponding scores, completion counts and analysis, the schedule alone cannot establish a pattern or indicate how precise a result might be. This illustrates why a registry's intervention description and outcome definition should be read separately from its reported findings.

The single-group design is central to interpretation. It can describe outcomes among assessed participants over time, but it does not offer a concurrent control comparison. General statistical reasoning therefore cautions against treating a change as an intervention effect without an appropriate comparison and clear analysis. This distinction matters particularly when a study's stated aim is meaningful but the available record does not show numerical results.

The record also lists multiple outcome measures, while identifying one primary endpoint. Prespecifying how primary and other outcomes are analyzed can help readers understand which questions guide inference and how multiplicity is addressed. That statistical plan is not reported in the registry record. The study consequently highlights the value of transparent outcome reporting: endpoint definitions, time-point summaries, participant counts, uncertainty estimates and analysis methods are all needed to evaluate what the data support.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation of the available registry record is that it does not report results for the primary endpoint. There are no score means or standard deviations at baseline, Month 3 or Month 6, and no estimate of change or uncertainty. The record lists 15 outcome measures but zero analyses, leaving no posted inferential results to evaluate.

The study has a single-group design and no separate comparator. Any reported time pattern would therefore be descriptive of the assessed participants and would not, by itself, establish that the course caused a change. The registry does not report a statistical model or test that could clarify how repeated assessments were analyzed.

The outcome description restricts the analysis to participants who completed assessments at the indicated time points, but the record does not report the number assessed at each time or the extent and pattern of missing data. It also does not state how missing assessments were handled. This leaves uncertainty about the information available at each time point and the relevance of the observed participants to those enrolled.

The record does not report a statistical analysis plan, multiplicity approach, confidence intervals, p-values or sensitivity analyses. It also does not provide response distributions or item-level results for the health-literacy subscale. These omissions limit assessment of precision, robustness and the interpretation of the bounded scale. The available information supports a description of the study design and intended endpoint, but not a conclusion about the primary outcome.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Caregiving While Black: LIVE — NCT06605391.
• Registry record last updated 2025-09-23; status last verified 2025-09.
• Results first posted 2025-09-23.
• 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

Caregiving While Black: LIVE is a completed, single-group behavioral study sponsored by Emory University. The registry lists enrollment of 40 and describes an 8 week psychoeducation course for Black caregivers of people with dementia. There is no separate comparator group.

The primary endpoint is the Health Literacy Questionnaire subscale for feeling understood and supported by healthcare providers, assessed at baseline, Month 3 and Month 6. Its score ranges from 1 to 4, with higher scores indicating a health-literacy strength in this area. The record lists 15 outcome measures and zero analyses.

Primary outcome values, analysis methods, missing-data handling and multiplicity procedures are not reported in the registry record. The registry reports zero serious adverse events, zero other adverse events and zero deaths in the intervention group, with 40 at risk for each adverse-event category.